chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives over back, sides and stomach/he has hives on his back, chest, legs and arms; This is a spontaneous report from a contactable consumer. A 33-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205, Expiration date: 30Jun2021), via an unspecified route of administration on 04Mar2021 09:30 AM (left arm) as a single dose for COVID-19 immunization. The patient medical history included obesity, sleep apnea, acid reflux, and triglycerides high. Concomitant medications included fenofibrate, omeprazole ongoing for acid reflux, fish oil (FISH OIL OMEGA 3) at 300 mg twice a day, and multivitamin. The patient previously took clindamycin and cyclobenzaprine and had allergy. The patient stated, "I ended up getting hives 10 or 11 hours after I received Pfizer-COVID-19 Vaccine (first dose at 9:30 am 04Mar2021)". It was reported that, about 10 hours after he received the injection, he had hives breakout on his back. They seem to reappear everyday around 4:00 PM or 5:00 PM since this past Thursday. They don't show up in the same spot. He felt that the vaccine was working in his body because he had hives on his back, chest, legs, and arms. On 04Mar2021, he got it at approximately 9:30 AM. He noticed everything starting to itch around 8 PM. On day 1 his entire back was covered. On day 2 it was more about 50 % and then 25 % on the arms and chest. It was better from the first day, but it still hadn't gone away. He did have reactions to two things a while back. They were both listed on the form he gave the person administering the vaccine. It was not a concern listed online. The reaction he had was jitteriness from a muscle relaxer. The name of the muscle relaxer started with a C, but he didn't remember. He didn't have the lot number for the muscle relaxer. He couldn't remember what the other medication was he had a reaction to. It had been 10 years or so. He wanted to get the second vaccine and he was not sure if Pfizer would see something that would prevent him from getting it. He went the next day and got a Prednisone shot at his PCP's office. He did not have the NDC, lot, and expiry for the Prednisone shot. His sister got the same dose somewhere else and had no reaction. His mom didn't have any reaction. Caller clarified what information he was looking for. The nurse practitioner told him not to get it. His PCP told him he should. He was reading conflicting things online. Some said hives were serious and some said mild reaction. He was trying to understand how severe of a reaction it was and should he get it based on Pfizer's studies. The outcome of the event was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain, SARS-CoV-2 antibody test
Clinical narrative: He suddenly became sick; pain; This is a spontaneous report from a Pfizer sponsored program. A contactable male consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient suddenly became sick on 30Jan2021 and tested positive for COVID on 02Feb2021. He took some prednisone and some other medications for pain. Given his situation, he was given an infusion of antibodies by his HCP. Then, he was advised to stay at home for an 8-9 day-quarantine. Now, he wondered known when he should be able to take his next dose of the vaccine sometime in May2021, if he should take it at all. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 48 hours after the second injection, I developed hives all over my forearms, chest, and back. It lasted for 48 more hours until it faded; This is a spontaneous report from a contactable Other HCP. This 72-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration, in left arm on 26Feb2021 12:45 (at age of 72 years) as single dose for covid-19 immunization. Medical history included barretts esophogus, gastrooesophageal reflux disease (GERD). The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: 229264) via an unspecified route of administration, in left arm on 05Feb2021 12:30 as single dose for covid-19 immunization. It was reported that hours after the second injection, on 28Feb2021 patient developed hives all over my forearms, chest, and back. It lasted for 48 more hours until it faded. In general, whenever patient get sick with a virus, his body mounts an immune response and break out in hives for several days. This post vaccine outbreak was similar but only lasted 2 days. Patient assumed his body was mounting an immune response to the injection. Patient did not seek treatment as he was familiar with this reaction and just took Benadryl. No COVID prior vaccination. No COVID tested post vaccination. The clinical outcome of the event was resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Started getting hives; This is a spontaneous report from a non-contactable consumer (patient). A patient an unknown age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on an unknown date as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient has the Pfizer first dose, the vaccine on Sunday. About an hour after the patient received the vaccine and started getting hives on an unspecified date and started taking Benadryl (treatment) and it helped. The patient just doesn't know, is that something should be concerned about for the second dose. The patient stated no and just need to talk to someone, don't want to follow up, just want to somebody to tell the patient what if going forward (sentence incomplete). The patient doesn't want to be the part of any survey. