chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Presyncope, Pyrexia
Clinical narrative: wave of dizziness; sweating; felt like passing out; weak; Did not sleep well throughout the night; fatigue in evening of getting the shot; chills; which turned to slight fever after going to bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 09:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 63 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose 3 (Booster), Single, Batch/Lot No: FJ1620, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 06Dec2021, when the patient was 62-year-old, for Covid-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: INSOMNIA (non-serious) with onset 07Sep2022 at 17:00, outcome "recovered" (Sep2022), described as "Did not sleep well throughout the night"; CHILLS (non-serious) with onset 07Sep2022 at 17:00, outcome "recovered" (Sep2022); FATIGUE (non-serious) with onset 07Sep2022 at 17:00, outcome "recovered" (Sep2022), described as "fatigue in evening of getting the shot"; PYREXIA (non-serious) with onset 07Sep2022 at 17:00, outcome "recovered" (Sep2022), described as "which turned to slight fever after going to bed"; PRESYNCOPE (non-serious) with onset 08Sep2022, outcome "recovered" (Sep2022), described as "felt like passing out"; HYPERHIDROSIS (non-serious) with onset 08Sep2022, outcome "recovered" (Sep2022), described as "sweating"; DIZZINESS (non-serious) with onset 08Sep2022, outcome "recovered" (Sep2022), described as "wave of dizziness"; ASTHENIA (non-serious) with onset 08Sep2022, outcome "recovered" (Sep2022), described as "weak". Therapeutic measures were not taken as a result of insomnia, fatigue, chills, pyrexia, dizziness, hyperhidrosis, presyncope, asthenia. Additional information: The patient has no known allergies. The patient did not have COVID prior vaccination and had not tested for COVID post vaccination. The patient did not receive other vaccines in four weeks and did not receive other medications in two weeks. The patient had chills and fatigue in evening of getting the shot, which turned to slight fever after going to bed. The patient did not sleep well throughout the night, but fever lessened by morning. The patient got out of bed late (11am) to catch up on sleep. He took shower and then started shaving but could not finish because of wave of dizziness. He had to sit down immediately. He was weak, sweating, felt like passing out. After a moment, he was able to make it back to bed. He had water, OJ, and a little cereal and rested 5 more hours. He felt better in the evening and slept well. He felt back to normal after waking up the next day.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 as dose 1, single (Lot number: EW0153), in right arm and on 04May2021 as dose 2, single (Lot number: EW0173) at the age of 36 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Nov2021 as dose 3 (booster), single (Lot number: 051F21A), in right arm and on 10Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Ulcerative colitis" (unspecified if ongoing), notes: Other medical history: Ulcerative colitis, vitamin D deficiency; "Vitamin D deficiency" (unspecified if ongoing), notes: Other medical history: Ulcerative colitis, vitamin D deficiency. The patient's concomitant medications were not reported. Past drug history included: Sudafed, reaction(s): "Known allergies: Sudafed", notes: Known allergies: Sudafed and Neosporin; Neosporin, reaction(s): "Known allergies: Neosporin", notes: Known allergies: Sudafed and Neosporin. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Sep2022) Positive, notes: I tested positive on rapid 01Sep; (09Sep2022) Negative, notes: This morning, 09Sep, I tested negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that, patient was tested positive on rapid 01Sep, started paxlovid on 04Sep and took the 3 pills morning and evening for 5 days. On 08Sep patient was started to feel lousy in the evening but continued with the last dose. That evening and through the night my symptoms returned, night sweats, aches, cough, running nose, fatigue, diarrhea and tickle at the back of my throat. This morning, 09Sep, patient tested negative despite the clear symptoms and overall sick feeling. Device timestamp: 09Sep2022.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Off label use, Pain, Pyrexia
Clinical narrative: Feverish; Achy; Headache; The patient received fourth (booster) dose of BNT162B2; The patient received fourth (booster) dose of BNT162B2; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP).  A 13-year-old female patient (not pregnant) received bnt162b2 (BNT162B2) on 07Sep2022 as dose 4 (booster), single (Lot number: BIV GH 9694) at the age of 13 years, Intramuscular in left arm for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EN5318), administration date: 12May2021, when the patient was 12 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0185), administration date: 02Jun2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: FJ5683), administration date: 10Jan2022, when the patient was 12 years old, for COVID-19 immunisation.  The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 07Sep2022, outcome "unknown", and all described as "The patient received fourth (booster) dose of BNT162B2"; PYREXIA (non-serious) with onset 08Sep2022, outcome "recovering", described as "Feverish"; PAIN (non-serious) with onset 08Sep2022, outcome "recovering", described as "Achy"; HEADACHE (non-serious) with onset 08Sep2022, outcome "recovering". Therapeutic measures were taken as a result of pyrexia, pain and headache.  