chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergies; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer reported that a female patient of an unspecified age received BNT162B2 via an unspecified route of administration on 01Mar2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient was needed to take Zyrtec (antihistamine) for her allergies. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested Covid positive/extreme tiredness, and was sleeping a lot, with terrible body aches and pains; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she wanted to reschedule her 2nd vaccine shot. The first dose was on 08Mar2021 and her next dose was supposed to be on 29Mar2021. The reason for her rescheduling was that she contracted COVID infection after having the first dose. She tested COVID positive last 10Mar2021. The advice to reschedule came from her doctor. The patient experienced extreme tiredness, and was sleeping a lot, with terrible body aches and pains. These have now subsided, but she was still not feeling 100% better. The patient underwent lab tests and procedures which included COVID test result positive on 10Mar2021. The outcome of the event was unknown.  Medical Information: Were any unaddressed medical questions referred or forwarded to Medical Information No  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This is a spontaneous report from a contactable consumer (Patient) via Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient stated that the 2nd dose of the Covid vaccine gave her hives because it contains preservatives. They advised that the vaccine does not contain preservatives and she told that was wrong and that it says differently on the Pfizer website. The outcome of event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Influenza like illness, Nausea
Clinical narrative: have had liquid diarrhea for the last 3 days; tired/feeling weak; Headache; flu like; nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old female patient (who was not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), first dose via an unspecified route of administration in Arm Left on 22Mar2021 10:15 as 1ST DOSE, SINGLE at pharmacy store for covid-19 immunisation. Medical history included hypertension, sleep apnoea syndrome, and drug hypersensitivity with penicillin. Concomitant medications included benazepril taken for an unspecified indication, start and stop date were not reported. Post vaccination patient was not diagnosed or tested for COVID-19 at the time of vaccination. Patient did not receive any other vaccinations with in 4 weeks time of vaccination. Patient received benazepril in two weeks of vaccination. Vaccine Facility ,Ethnicity and Race information was available.The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or congenital anomaly/birth defect. On 22Mar2021 the patient experienced headache, flu like, nausea, tired, feeling weak. On 25Mar2021 the patient had liquid diarrhoea lasting three days. No treatment was received for the events. The outcome of the events were not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3248), via an unspecified route of administration on 11Mar2021 09:00 (at the age of 52-years old) at 1st dose, single dose in the left arm for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications (reported as no other medications in two weeks) The patient was not pregnant at the time of vaccination and had no COVID prior vaccination. The patient also had no other vaccines in four weeks. On an unspecified date, the patient experienced fatigue. The patient received no treatment for this event. The patient has not tested for COVID post-vaccination. The patient was vaccinated at a workplace clinic. Outcome of the event was recovered on an unspecified date in 2021.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ligament sprain, Pain in extremity, Peripheral swelling, Poor quality sleep
Clinical narrative: She could not sleep the whole night; Right hand is swollen; She has a sprained wrist; Her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; Her left knee was hurting her a lot worse; Sore arm; First dose: sore arm; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EN6206) via an unspecified route of administration (age at vaccination 60-year) in Left Arm on 09Mar2021 as single dose for COVID-19 immunization. Medical history included accident (The accident was 25 years ago, and they told her that she had shrunk an inch from the accident. It is hard for her to say) and cardiac disorder (Her dad has heart disease) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 09Mar2021 the patient experienced sore arm after receiving first dose; On 30Mar2021 her hand, that is somewhat in pain from the sprain, and is most of the time fine, was in; her left knee was hurting her a lot worse; sore arm; her right hand is swollen and she has a sprained wrist. On 30Mar2021 09:30 she reported she could not sleep the whole night. The seriousness of all the event was reported as non-serious. Her left knee was hurting her a lot worse was recovering. The clinical outcome for all other events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles you know it is a second form of chicken pox in adult life; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received first dose of BNT162B2 (COVID Vaccine, Solution for injection) via an unspecified route of administration on 17Mar2021 (Lot number: EN6204, NDC/UPC number: Unknown, Expiry Date: Unknown) as single dose for Covid-19 immunization. Expiration date: Consumer stated, 6/2021 she guessed. The patient's medical history was not reported. Concomitant medications included metoprolol (Strength: 50 mg) at 50 mg once daily, ondansetron at 8 mg once daily, atorvastatin (Strength: 80 mg) at 80 mg once daily, gabapentin (Strength: 600 mg) at 600 mg, hydrocodone bitartrate/paracetamol (NORCO) at an unknown dose thrice daily and duloxetine hydrochloride (CYMBALTA, 600 mg) at 600 mg once daily. Concomitant Products: Topiramate 100 mg and Zantac 50 mg twice a day (Not appropriately clarified, hence not captured in tab). On 19Mar2021, the patient experienced developed shingles which was a second form of chicken pox in adult life. Consumer stated, she took the Pfizer vaccination the first one on 17Mar2021 and two days after she took it developed shingles which was a second form of chicken pox in adult life. She contacted her Primary Care Physician who bought her in and confirmed it and was given Prednisone and Acyclovir (Treatment), and she was just recently reading the document which was given when she got first COVID Vaccination. She was due for second one on 07Apr2021 at 3 o clock. It said if she had any side effect to give CDC a call. Outcome of the event was unknown.  Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: she started to experience a headache; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (herself as patient) reported that a female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 09Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 09Apr2021, it was reported that she started to experience a headache after receiving the 1st dose of the vaccine today 09Apr2021. Her headache started one hour after she received the vaccine and she wanted to know if she could take Tylenol as she might experience migraines. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got very ill from the second dose; This is a spontaneous report from a Pfizer Sponsored Program. A contactable male consumer (patient himself) reported that a male patient of an unspecified age 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. Previously the patient received first 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 patients medical history and concomitant medications were not reported. On an unspecified date the patient asked about ingredients in the vaccine, got very ill from the second dose and would like to know what was injected. The event was reported as non-serious. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Had allergic reaction to the first dose.; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a Single dose for covid-19 immunization. The patient past medical history and concomitant medications were not reported. The patient had allergic reaction to the first dose on 14Apr2021. Inquiring how well she is protected. The outcome was Unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Headache, Herpes zoster, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8737 and expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 04Apr2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Time the Vaccination Was Given: about 3-4pm. Patient's medical history included herpes zoster since 10 years ago and takes immunosuppression medication. The patient reports he takes medications and he doesn't want to list all of them. The patient experienced shingles (when he got in the shower), pain on 18Apr2021, felt pain on his shoulders (after 2 weeks), headache (which he states is pretty common) and reddish spots on an unknown date. He takes an immunosuppression medication and it may have triggered the shingles. He mentioned the word immunosuppressed. When attempting to clarify if he was immunosuppressed he said, his immune system is weak. The patient shingles is very close to the injection point, almost the same spot as where he received the injection. Consumer wants to know if he can proceed with receiving the 2nd dose even if he has not fully recovered from his shingles yet and asks if he can receive the second dose beyond the 21 days. He reports he did not get diagnosed by a doctor but he feels strongly that shingles is what it is based on the symptoms. Clinical course of events includes; e reports 3-4 days later maybe about the 22nd or 23rd the pain started to go away and now he has no pain, reddish spots were gradually getting smaller. When asked if he had any treatment caller reports he did have a video appointment with a provider and they wanted him to take antiviral medicine and he did not take the medicine. He stated if it was on his whole back or something dramatic like that but it improved and he has no pain now, so he decided not to take medicine. He can tolerate it and it did not cause him too much of a problem. He did note that he works 12 hours a day and he is pretty healthy and has no other effect. Upon follow-up; it was reported that; the patient who was administered the first dose of Pfizer Covid-19 Vaccination and 14 days after that dose developed shingles. There is no evidence of whether the shingles is or is not related to the Pfizer COVID-19 Vaccination he is not sure if it is related. He is due to have the second dose of Pfizer COVID-19 Vaccination but he is not 100% cured of shingles, he can still see spots there. He called to ask should he wait a little time to get the second Pfizer COVID-19 Vaccination relative to shingles.The outcome of the event shingles was recovering, pain was recovered on an unknown date in Apr2021 and felt pain on his shoulders was unknown, reddish spots was not recovered. Patient: Sex: Patient referred to as male during this report but sex not verified with caller who was unwilling to complete report. No Follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration as 2nd dose, single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that 2 weeks after receiving 2nd dose of vaccine patient developed shingles. Patient know 6 other people in age group (50s - 60s) that also developed shingles as well, 14 days after your vaccine. Patient had to be hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in my body. This had been an extremely painful experience, but patient still would have gotten the C19 vaccine. Patient was told by the doctors to let Pfizer know of my reaction. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report received from a contactable consumer. A 6-decade-old patient of unspecified gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at unknown, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date patient developed shingles 14 days after receiving BNT162B2. Patient stated that 2 weeks after receiving 2nd dose of vaccine, patient developed shingles. Patient knew 6 other people in there age group (50s - 60s) that also developed shingles as well, 14 days after vaccine. Patient had to be hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in body. This had been an extremely painful experience, but patient still would have gotten the C19 vaccine. Patient was told by the doctors to let Pfizer know of there reaction. The outcome of the event was unknown.   No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as, SINGLE DOSE for covid-19 immunisation. The patient 's medical history and concomitant medications were not reported. On 08Mar2021, the patient experienced shingles. The patient received second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 as, SINGLE DOSE for covid-19 immunisation. It was mentioned by patient that "on 18Mar got the second vaccine and was just wondering if there is any correlation between vaccine and shingles. as it is cleared on 30Mar2021".The outcome of the event was reported as recovered. on 30Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable consumer or other non- health care professional and health care professional. A 78-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via an unspecified route of administration administered in left arm on 03Apr2021 12:45 as single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) and high blood pressure. The patient's concomitant medications were not reported. Previously patient received vaccine first dose of BNT162B2, the lot number was E in left arm on 13Mar2021 at 12:45 for COVID-19 immunization. The patient experienced shingles on 14Apr2021. The event was assessed as non-serious. Therapeutic measures were taken as a result of shingles with valacyclovir. The adverse events resulted in physician office visit. The vaccination facility type was reported as pharmacy. The patient taking COVID 19 vaccine because she did not want to get COVID. The outcome of the event was reported as recovering. No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Aphthous ulcer, Herpes zoster
Clinical narrative: Canker sores inside her mouth; Small shingles reaction; This is a spontaneous report from a contactable consumer, the patient. A 64-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EW0153; NDC number and expiry date: unknown) via an unspecified route of administration on 14Apr2021 at 18:40 in left arm as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. Medical history included tick bite that was undiagnosed until 2000. The patient previously took antibiotics (NDC, lot number and expiration date not available) for chronic lyme's disease and the reaction had stuck around. Patient took antibiotics late in the game. When patient was a child, she had no reactions on getting vaccines. The patient's concomitant medications were not reported. Patient took flu vaccine (NDC, lot number and expiration date not available) in early 2000s that seemed to give her flu. On 24Apr2021 (10 days later), the patient experienced small shingles reaction and she was concerned because she never had shingles before. She also had some canker sores inside her mouth. She did not know if they were related as she was getting some dental work. She was not hospitalized for the events and did not require emergency room and physician office visit. She was scheduled to receive the 2nd dose of the COVID-19 Vaccine on 05May2021. However, she said her doctor told her to get the shingles vaccine (Shingrix). Patient took lot of heavy-duty Vitamin D3 and amino acid lysine to help her immune system and thus shingles did not get severe. The vitamins cleared up the shingles with no complications. Relevant tests were not reported. Event shingles recovered on 30Apr2021 while outcome of the event canker sores was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021515261 same reporter/drug/AE, different patient;US-PFIZER INC-2021515262 same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable pharmacist. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 19Apr2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in Apr2021, two or three days after getting the vaccine patient developed shingles which were being treated with Valtrex and gabapentin. It was reported that the patient was scheduled to get the second dose of the vaccine on 10May2021. It was mentioned that right now they do not have any open lesions and want to know if they can still get the second dose on the 10May2021. The outcome of shingles was unknown.  No follow-up attempts were needed; information about lot/batch number could not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Herpes zoster
Clinical narrative: shingles on her hip; Caller mentioned that she had shingles on her hip and wants to cancel; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unknown date, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she and husband were due tomorrow morning (04May2021) to get their second dose. The caller mentioned that she had shingles on her hip on an unknown date and wanted to cancel their appointment tomorrow. Outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Herpes zoster
