Pfizer

Skin & localized to injection site symptom reports

Female, 76 - 89 years

Age Reported Symptoms Notes
76 2021-01-07 vaccination site pain Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Em... Read more
Arm soreness / soreness in the arm and shoulder; Arm soreness / soreness in the arm and shoulder; Emesis; Nausea; This is a spontaneous report from a contactable nurse. This nurse reported different events for 6 patients. This is the sixth of the six reports. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiration date not provided) via an unspecified route of administration on 29Dec2020 at a single does in the left arm for COVID-19 immunization. Medical history included dementia from 10Mar2020 and ongoing. The patient's concomitant medications were not reported. The patient experienced arm soreness (soreness in the arm and shoulder), emesis and nausea on 01Jan2021. The patient received paracetamol (TYLENOL) for the soreness, nothing for the emesis and nausea. The events were all resolved on 01Jan2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021006274 same reporter/ drug , different patient /AE.
76 2021-01-14 itchy skin Mild itching throughout different parts of the body; This is a spontaneous report received from a co... Read more
Mild itching throughout different parts of the body; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: El3246), via an unspecified route of administration in left arm, on 07Jan2021 11:15 at single dose, for COVID-19 immunization, in a public health facility. Medical history included mitral valve prolapse, glaucoma, and allergy to strawberry. The patient is not pregnant. Concomitant medication included latanoprost; estradiol, norethisterone acetate (MIMVEY); multivitamins; and ergocalciferol (VIT D). The patient did not receive any vaccine within 4 weeks prior to COVID vaccine. The patient experienced mild itching throughout different parts of the body beginning on day 2, 09Jan2021 10:00, and continuing on day 5. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.
76 2021-01-17 cellulitis Fatigue, Chills, Low grade fever, Muscle aches. Resident also developed cellulitis to lower portion ... Read more
Fatigue, Chills, Low grade fever, Muscle aches. Resident also developed cellulitis to lower portion of arm in which vaccine was administered within 24 hours or less of receiving vaccine and had no previous indication of abnormalities to arm or s/s of infection to arm.
76 2021-01-17 shingles pt. noticed "shingles" outbreak starting after taking the vaccination - pt. uncertain if she should ... Read more
pt. noticed "shingles" outbreak starting after taking the vaccination - pt. uncertain if she should take acyclovir which has proven beneficial in past states physician not giving her confidence regarding take/do not take medication after vaccination due to limited data
76 2021-01-17 injection site pain Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . ... Read more
Sluggish feeling on 1/16/2021; extreme thirst chills, gassy, loose bowel movement - caramel color . Injection site soreness; today 1/18/21 slight headache - Tylenol dose, headache now subsiding; all other symptoms have resolved.
76 2021-01-19 itchy skin Lowered body temperature 30 min after dose, left hand began to itch approx. 45 minutes, both hands i... Read more
Lowered body temperature 30 min after dose, left hand began to itch approx. 45 minutes, both hands itching & swelling, then feet within hour. Total lose of vision within 90 min followed by fainting approx 10 minutes later. Fainted at check-in desk of emergency room
76 2021-01-20 rash with redness, itchy rash, skin warm A very itchy red hot rash on my right side of my back. Very hot red and lasted about 1 hour. I put... Read more
A very itchy red hot rash on my right side of my back. Very hot red and lasted about 1 hour. I put Fluocinolone Acetonide topical solution USP 0.01% on my right side from the neck down to bottom of back (only right side).
76 2021-01-21 bruising One day after receiving the vaccine, I developed a deep purple/blue bruise that extends from an inch... Read more
One day after receiving the vaccine, I developed a deep purple/blue bruise that extends from an inch above the injection site (shoulder of left arm) and extends to my elbow. It is 4 inches wide.
76 2021-01-21 rash papular, hives, redness Approximately 1 hour after the shot, I raised a hive on my upper lip. It very quickly (within 2 min... Read more
Approximately 1 hour after the shot, I raised a hive on my upper lip. It very quickly (within 2 minutes) got to its maximum size. Not noticeably swollen to an observer, but it felt swollen, red and throbbing. It was not a serious adverse reaction. After about an hour, it was NOT going away, but it was NOT getting worse. I never experienced trouble breathing. The office where I had the shot is "not available" on Friday afternoon, and my personal physician is not in the office on Friday. I was advised by another doctor friend to take benadryl, which I did. While looking at the CDC website, he also advised me that (having had this reaction) I should not receive the second shot.
76 2021-01-21 hives, itchy skin Four hrs. after getting the vaccine. My face started itching, could feel welts under the skin. Swe... Read more
Four hrs. after getting the vaccine. My face started itching, could feel welts under the skin. Swelling of the right side of my face started within a few hours later. Called Drs. , He recommended taking Tylenol. (Second Day) Next day, felt short of breath, weak, applied ice packs to my face. Third day, felt weak. By the fourth day, swelling and itching subsided; but skin on my face felt gritty under the skin. Drove me to the doctor's office the third day. I was short of breath walking from the car to the door to the doctor's office. I was wearing my mask. I saw a PA; but, she didn't tell me much of anything. I don't think she knew what to say.
76 2021-01-22 injection site pain Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Sever... Read more
Severe chills/tremors.....my entire body was shaking/spasming. It shook my bed and woke me up. Severe sore arm at injection site.
76 2021-01-23 injection site pain injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lou... Read more
injection site pain/arm hurts tiredness headache slight muscle pain/joint pain ***nausea feeling lousy arm feels like its blown up but doesn't look like it is
76 2021-01-24 blister, dry skin, redness RED, BLISTER TOP SORE. USED HYDROCORTISONE WITH NO CHANGE F0R 3 DAYS, NOW NO BLISTER, BUT SKIN STI... Read more
RED, BLISTER TOP SORE. USED HYDROCORTISONE WITH NO CHANGE F0R 3 DAYS, NOW NO BLISTER, BUT SKIN STILL RED AND DRY
76 2021-01-24 injection site warmth, injection site redness, injection site pain, injection site rash Late in the day of the shot on 01/21/2021, site on arm began to hurt and got worse in the increasing... Read more
Late in the day of the shot on 01/21/2021, site on arm began to hurt and got worse in the increasing 2 days. Red very warm rash began at the injection site and spread to the size of a soft ball. Today, 01/25, the site is still red and swollen but not as poinful. Temperature is normal. Along with the affected infection site from 01/21, had a series of fevers ranging from 99.9 - 100.9. Usual body temperature is 97.6. Along with this, severe body aches, fatigue, malaise, deep depression and bed stay for 2 1/2 days. Took Tylenol. Today, 01/25/21 at 11:27AM, temperature is 98.3.
76 2021-01-25 skin warm Patient vaccinated at 1215. Reaction began at 1250. Pt was told she would be observed for 30 minute... Read more
Patient vaccinated at 1215. Reaction began at 1250. Pt was told she would be observed for 30 minutes due to previous history of a reaction to the typhoid vaccine. After 30 minute observation patient stated she was light headed, dizzy, warm, and nauseous. Nausea subsided at 1325. Stated she was still dizzy at 1335 and stated her throat started to feel scratchy and difficult to swallow. Rapid Response called and patient evaluated. Patient transported to ED for further evaluation.
76 2021-01-25 vaccination site swelling Once the pt sat in the chair she began putting tension on her muscle. I asked the pt several time to... Read more
Once the pt sat in the chair she began putting tension on her muscle. I asked the pt several time to relax, I believe she was relaxed at the time of administer the pt again began place tension on the deltoid muscle, after retracting the vaccine needle the site started to swell. I then place a cold compression on the vaccine site and asked the on site physician to assets the site. The patient was place under observation for 20min and she reported feeling better and asked to leave.
76 2021-01-25 vaccination site warmth, vaccination site pain, vaccination site swelling Diarrhea; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection si... Read more
Diarrhea; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Swollen, very sore, hot arm by injection site; Fever; Very tired; Achy; Headache; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on left arm at 02:00 AM on 10Jan2021 at single dose for COVID-19 immunization. Medical history included thyroid disorder, reflux, elevated blood pressure and elevated cholesterol. Concomitant medication included lamotrigine, buspirone, levothyroxine sodium (SYNTHROID), liothyronine sodium (CYTOMEL) and others. The patient previously took compazine and experienced drug allergy. The patient experienced swollen, very sore, hot arm by injection site. Fever. Very tired. Achy. Headache at 05:00 PM on 10Jan2021. 3-30 hours after injection. Diarrhea (more than 6 times) 44 hours after injection and ongoing on 11Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any treatment for events. The outcome of events was recovering. Information on the Lot/Batch number has been requested.
76 2021-01-26 injection site bleeding Patient stated she had a moderate amount of bleeding out the injection site and a small amount of fl... Read more
Patient stated she had a moderate amount of bleeding out the injection site and a small amount of fluid drainage. Client denies any other symptoms and/or signs of infection. Injection site inspected and was clean with no signs of infection /discomfort.
76 2021-01-26 injection site pain Day 1 moderate to severe pain at site and headache treated with Acetaminophen. Extreme sleepiness fo... Read more
Day 1 moderate to severe pain at site and headache treated with Acetaminophen. Extreme sleepiness for 48 hours and slept for most of the day. 2nd Day pain at site and headache continued. Treated with Acetaminophen. Extreme sleepiness slept for most of the day. Sore throat,cough and nasal congestion and drip, and metallic taste in mouth. Loss of appetite. Loss of hearing and appetite. I woke up at night at 1:00 a.m. with severe nasal discharge and had to sit upright for 2 hours till it abated a little. Day 3 Pain at site continued as did nasal congestion and discharge. Loss of appetite and hearing also continued. I still have nasal congestion and discharge on my 3rd week and also the loss of appetite and hearing loss. The loss of hearing has improved very minutely.
76 2021-01-26 injection site rash, injection site redness, injection site pain possible "covid arm": 3 inch diameter red spot (rash?) at injection site; mild arm pain down to elbo... Read more
possible "covid arm": 3 inch diameter red spot (rash?) at injection site; mild arm pain down to elbow Rash did not appear until almost week 2 after injection.
76 2021-01-26 rash 1/23/2021 extreme vertigo at 10:00 AM lasting aabout 2 minutes 1/25/2021 at 4:00AM woke out of a ... Read more
1/23/2021 extreme vertigo at 10:00 AM lasting aabout 2 minutes 1/25/2021 at 4:00AM woke out of a sound sleep with strange sensation of spinning. dlosed eyes tights and fell back asleep That morning upon waking at 6:00 AM and getting out of bed, I could not walk and I was extremely dizzy. I made myself get up and all i could do was stumble. Had to hold on to wall. could not put one foot in front of the other. My head felt very heavy like it wasnt attached right..... after Deep breathing and other calming techiques during the day, I was able to walk straight. Tues 1/26/2021 I contacted my Doctor and told him my story. 1/27/2021 I developed a rash across my nose and cheeks which is today.
76 2021-01-26 rash Rash and severe swelling of the face, Hands and throat. Given intravenous benedryl, Pepcid, Ativan, ... Read more
Rash and severe swelling of the face, Hands and throat. Given intravenous benedryl, Pepcid, Ativan, Prednisone
76 2021-01-27 itchy skin, hives Hives in random places over body. Started 8 days after original shot. Started with itching. When I w... Read more
Hives in random places over body. Started 8 days after original shot. Started with itching. When I would scratch, hives would appear. After 2 days of intense itching, took an antihistamine. This stopped the itching. Took it for two days and itching has not returned.
76 2021-01-27 itchy skin itching, primarily arms and trunk; more noticeable in the evening; from 1/25 through today, 1/28
76 2021-01-27 rash with redness 1. Dry red rash over both legs, torso, chest and back. 2. Elevated liver enzyme values for ALP (2... Read more
1. Dry red rash over both legs, torso, chest and back. 2. Elevated liver enzyme values for ALP (289.00), AST (115.00), and ALT (168.0).
76 2021-01-27 skin warm, rash maculo-papular, rash Back felt hot, had small red macules. Received 2 doses of Benadryl 25 mg and macules turned to pink ... Read more
Back felt hot, had small red macules. Received 2 doses of Benadryl 25 mg and macules turned to pink color. Left for home.
76 2021-01-27 vaccination site discomfort, vaccination site pain slight discomfort at the site of injection; occasional soreness at the site of injection; This is a ... Read more
slight discomfort at the site of injection; occasional soreness at the site of injection; This is a spontaneous report from a contactable physician reporting for herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in left arm on 22Dec2020 12:00 at single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin, calcium, ibuprofen, estrogens conjugated (PREMARIN), ergocalciferol (VIT D) and multivit (as reported). The patient was not pregnant. For vaccine dose 1, it was reported that the patient experienced slight discomfort at the site of injection and occasional soreness at the site of injection over on 22Dec2020. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date. The facility where the most recent COVID-19 vaccine was administered was in the Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
76 2021-01-28 redness Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I tol... Read more
Took shot 1/20 and asked the RN if I should take it because I explained I just got over covid, I told her I wasn?t sure how long it was on Dec 19 I was raking leaves and I thought I should do this because I started having runny nose. I didn?t feel well that afternoon sneezing because I thought it was nothing. As the week went on I started sneezing and coughing and stopped up nose. I always end up with sinus infection when I get a cold Dec 28 I went to the doctor at doctors care and they did a covid test before the doctor would see I tested positive. I went home and rested, no energy, felt like I was hit by a train, couldn?t breathe, sneezed a lot and hardly coughed. January 1, I called ambulance and went to hospital, I was sick the first week of January. I didn?t know that you should wait 90 days to get the vaccine after you?ve had Covid. After I got the vaccination the adverse reaction, I woke up during the night with my arm hurting bad and throbbing and a very large red circle appeared on my arm 2? in diameter. The next 3 days I felt like I had covid all over again, the 4th day I woke up and felt a little better and got out of bed and started making progress each day. Now I?m not good, but I?m ok.
76 2021-01-28 rash, itchy skin A rash on my right arm (got the vaccine in my left arm) from my wrist to elbow. The rash had 3 rai... Read more
A rash on my right arm (got the vaccine in my left arm) from my wrist to elbow. The rash had 3 raised bumps and was swollen. It was not painful but was itchy. It went away in a couple of days. I did not take anything for it but did put Cletrimazole and Betamethasone Dipropionaate cream on it.
76 2021-01-28 vaccination site redness Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 o... Read more
Sore arm; mild nausea; mild headache; low grade fever; an odd red mark on my left shoulder about 2 or 3 inches from the injection site; This is a spontaneous report from a contactable consumer (reporting for herself). A non-pregnant 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EK9231), via an unspecified route of administration in the left arm on to 14Jan2021 07:15 at a single dose for COVID-19 immunization. Medical history included asthma, chronic obstructive pulmonary disease (COPD), known allergies: animals. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), montelukast sodium (SINGULAIR), lorazepam (ATIVAN), biotin (MANUFACTURER UNKNOWN), calcium (MANUFACTURER UNKNOWN). The patient previously received a typhoid shot (MANUFACTURER UNKNOWN), for immunization and had very adverse reaction to third typhoid shot. The patient experienced sore arm, mild nausea, mild headache and low-grade fever and an odd red mark on left shoulder about 2 or 3 inches from the injection site on 14Jan2021 21:00. No treatment was received for the events. The outcome of the events was recovering.
76 2021-01-31 injection site swelling, injection site redness Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild
76 2021-01-31 hives Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is... Read more
Chest tightness; hives on the side of her neck; scratchiness in throat; gums were throbbing; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EJ1686, Expire Date: 30Mar2021), intramuscular at Deltoid Left on 15Jan2021 11:08 at the 76 years old at 0.3 mL, single for COVID-19 immunization. The patient medical history included allergies issues with shellfish (allergic reactions), hyperlipidemia and hypertension. The concomitant medications were none. There was no additional vaccines administered on same date of the suspect. The patient was experienced for over 20 minutes with no side effects. After she left on an hour after administration (15Jan2021 12:08), she started feeling scratchiness in throat, her gums were throbbing and chest tightness. She did say she didn't take any Benadryl. She didn't have airway issues, but she did have hives on the side of her neck on 15Jan2021 12:08. She got the shot on 15Jan2021. The side effects started shortly after she left on an hour after administration. Her symptoms were relieved by 15Jan2021 21:30, and she got the shot at 11:08 am. The patient had allergic reactions in the past. She knew what to expect. She got the shot in her Left Deltoid. The reporter had a gut feeling she didn't need to get the second dose. The reporter assessed all the events were not serious. She did not require medical intervention. She did not go to the Emergency room or Physician Office. The patient was not hospitalized, or in the ICU. The Causality was not provided by the reporter. The outcome of the events was recovered on 15Jan2021 21:30.
76 2021-01-31 vaccination site pain had a little pain in her arm/ little pain in her arm where they gave the shot; This is a spontaneous... Read more
had a little pain in her arm/ little pain in her arm where they gave the shot; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL8982), intramuscular on 18Jan2021 (unspecified time, 13:15 or 13:30) at single dose on left arm for COVID-19 immunization (prevent COVID). Medical history included none. There were no concomitant medications. The patient experienced had a little pain in her arm/ little pain in her arm where they gave the shot on 18Jan2021. She received her first shot today and is "set up" for the second. She waited for 15 minutes after receiving vaccine and left the facility at 13:50. She had a little pain in her arm where they gave the shot and the patient asked if the pain gets worse can she take Ibuprofen? Her doctor told her she could take Ibuprofen everyday if she has pain, but she just wasn't sure if it was ok after the vaccine. Her left arm pain is not bad right now, she is more concerned if she can take ibuprofen if it gets worse. She does not take medicine just because. The outcome of the event was unknown. The event was assessed as non-serious. No additional vaccines administered on same date of the Pfizer. No AEs required a visit to emergency room or physician office. No prior vaccinations (within 4 weeks). No AEs following prior vaccinations.
76 2021-01-31 vaccination site swelling, vaccination site itchiness, vaccination site redness red swollen arm at injection site; red swollen arm at injection site; red swollen arm at injection s... Read more
red swollen arm at injection site; red swollen arm at injection site; red swollen arm at injection site, became itchy lasted 1 week.; elevated temperature; body weakness; severe headache for 3 days; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient (no pregnancy) received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine, lot number: EL3246), via an unspecified route of administration at site of left arm at 11:00 on 09Jan2021 at single dose for covid-19 immunization. Medical history included lung cancer, chronic obstructive pulmonary disease (COPD), atrial Fib, hypertension and COVID. The patient's concomitant medications were not reported. The patient experienced red swollen arm at injection site, became itchy lasted 1 week. elevated temperature, body weakness, severe headache for 3 days, all occurred at 05:00 on 10Jan2021. Facility type vaccine was Doctor's office/urgent care. No other vaccine received in four weeks. Other medications received in two weeks. Adverse reactions did not result any serious consequences. No treatment received for adverse event. No COVID tested post vaccination. No known allergies. The outcome of events was recovered in Jan2021.
76 2021-02-01 injection site warmth, injection site pruritus Fatigue injection site warm, itch Headache
76 2021-02-02 injection site redness, injection site swelling, injection site pain A fever of 102.5, chills, body aches, swelling, tenderness & redness on left arm- lymphedema
76 2021-02-02 itchy skin, rash Reaction on dorsal side of right wrist: what appeared to be tiny red pin pricks over an area of a... Read more
Reaction on dorsal side of right wrist: what appeared to be tiny red pin pricks over an area of about 1.5?x2? was observed at night of injection date. I applied Hydrocortisone cream USP, 2.5% to area and bandaged that night, and the next morning it appeared to be a rash. Reapplied ointment and rebandaged after shower every morning since then, through today 2/3/2021 It appears to be itching her and causing her to scratch until ointment is applied. No improvement so far.
76 2021-02-03 injection site redness, injection site pruritus, vaccination site swelling Vaccination site is raised, red and itchy. No treatment.
76 2021-02-03 injection site pain I received this shot on Jan 30 and have been sick ever since. I Threw up for several days and and st... Read more
I received this shot on Jan 30 and have been sick ever since. I Threw up for several days and and still sick to the stomach. I had severe diarrhea and my bowels are still messed up- they are light yellow verging on white. I have been having migraines and am very weak and shaky. Pain at injection site is trivial. Pain through out my body is not. I am often dizzy.
76 2021-02-03 injection site pain Within 15-minutes of vaccination, the patient reported arm soreness and pain at the injection site. ... Read more
Within 15-minutes of vaccination, the patient reported arm soreness and pain at the injection site. EMS monitored patient's condition on-site.
76 2021-02-03 vaccination site warmth, vaccination site swelling, vaccination site itchiness, vaccination site pain, vaccination site redness Approximately 2/3rds of the arm has swollen up/ mild swelling; her arm is still red, this happened a... Read more
Approximately 2/3rds of the arm has swollen up/ mild swelling; her arm is still red, this happened after the second dose/ it was very red and warm and itching/ it was a red area about 5 cm in diameter around the injection site in the upper arm; it was very red and warm and itching; Soreness of the arm/It hurt, it was warm, slightly swollen and raised from rest of the skin; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given; This is a spontaneous report from a contactable Physician. A 76 year old female Physician reported that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EK4176 Expiry date 31Mar2021), at single dose in the left Arm on 14Jan2021 at 2:30PM for COVID-19 immunization. The patient had received the first dose of BNT162B2 (lot E11865, Exp Mar2023) in the left arm on 23Dec2020 . Medical history included asthma and allergy. She had a contrast IV reaction before. She is Allergic to everything, inhalants, weeds, dust, trees, grasses, foods like chickpeas that have her bad asthma and fishes like Halibut. When she did a skin test she reacts to everything. She has been on prednisone. She was admitted to the hospital a year ago in November for an asthma attack. Concomitant drugs included inhalant steroid medication and other medication for Asthma. The patient reported that on 15Jan2021 after the second dose, approximately 2/3rds of the arm has swollen up, this lasted about 7 days. On the 8th day and it is beginning to go down. She also added that her arm was still red. The mild swelling actually started as itching, within 10-12 hours, when she woke up and looked it was a red area about 5 cm in diameter around the injection site in the upper arm. It hurt, it was warm, slightly swollen and raised from rest of the skin. It was initially located in like the back of the arm, right where the shot was given, like upper back of arm. On 16Jan2021, it was close to half of the upper arm, well not exactly half the arm, but it was very red and warm and itching, on the left Arm. On 17Jan2021 it was at 2/3rd of the arm, almost 15 cm's in length at that point. Still very red, it wrapped towards the front of the arm, she could see the color without looking in the mirror. The swelling has ended, the raise part stopped around the 19Jan2021. The redness as of the 19Jan2021, it was less, the skin is slight pink, pinker than the normal skin, she has put some steroid cream skin lotion on the red area, she did that on 16Jan2021 twice a day. She also took Benadryl for 2 nights on 16Jan2021 and 17Jan2021. The itching stopped, when the skin was covered it was not that bad, but when the air hits it, it itches. Caller also added that there was soreness on the arm, it was achy, but it was very minimal now, she notices it when lifting things, that was when it hurts.
76 2021-02-04 injection site bruising, hives, sensitive skin, injection site reaction, injection site rash, injection site pruritus, injection site pain, injection site redness Reaction 1: sore left shoulder at the injection site next day for one day only Reaction 2: 5 days af... Read more
Reaction 1: sore left shoulder at the injection site next day for one day only Reaction 2: 5 days after vaccine, noticed blood on my shirt where I had been itching, left upper arm between injection site and elbow. Appearance of skin is rash, welted, red, bruised and sensitive to touch in an area about 3x3 inches. OTC anti itch cream not effective. Itching became so severe, I went to my dermatologist 3 days after itching started. Diagnosed as Allergic Contact Dermatitis due to Covid 19 vaccine. Given Rx anti itch cream and told to use cold pack when it was itchy and take OTC antihistamine. Followed doctor's orders and itching finally stopped after 12 days from onset.
76 2021-02-04 injection site discomfort Site uncomfortable for week plus one day. Then hard pain in shoulder and spreading across shoulder,... Read more
Site uncomfortable for week plus one day. Then hard pain in shoulder and spreading across shoulder, up neck and down around collar bone. Went to Dr. and was told it was neuropathy and was prescibed Prednisone.
76 2021-02-04 rash with redness large red area 3" x 3"
76 2021-02-04 rash, itchy skin Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout bod... Read more
Rapid heartbeat, shaky, clammy skin, heavy perspiration, nausea, stomach cramps, pain throughout body along with pin and needle feeling mostly on the left side from my foot to the top on my head. Lips felt swollen. Itch in chest, neck with a rash, back legs, mostly all over.
76 2021-02-04 rash Rash, increased irregular heartbeat, feeling off-have not contacted anyone yet
76 2021-02-04 vaccination site pain headache; she had a mild soreness in her left arm after getting the COVID-19 Vaccine; This is a spon... Read more
headache; she had a mild soreness in her left arm after getting the COVID-19 Vaccine; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer-sponsored program Pfizer First Connect. This pharmacist reported similar events for two patients. This is the first of two reports. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 10:30 AM at single dose on left arm for COVID-19 immunization. Medical history included temporomandibular joint (TMJ) pain in jaw and headache. Concomitant medication included Tylenol for temporomandibular joint (TMJ) pain in her jaw. The patient (retired pharmacist) stated that she and her husband got the COVID shot on Tuesday (19Jan2021) and prior to getting the vaccine, she was suffering temporomandibular joint (TMJ) pain in her jaw and took Tylenol that morning. Patient just came back from urgent care and was prescribed a dose pack of prednisone to take for 5 days for the TMJ and she is concerned about taking it because she knows it can suppress the immune system and she does not want to make the vaccine less effective. She was trying to figure out if she should just tough it out and not take the steroid. She and her husband, who was on warfarin, had a mild headache after the first shot but he has sinus issues and she had the TMJ, they were not sure if the headaches were from those things or the vaccine. Patient asked if she can take Tylenol since she found out that that may not have been a good idea. She was advised to take Prednisone and she was asking if she can take it or will it affect the efficacy of the vaccine. She stated not knowing that taking Tylenol can effect the efficacy of the COVID-19 Vaccine, she had taken Tylenol before she received her COVID-19 Vaccine on 19Jan2021 (Tuesday). Patient said her TMJ jaw pain was still a problem after she received her COVID-19 Vaccine, so she had gone to her doctor, and her doctor prescribed Prednisone, a corticosteroid. She said she was not going to take the Prednisone because she does not want the Prednisone to cause an issue with the efficacy of the COVID-19 Vaccine. Patient said she then read that studies performed on children said that children that took Tylenol did not get as good of an immune response from the COVID-19 Vaccine. Patient said since she already took a dose of Tylenol for her TMJ jaw pain before receiving her first COVID-19 Vaccine dose, she was afraid to take any further Tylenol. Patient clarified that the Tylenol she took was the generic Equate brand, 500mg. She said she took 2 Equate brand generic Tylenol 500mg for jaw pain on Tuesday morning (19Jan2021) prior to getting her first COVID-19 Vaccine. She said she had disposed of Equate brand generic Tylenol bottle and cannot provide the UPC, Lot and Expiration Date. Reported that both her and her husband did have a headache all day long after receiving the COVID-19 Vaccine. She said her husband believes his headache was from the COVID-19 Vaccine. She said she was not sure if her headache was from the COVID-19 Vaccine or from her TMJ jaw pain. She said when she has TMJ jaw pain, she usually has a headache accompanying the TMJ jaw pain. Also reported that she always gets her vaccines in her left arm. Patient was surprised she and her husband did not have anything more than a headache after receiving the COVID-19 Vaccine. She said when she had the Shingles Vaccine, she could not lay on her left side for a week because her arm was so sore for 2 days, and when she had the flu shot she could not get out of bed for a day. Patient clarified she got her first dose of the Shingrix Shingles Vaccine in Nov2020, and does not plan to go and get her second Shingrix dose until the summer of 2021. Patient stated that she does not want the second dose of the Shingrix Vaccine interfering with the COVID-19 Vaccine. The patient had headache on 19Jan2021, reported as mild. Patient also had a mild soreness in her left arm after getting the COVID-19 Vaccine on 19Jan2021, and the left arm soreness was gone in less than 24 hours. Patient further clarified that she had a headache before getting the COVID-19 Vaccine. She said her TMJ jaw pain acts up if she eats. She said when she has TMJ jaw pain, she gets an excruciating headache. She said she has no headache pain at all right no. Patient expected to have kind of a worse reaction to the COVID-19 Vaccine based on what other people have been saying. The events were assessed as non-serious. Outcome of the event headache and mild soreness in her left arm was recovered in Jan2021. Patient does not think her headache pain was related to the COVID-19 Vaccine.; Sender's Comments: Based on the time association and drug's safety profile, the possible contribution of suspect vaccine BNT162B2 to the event headache cannot be totally excluded. The underlying temporomandibular joint and headache may be cofounders.,Linked Report(s) : US-PFIZER INC-2021082288 same drug/reporter, similar events, different patient
76 2021-02-08 redness Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12... Read more
Chills, fever, muscle aches, weakness, fatigue, nausea lasted 24 hours, then fatigued for another 12 hours. Recovered completely within 36 hours. Arm red, sore and swollen for 36 hours
76 2021-02-08 rash, itchy skin, rash with redness flu like symptoms--aches, chills, headache, fatigue, followed by red rash over left chest area, with... Read more
flu like symptoms--aches, chills, headache, fatigue, followed by red rash over left chest area, with itching Treated with benadryl with little effect. Received Rx for dosepack Prednisone. Also applied cortizone OTC to rash area. Flu like symptoms abated wtihin 36 hours; rash improving more slowly.
76 2021-02-09 redness When the nurse gave me the first dose, she said "your arm is so small I thought I might of hit your ... Read more
When the nurse gave me the first dose, she said "your arm is so small I thought I might of hit your bone". When I got home and took the Band-Aid off there was a small red mark, which went away by the next morning. Then next day after that I started having extreme pain and numbness in my left arm. The pain is from my shoulder, to my fingertips, and under my arm. It is still hurting today. I have been taking Advil, putting pain cream on it. It is still hurting as of now.
76 2021-02-10 itchy skin, rash BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back... Read more
BP;A bit high for her; Anaphylactic reaction; back rash; burning sensation; swollen face; itchy back; Back getting hot; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program. A 76-year-old female patient received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date not reported) , via an unspecified route of administration on the left arm on 27Jan2021 14:00 at single dose for COVID-19 immunization. Medical history included anaphylaxis with contrast media (Biaxin and eucalyptus), allergies: latex, antihistamines, sulfa, olive trees; allergic reactions to iodine, asthma, cardiac arrest, has a pacemaker; all from unknown dates. Concomitant medication included levothyroxine sodium (LEVOTHYROXIN), vitamin D3, levocabastine hydrochloride (ZYRTEC), iron, diltiazem, salbutamol sulfate (ALBUTEROL). The patient previously took Biaxin, eucalyptus and tiger balm and experienced anaphylaxis, Cipro, sucralfate, adrenaline (EPIPEN), corticosteroid and experienced allergies. The patient previously received Shingles vaccine on Nov2020 for immunization and experienced intermittent itchy back sensation. The patient reported that after vaccine reaction today (27Jan2021) - back rash, burning sensation, swollen face. It was further reported that the patient experienced potential anaphylactic reaction; 15 minutes after the administration she got her back getting hot and Itchy and a rash breakout. It was also reported that the patient's BP was a bit high for her on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: a bit high for her on an unspecified date. Therapeutic measures were taken as a result of anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot which included treatment with Benadryl (Took one 25 mg Benadryl. Then she took another 25 mg Benadryl); it was reported that 30 minutes later symptoms started to subside. The patient recovered from anaphylactic reaction, back rash, burning sensation, swollen face, itchy back, back getting hot on 27Jan2021, while the outcome of BP was a bit high for her was unknown.
76 2021-02-10 itchy skin Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a f... Read more
Client received Pfizer covid vaccine, and during her observed wait time, she became hot and felt a flush through her body. She also reported tingling in her tongue and throat. She reported itching of her chest, cheeks, and ears. Client was brought back to emergency area, and was assess by nurses. Client did have a prior history of allergy to Iodine and shellfish- but never anaphylaxis. 10:20am, pulse 68, bp 142/83, 98% O2. 10:25am, bp 140/85, still complaining of throat swelling and itching, pulse ox stil 98%. Once client was in a private area, she reported that the flushing and feeling of being hot, had gotten much better. Per Client , her tongue and throat, were not getting worse. Our Medical Director was contacted, and the decision was made to give Benadryl IM. 10:39 pulse 70, O2 95%, . 10:41 am 1ml (50 mg) Benadryl given IM in the right deltoid (lot # 080014, exp. 8/2022). Within a few minutes patient reported that signs and symptoms were better but had not completely gone away. 10:44, respirations 14/minute, O2 94%, patient sat up at this time to help clear some phlem. 10:46 client states tongue feels better. 10:53 am 96% O2, pulse 93. Nurses continued to monitor client, and asked if she felt any worsening of her symptoms to warrant more medication. Client stated she felt a little better and would like to go home. 11:15 am, spoke to Docter again, per his instruction, client was allowed to go home with her sister. Instructed to take more Benadryl in 4 hours if symptoms return. Client was told if anything gets worse than her original symptoms, regarding her airway, tongue, lips, swallowing, she should call 911.
76 2021-02-10 itchy rash a rash on her chest/have a rash on her chest that itches; This is a spontaneous report from a contac... Read more
a rash on her chest/have a rash on her chest that itches; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EK9231; expiration date: unknown), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. Medical history included blood pressure (blood pressure abnormal), borderline diabetes, hypertension, arrhythmia and cholesterol high. Concomitant medication included amlodipine besilate for blood pressure, metoprolol succinate (METOPROLOL SUCCER) for arrhythmia, metformin hcl and rosuvastatin calcium for cholesterol high. The patient reported that she received the first dose of the Pfizer vaccine on 22Jan2021 and two days later she noticed a rash on her chest. She mentioned that she has been using an anti-itch cream. She mentioned that she was supposed to schedule her second dose for 12Feb2021 but is unable access the website to schedule her appointment through. She mentioned that she had a rash on her chest that itches, and she have got some itching cream, but she keeps waiting for it to finally go away but so far it is still there. When asked about the treatment, she mentioned that she had Triamcinolone 0.1% for other usages from her skin doctor (her dermatologist). The outcome of the event was not recovered.
76 2021-02-11 injection site redness, injection site vesicles, injection site swelling, injection site pruritus, injection site pain 2/3/21 vaccine given rt. arm; 2/11/21 very hot bright red 3 inch diameter extremely itchy; 2/12/2... Read more
2/3/21 vaccine given rt. arm; 2/11/21 very hot bright red 3 inch diameter extremely itchy; 2/12/21 at 0300 injection site is raised up like blister 3 inch diameter; red is less than night before; at 0800 2/12 still swollen injection site; 1800 2/12/21 swelling is going down; but you can still see outline of 3 inch diameter; some itching; more muscle pain in area. Doctor did video with me at 1830 and he said it was delayed allergic reaction and to contact you. pictures taken of site at this time. will send if you wish. wonder if I should have second dose.
76 2021-02-12 itchy skin, skin irritation, rash I had my shot in my left arm Last night (02/12/2021) I noticed a slight irritation and itching on my... Read more
I had my shot in my left arm Last night (02/12/2021) I noticed a slight irritation and itching on my right forearm. Today (02/13/2021) I started rubbing and scratching on my right forearm as it increased in irritation and itching. I looked at it and there is a long rash on it. As I type the top of my left hand is starting to itch and top of right hand as well but no definitive visible rash.
76 2021-02-15 redness One week after the first vaccine, I had severe pain in my right arm. I could barely lift it. applie... Read more
One week after the first vaccine, I had severe pain in my right arm. I could barely lift it. applied ice and pain lessened...Then other events followed...My left wrist became swollen and red. then a day later the severe pain was in my left arm and I could barely lift it. I then had a swollen right foot. Podiatrist gave me a shot of cortisone but continued to have the pain and swelling...Shoulder pain returned. 2nd vaccine was 02/03/2021...Feb 10...both hands were stiff and I couldn?t open them...Then the shoulder pain in my right arm returned . This lasted 4 days...with the most severe pain.
76 2021-02-15 rash RIGHT FOOT RASH; REPORTED 1 WEEK AFTER INITIAL VISIT; ALERTED PHARMACY WHEN SHE CAME IN FOR THE 2ND ... Read more
RIGHT FOOT RASH; REPORTED 1 WEEK AFTER INITIAL VISIT; ALERTED PHARMACY WHEN SHE CAME IN FOR THE 2ND DOSE ON 2-16-21.
76 2021-02-15 hives Severe hives for 10 days
76 2021-02-16 injection site pain Injection was painful - arm numb and tingled to fingers. 10:45b/p 116/62 pulse68 respirations 1... Read more
Injection was painful - arm numb and tingled to fingers. 10:45b/p 116/62 pulse68 respirations 16 Normal movement,color and temperature in fingers. Capillary refill <3 seconds. Client refused further medical treatment.
76 2021-02-16 rash with redness UNKNOWN VACCINE BRAND; Subjective swelling of throat, swollen lips, diffuse eythematous rash on trun... Read more
UNKNOWN VACCINE BRAND; Subjective swelling of throat, swollen lips, diffuse eythematous rash on trunk and extremities, anxiety; received famotidine, NS, ativan, diphenhydramine, solumedrol
76 2021-02-17 itchy skin, skin burning sensation, shingles Burning itch, wound care. Doctor advised it was Shingles
76 2021-02-18 skin discolouration Patient developed brown spots above upper lip that appeared to crust over and itch; also developed t... Read more
Patient developed brown spots above upper lip that appeared to crust over and itch; also developed these right below lower lip; these are getting better as of 2/19/21 but are still there; patient contacted doctor on 2/18/21 re this
76 2021-02-19 redness, hives extreme sharp pain in vagina, intermittent - lasted about half an hour or more; no treatment; resolv... Read more
extreme sharp pain in vagina, intermittent - lasted about half an hour or more; no treatment; resolved and didn't return. hives: neck, chest, redness in armpits, and at temples/hairline; (appeared 48 hours after vaccine, 6 am on 2/18; worsened by morning of 2/19; gone by morning of 2/20. Treated with over-the-counter hydrocortisone topical cream.
76 2021-02-19 shingles, injection site pain, rash Developed shingles, given salves,valacyclovir, 1gm for 7 days, pain patches, gabapentin. Had very ac... Read more
Developed shingles, given salves,valacyclovir, 1gm for 7 days, pain patches, gabapentin. Had very achy joints and very sore arm that was injection sight, which is still tender and still sore today and still suffering from shingles. Shingles rash appeared 6 days after shot. Sore arm began 11 hours after shot.
76 2021-02-21 bruising I received my 2nd vaccine at 12:15 at the facility on Tuesday, Feb. 16. At about 10:30 that night I... Read more
I received my 2nd vaccine at 12:15 at the facility on Tuesday, Feb. 16. At about 10:30 that night I began to feel a bit light headed. I went to bed around 11:30 and didn't sleep very well. On Wed. am after going to the bathroom, I felt woozy while washing my hands. When I thought I felt better, I made my way back to the bedroom and passed out. I fell on my right side, bruising the right side of my face, my right hip and my right thigh. I apparently had my left hand under me when I fell because I broke the knuckle under the pinkie of my left hand.
76 2021-02-21 itchy skin, rash Immediate itch in the head and arm fifteen minutes after shot along with slight swelling of the lip... Read more
Immediate itch in the head and arm fifteen minutes after shot along with slight swelling of the lip. Then 2 weeks after 2nd dose the same itch has returned all over the body along with some open rashes on the skin.
76 2021-02-22 rash, rash with redness red rash on the chest area (under breast)
76 2021-02-23 injection site redness After receiving her vaccine client stated that she has stiffness and redness in the right arm in whi... Read more
After receiving her vaccine client stated that she has stiffness and redness in the right arm in which she had her vaccine was given. Vital signs obtained by EMS BP 115/73, HR=74, o@ sat 96%. Client states she feels better. Client declined to be transported to the ER. Discharged home by EMS.
76 2021-02-24 injection site mass On second day after second dose (2/22/21) lump on arm below injection site, and enlarged lymph node ... Read more
On second day after second dose (2/22/21) lump on arm below injection site, and enlarged lymph node on left side of neck.
76 2021-02-24 itchy skin, blister, hives, rash I started noticing small blisters on my right lower leg on shin area that were very itchy. Day by d... Read more
I started noticing small blisters on my right lower leg on shin area that were very itchy. Day by day I noticed an incease of clusters of blisters forming below the first site. They then circled from front to back halfway up my lower leg. Large whelpy itchy places continued to form on my upper forearms and back of right arm elbow. Then the same effects started on my left leg on the back side between my knee and ankle. I have now a large circular area on my lower back at the waistline with solid itchy hard bumps that has increased in size and discomfort. I have red itchy blisters on both my left and right uper wrists. I am noticing small clrcular bumps on my right and left forehead.
76 2021-02-25 skin warm, redness, cellulitis, hardening Three days after the Covid-19 vaccine injection, left arm became reddened, warm to the touch, painfu... Read more
Three days after the Covid-19 vaccine injection, left arm became reddened, warm to the touch, painfully tender, lumpy under the skin, over an irregular area approximately 4x5 inches. Doctor diagnosed infection as cellulitis, and prescribed doxycycline 100mg for 5 days. Because of the underlying primary immune deficiency, this will be a difficult adverse event to overcome. First noticed on February 25, 2021. Covid-19 vaccine was administered on Monday February 22nd 2021.
76 2021-02-25 hives 4 days after 2nd dose: hives all over my body and swelling of face and eyes. Called Telemedicine a... Read more
4 days after 2nd dose: hives all over my body and swelling of face and eyes. Called Telemedicine at Urgent Care Huntsville Hospital. Was given instructions to take 40 mg of Prednisone first day and taper off, 2-3 doses of antihistamine and Hydrocortisone on welts. Needed to go to ER for IV if face swelling did not go down. Today (second day after call): Face swelling is down but hives are possibly worse (large welts over large portion of body plus on hands and feet and chin)
76 2021-02-26 redness, rash macular, injection site pain Noticed large red spot (approx. 2" X 3" at Injection site on right arm today, 02-27-2021. Some soren... Read more
Noticed large red spot (approx. 2" X 3" at Injection site on right arm today, 02-27-2021. Some soreness still at the injection site. Have never had any reactions like this before when have taken Immunizations shots.
76 2021-02-26 injection site pain Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems... Read more
Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems with balance that induced dizziness and vertigo, wobbly gait, extreme weakness, continual tiredness--not refreshed by sleep, difficulty sleeping, insomnia, injection site pain, severe headaches for weeks, eyeball pain, chills, fever, inflammation, joint pain, muscle pain, activity-induced or cognitive exertion muscle fatigue, nausea, swollen lymph nodes, especially in neck, sore throat, difficulty swallowing, cognitive problems -- difficulty with memory, focus, concentration, problems with wordfinding ability, misspeaking; short-term blurry vision; extreme difficulty with body temperature control leading to shaking
76 2021-02-26 skin spots immunothrombocytopenia refractory to platelet transfusions, starting steroids and IVIG
76 2021-02-26 rash maculo-papular broke out in bumps all over the body and was given Fluocinonide ointment for topical use back to th... Read more
broke out in bumps all over the body and was given Fluocinonide ointment for topical use back to the doctor on March 8,2021
76 2021-02-26 rash Large patch of rash on arm, along with constant inflammation.
76 2021-02-27 skin laceration Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, di... Read more
Patient began feeling tired 1 hour post dose. At 3 hours post dose, patient began feeling woozy, dizzy and disoriented. Patient got dizzy and passed out while walking to bathroom. She fell and sustained a significant laceration to her arm. She continued to feel dizzy and "just not right" several times over the hour until she finally called 911. When paramedics arrived, she continued to lose consciousness and required full assistance to be placed onto the stretcher. Her BP was all over the place for the better part of 6 hours, with highs as high as 145/95 and lows as low as 81/42. This reaction lasted for a total of 8 hours.
76 2021-02-28 redness Aprox 10 minutes after receiving the vaccine client started c/o stinging and tingling in her hands a... Read more
Aprox 10 minutes after receiving the vaccine client started c/o stinging and tingling in her hands and they were red, she felt flushed. No medications given. She felt better shortly afterwards. She did not let her PCP know of this information.
76 2021-02-28 injection site redness, injection site swelling, injection site pruritus Vaccinated Arm is swollen, itchy and dark red from the shoulder to the wrist
76 2021-02-28 rash with redness Woke up Sunday morning with my face swollen and fire red on the right cheek and rash on the left che... Read more
Woke up Sunday morning with my face swollen and fire red on the right cheek and rash on the left cheek and brow. Right cheek hurts because of the swelling. Took 2 Benadryl at noon. Right cheek is burning. Today is Monday and it is still swollen but not as red. It hurts and got more Benadryl to take. Took 2 at 3pm today.
76 2021-02-28 vaccination site redness, vaccination site hardening, vaccination site itchiness, vaccination site swelling, vaccination site warmth Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Indurati... Read more
Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; Induration/3 inch diameter raised injection site; hot very red, itchy; hard area around it; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262; Expiration date was not reported) on 03Feb2021 (12:15) at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the physician's office. Medical history included vulvodynia; back issues; sulfa allergy; penicillin (PCN) allergy; and allergy to "mycins". Concomitant medication included estrogens conjugated (PREMARIN) and propranolol. The patient previously took morphine sulfate, and had drug allergy; lansoprazole (ZOLANAS), and had drug allergy; and tetanus vaccine, and had allergy to the vaccine. The patient was not pregnant at the time of vaccination. On 11Feb2021 (16:30), the patient had induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it. The reported events resulted into physician's office visit. The patient did not receive any treatment for the reported events. The outcome of the events, 'induration/3-inch diameter raised injection site that was hot, very red, itchy and hard around it', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
76 2021-02-28 vaccination site pain sore throat; Tenderness of the Right Arm; This is a spontaneous report from a contactable consumer (... Read more
sore throat; Tenderness of the Right Arm; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Batch/lot number: EH9899), via an unspecified route of administration on the right arm, at age 76 years first dose on 22Jan2021 at single dose for COVID-19 vaccination. Medical history was none. There were no concomitant medications. Patient had the vaccine first dose on Friday (22Jan2021), she had tenderness in the arm at the site but nothing major. Then this morning (27Jan2021) she had a really bad sore throat, it's really sore. She asks if this is a side effect. She asks can she take aspirin or Tylenol. Reporter Type: She has worked in a doctors office in the past but it was just doing medical records. She confirms that on 22Jan2021 was her first dose of the covid vaccine, the tenderness of the arm was on the same day, it happens anytime she gets a shot, the Sore Throat started this morning. Primary care: Declined, she has only been going through the vaccine program. The tenderness of the right arm, is barely there, its like nothing there, its just a little. For the Sore Throat , she drank from tea and had a lozenge and so its not as but is still there but not terrible. Patient stated that she just want to know if she can take aspirin or Tylenol Covid Vaccine Card: The Expiry is not written on the card. Date of second dose: 12Feb2021 Concomitant Medications; No She was just sleeping and woke up with it. The outcome of the event sore throat was not recovered, while for the other event, it was recovering.
76 2021-03-01 injection site pain Injection site pain, tiredness, headache slight, joint pain, fever up to 101.6, feeling unwell
76 2021-03-02 vaccination site redness Arm swollen and turned red 3 inches above and below injection site; Arm swollen and turned red 3 inc... Read more
Arm swollen and turned red 3 inches above and below injection site; Arm swollen and turned red 3 inches above and below injection site; arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received BNT162B2 (lot number: EN5318), intramuscular on 25Jan2021 08:30 at single dose in the right arm for Prevention. Medical history included diabetes diagnosed 10 years ago, acid reflux and cholesterol, all on unknown dates. Concomitant medication included esomeprazole sodium (NEXIUM) taking for 10 years for Acid Reflux, ongoing metformin for diabetes, "Sarxigo" taking for about 3 years for diabetes and unspecified cholesterol medication. On 26Jan2021 09:30, the patient experienced arm swollen and turned red 3 inches above and below injection site. She said it does not hurt, but just feels kind of heavy. The flu shot did that to her too, but not as bad. Flu shot turned her arm red this year also. She got it in Oct2020. She also got in the right arm in the muscle. She would like to know if she will she be safe to take second dose of BNT162B2. The patient did not receive any other vaccines within four weeks prior to the vaccination. The outcome of the events was not recovered.
76 2021-03-02 vaccination site pain more tired; left arm/injection arm, had a little bit of pain; little more drowsy than normal; This i... Read more
more tired; left arm/injection arm, had a little bit of pain; little more drowsy than normal; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: PFREL1283; expiry date: 30Apr2021) via an unspecified route of administration on 08Jan2021, at single dose, for COVID-19 immunization. Medical history included pre-diabetic, thyroid disorder and cholesterol abnormal. Concomitant medications included levothyroxine for couple of years for thyroid disorder and rosuvastatin for 30 some odd years for blood cholesterol abnormal. The patient reported that with the first shot, she had side effects she was aware of. On 08Jan2021, she was a little more drowsy than normal. It was nothing severe, but when she was up and awake, she could tell she was more tired. That lasted over 3 days. It wasn't like she couldn't do anything. She just felt more tired than normal. It was different than normal. On 09Jan2021, her left arm, which was her injection arm, had a little bit of pain. She understood that though. It lasted a couple of days. Outcome of the event tired was unknown, while for the other events was recovered on 10Jan2021.
76 2021-03-03 itchy skin Swollen Lympf Nodes(7 days), slight headache(two weeks) tiredness(1 week)muscle aches(1 week),severe... Read more
Swollen Lympf Nodes(7 days), slight headache(two weeks) tiredness(1 week)muscle aches(1 week),severe itching on back (no rash(2 weeks)nausea(1 day) Tylenol for headache, rest for tiredness, caladryl, Zyrtec, Pepcid for severe itchiness, Dr visit on Feb.22 - had me take a flu/covid test came back negative.
76 2021-03-04 itchy skin, redness, haematoma Patient developed a 2.5 cm hematoma and stated it was itchy. Inspection and light palpation showed ... Read more
Patient developed a 2.5 cm hematoma and stated it was itchy. Inspection and light palpation showed lump under skin with redness, no rash.
76 2021-03-07 itchy rash, rash, rash macular pustules across her back; In her throat she is getting hoarse; itching with the rash; rash that is a... Read more
pustules across her back; In her throat she is getting hoarse; itching with the rash; rash that is all over her body; splotches on her belly on her right side, right below her waist /Two splotches on right hand side; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), via an unspecified route of administration at left upper arm on 26Jan2021 at 14:19 at SINGLE DOSE for COVID-19 immunisation. The patient had no previous immunizations. The patient had no prior vaccinations within 4 weeks and no additional vaccines administered on the same date. Medical history included allergic to penicillin, bladder infection, in the middle of her chest she had the pain cling through her back, and thyroid getting lazy and does not work. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), levothyroxine sodium (SYNTHROID) for thyroid getting lazy and does not work, vitamins, and sulfa drugs for bladder infection. It was reported that after getting the first dose of the vaccine the patient noticed she had pustules across her back on an unspecified date. The patient stated she "got this rash from the tips of fingers, even the palm of my hands and it starts right under the neck and goes across my breast, on my belly, on my back and both arms and is now halfway down my shin bone." On an unspecified date in Jan2021, she noticed this the afternoon of her vaccine around 7:00 when she saw two splotches on her stomach and it kept spreading. Sunday morning she went to Quick Care and yesterday went to her regular doctor. Her doctor gave her prednisone to take 10 mg 4 times a day, and hydroxyzine 10 mg for itching. In her throat she was getting hoarse on an unspecified date and was keeping a water bottle on her desk to keep hydrated. She stated she read on (website) that a rash can be a symptom of the vaccine. The caller asked, "if the pustules burst will this cause anyone to get Covid 19? Is this a possible side effect of the vaccine? How long will this last? Is it okay to get my second shot with this reaction? Is there anything I should be taking to make it go away?" It was further reported that patient received paperwork to call if there was any type of reaction. The patient mentioned she has a rash that was all over her body on 28Jan2021. It was on the top of her hands, in the palm of her hands, on her arms, back, under her breast, on her chest, on her stomach, on her bottom end, it was going down her legs and to her knees at this point. The patient initially stated she noticed the rash on Friday (29Jan2021), she later stated it was Thursday 28Jan2021 when the rash first started. She stated she first noticed splotches on her belly on her right side, right below her waist on an unspecified date in Jan2021. At first when looking at it she did not think too much about it. Later in the call she further clarified and stated it was possible she noticed these splotches the same day in the evening on the day she got the vaccine. She was not sure. If it was not the same day it was the next day. Friday (29Jan2021), she started to get as initially stated bumps, but later clarified rash under skin and it really proceeded from there. Additionally, it was reported that the rash continued to spread throughout her whole body. It was down to her shin now. Her whole upper body was horrible. She has some across her back. There are pustules on them like a pimple. It was like water in it ready to break. Sunday she went to a (clinic name) to get it looked at. She went Sunday 31Jan2021. She was given an intravenous (IV) and three needles were placed in it. She knows one was a steroid, she does not know what the other two were for, but she thinks one was probably for itching. The patient also confirmed she also experienced itching with the rash on 28Jan2021. It started the same day she noticed the rash. The patient stated it was like a full blown case now. The itching was with the rash on 28Jan2021. The itching and rash has continued to go down her body. It was on her buttocks now. It was hard to sit. It was in private up between her legs and stuff. Her body was almost 80 % full and covered with this stuff. She saw her regular doctor yesterday. The doctor at (clinic name) thought this reaction may have been an allergic reaction to a Sulfa drug she was taking for a bladder infection coincidentally at the same time, but she does not believe this was the case. Stated she had taken that sulfa drug before previously. She does not have the name of the drug to provide of the sulfa drug. She does not have it with her. No blood work was done. She was just looked at. They saw what was going on. The patient also mentioned she went on the internet to do research. She saw on Pfizer page three pictures that resembled what she had going on. It was also reported that the two splotches on right hand side started about 7'clock in the evening. At first did not think anything of it. Thought it was possibly a bug bite at first. Additionally, it was reported that patient went to see a doctor. She was already going to the doctor for a bone density scan and she showed the doctor what was going on at the same time. Her primary doctor thought this was due to the COVID 19 Vaccine. At end of call, patient questioned "if the pustules across upper back and behind neck, will that cause anyone to get COVID 19? Side effect?" The patient had no emergency visit. Therapeutic measures were taken as a result of itching with the rash, rash that is all over her body, and two splotches on right hand side. The patient had not yet recovered from rash that is all over her body while outcome of the events pustules, itching with the rash, in her throat she is getting hoarse, and "splotches on her belly on her right side, right below her waist /Two splotches on right hand side" was unknown.