Additional information: The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Treatment included ADVIL for pyrexia, pain and headache. Since the vaccination, the patient had not been tested for COVID-19.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 as DOSE 4 (BOOSTER), SINGLE (lot number: GH9694) at the age of 42 years intramuscular, in the left arm for COVID-19 immunization. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (first dose, via intramuscular route of administration, administered in the left arm (lot number: EN6203) as DOSE 1, SINGLE), administration date: 03Mar2021, when the patient was 40 years old, for Covid-19 immunization, reactions: "Headache" and "stomach cramping"; BNT162b2 (second dose, via intramuscular route of administration, administered in the left arm (lot number: EL3248) as DOSE 2, SINGLE), administration date: 25Mar2021, when the patient was 40 years old, for Covid-19 immunization, reactions: "Left arm soreness/my arm was just sore", "Red mark about the size of a dime around the injection site", "the injection site had a bit of a burning or stinging sensation", and "Menstrual spotting"; BNT162b2 (third dose, via intramuscular route of administration, administered in the left arm (lot number: FJ1620) as DOSE 3 (BOOSTER), SINGLE), administration date: 23Nov2021, when the patient was 41 years old, for Covid-19 immunization, reactions: "jaw pain", "sore arm", "headache", and "sinus pressure." The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 08Sep2022, outcome "recovered" described as "sore arm." Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility type vaccine: Pharmacy or Drug Store. Patient had no known allergies: If COVID prior vaccination: Yes; If COVID tested post vaccination: No.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021239566 same reporter/ patient/ vaccine; different dose number and events (Dose 1);US-PFIZER INC-2021352149 same reporter/ patient/ vaccine; different dose number and events (Dose 2);US-PFIZER INC-202101654777 same reporter/ patient/ vaccine; different dose number and events (Dose 3);US-PFIZER INC-202200630423 same reporter/ patient/ vaccine; different dose number and events (LOE);
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Oct2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 67 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low level Back surgery" (unspecified if ongoing), notes: other medical history: Low level Back surgery; "known allergies Sulfa" (unspecified if ongoing). The patient took concomitant medications for allergy relief from 05Aug2022, lot number: NOC 59726-801-12. Past drug history included: Codeine, reaction(s): "known allergies: codeine", notes: known allergies: codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (Sep2022) Positive, notes: I re tested positive a couple of days after finishing the antivirals. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Diagnosed with Covid after vaccination; Diagnosed with Covid after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing), notes: Both caller and wife have COPD and emphysema; "emphysema" (unspecified if ongoing), notes: Both caller and wife have COPD and emphysema. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Diagnosed with Covid after vaccination". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical Course: Other conditions and Investigations were not provided. It was Unspecified that COVID-19 vaccine manufacturer unknown a pfizer product. number of COVID-19 vaccine not provided. Reason for no lot number of COVID-19 vaccine manufacturer unknown. Caller unwilling to complete the report. Expiry date of COVID-19 Vaccine was not provided. Other products were not provided. Question about the Booster shot. In may caller had Covid and took Paxlovid. Wife had Covid and got monoclonal antibodies. Are they able to get the new Covid-19 booster. Verified above information with the caller. Both caller and wife have COPD and emphysema. Declined to complete report. Additional lot number and sample of the product available to be returned, if requested that was not provided. Packaging sealed and intact that was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Loss of personal independence in daily activities
Clinical narrative: Stroke; She was normal before and know she cannot run her phone and he has to take care of her.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "She was normal before and know she cannot run her phone and he has to take care of her.".  Clinical course: It was reported as he was calling on behalf of his wife that got the vaccine. Asking if there was a compensation from Pfizer since his wife had a stroke after getting the Covid vaccine and she has not been ok since then. Has anxiety so bad and this happened two years ago since she got the shot. Not right, cannot read or spell good and wish that he could be sent something to help. He would like the doctor to be contacted. He did not have any contact details handy. He gets so confused. He was not the only person to be affected, there should be a line for the people to be hurt by this. Calling for two years trying to get help for his wife. There should be a phone number to be able to call. Other people have been hurt by it. People did not want to talk about compensation. He just got a doctor to say his wife's stroke was from the covid shot. He was going out of his mind. He has been giving her shots for two years now and there should be some help for him taking care of her. It should not be so hard to get help, he was not all there. They made his wife take it. He wants someone to call him. Ever have anxiety so bad that cannot sleep or eat, that's what going on with him since he was taking care of his wife.