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: tiny hives starting inside of knees on both legs-spreading to thighs; This is a spontaneous report from a contactable consumer. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Mar2021 08:30 AM as a single dose for covid-19 immunisation. The patient medical history included allergies to sulpha drugs, shellfish, gluten. Concomitant medication included levothyroxine daily. It was reported that, the patient had tiny hives starting inside of knees on both legs - spreading to thighs 3-4 hours after injection on 07Mar2021 12:00 PM. No therapeutic measures were taken. The outcome of the event was not recovered at the time of report.  No Follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: 5-10 minutes after injection, I noticed a small, itchy bump on my forehead-it feels like a tiny hive; the itching mostly subsided after an hour or so.I had no definite symptoms, but did feel a bit of rash around same time; This is a spontaneous report from a contactable consumer (patient). This 65-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot Number: EN6199), via an unspecified route of administration, in left arm on 07Mar2021 18:30 (at the age 65 years) as single dose for covid-19 immunisation. Medical history included irritable bowel syndrome, possible pityriasis lichenoides, respiratory allergy (many respiratory allergies, some of them severe), skin tests for food allergies (had strong reactions to many food, sunclear whether those are allergies), ragweed allergy (treated for years & a few times had strong reactions to those shots (not anaphylaxis)). Concomitant medications included montelukast; budesonide (NASOCORT) and cetirizine. It was reported that 5-10 minutes after injection, on 07Mar2021 18:45 patient noticed a small, itchy bump on my forehead -it felt like a tiny hive. The itching mostly subsided after an hour or so. Patient had no other definite symptoms but did feel a bit of a rush (maybe like feel when he take sudafed) around the same time. The clinical outcome of the events was resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I noticed hives on my torso at 4:00pm the following day.  They have gotten worse over the past week.; This is a spontaneous report from a contactable consumer (patient herself). A 45-years-old female patient (non-pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot Number: EN6203), via an unspecified route of administration on 01Mar2021 17:45 as SINGLE DOSE for covid-19 immunisation. Medical history reported as none. No Known allergies. Concomitant medication included ascorbic acid (VIT C). The patient noticed hives on her torso at 4:00 pm the following day on 02Mar2021. They have gotten worse over the past week. The patient received prescription cream, OTC allergy medicine for the event as a treatment for the event.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Urticaria
Clinical narrative: hives on my elbows and back of my thighs.; legs and arms felt like pins and needles; This is a spontaneous report from a contactable consumer (Patient). A 63-year-old non- pregnant female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 07Mar2021 09:15 (Lot Number: EN6206) (at the age of 63-year-old) as single dose for covid-19 immunisation. Medical history included Chronic hives, osteoporosis and known allergies to Penicillin. Concomitant medication included omalizumab (XOLAIR) from 01Mar2021 to 01Mar2021 (dose number 4) single. After 14 hours of receiving the covid shot patient woke up on 08Mar2021 at 12:00 with hives on her elbows and back of her thighs. Her legs and arms felt like pins and needles and her breathing was normal however she was aware of each breath her took. After two hours, the hives calmed down and her legs and arms were fine, her breathing was back to normal. She went back to sleep and woke 5 hours later, hives hardly noticeable, and she feel fine. She will contact her doctor day of report, too see what he recommends about taking the 2nd Shot. No treatment received for the events. Outcome of the events was recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Urticaria
Clinical narrative: welts/got welts on her neck; painful; This is a spontaneous report from a Pfizer Sponsored Program. A contactable female consumer (patient) of an unspecified age received the bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: Unknown) via unspecified route of administration on an unknown date as first dose, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, patient got the first covid vaccine. Last 2 days she got welts on her neck. It was painful. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on 02Mar2021 18:00 (Batch/Lot number was not reported) (at the age of 57-year-old) in arm left as an unknown, single dose for covid-19 immunisation. Medical history included cancer, and high blood pressure. No prior covid vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received amoxicillin and experienced allergies. The patient broke out in hives on 03Mar2021, one day after injection and it lasted for two days. The patient used self-prescribed Benadryl as treatment. The patient was not tested for covid post vaccination. No other vaccine used in four weeks. The outcome of the event was resolved on 05Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Urticaria