76 2021-03-07 skin peeling Within 8 hours of the vaccine, I experienced severe muscle weakness (could not lift arms above head;... Read more
Within 8 hours of the vaccine, I experienced severe muscle weakness (could not lift arms above head; could not stand from sitting position without pain). During night, could not turn over in bed without pain. This lasted for 3-4 days. Treated with Advil. Next symptoms were joint pains and stiffness and back pains, which also lasted about a week. Treated with Aleve and hot/cold compresses. Final symptoms are severe swelling and stiffness of hands and fingers, with cracked, peeling skin. I have had this for about a week now and it is not improving. Cannot grasp anything with either hand. Middle and index fingers on both hands useless.
76 2021-03-08 shingles Experienced right side aside pain 3 days after vaccination and broke out with shingles rash 6 days a... Read more
Experienced right side aside pain 3 days after vaccination and broke out with shingles rash 6 days after vaccination
76 2021-03-08 injection site redness, injection site pruritus, injection site pain At the time of the injection a small red area was identified. There was mild pain in my arm for a da... Read more
At the time of the injection a small red area was identified. There was mild pain in my arm for a day or two. Six days later the red area has became about four times larger and spread around. Pain is still mild- the upper arm is sore and itchy.
76 2021-03-08 itchy skin She received the second Pfizer-BioNTech vaccine in the right shoulder on 3/6/21. That afternoon she ... Read more
She received the second Pfizer-BioNTech vaccine in the right shoulder on 3/6/21. That afternoon she develops severe itching all over her body. The itching is still occurring as of 3/9/21. Treatments thus far have been topical otc steroids and benadryl cream, and today she received 4mg IM decadron. Outcome is still to be determined.
76 2021-03-09 itchy skin Lost consciousness; palms began to itch, then soles of feet; This is a spontaneous report from a con... Read more
Lost consciousness; palms began to itch, then soles of feet; This is a spontaneous report from a consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (lot number was EL8982 and expiration date was unknown) via an unspecified route of administration at left arm 18Jan2021 14:30 at single dose for COVID-19 immunisation, amoxicillin via an unspecified route of administration from 18Jan2021 at 14:50 at 4 DF for dental apt, procaine hydrochloride (NOVOCAIN) via an unspecified route of administration from 18Jan2021 at unknown dosing regimen for an unspecified indication. Medical history included 3 joint replacements and known allergies to raw celery, clover honey and ragweed. Concomitant medication included atorvastatin calcium (ATORVASTIN), brimonidine tartrate, timolol maleate (COMBIGAN), levothyroxine, tolterodine. There was no other vaccine in four weeks. Patient did not have COVID prior vaccination. The patient had no reaction in first 15 minutes. Within 20 minutes of shot, patient took 4 amoxicillin for dental apt (as reported), then received procaine hydrochloride (Novocain). 45 min after shot, her palms began to itch, then soles of feet. Then she total loss of sight on 18Jan2021 at 15:30. Patient lost consciousness at emergency room check-in. Patient visited emergency room/department or urgent care. Patient received epinephrine injection as treatment. She also had CT scan of head and chest in Jan2021. She did not have COVID tested post vaccination. The outcome of events was recovered in 2021. The action taken in response to the events for amoxicillin and procaine hydrochloride was unknown.
76 2021-03-09 rash I developed arm pain, up my arm to my neck, Then 2 days later developed a rash on my wrist, arm and ... Read more
I developed arm pain, up my arm to my neck, Then 2 days later developed a rash on my wrist, arm and top of my back.
76 2021-03-10 itchy skin Day of shot at 5:00 pm my palms on both hands had itching and I had to keep scratching them. It was ... Read more
Day of shot at 5:00 pm my palms on both hands had itching and I had to keep scratching them. It was driving me nuts. Later that evening my feet were also itching. All night long and into Tuesday but the itching also included my underarms, chest, and upper thighs. Finally on Tuesday I started taking 2 Benedryl tablets every 6 hours, however at 4 hours the itching came back but seemed to be only on the upper body. It is now a little over 72 hours since my shot and I'm still suffering the itching, but not quite as bad with Benedryl. Since I didn't see this on the list of possible side effects, I thought you should know.
76 2021-03-11 rash with redness, injection site reaction Rash (Redness) around the area of injection plus eching six day after adminsteration
76 2021-03-13 itchy skin, rash Rash in mouth and throat and shortness of breath on Thursday 3/11/21 around 7 p.m.. Called Covid ... Read more
Rash in mouth and throat and shortness of breath on Thursday 3/11/21 around 7 p.m.. Called Covid line and spoke to a RN who recommended that I take Ibuprofen and not to take an antihistamine, and to contact my doctor in the morning. Also to go to the ER if symptoms got worse I took Ibuprofen every 4 hours over night and called my primary care physician in the morning. He sent me to the Urgent Care center since the rash had persisted . The Urgent Care physician prescribed Prednisone and Benadryl. I am taking antihistamines and Ibuprofen for relief of rash and itching. I will follow-up doctor on Monday.
76 2021-03-14 skin warm Terrible nightmare during night of injection. Smothering and paralyzed feeling. Shouting out in my ... Read more
Terrible nightmare during night of injection. Smothering and paralyzed feeling. Shouting out in my sleep. Husband finally woke me . When I got up to take a Motrin I was disorientated. Did not know where I was. . Next day experienced several sudden feelings a syncopye. Lasting a few seconds. Had to grab on to something due to a feeling that I was going to fall. It lasted just a quick second or two. Happened several times that day. Like what I would think a TIA would feel like. Arm was just slightly tender and stinging the first day,. In the night it was aching and hot up into my neck. The next morning it was fine again. Just tender and a little stiff. I attempted to report this on line at instructed on forms given me when I left the site. however the CODE that was to be sent to my phone never came. I then entered the wed site and attempted to report it there. . Finally I called my primary Dr and he has instructed me to report this to the person giving the second injection. I doubt they will know what to do seeing as they are volunteers with little experienc.e
76 2021-03-14 hives, itchy skin Initial nausea, aches and chills and very sore arm. Two days following shot allergic reaction in th... Read more
Initial nausea, aches and chills and very sore arm. Two days following shot allergic reaction in the form of hives and itching on lower extremities and slightly on lower side of upper arms. (No adverse reaction to first shot)
76 2021-03-14 hives, rash Rash; Fever; Rash or hives are on her legs, thighs, neck, back, and head; Rash or hives are on her l... Read more
Rash; Fever; Rash or hives are on her legs, thighs, neck, back, and head; Rash or hives are on her legs, thighs, neck, back, and head; This is a spontaneous report from a contactable nurse (patient husband). A 76-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: solution for injection, Lot Number: EL3247, Expiration date: 31May2021) via an unspecified route of administration in the right arm on 01Feb2021 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient relevant medical history included allergy. The concomitant medication was not reported. The patient previously took septra and experienced allergic to septra (she had taken many years ago. She took something and developed an allergy, but she hasn't used it in maybe 20 years). It was reported that patient received first dose of the Pfizer COVID-19 vaccine on Monday (01Feb2021) and she felt good, then late Tuesday she got a rash at 09:30 (about 30 hours after her injection) and a fever on (02Feb2021), which was listed on the brochure and was kind of expected, but he wanted to be reassured this was ok and not something like a severe allergic reaction. It was reported that patient second dose was scheduled for 22Feb2021. It was reported that patient has been taking Benadryl 25mg, 50mg total a day, 25mg one in the morning and then one in the evening by mouth. The reporter informed that the benadryl (Lot number: P119020, EXP: Feb2022) seems to calm the rash down, though it was more like hives than a rash. It was reported that patient had rash or hives are on her legs, thighs, neck, back, and head on an unknown date in Feb2021. The reporter told that the rash was not getting worse, and Benadryl seems to help it. The reporter told that the vaccine instructions they got said it was possible to get a rash or have a side effect, he just wanted to be reassured. Therapeutic measures were taken as a result of rash, rash or hives are on her legs, thighs, neck, back, and head. The outcome of the event fever was unknown while for other events was recovering.
76 2021-03-14 vaccination site pain tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontan... Read more
tiredness; headache; muscle pain; chills; feeling unwell; injection site soreness; This is a spontaneous report from a contactable nurse (patient herself). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 31Jan2021 at 08:00 AM (at the age of 76-year-old) at a single dose for COVID-19 immunisation. The patient's medical history included coronary artery disease (CAD), hypothyroidism, and sleep apnea. Concomitant medications included levothyroxine, carvedilol, latanoprost, and amlodipine besilate (AMLOD). The patient previously took meperidine (DEMEROL) and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient experienced tiredness, headache, muscle pain, chills, feeling unwell, and injection site soreness on 31Jan2021 09:00 PM. The patient had not taken any other vaccine in 4 weeks. The outcome of the events was recovering. There was no treatment given due to the events. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information on the Lot/Batch number has been requested.
76 2021-03-15 injection site swelling, injection site pain Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the si... Read more
Pain and swelling (about the size of a boiled egg) on the shot site; Pain and swelling (about the size of a boiled egg) on the shot site; Cold hands and feet after receiving shot; My right hand also was numb and needed to be rubbed to increase circulation; Fever; joint aches; headache; This is a spontaneous report from a contactable consumer reported that: A 76-years-old female patient received bnt162b2 (BNT162B2; Manufacturer Pfizer-BioNTech), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (Batch/Lot Number: EL9261) as SINGLE DOSE for COVID-19 immunisation. Medical history included cerebrovascular accident, allergic to sulfa drugs (drug hypersensitivity). The patient received concomitant medications included losartan (LOSARTAN), atorvastatin (ATORVASTATIN), vitamin b12 nos (VITAMIN B 12 [VITAMIN B12 NOS]), acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were unknown. The patient did not receive any other vaccines with in four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 27Jan2021 03:00, the patient experienced Pain and swelling (about the size of a boiled egg) on the shot site. Cold hands and feet after receiving shot, including all night. My right hand also was numb and needed to be rubbed to increase circulation. Fever, joint aches, headache. The patient underwent lab tests and procedures which included body temperature: results unknown .Outcome of the events were recovered on unspecified date.
76 2021-03-15 rash with redness, rash papular Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes.... Read more
Headache first and 2nd day. A week later woke me up 2 nights in a row but only lasted 12-15 minutes. Skipped heart beats day after and the next am, none since. Rash of red irregular dots about the size of a pencil eraser with bumpy raised flesh directly on veins. started 2 weeks after, lasted 4 days, loss of appetite, much more intense joint pain and sleeplessness which comes and goes.
76 2021-03-18 rash, itchy skin onset itching and rash on face and upper chest with headache for 3 days. Rash on face and neck
76 2021-03-20 rash with redness Red rash under left breast and down side; This is a spontaneous report from a contactable consumer, ... Read more
Red rash under left breast and down side; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 15:00 (at the age of 76-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure. Concomitant medications were not reported. Past drug history included known allergies: amoxicillin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021, the patient experienced red rash under left breast and down side. No treatment was provided for the event red rash. The outcome of the event red rash was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
76 2021-03-20 rash macular Bright red blotches on both knees & just below the knees. Seen at 2:15 pm. No other symptoms. Redne... Read more
Bright red blotches on both knees & just below the knees. Seen at 2:15 pm. No other symptoms. Redness is fading now at 3:30 pm.
76 2021-03-20 vaccination site mass Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong ... Read more
Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong muscle and joint aches/pain; fever; White bump near injection site.; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9262 and expiry date: 31May2021) via Intramuscularly to left arm on 22Jan2021 10:30 at single dose for COVID-19 immunization. Patient medical history included bladder infection, blood pressure, she has some old age stuff like blood pressure, and she had Thyroid removed and takes a thyroid pill every day and she tends toward GERD. Concomitant medications included she does take other medications, but they are not relevant. Patient previously took Shingles shot for Shingles (Had the first of the Shingles shot but it was before that. She is due for the second one but she is putting it off for the COVID second dose). Patient reported that she got the COVID vaccine and was really excited because seemingly, she had no side effects. The shot did not hurt. Ten days after she go the shot, she got really hot at night and really strong muscle and joint aches on 31Jan2021. She was up almost all night. It just kept waking her up. So, she took something, an Ibuprofen thing to reduce fever and pain. The next night she took one proactively and did not have pain. The third night, she had it again but it was a headache all night and she was hot on 02Feb2021. It only seemed to happen at night. She felt like it was from the vaccine. She was not worried she had COVID. She had no breathing problems and did not feel like she was going to pass out. They said she should wait 48 hours and take a test to see if she had COVID. She did and it was negative. She does not feel any negativity toward the vaccine. She went in for a bladder infection and it was from a doctor's appointment that she got information and they told her she could go ahead and get it. Since she got the vaccine, she got white bump in the vicinity of the vaccine like a while mole, and another in the vicinity of the area as well. It does not itch or hurt. She noticed it about a week after the shot. She does not know the date. She was still on medication for a bladder infection but it would not have done anything. When she had reaction to the vaccine, it was already 10 days after she got the shot. She had asked them at Kaiser, and they think it was unrelated to any other medication. Outcome of event fever was recovered on 01Feb2021, for white bump near injection site was not recovered and recovering for all other events.
76 2021-03-21 redness, hardening, rash 2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; ex... Read more
2 degree temperature and feeling hot; arm swollen with egg size lump; rash on arm 2inch x 4 inch; extreme fatigue ; red cheeks; and 10 days later JAW HURTING which persists to date
76 2021-03-21 injection site pain Felt much like I did when I had COVID virus and after the first short. In bed for almost 2 days. No ... Read more
Felt much like I did when I had COVID virus and after the first short. In bed for almost 2 days. No fever but just felt awful. Did not eat or do anything. Worst part was the intense pain at injection site in right arm. Pain was excruciating and it took 6 days for it to subside. Sleeping was especially problematic.
76 2021-03-21 injection site pain Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea... Read more
Phizer-BioNTech COVID-19 Vaccine EUA Injection site pain, tiredness, headache, chills, fever, nausea, feeling unwell, dizziness & weakness
76 2021-03-22 shingles ER VISIT X 2 diagnosed with Shingles
76 2021-03-22 injection site redness, injection site bruising, injection site warmth redness and slight bruise at injection site. warm to the touch. began 6 days after 2nd injection. ... Read more
redness and slight bruise at injection site. warm to the touch. began 6 days after 2nd injection. did not notice until 6th day although not sure if it was there before. Monitored the area for side effects 2-3 days after the 2nd injection and only small, slight redness at that time. very little soreness immediately after 2nd injection.
76 2021-03-23 redness Intense pain in left knee. Red and swollen. Reports that she was screaming in pain and couldn't pu... Read more
Intense pain in left knee. Red and swollen. Reports that she was screaming in pain and couldn't put any weight on it. taken by ambulance to ER. They completed a CT Scan and an ultrasound but found nothing. No med given helped with pain. She sent us an email on 3-23 and I called her. She is still experiencing pain (better) but has to use a walker to ambulate.
76 2021-03-24 skin irritation 3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a ... Read more
3/5 Anxiety attack with increased heart rate ...lasted about 20 minutes after taking one half of a cyclobenzaprine and full glass of waterand deep breathing; had another evening of March 10. much shorter duration.. After second shot, day after slight headache and bone tired...tiredness continues to present and my head feels like is has a vise or a helmet on it. Also have developed a kind of dermatitus but don't know for sure if I had it before and didn't realize it. I just want to sit down or lie down...My leg/butt muscles feel not up to the job...and in general thru today I just feel "off". Some days better than others.
76 2021-03-24 injection site pruritus, injection site rash, injection site warmth Patient reports developing an itchy, warm rash at the injection site measuring 3-4 cm.
76 2021-03-24 vaccination site pain Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pai... Read more
Back hurt a tremendous amount; Lower back, hips, knees, neck pain; Lower back, hips, knees, neck pain; When she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes.; Very sore, uncomfortable stomach; Exhausted; Chills; Felt like she was having a heart attack; a bit congested; Aches; jaw pain; facial pain; Quite a bit of saliva in her mouth, it filled up quite a lot; sore on the injection site; Bit of a sore arm/left arm pain; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Right Arm on 02Mar2021 14:26 (Batch/Lot Number: EN619G) as single dose for vaccination. Medical history included joint replacements (specified as 1 hip done in 2007; right knee done in Jan2013; another knee was done in Feb2017; another knee was done in 1986); and in 2011, neck fracture. There were no concomitant medications. The patient had the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE and on 02Mar2021, she had sore on the injection site, experienced excess saliva production. On 05Mar2021, she experienced chills, feeling of heart attack: left arm pain, jaw pain, facial pain. She is worried to take the 2nd shot as she might have more symptoms on the 2nd dose. On an unspecified date, the patient had lower back, hips, knees, neck pain, eye socket hurts when rolling her eyes, sore stomach, and exhausted. It was also reported as follows: on 02Mar2021 after she got home from being administered the Pfizer-BioNTech COVID-19 Vaccine she had quite a bit of saliva in her mouth, it filled up quite a lot; and a bit of a sore arm for a couple of days but that was about it at that point. On Friday, 05Mar2021 she started getting chills and aches; and felt like she was having a heart attack: her left arm hurt and her left side of face hurt down in her jaw. She was afraid and considered going to the hospital but thought she was going to wait it out see what it is and it passed. She then once again got a lot of saliva in her mouth again. Over the next few days she developed aches that were primarily located in her joint replacements, it seemed like the aches attacked those areas of joint replacements in her hips, knees and where she had a neck fracture. She had a lot of pain and a lot of chills. She was never bedridden, but would lay down because she was exhausted. Her back hurt a tremendous amount. Another thing that happened is her eyes, when she would go to move her eyes left or right or up or down it seemed like her eye sockets just hurt to move her eyes; she did not have a headache; this whole indentation there with her eyes hurt to move them from one side to another. She also had a very sore, uncomfortable stomach; it was not an upset stomach; just seemed very sore, uncomfortable. At first that first part of 05Mar2021 she seemed a bit congested. She is very worried about second dose of Pfizer-BioNTech COVID-19 Vaccine because of the first dose creating all of these difficulties. She does not know what she should be doing. She is scheduled to get her second dose of the Pfizer-BioNTech COVID-19 Vaccine on 24Mar2021 because she is leaving by plane on 29Mar2021. That only gives her like 4-5 days before she leaves and she knows that the other symptoms after the first dose of the Pfizer-BioNTech COVID-19 Vaccine did not start until 3 days later. She is concerned about that, because she is flying to take care of her sister; she is worried about the second dose because she does not like what she experienced with the first dose because she heard that the second dose will be terrible; she is worried about leaving and experiencing those horrible things. She reported that there are no tests/investigations relative to this report to provide. The only thing recently done was having X-rays of her neck on 24Feb2021 because of her neck issues with the fractured neck she had in 2011. Outcome of the events was unknown.
76 2021-03-27 injection site warmth, injection site redness, injection site pruritus, injection site rash, injection site pain she did not have a reaction to first. After the second she got very cold and felt miserable like her... Read more
she did not have a reaction to first. After the second she got very cold and felt miserable like her legs had weights on them- this only lasted 1-2 days. Then two weeks later she got a ring around the injection site- and developed intense itching, burning, and erythema and warmth at the site and axillary lymph node swelling. The muscle on her arm were tender and swollen as well. The lymphadenopathy, and arm pain and swelling lasted for over a month. Pfizer : Lot: 12831/8/21 Lot 9261 1/25/21
76 2021-03-27 itchy skin, hives Gradual eruption of hives with worsening itching, almost all on the right side of my body, with even... Read more
Gradual eruption of hives with worsening itching, almost all on the right side of my body, with eventual swelling of my face, mostly on the right side, to the point of nearly closing my right eye.
76 2021-03-27 hives Severe hives since day one
76 2021-03-29 itchy skin, redness, hives She had welts and little red spots all over her back a couple of hours after the second dose of vacc... Read more
She had welts and little red spots all over her back a couple of hours after the second dose of vaccine. She got rubbed down with alcohol and cortisone cream that night. Today, the back welts went away but the red spots are still there. After checking her again around 8:30 p.m. because she complained of her left hand itching, I noticed more welts up her left arms and more came back on her middle and upper back. She was then rubbed down again and given an ibupropean. I am unsure of this side effect because it was not mentioned on any cdc website, so therefore I will be calling her physician to do a checkup. If there is any other information we need to know on how to treat the outbreaks please send email.
76 2021-03-30 itchy skin Tongue Enlargement, tingles around mouth, itchy ears and axillae, shortness of breath - Benadryl 25m... Read more
Tongue Enlargement, tingles around mouth, itchy ears and axillae, shortness of breath - Benadryl 25mg PO given
76 2021-03-30 vaccination site pain On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her... Read more
On Sunday at 10:00PM she checked her temperature and it was 100.6 degrees; she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly; she felt some slight joint pain in her left knee; she didn't feel good; she felt off balance after receiving her second COVID-19 Vaccine dose. She said she only felt off balance the first day after she received her second vaccine shot.; felt a little off; Chills; Ache; Headache; Injection site pain; soreness under her left arm; This is a spontaneous report from a contactable 76-year-old female consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9264), via an unspecified route of administration on 06Feb2021 17:15 at single dose in arm left for covid-19 immunization. The patient historical vaccine included BNT162B2 on 16Jan2021 for COVID-19 immunization and he she had Injection site pain (Lot Number: EL3247, Expiry Date: Unknown, Route: Intramuscular, Anatomical Location: Arm, Left, No. of Previous Doses: None) and about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. On 07Feb2021, the patient woke up and she felt a little off in the morning. On Sunday afternoon, between 1:00-2:00PM, she had chills, felt achy, slight headache and she didn't feel good. She said she was cold, and had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly. She said it dawned on her at 10:00PM Sunday night that maybe she had a temperature. She said she checked her temperature, and it was 100.6 degrees. She said she called to ask a nurse if she could take Tylenol for her fever. She said she had read about not taking Tylenol with the COVID-19 vaccine, but nurse told her it was OK to take Tylenol. She said she felt some slight joint pain in her left knee, too. The patient stated that she had a little bit of injection site pain with her first COVID-19 Vaccine shot. She said she thought the injection site pain was due more to where the COVID-19 Vaccine shot was given, and not from the COVID-19 Vaccine itself. She said with her second COVID-19 Vaccine shot, she had pain at the injection site and soreness under her left arm. The patient took the generic Tylenol Pain Reliever 325mg for her fever and chills. The outcome of the event felt a little off, ache and didn't feel good recovering on an unknown date, chills, headache, temperature was 100.6 degrees resolved on 08Feb2021 and she was cold, had her pajamas on, with a snuggly on top of her pajamas, and a blanket on top of her snuggly were resolved on 08Feb2021. injection site pain and soreness under her left arm resolved on 10Feb2021 and She said she only felt off balance resolved on 07Feb2021.
76 2021-03-30 vaccination site pain she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was fe... Read more
she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick; fall; bladder issue; sinuses; body aches; she was miserable; this was painful than the other shots she has taken; Chills; she was worn out/She was tired; nausea; Malaise/feeling sick; her "armpit" hurting; muscle and joint pain; muscle and joint pain; headache; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCIN) lot number: EL3247, via an unspecified route of administration, administered in left arm on 10Feb2021 as single dose for COVID-19 immunisation. Medical history included multiple sclerosis, Chronic obstructive pulmonary disease (COPD), overactive bladder, osteoporosis, sinus headache, allergies also bother her, back issues, and broken femurs from 2019. Concomitant medications were not reported. The patient received her first dose of the Pfizer COVID vaccine on 10Feb2021 and is due for the second dose tomorrow. The patient stated that she has really heavy reaction from the first dose, she felt like she was dying, fall, bladder issue, had headache, nausea, sinuses, body aches, muscle and joint pain, she was miserable, her "armpit" hurting, this was painful than the other shots she has taken. The patient wanted to know if its ok to take her nebulizer and other pain medications she is taking generic for Norco. The patient clarified that she had headaches, feelings with her muscles and joint, nausea, and then there was the big symptoms that hit her, she felt like she was dying, it was a strange feeling, like out of body feeling, she knew she was feeling sick. She herself didn't know what was wrong and so she couldn't go to the ER, she doesn't know what this is, it lasted 24 or more hours. The patient stated that it was the malaise, she's never had malaise before, it scared her. She is getting the second dose tomorrow and she is scared to death. The headache, muscle and joint pain and armpit hurting started 10Feb2021 while nausea and malaise/feeling sick started on 11Feb2021. The patient recovered from the event armpit hurting and malaise/feeling sick on an unspecified date. The outcome of the event headache, muscle and joint pain, was not recovered. The outcome of other events was unknown.
76 2021-03-31 vaccination site pain transferred from shoulder to her neck; shoulder was in pain/ elbow and shoulder were in pain; inject... Read more
transferred from shoulder to her neck; shoulder was in pain/ elbow and shoulder were in pain; injection area is a little sore; I cant sleep at night; She can't position her arm in a way that is not painful; deep muscle ache pain; she was miserable; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9266, expiration date: Mar2021), via an unspecified route of administration in left arm on 23Feb2021 as single dose for COVID-19 immunization. Patient's medical history included stomach problem and bleeding problems in her stomach. There were no concomitant medications. The patient said that absolutely everything was okay until she went to get the shot, and was even okay the evening of the shot, then it went down hill from there. She said nothing she has that is related to the pain in her arm, or that she feels she should provide. She did not had any other recent vaccinations or started any new medications. The patient stated that the injection area was a little sore and the area became bigger and bigger by Wednesday (24Feb2021). She woke up on Thursday (25Feb2021) and her elbow and shoulder was in pain, described as a dull pain. The patient stated she has a stomach problem where she can't take medicine. She started treating her pain with aspirin cream with Lidocaine. She said that its kind of worked, it didn't take it away, but more manageable. Now it's been 6 days later (01Mar2021), it was reported a deep deep pain in the point she can't sleep at night. She can't position her arm in a way that is not painful. It was getting unbearable. It transferred from shoulder to her neck on Friday (26Feb2021). It got worse Thursday evening and has been the same since. Patient said, "I am not going to get the second shot if this pain does not go away or if I am going to experience this again." The patient was calling about a possible side effect and was wondering if anyone else had it and does it go away. She was suffering, she wanted to know if the pain she is in, that she is still experiencing will go away. She said that she had a deep muscle ache pain to the point she can't sleep at night. Patient stated that her pain began as soreness at injection site that started Wednesday and then it just got worse and worse and became deeper and deeper just between her shoulder and elbow, a deep constant achy pain. During the day when she is using her arm she can kind of forget the pain, but at night there was no comfortable position she can put her arm in without pain, so she has not been sleeping the last 3-4 nights, she can't sleep, she was miserable. She said she would rather get COVID than this, it was ridiculous. As she has bleeding problems in her stomach, she can't take anything to treat the pain, so she was trying to use lidocaine on her arm, which did at first give some relief but no longer works. She said that the only number listed on the bottle was next to "EXP date, LOT: 19C506, EXP: Mar2021 (as reported)." The outcome of the events was not recovered.
76 2021-04-02 vaccination site pain nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in m... Read more
nauseas; hot flashes; slight sore throat; feel a little punk; slight soreness at injection site in my left arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: Batch/Lot Number: EL9264; Expiration Date: unknown), dose 1 via an unspecified route of administration in Arm Left on 04Feb2021 09:00 as SINGLE DOSE for COVID-19 immunization. Medical history was unknown. There were no concomitant medications. The patient experienced slight soreness at injection site in my left arm (vaccination site pain) on 04Feb2021 with outcome of recovered, feel a little punk on 08Feb2021 with outcome of unknown, nausea, hot flashes, slight sore throat on 09Feb2021 with outcome of not recovered. The patient is scheduled for the second dose on 25Feb2021. No follow-up attempts are possible. No information is required.
76 2021-04-03 injection site redness, itchy skin, injection site swelling redness and swelling at the injection site however this morning she woke up and it was itchy; rednes... Read more
redness and swelling at the injection site however this morning she woke up and it was itchy; redness and swelling at the injection site however this morning she woke up and it was itchy; redness and swelling at the injection site however this morning she woke up and it was itchy; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number; EL3249), NDC number, expiry date; unknown, Is COVID vaccine a Pfizer product; Yes, COVID vaccine manufacturer; unspecified via an unspecified route of administration from 01Feb2021 to 01Feb2021 at single dose on right arm (by injection once to right hand shoulder) for prevent from getting COVID. Identification of the country where the drug was obtained. Country of authorization/application;. Patient (weight; 60.78 kgs, height; 163 cm) was 76 years old at the time of vaccination. Patient's medical history and concomitant medications were not reported (Other Products; No, Patient History; No). Caller received the vaccine on 01Feb2021 and experienced right away the redness and swelling at the injection site however this morning she woke up and it was itchy, as well as the redness and swelling. Caller had Pfizer shot two weeks ago, the COVID vaccine, everything was fine, but this morning, on 09Feb2021 her arm is itching, red, and swollen at the shot area, is that normal? Reporter email address declined. She stated it was itching really bad, she got her bath, and it looked red and swollen and was sore. Primary care doctor's address, phone number, and email address unknown. Vaccine card has the return shot date of 15Feb2021, the card doesn't have the date of the first shot. The outcome of events was not recovered.
76 2021-04-03 itchy skin Itching mostly on face and scalp.; This is as spontaneous report received from a contactable consume... Read more
Itching mostly on face and scalp.; This is as spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264) via unspecified route of administration in the right arm on 11Feb2021 at 01:00 PM (at the age of 76-years-old) as a single dose for COVID-19 immunization. Patient's medical history included glaucoma, dry eye and allergy to tetracyclin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included hydrochlorothiazide, omeprazole, alendronate and latanoprost. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took Restasis, dorzolamide thymol, PredMild, Rhopressa, Latanoprost, Artificialtears, Night gel, Biaxin and expereinced allergy. On 12Feb2021 the patient had itching mostly on face and scalp. No teatment was given to the event. Outcome of event was resolving.
76 2021-04-05 itchy skin Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially... Read more
Pfizer-BioN Tech COVID-19 Vaccine EUA: Swelling in mouth/lips, severe itching (all over, especially legs, thighs, back, arms, scalp, eyebrows and in nostrils, sensitivity to sound, elevated blood pressure, swelling in ankles, nausea
76 2021-04-07 rash She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st ... Read more
She got the vaccine, when she came home she started feeling the fatigue that she felt after the 1st vaccine. She then started feeling very cold, laid down and watched TV. She then had chills all night and did not sleep well due to that. When she got up on Tuesday the chills were gone but had a slight headache off and on throughout the day, her temp was 97.2. Throughout the day she would get warm spurts/hot flashes, as well as fatigue. She did sleep that night, and when she got up yesterday morning still had the hot flashes and it was 94.2, and took it twice due to it being so low. She was like that with fatigue and not able to sit up. She went to bed, took some Tylenol and rested. The heat feeling it started going away. Around dinner time she felt more like herself, the headache was gone and her temp was 97. She was doing pretty good, and the last thing she had was she felt on her cheeks and noticed a rash on her face, like a prickly heat type rash. Before she went to bed she put Neosporin on it, and when she got up this morning it was almost gone but still has a tiny few bumps. The arm itself did not hurt at all. Feels that it is a stressful situation as to where to get the vaccine and having to travel to get it as it's not available in locations closer to their homes. The people at the pharmacy were great, but had to travel and if it wasn't for her daughter she would probably not have her shot.
76 2021-04-09 redness, rash macular I have a huge red spot on one and I have the little dots, red dots on the other; I have a huge red s... Read more
I have a huge red spot on one and I have the little dots, red dots on the other; I have a huge red spot on one and I have the little dots, red dots on the other; This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration date: Unknown) via an unspecified route of administration on 18Feb2021 (at the age of 76-year-old) as single dose for covid-19 immunization. On unspecified date the patient reported to have a huge red spot on one and little dots, red dots on the other (Rash macular/Erythema). The outcome of the events was unknown. Information on the lot/batch number has been requested.
76 2021-04-09 rash Right side of face swollen so the eye was almost invisible; rash on face, neck and hands, some on th... Read more
Right side of face swollen so the eye was almost invisible; rash on face, neck and hands, some on the upper right back; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP6955, expiry date: unknown), via an unspecified route of administration in the right arm, on 19Mar2021 08:30, as single dose, for COVID-19 immunisation. Medical history included Alpha gal (allergic to all mammal protein). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. Concomitant medications included hydrochlorothiazide; pravastatin sodium (PRAVASTINE); famotidine (PEPCID AC); and loratadine, all taken for unspecified indications, start and stop dates were not reported. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: En6200, expiry date: unknown), via an unspecified route of administration in the left arm, on 22Feb2021 08:45, as single dose, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. On 19Mar2021 at 12:30, the patient experienced right side of face swollen so the eye was almost invisible, rash on face, neck and hands, some on the upper right back. The events resulted to emergency room visit. Treatment included prednisone and Benadryl. The patient was recovering from the events.
76 2021-04-09 vaccination site itchiness, vaccination site redness Itching/itching at the injection site; injection site and area around it is really red; This is a sp... Read more
Itching/itching at the injection site; injection site and area around it is really red; This is a spontaneous case received report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 20Feb2021 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history and concomitant medications were not reported. No prior vaccines were administered within 4 weeks. The patient experienced injection site and area around it was really red on 21Feb2021; itching/itching at the injection site on 22Feb2021. The patient did not undergo any lab data or investigations. The outcome of the events were not recovered. Follow-up attempts are completed. No further information is expected.
76 2021-04-13 redness Patient noted that 2 days after vaccination that her left shoulder became very sore and achy. She wa... Read more
Patient noted that 2 days after vaccination that her left shoulder became very sore and achy. She was unable to left her shoulder. She denied redness or swelling at the site. Used tylenol. Did not contact MD. States her shoulder hurt for approx. 3 weeks post vaccination. Was massaging her arm to help relieve pain and it eventually felt better. Also shared that her left thumb also was sore and reddened post vaccination but unsure if it was related. Does not recall an injury.
76 2021-04-13 shingles, itchy skin, rash One week after last shot developed shingles. treatment to date consist of at home methods to reduc... Read more
One week after last shot developed shingles. treatment to date consist of at home methods to reduce pain and itching along path from back to center to edge of right breast. All rash is on my right side. Seven days since beginning of rash which proceeded by five days of back pain before realizing what was happening. Tried acetaminophen for pain relieve but developed a rash on arms and legs with intense itching and had never had a reaction before to this medicine. My immune system is not acting as it normally does.
76 2021-04-13 rash, skin spots Petechiae below the right knee. Per the patient, she also experienced this same rash when she had CO... Read more
Petechiae below the right knee. Per the patient, she also experienced this same rash when she had COVID-19 disease back in December 2020.
76 2021-04-16 itchy skin, redness It was very sore; Getting a reaction and it started to turn red; it keeps spreading on my arm it's f... Read more
It was very sore; Getting a reaction and it started to turn red; it keeps spreading on my arm it's from below where the shot was; Going around the arm and it's kind of like a burning itch; it is annoying; little redness on my arm; allergic to the preservatives in the vaccine; Going around the arm and it's kind of like a burning itch; it is annoying; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 17Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing cholesterol. Concomitant medication included rosuvastatin taken for cholesterol, start and stop date were not reported. Historical vaccine included FLU for patient had a Flu Shot but it only got little red, little redness on my arm and first dose of BNT162B2 (Lot number: EN6200, Expiration date: Jun2021) via an unspecified route of administration on 27Jan2021 for Covid-19 immunization. Patient stated, "patient got the Pfizer second shot on Wednesday (Clarified as 17Feb2021) patient arm didn't start to bother me or it was very sore (Further clarification was unknown if consumer's arm was sore or not, hence captured as event) but then on Friday patient noticed patient was getting a reaction and it started to turn red so patient had an allergic reaction to it, except that it keeps spreading on patient arm it's from below where the shot was, it didn't hit the elbow yet but it is going around the arm and it's kind of like a burning itch it's not something terrible it's not something patient cannot deal with but patient was concerned about it and patient wondering if there is something patient can take or do because it is annoying on 19Feb2021" Patient believe because patient had a Flu Shot (Captured as provided) but it only got little red. patient think patient was allergic to the preservatives in the vaccine (COVID-19 Vaccine) because a friends of my works in a doctor's office and she was with me and she said I am probably allergic to, what you call the preservatives in the vaccine." Patient stated, "No it's been a while, it's been, you know it was just a little redness on my arm on 19Feb2021." Patient received a treatment that put some Ice on its last night and then patient took a Benadryl, you know generic Benadryl from a Walmart. The patient underwent lab tests and procedures which included Cholesterol and Urine: unknown results on an unspecified date in 2021. The outcome of the events was unknown. Information on Batch/Lot number has been requested
76 2021-04-19 rash rash that started on the left arm 2 days after the injection. monitoring the rash for now. it is asy... Read more
rash that started on the left arm 2 days after the injection. monitoring the rash for now. it is asymptomatic outside of pink rash with slightly raised border
76 2021-04-21 shingles Two weeks after receiving vaccine, experiencing severe pain in under left breast, radiating around ... Read more
Two weeks after receiving vaccine, experiencing severe pain in under left breast, radiating around to the back. Chest pain and some breathlessness. I took her to the ER , on March 27, 2021, thinking it might be her heart. She was admitted for observation. She broke out with a severe case of shingles the next day, 3/28/21. She had been fully vaccinated for Shingles two years before (Shingrix).
76 2021-04-21 rash significant rash on chest - treatment unknown
76 2021-04-24 injection site pain, injection site redness Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; N... Read more
Injection site pain; Tiredness; Headache; Chills; Fever was 101.6; Injection site redness; Nausea; Not feeling well; Felt bad; Weakness; Soreness arm; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer (patient) reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 21Feb2021 at single dose for COVID-19 immunisation. Medical history included Pulmonary hypertension and high blood pressure from an unknown date and unknown if ongoing. Patient previously took first dose of vaccine for Covid-19 immunisation. Concomitant medication not reported. When probed for the concern, consumer stated, "I was just calling to pass on my experience with the second vaccine. I ended up having all of the side effects that you had listed. I have injection site pain and redness and it still is as up today and I had the injection on Tuesday (23Feb2021). I had tiredness, headache, chills, fever and my fever was 101.6, injection site redness, nausea and basically not feeling well and I also had some weakness and I think that was because, I mean I felt so bad I was pretty much in bed and today is my first day up since Tuesday." The patient underwent lab tests and procedures on unspecified date which included Body temperature: 101.6. The outcome of the events Injection site redness, Soreness arm was reported as not recovered and outcome for other events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
76 2021-04-24 rash rash; This is a spontaneous report from a contactable consumer reported in response to Non-HCP follo... Read more
rash; This is a spontaneous report from a contactable consumer reported in response to Non-HCP follow-up letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation causes pain, right knee-could barely walk and all of her joints that had been previously hurt in the past started killing her. The patient experienced rash on 16Feb2021. The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was recovered. Information on the lot/batch number has been requested.
76 2021-04-24 rash Extreme pain, went to ER and morphine didn't do anything so they gave me something stronger than mor... Read more
Extreme pain, went to ER and morphine didn't do anything so they gave me something stronger than morphine. Was released and sent home to which the pain got so bad when the med wore off that the following morning I was in the ER again. I also had a fever of 102.3 and a rash (red bumps all over my chest, stomach, back of neck and shoulder back area, nausea, chills. this lasted exactly for 5 days and then was gone.
76 2021-04-24 vaccination site pain Only has a little pain on my arm where I was given the shot; This is a spontaneous report from a con... Read more
Only has a little pain on my arm where I was given the shot; This is a spontaneous report from a contactable consumer reported for herself in response to Non-HCP letter sent in cross reference case. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included heart rate increased, blood cholesterol increased, hypertension from an unknown date and unknown if ongoing. Concomitant medications included ongoing metoprolol 25mg, twice daily, lisinopril 5mg once daily from Jun2020 for hypertension, ongoing atorvastatin (LIPITOR (ATORVASTATIN) 20 mg once daily from Jun2020 for blood cholesterol increased, ongoing levothyroxine, diphenhydramine hydrochloride (BENADRYL) from an unknown date to unknown date for unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection), dose 1 via an unspecified route of administration (Lot number: EL9261) as SINGLE DOSE for covid-19 immunisation causes rapid heartbeat was monitored, it keep going up and down/went to the emergency room. The patient only has a little pain on my arm where i was given the shot on an unspecified date. Drank a lot of water before after shot, Nurse suggested taking Benadryl after the shot which I did and had no reaction. The patient underwent lab tests and procedures which included heart rate increased: 135-120-110 bpm (Normal BPM 55-65 was up to 135-120-110 etc after vaccine (1st shot)), heart rate normal: 55-65 bpm (Normal BPM 55-65). The action taken in response to the event for bnt162b2 was not applicable. The outcome of event was unknown. Information about batch/lot number has been requested.
76 2021-04-24 vaccination site itchiness, rash Rash; itching from the injection site; pain on right arm; swelling on the Right arm; This is a spont... Read more
Rash; itching from the injection site; pain on right arm; swelling on the Right arm; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (BNT162B2, Lot Number: EN6200), dose 2 via an unspecified route of administration, administered in Arm Right on 20Feb2021 13:15 as SINGLE DOSE for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing Verbatim: Asthma, hypersensitivity from an unknown date and unknown if ongoing Verbatim: Allergy. On 22Feb2021, the patient experienced rash, itching from the injection site, pain on right arm, swelling on the right arm. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of rash. The outcome of the event rash was recovering, and rest event outcome was unknown. No follow-up attempts are possible. No further information is expected.
76 2021-04-26 shingles Facial and eye Shingles began (4/16/21) three weeks after second shot. Saw PA of Dermatology and r... Read more
Facial and eye Shingles began (4/16/21) three weeks after second shot. Saw PA of Dermatology and received Valacyclovir. Saw Dr. OD and received Prednisolone. Saw of Wellness Center and received more Valacyclovir.
76 2021-04-26 shingles Severe case of Shingles; This is a spontaneous report from a contactable consumer (patient). This 76... Read more
Severe case of Shingles; This is a spontaneous report from a contactable consumer (patient). This 76-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration in the left arm on 06Feb2021 at 09:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure from an unknown date and unknown if ongoing. Prior to vaccination the patient had not been diagnosed with COVID-19 and had not received any other vaccines with 4-weeks prior to the COVID vaccine. The patient had no allergies to medications, food or other products. Concomitant medications included amlodipine besylate from an unknown date for an unknown indication. The patient previously received the first dose of BNT162B2 (lot number unknown) on 16Jan2021 at 09:30 (at the age of 76-years-old) in the left arm for COVID-19 immunisation. The patient reported she contracted a severe case of shingles on 12Mar (2021). The event required a doctor or other healthcare professional office/clinic visit and the patient was treated with valacyclovir. The clinical outcome of shingles was not recovered. It was also reported that since vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
76 2021-04-26 rash, itchy skin, eczema eczema; had rash and itching on the front of her chest and stomach area and spreaded all over the fr... Read more
eczema; had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back; had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back; This is a spontaneous report received from a contactable health care professional (patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9265, Expiry date: Unknown) on 28Jan2021 at 11:40 (at the age of 76-years-old) via unknown route at single dose on high on left upper arm for COVID-19 immunization. Relevant medical history included cold sores in nose and mouth. The patient was allergic to morphine and the morphine family drug. She had reaction when she had her hysterectomy (Occurred just one time and was years ago). The patient takes one prescription for her thyroid. The patient also had a medical history of Herpes and shingles. On the same date 28Jan2021, after 4 to 6 hours of vaccination (at 16:00 to 17:00) the patient had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back. The patient did not have rash on arms and legs, only on torso. She had no trouble in breathing and swelling. The patient also had eczema immediately after the COVID-19 Vaccination and she does not know her stress might have triggered it.The patient wants to know whether she should receive the second dose and if the second dose would cause a worse reaction than the first time. The patient prescribing physician told it did not sound like anything serious, just a mild reaction. A week later the patient went to dermatologist. Both her doctor and dermatologist stated it does not sound like it was severe. The patient's dermatologist stated it was a mild reaction rash and itching and told her it was fine to receive the second dose. The patient to get a steroid cream to get rid of the itch and rash. The patient was anxiety and stuff from not living normally. The patient worked in a retirement and nursing home for a very short time, but was never a physician, pharmacist, or nurse. She received treatment with triamcinolone ointment 0.1 percent. The action taken in response to the event(s) for BNT162B2 was not applicable. Outcome of the events ‘had rash and itching on the front of her chest and stomach area and spreaded all over the front and then went to the back' and eczema was unknown.
76 2021-04-27 hives, rash, itchy skin Rash; would call it hives; very itchy; Rash; would call it hives; very itchy; Rash; would call it hi... Read more
Rash; would call it hives; very itchy; Rash; would call it hives; very itchy; Rash; would call it hives; very itchy; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for 02 patients (wife and Husband). This is 1st of 02 reports. A 76-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 04Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included type 2 diabetes was diagnosed A lot of years ago, she thinks in 1995, heart problem. Concomitant medication(s) included insulin (INSULIN) taken for an unspecified indication, start and stop date were not reported. Insulin was administered via pen, once a night. The patient stated that for diabetes, she takes a lot of medications and there are several of them. Consumer further stated that she has preventives for heart problem. She has been using and is on them permanently. Consumer stated, "They are all taken orally." She thinks her weight, it's like 180 pounds somewhere around there and she was not sure. The patient experienced rash; would call it hives; very itchy in Feb2021. Consumer stated, she had a side effect but she don't know if it's a side effect that you have. It's not listed on the sheet that she got when she got her shot of our vaccination. The patient had a rash. She would call it hives. They itch like double. There were a couple of on her right shoulder, she had two on the back of her left calf, on her leg and she had on her whole left arm where the vaccination shot was put in, completely covered in hives and they were very itchy. Consumer further stated that she wants to know what to do about it. The itch was like double, and this had been day 4 and she had the last, the second vaccination on 4th Feb on left upper arm. She wanted to get rid of these hives. They were driving her nuts. Consumer stated, 4 days ago, 19Feb 2021, somewhere around that she started having the events. Consumer further stated that she wants somebody to tell her what she was supposed to do. She don't want to go through all this stuff. She enquired what to do about these hives. The patient had got Calamine lotion, it's calamine topical suppressant and she had got Wal-dryl, it's a generic for Benadryl as treatment. The patient was still experiencing the adverse events and stated otherwise she wouldn't be calling. They were still there, it's still driving her nuts. The patient has not done lab test. She has got to do it another month. Outcome of the events was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021219067 same drug/same event, different patient.
76 2021-04-27 vaccination site pain Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depressio... Read more
Her legs got weak; she lost coordination; anxiety was exacerbated by her terrible fatigue; depression was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; nervousness was exacerbated by her terrible fatigue; She noticed that her blood pressure raised after receiving the first dose of the covid vaccine.; Total exhaustion/she is so tired; could not sleep; She experienced pain at the injection site./Her pain got worse and worse; left or right toe will get stuck; hysterical; she is stressed; did not have complete energy; She states that her illness is too much; This is a spontaneous report from a Pfizer sponsored program received from a contactable healthcare professional (patient). A 76-year-old female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 1 intramuscularly administered in the right deltoid on 30Mar2021 10:00 (Lot number: GR8732 or 6R8732 [as reported]; Expiration Date: 31Jul2021) as a single dose for covid-19 immunisation. Medical history included blood pressure/hypertension; had breast cancer twice with the last time was in 2010 to unknown date which was 23 years later than the first time she had it (1987). She had infiltrating ductal cancer, stage one, that was HER-2 positive. She states that this is the most malignant breast cancer. She had to have extensive chemotherapy and also took Herceptin every 3 weeks for a year. The overriding symptom from her cancer was extreme fatigue; has been in chronic fatigue syndrome and in bed for 7 years, she was getting over chemo and she can barely walk. She has trouble walking long distances; had a mastectomy from 2010 to an unknown date without lymph node dissection; had a central node dissection; took a wheelchair to the hospital whenever she received the first dose of the covid vaccine; ongoing anxiety, depression and nervousness which is not new to her. She has had this on and off for the past year; and antihistamine that raises her blood pressure dangerously, it does not matter which kind of antihistamine whether it is Benadryl or over the counter. The only antihistamine that does not raise her blood pressure was a children's allergy medication. She took half of a children's dose. It did not raise her blood pressure, but it did not stop her itching. Family history included her mother's sister and she are very sensitive to medications. She has the same type of problems. As her mother's sister has aged, her problems have gotten better. As caller gets older, her problems are getting worse. Concomitant medication included carvedilol taken for blood pressure on unknown therapy dates. The patient previously took dupilumab (DUPIXENT) for skin conditions that having itching which she had side effects (Lot number: 0LU23A; Expiration date: Feb2023). Dupixent is a medication used for skin conditions that having itching, not cirrhosis, she cannot remember the name of the skin condition. Her skin started itching around Jun2020 or Jul2020. She saw eight different dermatologists. She found a doctor who was an itch specialist. Dupixent is the only thing that is going to work for her because antihistamines raise her blood pressure dangerously; and one time her doctor made a mistake, he ordered her hydroxyzine 25mg PO (Per oral). The doctor did not look on her chart to see her allergy list. She cut the pill in half and took half a dose. By the time she realized what she took, she was having so much itching. She woke up and felt like her head was going to explode and her blood pressure was 220/112. She took three tablets of her antihypertensive medication. She taken carvedilol 3.125mg. She did not even bother going to the hospital because by the time they would have saw her, and treated her, she could have had a stroke. The hospital is slow to treat people. Because she is a nurse practitioner, she knew that 3 tablets would be the correct dose for how high (Apr2021) her blood pressure was. She also previously took Benadryl but that raises her blood pressure dangerously. The patient reported that she received her first dose of the covid vaccine on 30Mar2021 and she had many side effects. She reported that the most predominant symptom is total exhaustion. For the first seven days after receiving the first dose of the covid vaccine, she was in bed for seven days nonstop. She placed a large grocery shopping order. She was able to get up and use the bathroom and cook small meals. She had someone come in to help her with the dishes, and to clean up the house. She talked to her internist of 20 years, and he told her to take the vaccine. Within five minutes, she started getting side effects. She inquired if it was safe to take the second dose of the covid vaccine. She has been so fatigued that she has been in bed for a 3 weeks-time frame and then her Blood pressure went up, it was 200 something, like 223/103. She went to the ER, and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room, and because she waited so long, she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She added that the second week after receiving the first dose of the covid vaccine, she was able to get up every other day and go somewhere but the next day after she went somewhere, she was in bed all day and did not have complete energy (2021). She added that her refrigerator was going out, so someone drove her to department store 30 minutes away. She walked from the car, to the refrigerator section in department store, walked into the mall to get ice cream and then walked back to the car. By the time she got home, she immediately got back in her bed because she was so worn out. That was on Saturday. She was in bed all day yesterday. This morning, she feels better than yesterday. She thought about going to the store yesterday, but she knew she did not have the energy to go. Someone is coming later today to help her, and they will have to go to the store for her since she does not have any family nearby. She mentioned that the total exhaustion began on 31Mar2021. She took a wheelchair to the hospital whenever she received the first dose of the covid vaccine. She has trouble walking long distances. She called the hospital before she went, and the hospital did not have any wheelchairs she could use. The hospital cleared everything out of the way so they could fit the most patients as possible in the building. She had trouble walking the day that she received her first dose of the covid vaccine. Someone wheeled her in and out using her own wheelchair. She cannot go to the grocery store. Using a wheelchair is the only way she could have in and out. She could walk from her wheelchair into the examination room, and then after she went right back into her wheelchair. She is glad that she called because she does not know what she would have done without a wheelchair. It is hard for her to go on, sometimes she just feels like crying. Her trouble walking does not feel 100 percent, but it has gotten better. She is anxious, depressed and nervous also. Before her breast cancer, she had chronic fatigue. She could volunteer at a clinic for a few hours a week. She had radiation, and that caused exacerbation of her chronic fatigue. Her doctor told her that for some people, chemotherapy will make chronic fatigue better and that chemotherapy could help her chronic fatigue. Before she got chronic fatigue syndrome, she had a lot of energy. She used to work in an ICU that had 15 patients, with ambulatory patients on the outside. She worked six days a week then she transferred to a hospital where she took care of patients after they had open heart surgery. She used to be a very high energy person. Her exhaustion has gotten better, because she can get up every other day and leave the house. She cannot stop doing life. It is difficult for her that she cannot go to the grocery store. After seven days, she could go out every other day. Whenever she went to a certain company, she almost fell. Her legs got weak and she lost coordination on Tuesday (06Apr2021). Since then, it has happened a little bit here and there. It is almost like she is not sure when it will happen. In an instance, she can be working in the house, and her left or right toe will get stuck. This happens to her occasionally after chemotherapy. She noticed that her blood pressure raised after receiving the first dose of the covid vaccine (Apr2021) and she takes medication (small dose of carvedilol) for hypertension. She takes her blood pressure medication every other day. Out of the past four days, her blood pressure has been elevated twice (Apr2021). If her blood pressure is elevated more than normal, her doctor prescribed for her to take an extra dose. Her blood pressure has not been elevated dramatically. She did take an extra dose of carvedilol because her blood pressure was within the scope of her blood pressure expertise. She went to the ER and the ER said her blood pressure was not bad (Apr2021), they put her in the waiting room and because she waited so long she just got up and left the ER. Since she is so tired and her Blood pressure is high, she has made an appointment with the doctor. She also stated that her blood pressure went up yesterday last night (18Apr2021), not right after getting the first dose. Last night at 6:00 PM, she took a nap and after she woke up took her blood pressure, she didn't feel anything in specific, she always takes her blood Pressure pill twice a day anyway. When she checked her pressure, it was 223/120 (Apr2021) and immediately took 2 Carvedilol 3.125mg and went to the ER, by the time she got there it was down significantly (Apr2021), but she is anxious and sat there and waited. They said they were going to do some blood work and an EKG but they left her there, so she decided to take a company home. Her Blood pressure has been up, she then went to sleep and after (Apr2021), it was 189/105, 183/105, and 165/95, she is a nervous wreck. She was ill for a long time, she had cancer twice, now she lives alone, she has been alone for all these weeks, her friends are here and there and come over. The Last 3 weeks she has been alone. She hired someone, but it was expensive. Now she feels hysterical (2021), after she saw her blood pressure, last night she was crying, and called the neighbor and they drove her right to the hospital then she was waiting in the ER for so long. She got her first shot on 30Mar2021 and she couldn't do anything in bed for 7 days, she is supposed to get the second shot tomorrow (20Apr2021) but doesn't want to be in bed again like that. She is anxious, depressed and nervous that began on 03Apr2021. During the week, she is distracted by the market. She has not been able to trade, because she does not trust her judgment right now. She did buy one this morning. Anxiety, depression and nervousness is not new to her which she has had this on and off for the past year. She has a lot going on. She needed to sell her two-story house and move to a one-story house that is easily assessable to healthcare and meals. She thinks this is disabling in face that she does not feel strong enough to make a decision. She cannot make a decision and she does not feel good enough too. Her anxiety, depression and nervousness was exacerbated by her terrible fatigue. She is experiencing awful symptoms. She went to the grocery store, and the stumbled and went into a company. She had to carry her milk and other items in slowly, and little by little. She thought this is awful, and she got into bed. She could not do anything. She mentioned that her illness is too much (2021). She was crying and she lives alone. The patient mentioned that the pain at the injection site began four hours after receiving the first dose of the covid vaccine. She received the vaccine at 10:00 AM then started getting really bad pain about 6:00 PM and then about 10:00PM or 11:00PM, it started to get unbearable. By 12:00AM (31Mar2021), the pain was so bad that she could not sleep because of the pain. She was in agony. She took took Tylenol and it did not touch her pain, but her pain got worse and worse, so she took three Tylenol tablets then they worked. She her friend and asked him to come over since she is afraid to take narcotics. She just laid there in bed and spent all night in agony. She tried a thing she put in the freezer and tried heat. She does not remember if either of those worked. The pain resolved about 2 days after. The patient declined safety report, saying that she is stressed and anxious (2021), she just wants to be transferred for her question. The reporter considered the events fatigue aggravated serious and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as medically significant. The outcome of the events fatigue aggravated recovering; as for the events blood pressure raised, 'anxiety, depression and nervousness was exacerbated by her terrible fatigue', lower extremities weakness of and coordination impaired were not recovered; while the event vaccination site pain was recovered on 01Apr2021 (reported as 2 days after). The outcome of the other events was unknown.; Sender's Comments: Based on the information provided, the events fatigue aggravated and 'anxiety, depression and nervousness was exacerbated by her terrible fatigue' with seriousness criterion of disability while the events blood pressure raised lower extremities weakness of and coordination impaired as serious (IME).Based on the plausible temporal association and product safety profile, the reported events are possibly related to the vaccine BNT162B2. administration. This case will be reassessed upon receipt of additional information.
