chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: second dose: blood pressure has been a little high; right eye was affected somehow; second shot: swelling of left arm; second shot: headache; second shot :could not eat for three days; second shot: had normal aches and pains; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: ER8732) at the age of 66 years as dose 2, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: Pain(non-serious) with onset 24Mar2021, outcome "recovered" (25Mar2021), described as "second shot: had normal aches and pains"; Peripheral Swelling(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot: swelling of left arm"; Headache(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot: headache"; Decreased appetite(non-serious) with onset 14Apr2021, outcome "recovered" (17Apr2021), described as "second shot :could not eat for three days"; Blood pressure increased (non-serious) with onset 17Apr2021, outcome "not recovered", described as "second dose: blood pressure has been a little high"; Eye disorder(non-serious) with onset 16Apr2021, outcome "not recovered", described as "right eye was affected somehow". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (23Dec2021): Follow-up attempts are completed. No further information is expected.  Additional Information:Why was the patient taking Covid vaccine (Verbatim): trying to follow what they thought would be the best thing in the Covid situation Physician details: Stated that she went to the Health Department. Stated there was no doctor. Occupation/specialty, consent to contact, address, phone number and email address not provided.Treatment: Stated that she took Tylenol and cold compress for swelling of left arm. Stated that she went to the doctor and is monitoring her blood pressure.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101767816 Same patient and drug, different event separated in time
Sex: U
Vaccine: COVID19
Symptoms: Pain, Peripheral sensory neuropathy
Clinical narrative: a family member who was hurt by the Pfizer Covid-19 vaccine (adult dose); Sensory neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Can not work or care for their family" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "a family member who was hurt by the Pfizer Covid-19 vaccine (adult dose)"; PERIPHERAL SENSORY NEUROPATHY (non-serious) with onset 2021, outcome "not recovered", described as "Sensory neuropathy". The event "sensory neuropathy" was evaluated at the physician office visit.  Additional information: consumer calling about the Pfizer vaccine, clarified to adult Pfizer COVID-19 vaccine with a question. She says the family member got the Pfizer COVID-19 vaccine adult dose in the middle of April and only got one shot of adult Pfizer and it has been months of hell. She says that a family member was injured after their first injection and had been dealing with doctors and a neurologist after this happened back in April. She says that person was still having sensory neuropathy, and she wanted to know if there was any type of compensation available for a person who can not go to work or care for their family and needs help. She says she wondered if there was a program thru the  or something that could help with out compensation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: missed periods following each vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 10Apr2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: LEVOTHYROXINE; METFORMIN; TYLENOL; ADVIL [IBUPROFEN]. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 2021, outcome "unknown", described as "missed periods following each vaccine". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Noted missed periods following each vaccine shot and booster. Occurred with after each shot in series as well. The patient received no other vaccines within 4 weeks prior to the COVID vaccine. The patient was diagnosed with COVID-19 prior to vaccination and has tested for COVID-19 since the vaccination.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Upon receiving first dose, felt immediate burning pain radiating down left arm, affecting bicep and forearm.; loss of strength on left side to this date; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: FC3181) as dose 1, single for covid-19 immunisation. Relevant medical history included: "triple bypass", start date: 29Jan2005 (unspecified if ongoing), notes: triple bypass. Concomitant medication(s) included: METOPROLOL SUCCINATE; ROSUVASTATIN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Upon receiving first dose, felt immediate burning pain radiating down left arm, affecting bicep and forearm."; ASTHENIA (non-serious), outcome "not recovered", described as "loss of strength on left side to this date". The events "upon receiving first dose, felt immediate burning pain radiating down left arm, affecting bicep and forearm." and "loss of strength on left side to this date" were evaluated at the physician office visit.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Upon receiving first dose, felt immediate burning pain radiating down left arm, affecting bicep and forearm. Have burning pain and loss of strength on left side to this date. Upon receiving second dose pain radiating down full left side of body. Loss of Equilibrium, muscle loss on left arm and leg, burning aching pain in both arm and leg. Walk with a limp every day, very difficult to lift left leg more then a couple inches. Having irregular heartbeat. shortness of breath, gasping for air. Have to get up very slowly when sitting or loose balance. Never had an issue prior to getting Covid19 shot, patient health was in good order. Now life is falling apart. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I only had soreness of the arm as a side effect/felt the soreness in the site; 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 66 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 23Feb2021 (Lot number: EM9810) at the age of 66 years as dose 1, single and administered in arm, administration date 16Mar2021 (Lot number: EM6207) as dose 2, single for covid-19 immunisation. Relevant medical history included: "severe asthma" (ongoing), notes: patient with a history of asthma. There were no concomitant medications. Vaccination history included: Flu (Manufacturer: Fluzone High Dose 2122PF influenza split high dose preservative free 65+ Lot Number: UJ743AC , right arm, she had 0.7 mL, IM LD), administration date: 06Oct2021, when the patient was 65 years old.  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "I only had soreness of the arm as a side effect/felt the soreness in the site".  Additional information: this report was not related to a study or program.  Follow-up attempts are completed. No further information is expected.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: vomited; diarrhea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 6 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Dec2021 15:00 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Seasonal allergies" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VOMITING (non-serious) with onset 12Dec2021 07:30, outcome "recovering", described as "vomited"; DIARRHOEA (non-serious) with onset 12Dec2021 07:30, outcome "recovering", described as "diarrhea". Therapeutic measures were not taken as a result of vomiting, diarrhoea.  Additional information- It was reported that patient did not have any known allergies except seasonal allergies. The patient did not suffer from Covid prior  to vaccination and did not undergo COVID tested post vaccination. It was reported that 15 hours after the vaccine she vomited. She vomited 5-6 times over the next 6 or 7 hours. She also had diarrhea.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypomenorrhoea, Pregnancy test
Clinical narrative: Lighter periods after first two doses.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2021 (Lot number: EJ1686) as dose 1, single and administered in arm left, administration date 28Jan2021 (Lot number: EL3302) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hyperlipidaemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; WELLBUTRIN. Past drug history included: No, reaction(s): "Allergy". The following information was reported: HYPOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Lighter periods after first two doses.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Facility where the most recent COVID-19 vaccine was administered doctor's office/urgent care. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications patient received within 2 weeks was birth Control. Prior to vaccination the patient was not diagnosed with COVID-19. Previously always regular periods on schedule. Two pregnancy tests taken and both negative. Since the vaccination the patient had not tested for COVID-19. Device date was 10Dec2021.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache
Clinical narrative: Slight headache; Pressure headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 40-years-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 09Dec2021 11:00 (Lot number: 33030BD) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1), for COVID-19 Immunization; Covid-19 vaccine (Dose 2), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Slight headache"; HEAD DISCOMFORT (non-serious) with onset Dec2021, outcome "not recovered", described as "Pressure headache". Therapeutic measures were taken as a result of headache, head discomfort.  Additional Information: It was reported that consumer went yesterday morning at 11:00 to get her PFIZER BOOSTER shot and everything was fine and then later on that night, she started getting a slight headache but then it went away and she went to bed and woke up with slight headache again. So, she took some IBUPROFEN and went back to bed and when woke up had a pressure headache and it was been like this all day long. When probed if consumer wanted to report this or have some medical query too, she stated that need to know if there was something she needs to do or was she supposed to be worried about it or mean if it was going to go away. About weight she stated her weight, she did not know how much she weighed. About anatomical site and route of administration, she  stated, "You mean where I went in to get my PFIZER shot. Oh, it was kind of difficult to understand you, it was on my left shoulder. When probed for prior family medical history of same adverse event, she stated does anybody in my family have problem with like high blood pressure, yes actually her fiancé, he had his shot yesterday and he had the same symptoms as me. About treatment she stated that she used some Ibuprofen, dose used was 600mg.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: after the second shot her side effect was a bit of muscle pain whenever she pulled her arm straight; had a little soreness; 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 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: ER8727) at the age of 76 years as dose 2, single. Relevant medical history included: "allergies" (unspecified if ongoing), notes: states she has allergies but this isn't something she has seen before; "yellow fever" (unspecified if ongoing), notes: had no reaction like this.; "cholera" (unspecified if ongoing), notes: had no reaction like this.; "small pox" (unspecified if ongoing), notes: Caller states she had small pox and diphtheria with no problems in her childhood.; "diphtheria" (unspecified if ongoing), notes: Caller states she had small pox and diphtheria with no problems in her childhood.; "measles" (unspecified if ongoing), notes: Caller states she had the measles before all the tests and vaccines. There were no concomitant medications. Vaccination history included: Bnt162b2 (she did not experience any side effects with the first shot , , DOSE 1, SINGLE, Pfizer Covid 19 vaccination dose #1 26Feb2021 in her left arm around 2-3pm. lot EN6202. Caller does not have NDC or expiry to provide.), administration date: 26Feb2021, when the patient was 76 years old, for COVID-19 Immunization, reaction(s): "she did not experience any side effects"; Flu shot, administration date: 1962, for immunization. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "after the second shot her side effect was a bit of muscle pain whenever she pulled her arm straight"; PAIN (non-serious), outcome "unknown", described as "had a little soreness".  Follow-Up (23Dec2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She had a lot of sickness, so she couldn''t do it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old female patient received bnt162b2 (BNT162B2), administration date Oct2021 (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: ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "She had a lot of sickness, so she couldn''t do it". Additional information: On confirming the name of the vaccine, reporter stated, she took the first dose in Oct2021. Then she was taking (Voice not clear) because she had a lot of sickness, so she could not do it. The concern is that their mother, she had her second shot of COVID up there like a month after she had the first one. She is not feeling good since she had the shot. She has like muscle pain, bones pain, gas, headache. I want to know if this is a normal thing that happens to elderly people after the second shot. She did the second shot 2 days ago, 2 or 3 days ago and since then she is not feeling good. She has a headache, muscle pain, bones pain, gas, feeling tired. They just wanted to know if this is a normal reaction that an older person has. She is 91 years.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (29Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101775542 Same patient and drug, different dose
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Myalgia, Vaccination site pain
Clinical narrative: Insomnia; Injection Site Pain; Fatigue; Muscle Pain; Chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 55 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Dec2021 11:00 (Lot number: FF2589) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 02:30 PM, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 54 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 01:45 PM, Route of Administration: Intramuscular), administration date: 25Feb2021, when the patient was 54 years old, for COVID-19 immunization.  The following information was reported: INSOMNIA (non-serious) with onset 11Dec2021 05:00, outcome "recovering", described as "Insomnia"; VACCINATION SITE PAIN (non-serious) with onset 11Dec2021 05:00, outcome "recovering", described as "Injection Site Pain"; FATIGUE (non-serious) with onset 11Dec2021 05:00, outcome "recovering", described as "Fatigue"; MYALGIA (non-serious) with onset 11Dec2021 05:00, outcome "recovering", described as "Muscle Pain"; CHILLS (non-serious) with onset 11Dec2021 05:00, outcome "recovering", described as "Chills". Therapeutic measures were taken as a result of insomnia, vaccination site pain, fatigue, myalgia, chills.  Additional information: No other vaccine were received in four weeks. other medications were received in two weeks (unspecified). The patient received treatment with Ibuprofen. No covid prior vaccination and not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, SARS-CoV-2 test
Clinical narrative: My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses; My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 13:00 (Lot number: Fk5618) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: No. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses"; MYALGIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, myalgia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received no other medications within 2 weeks of vaccination. My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses. Only ibuprofen was given for comfort. The patient had no known allergies.   Follow-up: Follow-up attempts completed. No further information expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, SARS-CoV-2 test, Tenderness
Clinical narrative: My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses. Only ibuprofen was given for comfort.However, with the 2nd dose; My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses. Only ibuprofen was given for comfort.However, with the 2nd dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 11 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 13:00 (Lot number: 5-11 Fk5618) at the age of 11 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IBUPROFEN. Vaccination history included: Bnt162b2 (lot number=5-11 Fk5618,, dose administration date=18Nov2021 , dose administration time=13:00 , dose number=1,, vaccine Location=Left arm), administration date: 18Nov2021, when the patient was 11 years old, for Covid-19 Immunization. The following information was reported: AXILLARY PAIN (non-serious), TENDERNESS (non-serious) all with onset 10Dec2021 19:00, outcome "recovered" (2021) and all described as "My son complained of left arm pain, deltoid muscle soreness with both doses of the vaccine, which resolved in 3 days for both doses. Only ibuprofen was given for comfort.However, with the 2nd dose". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of axillary pain, tenderness.  Additional Information:  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. List of any other medications the patient received within 2 weeks of vaccination was reported as no. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, has the patient been tested for COVID-19 was reported as yes.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cough, Feeling abnormal, Headache, Nasopharyngitis
