chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyskinesia, Tremor
Clinical narrative: had a couple episodes that almost seemed like tardive dyskinesia for lack of a better term; headache; stomach ache; This is a spontaneous report received from 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 (reported as left shoulder), administration date 10Nov2021 17:45 (Lot number: FK5618) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pachygyria" (unspecified if ongoing), notes: Diagnosed when he was two years old; "thyroid" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for his thyroid (ongoing), taking almost a year; OXCARBAZEPINE taken for seizure (ongoing), taking for about 3 years. No Family Medical History Relevant to AE(s). No Prior Vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer Suspect. The following information was reported: TARDIVE DYSKINESIA (medically significant) with onset 2021, outcome "unknown", described as "had a couple episodes that almost seemed like tardive dyskinesia for lack of a better term"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered" (2021), described as "stomach ache". Therapeutic measures were not taken as a result of tardive dyskinesia, headache, abdominal pain upper. The AE(s) didn't require a visit to Emergency Room. Not yet went to physician Office, had a call out to his neurologist and waiting to hear back. No Relevant Tests. No Investigation Assessment.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain upper, Headache, Tardive dyskinesia
Clinical narrative: had a couple episodes that almost seemed like tardive dyskinesia for lack of a better term; headache; stomach ache; This is a spontaneous report received from 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 (reported as left shoulder), administration date 10Nov2021 17:45 (Lot number: FK5618) at the age of 11 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pachygyria" (unspecified if ongoing), notes: Diagnosed when he was two years old; "thyroid" (unspecified if ongoing); "Seizures" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for his thyroid (ongoing), taking almost a year; OXCARBAZEPINE taken for seizure (ongoing), taking for about 3 years. No Family Medical History Relevant to AE(s). No Prior Vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer Suspect. The following information was reported: TARDIVE DYSKINESIA (medically significant) with onset 2021, outcome "unknown", described as "had a couple episodes that almost seemed like tardive dyskinesia for lack of a better term"; HEADACHE (non-serious) with onset 2021, outcome "recovered" (2021), described as "headache"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "recovered" (2021), described as "stomach ache". Therapeutic measures were not taken as a result of tardive dyskinesia, headache, abdominal pain upper. The AE(s) didn't require a visit to Emergency Room. Not yet went to physician Office, had a call out to his neurologist and waiting to hear back. No Relevant Tests. No Investigation Assessment.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Immunisation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Patient tested positive for Covid after receiving booster dose; Patient tested positive for Covid after receiving booster dose; Patient tested positive for Covid after receiving booster dose; This is a spontaneous report received from a contactable reporter (Consumer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's 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. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2021, outcome "unknown" and all described as "Patient tested positive for Covid after receiving booster dose". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (2021) positive.  The lot number for the vaccine, [bnt162b2 ], was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Pain, Periarthritis, Vaccination site swelling, X-ray
Clinical narrative: Swollen arm at the site of injection; severe pain; lead to complete freeze of shoulder; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 02:30 (Lot number: EP6955) at the age of 66 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer,, prev dose brand unknown=False,, prev dose lot number=EP6955,, prev dose lot unknown=False,, prev dose administration date=03Mar2021,, prev dose administration time=02:30AM, prev dose dose number=1,, prev dose vaccine location: Left arm), administration date: 03Mar2021, when the patient was 65 years old, for covid 19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 26Mar2021, outcome "not recovered", described as "Swollen arm at the site of injection"; PAIN (non-serious) with onset 26Mar2021, outcome "not recovered", described as "severe pain"; PERIARTHRITIS (non-serious) with onset 26Mar2021, outcome "not recovered", described as "lead to complete freeze of shoulder". The events "swollen arm at the site of injection", "severe pain" and "lead to complete freeze of shoulder" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site swelling, pain, periarthritis.  Additional information: Swollen arm at the site of injection up till now (13Dec2021) and severe pain which kept increasing despite treatment finally lead to complete freeze of shoulder in October. Under treatment currently. Patient was not affected with COVID-19 prior vaccination. Patient was not tested with COVID-19 tested post vaccination. patient was not received any other vaccine within the 4 weeks of COVID vaccine. Patient had no other medications in two weeks. Adverse event treatment included physical therapy, x-rays, MRI, injection.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Tiredness; 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), administration date 26Feb2021 (Lot number: EN6202) at the age of 66 years as dose 1, single and administration date 19Mar2021 (Lot number: ER2613) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 27Feb2021, outcome "recovered" (28Feb2021), described as "Headache"; FATIGUE (non-serious) with onset 27Feb2021, outcome "recovered" (28Feb2021), described as "Tiredness". Additional Information: Age at second dose vaccination was 66-year-old. After second dose, the patient experienced headache and tiredness on 20Mar2021 with outcome "recovered" on 21Mar2021.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101781711 same patient, same reporter, different dose, similar event