Clinical narrative: Anxious; Shingles; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0158, Pfizer NTEC), via an unspecified route of administration in Arm Left on 20Apr2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After received vaccine, one week and a day later she developed shingles on 29Apr2021. She was wondering if this a reported side effect of the vaccine. She was also due to receive the second dose next week and still had shingles. She has never had shingles before. She was wondering if this has been reported. On unknown date she was anxious about the second shot next week. She did not have a prescribing doctor, offered it and she went to a clinic to get it. The shingles are still there, but she was on an antiviral medication so it has improved. It was not spreading anymore. She was on Acyclovir. The outcome of the event was reported as recovering and the event was reported as unknown.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Drug hypersensitivity, Fatigue, Headache, Malaise
Clinical narrative: having an allergic reaction, non-severe; Itching; Rashes; Hives; Headache; Raw feeling of not well; Arm soreness; No appetite; Tiredness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 62-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 19Apr2021 (at the age of 62-years-old) as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21Apr2021, after 2 days of vaccination, the patient experienced having an allergic reaction, non-severe, itching, rashes, hives, headache, raw feeling of not well, arm soreness, no appetite, tiredness. The patient did not receive any treatment for the adverse events. On 21Apr2021 the outcome of event arm soreness was recovered, while outcome of other events having an allergic reaction, non-severe, itching, rashes, hives, headache, raw feeling of not well, no appetite, tiredness was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: having an allergic reaction, non-severe; Itching; Rashes; Hives; Headache; Raw feeling of not well; Arm soreness; No appetite; Tiredness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 62-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 19Apr2021 (at the age of 62-years-old) as 1ST DOSE, SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On 21Apr2021, after 2 days of vaccination, the patient experienced having an allergic reaction, non-severe, itching, rashes, hives, headache, raw feeling of not well, arm soreness, no appetite, tiredness. The patient did not receive any treatment for the adverse events. On 21Apr2021 the outcome of event arm soreness was recovered, while outcome of other events having an allergic reaction, non-severe, itching, rashes, hives, headache, raw feeling of not well, no appetite, tiredness was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Nausea, Vomiting
Clinical narrative: Intense Nausea and vomiting; Intense Nausea and vomiting; Dose 1 administration date 06May2021/dose 2 administration date 06May2021; This is a spontaneous report from a contactable consumer (patient). This 24-year-old male patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EW0158) via an unspecified route of administration on 06May2021 at 10:15 (as reported) and dose 2 of BNT162B2 (lot number EW0175) via an unspecified route of administration on 06May2021 at 10:30 (as reported) as single doses in the left arm for COVID-19 immunization. Medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included aripiprazole (ABILIFY) from an unknown date for an unknown indication. On 07May2021 at 04:30, the patient experienced intense nausea and vomiting, threw up several times in several hours, and trouble holding food down. The patient received treatment with left over ondansetron (ZOFRAN). The outcome of nausea and vomiting was recovered. The outcome of dose 1 and dose 2 on 06May2021 was unknown. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dysaesthesia, Muscle twitching, Pain in extremity
Clinical narrative: getting very bad leg pain like throbbing ,aching ,burning; getting very bad leg pain like throbbing ,aching; feeling you know like especially around my knee and the front of my thighs; there were like twitching also; This is a spontaneous report received from a contactable consumer (patient). This 72-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number EL9263) via an unspecified route of administration on 25Feb2021 (at the age of 72-years-old) as a single dose for COVID-19 immunization. Medical history included a bad allergy to dust and her immune system was "kind of hyperactive." Concomitant medications were not reported. In Feb2021, when the patient took dose 1 of BNT162B2 she felt fine but the 11 hours later started getting very bad leg pain like throbbing, aching, burning. There was like twitching also that lasted very badly until the end of the next day and then it sort of went away. For almost three and a half weeks there was this feeling especially around her knee and the front of her thighs. The outcomes of bad leg pain, throbbing, aching, burning, twitching, and feeling around her knee and front of her thighs were recovered. It was also reported that the patient received dose 2 on 25Mar2021.   No follow-up attempts are needed. No further information is expected
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Dyspnoea, Rash
Clinical narrative: Suspect an allergic reaction; Rash; Shortness of breath; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A 38-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE); Lot/batch no: unspecified) via unspecified route in the left arm, as 1ST DOSE, SINGLE DOSE on 05May2021 for COVID-19 immunization (at the age of 38-years). The due date for the next shot was 02Jun2021. The patient medical history was not reported. Concomitant medication(s) included escitalopram (ESCITALOPRAM) taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient stated that he suspects an allergic reaction, he was not sure if it was. The patient also experienced rash and shortness of breath on an unspecified date. The patient did not receive any treatment for the events. The clinical outcome for the events was unknown.  No follow-up attempts are needed. Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: horrific migraine; nausea; This is a spontaneous report from a contactable consumer (patient) by a Pfizer sponsored program.