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: And injection site pain (mild, but noticeable).; muscle ache; fatigue; chills; fever (101.8 degrees),; headache; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 10:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose 4 (booster), single, lot: unknown, route of administration: unknown), for COVID-19 immunization; Bnt162b2 (Dose 3 (booster), single, lot: unknown, route of administration: unknown), for Covid-19 immunization; Bnt162b2 (Dose 2, single, lot: unknown, route of administration: unknown), for COVID-19 Immunization; Bnt162b2 (Dose 1, single, lot: unknown, route of administration: unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 08Sep2022 at 10:45, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering", described as "And injection site pain (mild, but noticeable)."; CHILLS (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering"; FATIGUE (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering"; PYREXIA (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering", described as "fever (101.8 degrees),"; HEADACHE (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering"; MYALGIA (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering", described as "muscle ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of off label use, vaccination site pain, myalgia, fatigue, chills, pyrexia, headache.  Additional information: It was reported that Approximately 8 hours after receiving the vaccine, the patient was hit pretty hard and fast with symptoms: muscle ache, fatigue, chills, fever (101.8 degrees), headache. And injection site pain (mild, but noticeable). That was unusual since he had never experienced such symptoms with any of the previous 4 vaccines (all Pfizer). The symptoms lasted into the night but were mostly gone (except for mild fatigue) by 8:00am the next day. There was no covid prior vaccination. Covid was tested post vaccination. He had no allergy.   Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pyrexia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: And injection site pain (mild, but noticeable).; muscle ache; fatigue; chills; fever (101.8 degrees),; headache; Off label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 10:45 as dose 5 (booster), single (Lot number: GH9694) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN; OMEPRAZOLE. Vaccination history included: Bnt162b2 (Dose 4 (booster), single, lot: unknown, route of administration: unknown), for COVID-19 immunization; Bnt162b2 (Dose 3 (booster), single, lot: unknown, route of administration: unknown), for Covid-19 immunization; Bnt162b2 (Dose 2, single, lot: unknown, route of administration: unknown), for COVID-19 Immunization; Bnt162b2 (Dose 1, single, lot: unknown, route of administration: unknown), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious) with onset 08Sep2022 at 10:45, outcome "unknown"; VACCINATION SITE PAIN (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering", described as "And injection site pain (mild, but noticeable)."; CHILLS (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering"; FATIGUE (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering"; PYREXIA (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering", described as "fever (101.8 degrees),"; HEADACHE (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering"; MYALGIA (non-serious) with onset 08Sep2022 at 18:30, outcome "recovering", described as "muscle ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of off label use, vaccination site pain, myalgia, fatigue, chills, pyrexia, headache.  Additional information: It was reported that Approximately 8 hours after receiving the vaccine, the patient was hit pretty hard and fast with symptoms: muscle ache, fatigue, chills, fever (101.8 degrees), headache. And injection site pain (mild, but noticeable). That was unusual since he had never experienced such symptoms with any of the previous 4 vaccines (all Pfizer). The symptoms lasted into the night but were mostly gone (except for mild fatigue) by 8:00am the next day. There was no covid prior vaccination. Covid was tested post vaccination. He had no allergy.   Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 05Apr2021 as dose 2, single (Lot number: ER2613), in left arm and on 19Oct2021 as dose 3 (booster), single (Lot number: EW0172) at the age of 52 years, in left arm for covid-19 immunisation; elasomeran (COVID-19 VACCINE MODERNA), on 10May2022 as dose 4 (booster), single (Lot number: OS7MZ1A), in left arm for covid-19 immunisation. The patient had no relevant medical history. There was no known allergies.Concomitant medication(s) included (Other medication in 2weeks): VOLNEA. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after testing "not positive" on day 8; Positive, notes: Testing positive again on day 10 of symptom onset. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course include testing positive again on day 10 of symptom onset, after testing not positive on day 8. Other medication in 2weeks product Volnea, Viorele 28 day, Shingles booster from 30Aug2022 on 30Aug2022. Paxlovid was used for treatment of COVID-19 from 02Sp2022 to 06Sep2022 with lot no. GE1627.