76 2021-04-29 itchy rash March 10, 2021 I received my second dose of the Pfizer vaccine and the following day I experienced t... Read more
March 10, 2021 I received my second dose of the Pfizer vaccine and the following day I experienced the predicted side effects of fever, chills, headache, fatigue and lack of appetite, which were all mild and I took Tylenol for the fever. The following day I was fine. After approximately two weeks I noticed there were subtle and unusual changes regarding my appetite, energy level an itchy rash on my back and a runny nose. I didn?t pay much attention to any of these as they weren?t debilitating symptoms, but very unique for me. Then I realized I needed to pay more attention to these symptoms as they were getting more significant, except for the fact I didn?t have a fever. Also my ears felt they were blocked. I thought perhaps because of the feeling of blocked ears I may be getting a sinus infection although I haven?t had one in years. I called the doctor?s office on April 5th and I was told to go to the Urgent Care, which I did. I was examined and given a prescription for a nasal spray, antihistamine and an antibiotic in case symptoms became more severe. It was also suggested that I may want to have a Covid test. I?m not used to taking any medications except for Trazodone, and was reluctant to take what was prescribed because if it was indeed a sinus infection it wasn?t in line with any I?d had years ago. I used the nasal spray for a few days and also the antihistamine. The headache got worse, and would move from one area of my head to another and also down the side of my face and neck. Tylenol didn?t help and Ibuprofen only helped now and again. The headache had a mind of its own. Warm compresses did help. I was in contact through the portal for recommendations from the medical staff.
76 2021-04-30 rash, redness Caller states it was very low, didn't think much of it, then it got worse.; she got a severe rash al... Read more
Caller states it was very low, didn't think much of it, then it got worse.; she got a severe rash all over her body; she has her neck and back in flame red color with spots; This is a spontaneous report received from a contactable consumer (reporting on herself). A 76-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and Expiry date was not reported), via an unspecified route of administration on 01Apr2021 14:00 as single dose for COVID-19 immunization. Medical history included blood pressure measurement from an unknown date and unknown if ongoing. Concomitant medication(s) included oxytetracycline (TERRAMYCINE [OXYTETRACYCLINE]) taken for blood pressure measurement, start and stop date were not reported. patient got the first dose of the BNT162B2 on 01Apr2021 and she got a severe rash all over her body: she has her neck and back in flame red color with spots on her body and spots on her legs. She wants to know if she can take, Benadryl. Patient mentions that she was sorry the she got the shot and if she knew all the trouble she had to go through he would have never got it. She says that she will not going for the second shot after this. Aside this she mentioned that she was tired of being on the phone for 45 min while waiting for someone. And wanted to know if her insurance covered the vaccination or how does it worked. Patient states she has a bad knee and doesn't have it with her right now. Patient states she takes blood pressure pills but she feels okay. Patient states it was Terramycin, the generic. The outcome of the events she got a severe rash all over her body and she has her neck and back in flame red color with spots was not recovered and for event Caller states it was very low, didn't think much of it, then it got worse was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
76 2021-05-04 dry skin, rash with redness, rash, itchy skin, hives, skin mass she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin under... Read more
she has a little bit of skin that is very dry; Pain under breastbone; Welts; lumps in her skin underneath; Swelling: lips, face swollen, arms, hands, fingers, left foot, left kneecap left thigh, feet swelled up like a balloon; Fingertips felt tingley; rash on her palm, a red circle; hand was hot and itchy; hand was hot and itchy; Tired and exhausted; toes feel puffy; urinary tract infection; not sleeping; Rash, painful; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Feb2021 (Lot number: EL9262; Expiration date: 31May2021) on the left arm at 0.3 mL, single for COVID-19 immunization. Medical history included AFib from 2009 and ongoing; allergies to antibiotics and Penicillin; shellfish allergy. No family medical history. Concomitant medications included nitrofurantoin (monohydrate/macrocrystals; Manufacturer: Alvogen Inc) from 17Mar2021 to 24Mar2021 for urinary tract infection; prednisolone from 10Apr2021 to 10Apr2021 for rash; chlorphenamine maleate (ANTIHISTAMIN) from 12Apr2021 for rash; and taking unspecified medications for a long time. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 (Lot Number: EN6201; Expiration Date: 30Jun2021) on the left shoulder at 0.3ml single for COVID-19 immunization. Patient previously also had something else 10 years ago that didn't work, it was not a vaccination; took doxycycline hydrochloride (DOXYCILLIN) and amoxicillin that both experienced allergies. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). Stated that she had a urinary tract infection and was put on antibiotics for 7 days. Two days after starting the medication, she came down with a rash. The patient husband, who was a family physician had never seen a rash like that in his 40 years of practice. In the newspaper, there was a woman who got the vaccination, but not sure if it was Pfizer, and had a rash; the article had a picture of the rash the woman had, after the vaccine. Patient stated that her rash looked worse than the woman in the newspaper. The rash happened after the second vaccine, several weeks later, but after the antibiotics. Patient was allergic to a lot of antibiotics. She stated she may have this problem, the rash because she was allergic to a lot of antibiotics. When she got the rash, she went to the Urgent Care and was given a Prednisone shot and Prednisone pills. She got some relief taking the Prednisone. Patient weight as about 5' 4", she gained 8 pounds over the year while being stuck in her house. Patient stated she hasn't seen healthcare provider in a while, but she called him and he gave her the antibiotic prescription. Patient experienced the rash was painful on 17Mar2021 and she could feel when another one would start happening. Patient put ice on it to sop the pain and moved the ice packs around as it was reactive to pressure. Stated if there was anything tight, like underwear, or sitting on the couch, she would get welts and lumps, initially mentioned the top of her head. Reclarified itchy in later part of report. Patient got a prescription for her medication on 17Mar2021 and took it for 7 days, and then the rash happened a couple of days after she stopped the medication. As she had a little bit of skin that was very dry and she can see a line where the rash was. The rash pretty much gone, but not 100 per cent gone. Stated she went to the Urgent Care walk in, when she noticed the rash. Patient had two Covid tests, one was a blood test and one was a nose swab; reported both as negative. Stated she should have gone to the emergency room, but the doctor, in the Urgent are gave her a Prednisone shot. The only reason she didn't go because of the Covid, pandemic, so she went to the Urgent Care. The last medication that she took for the rash was an antihistamine on 12Apr2021, and last Prednisone pill was 10Apr2021; both pills were effective in treating the rash. Patient had a Zoom call with an allergist, and the doctor saw the rash with the help of a flashlight and altered the Prednisone dose. Patient had pain under breastbone that it was really bad and the day before she went, to the Urgent Care on the 28th or 29Mar2021, may in the early afternoon. Stated it was going on the whole time, intermittently, not constant in the last few weeks. She didn't know what was causing it as she had blood work to rule out gallbladder issues and that was not back to rule out a Shellfish allergy. Patient had welts and it all blends in from when she first noticed the rash a couple of days before she went to the Urgent Care. Answered as they were faded out, it was severe, then acute, then extreme for a week or more, and improved with steroids and then faded. Patient had lumps and it started two days before she went to the Urgent Care. Stated when she was sitting on the couch, reclarified, the cords of the pillow put pressure on the areas and it hurt and felt like welts. When she pushed on her skin, here were lumps in her skin underneath, and they hurt and were hot. Described the areas of the lump as buttocks, top of head, legs, arms, groin, underwear line, ear, ear lobe and face. Patient had swelling of lips, and they looked like she had Botox. Also reported additional swelling of arms, hands, fingers, arm from the wrist up to elbow, left foot, left kneecap, left thigh, and her feet swelled up like a balloon. It was better now. Patient had fingertips felt tingley. The palm of hand that patient got rashes in response to pressure and was trying to open a bottle. When she did she got a rash on her palm, a red circle and her hand was hot and itchy. Started as two days before she went to the Urgent Care. Stated she was tired and exhausted from not sleeping and the redness faded away and then it went away a couple of days ago with the help of the steroids. Patient had toes, feel puffy that described as the feeling when she goes to the dentist after she gets Novocain, the feeling. Patient had tired and exhausted. Stated she was tired the first few days until the rash peaked, as she was up all night for two nights icing the rash. Stated she was better but was not doing too much and didn't get out of the house, only when she had to. Lab data included on unspecified dates the blood work for urinary tract infection was negative; negative results for two Covid tests, one was a blood test and one was a nose swab; blood work to rule out gallbladder issues and that was not back to rule out a shellfish allergy. No events required a visit to emergency room or physician office, but patient went to Urgent Care and had a Telehealth appointment. The outcome of events "Rash; Welts; Swelling" was recovering, while of the other events was unknown. No follow-up attempts are needed. No further information is expected.
76 2021-05-04 injection site pain Throbbing pain arm of injection site. Muscle soreness inside of arm. Has continued for last two mo... Read more
Throbbing pain arm of injection site. Muscle soreness inside of arm. Has continued for last two months.
76 2021-05-11 dry skin, rash bumps under skin , extra dry skin.
76 2021-05-11 vaccination site redness, vaccination site pain, vaccination site swelling, vaccination site mass injection site became red swollen and firm and warm within 24 hours of injection; injection site bec... Read more
injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; injection site became red swollen and firm and warm within 24 hours of injection; chills; nausea; diarrhea; site remains red swollen and little soreness area below injection site.; This is a spontaneous report from a contactable consumer. A 76-year-old female patient (non-pregnant) received second dose of BNT162B2 (BNT162B2, PFIZER BIONTECH, COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EL3302), via an unspecified route of administration, administered in Arm Left on 09Feb2021 at 13:15 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose in left arm (Lot number: EL3302) at 1.00pm on 20Jan2021 for COVID-19 Immunisation. COVID was not found prior vaccination. Medical history included hypertension. The patient's concomitant medications were not reported. Other medications were received in two weeks but not specified. The patient experienced injection site became red swollen and firm and warm within 24 hours of injection, chills, nausea, diarrhea and site remains red swollen and little soreness area below injection site. Treatment was not received. The outcome of the events was recovering for chills, nausea and diarrhea whereas not recovered for the other events.
76 2021-05-12 vaccination site pain Right knee pain; tenderness; swelling; Pain at injection site; This is a spontaneous report from a c... Read more
Right knee pain; tenderness; swelling; Pain at injection site; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN5318), on 26Jan2021 at 12:00 (at the age of 76-years-old) at 1st dose, single administered in left arm for COVID-19 immunisation. Medical history included allergies. The patient was not pregnant. No COVID prior vaccination and no COVID tested post vaccination. Concomitant medications included calcium, tocopherol (MEMORALL), cetirizine, KETO, unspecified (all reported as other medications in two weeks). The patient previously took ampicillin and experienced allergies. No other vaccine received in four weeks. The patient experienced right knee pain, tenderness, swelling, continued. Pain at injection site lasting 24 hours. The events occurred on 30Jan2021 at 8:00. No treatment was received for the events. The patient had recovered from pain at injection site on 31Jan2021 at 08:00, had not recovered from the other events.
76 2021-05-14 vaccination site redness, vaccination site itchiness, vaccination site warmth vaccination site red; vaccination site swollen; vaccination site hot; vaccination site itchy; This i... Read more
vaccination site red; vaccination site swollen; vaccination site hot; vaccination site itchy; This is a spontaneous report from a contactable consumer. This female consumer reported for herself that: A 76-year-old female patient received dose bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: E19264 but it could be EL9264, and expiration date were not reported) via a unspecified route of administration in left arm, on 05Feb2021 at 14:30PM (at the age of 76-year-old) as single dose for COVID-19 immunization. The patient was not administered an additional vaccine on same date of the Pfizer vaccine. The concomitant medications included a Proto-nix used for Barrett's oesophagus, Celexa used for Anxiety, Rosuvastatin used for Blood cholesterol increased, and baby Aspirin for a while. On 14Feb2021 at 9PM the patient had a huge reaction at the injection site where it was red, swollen, hot, and itchy. The reaction is in the left arm and that is where she received the injection. It is still hot and swollen and red. She has no fever. On 16Feb2021 for the first time she took a little Tylenol. She is due in 10 days for the next dose. The outcome of event is not recovered. Follow-up (16Feb2021): This is a follow-up spontaneous report from a contactable consumer. This 76-year-old consumer reported a significant information regarding suspect drug and events.
76 2021-05-17 skin warm, rash Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) ras... Read more
Dizzy,Fever, Disoriented, (expected: arm soreness, heat, swelling administered frozen pea bag) rash on forearms,, not hives, passed out for 9 hours I thought I would just relax with my frozen peas and watch tv. 9 hours later, I was slumped on the couch, tv had not been turned on , I was fully dressed including shoes, no blanket or pillow, very cold all the lights that I had turned on were still on and it was 5:10 in the am I had not brushed my teeth or taken evening medication. I had warmed left overs in the oven thinking I might just be hungry. Oven was off but oven door was open food was uneaten except for a couple of bites. I live alone. I still work and manage everything on my own.
76 2021-05-17 vaccination site pain Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site... Read more
Soreness under her arm unsure if muscle or lymph nodes; Pain under the arm, under the injection site in which it was a soreness; Aching in arm; Achy; This is a spontaneous report from a contactable consumer. A 76-year-old female consumer (patient) reported that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318; Expiration Date: May2021) via an unspecified route of administration, administered in right arm on 04Feb2021 at 10:30 as first dose,single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No Prior Vaccinations within 4 weeks. On 04Feb2021, the patient experienced after is that she felt a little achy and 04Feb2021 at 8:00 pm that evening her arm was aching, patient took an Ibuprofen and had no problem afterward, On 05Feb2021, the day after patient mentioned had pain under the arm, under the injection site in which it was a soreness which had no lump. She cannot discern whether it was a lymph node or muscle, but is leaning more into it being a muscle because patient could feel a pulling sensation when patient raises her arm at the shoulder. Patient was asking if these are common side effects and for how long do these usually last. On 06Feb2021 soreness under her arm, unsure if muscle or lymph nodes. The outcome of the events achy, pain under the arm, under the injection site in which it was a soreness were unknown, soreness under her arm was recovering and aching in arm was recovered on 04Feb2021. Follow-up attempts are completed. No further information is expected.
76 2021-05-18 itchy skin, skin swelling, skin reaction, rash, pain of skin, redness it shows no sign of going away, infact it seems to be worsening; Started 1-2 days following 2nd Pfiz... Read more
it shows no sign of going away, infact it seems to be worsening; Started 1-2 days following 2nd Pfizer Covid vaccine/more spread and violent eruptions all over; Body rash, itching. Started 1-2 days following 2nd Pfizer Covid vaccine/mMy skin continues to erupt from head to toe, both painful and itching; acute skin reaction, huge patches of bright red, and many areas swollen; acute skin reaction, huge patches of bright red, and many areas swollen; acute skin reaction, huge patches of bright red, and many areas swollen; My skin continues to erupt from head to toe, both painful and itching; This is a spontaneous report from contactable consumer(patient). A 76-year-old non-pregnant female patient received second dose on BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number EN6204) on 12Mar2021 via an unspecified route of administration in the left arm at single dose for COVID-19 immunisation. Medical history included Diabetes Type II controlled, hypoparathyroidism and bi-polar. Concomitant medications included CALCITRIOL (calcitrol [calcitriol]), CALCIUM (calcium), AMITRIPTYLINE HYDROCHLORIDE (amitriptyline) and LITHIUM (lithium) (medication in two weeks). No other vaccine in four weeks. The patient had no allergies. The patient previously took first dose of BNT62b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number EN6200) for on 19Feb2021 10:30 via an unspecified route of administration in left arm at SINGLE DOSE for COVID-19 Immunization. It was reported that, on 07Apr2021 adverse reaction to Pfizer covid vaccine: Body rash, itching. Started 1-2 days following 2nd Pfizer Covid vaccine on 12Mar2021. Rash has persisted reappearing over most of body, legs, hips, stomach, back, rib cage, feet hands, etc. Seems to flare up in areas, subsided then reappeared in another area. OTC antihistamine was not effective. Rash was continued nearly 4 weeks following 2nd vaccine and does not appear to be going away. Very distressing as rash persists. Patient has been to her primary care doctor and a dermatologist who had no idea what was causing her acute skin reaction to the Pfizer vaccine. Patient was quickly approaching two months with a violent skin reaction, huge patches of bright red and many areas swollen. Patient's skin continued to erupt from head to toe, both painful and itching. When red patches broke out then slowly recede more red patches broke out. Patient has never had such an allergic reaction and it showed no sign of going away, in fact it seems to be worsening. There was no information available as to what patient have been poisoned with, was there an antidote, would it ever go away. Every day patient awakened with more spread and violent eruptions all over her body. Patient said you need to respond, and you need to tell her what was wrong. This was no less than frightening and depressing. A high dose of antihistamine and topical steroid did nothing to control her acute reaction. The patient was treated with antihistamines and topical steroids. No COVID prior vaccination. Patient has not tested COVID post vaccination. The outcome of events was not recovered. No follow-up attempts are possible. No further information is expected.
76 2021-05-18 itchy rash Erythromelalgia; 3/19/2021 Patient is a 76-year-old female who presents to the emergency department ... Read more
Erythromelalgia; 3/19/2021 Patient is a 76-year-old female who presents to the emergency department for evaluation of a pruritic rash. Is been present for just over 1 month. She relates that began after receiving her second Covid vaccination. She denies any new exposures medicines foods cleaning items or hygiene supplies. She denies any systemic symptoms. No airway symptoms. Physical exam significant for dry erythematous rash. Is suggestive of eczema. His primary to the right hand in the palm. It seems to spare the dorsum of the hand. There is diffuse swelling. No fissures or lesions. No evidence of secondary infection.
76 2021-05-24 bruising, vaccination site pain, vaccination site haemorrhage She bled a little bit; A 'black and blue mark on the arm (as big as a tangerine, and is still there)... Read more
She bled a little bit; A 'black and blue mark on the arm (as big as a tangerine, and is still there)'; When she vaccination provider put the needle in, it really hurt/soreness; Her arm ached; This is a spontaneous report from a contactable consumer. This 76-year-old female consumer reported for herself that . A 76-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration, administered in Arm Right on 24Jan2021 13:00 as 1st dose, single for covid-19 immunisation. Medical history included for her belly. Concomitant medications included fish oil (OMEGA XL) (Has been taking for years) ongoing and glycopyrrolate [glycopyrronium bromide] taken for her belly, (Once a day) ongoing. On 24Jan2021 the patient experienced Black and Blue mark on arm, when she vaccination provider put the needle in, it really hurt/soreness and her arm ached. On an unknown date the patient experienced she bled a little bit. The patient stated that She got the vaccine on as confirmed Sunday 24Jan2021 and later that day her arm ached. She has heard a lot of people had ache, arm ache after getting the vaccine, but no specific patient details provided.She looked at her arm and she had a black and blue mark as big as a tangerine. She is not too happy that happened. She has to get the second dose of the vaccine 14Feb2021. She is not sure if she wants to get the second one. If this occurred with the first one. She also hurt with getting the vaccine. She is not sure where the needle was placed when getting the vaccine, but it hurt, and she bled a little bit. The nurse had to place a Band-Aid on it. Her arm is still black and blue. She noticed the black and blue mark on the same date she got the vaccine. It was later that day in the evening. She does not know the exact time. The black and blue mark is on her right arm. She noticed her arm ache shortly after she got the shot. It was a few hours after getting the vaccine, but she does not know what time. She stated this seems to be a complaint of a lot of other people, but no other specific patient details provided. It is her right arm that aches. She stated she is wondering if she needs to be concerned about these events. Should she be concerned about what her arm looks like. She is still having soreness. Therapeutic measures were taken as a result of a 'black and blue mark on the arm. The outcome for the events black and blue mark on the arm (as big as a tangerine, and is still there) and her arm ached was recovering. The outcome for the event when she vaccination provider put the needle in, it really hurt/soreness was not recovered. The outcome for the event she bled a little bit was unknown. Follow-up attempts are completed. No further information is expected.
76 2021-05-25 injection site warmth, injection site pruritus, injection site hardening, injection site redness, shingles, injection site swelling It was vaccine I noticed my arm turning red at the injection site and it was hard. It started to tra... Read more
It was vaccine I noticed my arm turning red at the injection site and it was hard. It started to travel up and down my arm as one large area. It was itchy and warm. It got larger over the course of two days and then it started to recede. I iced it and it helped a little. Benadryl did not help. I got the second shot in the same arm and it did not spread but it did get a little red. I also got the shingles about two weeks out from the vaccine. I have had the shingles before and I knew what it was so I took the medication and it cleared up quickly.
76 2021-05-26 rash macular Rash small red spots on face 4 days after second shot.; This is a spontaneous report from a contacta... Read more
Rash small red spots on face 4 days after second shot.; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received BNT162B2(PFIZER BIONTECH mRNA COVID-19 mRNA VACCINE; Lot no. EN6206), 2nd dose single on the right arm via an unspecified route of administration on 09Mar2021 as single dose for COVID-19 vaccination. Medical history included Arthritis and Hypothyroidism. Concomitant medication included bupropion (MANUFACTURER UNKNOWN), Metoporaltrx (MANUFACTURE UNKNOWN) Levothyroxine (MANUFACTURER UNKNOWN), Estradiol (MANUFACTURER UNKNOWN). The patient was allergic to Penicillin, Demerol. It was unknown whether patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not enrolled in clinical trial. The patient had no symptoms associated with COVID-19. Patient had not tested positive for COVID-19 since having the vaccine. On 12Mar2021 at 10:00, the patient experienced rash small red spots on face 4 days after second shot. It is unknown whether the patient received any treatment for the event. The clinical outcome of the event was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
76 2021-05-26 rash Large oval patch (plaque?) rough around the border, smooth and paler color inside. 1" long. Center... Read more
Large oval patch (plaque?) rough around the border, smooth and paler color inside. 1" long. Center of my back (I have a photo) I just noticed it yesterday. No treatments.
76 2021-05-26 hives Hives; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female pat... Read more
Hives; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (BNT162B2, Solution for injection), via an unspecified route of administration, administered in arm right on 13Mar2021 11:30 (Batch/Lot Number: Ew6205, expiration date: not reported) as second dose, single for covid-19 immunisation (at the age of 76-years and was not pregnant). The patient medical history included known allergies (but have not had any of them). Concomitant medication(s) included apixaban (ELIQUIS), metoprolol succinate taken for an unspecified indication, start and stop date were not reported and multivitamin (all as other medications in two weeks). No other vaccine in four weeks, no covid prior vaccination and no covid tested post vaccination. Previously, the patient received BNT162B2 via an unspecified route of administration, administered in arm right on 20Feb2021 11:30 (Batch/Lot Number: Em9810, expiration date: not reported) as first dose, single for covid-19 immunisation. On 15Mar2021 05:00, the patient experienced hives. No treatment received for the adverse event. Outcome for the event was not recovered. No follow-up attempts are possible. No further information is expected.
76 2021-05-26 vaccination site redness, vaccination site pain This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant fema... Read more
This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9265), via an unspecified route of administration on 30Jan2021 09:30 (at the age of 76-years) as 2nd dose, single dose in left buttocks for covid-19 immunization. Medical history included: slight high blood pressure and unspecified allergies. The patient didnot receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included carvedilol 12.5 mg, vitamin d [vitamin d nos], pantoprazole sodium. The patient received first dose of BNT162B2 (lot number: EL1283) via an unspecified route of administration on 09Jan2021 at 10:30 as 1st dose, single dose in Left buttocks for covid-19 immunization. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 31Jan2021 at 05:00, the patient experienced fever 102.6, chills and aches, headache, soreness at site of injection with a 3 inch red circle. The patient underwent lab tests and procedures which included body temperature: 102.6 on 31Jan2021. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Follow-up attempts are completed. No further information is expected.
76 2021-05-28 itchy skin weak; does not feel well; Stomach is upset 24/7; TSH is off; skin so itchy; dry heaves; nauseated/Na... Read more
weak; does not feel well; Stomach is upset 24/7; TSH is off; skin so itchy; dry heaves; nauseated/Nausea; sore arm; I don't like the way I'm feeling; This is a spontaneous report from a contactable consumer (the patient). A 76-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0773) via an unspecified route of administration in left upper arm on 04May2021 11:00 at age of 76-year-old at single dose for COVID-19 immunisation. Doctor wanted her to get it. Caller said that her doctor told her she wouldn't make it if she got COVID. Her heart couldn't pump very well and was very weak. Other medical history included a lot of allergies (They made her sit in a recliner for 30 minutes) and thyroid disorder. No further details provided by the caller regarding her thyroid condition. Caller did not think there were any other medical conditions that she had that would be relevant as she was pretty darn healthy. Family medical history relevant to AE: Not that she knows of. Daughter had the shot and was sick for 2 days. She had the Pfizer. No vaccine administered on same date of the Pfizer suspect. No history of all previous immunization with the Pfizer vaccine considered as suspect. No prior vaccinations (within 4 weeks). Concomitant medication included levothyroxine sodium (SYNTHROID) taken for thyroid from an unspecified start date for 20 years and ongoing. Got the shot 04May2021. Dry heaves on 04May2021: Didn't really throw up, but she had them all day. Still has them but not as bad. Nausea/ nauseated on 04May2021: It was actually kind of steady. Caller was able to eat and drink, not that she wanted to. She did not know what to do with herself. She was eating and drinking. She took TUMS [CALCIUM CARBONATE] and always had a cast iron stomach. Skin is so itchy on 04May2021: Skin started itching right away, that evening that she got the shot. She even used a back scratcher. It was all over and still felt the same. Treatment: Had taken diphenhydramine hydrochloride (BENADRYL) maybe once or twice and when she went to bed. She didn't take it steady. She did not take the TUMS steady either. Yesterday, she felt better, and currently felt worse again. Had a little more energy and was feeling good. Sore arm on 04May2021: Was sore right away, after the shot. It was still sore but it was better. It was not red or anything. Treatment: Took 1/4 of a paracetamol (TYLENOL), 325mg, so it was 12 or something. Weak on an unspecified date and did not feel well on an unspecified date. Her blood pressure was good and she has no fever. She also stated her stomach was upset 24/7. She didn't like the way she was feeling after the first dose (May2021). She just wish this would go away. She didn't feel good. 10 days was a long time to have a reaction. Tests: Recently had blood work and everything was normal. Even her thyroid stimulating hormone (TSH) which she got tested for every month is fine. It was off but currently was regular. The event did not require a visit to emergency room or physician office. Her next shot was on 25May2021 and was scared to get it. The patient asked what would happen if she did get the second dose. The outcome of events "skin so itchy", "nauseated/nausea" was not recovered, of events "dry heaves", "sore arm" was recovering, of "TSH is off" was recovered, of other events was unknown.
76 2021-05-28 hives hives go from face to chest both sides of body; This is a spontaneous report from a contactable cons... Read more
hives go from face to chest both sides of body; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9261 and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 15Feb2021 12:00 AM, as single dose for COVID-19 immunization. Medical history included sjogren's syndrome, Afib regulated and PMR. No known allergies were reported. The patient did not take other medications in two weeks. The patient did not receive other vaccine in four weeks. The patient did not had covid prior vaccination and was not tested for covid post vaccination. On 28Feb2021, 12:00 AM, the patient experienced hives which went from face to chest both sides of body. It was reported that, sunday (28Feb2021) hives go from face to chest both sides of body, never had hives before. No change in medications, food, or product use. The patient received treatment with benadryl. The outcome of the event was reported as not recovered. No follow-up attempts are possible. No further information is expected.
76 2021-05-31 hives, vaccination site pain Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after ... Read more
Outbreak, looked like hives, on her torso and stomach area, after the first vaccine:; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine; This is a spontaneous report received from a contactable consumer (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204, Expiration date was not reported), via an unspecified route of administration on 03Mar2021 14:00 as 1st dose, single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. On 03Mar2021, the patient experienced outbreak, looked like hives, on her torso and stomach area, with sequelae after the first dose, chills after first and second vaccine, injection site sore after first and second vaccine, Arm was numb, tingley and painful from the shoulder to the fingertips, after the first and second vaccine (Patient visited office). she would like to know about percentages in age groups who have experienced any numbness and tingling, and if there are any correlation with developing blood clots of this, and also, she wanted to know if she needs further medical attention and to prevent a serious outcome. The outcome of the event was recovered for urticaria on 21Mar2021, the outcome of chills was unknown. Vaccination site pain, Hypoaesthesia Paraesthesia was not recovered. No follow-up attempts are needed. No further information is expected.
76 2021-06-01 vaccination site swelling, vaccination site redness, vaccination site warmth This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female pa... Read more
This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20May2021 as 1 st dose single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient is a 76-year-old female patient who received her 1st dose of the COVID Vaccine a week ago today, 20May2021. She mentioned that she experienced basically every side effect on the fact sheet except nausea. She had fever, chills, injection site swelling. injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and a general feeling of unwellness. She mentioned that this lasted for 5 days and all came in gradually and not all at once. She is better now as of calling. She was asking if this is to be expected with the 2nd dose as well. The patient enquired whether using a heating pad would affect the effectiveness of the vaccine. The outcome of the events fever, chills, injection site swelling, injection site redness and warmness, swollen lymph nodes under her left arm, body aches, joint pains, tiredness, headaches, and general feeling of unwellness were recovered. Information on the lot/batch number has been requested.
76 2021-06-02 rash, skin burning sensation, itchy skin Systemic rash itchy / burning started on L arm and spread to torso and all other limbs over 1 week
76 2021-06-02 vaccination site pain and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right... Read more
and pain down to the foot, ankle and calf areas, after second vaccine; Headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head, after the second vaccine; Face spasms on the left side of face; after the second vaccine and it was worsened; Chills, after first and second vaccine; Injection site sore after first and second vaccine; Arm was numb, tingley and painful from the shoulder to the fingertips after first and second dose; Left side of the body had tingling, numbness; This is a spontaneous report from female contactable consumer (Patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection, lot number was not reported) via unspecified route of administration, administered in left arm on 31Mar2021 at 14:00 (at the age of 76-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Solution for injection Batch/Lot number: EN6204) via unspecified route of administration in left arm on 03Mar2021 at 14:00 as single dose for COVID-19 immunization and on same day patient experienced outbreak, looked like hives, on her torso and stomach area, chills, injection site sore (which subsided after 18-days), arm was numb, tingley and painful from the shoulder to the fingertips. Medical History and concomitant medications were not reported. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations within 4 weeks prior vaccinations. On 31Mar2021 (same day of 2nd dose of vaccination), patient experienced face spasms on the left side of face, after the second vaccine which was intermittent in the evening, headache: left side and right side of head, frontal area, feels like it is travelling from her arm to her head and left side of the body had tingling, numbness and pain down to the foot, ankle and calf areas, along with the events of first dose, which were worsened after second dose that included chills and injection site sore (which subsided 18-days after first dose), arm was numb, tingley and painful from the shoulder to the fingertips. Patient required to visit physician office, primary care doctor for her numbness, tingling and pain. Reporter stated she was very interested in percentages in age groups who have experienced any numbness and tingling and asked if there are any correlation with developing blood clots and would like the information to see if she needs further medical attention and to prevent a serious outcome and discuss it with her doctor and agrees to be transferred to Medical Information. The outcome of all the events was not recovered. No follow-up attempts are needed. No further information is expected.
76 2021-06-03 itchy skin, rash macular Itch; she broke out in spots that are red and raised up; This is a spontaneous report from a contact... Read more
Itch; she broke out in spots that are red and raised up; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 21Jan2021 16:00 (Batch/Lot Number: EL3246) as 1ST DOSE, SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Right on 11Feb2021 16:00 (Batch/Lot Number: EM9810) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation (COVID Prevention). Medical history included Allergic to Shellfish. The patient's concomitant medications were not reported. It was reported that on 22Jan2021 patient broke out in spots that are red and raised up. Reporter was calling about his wife. Reporter states that his wife broke out just a little with the first dose of the product, and with the second shot she broke out in 5 or 6 spots on her belly that are maybe an inch around, and raised up, like pumped up, and her skin is turning red. Reporter clarified the suspect product as the Pfizer COVID Vaccine. Reporter was wondering if this was a normal reaction. Reporter informed that the patient was 76 after the first dose of the product, and 77 when she received the second dose. It was also reported that the patient got her first dose of the product on 21Jan2021, and the spots appeared the next day. Caller reports that they thought they got bed bugs because the spots look like little bites, like welts that stay for two or three days and then they go down. Caller informs that the patient got the second dose on 11Feb2021 and the spots appeared again the day after the injection, and caller confirms they are ongoing and persisting. reporter was wondering how long the spots will last. Caller reports the patient saw a dermatologist and was given a cream. Caller also stated that patient has been using rubbing alcohol on the spots to help the itch. Reporter also stated that his brother, sister and sister-in-law have all received the vaccine and no one else has broken out so far. Patient not having previous doses of the COVID-19 vaccine prior to 21Jan2021. Outcome of the event Itch was unknown. Outcome of the other event was not recovered. No follow up attempts are possible. No further information is expected.
76 2021-06-03 rash pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She alread... Read more
pt says that she has a tremendous amount of body and muscles aches with extreme fatigue. She already had numbness and tingling throughout her entire body (including lips and face) but became much more severe in April. In the last couple of weeks she has developed rashes on various parts of her body. Pt had appt w/ PCP. She had blood work that was negative and was referred to a Rheumatologist. On 6/3/21 she went to another doctor. She had more blood work. Pt is waiting on results. She also went to see another doctor. She had more blood work and waiting on these results. She has an appt Neurologist. She also had swelling with her gums for a couple of days. She has a very foggy feeling like she is spaced out. She feels like her vision has been impaired. She still feels bad most days saying the her symptoms come and go and she has felt this way since taking the vaccine. She has headache that come and go for the last couple of weeks.
76 2021-06-04 skin burning sensation Burning sensation all over her skin; Very tired; This is a spontaneous report from a contactable con... Read more
Burning sensation all over her skin; Very tired; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch no: EN6205, NDC number; expiration date: unknown), via unspecified route in the deltoid left on 26Feb2021 at 15:00 as single dose for COVID-19 immunization. The patient medical history included blood pressure. Concomitant medication included atenolol taken for blood pressure as 25 mg, amlodipine as 2.5 mg and doxazosin as 1 mg, both taken for blood pressure measurement. Patient previously had first dose of BNT162b2 (Lot: EL9264, NDC; expiration date: unknown) on 05Feb2021 for COVID-19 immunization. On 27Feb2021, in the morning when she woke up, she had burning sensation all over her skin. She rested all day on the 27Feb2021 and then Sunday 28Feb2021 she was just a little tired but there was no more of the burning sensation. She confirmed the tiredness started on Saturday 27Feb2021. She usually works on Saturday, but she could not work because she was too tired. By Sunday 28Feb2021 she was better. She thought she rested and continued to rest because she was still a little tired. She recovered by Monday and she went back to work. The patient did not receive any treatment for the events. The clinical outcome for the event burning sensation was recovered on 28Feb2021 and very tired was recovered on 01Mar2021. No follow-up attempts are possible. No further information is expected.
76 2021-06-06 itchy skin, shingles, blister shingles with blisters on left side of neck and left side of head and face down to the front of my n... Read more
shingles with blisters on left side of neck and left side of head and face down to the front of my neck. I was treated with Valtrex 3 times and am suffering with the nerve endings itching. Very unpleasant.
76 2021-06-07 hair loss She has been experiencing hair loss for a while; had a little bit of muscle pain; This is a spontane... Read more
She has been experiencing hair loss for a while; had a little bit of muscle pain; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN5318) via intramuscular route of administration in left arm/shoulder on 02Feb2021 (at the age of 76 years old) in the morning as 1st dose, single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9266) via intramuscular route of administration in left arm/shoulder on 23Feb2021 (at the age of 76 years old) in the morning as 2nd dose, single dose both for COVID-19 immunisation. Medical history included psoriasis on legs. Concomitant medication included hydroxychloroquine sulfate (PLAQUENIL S) 200mg tablet by mouth once daily taken for psoriasis from 29Mar2021. The patient did not receive any additional vaccines on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the first administration date of suspect vaccine. The patient experienced she has been experiencing hair loss for a while on 07Apr2021 and had a little bit of muscle pain on an unspecified date in 2021. It was reported as, patient received both doses of the Pfizer Covid 19 vaccine in February. She has been experiencing hair loss for a while. Her dermatologist told her it was due to the vaccine. She enquired whether this happened to anyone else or was there other reports also. She was getting treatment for psoriasis and thought it was due to it. She contacted the FDA and was told it would take 120 days for it to drop to a half dose in her system. She asked about contacting CDC to report it. She was so upset that this happened to her. The patient hair loss was almost gone now, her daughter said she had fuzzies instead of bald spots. She just had bloodwork a few weeks ago, and had regular meds she takes, but has been taking those for a couple years but they don't make a difference with the shot, she doesn't believe. Patient has psoriasis on legs and was taking a new drug her dermatologist provided and she called the FDA about this med and they said it could cause hair loss but probably not, her doctor said it was not the cause of it. Drug was Plaquenil, but she was taking the generic for that, she was taking hydroxychloroquine 200mg tablet by mouth once daily, she started, she believes 29Mar2021 for psoriasis on legs. She stopped it as soon as her hair was falling out, as she thought it was that originally, but her dermatologist said it was not, it was from the shot. Patient did not visit physician office but it was panic, she was crying for 2 weeks, her daughter informed there was nothing to do, it will just fall out. Patient informed that when she got the shots, she didn't have any kind of reaction, just the second, she had a little bit of muscle pain, but overnight it went away. The patient underwent lab tests and procedures which included blood test: unknown on an unspecified date. Outcome of the event hair loss was recovering and for muscle pain recovered on an unspecified date in 2021. Follow up attempts are needed. Further information has been requested.
76 2021-06-07 vaccination site pain, skin tightness She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a ... Read more
She had high Blood pressure yesterday; Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose; started getting hungry; she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs; swelling under her eyes/eyes started getting swollen; face was swollen; Eye infection; face felt tight; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EM9810; NDC number: Not Provided Expiry Date: Unknown) via an unspecified route of administration on the left arm on 06Feb2021 at 8:31AM (at the age of 76 years), as a 2nd dose, single dose for COVID-19 immunization. The patient medical history included disc protruding (diagnosed before the covid vaccine in Jun2020 or around that, she recalls having several months of MRI's in 2020) and high blood pressure. The patient's concomitant medications included Epidural Shot (Verbatim) for Protruding Disc Patient on 27Jan2021 (she had to go to the doctor in the clinic and get epidural shot in the back at the disc thats protruding). Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot: EL3249; NDC number: Not Provided, Expiry Date: Unknown) via an unspecified route of administration on the left arm on 16Jan2021 at 12 PM (noon) as 1st dose, single dose (at the age of 76 years) for COVID-19 immunization. Clinical course: She took second dose of Pfizer Covid Vaccine on 06Feb2021, though she had no reaction initially. A week later from vaccination on Feb2021, she then began to notice her eyes started getting swollen couple days after, she then felt like her eyes felt like they were closing, then she saw her whole face was swelling, it looks like she had Chipmunk cheeks. She went to the doctor hoping it would go away, she was prescribed Benadryl and a decongestant as treatment. She takes Benadryl three times a day and the decongestant in the morning and her face is still swollen. It started with the eyes and the bag under the eyes, that was the first thing she noticed. She laughs and though she initially had an eye infection. She just wants to know if there is any other reports of this happening, or how to get rid of it, this has been there since she got her second dose on the 06Feb2021 since like 10Feb2021. After the second vaccine on 06Feb2021 around that time an hour later, she was on the way home and started getting hungry, she thought that was a symptom as well as her arm hurt a bit. She was starving till Monday got up 2AM, 6AM ate all day Sunday and Monday ate all day, as reported "all she knows is she was craving a crab sandwich." Her Eyes swelling started a couple days later and the Face swelling was either the second week or same time, she just recalls looking at the eyes. She recalls telling her son her face felt tight in Feb2021. At the doctors appointment she was 127lbs, probably because of the swelling, but she is usually 119lbs or 118lbs, she is a small girl. The Appointment with the doctor was yesterday (15Mar2021), they prescribed Benadryl. Patient clarified that she was not Prescribed Zyrtec, it was a decongestant but she does not know the name of it. The Druggist however told her she could take another medication also. As reported "The eye swelling and face swelling, at the moment she look like she been drunk, her face is plentiful, she is still swollen, her lids are not bad, but it is ongoing, it has gotten worse because prior she didnt even know it was there and its showing more now. She asked son if he thought she was swollen because she feels tight, over the weekend her face being swollen was noticeable, she is noticing people are pointing it out now." She adds her arm did not hurt with first dose. Second dose administered on the Left Arm, her arm did hurt a little on 06Feb2021, the day she got this dose and the next day (07Feb2021). She thought initially that she didn't have any side effects. She had High blood pressure yesterday (15Mar2021), but that usually goes up and down for her and nothing new. It was reported that, a week later, patient experienced swelling under her eyes, face was swollen, eye infection and face felt tight on Feb2021; hunger and vaccination site pain on 06Feb2021 (reported as the day she got this dose); hypertension on 15Mar2021 (reported as yesterday). Patient would like to know if swelling of the face is a reported side effect from the covid vaccine, how long her side effects from the covid vaccine will last and asking for suggestions on how to get rid of the side effects from the covid vaccine. The outcome of event vaccination site pain was recovered in Feb2021 (duration of event was 2 days), swelling under her eyes, face was swollen was not recovered while outcome of other events was unknown. Follow-up attempts are completed. No further information is expected.
76 2021-06-08 blister get more blisters in her mouth; progressed to two blisters, one on each arm; This is a spontaneous r... Read more
get more blisters in her mouth; progressed to two blisters, one on each arm; This is a spontaneous report from a contactable pharmacist. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 19Jan2021 (Batch/Lot number was not reported), at the age of 76-years-old as 1st dose, single; and dose 2 via an unspecified route of administration on 10Feb2021 (Batch/Lot number was not reported) as 2nd dose, single for COVID-19 immunization. Medical history included mucous membrane pemphigus. Historical vaccines included shingles vaccine and pneumonia vaccine on Nov2020 and flu shot on Dec2020; all taken at the age of 76-years-old. The patient's concomitant medications were not reported. The patient received her first shingles vaccine in November as well as pneumonia vaccine. She received Flu shot in December. She waited a month after second dose of product before receiving second dose of Shingrex. She knows vaccines can cause flare up of her historical condition of mucous membrane pemphigus and has been controlled with very low dose dapsone and under control for two years. She stated she started to get more blisters in her mouth and was prescribed dexamethasone wash. Then progressed to two blisters, one on each arm. Referred to her dermatologist who indicated she has seen the condition progress/ in those whose who are fully vaccinated. The outcome of the events was unknown. Information on the lot/batch number has been requested.
76 2021-06-08 rash with redness, eczema, psoriasis, rash Patient developed chills, fatigue, nausea, and a generalized rash (inflammed and red).
76 2021-06-13 shingles I received shingles and I was vaccinated for shingles and still got them after the shot.
76 2021-06-14 cellulitis I was very tired and I experienced Chills like I've never felt before and I had a high fever. After ... Read more
I was very tired and I experienced Chills like I've never felt before and I had a high fever. After I was admitted in the hospital I was diagnosed with cellulitis.
76 2021-06-15 vaccination site itchiness, vaccination site swelling, vaccination site redness redness of injection site; arm aches; itching around injection site; Swelling around injection site;... Read more
redness of injection site; arm aches; itching around injection site; Swelling around injection site; This is a spontaneous report from a contactable consumer reporting for herself. A non-pregnant 76-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm on 10Mar2021 13:30, at 76 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included hypertension, kidney disease, stroke survivor, breast cancer survivor and allergy to nichel and to shrimp, all from an unknown date. Historical vaccine included the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, administered via an unspecified route in right arm on 17Feb2021 13:30 , at 76 years of age, (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Concomitant medications included allopurinol, metoprolol, atorvastatin, lisinopril and rivaroxaban (XAREL), all taken for an unspecified indication, since an unspecified date. The patient didn't receive any other vaccine in the previous 4 weeks. She was not diagnosed with COVID-19 prior to vaccination and was not tested positive for COVID-19 post vaccination. On 11Mar2021 08:00 the patient experienced redness of injection site, arm aches, itching around injection site and swelling around injection site. No treatment was received for the events. At the time of the report the events had not resolved yet. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
76 2021-06-16 rash SOB,Rash,4/14 anaphylactic shock admitted to Er remained overnight for observation, 5/9 rash return... Read more
SOB,Rash,4/14 anaphylactic shock admitted to Er remained overnight for observation, 5/9 rash returned after prednisone ER , 6/10 dermatolgist Dr rash returned. Took scrapping of skin, came back as Grover,s Disease.
76 2021-06-16 skin irritation, psoriasis, itchy skin, redness About a couple weeks after my second dose of the vaccine I started to have extreme itching on my sca... Read more
About a couple weeks after my second dose of the vaccine I started to have extreme itching on my scalp. I did not see anything at first and then another week later I saw a red irritated area. Then a couple days later I saw a white plaque like material. So then I saw a dermatologist and he said it was plaque psoriasis. He injected some medication behind my left ear (I do not remember what) and gave me a medicated shampoo which was a prescription. It is called ketoconazole shampoo 2% for topical application only. I continue to use it because the plaque is still there, the itching continues as well. I itch a lot during the night and I will do a follow up with a DR.
76 2021-06-16 vaccination site redness, redness, rash papular Red Spot on Cheek; got the injection on her arm, it is red around the injection site and then went d... Read more
Red Spot on Cheek; got the injection on her arm, it is red around the injection site and then went down her arm and back up; broke out in little red bumps on her chest and her arms, and it was the same kind of redness where she had the shot injection; also on her legs/rash on chest spreading down arm; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EP6955, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 28Mar2021 at 11:15 hours as 2nd dose, single dose (at the age of 76-years-old) for covid-19 immunisation. Patient's had no medical history (including any illness at time of vaccination) and relevant family medical history. Concomitant medication(s) included vitamins (occasionally takes vitamins) taken for an unspecified indication, start and stop date were not reported. Patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiration date and NDC number was unknown), via an unspecified route of administration, administered in right arm on 07Mar2021 as 1st dose, single dose (at the age of 76-years-old) for covid-19 immunisation. Patient had no prior vaccinations (within 4 weeks). Patient stated that initially after first dose, there was no redness at injection site. On 05Apr2021, patient now indicates a big red circle/red around the injection site, patient had it since it just popped up 2 weeks after the shot. Patient stated it was red around the injection site and then went down her arm and back up and it was worsened and then she broke out in little red bumps on her chest and spreading down arm/rash on chest spreading down arm, and it was the same kind of redness where she had the shot injection. Patient stated she also had a few on her legs. Patient stated she was not sure if it was an allergic reaction or how to treat it. Patient stated the redness was on her arm down to her elbow, it was pink and red and warm and then it went away, and now it was just red at the injection site. Patient was trying sensitive soap bout expensive sensitive soap to try and dry them up as treatment as it was a two month delay to see dermatologist. Patient also reports on cheek starting last week. On 26May2021, patient had red spot on cheeks. The outcome for broke out in little red bumps on her chest and her arms, and it was the same kind of redness where she had the shot injection; also on her legs/rash on chest spreading down arm in 2021 was recovered and for rest of the events was not recovered.
76 2021-06-17 hair loss 30 days after second injection, an unusual amount of hair loss began (Apr 7, 2021)
76 2021-06-23 rash, skin peeling Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has ... Read more
Breakout rash around neck, shoulders, chest, arms and tops of legs. None under arms or breasts. Has had rash since 6/7/21. Some raised bumps within rash as well, resembled insect bites. Some of the rash looked like insect bites, other areas skin broken, looks like skin scraped. Skin has peeled off on those areas. Had got bladder infection since then as well. Had blood in urine and received antibiotic (6/9/2021). Since then bladder infection has cleared. But patient has had a cough since then (about 5 days into breaking out). Has also had a slight headache.
76 2021-06-24 itchy skin Inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives o... Read more
Inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs.; Itching of (pre-existent) eczema; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6208), via an unspecified route of administration in the left arm on 18Mar2021 at 10:00 (at the age of 76-years-old), as a single dose for COVID-19 immunisation. Medical history included eczema, taste disorder, gastro-intestinal reflux, arthritis, drug allergy (sulfa drugs) and breast cancer (small lump). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the left arm on 23Feb2021 at 10:00, as a single dose for COVID-19 immunisation. Concomitant medications included losartan (MANUFACTURER UNKOWN), pantoprazole (MANUFACTURER UNKOWN), rosuvastatin (MANUFACTURER UNKOWN) and sucralfate (MANUFACTURER UNKOWN) all for an unknown indication from an unspecified date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 12:00, the patient experienced inability to sleep night after second dose, itching of (pre-existent) eczema and several new hives on shoulder, breast, legs. The patient self-administered EUCRISA and hydrocortisone was given as treatment for the events. The clinical outcomes of the events insomnia and itching were recovering. No follow-up attempts are possible. No further information is expected.
