chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Antibody test, Endoscopy
Clinical narrative: she started having stomach pain; This is a spontaneous report received from a contactable reporter (Physician) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 21Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history.The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: 28Dec2020, for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "unknown", described as "she started having stomach pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper. The reporter considered "she started having stomach pain" not related to bnt162b2. Additional information: Patient had a semi-quantitative total antibody test done on 06May2021 and her antibody titer came back as 2,500. Patient was unsure if this high of an antibody result is considered out of range or expected this long after receiving the second dose. She stated that per most of her colleagues typical antibody results are in the 300-400 range. Patient already received both doses of Covid19 vaccine. She now concerned with the spike protein levels that she had after three months that she took the covid19 vaccine (as reported).Few weeks ago she started having stomach pain and started taking Nexium. She did not feel this was related to the Pfizer COVID-19 vaccine. She had an upper endoscopy performed on 12May2021 for that stomach pain, result not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported event of abdominal pain.  There is limited information provided in this report.  This case will be reassessed once additional information is available.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; but not real bad; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Apr2021 15:45 (Lot number: EW0162) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Soreness at injection site; but not real bad". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: Patient did not receive any other vaccine in four weeks. The patient had not covid prior vaccination. The patient had not covid test post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021535857 same patient/drug, different dose/event
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Muscular weakness
Clinical narrative: tired; feeling dizzy/she woke up dizzy; legs felt weak; weakness/she felt weak; This is a spontaneous report received from a contactable reporte from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 07May2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "tired"; DIZZINESS (non-serious) with onset 12May2021, outcome "recovered", described as "feeling dizzy/she woke up dizzy"; MUSCULAR WEAKNESS (non-serious) with onset 12May2021, outcome "not recovered", described as "legs felt weak"; ASTHENIA (non-serious) with onset 12May2021, outcome "unknown", described as "weakness/she felt weak".  Additional information: Patient had her first dose of the Covid 19 vaccine on Friday, 07May2021. That day she was fine, her arm was fine, she didn't get tired, none of that. Reporter (patient) stated her head didn't hurt, she didn't have a fever, she was tired but that was it. However, today (12May2021) she woke up feeling dizzy and her legs felt weak and she felt weak. Patient described it as weakness like when you have a fever, but she does not have a fever. She went back to sleep for 2 hours and is not dizzy anymore but her legs are still weak. Patient stated she is not sure if going to work on Monday and Tuesday tired her up. She asked if these symptoms are normal and is it normal for them to start this late. Reason for no lot number: of Pfizer Covid 19 vaccine: Caller unwilling to complete the report Expiry Date of Pfizer Covid 19 vaccine: Not Provided   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 33 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 11:00 (Lot number: EW0179) at the age of 33 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EW0164, Location: Upper left arm), administration date: 14Apr2021, when the patient was 33 years old, for COVID-19 immunization, reaction(s): "Chills". The following information was reported: VERTIGO (non-serious) with onset 08May2021, outcome "not recovered", described as "vertigo".   Additional information: The patient Mentioned the only thing was with the first vaccination of the Pfizer Coronavirus Shot he had chills for about 2-3 hours, but that is it. Patient took his shot on Friday (clarified as 07May2021) and he felt great. Over the last four days he has been getting really bad vertigo. He wanted to know how long to expect the vertigo.  The next day, Saturday, clarified as 08May2021, he started to feel the vertigo. He started to feel it Saturday afternoon. When probed for outcome he mentioned  he works behind a computer screen all day. In the morning he was okay. However, by the afternoon after sitting in front of the screen and wearing a headset it gets worse and worse. Right now it was 2:15 PM his time and he does not get off until 4 PM. The vertigo got worse throughout the day and he thought he would call since this has been ongoing.He mentioned he has never had vertigo in his life. Patient wanted to see if this was normal.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021536854 same reporter/drug/AE with different patient