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 19Jan2022 as dose 1, single (Lot number: EL9262), in left arm, on 19Feb2022 as dose 2, single (Lot number: EN6201), on 27Sep2021 as dose 3 (booster), single (Lot number: FD0809), in left arm and on 16May2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Seizure disorder" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; PHENYTOIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Sep2022) Negative; (06Sep2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Symptoms reappeared 2 days after last dose. Tested negative 05Sep2022. Tested positive 06Sep2022.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling and numbness in right arm; tingling and numbness in right arm; The initial case was missing the following minimum criteria: ICH-Unspecified AE. Upon receipt of follow-up information on (09Sep2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose number unknown (booster), 0.3 ml single (Lot number: GH9694) at the age of 42 years intramuscular, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUTICASONE nasal. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, unknown manufacturer), for Covid-19 immunization. The following information was reported: PARAESTHESIA (medically significant), HYPOAESTHESIA (medically significant) all with onset 09Sep2022, outcome "unknown" and all described as "tingling and numbness in right arm".  Clinical course: Pharmacist calling about Pfizer Biontech Covid 19 vaccine, bivalent booster, she wanted to file a report for an adverse event. She did not have further questions. She confirmed contact details upon transfer. Patient received Pfizer covid19 bivalent booster today and about 5 minutes later he started experiencing tingling and numbness in right arm where he had the injection. The paramedics were called and evaluated him and stated that it did not seem like a normal reaction so they recommended to go to urgent care. He opted to drive himself instead of taking an ambulance and paramedics said he was ok to do so. Time vaccination was given: around 12:30pm. He was experiencing the numbness and tingling when he was leaving to the urgent care but has not followed up with patient since he left. Treatment: declines any , She has to go and declined to complete the rest of the report.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events PARAESTHESIA and HYPOAESTHESIA  and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 77-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization; elasomeran (COVID-19 VACCINE MODERNA), on 06Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06Sep2022) Negative, notes: On the day of the booster patient was Covid negative; (09Sep2022) Positive, notes: Doctor mentioned patient tested positive for Covid this morning; (Sep2022) Positive, notes: is positive for Covid, within 3 days of Covid booster.  Clinical course: Doctor stated, one of her patients got the booster dose 3 days ago and on the day of the booster patient was Covid negative. After the covid-19 vaccine, patient had symptoms of fever, myalgia and sore throat. Stated that, today 3 of his symptoms were getting worse and was positive for Covid, within 3 days of Covid booster. Caller asked, was it safe to give the patient Paxlovid. Caller asked, any contraindication to use Paxlovid along with vaccine within 3 days time. Doctor stated that, she needed to either send the prescription or decline. Caller mentioned that, she thought it was okay to give Paxlovid but unsure what other consequences within 3 days of Covid-19 vaccine. Caller mentioned that, most of her patients were vaccinated and she was writing vaccinations for them and that they were fine. Caller mentioned that, she did not had a case where in the symptom just appeared immediately after the vaccination then to give Paxlovid. It could be vaccine side effects that patient was reacting to it but tested positive. Caller was speaking quite fast and unclear on some parts. Stated that, patient was 77-year-old and had no kidney, liver problems. Stated that, patient had just got his covid vaccine a few days ago. Stated that, patient was on the other line and mentioned that he received his Moderna booster dose, that was his fifth shot/dose. Stated that, patient got Pfizer back in February when he started, then got his 3rd Moderna booster. Patient confirmed that, he got 2 Pfizer vaccine and Moderna booster. Doctor mentioned that patient tested positive for Covid this morning.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug Ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cheilitis, Glossodynia
Clinical narrative: Developed sores on the left side of the tongue and one on my lip.; Developed sores on the left side of the tongue and one on my lip.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Sep2022 at 15:45 as dose 4 (booster), single (Lot number: GH9694) at the age of 47 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1 MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose: 2 MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (Dose: 3 ( 1 st Booster)  MANUFACTURER UNKNOWN), for Covid-19 immunization.  The following information was reported: STOMATITIS (non-serious), CHEILITIS (non-serious) all with onset 09Sep2022 at 14:00, outcome "not recovered" and all described as "Developed sores on the left side of the tongue and one on my lip.". Therapeutic measures were not taken as a result of stomatitis, cheilitis.  