76 2021-06-24 rash, redness weight is too much; she developed a rash on her body/blotches/rash on chest, small amount on arms, a... Read more
weight is too much; she developed a rash on her body/blotches/rash on chest, small amount on arms, and a couple on legs; face very red; This is a spontaneous report from a contactable consumer(patient). A 76-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EL9264, Expiry date: May2021), via an unspecified route of administration on 31Jan2021 at 15:30 into left upper arm as a 1st dose single dose for COVID-19 immunization at hospital. The patient had an allergy to penicillin. No other vaccine given the same day or 4 weeks prior. No problems with vaccines in past. On 04Feb2021, patient developed a rash on her body, blotches/rash on chest, small amount on arms, and a couple on legs and face very red. On an unspecified date, patient experienced shrinking, weight is too much. She got the first Covid-19 shot at (hospital) this past Sunday. Went to take a shower today and her face was very red so she looked at her chest and there were blotches that looked like a rash. Had a small amount on her arms, but not at the injection site. Also had a couple of blotches on the legs. Had called the doctors at (hospital name) and had a virtual visit and was told to take Benadryl. This was 4 days after and wants to know if we have found out any information about her. She asks should she get the second dose in the same arm. Mentions she and her husband did take a COVID test because her husband had a belly ache so they wanted to make sure it wasn't that or something that he ate. They suspected it was something he ate and it was, they both were negative. Clarifies this was before getting the Covid-19 shot. Later mentions she has an allergy to penicillin and was not sure if that is related. Had a reaction as a child and has not taken it since. The patient was not visited to emergency room for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on an unspecified date Jan2021.The outcome of the events was unknown for overweight and recovering for other events Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
76 2021-06-24 vaccination site pain chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet a... Read more
chills; the glands in her neck, under her chin were swollen and hurt a little; below knee and feet and toes are crampy; Her mouth has been dry and drinking more water; Her body just feels achy; injection site is sore; does not feel well; her tingling in her legs from the knee to the toe; the glands in her neck, under her chin were swollen and hurt a little; sore arm; weight is a little low at the moment; This is a spontaneous report from a contactable consumer reporting for herself. A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EM9810; Expiration date: not reported), dose 1 via an unspecified route of administration, administered in left arm (in the muscle in upper arm) on 03Feb2021 (at the age of 76-years-old) as first dose, single for prevention. The patient's medical history and concomitant medications was none. After receiving the first dose, in the afternoon the patient started experiencing side effects of chills, pain in the injection site, the glands in her neck, under her chin were swollen and hurt a little, a very dry mouth and her tingling in her legs from the knee to the toe. The next day morning sore arm was better, but still experiencing the other side effects. Patient was concerned and would like to know if they were normal. The patient reported that she just got the first dose 03Feb2021 and scheduled for second dose on 24Feb2021. Her weight was a little low at the time of report as she was getting dental work done. Patient went to the site and it did not give anything in terms of if anything happened or what to expect. Patient had chills, and the glands around her neck were swollen. The injection site was sore, but she expected that. Her legs below knees and feet are crampy. Because of her age and lives alone, patient just wanted to know if this was normal. Her mouth was very dry and had been drinking water with lime she squeezed in it. This started after she got vaccinated around 11:00-11:30. Patient just wanted to know what was normal and what was not. She took temperature and does not have a temp 98.1. She just was feeling like she did not feel well. Patient wanted to know if this would pass. The place she got the vaccine, they did not give her any information except the date to return. Patient reported the day before reporting was worse. Her glands were still swollen, but not as bad. Her feet were still crampy and the toes, body just felt achy. Patient would like to know if these symptoms were normal and what the time frame was that she should expect them to continue. Investigation assessments included none. The outcome of the events chills, the glands in her neck, under her chin were swollen and hurt a little, her mouth has been very dry and drinking more water, her body just feels achy, injection site was sore and sore arm was recovering; event of below knee and feet and toes are crampy was not recovered; other events was unknown. Follow-up attempts are completed. No further information is expected.
76 2021-06-27 blister, itchy rash, rash Blisters, rash, itching Rash on face, chest,back,stomach, backside, arms, legs and top of feet
76 2021-06-27 rash vesicular, itchy skin Blistering rash and itching on face , arms, chest, stomach, backside, back, arms, legs and feet.
76 2021-06-29 bruising, sensitive skin, vaccination site pain, rash, redness, itchy skin, hives itching; Allergic Contact Dermatitis; rash; welted; red; bruised and sensitive to touch; bruised and... Read more
itching; Allergic Contact Dermatitis; rash; welted; red; bruised and sensitive to touch; bruised and sensitive to touch; sore left shoulder at the injection site next day for one day only; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EL1283) via an unspecified route of administration on 19Jan2021 at 14:30 in left arm (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Not pregnant at the time of vaccination. The patient did not have any allergies to medications, food or other products. Medical history included atrial fibrillation (AFib) and hypothyroidism. Concomitant medication included multaq, bisoprolol and levothyroxine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, Since the vaccination. On 20Jan2021, patient experienced sore left shoulder at the injection site next day for one day only. On 24Jan2021 at 11:00 (5 days after vaccine), patient noticed blood on my shirt where she had been itching, left upper arm between injection site and elbow, appearance of skin was rash, welted, red, bruised and sensitive to touch in an area about 3x3 inches. OTC anti itch cream not effective. Itching became so severe, I went to dermatologist 3 days after itching started. diagnosed as allergic contact dermatitis due to covid 19 vaccine. Treatment received was anti itch cream and told to use cold pack when it was itchy and take OTC antihistamine. Followed doctor's orders and itching finally stopped after 12 days from onset. The adverse event result in visit to doctor or other healthcare professional office/clinic. Seriousness reported as non-serious. The outcome of events was recovered in Feb2021. Follow-up attempts completed. No further information expected.
76 2021-06-30 vaccination site rash Day 5 after shot, little itchy rash around injection site; This is a spontaneous report from a conta... Read more
Day 5 after shot, little itchy rash around injection site; This is a spontaneous report from a contactable consumer (patient). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9264, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 04Feb2021 at 03:00 (at the age of 76-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included alendronate sodium (ALENDRONATE). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no allergies to medications, food, or other products. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249, Expiration date: Unknown), via an unspecified route of administration, administered in right arm on 14Jan2021 03:00 (at the age of 76-years-old) as dose 1, single for covid-19 immunisation in other facility. On 09Feb2021 at 08:00, day 5 after shot the patient experienced little itchy rash around injection site. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of the event with self-hemp oil topical, and allergy pill. The outcome of the event was recovering. Follow-up attempts are completed. No further information is expected.
76 2021-07-06 cellulitis, redness Cellulitis / Cellulitis in her leg; the right eye was sensitive to light; her eyes kept fluttering; ... Read more
Cellulitis / Cellulitis in her leg; the right eye was sensitive to light; her eyes kept fluttering; It is still draining and is still a little red; It is still draining and is still a little red; right side of the face was swollen; both of her eyes were swollen; This is a spontaneous report from a contactable consumer or other non HCP (patient, self-reporting). A 77-year-old patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9266 and expiration date was not reported), via an unspecified route of administration in arm left on 09Mar2021 at 16:30 (at the age of 76 years) as a dose 2, single for COVID-19 immunisation. infliximab (REMICADE), via an unspecified route of administration from 27Apr2021 (Batch/Lot number was not reported) and ongoing, at unspecified dose for crohn's disease. Patient's medical history included ongoing crohn's disease, She's had it for about 3 years, immune system disorder from an unknown date and unknown if ongoing, She has low immunity, skin cancer from an unknown date and unknown if ongoing, She had skin cancer. The patient's concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL9265 and expiration date was not reported), via an unspecified route of administration in arm left on 17Feb2021 as a dose 1, single for COVID-19 immunisation and remicade for crohn's disease. Additional vaccines administered on same date of the Pfizer suspect If applicable, list all vaccines administered on same date with the Pfizer vaccine considered as suspect was none. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine were and AEs following prior vaccinations were none. It was reported that, Patient who had both doses of the Pfizer COVID Vaccine. She had a birthday yesterday (date unspecified), so she was 77 years old when she experienced the events. She had her 2nd dose on 9Mar2021 and had a Remicade infusion on 27Apr2021. After her infusion, both of her eyes were swollen, the right eye was sensitive to light, her eyes kept fluttering while looking up or bending over, and the right side of the face was swollen. This was constantly happening but is now getting better but not completely over. She mentioned that she talked to several doctors and they think that Remicade, since it lowers the immune system and decreases white blood cell count and the vaccine increases the white blood count, it has interfered with the signals with her eyes. She was also hospitalized from 29May2021 to 2Jun2021 for cellulitis and was given some antibiotics and steroids which she thinks helped with her symptoms. She was asking if this has been reported and if this will happen again on 24Jun2021 for her next Remicade infusion. she was taking Remicade before giving her the vaccine. she had concern, would the vaccine affect the Remicade and cause these reactions. Upon follow up, It was reported that, patient had her second dose of the Covid Vaccine on 09Mar2021, and on 27Apr2021 she had a Remicade infusion. Both of her eyes were swollen, and the right side of her face was a little swollen. She wants to know if it could be an effect of the vaccine and if she will experience this again after her next infusion this June. she comes on the line. Her right eye was the worst. When she looked up it started to go closed. If she goes into a bright light it would go closed and bending over it would go closed. It would keep fluttering, and she would have to go sit down and close her eyes until it settled down. It interfered with her activities, and she didn't feel comfortable driving because she didn't know when it would hit her. Every time she talked to a doctor, they acted like she is crazy. It only seemed after the Remicade that this started happening, and now she was due for another Remicade infusion on 24Jun2021. She had some other health issues earlier this month and was put on antibiotics. The antibiotics seemed to help the eye it is not completely gone but better. She was wondering now if she should get the Remicade on 24Jun2021. She had skin cancer, and when they removed it, she got cellulitis in her leg. She was in the hospital for 3 days. She asked the doctor there and they brushed her off. The last day before she came home the nurse came in and wanted to know if she had her shot. She asked the nurse the same question about the vaccine and Remicade, and the nurse said now they ask people before they get the shot if they are on Remicade. The nurse didn't have anyone that said yes. It was seeming like there is some kind of problem with Remicade and the vaccine. That is why she was a little bit concerned about having it again. Event details Both eyes swollen: They were still swollen. It was reported that, Sometimes her right eye will still go closed. It has gotten better. Right side of face a little swollen: It lasted for at least a month. Cellulitis in her leg: That would have started on 21May2021. She went to the hospital on 29May2021 and came home on 02Jun2021. She doesn't know if it went away. She finished her medication on Wednesday, she took the last of the antibiotics they gave her to take at home. It is still draining and is still a little red. She doesn't think it is quite as red, but it is still draining. It is about the same. Along the way she went to Urgent Care. They put her on steroids that didn't help. A couple weeks after she got an infection and they had her on 3 or 4 different antibiotics. She didn't know if one helped, or it was just the Remicade wearing off. She was on 3 different antibiotics. One was Doxycycline and that didn't help. The other one they gave her to take home was Amox Clav 875, and it was 125mg. She took it 2 times a day for 6 days. Both of the antibiotics she took are in amber colored pharmacy vials. She doesn't remember the name of the steroid that she took. She had her first dose of the Covid vaccine on 17Feb2021 and second dose of the Covid vaccine on 09Mar2021. She has been on Remicade for many years, at least 3 or 4 years. Before that she was taking a pill. The Remicade is an infusion. They mix it up when she comes in. She did not know a dosage. She had gone to the eye doctor, and she did a bunch of bloodwork. The patient underwent lab tests and procedures which included blood test and computerised tomogram with unknown details. She doesn't know what bloodwork she did. She also had a CAT scan of her eyes in the hospital. The patient was hospitalized for cellulitis / cellulitis in her leg (cellulitis) from 29May2021 to 02Jun2021. She was in hospital for 3 days. Events did not require a visit to Emergency Room, but Physician Office visit is required. For her eyes she went to Urgent Care, and they said to make an appointment with an eye doctor. Family Medical History Relevant to the events were none. It was the Product Complaint, Product strength and count size dispensed: Amox Clav 185: 125mg strength. Outcome of the cellulitis / cellulitis in her leg was not recovered, both of her eyes were, the right eye was sensitive to light, her eyes kept fluttering, right side of the face was swollen were recovering. Outcome of it is still draining and is still a little and it is still draining and is still a little red were unknown. Information on the lot/ batch number has been requested.
76 2021-07-07 shingles Shingles, treated with antiviral medication
76 2021-07-12 shingles Herpes Zoster - anti-viral and predizone. Shingles on my face (later called Ramsay-Hunt Syndrome), ... Read more
Herpes Zoster - anti-viral and predizone. Shingles on my face (later called Ramsay-Hunt Syndrome), Nine weeks on I am still having pain although the initial rash is gone. Taking gabapentin 4 times a day.
76 2021-07-12 hives Severe hives; This is a spontaneous report received from a contactable consumer, the patient. A 76-y... Read more
Severe hives; This is a spontaneous report received from a contactable consumer, the patient. A 76-years old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration in the right arm on 26Jan2021 at 08:00 (at the age of 76-years old) as a single dose for COVID-19 immunisation. Patient medical history was not reported. The patient had no known allergies. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Jan2021 at 13:00, the patient experienced severe hives since day of vaccine. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe hives was unknown at the time of this report. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
76 2021-07-13 itchy skin tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable con... Read more
tremor; insomnia; intense itching; loose stools; This is a spontaneous report from a contactable consumer (patient). A 76-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was reported as unknown) via an unspecified route of administration on 26Feb2021 at 10:30am (at the age of 76-years-old) in left arm as dose number unknown, single for covid-19 immunization at Hospital. Medical history included breast cancer and known allergies as IgG reactions to many substances both from an unknown date and unknown if ongoing. No other vaccine taken on same date. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks. Concomitant medications received within two weeks included pregabalin (LYRICA); ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); melatonin (MELATONIN) and fexofenadine hydrochloride (ALLEGRA) all taken for an unspecified indication, start and stop date were not reported. The patient experienced delayed reaction two days after vaccination which included intense itching, insomnia, loose stools, and tremor on 01Mar2021. The patient received treatment for the adverse events occurred. The outcome of the events was Recovering. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
76 2021-07-16 skin discolouration RIGHT LEG SWELLING, PURPLE IN COLOR, ER VISIT REQUIRING DUPLEX SCAN WITH RESULT OF EXTENSIVE BLOOD C... Read more
RIGHT LEG SWELLING, PURPLE IN COLOR, ER VISIT REQUIRING DUPLEX SCAN WITH RESULT OF EXTENSIVE BLOOD CLOT DOWN ENTIRE LEG, 80 % BLOCKAGE. THREE DAY HOSPITAL STAY, INTERVENES TREATMENT OF HEPRIN
76 2021-07-17 shingles This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pr... Read more
This is a spontaneous report received from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration in the left arm on 16Mar2021 at 11:30 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient included high blood pressure. Concomitant medications were not reported. The patient was allergic to latex, sulfonamide, cipro and eggs. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 21Mar2021,5 days after the vaccination, the patient had shingles . The patient applied cortizone as treatment for the adverse event. The event resulted in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event shingles was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
76 2021-07-17 skin discolouration Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day a... Read more
Since February 19th I have been in constant pain. Difficulty in walking, exercising, and every day activities. 1. Covid Toes: One inflamed, swollen and discolored toe on each foot. Constant pain. Painful to touch. Spurts of searing, burning pain on back side of toe. 2. Exacerbated arthritic pain in both hands. Joints in fingers and thumb are swollen and extremely painful. Voteran for treatment. Referral to Rheumatologist
76 2021-07-18 rash macular, rash red blotches on legs from back of knee to foot
76 2021-07-19 blister headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new bli... Read more
headache; dizziness; fever; chills; Strong stomach pains; nausea; vomiting; distorted taste; new blisters on toes; finger pain; armpit pain; fatigue; brain fog; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the left arm on 10Mar2021 at 16:00 (at the age of 76-year-old) as a single dose for COVID-19 immunisation. The patient was allergic to sulfa drugs, lidocaine, penicillin and mouthwash. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included aspirin (MANUFACTURER UNKNOWN) 325mg one pill per day. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269), via an unspecified route of administration in the left arm on 14Feb2021 at 09:45 (at the age of 75-year-old) as single dose for COVID-19 immunisation. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021 at 08:00 the patient experienced headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog. The patient did not receive any treatment for the events. The clinical outcome of the events headache, dizziness, fever, chills, strong stomach pain, nausea, vomiting, distorted taste, new blisters on toes, finger pain, armpit pain, fatigue and brain fog was recovered with sequela on an unknown date in Mar2021. No follow-up attempts are needed. No further information is expected.
76 2021-07-22 itchy skin, rash -March 4, 2020 - Morning after vaccine - Ankles swollen. I never had swollen ankles in the past. Bum... Read more
-March 4, 2020 - Morning after vaccine - Ankles swollen. I never had swollen ankles in the past. Bumps under skin on right forearm - felt like sand pebbles under skin. That has continued and is present now also. - March 6, 2020 - Breathing became tight - remained that way for a good two months. Shortness of breath - Month of March - Rash was breaking out on lower right leg and lower back. itchiness ( But, I was unaware that it was Covid Vaccine related) Gradually became larger rash on right shin area. Right ankle and leg started to swell. - Last week of March, First Week of April - Right leg became more swollen and inflamed. Then became frighteningly swollen. Rash on arms increased. April 15, 2021 - Dermatologist appointment - He told me that the protective barrier on my skin had broken down. Prescribed Steroid cream, and CereVe moisturing cream morning and night. Cetaphil Gentle Skin cleanser used very sparingly on only parts of body absolutely necessary to wash, but not on rash area. No hot showers ever again. He said he would not need an antihistamine. Refused to address swollen leg and ankle. ( Your site tells me it is closing, so I do not have time to continue.)
76 2021-07-27 skin discolouration she has developed chills; her fingers were turning blue.; her fingers were turning blue.; This is a ... Read more
she has developed chills; her fingers were turning blue.; her fingers were turning blue.; This is a spontaneous report from a contactable consumer and from a Pfizer sponsored program COVAX US support. This 76-year-old (age at vaccination) female consumer (patient) reported for herself that she received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number; EN6207, expiration date; 31Jul2021, Pfizer COVID 19 vaccine manufacturer; Unspecified, NDC number; unknown) via an unspecified route of administration on 17Mar2021 at 10:30 at left arm as dose 2, single for covid-19 immunisation. Vaccination facility was Health and Wellness Center. Patient's medical history included blood pressure high, high cholesterol, knee replacement from Jul2020 to unspecified, heart problems, breast cancer (dates unspecified). Patient mentions predating treatment with the Pfizer COVID 19 vaccine, she had knee replacement surgery in Jul2020 and Nov2020 and had a COVID 19 test done before each time. Both the COVID 19 test from Jul2020 and Nov2020 were negative. Family History included mother heart problems; sister breast cancer; daughter breast cancer; father cancer. Relevant tests included two COVID-19 tests both negative on Jul2020 and Nov2020. Historical vaccine included first dose of BNT162B2, lot number: EN6199, on 24Feb2021 at 10:30 am in left arm for covid-19 immunisation. Concomitant medications were not reported. Prior vaccinations (within 4 weeks) were reported as none. Consumer had the first dose of the Pfizer COVID-19 vaccine on 24Feb2021 and had no reaction after. Consumer got the second dose on 17Mar2021. On 24Mar2021, she has developed chills and her fingers were turning blue on 24Mar2021 to ongoing. Reporter seriousness for the events was unspecified. The AEs did not require a visit to emergency room or physician's office. Consumer wanted to know if that is an adverse events associated with the vaccine and if those are adverse events that would go away. She also would want to know if she should go to the ER for it. Consumer states she has received both of the vaccines. Last week on 17Mar2021 she got the second dose. Then on 24Mar2021 she noticed chills; and her hands and fingers turned blue. They are still that way today. She didn't know if she should call Pfizer or call the wellness center. She is asking if this will go away or should she go to the ER? Clarifies she received the first dose of the Pfizer COVID 19 vaccine on 24Feb2021 at 1030 am in the left arm and had no reaction. Then she had the second dose on 17Mar2021 at 1030 am in the left arm. Patient does not see NDC on her vaccination card. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.
77 2021-01-05 itchy skin, hives Patient c/o itching and hives that evening and went to bed. Patient states she took a Zyrtec home do... Read more
Patient c/o itching and hives that evening and went to bed. Patient states she took a Zyrtec home dose. Patient denies any trouble breathing. Associate states she came to hospital to report the event just in case. Patient states the itching and hives have resolved at this time.
77 2021-01-06 injection site warmth, injection site swelling, injection site redness Softball size, raised, red area with warmth around the injection site. (Right Deltoid) Started on K... Read more
Softball size, raised, red area with warmth around the injection site. (Right Deltoid) Started on Keflex 500mg TID X 7 days and ice packs to area until redness resolved Reaction on 12/27/20 Resolved on 1/3/2020
77 2021-01-07 injection site hardening, injection site redness, injection site warmth Injection site on left arm of resident turned red, warm, and firm. Reaction began two days after inj... Read more
Injection site on left arm of resident turned red, warm, and firm. Reaction began two days after injection. Chief nurse directed resident to contact their Primary Care Provider.
77 2021-01-07 itchy rash rash occurred on a recent surgical wound/rash developed on the back crease of her legs and neck/seve... Read more
rash occurred on a recent surgical wound/rash developed on the back crease of her legs and neck/severe rash that got worse/general practitioner got steroids to help with itching; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL3246, via an unspecified route of administration to left arm from 02Jan2021 to 02Jan2021 as SINGLE DOSE for COVID-19 immunization. Medical history included spinal surgery and surgical wound, a 7 inch scar along her back/she had spinal surgery and has a 7 inch scar, she had no problems. There were no concomitant medications. The patient reported a rash that developed after receiving vaccine on 02Jan2021. On 03Jan2021, her rash occurred on a recent surgical wound, a 7 inch scar along her back. The rash also developed on the back crease of her legs and neck. She has been managing her symptoms with Benadryl. The patient was asking is others has reported this side effect. The patient is also asking if she can get the second dose of the vaccine. Her surgeon suggested perhaps not receiving second vaccine. It was further reported as, "got Pfizer COVID-19 Vaccine on Saturday. Next day had a severe rash that got worse. Saw her general practitioner this morning and got steroids to help with itching. No further details provided, wants to know if she should forgo the second shot. The patient stated she was fortunate to get the Pfizer vaccine, later clarified as Pfizer COVID vaccine, Saturday in the early am, then on Sunday, developed a rash over part of her body, she can control with Benadryl, the itching, but the weird part, is a month ago, she had spinal surgery and has a 7 inch scar, she had no problems, like no reaction to glue, but the rash is concentrated down both sides of the scar. She had an appointment with her surgeon today, and showed it to him, since she thought it was unusual, and he said she may not want to take the second dose, it was not a terrible rash all over her body, mainly concentrated to the area of her back, and it is like a little bit on the back of her neck, not even anything she would notice, but it is there. The patient stated she can't get through to the Health Department, and she has a card to say to have the second dose on 23Jan2020, but she can't get through. States thanks so much, this is a miracle event and in a year's time, even if she did get a rash. The rash is a little more pronounced, but she has been rubbing it trying to not scratch, but it doesn't seem to be spreading any at all. States she is healthy. Seeking more information about getting the second dose after experiencing a rash. The outcome of the event was unknown.
77 2021-01-07 vaccination site rash arm was slightly swollen; rash around the injection site; Arm soreness; This is a spontaneous report... Read more
arm was slightly swollen; rash around the injection site; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: unknown), via an unspecified route of administration on 02Jan2021 08:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient noticed her arm was sore a few hours after vaccination on 02Jan2021. Yesterday on 03Jan2021, her arm was sore. On 04Jan2021, when getting dressed she noticed her arm was slightly swollen and there's a rash around the injection site. Outcome of the events was unknown.
77 2021-01-11 redness Red, warm, swollen, pain
77 2021-01-11 shingles 8 days after receiving vaccination I abruptly started a case of shingles
77 2021-01-13 hives hives most notably on my legs & lower abdomen, progressing today to my face, arms, chest & shoulders
77 2021-01-18 skin infection at injection site Cellulitis at injection site. Started aprox 60 hours post vaccination. Treated with PO antibiotics
77 2021-01-24 redness within 45 minutes my face turned bright red and felt very warm lasted for a day and a half otherwise... Read more
within 45 minutes my face turned bright red and felt very warm lasted for a day and a half otherwise felt fine
77 2021-01-24 injection site tingling, injection site numbness Patient received vaccine on 1/21/21 and then was waiting for 15 minutes per clinic protocol post vac... Read more
Patient received vaccine on 1/21/21 and then was waiting for 15 minutes per clinic protocol post vaccination to monitor for any adverse reactions. Patient reported that she began having some numbness and tingling down arm where vaccination was administered and into her hand and fingers of that arm. Patient denied any other symptoms that were different than her normal baseline. Patient declined further evaluation or medical treatment at DCMH and reported that she just wanted to return home to monitor symptoms. Encouraged patient to contact DCMH or PCP for any worsening or continuation of current symptoms, any additional reactions or concerns, pt. verb. understanding at that time. This nurse contacted patient later in the day to follow-up and at approx. 1520 (01/21/21) patient reported at that time that symptoms had resolved.
77 2021-01-24 itchy skin, hives Noticed the next day after the vaccination my arm was sore, then itching with hives. Took Benadryl a... Read more
Noticed the next day after the vaccination my arm was sore, then itching with hives. Took Benadryl and put some cortisone on it to stop the itching.
77 2021-01-24 skin tightness Saturday evening 1/23/21 after vaccine, just all of a sudden from one moment to the next, left hand ... Read more
Saturday evening 1/23/21 after vaccine, just all of a sudden from one moment to the next, left hand was very tingly and tight feeling and could not move very easily. A few minutes later her lip from the center left was also tingling, and then spread to entire left side of her body from head to feet, like her left side feel asleep that tingly feeling and numbness. Began to be worried, called 9-1-1 and the EMT reassured her that she was not having a stroke, and told her that they had heard of it before. Still today, Monday 1/25/21, particularly in her left hand which she is not able to use very much. Did take Ibuprofen but nothing else.
77 2021-01-25 redness, rash Headache / rash / pruritus / erythema / elevated B/P
77 2021-01-25 itchy skin, itchy skin, redness, redness Headache / Pruritus / erythema/flushed / elevated B/P
77 2021-01-26 injection site pain After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were... Read more
After a few days, muscle/joint pain ....headaches.....Tiredness......injection sit pain.... all were bearable and strong to disappear when i waek after the short I got Horrible chills, completely out of control, had to wear my night guard to stop teeth from getting chipped, lasted 3 or four hours. Could not warm up, had two down comforters on. The chills eventually stopped but the headaches Intensified, also I could. Or move my near and shoulders. Went to the ER, they did not believe it had anything to do with the shot, I was there for 12 hours, had head exrays, spinal taps to test for meningitis, they searched for anything else I might have...nothing else.. they would not say if I should have the second shot, called pfiser this morning, they could not tell me if I should have the second shot, that I should aske my doctor.......If Pfiser doctor does not know if it is safe how could my country doctor.
77 2021-01-26 itchy skin, redness, rash Approximately 4 hours later, experienced itching on the top part of the chest. Upon checking, the a... Read more
Approximately 4 hours later, experienced itching on the top part of the chest. Upon checking, the area had developed a rash with high red bumps, redness around the area and smaller bumps as well.
77 2021-01-27 redness Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage. Si... Read more
Slight swell in face, lips, cheeks; feeling of tightness; redness in face;, some nasal drainage. Similar to reaction to hot peppers. Took 1 Benadryl tablet. Symptoms subsided over 24-hour period.
77 2021-01-27 injection site pain Sore arm at injection site for 48 hours
77 2021-01-28 injection site pain Nausea, achy body pain and shoulder site
77 2021-01-29 vaccination site swelling, injection site pruritus, rash with redness, vaccination site pain, vaccination site warmth On day 7 after vaccine a red rash ( dotted spots like pimples) developed at vaccine site covering Ap... Read more
On day 7 after vaccine a red rash ( dotted spots like pimples) developed at vaccine site covering Approx 4" in diameter. The next day the whole area turned into one large red spot approx. 4" in diameter. There is an itch and slight swelling with slight pain. Also warm to the touch.
77 2021-01-31 redness, injection site swelling, injection site redness ABOUT AN THIRTY MINUTES OR SO AFTER THE SHOT THE PALM OF MY HANDS AND BOTTOMS OF MY FEET STARTED HEA... Read more
ABOUT AN THIRTY MINUTES OR SO AFTER THE SHOT THE PALM OF MY HANDS AND BOTTOMS OF MY FEET STARTED HEATING UP AND TURNING RED. I TOOK A BENADRYL AND IT HELPED A LITTLE. SUNDAY THE SHOT SITE STARTED TURNING RED AND WAS SWOLLEN A LITTLE LARGER THAN A QUARTER.
77 2021-01-31 injection site pain couldn't sleep; sudden hearing loss; complete hearing loss a few days later/hearing loss in right ea... Read more
couldn't sleep; sudden hearing loss; complete hearing loss a few days later/hearing loss in right ear; constant humming in her right ear/getting hissing in my ear; arm felt tender; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was either: EL1283, CL1283, or LL1283) on 11Jan2021 at 11:00 at single dose in left arm for COVID-19 immunization. Medical history was none. There were no concomitant medications. Patient previously took pneumonia shot on an unknown date and flu shot in Oct2020 for immunization. Patient got the first dose of the vaccine on 11Jan2021 at 11:00 in the morning. On 11Jan2021 her arm felt tender where the needle went in.On 12Jan2021 late afternoon, she started getting hissing in her ear that was still there and had not gone away at all and she also had a constant humming in her right ear. By 13Jan2021, she still had the humming. She saw an ENT on 13Jan2021 and doctor didn't know if it was correlated to the vaccine or not; doctor took some wax out of her ear and she seemed to get relief from the hissing for about 15 minutes but about 15-20 minutes later the hissing/ humming continued. On 14Jan2021, woke up with complete deafness in right ear. Immediately called ENT doctor and did a hearing test. Patient could not hear and they confirmed she had sudden hearing loss in her right ear on 14Jan2021, she had nothing in her right ear (as reported). They put her on 40 mg a day of Prednisone (20mg tablets) and so far, prednisone hadn't done anything: originally taking prednisone 40mg for four days and was taking two a day; on 16Jan2021 when she was getting no relief and couldn't sleep due to the humming in her ear, she called doctor and was advised to take the 40mg together in the morning, she will take 40mg a day. On 19Jan2021 she took 20mg for four days and then decreased by half again. She was also advised by doctor to take 25mg Benadryl (UPC: 30048284 Lot: SPS023 Exp: Jun2022) at night. They are scheduling her for an MRI in Jan2021.Patient was also scheduled for the second dose on 01Feb2021 and will be on the prednisone until 26Jan2021; she would like to know whether the prednisone will diminish the effectiveness of the vaccine. She also asked if there was a certain amount of time she should wait to restart in case the doctor decided she should not get the second dose; she also wanted to know if she should wait on the second vaccine and maybe start over in two months.She was concerned and wanted to know if she should proceed with the second shot. The patient underwent blood work on an unspecified date to see if she can receive contrast for an MRI. She never had problem with MRI contrast before. Final outcome of the events was reported as unknown.
77 2021-01-31 skin swelling, redness experienced allergic reactions; her eyes got red; Her eye lids were red; Her eye lids were red, swol... Read more
experienced allergic reactions; her eyes got red; Her eye lids were red; Her eye lids were red, swollen, and puffy.; Her eye lids were red, swollen, and puffy.; cheeks were bright red; This is a spontaneous report from a contactable nurse (patient) reported that a 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on the left arm on 14Jan2021 14:00 at a single dose for Covid-19 immunization. Medical history included that the patient was diabetic and hypertensive; both were ongoing. Concomitant medications included atenolol taken from 14Jan2021 for blood pressure high; pioglitazone hydrochloride (ACTOS) and ongoing metformin both were taken from an unspecified date for diabetes; ongoing montelukast sodium (SINGULAIR) for history of food and drug allergies and ongoing chlorothiazide for diuretic. It was reported that she had the first dose of the covid vaccine on 14Jan2021 and experienced allergic reactions after she left the facility; they were not life threatening but were not pleasant. She realized how bad it was after she got in the car, removed her mask, and looked at her face. She was concerned about getting the second dose. She even took Benadryl 1 hour before getting the shot and still had a reaction. She clarified her allergic reaction to be as her eyes got red. Her eye lids were red, swollen, and puffy. It looked bad. When she got in the car took her mask of her cheeks were bright red. She sat in the ER parking lot for an hour waiting for it to resolve. It resolved after like an hour and half. After it resolved and went away she went back home. She stated that this allergic reaction is anxiety producing. She gets anxious because she knew what could happen. The outcome of the events was recovered on 14Jan2021.
77 2021-02-01 injection site pain Starting about 3 hours after the injection, right arm began feeling sore at the injection site. Dis... Read more
Starting about 3 hours after the injection, right arm began feeling sore at the injection site. Discomfort turned into pain in the late afternoon and evening, to a maximum pain level of about 4 by bedtime. Pain level was down to about 2 or 3 by the next morning, and that continued throughout the next day.
77 2021-02-01 itchy skin, rash, redness Patient waited 30 min given prior history of reactions to medications (rash, no anaphylaxis) with ot... Read more
Patient waited 30 min given prior history of reactions to medications (rash, no anaphylaxis) with other medications. Left after 30 min with no complaint. Allergies Allergen Reactions ? Niacin Other (See Comments) Other Reaction: Other reaction ? Penicillins Rash ? Amlodipine Swelling ? Flagyl [Metronidazole Hcl] Other (See Comments) Other Reaction: Other reaction ? Lipitor [Atorvastatin] Rash ? Zocor [Simvastatin] Other (See Comments) and Unknown Other Reaction: Other reaction ? Colesevelam Other (See Comments) severe ? Metronidazole Rash ? Colesevelam Hcl Other (See Comments) severe She returned after approximately another 20 minutes to report rash and mild pruritis on upper chest and face. No complaints of shortness of breath, chest tightness, lightheadedness or dizziness. No facial swelling, pallor or cyanosis. No increased effort of breathing or wheezing appreciated. Skin only reaction, no respiratory, cardiovascular or GI reaction. On exam- 140/70 HR regular rate and rhythm. Lungs clear No cyanosis or pallor noted Patient able to converse normally, A+O , in no acute distress Mild erythema around mouth, no tongue swelling appreciated. Mild erythema between brows. Mild blotchy erythema on upper chest. Given oral diphenhydramine 25 mg at 4:30. No progression of symptoms and patient observed another 30 minutes without change. Given a oral diphenhydramine 25 mg to take with her in the event symptoms progress or to take as a second dose in 4 hrs. If any worsening symptoms she is to seek emergency medical attention. I will follow up with her this evening and tomorrow. I will provider her formal recommendations regarding her second vaccination. I spoke with her at 6:50- she is stable, still mild rash on upper chest, but no new symptoms. She will repeat with diphenhydramine 25 mg at 8 pm and I will check on her tomorrow. She is motivated to receive her second dose but asks if receiving a different medication is an option We will discuss this further tomorrow. I spoke with patient again on 1/21/21 at 8:30 am. She continues with mild rash on upper chest, will continue benedryl for mild itching, but no further progression of rash, no residual facial erythema and no shortness of breath or other new symptoms. I have asked her to consider premedicating with 50 mg diphenhydramine 1 hr prior to dose 2 of vaccine. I have also asked her to register with v-safe and have sent her the information in case she did not keep the paperwork. Pt then saw PCP several days later who suggested she not receive second vaccination
77 2021-02-02 injection site pain Burning pain going down into the forearm on the same side vaccine given; This is a spontaneous repor... Read more
Burning pain going down into the forearm on the same side vaccine given; This is a spontaneous report from a contactable pharmacist. A 77-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730) via an unspecified route of administration on 13Jan2021 12:30 single dose for covid-19 immunisation. Vaccine location was left arm. Patient did not receive any other vaccines that day and none 4 weeks prior. Medical history was none. There were no concomitant medications. The patient experienced burning pain going down into the forearm on the same side vaccine given on 17Jan2021. She has never experienced anything like this before having that vaccine. The event was reported as medically significant. The outcome was not recovered.; Sender's Comments: Based on the reasonable temporal association and considering he known safety profile of COVID-19 vaccine, BNT162B2, the Company considers there is a reasonable possibility that the reported "burning pain going down into the forearm on the same side vaccine given" is related to BNT162B2 administration. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
77 2021-02-03 itchy skin, skin warm, hives pt experiencing hives, itching, hot to touch--pt has had to take Benadryl
77 2021-02-03 hives, itchy skin Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two t... Read more
Itching/She was itching on her knee, leg, arm, neck, and ears.; She had hives on the knee; The two that had her most worried was the memory loss and chest pain; Chest pain; It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street; Spasms/spasms were like in her back where her shoulders were and it was bulging; It hurt from her neck and up into her head.; It hurt from her neck and up into her head.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL3246, expiration date unspecified), via an unspecified route of administration on 10Jan2021 (around noon) at single dose (left arm) for COVID-19 immunization. Medical history included ongoing diabetes, ongoing blood pressure high/blood pressure, ongoing heart problems; heart disease, kidney disease, history of itching, fluid (imbalance), stroke so taking for clotting, history of neck issues and she was allergic to a lot of medications. Ongoing concomitant medications included ubidecarenone (COQ-10), zinc, torsemide for fluid, clopidogrel for had a stroke so taking for clotting, insulin glargine (LANTUS) for diabetes and isosorbide mononitrate, carvedilol, irbesartan and amlodipine, all for blood pressure. Patient reported that she got the injection on Sunday and then later she started to get spasms on 12Jan2021. These spasms were like in her back where her shoulders were and it was bulging and it hurt from her neck and up into her head. She mentioned she was 77 years old and sometimes she has to think about a word before she gets it out, but yesterday (14Jan2021) it was different. It was like she went blank. She was looking around and she could not remember names she was trying to figure out name street on and this lasted 15 minutes and then it went away. She confirmed she does not have it right now. It did not last a long time, but it scared her so bad. Then yesterday evening (14Jan2021), she started to have funny chest pain. She told her husband if it did not go away she would go to the ER. However, after an 1 hour it went away. It was like a sticking pain. The chest pain lasted for an hour and started around 18:00. On an unspecified date, she started itching at night. She has a history of itching, but this was out the box. She had hives on the knee. It was crazy. She itched all over. She had to get out of bed and sit in a chair until 1:30AM. She was still itching, but it was not as bad. Patient reported that due to the kidney disease she has itching, but the itching she was having after this COVID Vaccine was different and more. It was out of the box. She confirmed this was the first injection and now she was scared to get the second injection. Patient reported that the itching started when she went to bed. She went to bed around 21:00 and around 21:30, she got out of bed because she was itching so bad. She stated there was not anything different on the bed. It was the same thing that was up there the night before. She did not change the sheets or anything. She had to get up and sit in a chair and she could not believe how bad her knee was itching. She was itching on her knee, leg, arm, neck, and ears. She stated she takes a lot of medications. She was very funny with medications and they have to work with her to get the right one for her. Due to having these other conditions was why she wanted to get the COVID Vaccine. She reported she will have her blood drawn next week. The two that had her most worried was the memory loss and chest pain. However, these passed and she did not go the ER or physician office. She was afraid if she gets the second injection this will happen again and she may not come out as well form it. Prior vaccinations within 4 weeks was none. Outcome of events spasms/spasms were like in her back where her shoulders were and it was bulging and itching/itching on her knee, leg, arm, neck, and ears was recovering; chest pain was recovered on 14Jan2021 at 19:00; and outcome of the rest of events was unknown.
77 2021-02-03 vaccination site pain Diarrhea; Upset stomach/stomach was jumping around; she woke up during the night after her stomach w... Read more
Diarrhea; Upset stomach/stomach was jumping around; she woke up during the night after her stomach was jumping around yesterday; her arm was not real sore, which she was surprised. She says that if she touches the injection site she can feel it; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1284, expiry date: unknown), via an unspecified route of administration in the left arm, on 16Jan2021 11:30, at single dose, for COVID-19 immunization. Medical history included ablation and watchmen procedure (successful) both in 2020, atrial fibrillation (A-fib) and sensitive stomach. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN 81 mg, lot number: NAA80DX, expiry date: Aug2021). The patient reported that she had her first dose of the vaccine this past Saturday (16Jan2021), and she did not have adverse events, but she was having some upset stomach on 17Jan2021 and diarrhea on 18Jan2021 and would like to know if this could be a side effect. She stated she woke up during the night of 17Jan2021 after her stomach was jumping around. She stated she has a sensitive stomach, anyway, normally; and her arm was not real sore, which she was surprised. She said that if she touches the injection site, she can feel it (pending clarification), but it is not throbbing, aching, or swollen. She stated that she was not sure if it could be the spaghetti they had for dinner, but this morning (18Jan221) she had some diarrhea. When asked about treatment, she said she didn't take anything for this because she doesn't like to take medicine, and if it is from the vaccine it should go away in a day or so but her diarrhea stayed about the same and has not gotten any better or worse. She also noticed the paperwork that said don't take Ibuprofen, Aspirin, or blood thinners, and mentioned she takes baby aspirin every day, she wanted to know if that was okay. The outcome of the event diarrhea was not recovered; and the remaining events was unknown.
77 2021-02-04 itchy skin, hives bad allergic reaction; itching and welts, like hives; itching and welts, like hives; didn't get any ... Read more
bad allergic reaction; itching and welts, like hives; itching and welts, like hives; didn't get any sleep last night; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302 and expiration date not provided), via an unspecified route of administration in the left arm on 18Jan2021 18:00 at a single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included other medications that she has never had a reaction to. The patient stated that she got her first dose of COVID vaccine on 18Jan2021 evening. On 19Jan2021, she had a bad allergic reaction, itching and welts, like hives or whatever that started on her arms that progressed to the rest of her body especially the buttocks, everywhere. She did not get any sleep on 19Jan2021 and was itching. She called the doctor's office to see if they could help her and they said they couldn't and told her she needed to contact the health department "or something." They aren't familiar with the vaccine and does not want to do anything that would put them in a legal situation. She stated she has an appointment on 08Feb for her next dose and she doesn't know if she can go through this again. She asked what can she do about this reaction. She started to get itching and "stuff" that was not bad until last night (unspecified date). She stated that it was like she had hives all over and itching out of control. She did not get any sleep and is still itching out of control. She wanted to know if she goes back to hospital if they will be able to do anything for her. It was her first shot and is scheduled for her second one on 08Feb2021. She was wondering will she have to go through all of this again. She had noticed hives on her arms on 19Jan2021 morning but mostly now are on her buttocks and thighs. She stated that she had thought it was an allergic reaction to a fabric softener that she changed to. No treatment was given in response to the events. She has stated that she takes other medications that she has never had a reaction to. She does not think that they were related to this. The outcome of the events was not recovered.
77 2021-02-06 rash, rash macular Friday evening (Feb.5th) after taking off my socks saw I had a dark red rash around my ankles. It d... Read more
Friday evening (Feb.5th) after taking off my socks saw I had a dark red rash around my ankles. It did not itch much. The next day on Saturday I had more red spots but not quite the same as around my ankles. More up my legs to my knees. This morning (Sunday Feb 7th) I now have more spots on my arms. These spots are not like the dark reds ones around my ankles. I also have a spot on my face. I went to the Urgent Care in my area and the opinion of the doctor on call these spots may be related to my vaccine even though it has been 2 and 1/2 weeks since I had the covid vaccine. Up until this eposide I have not had any reaction to the vaccine. They suggested I contact you with this information. I was given a Medrol Dose Pak for the rash. The doctor was not sure the vaccine was the cause of my rash. I would appreciate if someone would contact me and let me know if I should not take my next vaccine which is scheduled for Feb.10 at 9:45 AM.
77 2021-02-07 injection site pain, injection site swelling, injection site redness, injection site pruritus Injection site- swelling, redness, pain, tenderness, itching - chills, fever, body aches
77 2021-02-07 rash vesicular, redness, rash, shingles Pt developed Shingles after vaccination. Notes from call to PCP day after vaccination: "Since yeste... Read more
Pt developed Shingles after vaccination. Notes from call to PCP day after vaccination: "Since yesterday morning after vaccine after she received her covid vaccine, she noted that her right ear hurts. She says that the pain does not feel like it is in the ear but right around the ear, and the bones around the ear. She says it hurts to chew, and the area to the back of her ear has ringing sound. She does not note that the ear is red . When she rubs under the ear she says the area is painful is painful. She does not note a lump or bump under her ear.. She states that the jaw/bone area hurts with the vibration of the conversation." Sore throat and headache, only on right side. Pain progressed to the point of hospitalization, with vesicles erupting on right side of face/ear canal.
77 2021-02-07 skin burning sensation 24 hrs after shot i ran low fever and head ache. i had fatigue, But then i started 2ays later feel... Read more
24 hrs after shot i ran low fever and head ache. i had fatigue, But then i started 2ays later feeling like i had inflammation in my butt, external in vaginal area and was hard to use the restroom and back of thighs area. felt like a had a rash but there was nothing there. like it was burning. it just felt inflamed. It felt good to apply cold to it. it lasted until the next day.
77 2021-02-07 vaccination site itchiness, itchy skin arm pain; itching; It's become difficult to move her arm and has worsened since the injection/ I had... Read more
arm pain; itching; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; It's become difficult to move her arm and has worsened since the injection/ I had a hard time lift my arm in changing clothes; I feel in my arm, around that shot you know I had the injection, start itchy start feel itchy; my arm feel pink, it's swell up and it's scratch; my arm feel pink, it's swell up and it's scratch; This is a spontaneous report from a contactable consumer (patient herself). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246, expiry date not reported), via an unspecified route of administration on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included bone disorder (reported as bad bone problem). Concomitant medication included denosumab (PROLIA) for bone disorder. The patient received her first injection on 09Jan2021 and had been experiencing arm pain which was mild to moderate but about a week later she developed itching in the same arm. It's become difficult to move her arm and had worsened since the injection. She wanted to know if this type of experience had been reported and if she should receive the second vaccination scheduled for the 30th. The patient stated that she had a hard time lift my arm in changing clothes and she can't her shoulder. After one week later about almost 1 week later she felt in her arm, around that shot she had the injection, started itchy started to feel itchy and she was afraid maybe infection, dead skin, maybe infection or something. She showed it to her friend, saying "Look my arm feel pink, it's swell up and it's scratch, it's itchy." Clinical outcome of event "difficulty to move her arm and had worsened since the injection" was not recovered while for the other events was unknown.
77 2021-02-08 shingles Shingles break out 10 days after first injection, pain and pox on neck and head
77 2021-02-08 injection site rash, injection site pruritus 3x3 rash area below injection site itchy
77 2021-02-08 itchy rash, hives 5 by 6 cm pruritic urticarial plaque lasting 3 days
77 2021-02-08 rash, itchy rash Diffuse pruritic full body rash
77 2021-02-09 injection site pruritus, rash macular Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching at injectio... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: shortly after vaccination patient reported itching at injection site and in throat. Initial vital signs within normal ranges except pulse 100-110 beats per minute and blood pressure 180/90 mmHg. Patient administered diphenhydramine 25 mg orally and transported to the emergency department. On arrival and during physical exam patient noted to have red "splochyness" on chest wall but no hives. Patient awake, alert, oriented: no shortness of breath, stridor, or oral or pharyngeal swelling. Patient observed, symptoms improved, vital signs stable, and discharged to home.
77 2021-02-09 itchy skin, hives 3 hours post-vac: hives on scalp and rt side of forehead. Itchy scalp. 4 hr post-vac: itchy on stom... Read more
3 hours post-vac: hives on scalp and rt side of forehead. Itchy scalp. 4 hr post-vac: itchy on stomach.
77 2021-02-09 rash Started 10 days after she received the vaccine, 2/7/21, found while washing her head, bumps on her h... Read more
Started 10 days after she received the vaccine, 2/7/21, found while washing her head, bumps on her head. This progressed to her neck and on Monday 2/8/21, noticed that it was behind her ear. Yesterday and today she has noticed that it has traveled more to her throat area. She has taken Tylenol and this seems to have helped. The symptoms seem to subside while on the Tylenol, but after 6 hours she then notices that the feeling is coming back.
77 2021-02-09 vaccination site pain, vaccination site itchiness, vaccination site redness trouble sleeping; right arm plus red; right arm feel ithcy inside; night chills; headache; arm hurti... Read more
trouble sleeping; right arm plus red; right arm feel ithcy inside; night chills; headache; arm hurting/right arm pain was more painful; This is a spontaneous report from a contactable other health professional (reported for herself). A 77-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/lot number: E69261), via an unspecified route of administration in right arm on 27Jan2021 11:15 at single dose for covid-19 immunisation in hospital. Medical history included, two stents, hernia, prior to vaccination, the patient was diagnosed with COVID-19. Concomitant medication within 2 weeks of vaccination included omeprazole, rosuvastatin, ticagrelor (BRILINTA), metoprolol, sucralfate (SUCRA). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took amoxicillin sodium; clavulanate potassium (AUGMENTIN), carisoprodol, clopidogrel bisulfate (PLAVIX) all experienced allergies. First it was arm hurting first night on 27Jan2021, then next night on 28Jan2021 chills, headache occurred, last night on 29Jan2021 she had trouble sleeping. Her right arm pain was more painful, plus red, feel itchy inside, took diphenhydramine (BENADRYL) 1 tablet. The events were non-serious. The patient's COVID test post vaccination included nasal swab on 27Dec2020 with result negative. Outcome of the events was unknown.
77 2021-02-10 injection site redness, injection site swelling Date and time of vaccination: (list both if they received both shots): 1/6/2021 (First dose) 1/27/2... Read more
Date and time of vaccination: (list both if they received both shots): 1/6/2021 (First dose) 1/27/2021 (second dose) redness, swelling at injection site, feels like fat hanging from the arm. still occuring
77 2021-02-10 injection site pain chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, j... Read more
chills, shakiness followed by feeling very warm, sweating and sweaty, Extreme fatigue, body aches, joint pain. Injection site pain. Muscle pain. Nausea--did throw up twice. General feeling unwell. The fatigue has gone on for two weeks now. Starting to get better.
77 2021-02-10 injection site rash, injection site pruritus, injection site swelling, injection site redness Right arm at injection site red, slight rash, very itchy and slightly swollen Occurred 9 days after ... Read more
Right arm at injection site red, slight rash, very itchy and slightly swollen Occurred 9 days after shot given on 1/31/21
77 2021-02-10 pityriasis rosea (viral rash), itchy skin, rash I developed a rash under my left arm on Feb.1,2021. By Feb. 3, it had spread to under my right arm, ... Read more
I developed a rash under my left arm on Feb.1,2021. By Feb. 3, it had spread to under my right arm, my trunk, back and inner thigh area. The rash exhibited a classic pine tree pattern with an initial herald patch under the left arm. The rash is consistent with a diagnosis of Pityriasis Rosea. Over the last 5 days, the rash has begun to fade on the trunk and back and the herald patch has disappeared during the laast 24 hours. A low level if itching has been treated with 25 mg. of Benadryl taken at bedtime.
77 2021-02-10 vaccination site swelling, redness dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection... Read more
dont want to eat anything; hot and cold chills; headaches; muscle pain; fever; joint pain; injection site swelling; redness; nauseated; swollen lymph nodes on throat; face swelling; fast heartbeat; body didn't feel well; chills; didn't feel like herself; light headed; felt weak; tired/slept all day; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date were unknown), via an unspecified route of administration on 22Jan2021 15:30 at a single dose on right arm for COVID-19 immunization. Medical history included breast cancer 16 years ago, patient on defibrillator from Oct2016 (it was reported that this past October2020 would have been 4 years since she had the defibrillator put in), ongoing congestive heart failure, ongoing (COPD) chronic obstructive pulmonary disease, sinuses problems, back and hip problems, positive for COVID-19 from 11Jan2021, and hurting. The patient's concomitant medications were not reported. The patient previously received flu shot for immunization on unspecified date. On Saturday (23Jan2021), the patient reported that she "slept all day, felt weak, light-headed, and tired". The patient stated, "I have problems breathing anyways". The patient stated she "doesn't want to eat anything". On Sunday (24Jan2021), the patient "felt good", then Monday (25Jan2021), "didn't feel too bad". On unspecified date, patient experienced hot and cold chills, body didn't feel well, and breathing problems. She has breathing problems because she has COPD. Other things in the list of the adverse events (from the paperwork she was given) that the patient experienced include tiredness, headaches, muscle pain, chills, fever, joint pain, injection site swelling, redness, nauseated, feeling unwell, swollen lymph nodes on throat, face swelling, a fast heartbeat, dizziness, and weakness. Right now (26Jan2021), the patient did not even feel like going to her doctor's appointment (on Thursday). She just didn't feel like doing anything. She didn't feel like herself on 26Jan2021. She clarified on 11Jan2021 (prior to vaccination), she went to hospital because she was hurting. She clarified it was in and out of the Emergency Room. She was never admitted into the hospital. They ran some tests urine, blood, EKG tests. All the tests came back good. The patient underwent COVID test on 11Jan2021: positive; and same test on 22Jan2021: negative. Outcome of the events was unknown. Information about lot/batch number has been requested.
77 2021-02-11 bruising Ecchymosis around bruising site
77 2021-02-11 shingles Shingles symptoms
77 2021-02-11 rash macular, itchy skin 6 days after receiving the vaccine the patient developed a spotty rash in multiple places on my body... Read more
6 days after receiving the vaccine the patient developed a spotty rash in multiple places on my body. Patient is saying it is itching. I examined the patient today 2/12/2021 I prescribed Benadryl Cream and Benadryl tablets.
77 2021-02-12 skin tightness, hives, injection site warmth, injection site swelling, injection site redness One hour after receiving the vaccination, I had an uncontrolable bout of diarrhea in a public place.... Read more
One hour after receiving the vaccination, I had an uncontrolable bout of diarrhea in a public place. Later in the day, I felt fatigued, and aching, and my left arm started to get very tight and sore. The next day I felt the same, and my lymph nodes under both my arms began to swell and hurt and my rectum began to have severe pain. Still had diarrhea. By day 5 my left arm ,at the site of the injection ,started to swell, get very hot ,and a large, bright red welt appeared which almost reached my elbow and went across the width of my upper arm.. I called my doctor and went to see her on the next day because it had gotten worse. She thought it was a local reaction and recommended ice, tylenol and benedryl. Again, as with the first shot, I am not sure if this is an allergic reaction or not., but thought I would report it.