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Were down for 2 days after getting the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Were down for 2 days after getting the vaccine".  Additional information: reported stated of 2 girlfriends who were down for 2 days after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Were down for 2 days after getting the vaccine; This is a spontaneous report received from a contactable reporter.  A patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "Were down for 2 days after getting the vaccine".  Additional Info:reported stated of 2 friends who were down for 2 days after getting the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: he has a hard time being awake for the past few days after the first shot/sleepiness/drowsiness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 84 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05May2021 14:00 (Lot number: ER8732) at the age of 84 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: SOMNOLENCE (non-serious) with onset 11May2021, outcome "not recovered", described as "he has a hard time being awake for the past few days after the first shot/sleepiness/drowsiness". Therapeutic measures were not taken as a result of somnolence.  Additional information: Reporter wanting to know if sleepiness/drowsiness is considered an adverse event after getting his first shot of Pfizer BioNTech Covid-19 Vaccine (05May2021). He claimed that he has a hard time being awake for the past few days after the first shot. Lady stated she has a patient on the line, (withheld). Stated the caller had the first dose of the Pfizer Covid Vaccine on 5May2021, and he was calling to report his experience that he feels sleepiness and drowsiness, and this is not his normal routine. Reporter confirmed his name, contact information and reason for call. He stated he was also calling to see if the sleepiness and drowsiness was in alignment with previous studies. Caller stated he has looked over the fact sheet and, on the computer, and he saw 2 indications where drowsiness was associated with it, but not enough information to see if it is tied in, so he wanted to see if there are any other reports of this. Caller stated he has some medical background, but he was not qualified in the medical atmosphere to make an assessment of his condition. Stopped from taking the flu vaccination years ago. One side of tongue swelled up, no difficulty breather. At the time heavy drinker and asthmatic, combined health condition at the time was not conducive. NDC, Lot, Expiration Unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: Allergy symptoms due to first dose; This is a spontaneous report received from a non-contactable reporter  . The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergy symptoms due to first dose".  Additional information: I had a side effect after the first dose of the vaccine.  Should I get the second dose? As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. Patient called in requesting information about whether second dose takes too long in consequence of allergy symptoms due to first dose of Pfizer's COVID-19 vaccine, if she should start immunization against COVID-19 virus since first dose or continue with second dose for completion. Patient concerns about whether she should undergo a test to determine de Pfizer's COVID-19 vaccine efficacy. Patient called in requesting information about whether her husband could receive the second dose if he had COVID-19 last year. Patient called in requesting information about whether her cousin could receive the second dose if she had allergy symptoms. Patient reports her cousin received first dose on April 22nd and after that she started with throat irritation, like allergic reaction to pollen. Patient reports her husband had flu-like symptoms after first dose vaccination. Patient called in requesting information about whether someone with flu-like symptoms should receive second dose. Patient called in requesting information about whether symptoms caused by Pfizer's COVID-19 vaccine immediately appear after administration.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: She has felt nauseous; Experienced sick in the stomach; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and from a Pfizer-sponsored program. The reporter is the patient. A 49-year-old female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Lot number: ER8736, Expiration Date: Jul2021) at the age of 49 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot Number: EW0169, Expiration Date: Aug2021, Anatomical site of injection: upper arm), administration date: 15Apr2021, when the patient was 49 years old, for Covid-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset May2021, outcome "not recovered", described as "She has felt nauseous"; ABDOMINAL DISCOMFORT (non-serious) with onset May2021, outcome "unknown", described as "Experienced sick in the stomach". Therapeutic measures were taken as a result of nausea.  Additional information: Transferring agent stated, had a consumer on the line who after receiving the second dose of the Pfizer COVID19 vaccine past Thursday and she has been feeling nauseous for the last couple of days. She has taken some Dramamine (treatment) but it was not working. When confirmed the concern, consumer stated, she was actually calling to see how long did they last. Consumer stated, the doctor told her to get some Dramamine, so she took some of that today. When probed for if the consumer still taking the Dramamine, consumer stated, yes this was the first day she took it so. Caller experienced sick in the stomach and nauseous and caller wants to know how long these symptoms last.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of personal independence in daily activities, Malaise, Nausea