Clinical narrative: sore throat; runny nose; Feels bad; Cold; cough; weakness/low energy; headache; 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 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Dec2021 (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: Covid-19 vaccine (Dose 1, Single; Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "runny nose"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "Feels bad"; NASOPHARYNGITIS (non-serious) with onset Dec2021, outcome "unknown", described as "Cold"; COUGH (non-serious) with onset Dec2021, outcome "unknown", described as "cough"; ASTHENIA (non-serious) with onset Dec2021, outcome "unknown", described as "weakness/low energy"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of cough.  Additional information: Reporter stated that she got the second dose of the Pfizer BioNtech Covid-19 Vaccine on Thursday and after a couple of hours, she experienced weakness. On Saturday, reporter started to feel the other AEs (headache sore throat and colds with runny nose). She felt bad. She has a cold and a runny nose. She has a sore throat and low energy. She doesn't know what to do about it. She has been taking cough medicine. NCD number and expiry date was not provided. Any other products used, patient history and investigation assessment was not provided.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: sore throat; runny nose; Feels bad; Cold; cough; weakness/low energy; headache; 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 40 year-old female patient received bnt162b2 (COMIRNATY), administration date 09Dec2021 (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: Covid-19 vaccine (Dose 1, Single; Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious) with onset Dec2021, outcome "unknown", described as "runny nose"; FEELING ABNORMAL (non-serious) with onset Dec2021, outcome "unknown", described as "Feels bad"; NASOPHARYNGITIS (non-serious) with onset Dec2021, outcome "unknown", described as "Cold"; COUGH (non-serious) with onset Dec2021, outcome "unknown", described as "cough"; ASTHENIA (non-serious) with onset Dec2021, outcome "unknown", described as "weakness/low energy"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache". Therapeutic measures were taken as a result of cough.  Additional information: Reporter stated that she got the second dose of the Pfizer BioNtech Covid-19 Vaccine on Thursday and after a couple of hours, she experienced weakness. On Saturday, reporter started to feel the other AEs (headache sore throat and colds with runny nose). She felt bad. She has a cold and a runny nose. She has a sore throat and low energy. She doesn't know what to do about it. She has been taking cough medicine. NCD number and expiry date was not provided. Any other products used, patient history and investigation assessment was not provided.   Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus shortly after my second dose; 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), intramuscular, administered in arm right, administration date 06Apr2021 08:30 (Lot number: EP7533) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (location=Right arm, administration time=08:15AM, lot no: EN6204, dose number=1), administration date: 16Mar2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Apr2021, outcome "recovering", described as "tinnitus shortly after my second dose". Additional information: Experienced tinnitus and plugged up right ear shortly after the second dose. symptoms took months to go away, through not completely. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. COVID test type post vaccination=Nasal Swab. COVID test date=21Oct2021. COVID test result=Negative. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Influenza like illness, Malaise, Pain
Clinical narrative: Diarrhea; Abdominal cramp; I had an ache; flu type feeling; Malaise type of feeling; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: FJ8757) at the age of 47 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing), notes: I do have a history of GERD but would not that caused me to have Diarrhea. There were no concomitant medications. Vaccination history included: Flu shot (I took a flu shot I took the flu shot that was may be 2-3 weeks ago. Not sure but I think I took the flu shot on 17Nov2021.), administration date: 17Nov2021; Covid-19 vaccine (Dose Unknown, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 09Dec2021, outcome "unknown", described as "I had an ache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 09Dec2021, outcome "unknown", described as "flu type feeling"; MALAISE (non-serious) with onset 09Dec2021, outcome "unknown", described as "Malaise type of feeling"; DIARRHOEA (non-serious) with onset 12Dec2021, outcome "unknown", described as "Diarrhea"; ABDOMINAL PAIN (non-serious) with onset 12Dec2021, outcome "unknown", described as "Abdominal cramp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, influenza like illness, malaise, diarrhoea, abdominal pain.  Additional Information: Facility type was reported as a Clinic. Other products were reported as no. The nurse (patient) stated, "I was calling because I think I might have had the side effects as the result of COVID Booster shot. Well, I took the shot on Thursday and I had the occasional, Thursday morning at like 11:30 11:45, within may be 6 to 7 hours I had an ache and the flu type feeling, the Malaise type of feeling but the thing that kind of concern me was today I started developing Diarrhea, abdominal cramp and Diarrhea." Investigation assessment was reported as no. About treatment: Nurse stated, "It just started today". About causality: Nurse stated, "Do I think this is because of the booster. I would say yes because I wasn't having any problem before and this diarrhea as a side effect."  Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: Diarrhea; Abdominal cramp; I had an ache; flu type feeling; Malaise type of feeling; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 (Lot number: FJ8757) at the age of 47 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing), notes: I do have a history of GERD but would not that caused me to have Diarrhea. There were no concomitant medications. Vaccination history included: Flu shot (I took a flu shot I took the flu shot that was may be 2-3 weeks ago. Not sure but I think I took the flu shot on 17Nov2021.), administration date: 17Nov2021; Covid-19 vaccine (Dose Unknown, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 09Dec2021, outcome "unknown", described as "I had an ache"; INFLUENZA LIKE ILLNESS (non-serious) with onset 09Dec2021, outcome "unknown", described as "flu type feeling"; MALAISE (non-serious) with onset 09Dec2021, outcome "unknown", described as "Malaise type of feeling"; DIARRHOEA (non-serious) with onset 12Dec2021, outcome "unknown", described as "Diarrhea"; ABDOMINAL PAIN (non-serious) with onset 12Dec2021, outcome "unknown", described as "Abdominal cramp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, influenza like illness, malaise, diarrhoea, abdominal pain.  Additional Information: Facility type was reported as a Clinic. Other products were reported as no. The nurse (patient) stated, "I was calling because I think I might have had the side effects as the result of COVID Booster shot. Well, I took the shot on Thursday and I had the occasional, Thursday morning at like 11:30 11:45, within may be 6 to 7 hours I had an ache and the flu type feeling, the Malaise type of feeling but the thing that kind of concern me was today I started developing Diarrhea, abdominal cramp and Diarrhea." Investigation assessment was reported as no. About treatment: Nurse stated, "It just started today". About causality: Nurse stated, "Do I think this is because of the booster. I would say yes because I wasn't having any problem before and this diarrhea as a side effect."  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Heart rate increased, Pain in extremity
Clinical narrative: sore arm and stuff like that; my heart rate was elevated; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Dec2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 2), for COVID-19 immunization; Bnt162b2 (DOSE:1), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm and stuff like that"; HEART RATE INCREASED (non-serious) with onset Dec2021, outcome "unknown", described as "my heart rate was elevated". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient got booster shot yesterday, third shot of Pfizer booster and got the sore arm and stuff like that. Patient blood pressure was fine but heart rate was elevated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Pfizer COVID-19 vaccine made him sick after the dose; This is a spontaneous report received from a non-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 number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Pfizer COVID-19 vaccine made him sick after the dose".  Additional information:Unknown caller reported that the Pfizer COVID-19 vaccine made him sick after the dose. He wants to know why the vaccine is killing people. He asked if we, Pfizer employees, are exempted from taking the product. He said that he is recording the call and asked why we are recording the call. He requested for a supervisor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, Secretion discharge, Sneezing
Clinical narrative: just a clear mucus; since yesterday I have been feeling like I have a cold; I have been sneezing; have the (nasal) discharge but nothing else; 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 female patient received bnt162b2 (COMIRNATY) (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: SECRETION DISCHARGE (non-serious), outcome "unknown", described as "just a clear mucus"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "since yesterday I have been feeling like I have a cold"; SNEEZING (non-serious), outcome "unknown", described as "I have been sneezing "; RHINORRHOEA (non-serious), outcome "unknown", described as "have the (nasal) discharge but nothing else".  Additional information: Patient and her son and brother who are going to get the vaccine and she was going to the clinic to get tested and consult her healthcare provider about the vaccination and second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: buzzing and humming sounds in ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Apr2021 11:00 (Lot number: EW0171) at the age of 71 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: TINNITUS (non-serious) with onset 08May2021, outcome "not recovered", described as "buzzing and humming sounds in ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: Within 14 days of first vaccine patient had buzzing and humming sounds in ears. Stayed about same even after vaccine second dose which was taken on 19May2021.  