chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19 treatment; COVID-19 treatment; COVID-19 treatment; Vaccine brand other: Moderna/vaccine/dose number: 4; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 70-year-old male patient received BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 69 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 30Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) 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: "COPD" (unspecified if ongoing); "HTN" (unspecified if ongoing), notes: HTN; "HLD" (unspecified if ongoing), notes: HLD; "Osteopenia" (unspecified if ongoing). The patient took concomitant medications with in 2 weeks. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Apr2022, outcome "unknown", described as "Vaccine brand other: Moderna/vaccine/dose number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 treatment"; DISEASE RECURRENCE (medically significant) with onset 30Aug2022, outcome "unknown", described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Aug2022) Positive, notes: rebound positive test, very mild rebound sx (headache) tx'd; (21Aug2022) Negative, notes: negative test and improved sx; (30Aug2022) Positive, notes: positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19, disease recurrence with paxlovid from 16Aug2022 to 20Aug2022.  Clinical course: Rebound positive test, very mild rebound sx (headache) tx'd 16Aug, negative test and improved sx 21Aug, positive test 30Aug. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on available information, the causal association between the events Drug ineffective, Covid-19, Interchange of vaccine products, Disease recurrence and drug BNT162b2 cannot be excluded completely.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cerebrovascular accident, Concussion, Loss of consciousness, Magnetic resonance imaging
Clinical narrative: energy level down; incurred mild concussion and minor stroke; had spells where pass out while jogging; incurred mild concussion and minor stroke; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, unk, subcutaneous for crohn's disease. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 1, Route: Intramuscular), administration date: 21Jan2021, when the patient was 76-year-old, for Covid-19 immunization; BNT162b2 (Dose number: 2, Route: Intramuscular), administration date: 11Feb2021, when the patient was 76-year-old, for Covid-19 immunization.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 08May2022, outcome "unknown", described as "had spells where pass out while jogging"; CONCUSSION (medically significant) with onset 08May2022, outcome "unknown", CEREBROVASCULAR ACCIDENT (medically significant) with onset Jul2022, outcome "unknown" and all described as "incurred mild concussion and minor stroke"; ASTHENIA (non-serious), outcome "recovering", described as "energy level down". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (Jul2022) Unknown results; SARS-CoV-2 test: (01Apr2022) Unknown results. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "had spells where pass out while jogging", "incurred mild concussion and minor stroke" and "energy level down" with the suspect product(s) BNT162b2 was "Possible"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and 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.,Linked Report(s) : US-PFIZER INC-PV202200055142 same patient/vaccine different dose and AE;
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: energy level down; incurred mild concussion and minor stroke; had spells where pass out while jogging; incurred mild concussion and minor stroke; This is a report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, unk, subcutaneous for crohn's disease. The patient's relevant medical history included: "No" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Dose number: 1, Route: Intramuscular), administration date: 21Jan2021, when the patient was 76-year-old, for Covid-19 immunization; BNT162b2 (Dose number: 2, Route: Intramuscular), administration date: 11Feb2021, when the patient was 76-year-old, for Covid-19 immunization.  The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 08May2022, outcome "unknown", described as "had spells where pass out while jogging"; CONCUSSION (medically significant) with onset 08May2022, outcome "unknown", CEREBROVASCULAR ACCIDENT (medically significant) with onset Jul2022, outcome "unknown" and all described as "incurred mild concussion and minor stroke"; ASTHENIA (non-serious), outcome "recovering", described as "energy level down". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging: (Jul2022) Unknown results; SARS-CoV-2 test: (01Apr2022) Unknown results. The action taken for adalimumab was dosage not changed.  The reporter's assessment of the causal relationship of "had spells where pass out while jogging", "incurred mild concussion and minor stroke" and "energy level down" with the suspect product(s) BNT162b2 was "Possible"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available, the causal relationship between the reported events and 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.,Linked Report(s) : US-PFIZER INC-PV202200055142 same patient/vaccine different dose and AE;
Age: 70.0
Sex: M
Vaccine: 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). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 10May2022 at 18:00 as dose 4 (booster), single (Lot number: FM0173) at the age of 70 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Enlarged prostate" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Aug2022) Negative; (Aug2022) Negative; (Aug2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Antiviral as COVID-19 Treatment from 22Aug2022 to 26Aug2022 for treatment of COVID-19. Patient received other medications/products within 2 weeks of starting COVID-19 treatment was Tamsulosin 4 mg (Lot: HAD0555a). patient previously received a COVID-19 Vaccine. Five days after finishing the Paxlovid regimen, and twice testing negative, Ithe patient was tested positive again after experiencing some mild symptoms. Patient had no known allergies.