Additional information: Patient developed sores on the left side of the tongue and one on my lip. Patient did not receive other vaccine in four weeks. Patient did not receive any treatment for the events. Patient did not have covid prior vaccination or covid tested post vaccination. Patient had no known allergies.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Disease recurrence, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Disease recurrence; Caller stated that she has COVID at the moment; Caller stated that she has COVID at the moment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL9266), on 15Mar2021 as dose 2, single (Lot number: EN6204), on 23Aug2021 as dose 3 (booster), single (Lot number: FA7485) and on 04Feb2022 as dose 4 (booster), single (Lot number: 330368D) at the age of 52 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "unknown" and all described as "Caller stated that she has COVID at the moment"; DISEASE RECURRENCE (medically significant) with onset 02Sep2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive; (02Sep2022) Positive. Clinical course: Caller clarified that she had 4 vaccines, she has underlying conditions which she did mail all that information in. She is outside of the window, she got exposed because she is a special education teacher, for some reason they just do not feel masks are important where she works. Her husband and her went traveling for their 30th anniversary trip in the summer, and she was outside window, there was no vaccine available, and so she had to mask up and trust that and know what to do, she did take her flonase and decongestants and knew to rest but she got it, caller clarified that she got covid, she states that over there in other parts of the world there was over crowding, and they did not follow the 6 feet distance. She tested positive for covid on 24Jul2022. On 02Sep2022 is when she had 2 positive at home covid tests and she was symptomatic. She wants this to be informative for both, she thought she would get more immunity without being sick, she was hoping to at least get 90 days.
Sex: F
Vaccine: COVID19
Symptoms: Bone disorder, Fatigue, Feeling cold, Neck pain, Somnolence
Clinical narrative: my bones get cool; I get cold; severe pain in my neck; tired body and I have to lie down; I fall asleep/Sleeping is almost like being unconscious; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 09Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "depression" (unspecified if ongoing), notes: I have depression, and if I don't take the Clono Pill, I don't sleep for even a minute. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 2, Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (Dose 3, Unknown manufacturer), for COVID-19 immunization. The following information was reported: SOMNOLENCE (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "I fall asleep/Sleeping is almost like being unconscious"; FEELING COLD (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "I get cold"; BONE DISORDER (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "my bones get cool"; NECK PAIN (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "severe pain in my neck"; FATIGUE (non-serious) with onset Jun2022, outcome "recovered" (2022), described as "tired body and I have to lie down". The events "my bones get cool", "i get cold", "severe pain in my neck", "tired body and i have to lie down" and "i fall asleep/sleeping is almost like being unconscious" required physician office visit. Therapeutic measures were taken as a result of bone disorder, feeling cold, neck pain, fatigue, somnolence. Additional information: On 09Jun2022, patient got the COVID vaccine number 4. About 2 weeks later, she started to have strange and strong symptoms. She needed to resolve some of the adverse effects. Right now, she's fine, her bones get cool, she gets cold, gets severe pain in her neck, tired body and have to lie down, fall asleep. Sleeping was almost like being unconscious, because the alarm on the phone sounds, people call her and don't hear anything. Her body wakes up when it feel like it. She has a lot of problems because of the situation, and claims her doctor was crazy, all she knows to tell her was to take acetaminophen. Doctor tells her that these were the normal side effects of the pills.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He had Covid and turned negative; He had Covid and turned negative; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "He had Covid and turned negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Aug2022) Negative, notes: he had COVID and tested negative on 17Aug2022.  Clinical information: He had Covid and turned negative last August 17. He is asking if they should get the new Bivalent vaccine right away or should they wait for a while since he read in the CDC website that they can get it right away but may also wait for 3 months so he is asking what's the better thing. (Name withheld): Successful Sync Transfer. Caller is a patient that states he had COVID and tested negative on 17Aug2022. Caller requests information on when he may get the new Pfizer-BioNTech COVID-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster dose for 12 years of age and older if right away or within 3 months after having COVID according to the CDC's recommendations. Caller stated he had completed his primary vaccination series and two boosters of an mRNA vaccine. It was not clarified with caller whether these vaccines were the Pfizer-BioNTech COVID-19 vaccine or other mRNA vaccines. Caller could not be referred to HCP as when above information was provided to caller, caller declined to receive any additional information and stated: "I won't waste any more of your time."