It was an annoyance for most part but definitely something new that he did not have until after the 1st Pfizer vaccine. However, after the booster vaccine on 19Nov21 it became much worse within 24-48 hours after this 3rd dose. It persists to this date and was louder with buzzing/humming and hissing sound in ears. At times seems to be more piercing sound. He looked on internet and did find that some Covid vaccine recipients experienced these sounds and even tinnitus with ringing in ears. He was not sure if he would describe it ringing, but it was a very annoying sound and is constant. It affects sleep patterns due to this persisting sound when everything should be quiet and ready to sleep. Continued to this late with buzzing/humming and hissing sound in ears, sound can be louder piercing sound at times. This also affects sleeping with constant background sound in ears all Tv's and electronic lights off more evident when should be quiet for sleeping. Woke up after during night and do not get sound sleep anymore. He has not taken any medications or prescriptions, but he would say this was a side effect of the vaccines, much like some people took medications had side effects. patient had no known allergies. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks 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 vaccine was administered at Pharmacy's or Drug Store.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Immunisation, Influenza like illness, Off label use
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200411140 (Pfizer). A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 (Lot number: FC3183) at the age of 77 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing); "Bladder" (ongoing), notes: Verbatim: Helps Bladder; "Hernia", start date: 2016 (unspecified if ongoing), notes: Pertinent details: Surgery 2016; "Removal of stone in bile over" (unspecified if ongoing), notes: Verbatim: Removal of stone in bile over, Pertinent details: Surgery 2016; "Enlarged Prostate" (ongoing), notes: Medication. Concomitant medication(s) included: ALLEGRA taken for hypersensitivity (ongoing); TAMSULOSIN taken for bladder disorder (ongoing); ROSUVASTATIN (ongoing); FINASTERIDE taken for prostatomegaly (ongoing). Vaccination history included: Bnt162b2 (Lot/Batch number: EN6203, Anatomical location: Left arm, Dose no: 1), administration date: 26Feb2021, when the patient was 77 years old, for Covid-19 immunization, reaction(s): "No adverse reaction"; Bnt162b2 (Lot/Batch number: EN6209, Anatomical location: Left arm, Dose no: 2), administration date: 19Mar2021, when the patient was 77 years old, for Covid-19 immunization, reaction(s): "No adverse reaction". The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 31Aug2021, outcome "unknown" and all described as "he received his first booster dose at the end of August"; BLOOD PRESSURE INCREASED (medically significant), outcome "unknown", described as "triple BP"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "I had symptoms of Covid but test was OK". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) ok, notes: Nasopharyngeal swab, Ms2 ort s gene; blood pressure measurement: (unspecified date) increased. Patient asks Its been Six months when will she be able to take another booster. Patient had symptoms of Covid but test was ok. Relevant family medical history was Metoprolol blood pressure oral ongoing ipratropium bromide spray for nasal. Follow-up (07Feb2022): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. Follow-up (02Mar2022): This is a follow up spontaneous report from a same contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included: Case was upgraded to serious, CC reporter, RMH, lab data, Vaccine details, New AE and concomitant drugs details was added. Follow-up attempts have been completed and no further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200411140 (Pfizer). A 78 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 (Lot number: FC3183) at the age of 77 years as dose 3 (booster), single for Covid-19 immunisation. Relevant medical history included: "Allergy" (ongoing); "Bladder" (ongoing), notes: Verbatim: Helps Bladder; "Hernia", start date: 2016 (unspecified if ongoing), notes: Pertinent details: Surgery 2016; "Removal of stone in bile over" (unspecified if ongoing), notes: Verbatim: Removal of stone in bile over, Pertinent details: Surgery 2016; "Enlarged Prostate" (ongoing), notes: Medication. Concomitant medication(s) included: ALLEGRA taken for hypersensitivity (ongoing); TAMSULOSIN taken for bladder disorder (ongoing); ROSUVASTATIN (ongoing); FINASTERIDE taken for prostatomegaly (ongoing). Vaccination history included: Bnt162b2 (Lot/Batch number: EN6203, Anatomical location: Left arm, Dose no: 1), administration date: 26Feb2021, when the patient was 77 years old, for Covid-19 immunization, reaction(s): "No adverse reaction"; Bnt162b2 (Lot/Batch number: EN6209, Anatomical location: Left arm, Dose no: 2), administration date: 19Mar2021, when the patient was 77 years old, for Covid-19 immunization, reaction(s): "No adverse reaction". The following information was reported: OFF LABEL USE (medically significant), IMMUNISATION (medically significant) all with onset 31Aug2021, outcome "unknown" and all described as "he received his first booster dose at the end of August"; BLOOD PRESSURE INCREASED (medically significant), outcome "unknown", described as "triple BP"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "I had symptoms of Covid but test was OK". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jan2022) ok, notes: Nasopharyngeal swab, Ms2 ort s gene; blood pressure measurement: (unspecified date) increased. Patient asks Its been Six months when will she be able to take another booster. Patient had symptoms of Covid but test was ok. Relevant family medical history was Metoprolol blood pressure oral ongoing ipratropium bromide spray for nasal. Follow-up (07Feb2022): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected. Follow-up (02Mar2022): This is a follow up spontaneous report from a same contactable consumer. This consumer (patient) reported in response to consumer letter sent via follow-up letter which included: Case was upgraded to serious, CC reporter, RMH, lab data, Vaccine details, New AE and concomitant drugs details was added. Follow-up attempts have been completed and no further information is expected.