77 2021-02-13 injection site rash, injection site pruritus 3 inch rash and itching around injection site. Haven't contacted physician yet because of weekend.
77 2021-02-14 rash with redness, rash jan 6 first dose--jan 27 second dose calling to report arm swelling after the second dose of vaccine... Read more
jan 6 first dose--jan 27 second dose calling to report arm swelling after the second dose of vaccine vaccine--went down with ice--started this Sunday Feb. 7--subsided on Wednesday Feb. 10----claims to day she got a big red/rash mark underneath the naval--no other s/s she went to the hospital today
77 2021-02-15 itchy skin, injection site pain Patient tolerated her first dose of the COVID19 vaccine well, but her second dose on 02/12/2021 was ... Read more
Patient tolerated her first dose of the COVID19 vaccine well, but her second dose on 02/12/2021 was not tolerated as well. Patient experienced 4 days of a low-grade fever, fatigue, facial flushing, injection site pain, and itching of the upper arm with little relief from OTC ibuprofen. Recommended OTC acetaminophen and a follow-up appointment with her PCP.
77 2021-02-16 cellulitis, injection site redness Received 2nd vaccine on 2/4/21 developed redness below injection site on 2/7/21. Redness continued a... Read more
Received 2nd vaccine on 2/4/21 developed redness below injection site on 2/7/21. Redness continued and spread down arm. Contacted clinic with this information they took report. I was told to contact my personal physician. Called on 2/9/21 was given appointment to be seen 2/10/21 she diagnosed - cellulitis and i was given Rx for Cephalexin 500 MG.
77 2021-02-16 hives Patient presents to ED with hives and lip swelling. Treated with IV diphenhydramine, methylpredniso... Read more
Patient presents to ED with hives and lip swelling. Treated with IV diphenhydramine, methylprednisolone, famotidine, and oral cetirizine. Symptoms improved.
77 2021-02-17 redness, blister, hives, shingles Pfizer-BioNTech COVID-19 Vaccine EUA Within approx. four hours of receiving the vaccine, I had sever... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Within approx. four hours of receiving the vaccine, I had several red welts develop on my abdomen. Over a period of several days, these welts spread to my back and were angry, red and painful. Since then, they have blistered. I went to a walk-in clinic because my primary care physician clinic was closed due to lack of power. At the walk-in clinic, I was diagnosed as having shingles. I had the shingles vaccine in 2014. I am now taking Acyclovir 800 mg five times per day. I am also taking L-Lysine with meals and Oxycodone-acetaminophen for pain.
77 2021-02-17 redness, itchy skin, rash Itchy burny skin rash started in right armpit and lower back, then migrated sequentually to left arm... Read more
Itchy burny skin rash started in right armpit and lower back, then migrated sequentually to left armpit, the sides of both breasts, the back of the right shoulder, the left thigh, and finally to the abdomen. The rash starts as fine red spots that later become inflamed and join to form large irregular patches that could be a 2 or 3 inches in diameter. Televisited primary care physician who prescribed Zyrtec twice a day and Caladryl topical lotion and referred me to a dermatologist who prescribed 0.05% Clobetasol Propionate Ointment and Benadryl as needed. The rash persisted and became worse after the 2nd shot 21 days later, but was fading slightly and was less itchy and burny just before the 2nd shot. Will report 2nd shot events separately later.
77 2021-02-17 itchy skin, hives Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site.... Read more
Itching/hives bilateral axilla. Sensation of lump in throat/itching tingling in throat. EMS on site. Patient's Epi-pen used left thigh. EMS started IV in left AC gave fluids and gave 25 mg Benadryl IV. Vitals monitored. Symptoms improved shortly after medication administration. Med unit transported patient to hospital for further evaluation.
77 2021-02-17 hives pt stated that she developed hives on her torso and both legs down to the knees and slight headache ... Read more
pt stated that she developed hives on her torso and both legs down to the knees and slight headache after taking the covid. Pt states her symptoms are improving.
77 2021-02-17 vaccination site redness, vaccination site itchiness, vaccination site warmth This is a spontaneous report from a contactable other healthcare professional (patient). A 77-year-o... Read more
This is a spontaneous report from a contactable other healthcare professional (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EN5318) via an unspecified route of administration on the left arm on 31Jan2021 10:00 at a single dose for COVID-19 immunization. Medical history included diabetes (reported as diabetis), high blood pressure, allergy to penicillin and sulfer; and COVID-19 (prior to vaccination). Concomitant medications included metformin, apixaban (ELIQUIS), valsartan, propafenone and amlodipine besilate (AMLODI). On 31Jan2021 10:30 AM, the patient experienced redness, warm and itchy around injection site. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.
77 2021-02-18 injection site pain, injection site warmth, injection site swelling, injection site redness, injection site hardening RN administered shot subcutaneously (versus intramuscularly as indicated). By evening, patient with... Read more
RN administered shot subcutaneously (versus intramuscularly as indicated). By evening, patient with swelling, redness, warm & hard to touch at injection site, with pain.
77 2021-02-19 injection site pain Very low energy upon waking on morning after the vaccine. Lasted all day. Felt feverish but no fever... Read more
Very low energy upon waking on morning after the vaccine. Lasted all day. Felt feverish but no fever. Slept most of day until late afternoon when I finally took 2 aspirin. Injection site tenderness.
77 2021-02-21 rash with redness, itchy rash red rash appeared on chest. Within another 24 hours it moved over entire body...very red; red rash a... Read more
red rash appeared on chest. Within another 24 hours it moved over entire body...very red; red rash appeared on chest/ very red and extremely itchy; This is a spontaneous report from contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3246), via an unspecified route of administration on left arm on 23Jan2021 11:00 at single dose for covid-19 immunisation. Medical history included ongoing non- hodgkin lymphoma. Concomitant medication included ursodiol, furosemide, spironolacton, propranolol hydrochloride (PROPRANOL). Approximately 24hours after vaccination a slight fine, red rash appeared on chest. Within another 24 hours it moved over entire body. very red and extremely itchy on 24Jan2021. visited myoncologist and was prescribed Benadryl and cortisone cream for itch. The outcome of the events was not recovered.
77 2021-02-21 rash Moderate rash on neck and shoulders
77 2021-02-22 injection site pruritus, injection site rash Itchy rash around injection site. About 4? diameter
77 2021-02-22 injection site reaction Large local reaction to the injection site starting day of injection and worsening over 4 days time.... Read more
Large local reaction to the injection site starting day of injection and worsening over 4 days time. Secondary cellulitis developed requiring antibiotic treatment.
77 2021-02-22 itchy skin Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching... Read more
Experienced bad taste in my mouth right away, lips felt weird, breathing very raspy, chills, itching on head, ears, arms, headache, swallowing issues, stuffy nose, sinus pressure, extreme fatigue, dry mouth (felt like cotton in my mouth), temperature dropped. Took about five days to feel okay. Took Benadryl (took twice with six hours between doses, took antihistmine, Levocetiriine, used pro air quite often, 20 mg of Prednisone at 2:30 am on the 22 and finally felt relief. Dr.. was informed after I got better.
77 2021-02-24 dry skin, skin warm Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All 2/2... Read more
Progress Notes (Nurse Practitioner) ? ? Family Medicine Cosign Needed Expand AllCollapse All 2/25/2021 Date: 2/25/2021 Subjective a 77 y.o. female who was seen at Clinic today for her first dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15 minute waiting period after the injection, the patient began to experience L hand numbness. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. This provider was notified of patient reaction and she was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to blood pressure abnormality , chest pain, rapid progression of symptoms and respiratory distress. PMH includes DM, HTN, asthma. Takes metformin and losartan around noon every day. She has not taken her bp medication yet today as she takes it with lunch. ALLERGY REVIEW OF SYSTEMS: Patient denies chills, fever, malaise/fatigue, facial swelling, sore throat, eyes itching, cough, chest tightness, shortness of breath, wheezing, rash, hives, eczema, cysts, itching of skin, muscle aches, dizziness and headaches Previous Reactions: none Objective Vitals Vitals: 02/25/21 1145 02/25/21 1201 BP: (!) 160/97 124/83 Pulse: 72 SpO2: 99% Physical Exam Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is not diaphoretic. Neck: Thyroid: No thyromegaly. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing. Musculoskeletal: Cervical back: Neck supple. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Cranial Nerves: No cranial nerve deficit or facial asymmetry. Sensory: Sensation is intact. No sensory deficit. Coordination: Coordination is intact. Gait: Gait abnormal (walks with walker, steady gait). Comments: +5/5 strength against resistance to both upper and lower extremities. Assessment/Plan Treatment included: water Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Vaccine-Related Anxiety (include misc mental health) and Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash) Exam is stable/unremarkable. VS improved. Pt monitored for 20 minutes. She feels well. Possible more likely anxiety related than a local reaction. Pt aware to monitor and follow up with pcp if needed. Pt here with husband whom walked out with her. She declined wheelchair. She feels well. APRN Electronically Signed 2/25/2021 11:59 AM
77 2021-02-24 injection site rash Fever, syncope. Pt has small rash to administration site.
77 2021-02-24 itchy skin, hives Itching all over my body - arms legs back. Extreme itching hen starched causes swelling and/or hive... Read more
Itching all over my body - arms legs back. Extreme itching hen starched causes swelling and/or hives.
77 2021-02-24 rash papular, injection site swelling, injection site redness 1604 rt deltoid swelling raised area 2 in. in diameter no rendess/drainage ice pack applied new ban... Read more
1604 rt deltoid swelling raised area 2 in. in diameter no rendess/drainage ice pack applied new band aid applied 1620 swelling reduced pt left after visualizing and verbalizing no additional change or concern
77 2021-02-25 hives, rash, redness IN 24 HOURS AFTER 2ND VACCINATION -, RED WELTS AND RASH ON TORSO (FRONT & BACK), ARMS, LEGS. SYMPTO... Read more
IN 24 HOURS AFTER 2ND VACCINATION -, RED WELTS AND RASH ON TORSO (FRONT & BACK), ARMS, LEGS. SYMPTOMS STILL PRESENT ON 02/26/2021
77 2021-02-25 hives Notified by patient that she had "an allergic reaction" to her first dose of the vaccine. "It happen... Read more
Notified by patient that she had "an allergic reaction" to her first dose of the vaccine. "It happened a day later, but I don't know if it was the shrimp I had that day. I was flushed and I got welts, so I went to the urgent care. I was prescribed an Epi-pen by my allergist after following up with them. I feel comfortable getting the second dose." Pharmacist and vaccine clinic lead notified. 30 min after dose given, pt states, "My ears are feeling a little itchy." Vital signs @ 1002: BP 175/80 P 69 O2 97% Temp 98.3 F R 12. VS @ 1007: BP 165/79 P 64 O2 98% Temp 98.4 F R 14. 1015 Pt states, "I'm feeling better and my husband is at home to watch me. I think I was just nervous." Pt declines dizziness/lightheadedness upon standing and declines any itching after second set of VS. Educated pt on strict ER precautions. Pt verbalized understanding and was appreciative for visit.
77 2021-02-25 vaccination site swelling, vaccination site warmth, injection site redness, vaccination site bruising, vaccination site pain Within one week of second dose vaccine, blue/pink colored "hematoma-looking" 'bruise' underneath the... Read more
Within one week of second dose vaccine, blue/pink colored "hematoma-looking" 'bruise' underneath the skin about an inch long and an inch wide appear on the same arm as the vaccine location. Painful to lay on, hurt when using the arm. Over the next week, site became red, elevated, hot, and painful (like it was on fire).
77 2021-02-26 itchy skin LEFT ARM TINGLING AND ITCHING
77 2021-02-28 injection site pain, injection site redness, injection site mass, injection site discolouration Awakened from sleep, extremely cold, teeth chattering and shivering at 02:30 Returned to bed covere... Read more
Awakened from sleep, extremely cold, teeth chattering and shivering at 02:30 Returned to bed covered up with more blankets. Upon wakening, felt felt totally exhausted and weak. I slept and took naps throughout the day. Some aches in the body and sore arm where injection was given. Continued to feel extremely weak and cold the next 24 hours. Felt better day after but still tired and weak. injectgion site reddened and sore. Injetion site still sensitive, rpink discoloration and lump under the skin
77 2021-02-28 injection site pain, skin warm, redness Redness, swelling, and warmth over the right deltoid area. States there is tenderness to the site as... Read more
Redness, swelling, and warmth over the right deltoid area. States there is tenderness to the site as well.
77 2021-03-02 itchy skin Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itch... Read more
Mild headache, worse than normal fatigue, stiff neck, muscle ache, hot flashes, flushed cheeks, itching. Rash to antecubital area of right arm starting on Sunday night.
77 2021-03-02 rash with redness Shortly after vaccination, upper legs felt weak and head felt as if she was "floating" similar to b... Read more
Shortly after vaccination, upper legs felt weak and head felt as if she was "floating" similar to being put under anesthesia. Day 2 developed Redness and rash on chest and lower back. Day 3 developed a large cold sore on lower lip. Day 4 - 4 more cold sores on upper and lower lips. Day 5-6 fatigue. She was observed for an hour, offered water and juice following the vaccine and was released home.
77 2021-03-02 hives, itchy skin Itching/both arms near her wrist area only were itching like crazy/her back was itchy; two red welts... Read more
Itching/both arms near her wrist area only were itching like crazy/her back was itchy; two red welts, almost like hives on her body; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN5318, expiry date: not reported), via an unspecified route of administration at left upper arm on 28Jan2021 17:30 at SINGLE DOSE for COVID-19 immunisation. The patient had no prior vaccinations within 4 weeks. Medical history included ongoing macular degeneration and thyroid disorder. Concomitant medications included levothyroxine for thyroid and ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). The patient got the vaccine on Thursday 28Jan2021. Thursday and Friday she was fine. However, Saturday morning (30Jan2021) when she woke up she had two red welts, almost like hives on her body and a little bit of itching. Then, the wee hours of yesterday morning (Sunday morning) both arms near her wrist area only were itching like crazy. She was calling to see if it would be okay to take Benadryl for the itching. No one she has called yet has been able to answer her question. She tried contacting the hospital where she got the vaccine. The patient further reported that she noticed the two red welts like hives on her body on Saturday in the morning (30Jan2021) when she woke up, exact time not specified. This has gone away. It went away sometime yesterday (31Jan2021). These were also itchy. She noticed the inside of her arm by the wrist area in the early morning hours yesterday were extremely itchy. She thought for sure she would wake up with red welts but there wasn't any. Her arms are fine. Now, her back was itchy. Her back now was the only thing now really itching. She placed Cortisone cream on her back and it helped. Her back was still a little itchy, but not as bad. The patient scheduled for her second dose on 18Feb2021. Therapeutic measures were taken as a result of itching/both arms near her wrist area only were itching like crazy/her back was itchy. On 31Jan2021, the patient recovered from "two red welts, almost like hives on her body" and was recovering from itching.
77 2021-03-02 hives, vaccination site pain Pain; Burning sensation; Hives; Injection site soreness; This is a spontaneous report from a contact... Read more
Pain; Burning sensation; Hives; Injection site soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el1284 and expiry date: unknown), via an unspecified route of administration on the left arm, on 19Jan2021 14:50 at a single dose for COVID-19 immunization. Medical history included lymphoma from May2020, had chemotherapy for lymphoma from Jun2020 to 08Oct2020, shingles, knee replacement from 2008 and allergic to penicillin. The patient's concomitant medications were not reported. Patient stated she thinks she was having side effects from the Pfizer COVID-19 vaccine she got 19Jan2021, tomorrow 02Feb2020 was two weeks from when she got it. Patient didn't have any side effects to start with, just soreness to the injection site on Jan2021. She says last Wednesday, 27Jan2021, she noticed she had hives, not a rash, on her chest on the left side that are kind of on her breast, the top of her breast, which now spread under her arm up to her shoulder area and back. There was pain along with it, a burning sensation starting last night on 31Jan2021 in the inside area. Since she got her injection on her left side, she doesn't know if this could be a reaction to the injection or not. She had shingles several years ago, this was acting like that, and it looked like one of the side effects listed is lymphadenopathy, which she looked up information about that, but she doesn't know what it was, she doesn't know what else to blame it on. Patient hasn't seen her doctor yet for hives, and has not treated the hives. She got the OK from the nurse who said she didn't see a reason for her not to get the vaccine since she was coming off chemo several months prior. Patient was considered to be in remission right now, and she has an appointment next week with her oncologist for follow up. Outcome of the events was unknown.
77 2021-03-03 itchy skin, hives Hives; itching throughout her body; This is a spontaneous report from a contactable consumer. A 77-y... Read more
Hives; itching throughout her body; This is a spontaneous report from a contactable consumer. A 77-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL8982), intramuscular on the left arm at the age of 77 years, on 27Jan2021 11:30 at a SINGLE DOSE for covid-19 immunization and cefuroxime axetil (CEFUROXIME AXETIL), oral from 25Jan2021 to Jan2021 at 250 mg, 2x/day (250mg tablet, one tablet twice a day by mouth ) for urinary tract infection. Medical history included ongoing diabetes mellitus diagnosed many years ago, ongoing rash because she was still having a problem in her pubic area with a rash that is going on, states this is from the urinary tract infection and urinary tract infection from an unknown date and unknown if ongoing. When she got the vaccine she was on an antibiotic for a urinary tract infection (UTI), she is asking if there would be any correlation or any interaction between the antibiotic and the vaccine. The antibiotic was something she has taken quite often and has taken it before called cefuroxime axetil. Concomitant medication included insulin (INSULIN) for diabetes. The patient developed itching throughout her body, like hives that started late Friday (29Jan2021) and she will get areas on her hands and arms. This morning it was on her legs where it was red and warm. She reported it goes away and comes back. This morning the hives were fairly heavy and now that she has gotten up and cooled her body down, the hives were subsiding. The outcome of the events was recovering.
77 2021-03-03 itchy rash, rash, rash with redness Severe red rash and itching throughout torso and limbs.
77 2021-03-04 cellulitis Cellulitis
77 2021-03-04 injection site redness fatigue, headache, hip pain, site redness - all 8 hours - no treatment
77 2021-03-04 injection site reaction RN-reports local reaction of pt at injection site. RN- assesses injection site and ask pt to be fur... Read more
RN-reports local reaction of pt at injection site. RN- assesses injection site and ask pt to be further evaluated in treatment area. Pt refuses to have vital signs taken and only requests to be given cold compress. Cold compress applied at injection site and pt continued remainder of recovery in general recovery area.
77 2021-03-04 itchy skin Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & lig... Read more
Patient states she reacted immediately after receiving the vaccine. States that she felt dizzy & light headed, her BP went up to 163/90 and she had tingling in her feet "as if I were wearing tight compression socks". Medical record indicates that she called 911 the day after her vaccine & reported dizziness & slurred speech. She was told to go to the ER, but did not go. She reported to her PCP's office that she had arm itching, she was anxious & fatigued as well. She also reported that she "felt funny in the back of her throat" & seemed to be coughing more. Headache also reported.
77 2021-03-04 rash, itchy skin, injection site rash Patient developed a rash that occurred 2 days after administration. Patient woke up 2 days later ext... Read more
Patient developed a rash that occurred 2 days after administration. Patient woke up 2 days later extremely itchy and a rash localized on the right arm which was the one where the vaccine was given. Rash is improving today 3/5 but still present. No severe side effects noted.
77 2021-03-05 injection site swelling Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports fatigue, myalgias, chills, and a swollen arm (... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA: patient reports fatigue, myalgias, chills, and a swollen arm (at injection site) starting one day after receiving vaccination. Patient previously had COVID-19. During clinic visit three days after vaccination symptoms have resolved without intervention.
77 2021-03-05 rash rash covering thighs and up to flanks
77 2021-03-07 vaccination site pain injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills... Read more
injection site pain; Nausea; fatigue; joint and muscle pain; joint and muscle pain; headache; chills; This is a spontaneous report from a non-contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201), via an unspecified route of administration on 20Feb2021 at 08:45 at a single dose in the right arm for COVID-19 immunization. Medical history included stage 4 breast cancer and thyroid cancer. Concomitant medications included levothyroxine sodium (SYNTHROID) and lorazepam. The patient previously took sulfur and experienced allergies and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. On 21Feb2021 at 04:30, the patient experienced injection site pain, nausea, fatigue, joint and muscle pain, headache, and chills. The patient did not receive any treatment for the reported events. The patient underwent lab tests and procedures which included Nasal Swab/COV-2 RNA (RT-PCR) NAAT with negative result on 09Oct2020. The outcome of the events was recovered. No follow-up attempts are possible. No further information is expected.
77 2021-03-08 rash, rash with redness, itchy rash Patient reported having red, itchy rash 7 days post vaccination. Upon return for 2nd dose, still had... Read more
Patient reported having red, itchy rash 7 days post vaccination. Upon return for 2nd dose, still had rash on chest. Patient reports using OTC cream for itching. Medical Team consult, determined that patient was unable to receive 2nd dose Pfizer today and will wait at least 28 days and until rash is gone. Also referred for possible Jaansen vaccine.
77 2021-03-08 rash ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her ... Read more
ct reports having fever, body aches, stomach pain with nausea and diarrhea, palpations, rash on her face, vision problems
77 2021-03-09 hives Hives and welts appeared on various body parts, such as elbow, hands, around the knees, hips and mor... Read more
Hives and welts appeared on various body parts, such as elbow, hands, around the knees, hips and more. I've been treating them with hydrocortisone cream, calamine lotion, and diet. They are getting better, however some still pop up. 2 dosage of the vaccine was Feb. 15, 2021. This report is March 10, 2021. I am still getting some hives and welts; others are starting to disappear.
77 2021-03-10 injection site rash, rash with redness Pt states she developed swollen lymph nodes under her left armpit towards her breast. The next day ... Read more
Pt states she developed swollen lymph nodes under her left armpit towards her breast. The next day she had a itchy red rash at the injection site. Pt contacted her PCP and she was told to keep an eye on it and make a VEARS report since she had a reaction to taking the vax.
77 2021-03-10 hives, itchy skin Itching and Hives on face.
77 2021-03-11 injection site swelling severe body aches, fever, swelling at injection site, that lasted 5 days
77 2021-03-12 skin warm, redness, injection site pain March 3, 2021-Sore injection site of right arm March 4th- Injection site slightly sore March 5th -so... Read more
March 3, 2021-Sore injection site of right arm March 4th- Injection site slightly sore March 5th -sore left calf March 6th- Sore left calf a little more so March 7th- Outside left calf hot to touch & back of calf red and sore. March 8th- Same as above, and I put doterra Deep Blue ointment on it, and it relieved the heat and pain Redness is gone March 9th -Left side of body joints ached. left calf aches/applied Deep blue ointment and a Pain relief ointment . Feels a lot better March 10th- Redness gone, but still feels sore March 11th- Left leg Calf feels a lot better, I put on the ointment again. Deep Blue, and Frank Woods Pain Relief ointment. March 12- Left calf a little sore. No heat . Now my left eye has a light grey spot in it. I can see around it. March 13-Eye's don't feel right. I still have the light gray floater in the left eye.
77 2021-03-15 redness Soreness, bright redness, and slight swelling for five days. Applied antibiotic cream and it took th... Read more
Soreness, bright redness, and slight swelling for five days. Applied antibiotic cream and it took three more days for symptoms to disappear.
77 2021-03-15 redness severe redness in upper arm, throbbing in wrist traveling upward to upper arm. Loss of strength/gri... Read more
severe redness in upper arm, throbbing in wrist traveling upward to upper arm. Loss of strength/grip in arm/hand.
77 2021-03-15 vaccination site pain sore at vaccination point; tightness and heaviness in chest about two hours following injection, las... Read more
sore at vaccination point; tightness and heaviness in chest about two hours following injection, lasted about two minutes.
77 2021-03-16 itchy skin, redness 2nd day eye infection. Matted, itching,red. Plus tearing & burning
77 2021-03-16 rash Rash all over her body her back and front; some pain in her stomach; This is a spontaneous report fr... Read more
Rash all over her body her back and front; some pain in her stomach; This is a spontaneous report from a contactable consumer (patient's husband). A 77-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 Vaccine; lot number: EL9269; expiration date: unknown) at 77-year-old vaccination age via an unspecified route of administration on 07Feb2021 at a single dose for covid-19 immunisation. Medical history included prediabetes and slight blood pressure or something (blood pressure abnormal). Concomitant medication included hydrochlorothiazide and unspecified medication (reported as she takes all kind of medications), all on an unspecified dates and indication. The patient received her first dose of bnt162b2 (BNT162B2; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter inquired for his wife because her body now. They had the second shot on 07Feb2021 (Sunday) and he wonder how many days it takes after the shot to have side effects. She has rash all over her body her back and front on Feb2021 so he wonders if the shot could cause that. They had the vaccine given to them in a hospital. The reporter mentioned that she just a blood test (unknown results) on the 8th Monday (08Feb2021). She went to the ER (emergency room) in the same hospital. They did the whole work/lab work (unknown results) because she had some pain in her stomach on Feb2021. The outcome of the events was unknown.
77 2021-03-18 itchy skin Pt reported facial itching and trace throat tightness post-injection at 11:10 am. Given 25mg Benadry... Read more
Pt reported facial itching and trace throat tightness post-injection at 11:10 am. Given 25mg Benadryl PO and symptoms resolved with additional monitoring time.
77 2021-03-18 vaccination site pain Painful Headache; Arm where I received the vaccine is still sore; This is a spontaneous report from ... Read more
Painful Headache; Arm where I received the vaccine is still sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the second dose of BNT162B2 (COVID-19 Vaccine, lot number: EL9264), via an unspecified route of administration, administered in upper left arm on 09Feb2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. Medical history was none. Concomitant medication included vitamins (unspecified). The patient called to report that with the second shot, she experienced painful headache for 6 day no its more than 6 days and everyday she woke up with a horrible headache and this never happened before so she was assuming its because of that shot. She still has it and have been up already for four hours and already took two Tylenol (treatment). Also, her arm where she received the vaccine was still sore. The events occured on 09Feb2021. The outcome of the events was not recovered.
77 2021-03-20 cellulitis, skin spots Developed petechial rash within few days of receiving 2nd dose on bilateral lower legs. Also had com... Read more
Developed petechial rash within few days of receiving 2nd dose on bilateral lower legs. Also had complaints of tremor, weak voice and cough with deep inspiration. Appeared to be developing cellulitis to bilateral lower extremities- treated with oral antibiotic. Oxygen level was good in office, advised to monitor for worsening.
77 2021-03-20 vaccination site pain She had no appetite; She was very tired; a headache and an upset stomach; vomiting; a headache and a... Read more
She had no appetite; She was very tired; a headache and an upset stomach; vomiting; a headache and an upset stomach; sore arm at the site of the injection; This is a spontaneous report from a contactable consumer reported that: A 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot Number: EL3302; Expiration Date: 31May2021) as single dose for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were unknown. Caller is calling to see if anyone experienced a reaction like a week after having the first COVID shot. She says she didn't give it a thought because it had been a week, but her friend today suggested maybe she was having a delayed reaction. She received the shot on 25Jan2021, says she only had the sore arm on 26Jan and it was only at the site of the injection like a regular shot, and then last Monday evening 1Feb2021, she started getting headache and the next morning she felt miserable. On 02Feb2021, she had an upset stomach and was vomiting. She was very tired and that went on for a couple days. She couldn't get off the couch. She had no appetite. Gradually she got a little better and she texted the doctor's office they suggested she go. they could make her an appointment 25 minutes away to get a COVID test. She was not feeling like driving or riding in the car to get it. Or they suggested that she quarantine for 10 days which is what she has been doing. She is feeling just about back to herself, but she was curious if that could have been from the shot or maybe she just had some other bug. She thinks she was 143 last time a few months ago. The upset stomach and vomiting last also on the 03Feb which made the headache better. She says headache is gone but her head still feels little not quite itself, but the headache is gone. She says the upset stomach and vomiting have recovered completely. The tiredness is ongoing but is much better. She has not had anything else happen and she has had not been around anybody with who was sick unless they were asymptomatic and that would have been only a very few people. She wants to know if it is possible that the vaccine caused a side effect to show up 8 days later. She does not see NDC on her vaccine card. She provides lot number expiration from her vaccine card. Outcome of the events headache, tiredness, she had no appetite were recovering. Vomiting and upset stomach were recovered.
77 2021-03-21 injection site pain, injection site mass 2/28/2021 DAY OF INJECTION #1 - HEAVY SENSATION IN UPPER LEFT ARM, LASTED LESS THAN 24 HOURS 2/18/2... Read more
2/28/2021 DAY OF INJECTION #1 - HEAVY SENSATION IN UPPER LEFT ARM, LASTED LESS THAN 24 HOURS 2/18/2021 DAY OF INJECTION #2 - MILD SORE UPPER LEFT ARM RADIATED TO LEFT SHOULDER BLADE, USED TOPICAL ARNICARE FOR THE SORENESS WHICH LASTED ABOUT 24 HOURS 3/21/2021 VERY SORE UPPER LEFT ARM, SUDDEN "CHARLIE HORSE" RADIATED FROM THE INJECTION SITE TO THE LEFT SHOULDER BLADE, LUMP/KNOT UNDER THE INJECTION SITE ABOUT THE SIZE OF A WALNUT, USED ARNICARE AND MASSAGE, NO RASH OR VISIBLE BRUISING, SORENESS LASTED SEVERAL DAYS
77 2021-03-21 injection site pain Experienced soreness at injection sight, slight headache, fatigue, chills, weakness in legs, indiges... Read more
Experienced soreness at injection sight, slight headache, fatigue, chills, weakness in legs, indigestion (sour stomach). I was diagnosed with having Covid-19 on Nov. 9, 2020. I had a mild/moderate case which lasted over 2 weeks. After receiving my first dose of the vaccine in the morning, I started experiencing the same symptoms (in the evening) that I had when I had the actual virus. One week later, I'm feeling better.
77 2021-03-22 injection site redness, hives Red whelp developed at injection site approximately 24 hours ago, it was approximately a quarter in ... Read more
Red whelp developed at injection site approximately 24 hours ago, it was approximately a quarter in size and has progressed to redness down the arm. site is red and tender to the touch. The patient has applied an ice pack to the area.
77 2021-03-22 itchy skin, hives Hives on various areas, mostly on forearms. A few on neck, legs, back, hands, wrists. The bumps rang... Read more
Hives on various areas, mostly on forearms. A few on neck, legs, back, hands, wrists. The bumps range in size from marble size to quarter size and severely itch. I take Benadrel orally and apply Calamine lotion on bumps. I am currently still having hives.
77 2021-03-23 redness facial flushing and redness, mild swelling. No shortness of breath or itching. Started within 1-2 ... Read more
facial flushing and redness, mild swelling. No shortness of breath or itching. Started within 1-2 minutes of receiving vaccine Treatment: Benadryl 50mg IM within 5 mins of reaction onset. Observed for 30 mins; feeling better; sent home; advised to call 911 if recurrent or new symptoms
77 2021-03-24 vaccination site pain severe pain emanating from injection site; traveled upward over shoulder; continued up right side of... Read more
severe pain emanating from injection site; traveled upward over shoulder; continued up right side of neck; heavy right earache; sore throat; headache forehead and across top of my head; dry heaves; feverish/chills/shivering; feverish/chills/shivering; words mixed up; Felt pain in center chest; congestion across bronchial area and developed upper respiratory congestion temporarily; congestion across bronchial area and developed upper respiratory congestion temporarily; fatigued; had severe coughing spell which included choking and further nausea; had severe coughing spell which included choking and further nausea; severe nausea; Ripple effect across bridge of nose; strong metallic odor and taste within mouth; moving from back of throat and nostrils; it is both painful and difficult to raise my right arm very high; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN6060, first dose) solution for injection intramuscular in the right arm on 09Mar2021 at 16:00 (at the age of 77-years-old) at single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included known allergies: yes. Concomitant medication included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09Mar2021 16:15, the patient had severe coughing spell which included choking and further nausea, ripple effect across bridge of nose, strong metallic odor and taste within mouth moving from back of throat and nostrils, it is both painful and difficult to raise my right arm very high. On 10Mar2021, the patient experienced dry heaves, feverish/chills/shivering, words mixed up, felt pain in center chest, congestion across bronchial area and developed upper respiratory congestion temporarily, fatigued. On 10Mar2021 03:00 the patient had severe pain emanating from injection site traveled upward over shoulder continued up right side of neck heavy right earache, sore throat, headache forehead and across top of my head. Unspecified treatment was provided for the events. The outcome of the events choking, coughing, nausea, ripple effect across bridge of nose, strong metallic odor and taste and smell, severe pain emanating from injection site upward over shoulder continued up right side of neck heavy right earache, sore throat, headache, dry heaves, feverish, chills/shivering, words mixed up, Felt pain in center chest, painful and difficult to raise my right arm very high, fatigued was not recovered. The outcome of the event congestion across bronchial area and developed upper respiratory congestion temporarily was recovering. Since the vaccination, the patient has not been tested for COVID-19.
77 2021-03-25 redness Pain in left armpit and left breast. Entire left arm swollen and reddened. Upper arm covered with bl... Read more
Pain in left armpit and left breast. Entire left arm swollen and reddened. Upper arm covered with blue tiny veins extending into left chest area.
77 2021-03-28 rash Presented to emergency department with complaint of shortness of breath and chest discomfort. She r... Read more
Presented to emergency department with complaint of shortness of breath and chest discomfort. She reports shortness of breath began last night. States shortness of breath is exacerbated with exertion. She also reports generalized chest discomfort with shortness of breath. Recently placed on an antibiotic on the 22nd for a bilateral lower leg skin rash. States dermatologist was unsure what kind of rash or what the rash is, so biopsies were obtained and patient is to return next Wednesday for results. Otherwise respiratory history has had asthma as a child but has not had any exacerbation or symptoms as an adult. She recently received her second COVID-19 vaccine. Denies palpitations, fever, chills, congestion or cough.
77 2021-03-29 itchy skin, rash Itching followed by what resembles a shingles rash that began as patches on right arm and then conti... Read more
Itching followed by what resembles a shingles rash that began as patches on right arm and then continued spreading in strips down right arm, left arm, areas on torso especially back and continues spreading to this day. All rash areas continue to itch and have not healed. Yesterday PA prescribed Prednisone and Hydroxyzine HCL, which has somewhat helped with the itching.
77 2021-03-30 rash, blister -rash with blisters on bilateral arms & face -vaccine administered at a Hospital -
77 2021-04-03 vaccination site swelling, vaccination site itchiness numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; numbne... Read more
numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; Dizzy; little taste in mouth; numbness at the injection site and swelling; swelling reappeared, and this time it was itchy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3246) via an unspecified route of administration on 21Jan2021 (at the age of 77-years-old) as single dose for protection. There were no medical history and concomitant medications reported. The patient experienced Dizzy, little taste in mouth, numbness at injection area, swelling came back 1 week later, 4 inches and round in shape on 21Jan2021 and itchy in Jan2021. It was reported that the patient got her vaccination on 21Jan2021. When she got it, she felt a little dizzy, and a little taste in her mouth that disappeared. She did experience numbness at the injection area and swelling that disappeared after two days. Then, after one week, the swelling came back. She still has it. It is 4 inches, and round in shape on 28Jan2021. She wants to know if this is life threatening. Her next vaccine is on 12Feb2021. Her height has went down. She got it at the Hospital. She doesn't have a prescribing doctor. She experienced the dizziness and taste in her mouth occurred while in the recovery room, it lasted a couple of hours. The arm numbness and swelling started a few hours later and lasted two days. Right now it is itchy, but she tries not to scratch her arm. The initial injection wasn't itchy when she had the numbness and swelling. It was just numb and swollen the first time. This time, it is itchy and swollen. She got the vaccine because she wants to be safe, for protection. The patient underwent lab tests and procedures which included body height: her height has went down in Jan2021. The outcome of events, dizzy, little taste in mouth on 21Jan2021 and numbness at injection area on 23Jan2021. The outcome of swelling came back 1 week later, 4 inches and round in shape was resolving and was not recovered for event itchy. No follow-up attempts are possible. No further information is expected.
77 2021-04-04 injection site pain Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sun... Read more
Patient potentially received higher than the recommended 0.3ml dose of the Pfizer vaccine. As of Sunday 4/4, patient reports soreness at injection site and fatigue.
77 2021-04-05 itchy skin Right deltoid and upper right arm area are swollen and itchy
77 2021-04-05 rash with redness possible Type 3 hypersensitivity (immune complex mediated) to Pfizer - facial swelling, peeling eryt... Read more
possible Type 3 hypersensitivity (immune complex mediated) to Pfizer - facial swelling, peeling erythematous rash, eye swelling 2-3 weeks after vaccinations (twice).
77 2021-04-06 rash Rash on hands, arms, face. Also, with the first shot had a dry cough about a week after the vaccine... Read more
Rash on hands, arms, face. Also, with the first shot had a dry cough about a week after the vaccine. Feeling like i might be getting a cough now.
77 2021-04-07 itchy skin, rash with redness fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue;... Read more
fever up to 101 F; itching; severe head and spine pain; severe head and spine pain; Extreme fatigue; Erythematous; Loss of voice; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in left arm on 12Feb2021 12:30 as single dose for covid-19 immunisation. Medical history included psoriatic arthropathy, basedow's disease, psoriasis. Concomitant medications included levothyroxine sodium (SYNTHROID) (MANUFACTURER UNKNOWN); estrogens conjugated, medroxyprogesterone acetate (PREMPRO) (MANUFACTURER UNKNOWN). The patient previously took fentanyl and experienced drug hypersensitivity and bnt162b2 (product=COVID 19, brand=Pfizer BioNTech, lot number=EL9262, administration date=21Jan2021, administration time=04:00 PM, vaccine location=Left arm, dose number=1). On 13Feb2021 06:30 and experienced fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous. On an unspecified date in Feb2021, patient experienced loss of voice. 18 hours post injection, severe head and spine pain, extreme fatigue, fever up to 101 F persisting 36 hours. Loss of voice 96 hours later, intermittent fever. Erythematous, hot area, raised (size of an orange) with itching in the area persists. On 13Feb2021, the patient underwent lab tests which included body temperature: up to 101 fahrenheit (intermittent fever). The patient did not receive any treatment for the events. The clinical outcomes of the fever up to 101 f, itching, severe head and spine pain, severe head and spine pain, extreme fatigue, erythematous, loss of voice were recovering. No follow-up attempts are possible.
77 2021-04-08 redness, hives Hives - first on left arm then other arm, both thighs, torso to below breasts and down to knees. S... Read more
Hives - first on left arm then other arm, both thighs, torso to below breasts and down to knees. Started 1 hour after vaccination, continued to get bad for 1 1/2 hour more, took Benedryl and used B cream. Hives stabilized but remained for another hour and then slowly went away. 6 hours later there was still redness where the hives had been. I have photos.
77 2021-04-09 rash, skin burning sensation, itchy rash Please see Temporary Vaers E-Report 308709. The severe Itchy burny skin rash that continued 21 days... Read more
Please see Temporary Vaers E-Report 308709. The severe Itchy burny skin rash that continued 21 days after the first shot became more severe after the second shot with a large area forming and growing across the whole lower back. It had dimensions of about 12 inches across and 8 inches high that became solid red. A spotted rash formed on the sides of the breasts and upper back. Topical steroids were used. To not interfere with the immunization , the dermatologist waited 21 days before prescribing a programmed decreasing regiment of Prednesone tablets. The rash subsided 6 weeks after the second vaccination.
77 2021-04-13 itchy skin right ear and right neck pain.right foot pain and swelling.fatique. dysequilibrium. diffuse pruritis
77 2021-04-16 injection site pain site pain; tiredness; headache; unwell/sour gut; chills w/out fever; This is a spontaneous report fr... Read more
site pain; tiredness; headache; unwell/sour gut; chills w/out fever; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6201), via an unspecified route of administration in left arm on 10Feb2021 at 11:45(at the age of 77-year-old ) as a single dose for COVID-19 immunization. Patient medical history included asthma, some mild arthritis, osteopenia. Concomitant medications included Mometasone Furoate(ASMANEX) (MANUFACTURER UNKNOWN), Esomeprazole sodium (NEXIUM) (MANUFACTURER UNKNOWN), Montelukast sodium (SINGULAIR) (MANUFACTURER UNKNOWN), (FLUTICASONE), vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 16Feb2021, on the 2nd and 3rd day, the patient experienced site pain, tiredness, headache. On the 6th day, the patient experienced chills without fever, tiredness, unwell/sourgut, headache. The outcome of the events was Recovered on an unknown date.
77 2021-04-18 redness Pt admitted to hospital on 3/4/2021 with Extensive DVT to the LLE. No history of cancer or thrombos... Read more
Pt admitted to hospital on 3/4/2021 with Extensive DVT to the LLE. No history of cancer or thromboses. History of redness and swelling to entire left leg starting on 3/1/2021. Received Heparin infusion in hospital. Currently receiving Eliquis p.o. Pt also underwent trombectomy with iliac stent placement by IR.
77 2021-04-22 injection site pain, injection site rash chills flu like symptoms weakness sore gums sore lips with sores painful bumps at injection site
77 2021-04-23 redness allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2n... Read more
allergic response to isopropyl alcohol in second dose of COVID vaccine; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; 1st dose last 22Jan2021 - 2nd dose was on 08Feb2021; doesn't feel good; one heck of a temperature; By doing what she did, if that negated the COVID vaccine/ That's what she was afraid of; redness and swelling in her right arm; redness and swelling in her right arm; feeling hot all over the body; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported) via an unspecified route of administration on 08Feb2021 at a single dose for covid-19 immunisation. The patient's medical history included weakened immune system because of the alcohol allergy (started while 19), and aches and pains. Concomitant medications were not reported. The patient received the first dose of bnt162b2 (expiry date May2021) for COVID-19 immunisation at the age of 77 years old last 22Jan2021 administered on the upper righthand arm later clarified as upper right arm; and she was still going through that systemic reaction when she had her first COVID vaccine. The patient asked on regarding how effective the vaccine was related to receiving steroid therapy. Patient was advised by doctor to go to urgent care to have a covid test to see if she and husband were exposed to covid before the vaccines kicked in. Patient stated that on an unspecified date in 2021, she still didn't feel well and was running one heck of a temperature (increased). Patient reported she had a severe allergic reaction to the vaccine. She filled out the forms. Patient felt like she should be put in the hospital. She has a horrific allergy to alcohol. Each time she receives an injection it gets worse. She knew when she received the second dose that the third ingredient was alcohol. She thought about was worse, the virus or the reaction. Within a minute of taking the vaccine she had a reaction. She reported it at the site and was watched for a half hour. Her question was "because she took prednisone immediately after getting the vaccine does that negate the shot?" She was not asked the name of the steroid that she took. She was taking prednisone 20mg, 2 tablets as soon as she gets a shot then 2 daily Monday-Friday. It was still going through her system and it was reeking havoc on her. If she goes to the hospital they will give her Benadryl and monitor her. Patient stated that on 08Feb2021, she had an allergic response to isopropyl alcohol in second dose of COVID vaccine. Patient stated that she had both COVID shots and had adverse reactions and took some medicine for the adverse reaction and now the patient was concerned it might mess with the shot, it might not work for her as it should. She knew that this was going to be a long process and she knew her allergies were rare, but they were there. She is allergic to isopropyl alcohol, even if it is in shampoos or liquid soaps, she gets reactions. She had her first COVID vaccine and she had her own hospital cleanser that she has with her at all times and she used it which was not a problem. For her second COVID vaccine, the nurse was naming the 3 ingredients that were in the COVID vaccine and asked if she was allergic to any. She said this last shot had alcohol in it, she sat with her husband next to her, and thought which was worse: getting COVID, the cases in the city are high, or having a reaction to the alcohol. She chose the latter. When it went into her arm she immediately knew she was getting a reaction. She had steroids with her just in case this happened. Each time the reaction happens, it gets worse. She said she sat for half an hour and has been on steroids until last Friday. She was supposed to be on them for days. On Friday, she was wondering if taking the steroids negated the effectiveness of the COVID vaccine and that's why she called in. She knew that this was rare and it was not something that the company going to say that the company know how to fix it. Patient worked in the health unit of a university as a hiring and firing people person. So, she was around it, but she was not a doctor or a nurse. So, she guessed the answer was no. Last week she received her second COVID vaccine. She said, she has got to get rid of 5 pounds, but it's harder to do that when you're older. She experienced the reaction from the isopropyl alcohol within her second dose of the COVID vaccine last week, 08Feb2021. She said she was still going through it and will for a while. When asked for the outcome, she said she couldn't answer that honestly. She said she didn't feel good (2021). Period. She knew that when she goes through this it takes, each time, an extra 4 to 5 days to get over it. When she got up this morning, she didn't feel good. Her husband asked if she wanted to go sailing, and she said not in 30 degree weather, but for her to say no to sailing, her husband knew she didn't feel well. She couldn't say worse, but she can say she didn't know how long it was going to be, which was scaring her. By doing what she did, if that negated the COVID vaccine, then lets go from there. That's what she was afraid of. When she tells people she is allergic to alcohol, and when it happens, they look at her like "nobody is allergic to alcohol." She is 77 and has the aches and pains of a 77 year old, which she hates. But she doesn't think there are related medical conditions to what she experienced. This (allergy to alcohol) started when she was 19 and it has gotten progressively worse. So she tries to be careful. She says this was her, not dumb, but her decision that she made and now she is concerned. She said no to any tests done. She had the immediate reaction and she knew what to do. Patient further reported that she has allergy to alcohol and had an adverse reaction after the 2nd shot due to alcohol swab and on an unspecified date in 2021, she experienced redness and swelling in her right arm and feeling hot all over the body. Patient asked if her doctor will prescribe Benadryl to manage my allergy will it affect the effectiveness of the PFIZER-BIONTECH COVID-19 VACCINE. Therapeutic measures were taken as a result of the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The patient did not recover from the event "allergic response to isopropyl alcohol in second dose of COVID vaccine". The outcome of the other events reported was unknown. Information on the Lot/Batch Number has been requested.; Sender's Comments: Linked Report(s) : 2021167304 PFIZER INC
77 2021-04-23 itchy skin, rash with redness, skin peeling, skin burning sensation, psoriasis On April 12 a red burning rash appeared on face and scalp. Burning itching and peeling of face and s... Read more
On April 12 a red burning rash appeared on face and scalp. Burning itching and peeling of face and scalp like a bad sunburn Went to dr on April 16 and was told it was psoriasis. Was given prescription cream for face and scalp. Condition resolved a few days later.
77 2021-04-23 rash Experienced skin rash/Some of the rash showed up in new places like her trunk; This is a spontaneous... Read more
Experienced skin rash/Some of the rash showed up in new places like her trunk; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that: A 77-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: E13236), via an unspecified route of administration, administered in left arm on 21Jan2021 between 10:15-10:30 (at the age of 77 years old) as a single dose for COVID-19 immunisation. The patient medical history included Allergic to Sulfa drugs. The patient is generally a veru healthy person, does not have diabetes, not overweight and exercises. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took historical vaccine of Flu vaccines, Hepatitis A and Hepatitis B, shingles shot (sore arm), pneumonia shots. On 22Jan2021 at 20:00 the patient experienced Rash: began night of 22Jan2021. Rash is migrating. Started around right armpit all around the edges. At the same time it was on the edges of her left armpit. Rash is still there, but faint because she has been taking this medicine. There are larger blotches now on her right shoulder, both breasts, upper thighs, and small places. Might be one starting on her stomach. The patient visited dermatology doctor's office. The patient received treatment for the events with steroid creams: Fluocinonide Gel 0.5%, Clobetasol Propionate cream 0.05%, and Triamcinolone Acetonide cream 0.1% and Benadryl to lessen the rash. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.
77 2021-04-24 injection site mass, vaccination site mass she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm... Read more
she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm; she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm; lump at site of injection; This is a spontaneous report from a contactable consumer or other non hcp. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6200; Expiration Date: May2021), via an unspecified route of administration, administered in Arm Left on 26Feb2021 (at the age of 77-year-old) as single dose and received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208; Expiration Date: Jun2021)via an unspecified route of administration on 19Mar2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had already completed her 2 dose series of the vaccine. After her first dose, she noticed a lump surrounded by black and blue discolorations on the injection site of her left arm. After her second dose, the lump on her left arm had develop some rash, swelling and itching and just went away after a week. On 08Apr2021, the lump looks like a teenager skin blemish that looks close to a large pimple. She also noticed that on the exterior of the skin, there was still minute reddish purplish discoloration and that the little lump was still there. She mentioned that she did not feel alerted and concerned because initially when she asked a nurse in the vaccination center, they mentioned that they have already seen side effects that looks like this. Now, she was just wondering if there was any reported events about this. Reporter stated that she got her first vaccine on 26Feb2021, that it left her with a kind of like a little lump at the site, tomorrow will be six weeks. Stated at the time it was surrounded by black and blue and that finally went away, exact date not provided. Left with the blemish, although it is a reddish mark lump. Got it over at the hospital. Seriousness of the events was not specified and was considered non-serious. The outcome of vaccination site lump and injection site mass was not recovered and vaccination site discoloration was recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
77 2021-04-24 rash with redness 4/1 first shot: Broke out in a red rash upper body arms face 24 Hrs later after shower (hot Water... Read more
4/1 first shot: Broke out in a red rash upper body arms face 24 Hrs later after shower (hot Water). Went to skin Dr April 14. Have Triancinolone 0. 025% cream x 2weeks 2 x day plus Allegra AM & Zyrtec PM (Dr. said Dermatitis ). I am told reporting this??
77 2021-04-24 rash, rash macular, itchy rash itchy rash; eyes are itchy; blotches on both arms, under arms, some on her breasts, and buttocks, an... Read more
itchy rash; eyes are itchy; blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows; Rash; This is a spontaneous report received from a contactable consumer reported for herself. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection,Lot number: EN6201) via an unspecified route of administration in left arm on 15Feb2021 as single dose for COVID-19 immunization. Patient medical history and Concomitant medications were not reported. No other products or investigation assessment was reported. On 20Feb2021,the patient experienced itchy rash, eyes are itchy, rash, blotches on both arms, under arms, some on her breasts, and buttocks, and some on knees and on her elbows, stated her eyes were itchy and where the rash was itching. Age at time of onset of reaction/event was reported as 81. Stated that she was due for her second dose on 8Mar2021. Reporter wanted to know if the rash will happen again with her second dose. The patient was not recovered from the event. Follow up attempts are completed. No further information is expected.
77 2021-04-26 sensitive skin Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to se... Read more
Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue; Numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL7Z69 ; expiry was not reported) via an unspecified route of administration on 10Feb2021 as single dose for covid-19 immunisation (at the age of 77 years). The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced numbness and sensitivity on right side of my face, nose, right nostril, and upper lip; and she took Lyrica (lot number: 19074111; Investigation Assessment: No) to see if this was a nerve issue and as therapeutic measures. She took a Lyrica this morning (12Feb2021) to see if this was a nerve issue and she took a Lyrica, Saturday as well. She was just checking to see if she had numbness and sensitivity on the right side of my face and the nose, the right nostril, and the upper lip of the mouth, was this a cause of the shot and is this the reason of Covid or not. The outcome of numbness and sensitivity on right side of face, nose, right nostril and upper lip; took Lyrica to see if this was a nerve issue was unknown. Information about Lot/Batch number has been requested.
77 2021-04-26 vaccination site mass, vaccination site redness, itchy skin Started feeling like kind of small lumps in that muscle or little below; redness; Muscle soreness; i... Read more
Started feeling like kind of small lumps in that muscle or little below; redness; Muscle soreness; itching; This is a spontaneous report received from a contactable consumer (patient) via Medical Information Team. A 77-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201, expiry date: unknown), via an unspecified route of administration on 06Feb2021 (at the age of 77-years-old) at a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medication included DILTIAZEM. Patient stated I take Tiadylt and it is, I think maybe to dilate blood vessels and rest of the stuff is over the counter. The patient received the vaccine on 06Feb2021 and experienced some muscle soreness. Patient stated, I just wanted to report that I received a Pfizer Covid vaccine on February 6th and experienced some muscle soreness. But on the 12Feb2021, I started feeling like kind of small lumps in that muscle or little below and some redness and by Saturday, redness was about three and a half inches in length and two inches wide and lumps are still there, you could see the lumps. Also, I could feel that knot, it is probably like an inch and a half big knot. I am just thinking if it was reaction. It itched a lot but I didn't really have any pain or discomfort with it, it just was red and little warmer to touch. No treatment was received for the events. The outcome of redness and vaccination site lump was reported as recovering, while the outcome of itching and muscle soreness was unknown. Follow-up attempts are completed. No further information is expected.
77 2021-04-27 pain of skin, rash, hardening Mild sensation in left chest area and along left side neck, along with mild shortness of breath star... Read more
Mild sensation in left chest area and along left side neck, along with mild shortness of breath starting about 3/20/21 Has since disappeared. On or about 3/25/21 a hard, painful rash appeared on buttocks and has since healed. A second larger painful rash appeared in a different area on or about 4/5/21 and lasted about 2 weeks. Along with rash is tenderness of skin in surrendering area of rash, there is pain under breast area which extends to back and persists.
77 2021-05-03 pain of skin, skin discolouration, rash February 8th started right arm swelled up like a baseball bat for 3-5 days, went away after using ic... Read more
February 8th started right arm swelled up like a baseball bat for 3-5 days, went away after using ice pack. Symptoms came back around March 12th with rash on left arm, black and blue mark about 1-2 inches, no pain, lasted about two weeks. March 23rd had red 3.5 inch lesion, soar, painful, no itching.