Clinical narrative: On the 6th day at night I got hives on my legs; noticed red very tiny dots on my upper thighs; It's been almost 24 hours and still itchy and has sporadic hives appear and then slowly resolved; This is a spontaneous report from a contactable consumer (patient herself). A 29-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left in Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included Bronchial Asthma, Endometriosis, allergy to cat, allergy to Dog, Seasonsonal allergy, Papaya allergy and hazelnuts allergy. Concomitant medication included escitalopram oxalate (LEXAPRO); alprazolam (XANAX); ibuprofen (ADVIL).  The patient previously took sulfamethoxazole trimethoprim (BACTRIM) and experienced known allergies, dicycloverine hydrochloride (BENTYL) and experienced known allergies. On the 6th day, on 07Mar2021 at night 12:00 patient got hives on her legs and also noticed red very tiny dots on her upper thighs. It's been almost 24 hours and still itchy and has sporadic hives appear and then slowly resolve. The patient received Benadryl/allegra as a treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Chest discomfort, Cough, Fatigue, Laryngeal pain
Clinical narrative: Cough and it is not like usual coughs; it seems odd; heaviness at top of my chest or bottom of my throat that could be when I cough; was like an attack; Cough and it is not like usual coughs; it seems odd; heaviness at top of my chest or bottom of my throat that could be when I cough; was like an attack; Cough and it is not like usual coughs; it seems odd; heaviness at top of my chest or bottom of my throat that could be when I cough; was like an attack; Aching in my body; Extreme tiredness; Never went to sleep because started aching all over my body; This morning my temperature was 99; This is a spontaneous report from a contactable consumer (patient). A 97-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. Medical history included macular degeneration, hearing problem, and COVID-19 (when patient got the injection, patient already had the virus). The patient's concomitant medications were not reported. After vaccination, patient never felt a thing, for may be 4 or 5 days and all of a sudden about 3 or 4 days ago, patient had a cough and it was not like the usual coughs that patient got where patient can blame it on anything. Well than patient was having a little aching in body. Now this was in last 3, 4 days and back and from side, it was a different thing. Now patient will get to point, last night, last evening, all around 7 o'clock, patient really noticed a lot of aching and at 9 o clock patient went to bed because patient just felt have to and tiredness, extreme tiredness and then patient never went to sleep because patient started aching all over body and patient got up about 7 times during the evening. Now when patient got up this morning, patient have definitely improved. Right now, patient could not say really say that patient was aching noticeably anywhere. Patient was almost wondering when patient got the virus do not see the symptoms for a while and patient thought what if patient got the virus and when patient went in and got the injection patient already had the virus. Temperature was 90, last night it was 98. This morning it was 99 and patient felt a little bit nothing to talk about. A little bit of heaviness at the top of chest or the bottom of throat but that could be when patient cough like this to show patient can cough. So patient thought it was better to check and see if should Ignore all this because definitely what happened last night was almost like an attack, it is gone now, aching all over body. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Temperature perception test increased
Clinical narrative: Cough and it is not like usual coughs; it seems odd; heaviness at top of my chest or bottom of my throat that could be when I cough; was like an attack; Cough and it is not like usual coughs; it seems odd; heaviness at top of my chest or bottom of my throat that could be when I cough; was like an attack; Cough and it is not like usual coughs; it seems odd; heaviness at top of my chest or bottom of my throat that could be when I cough; was like an attack; Aching in my body; Extreme tiredness; Never went to sleep because started aching all over my body; This morning my temperature was 99; This is a spontaneous report from a contactable consumer (patient). A 97-year-old patient of unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for covid-19 immunisation. Medical history included macular degeneration, hearing problem, and COVID-19 (when patient got the injection, patient already had the virus). The patient's concomitant medications were not reported. After vaccination, patient never felt a thing, for may be 4 or 5 days and all of a sudden about 3 or 4 days ago, patient had a cough and it was not like the usual coughs that patient got where