Sex: U
Vaccine: COVID19
Symptoms: Disease recurrence, Drug ineffective, Suspected COVID-19
Clinical narrative: I am a fully vaccinated patient who previously had COVID and was just reinfected with the disease; I am a fully vaccinated patient who previously had COVID and was just reinfected with the disease; I am a fully vaccinated patient who previously had COVID and was just reinfected with the disease; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "had COVID" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "I am a fully vaccinated patient who previously had COVID and was just reinfected with the disease".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: Chills; body aches; tiredness; nausea; headache; sore right hip; sore back; dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Dec2021 12:00 (Lot number: FF2589) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 12:00, outcome "unknown", described as "dose received 3"; CHILLS (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "Chills"; PAIN (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "body aches"; FATIGUE (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "tiredness"; NAUSEA (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "nausea"; HEADACHE (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "headache"; ARTHRALGIA (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "sore right hip"; BACK PAIN (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "sore back".  Additional information: The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pain
Clinical narrative: Chills; body aches; tiredness; nausea; headache; sore right hip; sore back; dose received 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 50 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 10Dec2021 12:00 (Lot number: FF2589) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM, Route of Administration: Intramuscular), administration date: 25Mar2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 49 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021 12:00, outcome "unknown", described as "dose received 3"; CHILLS (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "Chills"; PAIN (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "body aches"; FATIGUE (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "tiredness"; NAUSEA (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "nausea"; HEADACHE (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "headache"; ARTHRALGIA (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "sore right hip"; BACK PAIN (non-serious) with onset 11Dec2021 12:00, outcome "recovered" (Dec2021), described as "sore back".  Additional information: The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: unable to expand my lungs to breathe/ Constant difficulty in breathing; This is a spontaneous report received from a contactable Other HCP (patient).A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Aug2021 14:00 (Lot number: FD8448) at the age of 46 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Thyroidectomy" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing). No covid prior vaccination. The patient took concomitant medications, included Armor Thyroid. No other vaccine in four weeks. The following information was reported: DYSPNOEA (medically significant) with onset 04Sep2021 09:00, outcome "not recovered", described as "unable to expand my lungs to breathe/ Constant difficulty in breathing". The patient underwent the following laboratory tests and procedures: Nasal Swab: (04Sep2021) negative. Therapeutic measures were taken as a result of dyspnoea which included treatment with benedryl. Clinical course: 4 Days after vaccination woke unable to expand her lungs to breathe, for an additional 4 days she had to medicate with benedryl to allow for breathing. Still not able to fully breathe. Constant difficulty in breathing.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event Dyspnoea and the suspect drug BNT162B2 cannot be excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Condition aggravated, Eye pain, Fear, Headache
Clinical narrative: neuropathy became worse; neuropathy became worse; she felt very heavy in her lower back; Fever; Eye pain; Headache; twitching in her arm and leg and the twitching on and off/twitching on the left side of her body; She is scared to go for her second dose; she is afraid to go for the second dose; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12May2021 (Lot number: ER8736) as dose 1, single for covid-19 immunisation. Relevant medical history included: "already had a neuropathy problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 2021, outcome "recovered" (2021) and all described as "neuropathy became worse"; BACK DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "she felt very heavy in her lower back"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; EYE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Eye pain"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "Not recovered", described as "twitching in her arm and leg and the twitching on and off/twitching on the left side of her body"; NERVOUSNESS (non-serious) with onset 2021, outcome "unknown", described as "She is scared to go for her second dose"; FEAR (non-serious) with onset 2021, outcome "unknown", described as "she is afraid to go for the second dose". Clinical details as follows: She had the Pfizer covid vaccine on 12May2021 at (Withheld) Hospital. She had an adverse reaction for about 5 weeks. She had symptoms. Reports she already had a neuropathy problem but it became worse and she felt very heavy in her lower back after the vaccine. She knows a fever was normal, she had a fever. She is scared to go for her second dose. She told the doctor and the doctor does not think it is the vaccine. She was not experiencing eye pain, headache, twitching on the left side of her body, reports she had twitching in her arm and leg and the twitching on and off. Because of the reaction she is afraid to go for the second dose. She had no symptoms before the vaccine.; Sender's Comments: Based on the reported information ,a causal relationship between the events NEUROPATHY PERIPHERAL, condition aggravated and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Nervousness, Neuropathy peripheral, Pyrexia