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Her temp is 101.7 F; 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 71-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 19:45 as dose number unknown (booster), single (Lot number: GH9694) at the age of 71 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: High blood pressure; "Cholesterol" (unspecified if ongoing), notes: Cholesterol. The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer.), for COVID-19 immunization.  The following information was reported: PYREXIA (non-serious) with onset 09Sep2022, outcome "recovering", described as "Her temp is 101.7 F". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body-wide aches 24+ hours after vaccination; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Sep2022 at 16:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years, in left arm for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: COVID-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 Immunization; COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization; COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 09Sep2022 at 16:00, outcome "recovering", described as "Body-wide aches 24+ hours after vaccination". Therapeutic measures were not taken as a result of pain.  Additional information: The patient did not receive other vaccine in four weeks. The patient did not test for COVID-19 post-vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Swelling, Swelling face
Clinical narrative: my face and neck felt very hot with swelling; my face and neck felt very hot with swelling; my face and neck felt very hot with swelling; face broke out in rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 4 (booster), single (Lot number: GH9694) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer", start date: 2009 (unspecified if ongoing); "thymoma", start date: 2022 (unspecified if ongoing); "hysterectomy" (unspecified if ongoing); "kidney stone" (unspecified if ongoing); "gall bladder removal" (unspecified if ongoing); "Known allergies: Antibiotics: sulfa" (unspecified if ongoing); "Known allergies: Antibiotics: macrolides" (unspecified if ongoing); "Known allergies: Antibiotics: penicillins" (unspecified if ongoing). Concomitant medication(s) included: ESCITALOPRAM; VITAMIN D 2000 DUO. Past drug history included: Clindamycin, reaction(s): "Known allergies: Antibiotics: clindamycin". Vaccination history included: Covid-19 vaccine (Dose 1; Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2; Unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 3 (booster); Unknown manufacturer), for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 09Sep2022 at 20:00, outcome "recovered", described as "face broke out in rash"; FEELING HOT (non-serious), SWELLING FACE (non-serious), SWELLING (non-serious) all with onset 09Sep2022 at 20:00, outcome "recovered" and all described as "my face and neck felt very hot with swelling". Therapeutic measures were taken as a result of feeling hot, swelling face, swelling, rash. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination nor was tested for COVID-19 since vaccination. Within 2 to 3 hours of vaccination (as reported), patient's face and neck felt very hot with swelling and her face broke out in rash. Took 50 mg of diphenhydramine (BENADRYL).  Follow-up attempts are completed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngeal swab, Thyroiditis subacute
Clinical narrative: subacute thyroiditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2021 at 16:00 as dose 2, single (Lot number: EW0168) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: ER8729; Location of injection: right arm; Vaccine Administration Time: 04:00 PM), administration date: 06Apr2021, when the patient was 29-year-old, for COVID-19 immunisation. The following information was reported: THYROIDITIS SUBACUTE (non-serious) with onset 22Nov2021, outcome "recovered", described as "subacute thyroiditis". The event "subacute thyroiditis" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of thyroiditis subacute.   Additional information: The patient did not receive other vaccine within four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient took thyroid medication as treatment for subacute thyroiditis. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Patient was tested for COVID post vaccination. Dose 1 vaccination date was also reported as 06Apr2022 and dose 2 vaccination date was also reported as 04May2022.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pain
Clinical narrative: Fever; Chills; Body aches; Shivers; Nausea; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. Vaccination history included: Covid-19 vaccine (Primary series of Immunization completed, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization.  The following information was reported: PAIN (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering", described as "Body aches"; CHILLS (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering"; PYREXIA (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering", described as "Fever"; HEADACHE (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering"; NAUSEA (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering"; CHILLS (non-serious) with onset 10Sep2022 at 22:00, outcome "recovering", described as "Shivers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia, chills, pain, chills, nausea, headache.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.