patient can blame it on anything. Well than patient was having a little aching in body. Now this was in last 3, 4 days and back and from side, it was a different thing. Now patient will get to point, last night, last evening, all around 7 o'clock, patient really noticed a lot of aching and at 9 o clock patient went to bed because patient just felt have to and tiredness, extreme tiredness and then patient never went to sleep because patient started aching all over body and patient got up about 7 times during the evening. Now when patient got up this morning, patient have definitely improved. Right now, patient could not say really say that patient was aching noticeably anywhere. Patient was almost wondering when patient got the virus do not see the symptoms for a while and patient thought what if patient got the virus and when patient went in and got the injection patient already had the virus. Temperature was 90, last night it was 98. This morning it was 99 and patient felt a little bit nothing to talk about. A little bit of heaviness at the top of chest or the bottom of throat but that could be when patient cough like this to show patient can cough. So patient thought it was better to check and see if should Ignore all this because definitely what happened last night was almost like an attack, it is gone now, aching all over body. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives; Rashes; This is a spontaneous report from a contactable consumer. A 76-year-old female patient received bnt162b2 (BNT162B2, Solution for injection; Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications include "Vitamins". On an unknown date patient experienced hives, rashes. I am calling to report the side effects I have been experiencing since my second Pfizer vaccination on 27Feb. When probed about the side effects, consumer stated, "Hives, rashes, mainly hives and rashes. I am still experiencing 17-18 days later flare-ups". Consumer stated, "lot number looks like ENG201". Consumer stated, "Yes and they kicked in 26 hours after I had the shot. That's when I had my first flare-up, the following day and nothing at all at the site of the actual injection, no swelling or rash but I took Benadryl and probably Loratadine, just one of each for the next 2 days. And these are questions you need to hear or reasons you need to hear or if somebody else is going to be interviewing me, so tell me if you don't need to hear, the flare-up occurred for 5 days and then there was a break of 2 days but nothing happened. That took to 7 days but then it reappeared and I have had these flare-ups everyday for the last 10 days right up to today". Consumer stated, "I would like to know if I am supposed to be taking anti-histamines since the condition continues because I'm not doing, they do go away only to reappear a few hours later in a different part of the body, the rashes, the hives". The outcome for the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: severe hives; skin rash on arms; This is a spontaneous report from a contactable consumer (patient), in response to Non-HCP letter sent in cross-reference case. An 86-year-old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EN6200 and Expiration date was not reported), via an unknown route of administration in right arm on 16Feb2021, as 2nd DOSE, SINLE for COVID-19 immunization. The patient received of BNT162B2 (Lot number: EN5318 and Expiration date was not reported), dose 1 via an unknown route of administration in right arm on 26Jan2021, as SINGLE DOSE for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On 17Feb2021 the patient experienced severe hives and skin rash on the arm day after second dose of vaccination, mostly in the arms. Skin doctor recommended vera cream, anti itch pill, an ointment. Patient was still experiencing the event. The patient visited physician office for treatment of events. There was no surgery planned prior to vaccination. There were no predisposing factors, and no culture was performed. The outcome of the event was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: welts; welts that are very itchy; burning sensation; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) as a single dose for Covid-19 immunization. It was reported that the patient had a reaction to second dose of covid vaccine. Patients entire body has raised welts as a result of shot. This is not a rash but welts that are very itchy and have a burning sensation. Patient have taken photos and would like the opportunity to send them to Pfizer. Patient don't have medical insurance so I am unable to have a doctor certify my condition. This side effect must be entered in CDC data to warn potential patient side effects. The outcome of events was unknown.  No follow-up attempts are possible;information about lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: experiencing hives after getting the first dose; This is a spontaneous report from a Pfizer Sponsored program. A contactable female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date, the caller (name) is experiencing hives after getting the first dose. Offer to cold transfer to DSU, but the caller wanted to callback instead. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives within minutes of the injections; Chills; massive headache; back pain; This is a spontaneous report from a contactable consumer. This 40-year-old non-pregnant female consumer (patient) received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 at 03:00 PM (Batch/Lot Number: Ec3247) in hospital as SINGLE DOSE for COVID-19 immunization. Medical history included known allergies: mushrooms, break out in hives on morphine and oxycontin. The patient's concomitant medications were not reported. The patient previously took morphine and oxycontin, experienced urticaria with both. No other vaccine reported in four weeks and two weeks. The patient experienced hives within minutes of the injections, chills, massive and back pain on 04Feb2021 03:15 PM. The patient underwent lab tests and procedures which included COVID tested: negative in 2021. The patient was treated with Benadryl and Tylenol. Outcome of the event was recovered on 10Feb2021, side effects last about 5 days.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache
Clinical narrative: light headaches; This is a spontaneous report from a contactable consumer or other non-Health Professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 02Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021 the patient experienced light headaches. Patient was asking if it's okay to take Tylenol to relieve the pain (she did not took any medications yet). The outcome of event was unknown.  Information on the lot/batch number is requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on lower arms starting 2 weeks after 1st dose; This is a spontaneous report from a contactable consumer. A 23-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 10Feb2021 as a single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included oral contraceptive. It was reported that, the patient had hives on lower arms starting 2 weeks after 1st dose on 24Feb2021. It was also reported that, the patient received second dose of BNT162B2 on 03Mar2021 (left arm). The outcome of the event was not recovered at the time of report.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives - within 5 minutes of receiving vaccine developed hive on right forearm, then developed several others on both left and right arms; This is spontaneous report from a contactable consumer (patient). A 59-year- old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6199), via an unspecified route of administration on 06Mar2021 18:30 at left arm as a single dose for COVID-19 immunisation. The patient medical history included allergy to sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID 19. Since the vaccination, the patient had not been tested for COVID 19. Concomitant medications included paracetamol (TYLENOL) and vitamin D3. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took cefalexin monohydrate (KEFLEX) and ciprofloxacin (CIPRO) and had allergy with both the drugs. It was stated that the patient experienced hives- within 5 minutes of receiving vaccine developed hive on right forearm, then developed several others on both left and right arms on an unknown date in 2021. Therapeutic measures received for the event included that within 60 mins the patient took 12.5 mg antihistamine. The outcome of hives was recovered on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Urticaria
Clinical narrative: Itchy welts and rash on neck, trunk, arms, legs face.; Itchy welts and rash on neck, trunk, arms, legs face.; Itchy welts and rash on neck, trunk, arms, legs face.; Patchy clusters or individual spots. Last 2-3 weeks.; This is a spontaneous report from a contactable consumer (patient herself). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection; Batch/Lot Number: EL9267), via an unspecified route of administration, administered in Arm Left on 03Mar2021 13:00 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: unknown;) for COVID-19 immunisation. The patient experienced Itchy welts and rash on neck, trunk, arms, legs face. Patchy clusters or individual spots. Last 2-3 weeks on 05Mar2021 07:00. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a non-contactable consumer. A 61-year-old male patient received first dose of BNT162B2 (COMIRNATY, Solution for Injection, Batch/Lot Number: unknown, Expiration Date: Unknown), via unspecified route of administration on right arm on 07 Mar 2021 for COVID-19 immunization. The patient medical history was not reported. The patient was allergic to strawberries, latex. The patient's concomitant medications were not reported. Patient had no other vaccine in four weeks. The patient had no COVID-19 prior vaccination nor tested post vaccination. On 08 Mar 2021 the patient experienced breaking out in big hives, right shoulder, under right arm, left shoulder. Some hives round, some square, some long and thin after 30 hours of vaccination. The outcome of the event was not recovered. Treatment for the event taken by the patient included hydrocortisone cream as self application. No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Urticaria