Clinical narrative: neuropathy became worse; neuropathy became worse; she felt very heavy in her lower back; Fever; Eye pain; Headache; twitching in her arm and leg and the twitching on and off/twitching on the left side of her body; She is scared to go for her second dose; she is afraid to go for the second dose; This is a spontaneous report received from a contactable reporter (nurse). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12May2021 (Lot number: ER8736) as dose 1, single for covid-19 immunisation. Relevant medical history included: "already had a neuropathy problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), CONDITION AGGRAVATED (medically significant) all with onset 2021, outcome "recovered" (2021) and all described as "neuropathy became worse"; BACK DISORDER (non-serious) with onset 2021, outcome "recovered" (2021), described as "she felt very heavy in her lower back"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; EYE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Eye pain"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; MUSCLE TWITCHING (non-serious) with onset 2021, outcome "Not recovered", described as "twitching in her arm and leg and the twitching on and off/twitching on the left side of her body"; NERVOUSNESS (non-serious) with onset 2021, outcome "unknown", described as "She is scared to go for her second dose"; FEAR (non-serious) with onset 2021, outcome "unknown", described as "she is afraid to go for the second dose". Clinical details as follows: She had the Pfizer covid vaccine on 12May2021 at (Withheld) Hospital. She had an adverse reaction for about 5 weeks. She had symptoms. Reports she already had a neuropathy problem but it became worse and she felt very heavy in her lower back after the vaccine. She knows a fever was normal, she had a fever. She is scared to go for her second dose. She told the doctor and the doctor does not think it is the vaccine. She was not experiencing eye pain, headache, twitching on the left side of her body, reports she had twitching in her arm and leg and the twitching on and off. Because of the reaction she is afraid to go for the second dose. She had no symptoms before the vaccine.; Sender's Comments: Based on the reported information ,a causal relationship between the events NEUROPATHY PERIPHERAL, condition aggravated and suspected drug cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19, Systemic lupus erythematosus
Clinical narrative: was  fully vaccinated with the Pfizer BTC vaccine; got covid-19 disease; lupus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "was  fully vaccinated with the Pfizer BTC vaccine"; SUSPECTED COVID-19 (medically significant), outcome "unknown", described as "got covid-19 disease"; SYSTEMIC LUPUS ERYTHEMATOSUS (medically significant), outcome "unknown", described as "lupus". As the patient's brother reported: his sister was fully vaccinated with the Pfizer BTC vaccine, got covid-19 disease, had lupus and got "hit harder than anyone else."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Swelling
Clinical narrative: Shortness of breath; swelling in the body; dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autismo" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (life threatening) with onset 22Nov2021 12:00, outcome "recovered with sequelae", described as "Shortness of breath"; SWELLING (life threatening) with onset 22Nov2021 12:00, outcome "recovered with sequelae", described as "swelling in the body"; DIZZINESS (life threatening) with onset 22Nov2021 12:00, outcome "recovered with sequelae", described as "dizziness". The events "shortness of breath", "swelling in the body" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dyspnoea, swelling, dizziness.  Clinical information: Patient did not receive other vaccine in four weeks. Ae resulted in Doctor or other healthcare professional office/clinic visit, Life threatening illness (immediate risk of death from the event). Patient received treatment with Oxygen, benadryl, provid, prednisone. Patient had no covid prior vaccination and was not covid tested post vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Multiple sclerosis relapse
Clinical narrative: the vaccine increasing immune system, MS flare up; This is a spontaneous report received from contactable other health professional. A 46-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Uveitis" (unspecified if ongoing), notes: symptoms from previous diagnosis of Uveitis; "eyes light sensitivity: Photophobia" (unspecified if ongoing), notes: symptoms from previous diagnosis of  eyes light sensitivity; "inflamed" (unspecified if ongoing), notes: symptoms from previous diagnosis of inflamed; "painful" (unspecified if ongoing), notes: symptoms from previous diagnosis of painful; "had feeling like something crawling on" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MULTIPLE SCLEROSIS RELAPSE (medically significant), outcome "unknown", described as "the vaccine increasing immune system, MS flare up".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the event multiple sclerosis relapse cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: booster; COVID positive test on 13Dec, had 2 shot series and booster; COVID positive test on 13Dec, had 2 shot series and booster; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 41 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 13Dec2021, outcome "not recovered" and all described as "COVID positive test on 13Dec, had 2 shot series and booster". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (13Dec2021) posative. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Immunisation, Insomnia, Lip swelling, Near death experience