77 2021-05-04 injection site pain SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 mon... Read more
SWOLLEN LYMPH NODES in Right armpit. Still have the swollen lymph nodes today 5/5/2021, almost 2 months. Frightening. Swollen under left eye 3/9/2021 to 3/11/2021. Upper back of both legs painful 3/9/2021. Still have this today 5/5/2021, almost 2 months. Sore at injection site 3/8/2021. Fatigue 3/9/2021.
77 2021-05-06 shingles, blister Right eye pain with tenderness and blistering around the eye. Nose numbness on the right side of nos... Read more
Right eye pain with tenderness and blistering around the eye. Nose numbness on the right side of nose and around. Top of head sensitive. She went to the ED, which diagnosed shingles and referred her to the eye doctor. Prescribed 10 days of Valcyclovir, erythromycin opthalmic ointment, and prednisolone opthalmic suspension. Symptoms lasted the month of April.
77 2021-05-07 itchy rash abdominal discomfort; 3 itchy bumps also appeared in the left breast area; This is a spontaneous rep... Read more
abdominal discomfort; 3 itchy bumps also appeared in the left breast area; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 08:30 (Lot Number: EL9265) at single dose for COVID-19 immunization. Medical history included hypertension and irritable bowel syndrome (IBS), Shellfish allergy. Patient didn't have COVID prior vaccination. Concomitant medications included metoprolol succinate ER 25mg taken for an unspecified indication, start and stop date were not reported; acetylsalicylic acid (BABY ASPIRIN) taken for an unspecified indication, start and stop date were not reported. No other vaccines were administered in four weeks. After the shot on 01Feb2021, there was abdominal discomfort within 15 minutes. 3 itchy bumps also appeared in the left breast area. No treatment was received for the events. The outcome of the events was not recovered. COVID was not tested post vaccination.
77 2021-05-10 rash macular, rash Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotch... Read more
Legs swelled up really bad ; it left blotches in my leg; Legs swelled up really bad ; it left blotches in my leg; Fever; Bladder infection; UTI; He gave me some medications and it is helping the rash; stomach even swelled up; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 77 years old) for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine information included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, for COVID-19 immunization, dose 1 on 17Jan2021 at age of 77 years old. On 23Feb2021, the patient experienced legs swelled up really bad it left blotches in my leg and she went to the doctor, she had fever, bladder infection and Urinary tract infection (UTI). The legs swelled up real bad, her thighs from the waist, she just swelled up everywhere. Her stomach even swelled up but the right leg mostly. She experienced the blotching, it looks like a birth mark on my right leg and the left leg. It is blotchy, looks like a birth mark on the legs. The right one got really big. She did go to doctor and he said it was not a blood clot. He said people are getting swelled up with rash, some people are having rashes and swelling. Treatment included the physician gave her some medications and it is helping the rash and "cephalexin 500 mg, 3 times a day" for the UTI. Outcome of the events was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
77 2021-05-11 shingles shingles; This is a spontaneous report from a contactable consumer (patient) reported that a 77-year... Read more
shingles; This is a spontaneous report from a contactable consumer (patient) reported that a 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9265; expiration date: 31May2021), intramuscular, administered in arm right on 28Jan2021 16:00 (at the age of 77-years-old) as 1st dose, single for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included hysterectomy from 07Dec2020. There were no concomitant medications. Ten days later on 07Feb2021, the patient had onset of shingles. She was prescribed medication for shingles, and finished her last pill of that medication on 20Feb2021. She was scheduled to get her second dose of Pfizer COVID-19 Vaccine, and wanted to know if it would be ok to get that second dose relative to this event. She was scheduled to get her second covid-19 vaccine dose on the 11Mar2021. The clinical course of patient's shingles was described as all the bumps that she did get have dried except for one little spot; it all was on left side of head and face and it seems to be pretty much gone. One little sensitive spot remains where it first began back on the crown of her head on the left side. The itching is gone. The areas on the scalp and forehead have dried up, although there is still a little bumpiness but no itching or burning or anything like that. It's been an ordeal. She does feel like her doctor got her treated quickly and the medication was effective; the shingles was not as severe as some shingles cases can be. The event 'shingles' resulted in physician office visit. The patient underwent lab tests and procedures which included blood test: everything looked good on 22Feb2021. The outcome of the event was recovering.
77 2021-05-12 rash Headache, lethargy, nausea, fever for first three days then rash covering all extremeties and abdome... Read more
Headache, lethargy, nausea, fever for first three days then rash covering all extremeties and abdomena nd chest
77 2021-05-12 vaccination site itchiness, vaccination site warmth, vaccination site swelling, vaccination site hardening Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" di... Read more
Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" diameter, warm, hard and itchy; Injection site swelling about 3" diameter, warm, hard and itchy; This is a spontaneous report from a contactable consumer (patient). A 77-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06Feb2021 11:15 (Batch/Lot Number: EL9264) as single dose for COVID-19 immunisation. Medical history included Asthma, Hypertension, Thyroid, high cholesterol, Chronic obstructive pulmonary disease (COPD), patient had allergy to Penicillin. Concomitant medication(s) included levothyroxine sodium (SYNTHROID); simvastatin (SIMVASTATIN); losartan (LOSARTAN); ibandronate sodium (BONIVA) and gabapentin (NEURONTIN) taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 (lot number= EK4176) in the right arm on 16Jan2021. No covid prior vaccination. No covid tested post vaccination. On 07Feb2021, 06:00 AM, the patient had injection site swelling about 3" diameter, warm, hard and itchy. Hasn't gotten better in 4 days. No treatment received for AE. Outcome of the events was not recovered.
77 2021-05-15 psoriasis Am waiting for appointment with dermatologist
77 2021-05-17 shingles, rash April 14 pain in side of face; next day watery eye and rash above eye. Clariton D and advil helpful;... Read more
April 14 pain in side of face; next day watery eye and rash above eye. Clariton D and advil helpful; April 27th am pain on top of left side of head and face and over eye. Urgent care diagnosis shingles with eye complication; ER tested and then treated me for shingles. One week anti viral with f/u with ophtalmalogist and internist. Antiviral extended one more week and cortisone and triple for eye area. I am still doing the lotion treatment and have gone back to eye doc twice and tomorrow again. Tylenol 3 time a day. I have since come down with a cold but getting over that. It appears pfizer vacine has weakened my immune system for these other diseases.
77 2021-05-19 skin laceration became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussio... Read more
became extremely dizzy; when I came home and passed out.; Hit my head on floor; received a concussion; cut on scalp; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration administered in left arm on 15Mar2021 13:45 (at the age of 77-year-old) (Batch/Lot Number: en6205) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient had no other vaccine in four weeks. The patient had no COVID prior to vaccination. The patient had no relevant medical history. The patient had no known allergies. Concomitant medications included atorvastatin; furosemide; and calcium. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: el9265), administered in left arm on 22Feb2021 at 02:30 PM (at the age of 77-year-old) for COVID-19 immunisation. On 15Mar2021, the patient became extremely dizzy when she came home and passed out. She hit her head on floor and received a concussion and cut on scalp. The events caused hospitalization for 2 days. The patient was tested for COVID post vaccination via nasal swab on 22Apr2021 which was negative. Therapeutic measures were taken as a result of all events which includes computed tomography (CAT) scan and electrocardiogram (EKG) with unknown results. The patient recovered from the events on an unspecified date.
77 2021-05-25 rash, injection site hives Patient showed copious rash and urticaria on the right arm (arm where the vaccine was injected)
77 2021-05-31 itchy skin nauseated; upset stomach; itching all over her body; threw up at breakfast; Headache; This is a spon... Read more
nauseated; upset stomach; itching all over her body; threw up at breakfast; Headache; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number EL9265, Expiration date: unknown), dose 1 via an unspecified route of administration on 28Jan2021 as 1st dose, single for COVID-19 immunization. Medical history included ongoing blood pressure and acid reflux. Concomitant medication(s) included vitamin c, VITAMIN D3, calcium, zinc, blood pressure medication and acid reflux medication. The patient did not want to take the vaccine but her son insisted she took it so she went with him. The patient reported that she got the first dose of the vaccine and she did not think she paid much attention that day. The first day the patient threw up at breakfast and felt real nauseated then continued to have nausea with an upset stomach all day long and she did not know if that was making her headache or what, but she was nauseated all day long. The second day, she had a stomach upset. She went out that day and came home. She could not remember if she ate anything or not but then the next day she got nauseated with an upsets stomach. One night, she had itching all over her body then she feels like just blah. She took a Benadryl toward the morning because she could not stand the itching and thought if it was some type of allergy or something, maybe it could cut it down and she finally got to sleep. She wanted to know about the second dose because she heard a lot of people were super sick with the next vaccine and if she was having problems right now, whether she should take the another one. She saw the date range 17Feb2021-24Feb2021 and COVID 19 vaccine. She regularly took a blood pressure medication and an acid reflux. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
77 2021-06-01 itchy rash headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal... Read more
headache; tiredness; got sleepy; felt a little bad; cysts bleeding; breast pain; knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful; cysts in the rectal area; rash on her face and it's itching/ rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear; soreness in arm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in left arm on 12May2021 11:30 (Batch/Lot Number: EW0168) as 1st dose, single for covid-19 immunisation. Medical history included acne and migraine. The patient's concomitant medications were not reported. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 12May2021, patient experienced soreness in arm. On 13May2021, she had symptoms of rash on her face and it's itching, and the rash started in her face and ear, all on the left side, on her ear half way down the outside of the ear. She could see all the pimples on the face so she put hot water on it and used rubbing alcohol, which she thought would help curb the itching and dry it up, the bottom of the ear lobe is very much active going into jaw area still. She also had headache, and tiredness following her dose, the doctor told her if headache was severe, take a Tylenol with codeine, she took something with codeine and it went away after about three hours. She also had some breast pain (only in the enfold of her breast closest to the middle of her chest), sore to the touch, and it was very sore for about 24 hours, and that it hasn't fully resolved. Then, while bathing, she noticed a knot in the vaginal area right in the fold of pelvis and thigh inside of the pelvis that was painful, large, and the size of a quarter, if she push on the pelvic bone area, it would be painful. Also, while bathing, she identified cysts in the rectal area; after bathing she was trying to identify what they were, when she touched it, it hurt, it felt like a ball and eventually it went down and she caused them to bleed, not a lot of blood, just a small amount. She also started getting more growths in the vaginal area/bottom area near the rectum. Patient got sleepy and now made herself go lay down and she doesn't usually do that. She felt a little bad, she didn't think it was severe side effects, she knew things were going on that she could pinpoint to what would possibly happen but not these cysts. She was recently seen by her gynecologist, a week ago, and none of these problems were apparent at that time. No Emergency Room or Physician Office visit. Patient had blood work done on 07Apr2021 and 10Apr2021 before the vaccine. The outcome of cysts bleeding and soreness in arm was recovered on 13May2021, itching rash, breast pain, painful knot, cysts in the rectal area was recovering, headache was recovered, other event outcome was unknown.
77 2021-06-01 vaccination site hardening redness below injection site; upper arm at injection site feels heavy and tight; This is a spontaneo... Read more
redness below injection site; upper arm at injection site feels heavy and tight; This is a spontaneous report from a contactable consumer (reported on herself). The 77-year-old female patient received BNT162B2 (Solution for injection, Lot number: EN6200 expiry date: unknown) via an unspecified route of administration in left arm on 23Feb2021 9:58 am, as a single dose for Covid-19 immunization. Medical history included Diabetic since in her 30's or 40's, and problems with her spine. Concomitant PIOGLITAZONE HYDROCHLORIDE (ACTOS) 15mg daily Ongoing for Diabetes has been taking for over 10 years, HYDROCHLOROTHIAZIDE, TRIAM-TERENE (TRIAMTERENE/HCTZ) 37.5mg/25mg daily Ongoing had been taking for over 10 years for high blood pressure, LISINOPRIL 40mg daily ongoing for Blood pressure taking for over 10 years, ALENDRONATE SODIUM 35mg every Saturday from 2018 Ongoing) for bones. She would receive injections (unspecified) for back. She had one just before Covid but has had none since. She had problems with her spine. She had inflammation of the spine. She was unable to pronounce the name. On 23Feb2021, everything went ok. She waited for 15 minutes after she received the vaccine. When she got home there was a big red spot the size of a nickel down below the injection site. It had faded. She does not recall hitting her arm. The paper that they gave her mentions redness and a rash. This was down below the injection site. The redness had gone away. It looked like a bruise that had changed back to her skin tone. She could see blotches of the redness. It was a dark color but not bruised. Her upper arm felt heavy and tight. She did not have history of previous immunization with the Pfizer vaccine considered as suspect or additional Vaccines Administered on Same Date of the Pfizer Suspect. Events did not require to visit Emergency Room/ Physician Office. She did not receive prior vaccinations (within 4 weeks) and no relevant tests were performed. Outcome of the event of redness below injection site was recovering, however outcome of the event of upper arm at injection site feels heavy and tight was unknown. No other information was reported.
77 2021-06-04 vaccination site redness, vaccination site warmth Arm is like bright red in that area and it's warm; arm is like bright red in that area and it's warm... Read more
Arm is like bright red in that area and it's warm; arm is like bright red in that area and it's warm; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6204), via an unspecified route of administration on 27Feb2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date (a week since vaccination), patient still had her arm was like bright red in that area and it's warm. Patient saw it was even listed as one of the side effects and she was wondering whether this was okay and how long that would last. The outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.
77 2021-06-06 shingles Shingles outbreak on her right back and torso that began within 6 hours of the injection
77 2021-06-07 skin peeling, skin discolouration, rash macular, redness, dry skin my chest to all the way up to my neck was brilliant, brilliant red and felt like really hard sandpap... Read more
my chest to all the way up to my neck was brilliant, brilliant red and felt like really hard sandpaper; my chest to all the way up to my neck was brilliant, brilliant red and felt like really hard sandpaper; around my neck 2 long red lines, It looked like someone is trying to strangle me; my whole body got covered in little red spots, and then slowly it started to peel off and the peeling was even on top of my hand; when as far as the top of my neck where the chin starts because I thought oh my god it has got my face too but it stopped their but everything else is got it; I am still peeling, my rear end is still peeling skin off, It's like big sheets coming off, It's like big sheets coming off/skin is still 'fluffing' off; It scares the hell out of me; This is a spontaneous report from a contactable consumer (Patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for Injection; Lot number: EW0753; Expiration date: unknown), via an unspecified route of administration on 29Apr2021 (at the age of 77-year-old) as 2nd dose, single dose in left arm for COVID-19 immunisation. The patient's medical history included surgeries. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for Injection; Lot Number: EW0173), as single dose for COVID-19 immunisation. On unspecified date in May2021, a few days later after second dose, the patient's chest to all the way up to neck was brilliant, brilliant red and felt like really hard sandpaper, and around neck 2 long red lines, it looked like someone was trying to strangle. The patient went to the dermatologist, they did not know what it was, and they sent the sample out. In the meantime, the patient's whole body got covered in little red spots, and then slowly it started to peel off and the peeling was even on top of the hand, the patient still peeling, her rear end was still peeling skin off, It was like big sheets coming off, It scared the hell out of her, she did not know what was going on. Patient just told that no one else was having that kind of reaction that she had. It really scared her when it reached this far on the top of her neck where the chin starts because she thought oh my god it has got on the face too, but it stopped their and everything else got it. The first symptom was on her chest and that became brilliant red and looked like she was on fire and that was just as hard as a sandpaper. That was the first thing and slowly other things started, that brilliant red start and her body all started coming out with red spots. It did not itch and slowly it started to 'fluffing' off and the skin was still 'fluffing' off. Patient had the second vaccine almost a month ago. On the top of her hand there was peeling. It scared her to death because this thing has not been happened it was 6 months and she do not know why she got it and really do not know. She just wanted to report because she went to her own doctor and then to dermatologist. The clinical outcome of the events was unknown. Follow up needed, further information has been requested.
77 2021-06-10 shingles Pain on left side with tingling, Shingles, Antiviral Valtrex, Nerve pain Gabapentin, and Zyrtec for ... Read more
Pain on left side with tingling, Shingles, Antiviral Valtrex, Nerve pain Gabapentin, and Zyrtec for treatment.
77 2021-06-11 injection site pain Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (da... Read more
Soreness at injection site (3 days) Swollen lymph glands (2 days) Lethargy (2 days) Fever spikes (day following shot) Brain fog (2 weeks) Achiness in shoulders & neck (2 days) Diarrhea (2 weeks - ongoing)
77 2021-06-16 pain of skin she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also ver... Read more
she had 5 days of exhaustion where she felt like she couldn't get out of her chair; she was also very aware of her stomach; two twinges in her arm; she couldn't even stand clothes on her legs; skin on her left leg started to hurt so much that it reminded of her of having a neuralgia; She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh/stinging in certain parts of her leg; skin on her left leg feels burning; left leg felt like it needed cold and not heat; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0178; Expiration Date: 31Aug2021), via an unspecified route of administration, administered in left arm on 25May2021 at 14:30 (at the age of 77-year-old) at a single dose for covid-19 immunisation at Clinic. Medical history included ongoing high blood pressure, high cholesterol and it runs in her family (She has tried all the different "statin" medications and she couldn't tolerate any of them. Her cardiologist told her there was an injection she could take for her cholesterol every two weeks and it was supposed to be like a "liquid plumber" for your veins. She is so sensitive to medications including all these "statin" medications, there is no way she can take the bi-weekly injection. It might have a much more profound negative affect on her. She was so leery of taking medications, even over the counter medications), gastrooesophageal reflux disease (GERD), 4 cardiac stent placements in 2015, blood pressure abnormal, allergies (unspecified), sinus are swollen, neuralgia, cataract surgery (a year and half ago), retina had swelled and sensitivity to heat. Concomitant medications included acetylsalicylic acid (ASPIRINE) chewable tablets at a dose of 81 mg daily for sinuses are swollen (her sinuses are not swollen at this time), loteprednol etabonate (LOTREL) for blood pressure abnormal. The Lotrel keeps her blood pressure around 120/70mmHg, famotidine (PEPCID) for gastrooesophageal reflux disease. The patient previously took tylenol and experienced allergy and giant hives. Aspirin give her hives but usually a hive here or there, not real big hives, ilevro for retina swelling and affected her skin on her face (She did have a problem while she was taking the steroid eye drops. They made her feel very unwell. She does not take Prednisone for the same reason. She had tried many different steroid eye drops and so many of them gave her a problem. She ended up taking Ilevro. She had no choice but to take it. The Ilevro affected the skin on her face. Her retinas had to stop swelling. Everything is fine now. She has no glaucoma or macular degeneration. This occurred a year and half ago when she had her cataract surgery). She had given the nurse who gave her the injection a list of all her allergies and sensitivities and the nurse reviewed the list and didn't see anything in the Covid 19 vaccine that would cause the caller harm based on her list of allergies and sensitivities. The caller took a deep breath and prayed while she received the Covid 19 vaccine. After the vaccine she waited at the facility and she was fine and then she left to go home. She ever had an adverse event with any other vaccines she reports she has not been vaccinated with anything since she was a child. She didn't even have the Polio vaccine. The patient did not receive any other vaccinations within four weeks prior to the first administration of the suspect vaccine. After getting the Covid 19 vaccine, on an unspecified date, the patient had 5 days of exhaustion where she felt like she couldn't get out of her chair and she was also very aware of her stomach. Her stomach wasn't upset but she was aware of it. That slowly passed and she started doing the things she needed to do. She needs to walk because of her heart stents. She had been fine after the Covid 19 vaccine until last night on 10Jun2021 at 21:30 the patient skin on her left leg started to hurt so much that it reminded of her of having a neuralgia. She provides an example of her sometimes feeling a draft and she can develop a neuralgia from the draft for a day or two. That's what her leg felt like initially. As the night wore on, around 22:00, she realized she couldn't even stand clothes on her legs. She wears nightgowns, not pajamas and she had to take her nightgown off her leg. The sensation in her leg started changing, she could feel that she not only had the skin hurting sensation but now she had stinging in certain parts of her leg. She had stinging on the top and behind her knee and it traveled down towards her ankle and up towards her upper thigh. It was bizarre. She thought about it this morning, 11Jun2021, what it felt like. She remembered way back, long ago, and she was not a sun person, but it felt like how a sunburn would feel. The skin on her left leg feels burning. She used Aspercreme on her leg thinking it will help with the pain. She wiped all the Aspercreme off her leg. She could not cover her left leg. Her left leg felt like it needed cold and not heat. She does have a history of sensitivity to heat. She runs her air conditioner, and she had a ceiling fan above her bed. She had her left leg exposed and out of her bed covers to try and get the cold air on her hot leg. Finally, around 23:30, her leg still bothered her, but she was able to go to sleep. She twisted and turned at night but was finally able to put her bed cover back on her leg but lightly. The sensation was still there in her leg. She was so sensitive. On an unspecified date, the patient had two twinges in her arm and then her arm never hurt again. The events did not result in emergency room or Physician Office. She is due for her second Covid 19 vaccine on 15Jun2021. The outcome of the events she had 5 days of exhaustion where she felt like she couldn't get out of her chair, she was also very aware of her stomach, two twinges in her arm was unknown and the rest of the events was not recovered. Information on lot/batch number was available. Additional information has been requested.
77 2021-06-17 vaccination site pain, rash getting a rash on her back; sore arm; She mentioned that she had a sore arm after the first shot; Sh... Read more
getting a rash on her back; sore arm; She mentioned that she had a sore arm after the first shot; She was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects.; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265; Expiration Date: 31May2021)via an unspecified route of administration, administered in Left Arm on 28Jan2021 at 08:30 as First Dose, Single Dose COVID-19 immunization. The patient's medical history included shingles seven years ago, blood pressure abnormal, rheumatoid arthritis, hysterectomy at a young age and was put on Premarin. She was on a higher dose initially but is currently taking 0.3mg daily. When they have tried to take her off of Premarin she has a reaction. She is unsure if it is a reaction or mental. Product is filled in a pharmacy bottle. NDC, Lot and Expiry are not on the label. She has had shingles twice. Clarifies that her last episode was 10 years ago. She is due a Shingrix vaccine. Her physician says with her rheumatoid arthritis, taking Hydroxychloroquine and Covid he doesn't recommend that she get the Shingrix vaccine. No Patient's Medical History including any illness at time of vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN)Hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for blood pressure abnormal from 2011 and ongoing; hydroxychloroquine (HYDROXYCHLOROQUINE) taken for rheumatoid arthritis from Dec2019 and ongoing; estrogens conjugated (PREMARIN) taken for hysterectomy. No History of all previous immunization with the Pfizer vaccine considered as suspect. No Prior Vaccinations within 4 weeks No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient mentioned that she had a sore arm after the first shot from 28Jan2021 to 01Feb2021 and she was told by a nurse that she could take claritin, dimetapp, or tylenol before receiving her second dose, to help lessen the potential for side effects, she was getting a rash on her back from 04Feb2021 and ongoing. This started as a little circle under her shoulder blade. Is this a reaction to the vaccine or could it be shingles. No relevant tests were performed. The patient did not visit any Emergency or Physician office for the AEs. The outcome for the events was sore arm was recovered/resolved and the Rash was not recovered/not resolved and Unknown for rest of the events. Follow-up attempts are completed. No further information is expected.
77 2021-06-20 rash Bumps on arms and back
77 2021-06-22 shingles Shingles flare following vaccination. Office Visit with provider on 5/13/21
77 2021-06-24 redness, rash with redness, rash, itchy skin Today whelps are fading, but light red; Itching; Was sitting on the sofa and it felt like something ... Read more
Today whelps are fading, but light red; Itching; Was sitting on the sofa and it felt like something bit her/Awful; Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported that a 77-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EL8982), dose 1 via an unspecified route of administration, administered in Deltoid Right on 27Jan2021 14:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included heart surgery from 17Mar2020 to an unknown date. There were no concomitant medications. Patient did not had family medical history and illness. Patient did not had any history of previous immunization. On 04Feb2021, the patient experienced Whelps on back near shoulder and side of breast; Whelps very red, like blood red, raised; Itching and was sitting on the sofa and it felt like something bit her; On 05Feb2021, Today whelps are fading, but light red. Patient did not performed any relevant test. Patient took COVID vaccine because she wanted to be protected from the virus, it was awful. It was reported that caller reports she had the COVID shot on 27Jan and everything was fine. Yesterday she had some whelps on her back near the shoulder and on the side of her breast. It was so very red, like blood red yesterday and itching. Today they are fading, but are light red. Yesterday she was sitting on the sofa and it felt like something bit her. Then she noticed the whelps and they were raised. Still has a few on the breast and one almost on the dark area near the nipple and still itching right now. No other vaccines given the same day or 4 weeks prior. No problems with vaccines in past. They called her to come get the vaccine due to her age group. Patient had no AE prior vaccination. Patient was not visited to emergency room and physician room. The clinical outcome of event Whelps very red, like blood red, raised was recovering; Was sitting on the sofa and it felt like something bit her was unknown; while all other event was not recovered. Follow-up attempts are completed. No further information is expected.
77 2021-06-24 redness hard time walking; tiredness; foot swollen; foot hot to touch; Since receiving the vaccine she has b... Read more
hard time walking; tiredness; foot swollen; foot hot to touch; Since receiving the vaccine she has been sleeping a lot for about 3 days; Foot pain; foot redness; This is a spontaneous report from a contactable consumer. A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EL9261)via an unspecified route of administration, administered in Left Arm on 02Feb2021 at 12:00 (at the age of 77-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included parkinson's disease, transient ischaemic attack, hypersensitivity, sinus disorder, Cardiac disorder, vaginal infection, pain, incontinence, antidepressant therapy, hallucination, unspecified vitamin D deficiency. No relevant tests done. The concomitant medications included ongoing estradiol (ESTRACE VAGINAL) taken for vaginal infection from 2019, ongoing colecalciferol (VITAMIN D 3) taken for vitamin d deficiency, ongoing pimavanserin tartrate (NUPLAZID) taken for hallucination from 05Feb2021,ongoing venlafaxine (VENLAFAXINE) taken for antidepressant therapy, ongoing carbidopa, levodopa (RYTARY) taken for parkinson's disease, ongoing mirabegron (MYRBETRIQ) taken for incontinence, ongoing atorvastatin calcium (ATORVASTATIN CALCIUM) taken for cardiac disorder, ongoing aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for transient ischaemic attack ,ongoing clopidogrel bisulfate (CLOPIDOGREL BISULFATE) taken for transient ischaemic attack, ongoing paracetamol (ACETAMINOPHEN) taken for pain, ongoing loratadine (LORATADINE) taken for hypersensitivity, sinus disorder, ongoing ascorbic acid, biotin, calcium, colecalciferol, cyanocobalamin, dl-alpha tocopheryl acetate, folic acid, potassium iodide, pyridoxine hydrochloride, retinol acetate, zinc sulfate (CENTRUM MULTIGUMMIES WOMEN), amantadine hydrochloride (AMANTADINE HYDROCHLORIDE) taken for parkinson's disease. Since receiving the vaccine she had been sleeping a lot for about 3 days (on 03Feb2021). Caller stated she knew that was supposed to be a side effect. Adds her mother was a Parkinson's patient and usually able to walk using a walker. She was having a hard time walking (03Feb2021) and had to use the wheelchair. Clarifies her mother started sleeping quite a bit about three days after the vaccine on Friday 03Feb2021. Mentions previous to this on Wednesday after the vaccine, her mother was complaining of foot pain (on 03Feb2021) towards the side midway on the foot in the arch and on the top where you tie your shoe. It was almost like she dropped something on it but she did not. It was slightly swollen on the top and red and warm (on 03Feb2021). Friday when her mother started sleeping so much, they had resort to the wheelchair. She took her to see the nurse practitioner on Friday for the foot, who sent her to the ER for an X-ray on Saturday so they went out again on Saturday to get the foot x-ray done. The foot was not broken. They did treat her mother's foot with Cephalexin. Her foot was fully recovered now. Her mother's tiredness (on 05Feb2021) was persisting and she was having a hard time just getting up from the bed and to go across the room even though the foot was fine. Today they have a message into her neurologist. Adds today was the first day her mother started talking about needing or wanting to go to the hospital for her tiredness and not being able to walk (06Feb2021) Her mother was scheduled for the next dose 23Feb2021.The patient underwent lab tests and procedures which included x-ray limb: the foot was not broken on. Therapeutic measures were taken as a result of foot pain, foot redness, foot swollen, foot hot to touch.The outcome for the events foot pain, foot redness, foot swollen, foot hot to touch was recovered/resolved on 08Feb2021 and not recovered/not resolved for rest of the events. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected
77 2021-06-24 rash, itchy skin Itchiness on chest; rash on chest; Shortness of breath; This is a spontaneous report from a contacta... Read more
Itchiness on chest; rash on chest; Shortness of breath; This is a spontaneous report from a contactable consumer or other non hcp. A 77-years-old non pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration, in Arm Right on 24Feb2021 13:30 (at the age of 77 years old) (Batch/Lot Number: ERV6200) as single dose for COVID-19 immunization. Previously the patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, in Arm Right on 04Feb2021 14:00 (at the age of 77 years old) (Batch/Lot Number: EL9264) as single dose for COVID-19 immunization. Medical history included trigeminal neuralgia. Concomitant medications included gabapentin; oxcarbazepine taken for an unspecified indication. The patient has no known allergies. On 24Feb2021 at 09:00 the patient experienced itchiness and rash on chest, Shortness of breath and self-administered Cortisone cream only on chest. No other vaccines were received in four weeks. The patient had no covid prior vaccination and was has not been tested for Covid-19 post vaccination. Therapeutic measures were taken as a result of itchiness and rash on chest, shortness of breath. The clinical outcome of the events was recovering. Follow-up attempts completed. No further information expected.
77 2021-06-29 vaccination site itchiness Flu-like symptoms; headache; Body aches; fatigue; in bed all next day; Left arm swollen; itchy at in... Read more
Flu-like symptoms; headache; Body aches; fatigue; in bed all next day; Left arm swollen; itchy at injection site; This is a spontaneous report from a contactable consumer. A 77-year-old non-pregnant female consumer (Patient) reported that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Jan2021 at 02:15 AM (at 77-year old) on left arm at dose 1, single for COVID-19 immunization. The medical history of the patient included that she was tested covid-19 positive. The patient had no allergies. The patient's concomitant medications were not reported. Patient had not received any Other vaccine same date and had not received other vaccine same date product. It was mentioned that patient got no other vaccine in four weeks and no medications in two weeks. On 30Jan2021, the same day patient had itchy at injection site; Monday he was site still itchy. On 31Jan2021 at 12:00 hours the patient experienced flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen. On 08Feb2021 the nasal swab covid test was done for which results was unknown. The patient was scheduled for 2nd shot on 20Feb2021. The outcome of injection site itchy was not recovered and outcome of other events flu-like symptoms, headache, body aches, fatigue, in bed all next day after shot and his left arm was swollen was unknown. No follow-up attempts were possible; information about Lot/batch number could not be obtained.
77 2021-06-30 bruising, rash macular, itchy rash red blotch with lump on left arm, black and blue marks left leg, itchy little bumps, top left foot, ... Read more
red blotch with lump on left arm, black and blue marks left leg, itchy little bumps, top left foot, very black and blue on top of right foot going on to toes took pictures on my cell phone
77 2021-06-30 redness Redness, swelling and extreme pain. Started right after injection and it continues as of today. Sh... Read more
Redness, swelling and extreme pain. Started right after injection and it continues as of today. She was started on Keflex at first and is now on amoxicillin.
77 2021-06-30 rash, itchy skin "rash on her stomach and bumps on the body but now went away" but she is still "itchy"/and chest wit... Read more
"rash on her stomach and bumps on the body but now went away" but she is still "itchy"/and chest with a few bumps; "rash on her stomach and bumps on the body but now went away" but she is still "itchy".; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 22May2021 (Batch/Lot Number: EW0172) as dose 1, single (age at vaccination 77-year-old) for covid-19 immunisation. Medical history included glaucoma from an unknown date. Concomitant medication(s) included dorzolamide hydrochloride, timolol maleate (COSOPT) and brimonidine tartrate (BRIMONIDINE AFT) taken for glaucoma from an unspecified start date and ongoing; latanoprost, netarsudil mesilate (ROCKLATAN) taken for glaucoma, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaaccination. On May2021, the patient experienced rash on her stomach and bumps on the body but now went away but she is still itchy and chest with a few bumps. "She is still a little itchy. she has been scratching on her back and arms". Caller had her first dose of the Pfizer BioNTech Covid-19 last 19May2021 and a couple days after, she had a light reaction. She developed rash on her stomach and bumps on the body but now went away but she is still itchy. Caller asked if she should hold up a day or 2 for the next vaccine because she is scheduled tomorrow for her second dose and she doesn't want to have a severe reaction to the next one because she is still itchy all over. The rash and bumps began a few days later. The rash and bumps did not happen right away, it was a delayed reaction. It was not a bad rash; it was just a slight rash. Most of the rash was on the side of her stomach and chest with a few bumps. She also had a couple of bumps on her leg and thigh. The bumps on her leg and body did not all come at once. A couple of bumps would appear, and then a couple more, and then a little bit more. She took some Benadryl, and her granddaughter brought her some cream. She had been scratching on her back and arms: She had been scratching her back and arms, but there were no bumps or anything. She had been quite itching. Some days she was really itchy. This had been going on since she received the first dose of the covid vaccine. It was not a really bad itch, but she finds herself itching, and it was not normal for her. She thinks she received the first dose of the covid vaccine on 19May2021, but she might have that date wrong. She has trouble seeing and had to get a magnifying glass to read the information off of her vaccine record card. She clarifies that she did not receive the first dose of the covid vaccine on 19May 2021. She received the first dose of the covid vaccine three weeks ago from tomorrow. She received the first dose of the covid vaccine on 22May2021. She had to get something to enlarge the writing so she could read the correct date off of her vaccine record card. Therapeutic measures were taken as a result of events includes Benadryl and some cream. The treatment not received for events She is still a little itchy. She has been scratching on her back and arms and rash on her stomach and bumps on the body but now went away but she is still itchy. The outcome for event rash on her stomach and bumps on the body but now went away but she is still itchy/and chest with a few bumps was recovered on an unknown date in May2021 and another event was not recovered. Follow-up attempts are completed. No further information is expected.
77 2021-07-06 rash, itchy rash, hives Did not receive 2nd dose of vaccine, lisp tongue, couldn't pronounce any words, dizzy, itchy rash/hi... Read more
Did not receive 2nd dose of vaccine, lisp tongue, couldn't pronounce any words, dizzy, itchy rash/hives on torso, very wobbly could not stand, prescribed an EpiPen.
77 2021-07-07 injection site swelling, injection site pruritus Site: Itching at Injection Site-Mild, Site: Swelling at Injection Site-Mild
77 2021-07-08 itchy skin PT DID NOT REPORT THIS REACTION UNTIL 7/9/21. SHE HAS HAD TELANGIECTASIA MACULARIS ERUPTIVA PERSTANS... Read more
PT DID NOT REPORT THIS REACTION UNTIL 7/9/21. SHE HAS HAD TELANGIECTASIA MACULARIS ERUPTIVA PERSTANS ON HER UPPER BACK FOR YEARS, BUT AFTER HER FIRST DOSE PT NOTED A NEW AREA FORM ON HER LOWER BACK AND UPPER BUTTOCK AREA. IT IS ITCHY. DAYS VARY WITH ITCHINESS AND IT NEVER GOES AWAY.
77 2021-07-11 redness, itchy skin, rash macular, hives very very itchy.; inflamed; these isolated spots on your right and your left elbow and one side of m... Read more
very very itchy.; inflamed; these isolated spots on your right and your left elbow and one side of my face and my neck, so it was isolated, it was not a rash but so itchy and red and inflamed; big red blotch that was very itchy; I was going crazy; didn't sleep; My asthma has been worse; hive like hard bumps around elbow of same arm, as well as near ear of right side.; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM6198) via an unspecified route of administration on 02Mar2021 (at the age of 77-year-old) as dose 2, single for COVID-19 immunization. Medical history included years ago penicillin allergy but have had since, bug bites allergy, allergic to mosquito bites and to insect bites, asthma, minor arthritis/spine, acid Reflux, high cholesterol. Concomitant medication(s) included atorvastatin calcium (STATIN), folic acid and multi-vitamin, vi taken for an unspecified indication in two weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) administration on right arm on 09Feb2021 (at the age of 77-year-old) as dose 1 single for Covid-19 immunization and experienced similar event with 2nd dose along with large blister. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. On an unspecified date in Mar2021, the patient experienced similar events happened again after 2nd vaccine 02Mar2021 in same spots, no big blister just both elbows and neck, very very itchy as well as hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side. Followed by very itchy bumps on left arm at elbow site. Patient informed that after the 2nd shot it affected 2 elbows and the neck but no blister (same as the first but the first had the giant blister) and had gone to 2 physicians who didn't know what it was or if it may be an allergic reaction no one had identified it. Patient thought it was bug bites (allergic to mosquito bites and allergic to insect bites). It was so inflamed for a month patient was going crazy and doctor gave prednisone and Zyrtec. The 3rd person, patient spoke with thinks it's covid arm. No one can tell her what it was. Patient been to a dermatologist and internal doctor. Thinks it's the reaction to the covid vaccine. The problem with the reaction was when it's so inflamed. It feels like she got mosquito bite (like when she get a reaction) and didn't sleep the whole night. The doctor said, "I can't tell if it's a bug bite because it's so inflamed." Patient's asthma has been worse. It's horrible to have this. Thinking patient had bed bugs, it's been driving her crazy for a month. Patient informed that it's not just some itchiness, at first sight she thought she had insect bites. It happened in two locations under the right side of my neck which is like a big red blotch that was very itchy at the same time on my right arm and so the second time it happen it was not that bad, just in these isolated spots on right and left elbow and one side of face and neck, so it was isolated, it was not a rash, it was like an allergic reaction to mosquito bite but so itchy and red and inflamed. The doctor gave the patient antihistamine and now taking prednisone. Patient also asked about tests available to see if she had an allergic reaction to the pfizer vaccine. If the vaccine had histamine or would people who had allergies to bug bites have allergies to the Pfizer vaccine. The outcome of events hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side and very very itchy was recovering and rest all events was unknown. No follow-up attempts are possible. No further information is expected.
77 2021-07-13 injection site pain Site: Pain at Injection Site-Medium
77 2021-07-15 rash Rashes: left breast approximately 3 inches by 3 inches, left thigh approximately 2 inches by 2 inch... Read more
Rashes: left breast approximately 3 inches by 3 inches, left thigh approximately 2 inches by 2 inches
77 2021-07-15 rash Neck rash, about 6 inches x 5 inches
77 2021-07-17 itchy skin Itching; Tongue redness; Tongue swelling; This is a spontaneous report from a contactable consumer (... Read more
Itching; Tongue redness; Tongue swelling; This is a spontaneous report from a contactable consumer (patient). A 77-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283 and Expiration Date not reported) dose 1 via an unspecified route of administration on 04Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received historical vaccine of flu shot (no details provided) in September. The patient has no known allergies. The patient received the first dose of the COVID-19 vaccine a week ago and had a reaction of itching and the tip of her tongue got a little red and a bit swollen. She says she was scheduled to take the next dose of the vaccine on the 25th of this month and had some concerns. She said that the reason she called was she wanted to make sure it was ok for her to take second dose. She said she already talked to her doctor who told her to call Pfizer. The patient told that, the itching was probably for 12 hours. The patient said that, the tongue redness and being a bit swollen did not last long, she came home and had lunch and drank a lot of water. She said that the itching stayed until almost the next day and her tongue was better. She said she was concerned and went to her doctor. The patient received treatment with Benadryl one time at night, UPC: Unknown and product did not have a barcode on it and it was small tablet size and Diphenhydramine HCI 25mg said it as antihistamine on the label, with EXP Dec2021 and LOT SEF004 and took one by mouth one time. The outcome of events was unknown. Follow-up attempts are completed. No further information is expected.
77 2021-07-17 hives, blister Large itchy blister under arm where vaccine was givenapproximately 10-12 days after 1st vaccine as w... Read more
Large itchy blister under arm where vaccine was givenapproximately 10-12 days after 1st vaccine as well as hive likehard bumps around elbow of same arm, as well as hive likebump near ear of right side; Large itchy blister under arm where vaccine was givenapproximately 10-12 days after 1st vaccine as well as hive likehard bumps around elbow of same arm, as well as hive likebump near ear of right side; I had a big blister; This is a spontaneous report received from a contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection, Lot number was not reported), via an unspecified route of administration in the right arm on 09Feb2021 (at the age of 77-years-old) as first dose, single dose for COVID-19 immunization. The patient's medical history included asthma, minor arthritis, acid reflux, high cholesterol, penicilin allergy, bug bites allergy and mosquito bites allergy. Concomitant medications included Atorvastatin calcium (STATIN) 5 mg. Multi-Vitamin and Folic Acid pill (received within 2 weeks of vaccination). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor had been tested for COVID-19 since the vaccination. The patient experienced large itchy blister under arm where vaccine was given approximately 10-12 days after 1st vaccine as well as hive like hard bumps around elbow of same arm, as well as hive like bump near ear of right side. Followed by very itchy bumps on left arm at elbow site.The patient was given treatment for not totally yet, but itching, redness and swelling and was put on antibiotics, then prednisone, then Zyrtec. She had both doses. She stated that "after first dose I had a worse reaction (I had a big blister). It appeared 11 days after the shot; didn't happen right away. After the 2nd shot it affected 2 elbows and the neck but no blister (same as the first but the first had the giant blister). I've gone to 2 physicians who didn't know what it was or if it may be an allergic reaction no one had identified it. I thought it was bug bites (I'm allergic to mosquito bites and allergic to insect bites). It was so inflamed for a month I was going crazy. The first doctor gave me: cortisone, steroids, and an anti-inflammatory. 2nd time (after the 2nd dose) another doctor put me on prednisone and Zyrtec. The 3rd person I spoke with thinks it's covid arm. No one can tell me what it is. I saw some photos of what people had. Although I've had it in 3 different spots, under the arm, and elbow, the hand I got the shot on, under my ear (lump) and left elbow. It's on 2 arms, and part of the neck. I've been to a dermatologist and my internal doctor. Thinks it's the reaction to the covid vaccine. It on the right side, neck and right arm (not where the injection site was) giant blister on right arm between elbow and wrist at least 6 inches long and 3 inches wide. On the left side: left elbow and above the elbow. The big blister under my arm where I had my shot, neck and two elbows. The first reaction it happened 10-11 days after the first shot, after the 2nd shot: it came back, but not as a blister (soon after the 2nd shot). No body knows what it is. The problem with the reaction was when it's so inflamed. It feels like I got mosquito bite (like when I get a reaction) I didn't sleep the whole night. She (the doctor) said, I can't tell if it's a bug bite because it's so inflamed. The doctors don't know. I got no results with 2 doctors. They didn't know what to tell me, Maybe an allergist? My asthma has been worse. It's horrible to have this. Thinking I had bed bugs, it's been driving me crazy for a month. I was going to get a new bed. I have pictures; it's on my phone from the first dose. My doctor saw this and they didn't know what it was on my elbows and neck. contact caller if needed". The patient further reported that , "I have been to two doctors for some itchy things that have been happening and I did my own research and I am wondering if it could be either reaction, allergic reaction to the COVID Vaccine. Are you qualified to answer question if I give you symptoms? Well, I just want to tell you it's not just some itchiness, at first sight I thought I had insect bites. It happened in two locations under the right side of my neck which is like a big red blotch that was very itchy at the same time on my right arm where I had the shot there was a blister on the inside of my arm that was probably 6 or 7 inches long and may be 4 inches wide, and then at my elbow, it felt like I had mosquito bite that itched so much my elbow turn red and then my other arm at the elbow turn red and itchy. I went to the dermatologist, they didn't know what the heck it was, so what they did was they gave me antibiotics (captured as Unspecified medication) and it subsided for a while but it did not go away and I was using cortisone cream, steroid cream. And then after the second shot, now this reaction, the first time was not right after the vaccination it was probably close to 2 weeks after the vaccination and I didn't know what it was and nobody knew what it was. So I was thinking, I had bugs in my house. I was getting all kind of things, I called exterminator. I did not know what to do, so the second time it happen it was not that bad, but then I went to the Doctor and she said well it may be a COVID reaction but I do not understand why it's happening in these isolated spots on your right and your left elbow and one side of my face and my neck, so it was isolated, it was not a rash, it was like if you got an allergic reaction to mosquito bite but so itchy and red and inflamed, it was not funny. So nobody knew what it was, so the second doctor than gave me antihistamine and am I now taking prednisone so I am hoping that what I am doing is the right thing because nobody seems to know what it is. Let me just tell you that while I was waiting for you to answer I filled out the form but I only fill it that because I was confused at the question. I filled it out noting the reaction to the first vaccine but I did not see a spot where it say second vaccine so I just put that in section where you explain certain things, but I would rather get some information for you to make sure that I am doing the right thing what I am taking (hence no further probing was done." Outcome of the events was resolving. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
77 2021-07-21 redness, rash, vaccination site pain Swelling; Redness; Vaccination site pain; Tiredness; Rash 4 inch circle since shot; This is a sponta... Read more
Swelling; Redness; Vaccination site pain; Tiredness; Rash 4 inch circle since shot; This is a spontaneous report from a contactable consumer, the patient. A 77-year-old, non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP0955) via an unspecified route in the right arm on 25Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The medical history of the patient included osteopenia, sulphur and shellfish allergy. The past drug history of the patient included gabapentin started on an unknown date for an unknown indication. The patient received lovastatin (MANUFACTURER UNKNOWN) started on an unknown date within 2 weeks prior to the COVID-19 vaccine for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route in the right arm on 04Mar2021 at 12:00 (at the age of 77-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccination within 4 weeks prior to the COVID vaccine. Post the vaccination, the patient was not tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot. The adverse events did not result in a visit to the doctors or other healthcare professional office or clinic visit and emergency room or department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events swelling, redness, pain at injection site (vaccination site pain), tiredness and rash of 4-inch circle since the shot was not recovered at the time of this report. No follow-up attempts are possible. No further information is expected.
77 2021-07-28 injection site pain 7/20/21 1st Covid vaccination (pfizer) appt was at 10:30 actually received injection approx 11:15 am... Read more
7/20/21 1st Covid vaccination (pfizer) appt was at 10:30 actually received injection approx 11:15 am. around 6 hrs later, left arm/injection site began to ache. THEN, approx 8:00 pm, (approx 9 hrs after injection) I experienced slight shortness of breath (sob) plus some fatigue, headache, dizziness. Was able to go to sleep--after a while. Next morning, 7/21/21 sob more noticeable. Didn't do my regular 3-4 mile walk. By afternoon (7/21/21) great fatigue, greater headache, dizziness and shortness of breath stronger. In middle of day I went to bed and slept 4 hrs. --to nap like this...very rare except when I had Covid, late 2019/early 2020. Following evening, 7/22/21, approx. 8:00 PM, because that day had been free of sob, I took dog for walk...only reached l/8 mile, or less, because sob returned, in a stronger manner. I had to rest before able to walk back home. By 9:15 pm, same evening (7/22/21), sob worsened--although only sitting at computer. Husband found my 2019 rx of "albuterol sulfate" inhaler...( 90 mcg per puff, take 2 puffs back to back) something I've NEVER used before. This was prescribed because in 2019 because of extreme sob, now considered to be symptom of Covid. The inhalant helped. July 27, 2021, I had to use inhalent again--sob.
77 2021-07-28 itchy skin Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all o... Read more
Elevated blood pressure; swelling in mouth/lips; Nausea; Sensitivity to sound; Severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils); This is a spontaneous report from a contactable consumer, the patient. A 77-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 0140), via an unspecified route of administration in the left arm on 20Jan2021 at 10:00 (at the age of 77-years-old), as a single dose for COVID-19 immunisation. Medical history included spinal stenosis, degenerative disc disease, arthritis, sciatica, high blood pressure, diabetes, high cholesterol, pollen allergy, dust allergy, ragweed allergy, carageenan allergy and fruit allergy (tomatoes). Concomitant medications included morphine sulfate (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN) and metoprolol succinate (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously took simvastatin on unknown date for an unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Jan2021 at 22:00, the patient experienced swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure. It was unknown if therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events swelling in mouth/lips, severe itching (all over, especially legs, thighs back, arms, scalp, eyebrows and in nostrils), nausea, sensitivity to sound and elevated blood pressure were resolved on an unknown date in 2021. No follow-up attempts are needed. No further information is expected.
77 2021-07-28 skin warm, redness Pt received first dose on Monday 7/26/21 and returned to pharmacy on Thursday 7/29/21 reporting she ... Read more
Pt received first dose on Monday 7/26/21 and returned to pharmacy on Thursday 7/29/21 reporting she had a sore throat the night she got her vaccine. She now has redness/red-like and warm-to-the-touch circular appearance about 3 inches below her injection site (may be cellulitis). Pt denied she did not have other symptoms like throat swelling, itching, lip swelling, etc. She will take benadryl and ibuprofen to reduce the redness/inflammation. She will also keep the area clean by washing with warm water and soap. She was advised to contact MD if she does not see it going away or symptoms persist or new symptoms occur.
78 2021-01-03 skin infection at injection site, injection site pain, injection site redness, injection site swelling, injection site warmth "Pfizer-BioNTech COVID-19 Vaccine" 12/29 patient developed SOB, fever tmax 103 degrees F, diaphoreti... Read more
"Pfizer-BioNTech COVID-19 Vaccine" 12/29 patient developed SOB, fever tmax 103 degrees F, diaphoretic, dry heaves all started approximately 16 hours after vaccination given. patient then transferred to Hospital for further treatment and observation. 12/30 seen at injection site- erythema, swelling, warmth and tenderness Discharged back to home on 1/1 with RX for cephalexin to treat cellulitis of injection site
78 2021-01-14 injection site pain Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, tempera... Read more
Injection site pain,tiredness,headache,muscle pain,chills, joint pain,nausea,feeling unwell, temperature 99.6
78 2021-01-15 sensitive skin, pain of skin 7 am. 1/13/2021 increased poly arthritis joint pain Chills Headache Malaise . Tylenol every 6 hour... Read more
7 am. 1/13/2021 increased poly arthritis joint pain Chills Headache Malaise . Tylenol every 6 hours 1/14/2021. headache , malaise, hyper skin sensitivity on back arms; felt like sunburn 1/15/2021 increased pain on skin especially on back headache increased malaise ; joint pain subsided, Malaise and headache has lasted for 3 full days
78 2021-01-21 skin mass When I awoke this morning and was getting dressed, I noticed a soreness in the back of my left leg (... Read more
When I awoke this morning and was getting dressed, I noticed a soreness in the back of my left leg (on the right side of the left leg). I felt a lump, It was about 2-3 inches above the knee. It was what I would describe as a medium-sized lump. I called my doctor to leave a message about my symptoms. My doctor called a few minutes after 11 am and asked me to immediately come in so he could see the lump. He thought I might have a blood clot. This lump was not present late last night because when I put lotion on my legs after my shower, I felt no lump or soreness. I worked out this morning and by 11:00, it seemed to me the lump was not as big as it was when I was getting dressed earlier this morning.
78 2021-01-22 itchy skin Severe itchiness from the waist up - head, behind ears, throat, shoulders, back and chest
78 2021-01-24 hives Patient developed generalized hives starting 2 dys after her shot with worsening of her generaliz... Read more
Patient developed generalized hives starting 2 dys after her shot with worsening of her generalized hives thru the 2 dys afterward
78 2021-01-25 itchy skin, rash rash which gotten bigger on the chest/rash around the side it has gotten bigger and now she is havin... Read more
rash which gotten bigger on the chest/rash around the side it has gotten bigger and now she is having them in other areas/rash around the left side on the arm; Very tired/Tiredness; Itching; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date: not known), via an unspecified route of administration on 07Jan2021 in the left arm at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) which she uses a nebulizer for this. There were no concomitant medications. The patient previously received first dose of BNT162B2 (lot number: EJ1685) on 18Dec2020 in the right arm for COVID-19 immunization. The patient reported that she was very tired, tiredness started on the same day as she received the second dose of the vaccine on 07Jan2021. The patient also developed a rash which gotten bigger on the chest, a rash around the side it has gotten bigger and now she was having them in other areas 3 days later (10Jan2021). The patient further explained that it also developed rash around the left side on the arm. The patient was using Cortizone cream over the counter and it relieved itching (started in Jan2021) but it didn't totally take it away. She still felt tired today. The patient had no positive tests for COVID and no antibody test before the vaccine. She had no issues with vaccine in the past. The outcome of the events was not recovered. Information on the lot/batch number has been requested.