Clinical narrative: Four inch raised red welt across abdomen; Four inch raised red welt across abdomen; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received bnt162b2 (BNT162B2, Solution for injection; Batch/Lot Number: EV6199), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 14:00 as SINGLE DOSE for covid-19 immunisation. The patient's Medical history and concomitant medications were not reported. The patient was not pregnant. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The patient previously took "BNT162B2" on 10Feb2021 at 67 years for "COVID-19 immunisation" (product=COVID 19, brand=Pfizer, lot number=EM9809, lot unknown=False, administration date=10Feb2021, administration time=03:00 PM, vaccine location=Left arm, dose number=1). On 03Mar2021 15:00 patient experienced four inch raised red welt across abdomen. No treatment was provided for the events. The outcome for the events was recovered on 03Mar20201 16:00.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: noticed a dime sized thing that looks like hive on her body going towards back and arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date: not reported) via an unspecified route of administration on 28Feb2021 as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication was not reported. It was reported that she felt fine until yesterday, she noticed a dime sized thing that looks like hives on her body going towards her back and arm. She said there are more now. It's multiplying. She has second dose on 21Mar. She wants to know what to do and if it may be related to the vaccine. She does take a blood thinner. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pyrexia
Clinical narrative: Headache; Chill; Fever; Slight joint pain; This is a spontaneous report received from contactable consumer (husband reporting for her wife) via contactable Pfizer Sponsored Patient Assistance Program . A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on 05Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Mar2021 the patient experienced headache, chill, fever and slight joint pain. The outcome of events unknown.  Information on the lot/batch number has been requested  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vomiting
Clinical narrative: large hives covering the trunk, arms, and upper legs; Vomiting; This is a spontaneous report from a contactable (Patient, self-reported). A 54-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Right on 01Mar2021 11:45 as 2ND DOSE, SINGLE; dose 1 of bnt162b2 (lot number: EL9269), via an unspecified route of administration, administered in Arm Left on 08Feb2021 11:45 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient did not have any relevant medical history. Concomitant medications included vitamin d [vitamin d nos]. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has not been tested for COVID-19, post vaccination. Reportedly, patient had daily episodes of large hives covering the trunk, arms, and upper legs. These started on the evening of 05Mar (accompanied by one episode of vomiting that night). The hive appear every evening between about 4-9 pm and last for several hours. By the morning, they are gone and I feel normal - no evidence of the hives. Then they redevelop in the evening. Vomiting was only the first day of the hives. The hives have appeared for 7 evenings in a row, always going away overnight and redeveloping the next day. Patient finally purchased some Benadryl five days. A couple of doses seem to blunt the hives within approximately an hour. Patient sometimes need to take another dose a few hours later. patient went to urgent care today, 11Mar, and was put on Prednisone. The episode tonight has not been nearly as significant as the past ones. On 05Mar2021 18:00, the patient experienced large hives covering the trunk, arms, and upper legs and vomiting. Therapeutic measures were taken as a result of large hives covering the trunk, arms, and upper legs, vomiting. Outcome of the event large hives covering the trunk, arms, and upper legs was not recovered, for vomiting was recovered on 05Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on my neck; This is a spontaneous report from a contactable consumer (the patient). A 31-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6201), via an unspecified route of administration in left arm on 11Mar2021 at 10:00 (at the age of 31-years-old) as a single dose for COVID-19 immunization. Medical history included asthma. Patient was allergic to Augmentin. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING), albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]).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. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. On 12Mar2021 at 05:00, the patient experienced hives on neck. The patient did not receive any treatment for the adverse event. The event was assessed as non-serious. The outcome of event was recovering.   Information on the expiration date has been requested.   Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Dysphagia, Pain in extremity, Swelling, Upper-airway cough syndrome