Clinical narrative: it's killing me; Hives; Itch is terrible after I took the booster Shot/Started getting itching like rashes like you know like mosquito bites; I wake up like my lips swelling; Allergy or rash, it''s all over my body; Allergy or rash, it''s all over my body; it don't even let me sleep; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing), notes: I take Synthroid for my thyroid. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Covid-19 vaccine (Dose:1, single, manufacturer unknown), administration date: 26Mar2021, when the patient was 54 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose:2, single, manufacturer unknown), administration date: 16Apr2021, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "not recovered", described as "Booster"; NEAR DEATH EXPERIENCE (medically significant) with onset Nov2021, outcome "not recovered", described as "it's killing me"; URTICARIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Hives"; PRURITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "Itch is terrible after I took the booster Shot/Started getting itching like rashes like you know like mosquito bites"; LIP SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "I wake up like my lips swelling"; HYPERSENSITIVITY (non-serious), RASH (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "Allergy or rash, it''s all over my body"; INSOMNIA (non-serious) with onset Nov2021, outcome "not recovered", described as "it don't even let me sleep". Therapeutic measures were taken as a result of near death experience, urticaria, pruritus, lip swelling, hypersensitivity, rash, insomnia. Clinical course: Well after I got the shot but I didn't realized I started getting itching like rashes like you know like mosquito bites, hives and it's being like every day is getting worse and worse and worse and I don't know what it was. I have been taking like Allegra (non-Pfizer product) once a day and that itch is terrible after I took the booster shot but you know I am getting worse and worse each day. It's so bad that in the morning I wake up like my lips swelling. Additional information: Start date of adverse events reported as on November 19 or November 20. No other vaccination within 4 weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: it's killing me; Hives; Itch is terrible after I took the booster Shot/Started getting itching like rashes like you know like mosquito bites; I wake up like my lips swelling; Allergy or rash, it''s all over my body; Allergy or rash, it''s all over my body; it don't even let me sleep; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "thyroid" (unspecified if ongoing), notes: I take Synthroid for my thyroid. Concomitant medication(s) included: SYNTHROID taken for thyroid disorder. Vaccination history included: Covid-19 vaccine (Dose:1, single, manufacturer unknown), administration date: 26Mar2021, when the patient was 54 years old, for COVID-19 Immunization; Covid-19 vaccine (Dose:2, single, manufacturer unknown), administration date: 16Apr2021, when the patient was 54 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (medically significant) with onset 2021, outcome "not recovered", described as "Booster"; NEAR DEATH EXPERIENCE (medically significant) with onset Nov2021, outcome "not recovered", described as "it's killing me"; URTICARIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Hives"; PRURITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "Itch is terrible after I took the booster Shot/Started getting itching like rashes like you know like mosquito bites"; LIP SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "I wake up like my lips swelling"; HYPERSENSITIVITY (non-serious), RASH (non-serious) all with onset Nov2021, outcome "not recovered" and all described as "Allergy or rash, it''s all over my body"; INSOMNIA (non-serious) with onset Nov2021, outcome "not recovered", described as "it don't even let me sleep". Therapeutic measures were taken as a result of near death experience, urticaria, pruritus, lip swelling, hypersensitivity, rash, insomnia. Clinical course: Well after I got the shot but I didn't realized I started getting itching like rashes like you know like mosquito bites, hives and it's being like every day is getting worse and worse and worse and I don't know what it was. I have been taking like Allegra (non-Pfizer product) once a day and that itch is terrible after I took the booster shot but you know I am getting worse and worse each day. It's so bad that in the morning I wake up like my lips swelling. Additional information: Start date of adverse events reported as on November 19 or November 20. No other vaccination within 4 weeks.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Nasal congestion
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. An 8 year-old male patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# FK5618), at the age of 8, intramuscularly, in left arm, administration date Dec 10, 2021, at 14:00, single dose, for COVID-19 immunisation. Medical history included known allergies to egg (unspecified if ongoing). There were no concomitant medications. The patient reported chest pain/chest pains (medically significant), dyspnea/breathlessness (medically significant) and nasal congestion/blocked/stuffy nose (medically significant), all onset Dec 13, 2021, at 11:30, with outcome of recovered (Dec 2021). Chest pains, breathlessness and blocked/stuffy nose were evaluated at a physician office visit. Patient had no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient has not tested for COVID-19. The patient complained of chest pains and breathlessness at school, but didn't appear to have any initiating event. No food was consumed prior to chest pains. Prior days (since vaccination), patient had blocked/stuffy nose but no coughing. No therapeutic measures taken as a result of chest pain, dyspnea and nasal congestion. Follow-up attempts completed. No further information expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: massive pulmonary embolism; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 37 -old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Apr2021 (Lot number: EW0158) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing). Concomitant medications included: JUNEL FE 1.5/30 taken for contraception, stop date: 04Dec2021; ZOLOFT ODT taken for depression, start date: Apr2021 (ongoing).  