Clinical narrative: fatigue with weakness; fatigue with weakness; inability to carry out the daily schedule; nausea, and overall felling sick; overall felling sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 39-year-old female patient received bnt162b2 (BNT162B2), administration date 30Apr2021 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 2021, outcome "unknown" and all described as "fatigue with weakness"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "inability to carry out the daily schedule"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "nausea, and overall felling sick"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "overall felling sick".  Additional information: She specified her sick feeling is not the typical body aches talked about. She further said she had to delay her second dose due to her symptoms that are now persisting for 5-6 weeks. She also mentioned she read about an incident at a retirement home where Pfizer-BioNTech COVID-19 vials with a particular lot number had too much vaccine in each vial and thus caused problem to the recipients. She asked if there were similar reports of side effects associated with the lot number of the vaccine she received. She asked if there were similar reports of side effects associated with the lot number of the vaccine she received.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: her pain is not getting any better it is actually getting worse; arm has been in so much pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset May2021, outcome "unknown", described as "arm has been in so much pain"; PAIN (non-serious), outcome "unknown", described as "her pain is not getting any better it is actually getting worse". Therapeutic measures were taken as a result of pain in extremity. Additional information she is calling about the COVID 19 vaccine. she had the COVID vaccine on 04May2021 and her arm has been in so much pain and she is taking pain killers and her pain is not getting any better it is actually getting worse. She asked if this agent has any insight. she has already called the urgent care and they were not helpful. She asked if would be able to tell her what they think it is and what she should do. She informed for COVID 19 vaccine specific questions  may be able to assist but for medical advice a doctor would be the best person to contact.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Vomiting; Diarrhea; Nausea/Nausea was reported as worsened; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EW167) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 11May2021, outcome "not recovered", described as "Diarrhea"; VOMITING (non-serious) with onset 12May2021, outcome "not recovered", described as "Vomiting"; NAUSEA (non-serious) with onset 11May2021, outcome "not recovered", described as "Nausea/Nausea was reported as worsened". Therapeutic measures were taken as a result of diarrhoea, vomiting, nausea.  Additional information: This report is not related to study or program. NDC number of COVID-19 vaccine reported as unknown. The expiry date of COVID-19 vaccine reported as unknown. The reporter took COVID-19 vaccine because she works in different houses since she cleans house. The patient was not taken any other products. Investigation assessment reported as no. The reported called about the COVID-19 vaccine. The reporter states, she got the vaccine yesterday and she is having diarrhea, vomiting, and nausea. The reporter asked, what she can do. The reporter asked, she wants to know does she need to go to the emergency room she started getting some of these symptoms a couple hours after she got the vaccine. The reporter stated, she does not speak too much English. The reporter states, her doctor practices at family clinic. The reporter states, she took one Tylenol this morning.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain, Vaccination site pain
Clinical narrative: Really hurt my arm, very sour and uncomfortable/shot in the arm hurt; Lot of achiness; I'm still very sour and uncomfortable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Lot number: Unknown) at the age of 74 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), administration date: 04Mar2021, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "not recovered", described as "Really hurt my arm, very sour and uncomfortable/shot in the arm hurt"; PAIN (non-serious) with onset Mar2021, outcome "recovered with sequelae", described as "Lot of achiness"; DISCOMFORT (non-serious) with onset Mar2021, outcome "not recovered", described as "I'm still very sour and uncomfortable". No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Clostridium test, Diarrhoea, Parasite stool test
Clinical narrative: first dose: loose stools; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP).  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 (Lot number: EL9263) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: BENEFIBER FIBER SUPPLEMENT; PEDIALYTE [GLUCOSE;POTASSIUM CITRATE;SODIUM CITRATE ACID]; PREBIOTICS NOS; PEPTO BISMOL [BISMUTH SUBSALICYLATE;CALCIUM CARBONATE]. The following information was reported: DIARRHOEA (non-serious) with onset 05Feb2021, outcome "recovered" (Feb2021), described as "first dose: loose stools". Therapeutic measures were taken as a result of diarrhoea. Additional information: Patient's Medical History (including any illness at time of vaccination) and Family Medical History Relevant to AE(s) was None. History of all previous immunization with the Pfizer vaccine considered as suspect: First and second doses mentioned today, she confirmed no other history with the product. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations was None. She has been to both her primary care after the first dose and then a gastroenterologist after the second dose and he told her to increase fiber and she has been having fiber and nothing seems to be working. The first dose was 02Feb2021. The loose stools began about 4 days after the first dose. She says it probably lasted about 4-6 days. She also tried Imodium Multi-symptom for gas or bloating.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye inflammation