Clinical narrative: hives; swelling; metallic post nasal drip and having trouble swallowing.; metallic taste in throat; trouble swallowing/ hard to swallow; experienced very little pain in my arm; This is a spontaneous report from a contactable consumer or other non hcp.  A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing vioxx ,asthma from an unknown date and unknown if ongoing , allergy to arthropod sting from an unknown date and unknown if ongoing. Concomitant medication included rofecoxib (VIOXX) taken for an unspecified indication, start and stop date were not reported.  The patient experienced hives, swelling, metallic postnasal drip and having trouble swallowing., metallic taste in throat, trouble swallowing/ hard to swallow, experienced very little pain in my arm on an unspecified date. . I sat down for 15-30 minutes to monitor. I do have an allergy to bee sting and to 1 prescription drug:  vioxx but they took it off the market. I got hives and swelling.  I have asthma. Within 10-12 minutes; 15 minutes at the most I had a metallic postnasal drip and having trouble swallowing took me outside and told me to take off my double mask and was trying to get air into me. I had no intervention, no anaphylactic reaction. 10 minutes after that it dissipated totally. I experienced very little pain in my arm. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; swelling; metallic post nasal drip and having trouble swallowing.; metallic taste in throat; trouble swallowing/ hard to swallow; experienced very little pain in my arm; This is a spontaneous report from a contactable consumer or other non hcp.  A 64-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing vioxx ,asthma from an unknown date and unknown if ongoing , allergy to arthropod sting from an unknown date and unknown if ongoing. Concomitant medication included rofecoxib (VIOXX) taken for an unspecified indication, start and stop date were not reported.  The patient experienced hives, swelling, metallic postnasal drip and having trouble swallowing., metallic taste in throat, trouble swallowing/ hard to swallow, experienced very little pain in my arm on an unspecified date. . I sat down for 15-30 minutes to monitor. I do have an allergy to bee sting and to 1 prescription drug:  vioxx but they took it off the market. I got hives and swelling.  I have asthma. Within 10-12 minutes; 15 minutes at the most I had a metallic postnasal drip and having trouble swallowing took me outside and told me to take off my double mask and was trying to get air into me. I had no intervention, no anaphylactic reaction. 10 minutes after that it dissipated totally. I experienced very little pain in my arm. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on both sides of face/hives on both sides of the face about 48 hours after injection; This is a spontaneous report from a contactable consumer (patient). A 64-year-old non-pregnant female consumer (patient) received her first dose of BNT162B2 (Pfizer COVID-19, Solution for injection, Lot number: UNKNOWN) via an unspecified route of administration into the left arm on 12Mar2021 14:45 (at the time of 64-year-old) as single dose for COVID-19 immunisation. Medical history included celiac, obese, dust and mite allergies and known allergies to sulfa drugs. Prior vaccination, the patient had no covid. Post vaccination, patient not tested for covid. Facility type vaccine was hospital. No vaccine received in four weeks. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), zolpidem (MANUFACTURER UNKNOWN) and clozapine (MANUFACTURER UNKNOWN), all for an unspecified indication, from unknown dates and unknown if ongoing. On 14Mar2021 14:00, the patient reported of hives on both sides of the face about 48 hours after injection. She received treatment with Benadryl itch original strength itch cream. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives, 1 - 3 inches; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an intramuscular route on 10Mar2021 at 02:30 pm, in the left arm as a single dose for COVID-19 immunization. The patient had no known allergy. The patient's medical history included No spline, blood disorder, diabetes. The patient concomitant medications were Metformin 500mg, Lisinopril 2.5 mg, Rosuvastatin 5. Patient was not tested positive for Covid prior vaccination and post vaccination. Patient's 4 weeks prior vaccination included Hepatitis B 2nd shot on 18Feb2021. On 11Mar2021 at 04:00 pm, the patient experienced hives of size 1 to 3 inches. The patient was treated with Cetrizine 10mg and Hydroxyzine 25 mg for the events. The outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over my body; This is a spontaneous report from a contactable consumer, the patient. A 33-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration, administered in left arm on 13Mar2021 13:30 (at the age of 33-years-old) as a single dose for covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient medical history was not reported. There were no concomitant medications. The patient previously took tylenol and experienced drug hypersensitivity. The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. 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 13Mar2021 16:00, the patient experienced hives all over my body as resulted in emergency room visit and was treated with benadryl. It started 3/4 hours after the vaccine and it has carried on over the next two days. Outcome of the event was recovering. No follow-up attempts are possible; information about lot/batch number cannot been obtained.