78 2021-01-26 rash, skin warm Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All ... Read more
Progress Notes (Physician Assistant) ? ? Family Medicine Cosign Needed Expand All Collapse All Date: 1/25/2021 Subjective 78 y.o. male who was seen today for his first dose of the COVID 19 vaccination. He was given the Pfizer vaccination in the right deltoid muscle. During his 15 minute waiting period after the injection, the patient began to experience dizziness. He denied difficulty breathing and difficulty swallowing. This provider was notified of patient reaction and he was then assessed in the emergency bay area. Monitored patient for severe reaction symptoms, including but not limited to hypotension and rapid progression of symptoms. Patient ate a bowl of oatmeal this morning prior to receiving his vaccine. He has only drank a small amount of diet coke today, no water. He became dizzy when standing up and some while walking. He notes the dizziness resolved on his walk to the medical evaluation bay. ALLERGY REVIEW OF SYSTEMS: Patient complains of dizziness Patient denies chills, fever, facial swelling, chest tightness, shortness of breath, wheezing and headaches Previous Reactions: Denies Objective Vitals Vitals: 01/25/21 1150 BP: 133/86 Pulse: 84 SpO2: 97% Physical Exam Constitutional: Appearance: Normal appearance. HENT: Head: Normocephalic and atraumatic. Mouth/Throat: Comments: No swelling or lips or tongue. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulmonary: Effort: Pulmonary effort is normal. No respiratory distress. Breath sounds: Normal breath sounds. No wheezing or rales. Skin: General: Skin is warm and dry. Neurological: General: No focal deficit present. Mental Status: He is alert and oriented to person, place, and time. Psychiatric: Mood and Affect: Mood normal. Behavior: Behavior normal. Assessment/Plan Treatment included: water Follow up response to treatment: good. Patient discharge: Stable to go home and follow up with PCP. Differential Diagnosis: Systemic reaction (hypoglycemia, hypotension, generalized rash) Patients symptoms of dizziness completely resolved prior to discharge. He denied dizziness when standing up and walking to leave the medical evaluation bay. Electronically Signed 1/25/2021 12:02 PM
78 2021-01-26 rash Rash on right scapula
78 2021-01-27 injection site redness, injection site swelling initially next day had redness and swelling at site >3 inches around site, still red when speaking t... Read more
initially next day had redness and swelling at site >3 inches around site, still red when speaking today, but dizziness onset 1/28/2021 in the morning. Drinking plenty of fluids
78 2021-01-27 rash pt stated that she noticed pink rash on her back in between shoulders and down both arms to the elbo... Read more
pt stated that she noticed pink rash on her back in between shoulders and down both arms to the elbow.
78 2021-01-28 injection site pruritus, injection site redness, injection site swelling Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about ... Read more
Chills; feeling very hot; arm also swelled, about 3 inches around the site; arm also swelled, about 3 inches around the site/ it was red and itchy; arm also swelled, about 3 inches around the site/ it was red and itchy; she woke up in a horrible sweat; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1284, expiry date: 30Apr2021), via an unspecified route of administration upper arm probably only about 4inches down from shoulder blade on the left on 12Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included COVID on 01Oct2020. Concomitant medication included rivaroxaban (XARELTO) as blood thinner. The patient previously took a flu and shingles shot and experienced her redness and swelling on her arm. The patient did not have vaccinations four weeks prior, and no additional vaccines were administered on the same date. She got it because she was told by her doctor that her antibodies will not last forever and it was still necessary to get it even though she already had COVID antibodies. She contracted COVID on 01Oct2020, that was the date when she had a positive test then she was last tested in December and she still had the antibodies then. She received her first dose of the vaccine on Tuesday 12Jan2021 and 24 hours later on 13Jan2021, she experienced chills and feeling very hot, which she took Tylenol extra strength for and it disappeared the next day. Her arm also swelled, not the whole arm, she would say about 3 inches around the site, 4 inches at the most and it was still swollen, it was red and itchy. Then she woke up in a horrible sweat but by the following morning it was gone. She wouldn't say it was a horrible reaction but she wanted to be certain she can go ahead and get the second shot which she had an appointment for. She said everything has resolved completely except for the swelling, her arm was still swollen, itchy, and red. Since the swelling, redness and itchiness began she would say it was slightly better than it was. The patient received the vaccine at an independent assisted living facility, not a military facility. The adverse events did not require a visit to the emergency room or physician's office. Outcome of the events chills, feeling very hot and woke up in a horrible sweat was recovered on 14Jan2021, while the remaining events was recovering.
78 2021-01-28 skin burning sensation She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vacci... Read more
She has shrunk; weighs less. Maybe 154 pounds. She was 170; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; she got first dose of Pfizer COVID vaccine on Monday 04Jan2021/She will get the second dose on 01Feb2021; had congestion; Coughing; choking; body was more than hot it was burning/body turned very hot; could not sleep/two sleepless nights; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization, ciprofloxacin (CIPRO), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication and pirfenidone (ESBRIET), via an unspecified route of administration from an unspecified date at an unknown dose and frequency for an unspecified indication. Medical history included pulmonary fibrosis (diagnosed between 2007-2010), Lymphoma type B, blood pressure (abnormal), cholesterol (abnormal), vertigo, biopsy, tightening of legs and feet, drip (nasal) and pain. Concomitant medication included gabapentin for tightening of her legs and feet, diphenhydramine hydrochloride (BENADRYL) for drip (nasal) and meloxicam for pain. It was reported that the patient took the vaccine and had two sleepless nights on 05Jan2021, her body turned very hot but she have some conditions. Sleepless nights: they have been really rough nights. Scary. Coughing and choking. She thinks the vaccine kicked in and started beating the hell out of it. The patient clarified that she is having sleepless nights because of the coughing, choking, and burning and she feels that it is related to the vaccine kicking in. She slept last night, 14Jan2021. The cough is starting again today (as reported). She hopes it calms down. When she said her body was hot, like burning she was describing her sleepless nights. She is afraid. She is keeping in contact with her doctor. She figured she better call because more people are on this medication. The patient also experienced congestion on 06Jan2021. It was reported that the patient has shrunk and weighed less. Maybe 154 pounds. She was 170. The action taken for ciprofloxacin and pirfenidone was unknown. The outcome of the event congestion was not recovered, while unknown for the rest of the events.
78 2021-01-28 vaccination site swelling, vaccination site redness, vaccination site pain This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient rec... Read more
This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot no: EL0142), via an unspecified route of administration on 12Jan2021 at a single dose on the right arm because she doesn't want to get Covid. Medical history includes the patient being sick before she got the shot, she had the flu since an unspecified date in Dec2020 during Christmas time. She didn't feel well before. She thought it was Covid and her friend was also sick that time and did have Covid. She stated that her own symptoms were like the flu, no fever, just regular flu symptoms. There were no concomitant medications. The patient reported that got her first vaccine this past Tuesday, 12Jan2021. She has been fine, but her arm is quite red since an unspecified date in Jan2021, and was tender since 13Jan2021 but was not hurting. When she took off the band aid the next day to take a shower, everything was okay. On Thursday, 14Jan2021 when she woke up she noticed redness and it was tender. SHe added that her arm is quite red and tender to the touch. She was asking if she should put hear or ice on it or just leave it alone. She wanted to know if this was normal. She stated that she has had a dull headache since an unspecified date after receiving the vaccine. Her arm was also swollen on an unspecified date after receiving the vaccine and sore. The patient wants to know if there are any recommendations for treatment. The outcome of the event vaccination site erythema was not recovered, the outcome of the event vaccination site pain was recovering the outcome of the other events was unknown.
78 2021-01-29 skin irritation, redness, injection site redness Around 3PM about 7 hours later of shot The left side injection / problem left side of Face from c... Read more
Around 3PM about 7 hours later of shot The left side injection / problem left side of Face from cheek bone to jaw line redness , puffiness plus skin irritation chaffing . her left side of lip she complained of slight numbness it was suggested that if irritation take Tylenol which we did two over 4 hours before bed around 1AM took one Advil she was restless to go to sleep fearful finally around 3AM tired enough to fall asleep About 11AM called my niece Nurse Hospital she said take Benadryl but speak to DOCTOR First he said same thing did for about 4 days Swelling and Redness went down numbness lower lip still slight their now about 10 days later acceptable feeling still wondering why??
78 2021-01-29 vaccination site swelling, injection site redness, vaccination site pain Debilitating pain and swelling at vaccination site with a ring around the shot. Pain then transferr... Read more
Debilitating pain and swelling at vaccination site with a ring around the shot. Pain then transferred to other arm with body aches and low grade fever. Pain at shot site duration was 10 days with no relieving factors.
78 2021-01-30 itchy rash, rash Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt dev... Read more
Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17 Rapid response team arrived at 427pm. 429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.
78 2021-01-31 vaccination site pain, vaccination site warmth, vaccination site itchiness, vaccination site redness Around the site of injection, it was like a red circle like a size of an inch; I felt like a little ... Read more
Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; Around the site of injection, it was like a red circle like a size of an inch; I felt like a little warm to me; She didn't know what but it is itchy, it hurts or a combination of both; She didn't know what but it is itchy, it hurts or a combination of both; My arm hurts/her arm felt like a little sore; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3246) via an unspecified route of administration, on 06Jan2021 at single dose for covid-19 immunisation. Medical history included high blood pressure. Concomitant medications included metoprolol and lisinopril, both for high blood pressure. Patient stated that she got the Pfizer vaccine on 06Jan2021. The regular reaction to it like her arm hurts and that was it, it lasted like for three days and it went away. Not yesterday, but the day before (15Jan2021), her arm felt like a little sore. Yesterday (16Jan2021), when she was in the showering, she noticed that the around the site of injection, it was like a red circle like a size of an inch that was (sentence incomplete). She felt like a little warm to her. She didn't know what but it was itchy, it hurt or a combination of both, it didn't bother her unless she touched it or rubbed against it but it was there. So, she just wanted to know whether that was a reaction to the injection or what that was, is that common or is that not common. Patient said she still felt it. As treatment, patient took a paracetamol (TYLENOL). She took one paracetamol this morning (17Jan2021) and one yesterday (16Jan2021). Outcome of arm hurts/arm felt like a little sore was recovered, outcome of other events was not recovered.
78 2021-02-01 injection site pain she had a wave that started at the top of her head and felt like she was losing consciousness and th... Read more
she had a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest; Chest tightness; like she was going to faint or go to sleep; like she was going to faint or go to sleep; she barely had a little pain at the COVID-19 Vaccine injection site that went away quickly; This is a spontaneous report from a contactable consumer, the patient. This 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249), dose 1 , single dose via an unspecified route of administration in the left upper arm on 08Jan2021 at 09:15 AM (at the age of 78 years-old) for COVID-19 vaccination. Relevant medical history included ongoing high blood pressure in Dec2020. Concomitant medications included valsartan (DIOVAN) 160mg tablet, once a day from 10Dec2020 and ongoing for high blood pressure and clobazem (CALM) from Jan2021, lot: 1115941, expiration: Mar2022. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 08Jan2021 at 09:15 AM, the patient barely had a little pain at the COVID-19 vaccine injection site that went away quickly. On 18Jan2021, the patient had chest tightness and a wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head and into her chest. She said it was like she was going to faint or go to sleep. She said the wave went down to her chest area and stayed for a big portion of the day. She said she had a heaviness in her chest, clarified as a chest tightness. She said she has no heart issues. The patient still had some tightness in her chest and it may be just from worry. She said she was normally calm, so she was not sure about what was causing her current chest tightness. The patient did not think what she experienced on 18Jan2021 was serious enough to contact her primary care doctor. There were no relevant laboratory tests done. The patient did not require a visit to the emergency room or physician's office. The clinical outcome of event, barely had a little pain at the COVID-19 vaccine injection site was recovered on an unknown date in Jan2021. The clinical outcome of event, wave that started at the top of her head and felt like she was losing consciousness and the wave went down her head was recovered on 18Jan2021 after treatment was given. The clinical outcome of chest tightness was recovering after treatment was given. The clinical outcome of like she was going to faint or go to sleep was unknown.
78 2021-02-01 itchy skin, rash [Pfizer covid -19 vaccine] treatment under Emergency Use Authorization(EUA): Patient in clinic for 2... Read more
[Pfizer covid -19 vaccine] treatment under Emergency Use Authorization(EUA): Patient in clinic for 2nd dose of covid vaccine. Within 8 minutes of receiving her injection, pt developed a rash on both arms; pt states both arms are itch and her throat felt as if it were closing. Rapid response called and patient was given Epinephrine per anaphylaxis protocol by LPN at 4:26pm. BP-146/98 p88 R17 Rapid response team arrived at 427pm. 429pm: Assessment: patient stable but felt no improvement in her throat. Pt was transported to ED for assessment.
78 2021-02-01 rash Patient received Shingles Vaccine on 01/6/2021 and COVID-19 Vaccine on 01/26/2021. Pt began with ras... Read more
Patient received Shingles Vaccine on 01/6/2021 and COVID-19 Vaccine on 01/26/2021. Pt began with rash on 01/27/2021, rash is located on the center of her back. She began with pain on 01/26/2021 in the morning, reports her pain is located beneath her armpit radiating both toward the front and back
78 2021-02-03 shingles broke out in shingles on opposite side; This is a spontaneous report from a contactable consumer (pa... Read more
broke out in shingles on opposite side; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received her first dose of bnt162b2 (BNT162B2 also reported as Pfizer Covid vaccine, lot EL9261), via an unspecified route of administration on 15Jan2021 11:00 at SINGLE DOSE for Covid-19 immunisation. Medical history included blood cholesterol increased and high blood pressure. She takes other stuff for cholesterol and high blood pressure. The patient experienced broke out in shingles on opposite side on 15Jan2021. She was treating it with a steroid shot and taking acyclovir, 5 a day for 7 days and also methyl prednisone and it is a packet and takes 6 a day. Her doctor also gave her a compound to rub on it. The outcome of event was not recovered.
78 2021-02-03 itchy skin severe itchiness from waist up - behind ears, head, back, neck, shoulders; This is a spontaneous rep... Read more
severe itchiness from waist up - behind ears, head, back, neck, shoulders; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE;lot EL9261) on 21Jan2021 at 12:45 at single dose in Left arm for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), asthma, osteopenia/porosus and sulfa allergy. Patient was not pregnant. Concomitant medication included fluticasone propionate (FLONASE); nitrofurantoin (MACRODANTIN); alendronate sodium; budesonide/ formoterol fumarate (SYMBICORT); dupilumab (DUPIXENT) from12Jan2021. On 22Jan2021 the patient experienced severe itchiness from waist up - behind ears, head, back, neck, shoulders. Case is reported as non serious. No treatment administered for the adverse event. Outcome of the event was not recovered.
78 2021-02-03 skin discolouration Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, ... Read more
Approximately 10 minutes after receiving the COVID- 19 vaccine resident displayed seizure activity, staring straight ahead and strong allover muscle jerking of both the up and lower extremities, color became gray, activity lasted approximately 3 minutes, resident then became relaxed, color returned to normal, BP-140/80, 97.8, 60, 16, sleeping the remainder of the shift,. Resident continued to decline until resident CTB on 1/19/21
78 2021-02-03 skin warm, redness About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her f... Read more
About 7-10 minutes after receiving the shot, patient started to feel extremely shaky and warm. Her face turned red and hands were shaking. Patient felt her heart skipping with irregular heart beats. The nurse measured the patient's blood pressure and it was 183/95 with a pulse of 104. The patient was observed for an hour.
78 2021-02-04 dry skin, skin warm view 2/5/2021 09:23 e Progress Note Note Text: Patient passed away in the facility this morning.... Read more
view 2/5/2021 09:23 e Progress Note Note Text: Patient passed away in the facility this morning. view 2/5/2021 08:39 Orders - Administration Note Note Text: Resident passed. view 2/5/2021 08:33 Nurses Note Note Text: Body released to funeral home at this time. Personal effects sent with resident include: 1 pair of glasses, 1 yellow wedding band, 1silver spoon ring, 1 ring with black and clear stones. Resident has own teeth view 2/5/2021 08:32 Nurses Note Note Text: cause of death per CRNP failure to thrive. view 2/5/2021 07:44 Orders - Administration Note Note Text: Take and document temp & PO2 every 4 hours for MONITORING Resident passed. view 2/5/2021 06:49 Nurses Note Note Text: Son returned call and was updated of resident's passing this am view 2/5/2021 06:33 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Unknown Resident expired @ 0604 [linked] view 2/5/2021 06:06 Nurses Note Note Text: Res found without pulse or respirations. Pronounced at 0604. Updated. N/o's for RN to pronounce, release body to funeral home, dispose of medications per facility policy. Daughter updated. Funeral Home called to release body. view 2/5/2021 05:26 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Pulse ox 60% on O2 @ 5L/min via mask. Resps 44 per minute. view 2/5/2021 01:57 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/5/2021 00:52 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger Residents resps are 40 per minute, pulse ox 76% on O2 @ 5L/min via mask. Resps are labored, shallow and rapid. view 2/5/2021 00:48 Nurses Note Note Text: Nonresponsive to verbal and tactile stimulation. Appears comfortable. view 2/4/2021 22:01 Nurses Note Note Text: Resident resting comfortably, breathing becoming increasingly shallow, wearing O2 via mask at 5L via mask, no dyspnea noted, feet are mottled, oral and peri care provided Q2H. No s/s of pain or discomfort. view 2/4/2021 21:40 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger PRN Administration was: Effective [linked] view 2/4/2021 19:32 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 2 hours as needed for pain/air hunger medicated for air hunger, RR 28 to 32/ min view 2/4/2021 19:22 Nurses Note Note Text: Daughter updated on N/O to increase Morphine Sulfate 20mg/mL 0.25mL to Q2H prn from Q6H prn. view 2/4/2021 18:06 Nurses Note Note Text: POA Daughter and daughter aware of residents current condition. view 2/4/2021 11:58 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective Follow-up Pain Scale was: 2 [linked] view 2/4/2021 11:13 Nurses Note Note Text: Pt. noted to be lethargic at this time. Does respond to verbal and tactile stimuli by opening her eyes but non verbal currently. Skin warm and dry. No mottling or apnea observed at this time. O2 sat 88% with O2 at 2 LPM via n/c. On increased to 3 LPM via mask as pt. noted to be mouth breathing. Respirations 28. F/U O2 sat 93%. HOB elevated. Pt. medicated with morphine by LPN. Daughter updated on pt.'s condition. Does not want pt. sent out to hospital and would like comfort measures to continue. Daughter also in agreement with delay in d/c d/t pt.'s condition.CRNP updated on pt.'s condition, delay in d/c and daughter's wishes. No n/o's at this time. view 2/4/2021 10:56 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB Resident showing s/s of discomfort. SOB at this time and high respirations. Repositioned, changed for incontinence care and mouth care provided. view 2/4/2021 10:34 Progress Note Note Text: Spoke with RN regarding change in condition. Updated Sr Living regarding change. Recommendation to cancel d/c/transfer for today, see how resident does through the weekend and re-evaluate on Monday. Daughter updated on cancellation of d/c today. view 2/4/2021 10:04 Nurses Note Note Text: Daughter aware that resident's O2 sat was 88% on room air on 3-11 shift and that oxygen was applied via nasal cannula. view 2/4/2021 10:03 Nurses Note Note Text: N/O: Discharge 2/4/21 with scripts to Sr. Living. Daughter aware. view 2/4/2021 09:53 Nurses Note Note Text: Pt. to be d/c'd to another facility this am as per MD order. Pt. alert and responsive. Skin assessment done as per facility policy. No pressure areas noted at this time. No s/sx of pain or discomfort observed at this time. V.S. 97.0 67 20 O2 sat 95% with O2 at 2 LPM via n/c. view 2/4/2021 07:45 Nurses Note Note Text: Resident seen by Dr. for discharge. Orders pending at this time. view 2/4/2021 07:36 Nurses Note Note Text: CRNP and Dr. updated on O2 sat 88% on RA with f/u of 93% with O2 on at 2 LPM as well as rest of VS, 3-11 shift 2/3/21. No n/o's at this time. view 2/3/2021 21:17 Nurses Note Note Text: Resident Sp02 88% on RA. Pulse 124. Respirations 40. PRN morphine given and O2 applied via NC at 2L/min. After recheck pulse ox up to 93%, pulse 100, and respirations 22. Resident appears comfortable at this time. view 2/3/2021 20:05 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN Administration was: Effective [linked] view 2/3/2021 19:48 Orders - Administration Note Note Text: Morphine Sulfate (Concentrate) Solution 20 MG/ML Give 0.25 ml by mouth every 6 hours as needed for pain/SOB PRN given for SOB after elevation of HOB not effective. view 2/3/2021 11:51 Nurses Note Note Text: CRNP updated rapid COVID test done for d/c tomorrow was negative. No n/o's at this time. view 2/3/2021 11:44 Nurses Note Note Text: Daughter notified of rapid covid swab being negative. view 2/3/2021 09:50 Orders - Administration Note Note Text: Obtain Rapid Covid test on 2/3/2021 for discharge. Please give copy of results to Social Worker every day shift for covid testing for 1 Day Completed and negative. view 2/3/2021 08:45 Skilled Nursing Note Reason for skilled service: Therapy describe skilled service: Nursing, therapy assessment: V.S. 97.8 79 18 138/84 Orientation: Oriented to self only. Oxygen: O2 sat 94% on RA Edema: Trace edema noted BLE. Pedal pulses present. Pain: Denies pain or discomfort at this time. Nursing note: Pt. alert and responsive. Skin warm and dry. Lung sounds diminished. No respiratory distress observed at this time. Abdomen soft. BS+ in all 4 quads. Continent/Incontinent of B&B. 1 assist with ambulation, transfers. 1 assist with ADL's. Working with therapy on gait training, therapeutic exercise, therapeutic activities & neuromuscular reeducation. view 2/2/2021 14:37 Progress Note Note Text: Per health professional at Sr Living, prepared to accept patient to their Memory Care Unit 2/4. Transportation arranged for 11 AM per family request. Daughter (POA) updated on d/c time on 2/4/21. Facility requesting rapid COVID test completed prior to d/c and results sent to them. All other information sent for continuity of care.
78 2021-02-04 injection site rash Rash at injection site
78 2021-02-07 redness, skin peeling About 10 minutes after receiving the covid vaccine, I developed a red flush on my face which was bri... Read more
About 10 minutes after receiving the covid vaccine, I developed a red flush on my face which was bright, hot and uncomfortable. The flush appeared nowhere else on my body so I concluded that the vaccine must have interacted with the tretinoin cream I use nightly. That is the only area of my skin on which i apply the cream. When I got home, I applied soothing skin cream but no relief. I then tried aloe, which grows in the area, and the flush/burning abated somewhat. The next day, my face was still flushed but less red. the skin surface was scaly. I am continuing to treat at home. No MDs involved.
78 2021-02-07 itchy skin, hives welts/ she has had welts before in the past/welts on right and left arm, Left shoulder, Right buttoc... Read more
welts/ she has had welts before in the past/welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs; welts/she has had welts before in the past/welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs; Itching; This is a spontaneous report from a contactable consumer. a 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283, expiration date: 30Apr2021, NDC number: 5926710001) on 14Jan2021 at right arm at single dose for covid-19 immunization. Medical history included Welts. Concomitant medication was not reported. Caller is a Pharmacy Tech and a patient had the first dose of the Covid 19 vaccine and had itching (15Jan2021) and whelps (17Jan2021). She would like to know if these are normal side effects and if the patient can get the 2nd dose. Pharmacy Technician is calling about the Covid Vaccine. It was administered to a patient and the patient experienced an AE. Pharmacy Technician clarifies that she is calling on behalf of the patient. She started itching a little on Friday 15Jan2021, then Sunday she started getting welts that were the size of pencil erasers to a dime. She would take Benadryl and when she took it, she was fine for 24 hours. Then welts every day, in different areas, she had the welts on right and left arm, Left shoulder, Right buttocks fold, and both lowers legs. The added that she has had welts before in the past but she was not sure what caused them in the past. Reporter does not know if the itching and welts are still ongoing or when it stopped. The Patient did state that Itching went away with Benadryl however reporter does not know when or if that is still the case. Not sure when it stopped. Patient didn't provide end dates or if the adverse events ended. The Patient did not list any allergies. When queried if the patient had any positive covid or antibody test prior to the vaccine, caller states that all of the patients that they vaccinated, they ask them if they had any positive test within 90 days, all stated no, if they state, they do not give the vaccine and make then wait. Caller asks if there is any information about if these side effects are normal, as well as if the patient is still able to receive the second dose. the last outcome of the events was unknown. It was reported as non-serious.
78 2021-02-07 rash Off and On High Fever (102.7) with sever chills, nausea, fatigue lasting six days. Chills stop, low ... Read more
Off and On High Fever (102.7) with sever chills, nausea, fatigue lasting six days. Chills stop, low grade fever continue for three more days, rash appears on my neck, back and front of my body. Doctor insist I get a Covid 19 test. It came back negative. This was my first pfizer vaccine.
78 2021-02-08 injection site swelling, injection site bruising swelling and significant bruise at injection site; swelling and significant bruise at injection site... Read more
swelling and significant bruise at injection site; swelling and significant bruise at injection site; This is a spontaneous report from two contactable nurses. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular into the left arm on 21Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant drugs were none. The patient developed swelling and a pretty significant bruise where the injection was given in her left arm. The caller noticed the bruise and swelling on 25Jan2021 but states it could be older. The events were reported as medically significant. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: A causal association between administration of BNT162B2 and the onset of vaccination site swelling and bruise cannot be excluded, considering the temporal association and the known adverse event profile of the suspect product.
78 2021-02-10 redness Bilateral upper arms reddened, swollen and pain resident also presented with a temperature. No trea... Read more
Bilateral upper arms reddened, swollen and pain resident also presented with a temperature. No treatment rendered for the localized reaction however antipyretic medication given and resolution of temperature achieved. Primary care physician ordered allergy to the COVID-19 vaccine.
78 2021-02-10 injection site redness Site: Redness at Injection Site-Mild
78 2021-02-10 injection site pain Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better. I lite... Read more
Exhaustion onset about 8:00 PM 1/26/21 lasting over 36 hours before starting to feel better. I literally slept all of the next day only getting up occasionally and most of the day after that. I started to become more normal feeling the late afternoon of 1/28/21. I also felt very stiff and uncomfortable. Sore neck and joint pain and a slight headache. I had a sore area across my arm (felt like a bruise although there was no discoloration) about 1 inch inch below the injection sight which was on my upper left arm. That persisted for several days. I slept and took 1 800 mg Ibuprofen (on 1/27/2021). Am feeling better but still not feeling 100 %. That may be due to increased allergies due to time of year of etc a
78 2021-02-10 itchy skin, rash Slight rash. Some itch neck? Chest
78 2021-02-10 vaccination site warmth, vaccination site pain, vaccination site redness she had quite a rash, it was red, right where the injection was made; it was warm; her arm was hurti... Read more
she had quite a rash, it was red, right where the injection was made; it was warm; her arm was hurting a bit; slight headache; This is a spontaneous report from a contactable consumer (patient) and contactable physician. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263), via an unspecified route of administration at arm left on 22Jan2021 at single dose for COVID-19 immunization. The patient medical history included COVID-19 (with symptoms: terrible headache, cough, shortness of breath for good 6 weeks and fatigue) from Nov2020 to an unknown date. The patient experienced slight headache on 23Jan2021, her arm was hurting a bit on 25Jan2021. On 26Jan2021, her arm was still sore, it was warm, she had quite a rash, it was red, right where the injection was made, the rest was more pink. The patient outcome of headache was recovered on 24Jan2021, the outcome of the other events was not recovered.
78 2021-02-11 rash, itchy skin Slight swelling, rash and itching on my face.
78 2021-02-12 hives Pt c/o hives on face. Benadryl 25mg was given po. EMS evaluated patient and pt declined to go to... Read more
Pt c/o hives on face. Benadryl 25mg was given po. EMS evaluated patient and pt declined to go to ER.
78 2021-02-13 redness, itchy skin The right arm started itching on2/13/2021. It was a little redish, itched was why I noticed it. Am g... Read more
The right arm started itching on2/13/2021. It was a little redish, itched was why I noticed it. Am going to see my Health car doctor Monday 2/15/2021. I have filled this out as best I know how. I have had no pain, no syptoms of any thing else. Just the itch swelling .
78 2021-02-14 injection site bruising Back of Lower arm of injection site has bruising. Still appears a week after vaccine.
78 2021-02-14 injection site pruritus Severe exacerbation of fibromyalgia for 3 days and itching at the injection site
78 2021-02-14 injection site warmth, injection site pruritus, injection site swelling, injection site redness Developed red, swollen area around injection site, approximately 3?X3?. Site is warm to touch and pe... Read more
Developed red, swollen area around injection site, approximately 3?X3?. Site is warm to touch and per patient is ?itchy?. Denies any pain, muscle aches, fever or headache.
78 2021-02-16 blister blister developed on left foot 4 hours after 1st vaccine 01/25/2021. blister formed on left great t... Read more
blister developed on left foot 4 hours after 1st vaccine 01/25/2021. blister formed on left great toe 4 hours after 2nd vaccine 02/15/2021
78 2021-02-17 redness My Mom had an an allergic reaction four hours after receiving her first dose of the Pfizer Covid 19 ... Read more
My Mom had an an allergic reaction four hours after receiving her first dose of the Pfizer Covid 19 vaccine. Her face swelled up and became red....worse on the right side than the left...her eyes were swollen as well. It lasted this way for four days....it is a little better now, but her face is still a little swollen (seven days after shot). She had a headache on and off and felt tired (which we understand is not an allergic reaction, but rather an immune response). Her family physician suggested taking antihistamines before her second shot. Needless to say, we are apprehensive about what the outcome from the second shot will be like for her.
78 2021-02-17 shingles Had CoVid vaccine #1 1/22/21 - felt fine. 2/5/21, eyes became swollen and red - called her eye Dr, w... Read more
Had CoVid vaccine #1 1/22/21 - felt fine. 2/5/21, eyes became swollen and red - called her eye Dr, who met her after hours at his clinic and diagnosed with shingles. She does not remember ever having chicken pox but states she might have forgotten. She called MC to inform us she could not return 2/11/21 for her second vaccination d/t the shingles. We also had a second person vaccinated the same day that also called with shingles so decision was made to enter this variance report.
78 2021-02-17 injection site redness, injection site pain Pain and redness at injection site 8 days after vaccine. Lasted for days 8, 9, and half of 10.
78 2021-02-17 injection site swelling Exp. Date 6/30/2021. Unable to lift my left arm higher than my shoulder, swelling of upper left arm,... Read more
Exp. Date 6/30/2021. Unable to lift my left arm higher than my shoulder, swelling of upper left arm, tiredness.
78 2021-02-17 rash (Registered Nurse) Pt reports a rash developed the next day after receiving her first Pfizer vacc... Read more
(Registered Nurse) Pt reports a rash developed the next day after receiving her first Pfizer vaccine, occurring across her midsection of abdomen. It lasted for 2 weeks. No other problems with the vaccination. Reports that her physician recommended that she continue with second dose as scheduled.
78 2021-02-19 injection site pain 1. Immediately had very unpleasant metallic taste in mouth. 2. Five to ten minutes after injection... Read more
1. Immediately had very unpleasant metallic taste in mouth. 2. Five to ten minutes after injection had very severe headache. After returning to car, took 2 extra strength (500 mg) rapid release Tylenol. Headache lasted 5/6 hours. 3. Soreness around injection site for 2 1/2 days.
78 2021-02-19 injection site pain Swelling. And pain injection site, severe muscle pain whole body
78 2021-02-21 hives On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and ... Read more
On 2/19/2021, 78yr old female with history of asthma, diverticulitis, GERD, hiatal hernia, HTN, and hyperlipidemia was administered second dose of COVID-19 Pfizer vaccine 0.3mL in left deltoid (LOT # EN6201). Patient has several documented allergies including dextromethorphan (anaphylaxis), guaifenesin (anaphylaxis), olmesartan (itching), erythromycin (unknown), hydrocodone (unknown), atorvastatin/pravastatin/rosuvastatin (muscle pain), codeine (throat swelling), shrimp (hives, itching). Patient received first dose of COVID-19 Pfizer vaccine on 1/27/21 without any documented issues. Patient initially tolerated injection without incident and was sent for post-injection 15min observation. During 15min observation period, patient became dizzy, diaphoretic, nauseated, and unable to walk with steady gait, hypertensive and endorsed hives. EMS called and patient sent to ED. During initial presentation to ED, BP 180/80, HR 85, and 97% on RA. Patient given Benadryl 25mg PO and ondansetron 4mg IVP at 2055. 1L LR bolus given at 2059. BP lowered during ED observation (BP 160/80 on 2/20 at 0442). Acetaminophen 650mg PO given at 0442 prior to discharge. Patient discharged home in stable condition ~ 0500 on 2/20 with plan for patient to follow up with outpatient provider. EpiPen was not prescribed at discharge. No update to EPIC allergies noted at this time. Of note, reporter notes unable to check POC BG at clinic (glucometer unavailable). Patient has no history of diabetes, but noted that has similar "episodes" with low BG. EMS checked BG (POC = 144).
78 2021-02-22 redness 1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand a... Read more
1/12/21 er HPI: HPI 78 y.o. female who presents with pain swelling and redness left wrist and hand associated with fever according to EMS, but temperature in the ER is 98.4° F. patient was said to have fallen on 1/7/2021. *incidental finding bacterial pne* 1/12/21 admission History: The patient is a 78 y.o. female with a past medical history notable for Dementia, atrial fibrillation, CHF, diabetes, reflux. The patient presents for evaluation of Worsening issues of decline and trouble with breathing. Patient was evaluated the ER and found to have a urinary tract infection in addition to pneumonia. Due to patient's dementia history is difficult to take outside of history of which was taken for patient's nursing staff at skilled care facility. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed
78 2021-02-22 hives, rash Developed urticaria within 2 hours of vaccine. Rash began on chest and spread to her neck and on her... Read more
Developed urticaria within 2 hours of vaccine. Rash began on chest and spread to her neck and on her face.
78 2021-02-24 redness I have osteoarthritis, with Heberden's nodes on all of my fingers. 3 days ago the two nodes on the... Read more
I have osteoarthritis, with Heberden's nodes on all of my fingers. 3 days ago the two nodes on the most affected finger (and the first that showed the arthritis) turned bright red. Now the whole joint is red and a few of the other nodes have turned red. Except for binding the first finger with the hope it would help (it didn't), I'm not treating them, since of course one can't do anything about osteoarthritis except ease the pain.
78 2021-02-24 injection site redness, itchy skin A couple of days after receiving 2nd shot my arm was a little sore and then began to itch. Then I go... Read more
A couple of days after receiving 2nd shot my arm was a little sore and then began to itch. Then I got a round red spot on my arm at the injection site. It continued to spread and get bigger
78 2021-02-25 vaccination site redness, vaccination site swelling Swelling, which is hard like an egg, at the injection site; Redness at the injection site; Very leth... Read more
Swelling, which is hard like an egg, at the injection site; Redness at the injection site; Very lethargic; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry date unknown), via an unspecified route of administration at the age of 78 years, on 22Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included ongoing type 2 diabetes mellitus, ongoing urinary tract infection, hyperparathyroidism from 21Jan2021 and ongoing, ongoing osteopenia, ongoing meningioma, seizure from an unknown date and unknown if ongoing. The patient received the first dose on 02Jan2021. On 23Jan2021, the patient experienced swelling, which was hard like an egg, at the injection site and redness at the injection site. The patient was also very lethargic on an unspecified date. No treatment was received for the events. The outcome of the event lethargic was unknown while other events were not recovered. Information on the Lot/Batch number has been requested.
78 2021-02-27 itchy skin, rash, redness, rash macular Red; blotchy rash on back, front, neck, upper arms . Itchy
78 2021-02-28 itchy skin itching, swelling and rash in the genital and anal area, itchy also on her legs, was sore in the glu... Read more
itching, swelling and rash in the genital and anal area, itchy also on her legs, was sore in the gluteus area Has not seen the doctor yet (2/26/2021)
78 2021-02-28 rash medical history of arthritis treated with cortisone; medical history of arthritis treated with corti... Read more
medical history of arthritis treated with cortisone; medical history of arthritis treated with cortisone; Rash on her face/rash on the cheek; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history included ongoing arthritis in her knee (for 7-8 years) and blood pressure high but so far so good. Concomitant medication included cortisone for arthritis in her knee. The patient previously had cortisone shot for arthritis and experienced rash on her face. On 14Jan2021, patient got the first vaccine dose and had rash on her face/rash on the cheek. Her next one is due 04Feb2021. The outcome of the events was unknown. Information on Lot/Batch number has been requested.
78 2021-02-28 vaccination site swelling, vaccination site mass, vaccination site pain Swollen at the injection site; Lump on Left Arm; Left arm was painful /it was painful to the touch/i... Read more
Swollen at the injection site; Lump on Left Arm; Left arm was painful /it was painful to the touch/it more like a numb dull pain; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3246; Expiration Date 28Jan2021), via an unspecified route of administration in the left arm on 26Jan2021 12:15 (at the age of 78-years) as a single dose for COVID-19 immunization. There was a no medical history. The patient's concomitant medications were not reported. The patient received the vaccine on 26Jan2021 and in the evening her left arm was painful, she could not sleep on the arm. On 27Jan2021, before she took a bath, she still had the band aid on and it was still hurting a little, the area was swollen at the injection site, it was painful to the touch, she could feel a lump on the left arm, she still could not sleep on the arm. On 28Jan2021 the swelling went down and was still painful, but it was not a sharp pain, it more like a numb dull pain, she was calling to ask if that is normal. The patient treated herself with paracetamol (TYLENOL) prophylactically 2 hours prior to vaccination and on an unspecified date rubbed some alcohol on the injection site. The swelling was reported as just a little. The lump was completely gone but she still felt the dull pain. The clinical outcome of the event left arm was painful and swollen at the injection site was recovering; and lump on the left arm was recovered on 27Jan2021.
78 2021-02-28 vaccination site warmth, vaccination site redness, vaccination site itchiness she has been shrinking; the COVID-19 Vaccine injection site was a little itchy, red, and hot when sh... Read more
she has been shrinking; the COVID-19 Vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on 15Jan2021; the COVID-19 Vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on 15Jan2021; the COVID-19 Vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on 15Jan2021; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number 61R84), via an unspecified route of administration on 14Jan2021 at 12:00 (at the age of 78-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included macular degeneration from an unknown date (for which patient received macular degeneration shot in her eye on 11Jan2021. The shot was the medication "Elyce"), high blood pressure and thyroid condition (both for which patient takes unspecified medications) and bad back for which patient received epidural (unspecified medication) on 13Jan2021. Concomitant medications Elyce (as reported) for macular degeneration, epidural (unspecified medication) for back pain, and unspecified mediations for high blood pressure and thyroid condition. The patient did not receive any other vaccines within four weeks prior to the vaccination and had no additional vaccines administered on the same date of the vaccination. On 15Jan2021 the patient experienced vaccine injection site was a little itchy, red, and hot when she first noticed the adverse reaction on the second day, 15Jan2021. She said the COVID-19 Vaccine injection site stayed warm and itchy for 3 days. She said she noticed the red spot was still at the COVID-19 Vaccine injection site this morning, and asked does she need to worry about the red spot. She clarified the redness at the vaccine injection site is a half circle, and the vaccine injection site is not burning or itching. The patient did not receive any treatments for the vaccine injection site was a little itchy, red, and hot> The patient stated she "has been shrinking" from an unknown date. The patient also reported she has a history of a bad back and she had an epidural the day before getting her first COVID-19 Vaccine dose. She clarified she had the epidural on 13Jan2021. The patient stated she does not have the epidural medication name, dose, NDC, Lot and Expiration Date, since the epidural was given at the orthopedist's office. She said she received a notice from her orthopedist, who administered the epidural on 13Jan2021, stating that Pfizer recommended not to have an epidural when having the COVID-19 Vaccine because the epidural may not be as effective. She said she is not going to go back for her second epidural with the orthopedist, but plans to have her second COVID-19 Vaccine dose. She clarified that the letter from her orthopedist stated she can schedule her next epidural a week after receiving the COVID-19 Vaccine. The patient stated she was more concerned about getting her second dose of the COVID-19 Vaccine than getting a second epidural with her orthopedist. The patient reported she still had a half dollar sized red mark at the COVID-19 Vaccine injection site. The clinical outcomes of the vaccine injection site was a little itchy, red, and hot were recovering. The outcome of the event she has been shrinking was unknown.
78 2021-03-02 rash, itchy skin, redness, shingles I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stom... Read more
I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; I started really scratching and it's really is pink red pumps on my stomach; it spread my whole stomach, then over the breast and under the arm, around my back; rash; Blood sugar was very high; Blood pressure was very high; I had shingles on it; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 29Jan2021 (at 78-year-old) at single dose for COVID-19 immunization (Because she was of that age and she wanted to travel again). Medical history included ongoing Diabetic. There were no concomitant medications. Reason for no lot number of COVID 19 Vaccine, consumer stated, "It says Pfizer, EL9267, no 62, I am not sure now. Maybe I think it says 2, it's a 2." She woke up at 1 in the morning and started really scratching (31Jan2021) and it's really is pink red pumps (31Jan2021) on her stomach. It started to spread in the whole stomach, then over the breast and under the arm, around her back. She had the reactions. It was a total rash (31Jan2021) and red. She took her blood sugar, she was diabetic, her blood sugar was very high (Jan2021), then she took her blood pressure, her blood pressure was very high (Jan2021). She was all ready to go to the hospital because when you have a rash that's not good. But now 3 hours later her rash disappeared and she felt much better again. When confirmed if the consumer wanted to report the same or have some questions, consumer stated, that she have question, why did she get the rash after she had the COVID vaccine, she had her shot on Friday, Pfizer shot vaccine on Friday. She stated that she felt better, she only have a little bit in her back itching. But everything else it was so red, she meant she had shingles (Jan2021) on it. It's the hospital who gave her the shot. Due date for the next shot was on 19Feb2021. It was stated that she is Diabetic, she don't take any medication, she did it on her own and she is border lined. On lab work, consumer stated that every half a year she had a blood test. Regarding treatment, the consumer stated that she didn't take anything, she was wondering if she was allowed to take anti-histamine. The outcome of the event Itching and Redness was recovering, rash was recovered, while other events was unknown. Information on the lot/batch number has been requested.
78 2021-03-02 vaccination site pain some soreness in left arm; This is a spontaneous report from a contactable consumer (patient). A 78... Read more
some soreness in left arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9261), via an unspecified route of administration on 25Jan2021 at 13:45 at a single dose on the left arm for COVID-19 immunization. Medical history included high blood pressure and a-fib (atrial fibrillation) both from an unknown date and unknown if ongoing. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medication included lisinopril (LISINOPRIL), amlodipine (AMLODIPINE), atenolol (ATENOLOL), apixaban (ELIQUIS). Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced some soreness in left arm next day, 26Jan2021. The patient did not receive any treatment for the event. The outcome of the event was recovered. The event was reported as non-serious.
78 2021-03-02 vaccination site pain Very mild soreness at the injection site; Very Mild fatigue; This is a spontaneous report from a non... Read more
Very mild soreness at the injection site; Very Mild fatigue; This is a spontaneous report from a non-contactable consumer (female patient). A 78-year-old female non pregnant patient received second dose of bnt162b2 (Formulation: Solution for injection, Lot number: em9809) via unspecified route of administration on left arm, on an unknown date at single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously took historical vaccine, first dose of bnt162b2 for COVID-19 immunization. It was reported that the patient experienced very mild soreness at the injection site and very mild fatigue on 08Feb2021. The patient administered most recent COVID-19 vaccine at doctor's office/urgent care, had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medication (unspecified) within 2 weeks of vaccination (as reported). The patient didn't receive treatment for the adverse events. The patient had not diagnosed with COVID-19 prior to vaccination and since the vaccination. It was reported that patient had no allergies to medications, food, or other products. The seriousness of the events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021. No follow-up attempts are possible. No further information is expected.
78 2021-03-03 itchy skin, rash rash upper arms; Itching; This is a spontaneous report from a contactable consumer. A 78-year-old fe... Read more
rash upper arms; Itching; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on the left arm, at the age of 78 years, on 20Jan2021 at a SINGLE DOSE for covid-19 immunisation. Medical history included diabetes mellitus from 1980 to an unknown date and rheumatoid arthritis from 1980 to an unknown date. The patient's concomitant medications included an unspecified flu shot in Nov2020. The patient experienced some rash in the upper arm and itching on 20Jan2021 which has gotten better (she added that she did not take anything medical for this, just a night cream). She added that she was allergic to epinephrine which she mentioned during her first shot. She was asking if it was okay to proceed with the second dose. The patient said that she got the first dose injected on January 20th to her left arm, and that evening she had the rash. She says she didn't really treat the rash, she just used cream for the itching. She says the rash was that she broke out on the upper part of both of her arms. She says that the itching did get better. Therapeutic measures were taken as a result of itching (pruritus). The outcome of the events was unknown.
78 2021-03-03 hives PT received 2nd dose of Pfizer at 1730. PT presented with hives down her arms in the observation ro... Read more
PT received 2nd dose of Pfizer at 1730. PT presented with hives down her arms in the observation room and EMS was alerted at 1735. EMS took vitals, and PT refused Benadryl. PT presented with hypertension (NIBP 227/116) and hospital contacted by EMS. PT agreed to be transported to the Hospital. Medic arrived at 1805 and transported PT to ER.
78 2021-03-04 itchy skin Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recip... Read more
Pfizer-BioNTech COVID- 19 Vaccine EUA: During the post-vaccination observation period, vaccine recipient experience an allergic reaction. They developed headache and throat closing. They were treated by EMS on site with diphenhydramine and methylprednisolone. They were transported to emergency department at Regional Medical Center. They reported itching, swelling, and tingling around the mouth. During reexamination, the patient?s symptoms did not recur and they were discharged to home. Registered 03/03/2021 3:00 PM, Discharged 03/03/2021 6:13 PM.
78 2021-03-04 hives urticarial reaction on lower neck immediate onset, persisting >1 week
78 2021-03-07 hives, itchy skin Patient experienced bad back pain, stomach spasms on night of vaccine. Starting on 2/28 hives and w... Read more
Patient experienced bad back pain, stomach spasms on night of vaccine. Starting on 2/28 hives and welts covered entire body. Very itchy. When she called to report on 3/4, reported they come and go and are not as severe as at onset.
78 2021-03-08 rash Admitted to the hospital in observation status on 3/8/21 with chief complaint of "I don't feel well,... Read more
Admitted to the hospital in observation status on 3/8/21 with chief complaint of "I don't feel well, I feel dizzy and I had a rash." Patient treated in urgent care on 2/24/21 for possible UTI and again in urgent care on 3/2/21 for cat bite and given ceftriaxone IM as well as Augmentin. Patient complains of feeling a little dizzy and not quite well, rash was fleeting but she has not been eating or drinking well since vaccination and has been having headaches since that time. She is afebrile and has no respiratory symptoms but positive covid-19 test (and antibodies). Patient did complain of nausea and dehydration. Discharged on 3/9/21.
78 2021-03-09 redness, rash macular, injection site pain, itchy rash Initial slightly sore arm at injection site. Two days later noted slightly erythematous, mildly itch... Read more
Initial slightly sore arm at injection site. Two days later noted slightly erythematous, mildly itchy confluent macular rash near (but separate from) injection site. Rash persisted has persisted and is still present, though appears to be fading. Photo taken on day 5 of rash and is available if desired. No other side effects from vaccine #2. Slight sore arm from vaccine #1 only.
78 2021-03-13 itchy skin Facial itching then burning (no redness or swelling)
78 2021-03-14 bruising Patient called stating four days after shot, started to have pain in arm and was black and blue. Had... Read more
Patient called stating four days after shot, started to have pain in arm and was black and blue. Had been taking pain relievers and ice pack around the clock. Referred patient to PCP for follow - up and to continue until seen.
78 2021-03-15 redness Redness and swelling in face
78 2021-03-15 rash, itchy skin, redness fire red palms, soles of feet, ears; fire red palms, soles of feet, ears; fire red palms, soles of f... Read more
fire red palms, soles of feet, ears; fire red palms, soles of feet, ears; fire red palms, soles of feet, ears; Pinpoint rash on arms, legs, torso; Palms extremely itchy; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration in the right arm on 02Feb2021 at a single dose for COVID-19 immunization. Medical history included iodine allergy and opioid pain meds allergy. Concomitant medication included chlorphenamine maleate (ALLERGY OTC) and an unspecified statin. Patient not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) on 12Jan2021 in the right arm. On 07Feb2021 12:00, 5 days after the second COVID shot, patient experienced fire red palms, soles of feet, and ears; pinpoint rash on arms legs, torso; and palms extremely itchy. Events lasted 4 hours, faded in same order of appearance. Treatment received for the adverse events was Benadryl. This case was reported as non-serious. COVID-test post vaccination (nasal swab) on 08Feb2021 with result unknown. Outcome of the events was recovered on 07Feb2021 16:00. Information on the lot/batch number has been requested.
78 2021-03-17 itchy skin, rash 2/15/2021 covered with unbelievable rash from my neck to my ankles!! Lasted for more than 12 days an... Read more
2/15/2021 covered with unbelievable rash from my neck to my ankles!! Lasted for more than 12 days and was extremely itchy.
78 2021-03-18 injection site pruritus, injection site swelling, injection site pain, injection site redness Soreness, redness, swelling and itching on shot site. Used cold compress
78 2021-03-18 itchy skin, vaccination site pain left arm aching from the site of the injection; aching from back of her arm to the back part of her ... Read more
left arm aching from the site of the injection; aching from back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger.; numbness down left arm/partially numb, she has feeling because it's aching; itchy torso from armpits to hips/itchy back and stomach; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EN6201), intramuscular, administered in left arm on 23Feb2021, 14:00 as single dose for COVID-19 immunisation. Medical history included neuropathy in feet, cholesterol (abnormal), 2 vertebra in her back that are starting to fuse, shrinking as she's getting older, allergic to NSAIDS, she clarifies Advil, Tylenol and the medications reverses on her and gives her a headache, and she gets itchy; was in the hospital for surgery, for lady stuff and needs glasses. She doesn't have a heart problem she doesn't have any other medical issues. She's not diabetic the neuropathy was idiopathic. Concomitant medications included atorvastatin for cholesterol (abnormal), acetylsalicylic acid (BABY ASPIRIN), and duloxetine hydrochloride (CYMBALTA). The patient previously took morphine and was allergic, and hallucinating as she was told by the nurse, she said there were monkeys on the ceiling and her husband was trying to kill her and gets itchy with morphine. This is the same reaction she had when found out she had the reaction to NSAIDs, for example, she could take Advil or Tylenol for one night but it she took it two nights, that was when she woke up itching all over. She reports no rash, just itch. It just lasted that one night and it was gone. She could take some Advil and get that itchy feeling. On 01Mar2021, the patient experienced left arm aching from the site of the injection back down under the back of her arm to the back part of her elbow, then it comes to the far outer part of her forearm down to the wrist and ring finger and pinky finger; numbness down left arm/it was also partially numb, she has feeling because it's aching and she was describing it as an ache, not sharp just an ache. She can feel it, but its not all there. She knows all this stuff was new to all of us. She's following up and doesn't keep her up at night it's just not normal; and on 24Feb2021, her torso, the night after injection, from her armpits to her hips was itchy. She woke up and she went to the bathroom scratching her back and stomach. Her Covid 19 vaccine card was handwritten she sees 23Feb2021 and that's the date she got the shot. She's been isolating since Feb2020. She was only going out for necessity. She took a risk and had family at her home for Christmas. She hasn't been to church in almost a year, so she was taking this very seriously. Before they even started telling you to wear a mask she was listening to the news in December and January. She states, alright she's isolating, it's the safest thing she can do she's not ready to leave this world yet even knowing she's past her golden years. Her doctor put her on Atorvastatin it because of her age, she had blood drawn but she wasn't given any counts on an unspecified date. Her first thought was she had a chest problem but it's not a heart attack, the ache doesn't go any farther than what she told. It's not stopping her from being productive, from doing things. The events did not require a visit to the emergency room, physician office and was not hospitalized. The patient had no prior vaccinations within 4 weeks and no events following prior vaccinations. Outcome of event itchy torso from armpits to hips/itchy back and stomach was unknown; and outcome of the rest of events was not recovered.
78 2021-03-18 skin peeling Eyes swollen; lids puffy and red, red circles around each eye; lids puffy and red, red circles aroun... Read more
Eyes swollen; lids puffy and red, red circles around each eye; lids puffy and red, red circles around each eye; yellow jaundice look below each eye in a little pouch filled with fluid; itchy eyes; skin on eye lids peeled off; yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot).; This is a spontaneous report from a contactable female other healthcare professional reported for herself that 78-year-old female patient received first dose bnt162b2 (Solution for injection, pfizer (Batch/Lot Number: EL9265)) via an unspecified route of administration, administered in Arm Left on 28Jan2021, 16:45 as single dose for covid-19 immunisation. Medical history included myocardial infarction from 2014 to an unknown date In good health - Heart Attack 2014 , drug hypersensitivity from an unknown date and unknown if ongoing known_allergies: Sulfa drugs. The patient historical vaccine bnt162b2 (Solution for injection) on 28Jan2021 Start Date/Time: [Pfizer Lot EN6198] 19Feb2021 09:45 AM, left arm for covid-19 immunisation. Facility most recent COVID-19 vaccine was administeredin Doctor's office/urgent care. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. On 01Feb2021 07:00 AM, Eyes swollen, lids puffy and red, red circles around each eye, itchy eyes, skin on eye lids peeled off, yellow jaundice look below each eye in a little pouch filled with fluid (this jaundice look with pouch disappeared within 5 -6 days from receiving 1st shot). Other eye condition remains. The event Yellow ocular coloring was recovered in 2021 and other events not recovered.
78 2021-03-20 itchy skin Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; ... Read more
Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; started hurting and felt strained; started itching in her body; Headache; muscle aches; Nausea; Chills; This is spontaneous report from a 78-Year-old Female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunization on arm left. The patient relevant medical history and concurrent conditions included cataracts from 2005 with ongoing, macular degeneration from 2012 with ongoing, arthritis from an unknown date and ongoing and fingers and both hands that had knots since 2010. The patient stated that she had nausea, chills, headache, and muscle aches on 02Feb2021, and on 03Feb2021, she had lightheadedness, tired, and aches in her hands where she has arthritis and all at once that the corner of her eye and around it was itching really bad and she touched it to relieve the itch and they started hurting and felt strained. The patient got Systane over the counter eye drops that she had and held hot compresses to it. She reported that it lasted for a few hours and she had cataracts and a little macular. The patient started itching in her body at 7:30 and took Benadryl and went to bed and it went away. She was concerned with second vaccine as she got through the nausea and everything else, but her eyes scared her. The patient received treatment medication for nausea and took Tylenol for Arthritis and muscle aches. The patient had an x-ray 3 years ago for her back and was diagnosed for unknown results. The outcome of the events nausea, aches in her hands, corner of her eye and around it was itching really bad, started hurting and felt strained and started itching in her body was resolved on 03feb2020, whereas the events chills, lightheadedness, tired, headache and muscle aches were resolved on 04Feb2021.