Clinical narrative: severe inflammation in his eyes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 11May2021 06:00 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: EYE INFLAMMATION (non-serious) with onset 11May2021 09:00, outcome "unknown", described as "severe inflammation in his eyes".  Additional information: Caller was mom who explained yesterday her son had the Pfizer Covid 19 shot at 6:00, three hours later at 9:00 he had severe inflammation in his eyes. She didn't know what to do or where to go. She called the (withheld) where he got the shot but no one was there, no one answered. She would like to what was the reaction was. She doesn't know why he had this reaction and would like us to tell her what caused it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo, after the first and second vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 15:30 (Lot number: ER8734) at the age of 64 years as dose 1, single and administered in arm left, administration date 22Apr2021 10:15 (Lot number: ER8735) as dose 2, single for covid-19 immunisation. Family history included: "Covid virus" (unspecified if ongoing), notes: Verbatim: Her daughter got the Covid virus. The patient's concomitant medications were not reported. The following information was reported: VERTIGO (non-serious) with onset 04Apr2021, outcome "not recovered", described as "Vertigo, after the first and second vaccine". The event "vertigo, after the first and second vaccine" was evaluated at the physician office visit. Additional information: NDC number and Expiry Date of the vaccine were Unknown. The Patient did not have any Medical History (including any illness at time of vaccination). There was not any Family Medical History Relevant to Adverse Event. No additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No Adverse Event following prior vaccinations. Additional Context: The reporter stated that she is calling about the Pfizer and confirmed as Covid shot. She reported after the first vaccine she had Vertigo. She also stated that a couple of days before the second shot, she felt better, and before the second shot, she got over, the Vertigo. She also reported that she had the second vaccine, and she has had vertigo ever since.  she was fine in the afternoon of the second vaccine and the next morning when she got up, she had the Vertigo again. She also was agreeing to fill out a safety report. Initially she also stated that she did not know the date that it started after the first vaccine. Later in the call, she reported the date as 04Apr2021. She has health problems, and her daughter got the Covid virus. She stated her daughter had a rough time and she felt, because of that, she should get the Covid vaccine. She also stated s initially, she was not planning on getting the vaccine. She is on all the same medications and does not feel they are relevant to the report. She saw her doctor twice, on the phone, once after the first vaccine and once after the second vaccine.  She reported that some days are worse than others.  She did not have Relevant Tests.   No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 (Lot number: EW0158) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 10May2021, outcome "unknown", described as "Sore throat". The action taken for bnt162b2 was unknown.  Additional Information: Expiry Date of Covid-19 vaccine: Unknown.Other Products: No.Investigation Assessment: No.Caller is asking if her mother can get the second dose since she has a sore throat. Caller states her mother takes a lot of medications. Declines to provide medication details.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea
Clinical narrative: Nauseous; he has never been so sick before; major headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11May2021 (Batch/Lot number: unknown) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2020 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose), administration date: 15Apr2021, when the patient was 30 years old, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 11May2021, outcome "unknown", described as "Nauseous"; ILLNESS (non-serious) with onset 11May2021, outcome "unknown", described as "he has never been so sick before"; HEADACHE (non-serious) with onset 11May2021, outcome "unknown", described as "major headache". Therapeutic measures were taken as a result of headache.  Additional information: The consumer was calling about the Pfizer vaccination for COVID-19. He said he was having some side effects and he has never been so sick before. The consumer said he experienced nausea. He said he got the shot yesterday 11MAY2021 and all of his symptoms started last night. consumer said he got the second dose of the vaccine yesterday, and started having side effects last night. He said he doesn't have the vaccine card with him to provide unspecified Pfizer vaccine NDC/LOT/EXP from it. He said that he thinks his first dose of this vaccine was 15Apr2021. He said that his side effect is that he has never felt so sick before. He said he feels nauseous and has a major headache. AE Treatment: consumer said he took Tylenol, the regular dose, he took one, he doesn't know how much they are. He said he thinks the EXP was 15Nov2021, but he was not looking at the Tylenol packaging currently, he doesn't have that with him. Concomitant Medications: consumer says he did not get any other vaccinations with his doses or start any new medications.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hot flush, Hypertension, Magnetic resonance imaging