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration in Mar2021 (Batch/Lot number was not reported) as single for covid-19 immunisation. Medical history included migraine from an unknown date and ongoing (10-year struggle). The patient's concomitant medications were not reported.   The patient experienced horrific migraine and nausea on an unspecified date for 5 days. The patient recovered from the events on an unspecified date. The patient was really nervous to receive the second shot but did so on 01Apr2021 expecting the worst, however she did not have any symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021530508 same patient/drug, different dose/event.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: feeling very very low and depressed and moody/ sadness, not myself/ events worsened yesterday its seems; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number and expiration date were not reported), via unspecified route of administration on the left arm on an unspecified date (at the age of 61-years-old) as second dose, single dose for COVID-19 immunization. Medical history included ongoing depression (that was reported as currently and have this for several years on medication). Concomitant medications included venlafaxine hydrochloride (EFFEXOR), bupropion hydrochloride (WELLBUTRIN SR), quetiapine, atorvastatin (LIPITOR), amlodipine, levothyroxine sodium (SYNTHROID) and hydrochlorothiazide; all taken for an unspecified indication, start and stop dates were not reported. On an unspecified date in 2021 (reported as Saturday, yesterday), the patient experienced feeling very very low, depressed, moody, sadness and not herself. The events were reported as seemed to have worsened. The patient was not sure if the events were reaction to the second vaccine she had on Thursday and stated that it may be the vaccine was effecting. The event seriousness was unspecified by the reporter. There was no investigation assessment. No treatment was given as a result of the events. The outcome of the event was not recovered. The patient was querying if this could be experienced by the medication that she was taking.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: Sore arm; Received the entire vial of the undiluted Pfizer COVID vaccine; Received the entire vial of the undiluted Pfizer COVID vaccine; This is a spontaneous report from a contactable nurse. This nurse reported same event for two patients. This is the second of the two reports. An 84-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EW0168, Expiration Date: Aug2021; 84-year age at time of vaccination) via intramuscular route administered in the right deltoid on 12May2021 at 09:38 (at the age of 84-years-old) as 2nd dose, single for COVID-19 immunisation. Medical history included diabetes mellitus from 14Sep2017 and ongoing, dialysis and end stage renal disease from 18Sep2017 and ongoing, and cardiac disorder from 22Jul2017 and ongoing; ESRD from 18-SEP-2017 ongoing; Heart Disease from 22-JUL-2017 ongoing. The patient's family history and concomitant medications included none. The patient previously received first dose of BNT162B2 (Lot ER8736, Expiration Jul2021) administered intramuscularly in right deltoid on 21Apr2021 at 9:29 for COVID-19 immunisation. No other history of prior vaccinations. The nurse reported a medication error for two patients who received the entire vial of the undiluted Pfizer COVID vaccine on 12May2021. The reporter did not provide specific signs and symptoms. They were in their care after the vaccine was given for an hour and sent home. They were instructed for any signs and symptoms to report to ER immediately. Neither patient was experiencing any symptoms at the time. Upon follow-up on 02Jun2021, it was reported patient had sore arm on 12May2021 17:30; Reported seriousness criteria non serious, not received Treatment. The outcome of the event sore arm was recovered on unspecified date in May2021, and the outcome of other events was unknown.  Follow up (02Jun2021): This follow up-spontaneous report received from a contactable other HCP in response to HCP letter (sent) via follow-up letter which included that: New AE details (sore arm); Relevant Medical History (ESRD, heart disease, diabetes).  Follow-up attempts were closed and completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021537945 same reporter/product/event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: had cold sores; This is a spontaneous report from a contactable nurse reporting different events under the same suspect product for 5 patients. This is one of 5 reports (2nd of the 2 additional reports). A patient of an unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as unknown, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient had cold sores after getting the COVID-19 vaccine. The outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021541866 Same reporter/ drug, different patients/ events
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Genital herpes, Herpes zoster
Clinical narrative: Outbreak of Shingles; 3 outbreaks of genital herpes; This is a spontaneous report from a contactable consumer. A 62-year-old non-pregnant female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 18Mar2021 01:30 (Batch/Lot Number: EN6207) at single dose, dose 2 via an unspecified route of administration, administered in right arm on 09Apr2021 01:30 (Batch/Lot Number: EW0158) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24May2021 patient had an outbreak of Shingles. She had Shingrix shots on Sep. 14 and Nov 13 2020. She also on a suppressive dose 1g per day of Valacyclovir and the Shingles still broke through. She filed another report on approx May 14 stating that she had had 3 outbreaks of genital herpes in a 6 week period beginning on the week after first shot. The patient was getting very concerned about this. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event was 1 gm Valacyclovir per day. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is requested.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disease recurrence, Herpes zoster