78 2021-03-21 rash macular, itchy rash, rash with redness, rash I had the second Covid (Pfizer) vaccine on February 22. The next day I had chills, fever, aches, nau... Read more
I had the second Covid (Pfizer) vaccine on February 22. The next day I had chills, fever, aches, nausea and was very weak. After about 30 hours I felt okay again. However, a week and a half later, I noticed red bumps on the back of my neck. The next day, my neck and scalp had red, itchy blotches. Through the next five days, these spread down my body to my ankles until I was covered with the red, very itchy blotches. I did go to Urgent Care on the third day and I was given a 5-day prescription of Prednisone. It did not do much until the third day and then it relieved the itching somewhat for about 6 hours, but then it would start again. After the five days of Prednisone, I took Benedryl for three days until the itch and redness disappeared. I checked the facility web site on types of rashes and my rash fits the description (and the photo) of a drug-related rash, but I have not changed or added any drugs for several years other than the Covid vaccine (I did some research online and found two other people who have had the same problems I have had after the second Covid vaccine. Both of them had the typical reaction of chills, fever, aches and dizziness for about a day after the second shot and then 1-2 weeks later, broke out in a rash. Both reported having the rash start at the neck or head and then spreading down the body throughout one to two weeks before disappearing. There were photos on the facility site of drug-related rashes and they were exactly like what I had. Since the rash was almost certainly covid vaccine related, I am making this report, which my doctor recommended. I had no other changes in diet, medications, environment, etc. ? only the Pfizer vaccine was new to my body.
78 2021-03-21 itchy rash, rash, rash with redness Rash: Very itchy, dry, red, pimple-like rash over head, face and back. Pain onset 03/20/2021. Onset... Read more
Rash: Very itchy, dry, red, pimple-like rash over head, face and back. Pain onset 03/20/2021. Onset about a day after injection; continues on 03/22/2021. No other symptoms.
78 2021-03-25 injection site warmth, itchy skin, redness Redness, pain, itching, warmth to the site of injection
78 2021-03-25 rash Pt reports rash under left breast after covid shot.
78 2021-03-25 rash Pt received 1st dose of Pfizer on 3/17/21 at 2pm in right arm. Then, on 3/18/2021, at 7pm, patient n... Read more
Pt received 1st dose of Pfizer on 3/17/21 at 2pm in right arm. Then, on 3/18/2021, at 7pm, patient noticed rash under armpit of left arm while in the bath. Patient called PCP who instructed her to take benadryl. Rash progressed, so patient went to ER. ER doctor recommended patient not take any further medication (patient had already taken benadryl prior to going to ER). 3/19/2021 patient decided to continue benadryl 25 mg three times that day. By 3/20/2021, rash had progressed further down her legs, so patient returned to the ER. Rash was only on the arms and legs, and was NOT on torso or chest. No itching, no SOB, no lip/tongue swelling, no fever. In ER, patient was instructed to continue benadryl and was given medrol dose pack, which she was encouraged NOT to take. Patient discharged from ER and returned home. On 3/21/21, new lesions were still appearing, and patient was told to visit PCP on 3/22/2021. On 3/22/2021, patient noticed her left hand was swelling, so medrol dose pack was started. Patient had dramatic improvement in rash and swelling with 24 hours of steroids. On 3/25/2021 patient returned to PCP, rash was resolving well.
78 2021-03-27 injection site pain The injection was given high up on my arm and was very painful. About an hour after receiving the s... Read more
The injection was given high up on my arm and was very painful. About an hour after receiving the shot my arm felt weak and my hand and fingers felt numb. I could not raise my arm. This lasted into the next day, when my shoulder began to hurt. The feeling returned to my hand but I started getting drawing pains in my arm, and increasing pain in my arm when raising it.
78 2021-03-28 injection site rash 1st dose: Syncope 2nd dose: rash (Chest and injection site, lip edema)
78 2021-03-28 jaundice Cholestasis and Pneumonitis. Improved over 2 months after course of steroids. Noted to be jaundiced ... Read more
Cholestasis and Pneumonitis. Improved over 2 months after course of steroids. Noted to be jaundiced about 7 days after vaccine. Liver biopsy demonstrated likely drug injury superimposed on steatohepatitis. Then had worsening dyspnea requiring admission on 2/21/21 for 2 days.
78 2021-03-28 rash with redness 2/2/2021 red scaly skin rash dorsum right hand. Next day pinpoint hemorrhagic 2-4 mm sized lesions ... Read more
2/2/2021 red scaly skin rash dorsum right hand. Next day pinpoint hemorrhagic 2-4 mm sized lesions on palmar surface of fingertips and sides of fingers, 21 in all. Diagnosed as clots by cardiologist and dermatologist on 2/25.Gradual resolution and healing by 3/14/2021.
78 2021-03-28 rash macular, rash, itchy skin, skin irritation Skin eruptions all over my body. They are itchy and irritating. They are little red spots, some of... Read more
Skin eruptions all over my body. They are itchy and irritating. They are little red spots, some of them puss filled. I took prednisone pills with no result so was give cortisone shot. Still no relief. This has been going on since a week following the second vaccine shot. There have been no changes that I can recall in foods I eat or cleaning products I use or other things that might affect the skin. The only new thing seems to be the vaccine.
78 2021-03-29 skin discolouration pt stated that about an hour after she got the vax she had severe headache, extremely tired and pain... Read more
pt stated that about an hour after she got the vax she had severe headache, extremely tired and pain in right leg muscle. On 2/20/21 all symptoms were gone except the pain the the right leg between her hip and knee on the outside of the leg. On 2/26/2021 she went to the ER. They did Covid Test, EKG, Chest X-ray and blood work. All test were negative. She was released to go home. On 3/4/2021 she woke up and her right leg had turned black and blue. She call 911 and taken to the ER where they did blood test, EKG, Chest Xray, CT, Spine Xray and US to see if she had any blood clots. She did not have any blood clots and all test were negative. Pt was released to FU w/ her PCP on 3/12/21. He took more blood work. Pt was told to drink water take more vitamin D. Pt still has some pain.
78 2021-03-30 bruising I lost consciousness; hitting my head; bruising body; when I had my blood pressure taken it was over... Read more
I lost consciousness; hitting my head; bruising body; when I had my blood pressure taken it was over 200 landing me in ER overnight to try to get my BP down; suffering with Arrhythmia; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 22Feb2021 (lot number: EN6201) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9261), administered in the right arm on 01Feb2021 12:00 AM for COVID-19 immunisation and experienced achy body, tiredness, fever and chills. After the second vaccine early in the next morning (23Feb2021) around 3 am, the patient lost consciousness when retuning from the bathroom hitting her head and bruising body. She lay on the floor for approximately 15-20 minutes. She was ordered by her primary care physician to have a brain scan but when she had her blood pressure taken it was over 200 landing her in emergency room (ER) overnight to try to get her BP down. She was now on beta blockers and was still suffering with arrhythmia awaiting an appointment with her new cardiologist. She was hospitalized for 2 days due to the events. She had no COVID prior vaccination and has not tested COVID post vaccination. She has no other vaccine in four weeks. Therapeutic measures were taken as a result of the events. The outcome of the events were not recovered.
78 2021-03-30 rash cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no ... Read more
cannot take good deep breaths because of the soreness in her ribs; soreness in her ribs; She had no urge to eat/Has no desire to eat or drink; lost 10 lbs; feel ill; General feeling of the flu; had a slight sore arm; nausea; severe pain, her hip and knee were killing her; was having major problems, a delayed immune response; Rash covering her entire body; acute pain and with deep breaths; low grade fever; cough/Cough was a dry, tight, non-productive cough; Weakness; Chronically dehydrated; the COVID Vaccine wasn't working; the COVID Vaccine wasn't working; This is a spontaneous report from a contactable nurse. This nurse (patient) reported that a 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EN6204) at the age of 78-years, via an unspecified route of administration on 04Mar2021 at single dose; first single dose of BNT162B2 (lot: EM9810) on 11Feb2021; both for COVID-19 immunisation. Medical history included osteoarthritis (having aches and pains) had for 20 years; large sliding hiatal hernia was diagnosed from an EGD six months before, didn't want surgery to fix it; heartburn (last five years); fatty liver, was not from drinking alcohol; generalized anxiety; was tuberculosis positive only because she was exposed years ago. Concomitant medications included pantoprazole started four to five years before at 40 mg twice a day for heartburn; escitalopram (tablet) been on for 15 years or longer at 10 mg 1 DF every day for generalized anxiety; clonazepam 0.5 mg nightly at bedtime for anxiety (been taking for last ten years or more, stops her from worrying about her kids and stuff like that). The patient experienced on 07Mar2021, low grade fever, weakness, chronically dehydrated and cough; on 15Mar2021, rash, acute pain and with deep breaths; on an unspecified date, no desire to eat or drink. Seriousness criteria of these events were reported as disabling. Patient reported that was having major problems, a delayed immune response. Told everybody if this keeps up she was not going to make it. It was wearing her down and she was not going to survive. Occurred after second COVID vaccine. She is active, goes to pool, and does different things. Had vaccine on Thursday and was ok until Sunday. Started Sunday with low grade fever. Kept being low grade and never got to 101, 102, or 103. She didn't take ibuprofen. Usually takes ibuprofen once a day for routine aches and pains. Having weakness. Had no desire to eat or drink. She waited a couple days, but then called her doctor. Doctor's office wouldn't give her an appointment. Stated this wasn't the routine and has been going on for 10 days. This was too much. Two days later, caller's daughter-in-law took her to a place like an ER. A bunch of tests were done. She asked for an IV because she was chronically dehydrated. Weakness was getting to her. After seeing the doctor in the mini surgical ER, she didn't feel any better. She felt the same. Same nausea, weakness, low grade fever, the whole thing. Decided to see her regular doctor. Stated it wasn't her chest. Wanted to be told what was going on. Her regular doctor didn't order any labs. She was given a steroid shot. Thought she was in deep doo-doo. Stated this was not a good sign and she was not going to make it. She woke up yesterday with a rash covering her entire body. She had no clue she had the rash. Never saw the rash. Rash didn't itch, but she still had it. After steroid shot from doctor, she felt a little bit stronger and thought maybe she was going to make it, but then started getting severe pain. Patient was used to having aches and pains that went along with old age and her osteoarthritis. This was severe pain as if she fell and hurt her ribs. It hurts to take deep breaths. Her hip and knee were killing her. It was acute pain, not normal pain. This morning stated she couldn't take it and was going to take ibuprofen, which was not the best for her. She didn't want to eat, but tried to have food in her stomach to take the ibuprofen. She cannot take good deep breaths because of the soreness in her ribs. Thought something in her body was having a delayed immune response and her gut told her it was not good. For low grade fever, did not take ibuprofen, 07Mar2021 was when she started feeling yucky, she wanted to see how she felt and her temperature never really got up, stuck it out, normal temperature for her was 97 or lower, her temperature once in a while would range from 98 to 100.3 or 100.8, she cannot take paracetamol (TYLENOL). For weakness, noticed right away, felt a little better after steroid, had not been out of her door except to the ER. For chronically dehydrated, clarified she had no desire to eat, usually drinks coffee and tea in the morning, but now had no desire, was making herself drink, felt something wasn't right beginning on 07Mar2021, everything went south and got worse, clarified it really wasn't nausea, but no desire to eat or drink, doctor today gave her ondansetron (4mg) which didn't help and made it worse, eating and drinking didn't make her sick, just didn't want it. She had labs done in the ER and was told her labs weren't really that off for her to be that dehydrated. Asked for an IV because she was not drinking what she normally drinks, didn't feel any better after the IV. Rash covering her whole body, but didn't itch. Acute pain and with deep breaths began evening of 15Mar2021, seemed the same today, she just took an ibuprofen a little while ago and was feeling better. Patient also mentioned that realized her body was trying to get monoclonal antibodies and resistance to build up her immunity so that if she ever got infected with COVID virus she could fight it, it was just not working, it was not doing its thing, she was having a delayed immune response, was very worried about that, going on 8-9 days and it was weakening her by the day, didn't think she could take this too much longer. Clarified the COVID Vaccine wasn't working and her body couldn't get its act together. Patient had a slight sore arm after the second dose, never reacted at the injection sight, it was strictly internal, which kind of scares her, something was not right, was having the rash, pain, and severe weakness. Was not expecting any kind of problem. Didn't think too much about the second COVID Vaccine. Stated people were like "oh that second shot." If she didn't get better soon she is not going to do well. Cough was a dry, tight, non-productive cough, lungs were checked yesterday and were clear, felt like all of a sudden she has an urge to cough and nothing comes up. For steroid shot, didn't know if it was dexamethasone (DECADRON) or not, made her feel a little stronger for the day, but then brought on severe aches and pains in her joints and ribs, did not have this until the steroid shot. Patient said that didn't take ibuprofen the first couple days because she didn't want to mess up the immune response starting in her body, asked doctor about immune globulin for her delayed immune response, but doctor shook his head, knew that people with autoimmune are ordered IGE or IGG to test the immune system, asked doctor about this, but he shook his head. Stated she didn't think a CBC with different was performed at the ER, confirmed she was only in the ER after the second dose and was not admitted to the hospital. As of 17Mar2021, she stated then two to three days after that she woke up with rash over her entire body that showed up overnight, that alarmed her even more of course, no itch or nothing, no clue it was there until she washed off and could see it, she had never had a rash before, her arm never got red, but she had a low grade fever, stated now didn't know if good or bad, cough, not productive, some urge to cough, no appetite, not eating or drinking, and increasing weakness, today she couldn't say anything was different about her rash maybe slightly faded but she didn't feel any better, she did get a steroid shot when she went to doctor yesterday and that made her feel less weak. As of 18Mar2021, patient stated that had no reactions for the 1st 2 days following her 2nd dose however she started to feel ill, low grade fever that never went above 100. General feeling of the flu; aches and pain, which she had before but more than usual. She had no urge to eat. Tried to see her doctor when it had been going on for 5 days but they were not concerned. By that Friday, she went to the hospital. They found nothing wrong in her lab tests but she asked them for I.V fluids since she hadn't eaten or drank anything. On Monday, she went back to her initial doctor because she had a rash all over her body, it did not itch and her injection site had no redness. She was given a steroid shot, today she might be feeling a bit better. She lost 10 lbs. She had to stay inside for the past 10 days, except for doctor visits, although she was usually an active person. She would like to know how long the side effects would last. Outcome of the events low grade fever/ wasn't working, weakness, rash and acute pain and with deep breaths, cannot take good deep breaths and soreness in her ribs was not recovered/not resolved while of remain was unknown. Relatedness per primary source reporter via global introspection of BNT162B2 to events low grade fever, weakness, chronically dehydrated, no desire to eat or drink, acute pain and with deep breaths and cough were related.; Sender's Comments: Based on a temporal association and the known drug safety profile, the reported events are considered possibly related to BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
78 2021-03-30 vaccination site itchiness 1 giant hive at vaccination site- itchy for about 1 week; 1 giant hive at vaccination site- itchy fo... Read more
1 giant hive at vaccination site- itchy for about 1 week; 1 giant hive at vaccination site- itchy for about 1 week; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 14Feb2021 13:15 (Lot Number: EN6201) as 0.3 mL, single for COVID-19 immunisation. Medical history Thyroid Nodules, Mild macular degeneration, postmenopausal syndrome, HBP, total hysterectomy w/ oophorectomy, gall bladder removal, appendectomy, penicillin allergies, adhesives allergies, HOH allergies, allergies: contrast dye. Concomitant medications included valsartan (DIOVAN); estrogens conjugated (PREMARIN); levothyroxine sodium (SYNTHROID); pravastatin; colecalciferol (VIT D3); famotidine (FAMO). The patient previously took nitrofurantoin (MACRODANTIN) and experienced allergies, claritine (CLARITIN) and experienced allergies. The patient experienced 21Feb2021- 1 giant hive at vaccination site - itchy for about 1 week, started 2 days after injection (16Feb2021) - very mild - arm was not sore at all. Treatment received for the events which included self medicated with benadryl & Aleve. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The outcome of the events was recovering.
78 2021-03-31 hair loss Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 1 week after receiving my second vaccination... Read more
Pfizer-BioNTech COVID-19 Vaccine EUA Approximately 1 week after receiving my second vaccination, my hair starting falling out and is still falling out at an alarming rate
78 2021-04-02 injection site pain, injection site redness, injection site swelling Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many ... Read more
Headache at base of skull 1st night (Sun), next morning all muscles ached, significant pain in many joints, tremendous fatigue, inability to concentrate, dizziness. Swelling, pain, redness left arm shoulder to elbow.Took Tylenol, spent most of the day in bed. Not hungry. By Tues I felt much better, but fatigued (still needed 2 naps), little appetite. Wed continued recovery, but weak, arm continued red, swollen, painful to the touch. Today, Sunday and a week after injection, I feel normal.
78 2021-04-02 rash, itchy rash Rash/The rash got worse from day to day as it spread throughout her body/The rash went from there to... Read more
Rash/The rash got worse from day to day as it spread throughout her body/The rash went from there to her face and went throughout body.; She also had swelling and itchiness with the rash.; She also had swelling and itchiness with the rash.; Low grade temperature 99.3 degrees; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 02Feb2021 15:00 (Batch/Lot Number: EN5318) as SINGLE DOSE for covid-19 immunisation. Medical history included hodgkin's disease from 2007, cardiac disorder was the patient taking concomitant products. Concomitant medication(s) included losartan (LOSARTAN) taken for cardiac disorder from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for cardiac disorder from an unspecified start date and ongoing; warfarin (WARFARIN) taken for anticoagulant therapy from an unspecified start date and ongoing; Toprolol taken for cardiac disorder from an unspecified start date and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not have history of all previous immunizations with the Pfizer vaccine considered as suspect. The patient did not administered any other vaccine on same date of the suspect. Caller on the line calling about the COVID 19 Vaccine. She was informed to call and report any reactions to the vaccine. She received the vaccine on 02Feb2021 and three days later she developed a rash. The rash started on her feet and spread throughout her whole body. She also had swelling and itchiness with the rash. Caller went to her primary care doctor on Monday 08Feb2021 and it was suggested to her to go see an allergist because the primary care doctor could not determine what this reaction could be other than the vaccine. The rash got worse from day to day as it spread throughout her body. It started on her feet went to her ankles. She then had swelling with it; it was itchy, very itchy. The rash went from there to her face and went throughout body. She noticed it in the afternoon on 05Feb2021. She had socks on and her socks were getting tighter due to swelling. She took her socks off and then noticed the rash. She also added, she had a low grade temperature. It was 99.3 degrees. Initially stated the low grade temperature started on Thursday 04Feb2021, but then stated it could have started Friday, she is not sure. It was one of those days. She thought she had a low grade temperature for two days. She did not even take the temperature the second day because she felt so crappy and did not feel like taking it. The caller was given a name of an allergist and she would go see the allergist on 18Feb2021. The patient did not visited to emergency room. The patient visited to physician's office. Outcome of the events rash, she also had swelling and itchiness with the rash were not recovered and unknown for other event.
78 2021-04-02 rash rash; headache; No appetite; chills; sweat; fever; body aches; This is a spontaneous report from a c... Read more
rash; headache; No appetite; chills; sweat; fever; body aches; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received second dose of bnt162b2 (BNT162B2; Solution for injection; Lot number: EM9809) via unspecified route of administration on 09Feb2021 at single dose for covid-19 immunization. Relevant medical history and concomitant medications were not provided. It was reported that caller and his wife received the second dose of the Pfizer-BioNtech Covid-19 vaccine on Tuesday, he experienced a little of body aches that disappeared; however, his wife experienced a severe reaction: ongoing chills from 10feb2021, ongoing sweating from 10feb2021, ongoing headache from 10feb2021, from 10feb2021 to 11feb2021 experienced fever, ongoing body aches from 10feb2021 and today she broke out in rash on the front of her body from 11Feb2021 and ongoing no appetite from 10feb2021. They would like to know if there are any recommendations on what to do. Calling about the Covid 19 Vaccine. States that he and his wife had their 2nd doses of the vaccine on Tuesday afternoon. He had very little side effects; just body aches. But his wife woke up the first night after getting the shot with chills, fever, sweats, headache, and body aches. Today she is feeling a little better; her temperature this morning was 99.2, and she had a really bad headache. When she got in the shower, she noticed that she had a rash on her body; it doesn't itch. States that she has a little appetite today, which is good because she didn't eat at all yesterday. Asks, what does he need to do, if anything at all? States that he went on the Pfizer website and the side effects were listed there, one of the bad ones was a rash, so he would like to speak with Medical Information. Caller does not have the full contact information to provide for the prescribing physician. States that she got the shot about 2:15-2:30pm and the aide effects started about 12 hours later. States that she goes from being hot to cold to lukewarm, so the chills come and go. Her fever is gone, her temperature is now 97.5. The headache was really bad this morning, but she only feels a little pressure now. The rash is on her back and legs, but it has gotten better in the last hour. States that her appetite has improved; she just ate some breakfast. The lot number on the card is difficult to read due to the handwriting. Caller states that by comparing her card to his card, they think the Lot number is either EU9809 or EM9809. Caller later states that after looking at if for longer he really thinks it's EM9809. The outcome of the events for "Chills", and "Sweating" was "Not Recovered", for "Fever" was "Recovered", and for "Headache", "Body aches", "Rash", "No appetite" was "Recovering". Follow-up attempts are completed. No further information is expected.
78 2021-04-03 rash, hives severe rash and hives over entire body; severe rash and hives over entire body; This is a spontaneou... Read more
severe rash and hives over entire body; severe rash and hives over entire body; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9262), via an unspecified route of administration in the left arm on 22Jan2021 at 09:30 AM as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were reported as eliquis 5mg, venlafaxine 150mg, atorvastatin 10mg. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that on 22Jan2021 at 11:00 PM patient experienced severe rash and hives over entire body.Patient received the treatment with zyrtec, prednisone, benadryl, hydrocortisone. Outcome of all the events were recovering.
78 2021-04-03 vaccination site swelling, vaccination site warmth arm swelled; hot at injection site; This is a spontaneous report received from a contactable consume... Read more
arm swelled; hot at injection site; This is a spontaneous report received from a contactable consumer reported that: A 78-years-old female patient received bnt162b2 (BNT162B2; solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Feb2021 17:30 (Batch/Lot Number: EL1283) as single dose and on 13Jan21 receveid BNT162b2 (Lot#EL0142)as single dose for covid-19 immunisation. The patient medical history was unknown. The patient's concomitant medications were unknown. On an unspecified date, the patient experienced arm swelled, hot at injection site. After 2nd day, occurred after 4th day. number of previous doses was 2nd shot. Outcome of the events were unknown.
78 2021-04-05 injection site bruising 3/3/2021 - Left Upper Arm Swollen Hard Muscle, no Pain, 3/8/2021 - Periodic Tingling up and down be... Read more
3/3/2021 - Left Upper Arm Swollen Hard Muscle, no Pain, 3/8/2021 - Periodic Tingling up and down beneath skin of Left Arm,in addition to Swollen Muscle Applied Cold Compresses and Tylenol Caplets with relief of tingling sensations 3/16/2021 - Covid Pfizer Vaccine #2 (Right Arm) - only temporary small bruise spot at injection site 3/25/2021 - Urgent Care for Swollen Upper Left Arm and unchanged Tingling discomfort (Advised to continue Cold Compresses and follow up with Primary Care Provider) 3/29/2021 - Left Arm increasing pain up to Shoulder and Neck - weakened arm strength, use challenge, and sleep discomfort 4/12/2021 Earliest Upcoming Appointment with my Primary Care Provider
78 2021-04-06 blister, hives, skin burning sensation, itchy rash, redness, itchy skin Awakened morning of March 20, 2021, with flaming red burning skin on left chest from scapula to edge... Read more
Awakened morning of March 20, 2021, with flaming red burning skin on left chest from scapula to edge of atrial, huge welts of 2? and 1? in diameter, appearance of blisters, itchy rash, intensely itching. Today is April 7, and the area is faintly pink with itchy bumps near clavicle of an area 4?x4?.
78 2021-04-06 itchy rash, rash Itchy rash on lower legs developed 5 days post vaccination; then spread to arms. Continues
78 2021-04-07 jaundice Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had aci... Read more
Pt admitted on 4/5/2021 c/o roughly 4 weeks of just general dyspepsia and feeling like she had acid reflux. She reports that then progressed to some nausea and then vomiting and then some generalized right upper quadrant midepigastric abdominal pain. She also noticed that her skin was becoming yellow. She reports no changes in any of her medications recently she had her second COVID-19 vaccination on 2/14 and blood work on 2/ 8 consisting of liver enzymes/CMP was normal. she arrived severely jaundiced with severe transaminitis, hyperbilirubinemia and acute renal failure. ERCP revealed no gross obstruction and free flowing bile and sphincterotomy was done with no improvement in her blood work. she remains hospitalized and is being transferred for HLOC due to worsening condition REVIEW OF SYSTEMS:
78 2021-04-07 rash rash requiring benadryl and extended observation in vaccine clinic, discharged home
78 2021-04-08 injection site pain 3/27 got 1st pfizer vaccine in her right arm had injection site pain for a week and finally resolv... Read more
3/27 got 1st pfizer vaccine in her right arm had injection site pain for a week and finally resolved the next day woke up with severe right arm pain, hurts to lift it sleeps on side and this also hurts it no weakness but hurts to raise it up no prior injuries no trauma pain in lateral shoulder, minimal neck pain, no pain distal to elbow no numbness or tingling on warfarin so has been afraid to take anything for this pain 5/10 at rest and much worse with movement
78 2021-04-08 itchy skin Patient received her first Pfizer COVID-19 vaccine and began feeling throat tightness, SOB, chest ti... Read more
Patient received her first Pfizer COVID-19 vaccine and began feeling throat tightness, SOB, chest tightness and itching about 15 minutes after vaccine. Patient was going to be observed for 30 minute due to history of anaphylaxis. Patient was given 0.3 mg epinephrine in left thigh and 50 mg benadryl IM in right deltoid at 17:06. VS before medications 174/73 HR 73 and after medications was 187/64 HR 78. Nitro patch was removed by Dr. prior to medication administration.
78 2021-04-08 rash, itchy skin About 5 days after injection, I had a bout of nausea and diarrhea and noticed severe itching. The s... Read more
About 5 days after injection, I had a bout of nausea and diarrhea and noticed severe itching. The stomach issues resolved after a couple of days, but the severe itching continued and is especially bad wherever my clothing comes in contact with my skin. Over the next several weeks, I tried hydrocortisone cream, Benadryl gel, Benadryl tablets, Calamine lotion, corn starch, menthol itch cream, but nothing has helped for very long. I don't have much of a rash...just a bit of raised redness when the itching is particularly bad. I have been miserable with it. I visited my neurologist for Botox injections and asked her about it and she said she thinks I'm having a histamine reaction to the Covid vaccine. The severity of the itching is getting slightly better, but it's now been almost 6 weeks of unrelenting itching. I'm not taking Benadryl 3 times a day.
78 2021-04-09 injection site pain 2/24/2021 thru 3/1/2021 - Left Arm pain and tenderness at injection site - less pain each day. Trea... Read more
2/24/2021 thru 3/1/2021 - Left Arm pain and tenderness at injection site - less pain each day. Treatment: Tylenol Caplets (temporary relief) 3/3/2021 - Left Upper Arm Tricep Muscle noticeably Swollen and Hard when touched- No pain. Treatment: Cold compresses (little relief) 3/8/2021 - Left Arm Periodic Tingling up and down under skin, in addition to Swollen Tricep Muscle Treatment: Cold compresses & Tylenol Caplets (temporary relief) 3/25/2021 - Urgent Care for Swollen Upper Arm & Tingling discomfort Advice: Continue Cold Compresses, Monitor and follow up with Primary Care Provider 3/29/2021 - Continued Left Arm Tingling and increasing Pain at Left Upper Back & Shoulder, weakening Left Arm Strength, usage challenge, sleep discomfort, Tricep Muscle less swoIlen, Treatment: Cold Compresses and Tylenol (temporary relief) 4/12/2021 - (Pending) earliest available appointment with my Primary Care Provider
78 2021-04-13 shingles Shingles rash, headache, chills, body aches, couldn't get out of bed very tired
78 2021-04-14 rash, vaccination site rash After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizzines... Read more
After 5 minutes of receiving vaccine, patient became nauseous. Once home, she complained of dizziness. Around 4am, patient was awakened with strong heart palpitations. She noticed ankle and foot swelling after about a day. She also noticed a rash on the vaccine arm, neck and under chin. She experienced severe nausea and vomiting over the next 3 days and could not eat food. She did not seek medical attention and chose to stay in bed to recover. As of today, the patient says she is almost recovered from these events.
78 2021-04-16 vaccination site pain, vaccination site itchiness, vaccination site redness site sore to touch/Left arm injection site hot, red and starting to itch and hard.; site sore to tou... Read more
site sore to touch/Left arm injection site hot, red and starting to itch and hard.; site sore to touch/Left arm injection site hot, red and starting to itch and hard; site sore to touch/Left arm injection site hot, red and starting to itch and hard; This is a spontaneous report from a contactable consumer (Patient). A 78-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an intramuscular route of administration, administered in Arm Left on 12Feb2021 11:00 (Batch/Lot Number: EN6201) as SINGLE DOSE for covid-19 immunisation. Medical history cholesterol and When she was 3 years old, she had whooping cough. Concomitant medication(s) included Livalo 4 mg once a day for cholesterol, Clopidogrel 75 mg daily for blood thinner for stents in heart both taking for 2 year. On 14Feb2021 the patient experienced vaccination site sore to touch/left arm injection site hot, red and starting to itch and hard. She measured it 3 inches by 1.5 inches wide. They have her scheduled to receive second dose on 05Mar2021. She would like to know if she should receive it on the same arm, or was that too soon to get it on the same arm. She was on a walker and don't know if using walker had agitated her arm. She needed to use walker for 4 1/2 years prior. They pinched it up and she did not feel it when she gave her the injection. Because of her age and she has always gotten a flu shot, everybody was asking her if she wanted to get this vaccine. She was on a blood thinner, and she did tell them she was when she got the vaccine. She had stents put in her heart prior to the vaccine. She had Historical Vaccine Flu shot for immunization in Oct2020, but none after that except the Pfizer COVID vaccine. The patient underwent lab tests and procedures which included investigation: she measured it 3 inches by 1.5 inches wide on 14Feb2021. The outcome of event was not recovered.
78 2021-04-17 injection site pain, injection site redness Extreme joint and muscle pain, extreme fatigue I took tyleno, tramadol and advil at the appropriate ... Read more
Extreme joint and muscle pain, extreme fatigue I took tyleno, tramadol and advil at the appropriate time periods, Very sore injection site; became very, very red swollen and went down my arm almost to my elbow, around to underside of my arm. The pain and fatigue lasted 1 week and I stayed in be most of the time as I felt terrible. The arm lasted approx 3 weeks, I used benadryl and over the counter cortisone cream.
78 2021-04-18 rash Rash one week after second shot
78 2021-04-19 redness swollen lymph node in my left arm pit that was red and tender to the touch. Swelling and tendernes... Read more
swollen lymph node in my left arm pit that was red and tender to the touch. Swelling and tenderness disappeared in approximately 25 days. Dr viewed it on April 13th & confirmed it was a swollen lymph node
78 2021-04-21 shingles, pain of skin About 5 or 4 days ago my scalp towards the top of the head hurt while going to sleep on my back. I a... Read more
About 5 or 4 days ago my scalp towards the top of the head hurt while going to sleep on my back. I assume that I probably scratched my head while shampooing my hair. Then next day my right eye started to bother me. I thought I had bumped my eye while trying to clean the discharge I have in the mornings with q-tips. But finally it got worse until it hurt me. So I went to the ophtlamologist today who according to his diagnosis I had shingles. I just got an antiviral medication for the next seven days and drops to help clean my eyelids. This is so bothersome, sometimes while trying to read I see blurry.
78 2021-04-21 shingles I had a mild reaction to the vaccines both times. I am now reporting that I have developed Shingles... Read more
I had a mild reaction to the vaccines both times. I am now reporting that I have developed Shingles for the first time, My symptoms began on 4/16/21. I was diagnoses as having shingles on 4/20/21. I researched shingles and Covid and found that Israel has reported several post vaccine cases of shingles. Thus I am reporting my own condition to determine if there is a causal relationship.
78 2021-04-23 psoriasis Psoriasis appeared on my scalp in several areas.A dermatologist was consulted and diagnosed this..; ... Read more
Psoriasis appeared on my scalp in several areas.A dermatologist was consulted and diagnosed this..; This is a spontaneous report from a contactable Consumer. A 78 -year-old non pregnant female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Left arm on 13Jan2021 10:00 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 18Jan2021, the patient had experienced Psoriasis appeared on scalp in several areas. A dermatologist was consulted and diagnosed this. Betamethasone dipropionate lotion was received in response to the adverse events. On 04 Feb2021, patient had other vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the event was resolving.
78 2021-04-25 injection site redness, injection site warmth left arm feels "heavy", warm to touch and continued redness at injection site. No pain or tenderness... Read more
left arm feels "heavy", warm to touch and continued redness at injection site. No pain or tenderness voiced.Patient has antihistamine cream, advised to apply anti histamine cream to affected area.
78 2021-04-25 vaccination site pain, injection site redness Location of vaccine shot still pink and slightly painful almost a month after shot. Breathing diffi... Read more
Location of vaccine shot still pink and slightly painful almost a month after shot. Breathing difficulty 3 days after shot was resolved using Benadryl.
78 2021-04-28 rash hurting on right side of face, in and around R ear; hurting on right side of face, in and around R e... Read more
hurting on right side of face, in and around R ear; hurting on right side of face, in and around R ear; severe headache; nausea; vomiting; severe dizziness; All over body rash; This is a spontaneous report from a contactable consumer or other non hcp. A 78-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jan2021 08:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included high BP, hx of blood clots/CAD, covid-19 from 10Dec2020 to an unknown date. Concomitant medications included warfarin sodium (COUMADIN); and atorvastatin calcium (STATIN [ATORVASTATIN CALCIUM]); both taken for unspecified indications, start and stop dates were not reported. On 26Jan2021, 12:00 AM, 3 days later started hurting on right side of face, in and around R ear, severe headache/nausea/vomiting & severe dizziness. All over body rash occurred. 10 days later and lasted 3 weeks. The patient received treatment for the events: antibiotic/anti nausea/MRI/CT. The patient was hospitalized for five days for the events. The outcome of the events was not recovered. The patient underwent lab tests and procedures which included computerised tomogram: unknown results on an unspecified date, magnetic resonance imaging: unknown results on an unspecified date. The patient has not been COVID tested post vaccination. Information on the lot/batch number has been requested.
78 2021-05-01 injection site pain Sore at injection sight (mild) next day. Nothing noticeable until 24 Apr 21 Pounding headache... Read more
Sore at injection sight (mild) next day. Nothing noticeable until 24 Apr 21 Pounding headache, fatigue, sleepy long periods , mild sore throat, blood pressure lower than usual . Temperature with in normal limits . I have been resting a lot , waiting for conditions to improve, however, as of this writing nothing has changed. Thus I decided to file this report. my I have not seen my healthcare provider yet but will make contact tomorrow
78 2021-05-04 vaccination site mass Pain; a lump down from where the injection site was/ lump in the arm, 4 inches down from the shoulde... Read more
Pain; a lump down from where the injection site was/ lump in the arm, 4 inches down from the shoulder where she got the shot; her shoulder aches; shoulder aches and the feeling goes into the arm; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 78-years, at single dose in left arm on 03Mar2021 10:00 (Lot number was not reported) for covid-19 immunisation. Medical history included type 2 diabetes that diagnosed about 3 years ago, this year makes 4 years, and she took medications for it. And she was a little overweight, supposed to drop some but gained some back that because of diabetes. Historical Vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) also at age of 78-years, at single dose in left arm on 02Feb2021 13:00 for covid-19 immunisation and she had no problem with that one. Another Historical Vaccine included flu shots, it just lasted a day or two, maybe that's it, never had problems before. The patient's concomitant medications were not reported. The patient reported side effects from the Pfizer COVID vaccine. Her arm was still bothering her. There was a lump down from where the injection site was and that she kept rubbing it but it won't go away and that she still had pain. She was told she should go to the doctor, but she thought she would call to see what was best to do. She had not a fever, just the lump on the arm, 4 inches down from the shoulder where she got the shot. The patient stated that both Pfizer COVID vaccines were in her left arm, she should have gotten it in the other arm. The patient stated she heard about blood clots and thought she'd better check it out. The patient stated that she had the lump and her shoulder aches; not the shoulder the upper arm. The lump was on the inside and she kept rubbing it but it didn't go away. The patient had the second Pfizer COVID vaccine in the morning around 10:00 AM on 3Mar2021. The pain started the same day on 03Mar2021, then stated that night after midnight and that she thought it would go away. The lump in the arm started a couple of days after the Pfizer COVID vaccine, she thought it was a couple of days but maybe sooner, she didn't pay too much attention. The patient stated the lump felt like it was the size of a nickel, she was pushing to try to feel it and that maybe the lump was a little larger than a nickel. Her shoulder aches and the feeling went into the arm and it started the same week she had the shot but that she didn't pay any attention so is not sure exactly when it started. It was best to check it out with her doctor. The outcome for event pain and vaccination site lump was not recovered, while for remains event was unknown. Information on the lot/batch number has been requested.
78 2021-05-07 itchy skin Dull headache; Extreme Itching skin; This is a spontaneous report from a non-contactable other healt... Read more
Dull headache; Extreme Itching skin; This is a spontaneous report from a non-contactable other healthcare professional (HCP, patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at right arm on 28Jan2021 11:45 AM, at single dose for COVID-19 immunization. Medical history included High blood pressure, known allergies to Sulfa drugs, shellfish. Patient is not pregnant. Concomitant medication included other medications in two weeks. No other vaccine in four weeks. Patient experienced dull headache for exactly 1 week. Extreme Itching skin from 1 week after and ongoing. Mostly in evening. event start date was 04Feb2021 07:00 PM. No covid prior vaccination. No covid tested post vaccination. No treatment received for the events. Patient was not recovered from the events. No follow-up attempts are possible, Information about batch/lot number cannot be obtained. No further information is expected.
78 2021-05-07 rash with redness First dose of BNT162B2 on 22Jan2021 13:00 and Second dose of BNT162B2 on 08Mar2021 15:00; First dose... Read more
First dose of BNT162B2 on 22Jan2021 13:00 and Second dose of BNT162B2 on 08Mar2021 15:00; First dose of BNT162B2 on 22Jan2021 13:00 and Second dose of BNT162B2 on 08Mar2021 15:00; red rash all over her body; This is a spontaneous report from two contactable consumers (patient and patient's husband). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on 08Mar2021 15:00 (lot number: EN6205) as single dose for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 22Jan2021 13:00 (lot number: EL9261) at single dose for COVID-19 immunization, and experienced red rash all over her body on 25Jan2021 09:00, had required visit to physician office, treatment with prednisone given, and was recovering. The patient experienced red rash all over her body on 08Mar2021 (reported at "09:00"), which required physician office visit, treatment received with Triamcinolone acetonide ointment. Red rash developed after 1st shot (also reported after 2 days) and after 2nd shot (also reported after 3 days) after vaccination. Doctors had her tab Prednisone. The rash had cleaned up, but 2nd shot caused reoccurrence. She is applying cream now. The outcome of the event red rash all over her body was recovering. No follow-up attempts are possible. No further information expected.
78 2021-05-10 shingles went in for her second dose on Tuesday she also got shingles; This is a spontaneous report from a co... Read more
went in for her second dose on Tuesday she also got shingles; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported same events for two patients (patient himself and his mom). This is the second of two reports. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 78 years of age), via an unspecified route of administration, administered in arm right on 13Apr2021 (Batch/Lot Number: ER8729) as 2nd dose, single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. Historical vaccine included BNT162B2 dose 1 on 22Mar2021 (lot number: EN6208) (at 78 years of age) for COVID-19 immunisation. The patient went in for her second dose on Tuesday, she also got shingles. It was mentioned that the patient recently got diagnosed today (unspecified) so she was not taking anything currently but she takes some antiviral (not sure exactly what it was). It was clarified that the patient had not yet taken treatment for the event but the reporting other healthcare professional was sure that she will be. The outcome of the event was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021381912 same reporter/drugs/events; different patients
78 2021-05-10 rash macular had blotches on her arm; This is a spontaneous report from a contactable consumer reported for herse... Read more
had blotches on her arm; This is a spontaneous report from a contactable consumer reported for herself. A 78-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Apr2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included the first dose of BNT162B2 for Covid-19 Immunization. The patient experienced had blotches on her arm on Apr2021. She went to the dermatologist Friday and she didn't think it was that. She stated now that she knows some people might have this, she might mention it to her. The dermatologist prescribed her with a cream. She stated the internet was saying take Allegra or Benadryl. How long does this last. She stated this was with her second dose of the vaccine on 01Apr2021, but this didn't show up until Thursday, 2 weeks later. Therapeutic measures were taken as a result of had blotches on her arm. Outcome of the event was unknown. No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
78 2021-05-10 vaccination site bruising Caller reports that her right arm is black and blue; This is a spontaneous report from a contactable... Read more
Caller reports that her right arm is black and blue; This is a spontaneous report from a contactable consumer (patient herself). A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications was not reported. Previously the patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient received the second dose of the Covid vaccine on Saturday. Her right arm was black and blue. When she received the first vaccine, she didnot feel anything. When the second vaccine was administered, it felt as they took a dart into her arm or punched her arm. She was unable to utilize her left arm, in which she was unsure if this could have occurred due to having the vaccine in the same arm both times. The outcome of the event was unknown. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
78 2021-05-10 vaccination site pain intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, j... Read more
intestinal problems after she eats, and feels like intestinal flu; Balance is off; feeling unwell, just didn't feel good/just hasn't felt right; bursitis in her hands./both of her arms that felt like bursitis; feeling weak, her legs, she could barely stand she had to go to bed; feeling weak, her legs, she could barely stand she had to go to bed; problems with her stomach, intestinal things, intestinal problems; problems with her stomach, intestinal things, intestinal problems further described as lower intestinal; joint pain/shoulders, knees and wrists hurt; Muscle pain; Tenderness; fever; weak; tired; Left arm hurt, injection site pain/tenderness at the injection site; This is a spontaneous report from a contactable consumer (patient) A 78-years-old female patient received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 05Apr2021 at 13:37 (Batch/Lot Number: EW0150; Expiration Date: 31Jul2021) as SINGLE DOSE for covid-19 immunization. The facility in which the vaccine was given was . Medical history included ongoing arthritis (If she does much your arms will ache/Doesn't take anything for her arthritis, her fingers and joints), hypersensitivity from an unknown date and unknown if ongoing allergy to milk , urticaria from an unknown date and unknown if ongoing (When she gets stressed she gets hives if she does not take her liquid Benadryl she will swell up) , covid-19 from Nov2020 to an unknown date Sick for 3 weeks/intestinal flu, diarrhea, couldn't eat anything/ test oxygen level; knuckles are so big it was registering like 76. Patient's doctor recommended the vaccine since she had Covid virus in Nov2020. Concomitant medication(s) included takes cholesterol and thyroid medication (details not provided); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication from an unspecified start date and ongoing; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication from an unspecified start date and ongoing; calcium (CALCIUM) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took influenza vaccine and experienced influenza, Previously took Aspirin and experienced angioedema. The patient experienced left arm hurt, injection site pain/tenderness at the injection site on 05Apr2021, fever, weak on 06Apr2021, weak, tired on 06Apr2021; joint pain/shoulders, knees and wrists hurt, muscle pain, tenderness on 08Apr2021, problems with her stomach, intestinal things, intestinal problems on 12Apr2021, intestinal problems after she eats, and feels like intestinal flu, balance is off, feeling unwell, just didn't feel good/just hasn't felt right,bursitis in her hands./both of her arms that felt like bursitis, feeling weak, her legs, she could barely stand she had to go to bed on an unspecified date. The adverse events did not require a visit to the Emergency Room or Physician's Office. The patient underwent lab tests and procedures which included body temperature: '100.57 ' fahrenheit on 06Apr2021. Clinical course was reported as follows the patient received the first Pfizer-BioNTech Covid-19 Vaccine on 05Apr2021. On the same day 05Apr2021 her left arm hurt, injection site pain. On 06Apr2021 in the afternoon she had a fever of 100.57 Fahrenheit. She was also very weak and had to lay down because she was tired. She had site pain, joint pain, and muscle pain. With the joint pain her wrists hurt, it was her shoulders, knees and wrists hurt. The tenderness at the site didn't go away until Sunday. She reported her problems with her stomach, intestinal things, intestinal problems, further described as lower intestinal. She started feeling weak, her legs, she could barely stand she had to go to bed. She was tired, started to get joint pain and feeling unwell, just didn't feel good. She felt that just to stand she would fall down, so she had to lie down. Her balance is off, and she felt weak for about 2-3 days, weak is not completely gone but noticed her balance is off a little bit which is ongoing. She just hasn't felt right since she's had the shot. With the muscle pain it felt like she had bursitis in her hands. She had tenderness at the injection site as well as in both of her arms that felt like bursitis, which went away on 12Apr2021 or 13Apr2021. She has intestinal problems after she eats, and feels like intestinal flu. Someone saw her and said she looks tired. On 7Apr2021, she had a visit from the the insurance company doctor and he recommended her not to take the second shot, and that's why she called Pfizer. The second dose of Pfizer-BioNTech Covid-19 Vaccine is due on 26Apr2021 but she's not sure she wants to because she is still recovering from the first one. The clinical outcome of the events Joint Pain, Muscle pain recovered on 12Apr2021, Vaccination site pin Recovered 10Apr2021, Fever recovered 06Apr2021, Weak, tired, balance is off, feeling unwell, just didn't feel good, intestinal problems after she eats, and feels like intestinal flu was unknown, Tenderness was recovered Apr2021, problems with her stomach, intestinal things, intestinal problems was not recovered
78 2021-05-14 skin irritation, itchy skin A severe irritation, burning and itching all over legs and arms. It was like a sun poisioning or sev... Read more
A severe irritation, burning and itching all over legs and arms. It was like a sun poisioning or severe sunburn. Dermatologist treated me with a steroid shot and betamethasone cream. Followed up with dermatologist a week later and it had improved but was not fully healed.
78 2021-05-18 eczema, rash Rash with plaques that began on arms less than one week post first Covid-19 vaccination, that contin... Read more
Rash with plaques that began on arms less than one week post first Covid-19 vaccination, that continued to spread to legs shortly after. Patient had Lachydren lotion at home, which she began applying before her appointment with her dermatologist, Dr. . At the time of the patient's Dermatology appointment, she was prescribed Betamethasone, Augmented cream to apply BID & refilled Lachydren, and also given an IM injection of Kenelog 40mg.
78 2021-05-18 rash INTERMITTENT BILATERAL PATCHY ARM RASH
78 2021-05-19 rash Rash; This is a spontaneous report from a non-contactable nurse. A 78-years-old female patient recei... Read more
Rash; This is a spontaneous report from a non-contactable nurse. A 78-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), intramuscular on an unspecified date (at the age of 78-years-old) as 1st dose, single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash, developed the next day after receiving her first Pfizer vaccine, occurring across her midsection of abdomen. It lasted for 2 weeks. No other problems with the vaccination. Reports that her physician recommended that she continue with second dose as scheduled. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.
78 2021-05-24 injection site pain 1 week later - aches (arthritis was worse), leg cramping, general feeling of being unwell seems to c... Read more
1 week later - aches (arthritis was worse), leg cramping, general feeling of being unwell seems to come and go still having pain in arm where injection was
78 2021-05-27 shingles sounded like she had shingles; severe pain up her back that goes to her upper torso, left side only;... Read more
sounded like she had shingles; severe pain up her back that goes to her upper torso, left side only; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01Mar2021 (Batch/Lot Number: Unknown) as 1ST DOSE, SINGLE for covid-19 immunisation (Age at vaccination: 78 years). Medical history included ongoing diabetes mellitus, ongoing degenerative joint disease, ongoing osteoarthritis and ongoing heart disorder. Concomitant medications included tramadol; pregabalin (LYRICA); gabapentin (GABAPENTIN "PCD"). The patient experienced severe pain up her back that goes to her upper torso, left side only on 03Mar2021. The patient also stated that she had sounded like she had shingles on an unspecified date. They felt that the vaccine was trying to fight the shingles virus that stays in her body. She has no bumps, fever or breakout. She went to the Emergency Room once to get pain medicine. She went to her doctor (physician office visit), she doesn't know if he reported this. The events were assessed as medically significant. The patient underwent lab tests and procedures which included MRI, scan and x-ray: unknown results on an unspecified date. Therapeutic measures were taken as a result of pain and shingles. Outcome of the events was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
78 2021-05-31 itchy skin, rash Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction... Read more
Shortness of breath, extremely tired, chills. nausea, feeling unwell, lymph nodes, allergic reaction such as rash, extreme itching, swelling of face, loss of taste and smell, severe congestion upon awakening. PCP is out of town entire month of June. Sick of being sick. Must be remedy to all of this! Am not recommending to my friends. I should have never had second vaccination.
78 2021-06-01 injection site pain Patient said shot hurt badly, arm was sore but felt better after 15 minute observation time. Patient... Read more
Patient said shot hurt badly, arm was sore but felt better after 15 minute observation time. Patient was able to grocery shop after and felt fine. She started to feel bad later in the day and went to bed around 8PM. Patient says she could not sleep, dozed on and off and had chills and sweats. When she woke up at 5:30AM, she said her legs felt like they had been crushed, she was in extreme pain and her legs felt paralyzed and she could not move them an inch. She had to use her arms to move her legs. She states it took her an hour to get to a chair. She sat in the chair for 45 minutes and was then able to gradually prop herself up to a dresser and eventually made it to her bathroom. Her condition gradually improved over time and she was able to walk much better on 5/29, Today she reports no leg pain, but reduced energy levels.
78 2021-06-01 itchy skin, eczema, hives On Wednesday 5/26, days after vaccination I started having a itch on my chin, then a welt appeared a... Read more
On Wednesday 5/26, days after vaccination I started having a itch on my chin, then a welt appeared and another one came up shortly after. By Friday it spread and got red and itched. The ones that camp on my had itched and on Friday 5/28 my hands started itching and it looked like a beginning of a chicken poc and that evening there was a sore spot by left nostril the spot looked like what was on my hand and it is spreading on my breast, shoulder. On 5/31 there was a spot on my belly button and on the right side of my leg by my groin the red mark was the size of my hand, and on my waist line, then more of the blistery bumps come up on check on face and around right side of my lip and chin and chin line on left side. The doctor provided a steroid cream. I was diagnosed with Hydyshydistic Eczema
78 2021-06-01 hives, rash, itchy skin rash/hives all over her body, rash became worse; rash/hives all over her body; Itching; This is a sp... Read more
rash/hives all over her body, rash became worse; rash/hives all over her body; Itching; This is a spontaneous report from a contactable consumer for mother. A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/ Lot number and Expiry date was unknown), via an unspecified route of administration, on 22Jan2021, as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient got her first Pfizer Covid vaccine on 22Jan2021 and her second dose of vaccination was due on 12Feb2021. On 22Jan2021, after 1.5 hours receiving the first dose of vaccination, patient developed a rash/hives all over her body (not much on her face, but all over the rest of her body). Patient's HCP recommended Zyrtec that day for the rash and then overnight it became worse, after then HCP prescribed prednisone and hydrocortisone for the itching and Benadryl. After receiving 4 days of steroids, it started to clear up in about a day or 2. Patient was scheduled for second dose on 12Feb2021 and inquired whether she can receive the dose. The outcome of the event was reported as recovered on unknown date in 2021. Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
78 2021-06-03 bruising, haematoma syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural h... Read more
syncope; Acute subarachnoid hemorrhage involving both hemispheres; acute on chronic right subdural hematoma up to 7 mm thick; hemorrhagic contusion with edema; hemorrhagic contusion with edema; fatigue; malaise; HA; This is a spontaneous report from a contactable physician. A 78-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 21Feb2021 (Lot Number: EN6200) (at the age of 78-year-old) as single dose for COVID-19 immunisation. Medical history included hypertension (HTN), hyperlipidemia (HDL) and hypothyroidism, all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination the patient has not been tested for COVID-19. The patient previously took SSRI, PNC (unknown), sulfa and oxycodone; the patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm left on 31Jan2021 (Batch/Lot Number: EL9265) as single dose for COVID-19 immunisation. Within 12 hours of vaccine (on 22Feb2021) the patient developed symptoms of fatigue, malaise, headache (HA) and severe and near syncope. She visited the emergency department (ED) the following day. Work up at that time including blood work and no imaging. She was treated with IVFs and discharged. Symptoms of malaise, fatigue and HA persisted for > 1 week. A computerized tomogram (CT) of the head was performed on 05Mar2021, this CT showed the following: acute subarachnoid hemorrhage involving both hemispheres; acute on