Clinical narrative: Headache; Hot flashes; Blood pressure high; Sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; HOT FLUSH (non-serious) with onset 2021, outcome "unknown", described as "Hot flashes"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "Blood pressure high"; SINUSITIS (non-serious) with onset 2021, outcome "unknown", described as "Sinus infection". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had head ache and hot flashing ever since patient got second vaccine and it was now going into 6 weeks . Does anybody had reported crazy things like that. Patient had hot flushing Patient may be 86 years old so patient never had hot flushes when patient changed life later on now.  Patient was just wondering if anybody else have reported the things such as headache and hot flushing. They did an MRI because patient did not think it was the best thing. patient did MRI and they said oh patient had a sinus infection (captured conservatively). Patient did some washing for sinus infection then patient experienced high blood pressure which patient never had. So all these things happened to patient ever since the vaccine and patient was wondering if anybody else have reported things like that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 86.0
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Headache; Hot flashes; Blood pressure high; Sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; HOT FLUSH (non-serious) with onset 2021, outcome "unknown", described as "Hot flashes"; HYPERTENSION (non-serious) with onset 2021, outcome "unknown", described as "Blood pressure high"; SINUSITIS (non-serious) with onset 2021, outcome "unknown", described as "Sinus infection". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient had head ache and hot flashing ever since patient got second vaccine and it was now going into 6 weeks . Does anybody had reported crazy things like that. Patient had hot flushing Patient may be 86 years old so patient never had hot flushes when patient changed life later on now.  Patient was just wondering if anybody else have reported the things such as headache and hot flushing. They did an MRI because patient did not think it was the best thing. patient did MRI and they said oh patient had a sinus infection (captured conservatively). Patient did some washing for sinus infection then patient experienced high blood pressure which patient never had. So all these things happened to patient ever since the vaccine and patient was wondering if anybody else have reported things like that.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Headache, Nasal congestion
Clinical narrative: headache; congestion; really bad allergies; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "really bad allergies".  Additional information: The patient had been having really bad allergies for the past 3 days, along with constant headache and congestion. The patient wanted to know if he should wait to receive second dose or if it would be okay to get the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Feeling hot, Vomiting
Clinical narrative: Chills; her body got real hot; Stomach ache; vomiting like dry heaving; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (reporter's wife) that:  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; FEELING HOT (non-serious), outcome "unknown", described as "her body got real hot"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "Stomach ache"; VOMITING (non-serious), outcome "unknown", described as "vomiting like dry heaving".  Additional information: Reporter stated he is calling about the COVID 19 vaccine. Reporter stated he is calling about his wife. Reporter stated his wife took the second shot yesterday at about 11 o'clock and around 4:30 yesterday his wife started having chills, her body got real hot, kind of had like a stomach ache and has been vomiting like dry heaving. Reporter asked how long is that going to last and when should he start to get worried.  Reporter Communication: Full details not obtained as reporter declined to proceed with report at this time. Informed reporter that Medical Information may be able to speak to if these symptoms are reported side effects from the vaccine but for medical advice a doctor may be the best person to contact.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Illness, Vomiting
Clinical narrative: I was extremely sick; throwing up and constantly tired; I was extremely sick; throwing up and constantly tired; I was extremely sick; throwing up and constantly tired; Diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) (patient).  A 80 year-old patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number 1), for COVID-19 immunisation. The following information was reported: ILLNESS (non-serious), VOMITING (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "I was extremely sick; throwing up and constantly tired"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Diarrhea".  Additional information: When probed for name and Telephone#, consumer stated, "I really I don't want to give you my information." When probed for the concern, consumer stated, "I was like looking about side effects of (Pfizer) Covid-19 (Vaccine) two months after the last shot (second shot). I was extremely sick for about 5 days, throwing up, constantly tired and little diarrhea just Fairly Normal. I am 80 (years) old, are you finding if older people or some people having this kind of reaction? Today I feel fine, so it just lasted about 5 days, date of second shot was 18Mar2021 and date of first shot I don't know. I don't have my card right here with me." When paraphrased the concern, consumer stated, "My concern, is this normal? Has other people have faced anything two months later because after I had the first and second shot, I was fine, I didn't have any problem but 2 months later suddenly I have this reaction. I am going kind of thing, but I always wear our masks and everything." Consumer was informed about Pfizer Medical Information Department. Consumer abruptly hug up the call. Product details (LOT#, expiration date, NDC# and UOC#), Pharmacy details and treatment could not be probed over the call. Limited information available over the call and appropriate response could not be provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Acne, Diarrhoea, Fatigue, Headache