Clinical narrative: Outbreak of Shingles; 3 outbreaks of genital herpes; This is a spontaneous report from a contactable consumer. A 62-year-old non-pregnant female patient received BNT162B2, via an unspecified route of administration, administered in left arm on 18Mar2021 01:30 (Batch/Lot Number: EN6207) at single dose, dose 2 via an unspecified route of administration, administered in right arm on 09Apr2021 01:30 (Batch/Lot Number: EW0158) at single dose for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24May2021 patient had an outbreak of Shingles. She had Shingrix shots on Sep. 14 and Nov 13 2020. She also on a suppressive dose 1g per day of Valacyclovir and the Shingles still broke through. She filed another report on approx May 14 stating that she had had 3 outbreaks of genital herpes in a 6 week period beginning on the week after first shot. The patient was getting very concerned about this. The adverse event result in doctor or other healthcare professional office/clinic visit. The treatment received for the adverse event was 1 gm Valacyclovir per day. The outcome of the events was not recovered.  Follow-up attempts are needed. Further information is requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Varicose vein
Clinical narrative: bulging veins in wrists and hands; Neck pain; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for patient (husband) that a 60-years-old male patient received bnt162b2  (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EW0183; Expiration Date: 31Aug2021), dose 1 via an unspecified route of administration, administered in Arm Left on 17May2021 as 1ST DOSE, SINGLE for covid-19 immunisation. Patient had no medical history. Concomitant medications included fluvoxamine (FLUVOXAMINE) taken for obsessive-compulsive disorder (Has been taking over 20 years); clonazepam (KLONOPIN) taken for obsessive-compulsive disorder, anxiety (Has been taking maybe about 5 years). On 18May2021, the patient experienced bulging veins in wrists and hands; while on 17May2021 neck pain. Patient was treated with Tylenol. Patient taking Pfizer COVID  19 vaccine because he wants his mask off. Consumer reported that patient know about his feet or legs, he was sleeping. She noticed his hands this morning. It was reported that patient had the neck pain last night and woke up with it this morning. Everything has now gone away. He took a Tylenol this morning. It was reported that vaccine scheduled around 10:30 am, was probably around 11:30am. History of all previous immunization with the Pfizer vaccine did not considered as suspect. Additional Vaccines was not administered on Same Date of the Pfizer Suspect. Patient was not visited to emergency room and physician office. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not had any illness at the time of vaccination. Patient did not had any family medical history. Patient did not performed any lab test. The outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report received from a contactable consumer (patient's parent). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had an appointment today at 4PM for his second shot of the COVID-19 vaccine from Pfizer. The reporter wanted to reschedule, because the patient had a sinus infection and wouldn't be able to go. The outcome of sinus infection was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Chills, Epstein-Barr virus test, Epstein-Barr virus test positive, Hypotension
Clinical narrative: hypotension; acute renal failure; fever; rigors; persistent rash; He had an IgG and PCR positive for EBV; This is a spontaneous report from a contactable pharmacist. A 49-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 49-years-old, via an unspecified route of administration on 23Apr2021 as single dose for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. Pharmacist stated that a patient received the first dose of the Pfizer Covid-19 vaccine on 23APR2021 and a week after he presented fever, rigors and persistent rash. He was the discharged and then presented acute renal failure and hypotension on 19May2021. He had an IgG and PCR positive for EBV. Pharmacist would like to know if there are reports of EBV (Epstein-Barr virus) reactivation. They have a patient who was admitted to the hospital and was wondering if Pfizer has any reports of reactivation of EBV after receiving the vaccine.  She is not sure if it is related to the vaccine or not. The first hospital admission was because of continued fevers, rigors and rash. Patient received first dose on 23 Apr 2021, and then rash started on 29 Apr 2021. It is unknown when fever and rigors started. Patient was readmitted for same thing and is sicker. She then clarified that this admission was for hypotension with acute renal failure. The patient is now in ICU. The rash is still there and it is worse. The patient still has fevers. Reporter seriousness for Persistent Fevers, Rigors and Rash: Hospitalization. Patient was in hospital for Persistent Fevers, Rigors and Rash from 2 May 2021 to 15 May 2021. Reporter seriousness for Hypotension and acute renal failure: Hospitalization. Patient was in hospital for Hypotension and acute renal failure from 19 May 2021 to Ongoing. Event outcome of fever and rash was not recovered, the other events was unknown.; Sender's Comments: Based on the narrative information provided and the known drug safety profile, the reported events Pyrexia, Chills and Rash are considered as related to bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine).  A causal association between the reported events Hypotension and Acute kidney injury and bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) cannot be totally excluded. 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 RAs, Ethics Committees, and Investigators, as appropriate.