The following information was reported: PULMONARY EMBOLISM (hospitalization, life threatening, medically significant) with onset 12Apr2021, outcome "recovering", described as "massive pulmonary embolism". The patient was hospitalized for pulmonary embolism (start date: 12Apr2021, discharge date: 12Jun2021, hospitalization duration: 61 day(s)). The event "massive pulmonary embolism" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism. Patient was taking treatment drug Lovenox 2x/day.  No follow-up attempts are possible. No further information is expected.  Follow-Up (16DEC2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: her mother died recently due to Covid; her mother died recently due to Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (death, medically significant), COVID-19 (death, medically significant), outcome "fatal" and all described as "her mother died recently due to Covid". The patient date of death was unknown. The reported cause of death was covid-19, drug ineffective. It was not reported if an autopsy was performed.  Additional information: Pfizer Covid 19 Vaccine Start date and Stop date was unknown. Medical Information: No any unaddressed medical questions referred or forwarded to Medical Information. Customer and/or medical inquiry was NOT forwarded or referred to MI.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: her mother died recently due to Covid; her mother died recently due to Covid
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: Super Heavy periods starting the first month after being fully vaccinated. Blood running down my leg, changing super tampon every hour.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 12Apr2021 (Lot number: EN6199) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Coeliac disease" (unspecified if ongoing), notes: other medical history: Celiac disease. Concomitant medication(s) included: FLAXSEED. Past drug history included: Augmentin, reaction(s): "known allergies: Augmentin", notes: known allergies: Augmentin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN5318), administration date: 22Mar2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 24May2021, outcome "not recovered", described as "Super Heavy periods starting the first month after being fully vaccinated. Blood running down my leg, changing super tampon every hour.". Therapeutic measures were not taken as a result of heavy menstrual bleeding.  Additional information: Patient received Womens daily multivitamin in two weeks. Events considered as non-serious as per the reporter. Patient did not receive other vaccine in four weeks. Patient was not diagnosed with covid-19 prior vaccination and was not tested for covid-19 post vaccination. Device Date: 15Dec2021  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Onset of COVID-19 virus. Positive result from at home rapid diagnostic test (Quidel); Onset of COVID-19 virus. Positive result from at home rapid diagnostic test (Quidel); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A 45 year-old male patient received bnt162b2 (COMIRNATY), administration date 17Feb2021 (Lot number: EN6201) at the age of 44 years as dose 2, single and administration date 25Jan2021 (Lot number: EL9261) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Patient receive other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, the patient diagnosed with COVID-19: No. Since the vaccination, the patient been tested for COVID-19: Yes. The following information was reported: COVID-19 (medically significant) with onset 15Dec2021, outcome "not recovered", VACCINATION FAILURE (medically significant) with onset 15Dec2021, outcome "unknown" and all described as "Onset of COVID-19 virus. Positive result from at home rapid diagnostic test (Quidel)". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Dec2021) positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of covid-19.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation, Malaise, Tremor
Clinical narrative: Shaking; Chills; General malaise; Dose received: 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP).   A 58-year-old male patient received bnt162b2 (BNT162B2), administration date an unknown date in 2021 (Lot number: unknown) at the age of 58 years 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 1, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: unspecified), for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in 2021, outcome "unknown", described as "Dose received: 3"; TREMOR (non-serious) with onset 16Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Shaking"; CHILLS (non-serious) with onset 16Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "Chills"; MALAISE (non-serious) with onset 16Dec2021, outcome "recovered" (an unknown date in Dec2021), described as "General malaise". Therapeutic measures were not taken as a result of tremor, chills and malaise.  Additional Information: It was unknown whether the patient received any other vaccines within four weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 58-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# and manufacturer unknown), at the age of 58, in 2021, single dose, for COVID-19 immunisation. The patient did not have any medical history to report. The patient took unspecified concomitant medications. The patient experienced immunisation/booster shot, onset an unknown date in 2021, with outcome of unknown; and tinnitus/ringing in one or maybe both ears, the ringing started shortly after the COVID-19 shot, onset Dec 14, 2021, with outcome of not recovered. No therapeutic measures taken as a result of tinnitus. Additional information: The patient has no known allergies. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, patient has not tested for COVID-19. The lot number for BNT162B2 not provided and will be requested during follow-up.