Clinical narrative: Olfactory damage; Severe acne(dermatology); Headache; Smell (rancid); Taste; Slight nauseated feeling; Loose bowels; Stomach cramping; Sore arm site inj; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient in her 10's received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EW0169) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: EW0150, Anatomical location: Left Arm), administration date: 02Apr2021, for Covid-19 Immunization. The following information was reported: OLFACTORY NERVE DISORDER (non-serious) with onset 01May2021, outcome "unknown", described as "Olfactory damage"; ACNE (non-serious) with onset 01May2021, outcome "unknown", described as "Severe acne(dermatology)"; HEADACHE (non-serious) with onset 01May2021, outcome "unknown", described as "Headache"; PAROSMIA (non-serious) with onset 01May2021, outcome "unknown", described as "Smell (rancid)"; TASTE DISORDER (non-serious) with onset 01May2021, outcome "unknown", described as "Taste"; NAUSEA (non-serious) with onset 01May2021, outcome "unknown", described as "Slight nauseated feeling"; DIARRHOEA (non-serious) with onset 01May2021, outcome "unknown", described as "Loose bowels"; ABDOMINAL PAIN UPPER (non-serious) with onset 01May2021, outcome "unknown", described as "Stomach cramping"; VACCINATION SITE PAIN (non-serious) with onset 01May2021, outcome "unknown", described as "Sore arm site inj"; FATIGUE (non-serious) with onset 01May2021, outcome "unknown", described as "Fatigue".  Additional information: 16.5 years of Age- Healthy. No Meds.  No follow-up attempts are possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Olfactory nerve disorder, Parosmia, Taste disorder, Vaccination site pain
Clinical narrative: Olfactory damage; Severe acne(dermatology); Headache; Smell (rancid); Taste; Slight nauseated feeling; Loose bowels; Stomach cramping; Sore arm site inj; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient in her 10's received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EW0169) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: EW0150, Anatomical location: Left Arm), administration date: 02Apr2021, for Covid-19 Immunization. The following information was reported: OLFACTORY NERVE DISORDER (non-serious) with onset 01May2021, outcome "unknown", described as "Olfactory damage"; ACNE (non-serious) with onset 01May2021, outcome "unknown", described as "Severe acne(dermatology)"; HEADACHE (non-serious) with onset 01May2021, outcome "unknown", described as "Headache"; PAROSMIA (non-serious) with onset 01May2021, outcome "unknown", described as "Smell (rancid)"; TASTE DISORDER (non-serious) with onset 01May2021, outcome "unknown", described as "Taste"; NAUSEA (non-serious) with onset 01May2021, outcome "unknown", described as "Slight nauseated feeling"; DIARRHOEA (non-serious) with onset 01May2021, outcome "unknown", described as "Loose bowels"; ABDOMINAL PAIN UPPER (non-serious) with onset 01May2021, outcome "unknown", described as "Stomach cramping"; VACCINATION SITE PAIN (non-serious) with onset 01May2021, outcome "unknown", described as "Sore arm site inj"; FATIGUE (non-serious) with onset 01May2021, outcome "unknown", described as "Fatigue".  Additional information: 16.5 years of Age- Healthy. No Meds.  No follow-up attempts are possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Thermal burn
Clinical narrative: Experienced burn in her arm and it's about 5 inches and it feels like the iron put on her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), administration date: 10Apr2021, for COVID-19 immunization. The following information was reported: THERMAL BURN (non-serious), outcome "unknown", described as "Experienced burn in her arm and it's about 5 inches and it feels like the iron put on her arm".  Additional Information: caller had the first dose of the vaccine on 10Apr right and she had the second dose of Pfizer vaccine on 01May, however caller experienced burn in her arm and it is about 5 inches and it feels like the iron put on her arm and she wants to report the complain regarding this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Malaise, Pain
Clinical narrative: feeling sick; body aches; Headache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Apr2021 15:45 (Lot number: ER8733) at the age of 51 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "feeling sick"; PAIN (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "body aches"; HEADACHE (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "Headache"; FATIGUE (non-serious) with onset 02Apr2021 18:00, outcome "recovered" (Apr2021), described as "Fatigue". Therapeutic measures were not taken as a result of malaise, pain, headache, fatigue.  Additional information: The patient reported Few hours after the first dose started feeling sick, body aches head ache and fatigue, this lasted 48 hours. No other vaccine in four weeks. No other Medication in two weeks. No COVID prior vaccination. No COVID tested post vaccination. No Known allergies. Other medical history reported none was in good health prior to vaccination.   No follow-up attempts are possible. No further information is expected.