Sex: F
Vaccine: COVID19
Symptoms: Brain operation
Clinical narrative: Brain surgery; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Lorbrena, notes: was on a clinical trial for Lorbrena, a chemo medication that she has ben taking for the past 5 years. Vaccination history included: Covid-19 vaccine (Primary immunization series completed but manufacture unknown.), for Covid-19 immunization. The following information was reported: BRAIN OPERATION (medically significant), outcome "unknown", described as "Brain surgery". Therapeutic measures were taken as a result of brain operation.  Clinical information: Got the Covid-19 vaccine and booster shot. Traveling abroad in 2 weeks time on the 15Sep2022. The patient mentioned that she had brain surgery four months ago. The patient enquired if she can get the approved booster shot. Calling regarding the omicron booster shot that was released and approved by the FDA today. The patient enquired would it be released to the public on Thursday. The patient enquired would the omicron booster cover all the other variations of the Covid-19 vaccine as well as the omicron variant. She did have brain surgery four months ago and was on a clinical trial for Lorbrena, a chemo medication that she has ben taking for the past 5 years. The patient was calling because she wanted to know if the Omicron booster was available for her and what variants the vaccine will cover. Pfizer sends her medication every month because She was a cancer patient on a Pfizer clinical trial medication, Lorbrena. She was really in a hurry. Has an appointment she needs to get to.   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: Blood pressure increased, Deafness unilateral, Tinnitus
Clinical narrative: hearing loss in left ear; Extremely loud tinnitus; Dangerous rise in blood pressure; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies Sulfa" (unspecified if ongoing), notes: Known allergies Sulfa. Concomitant medication(s) included: LOSARTAN; PANTOPRAZOLE. Vaccination history included: BNT162b2 (Dose 2, location: Right arm), administration date: 05Mar2021, for COVID-19 immunization; BNT162b2 (Dose 1, Location: Right arm), administration date: 10Feb2021, for COVID-19 immunization. Facility type vaccine: Pharmacy or drug store.  The following information was reported: BLOOD PRESSURE INCREASED (disability) with onset 09Oct2021, outcome "not recovered", described as "Dangerous rise in blood pressure"; TINNITUS (disability) with onset 09Oct2021, outcome "not recovered", described as "Extremely loud tinnitus"; DEAFNESS UNILATERAL (disability, medically significant) with onset 09Oct2021, outcome "not recovered", described as "hearing loss in left ear". The events "hearing loss in left ear", "extremely loud tinnitus" and "dangerous rise in blood pressure" required physician office visit. The patient underwent the following laboratory tests and procedures: Blood pressure increased: Rise, notes: Dangerous rise in blood pressure caused me to increase BP meds. Therapeutic measures were taken as a result of deafness unilateral, tinnitus, blood pressure increased (Blood pressure meds twice daily and hearing aid). No Covid prior vaccination. Patient was not tested for covid post vaccination. Patient did not received any other vaccine in four weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  An elderly male patient received BNT162b2 (BNT162B2), on 19Apr2022 at 12:00 as dose 4 (booster), single (Lot number: EJ4989), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 DM" (unspecified if ongoing); "PRN" (unspecified if ongoing). Concomitant medication(s) included: INSULIN ASPART subcutaneous. Past drug history included: Moxifloxin, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 as oral Paxlovid from 21Aug2022 to 26Aug2022.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect products to the reported event Drug ineffective and Covid-19 cannot be completely excluded.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Disease recurrence, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Patient began experiencing symptoms on day 10 and tested positive on day 11; Treatment of COVID-19; Treatment of COVID-19; 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jun2022 at 15:30 as dose 4 (booster), single (Lot number: FM7563) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hoshimoto's Thyroiditis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin ( maybe?). Concomitant medication(s) included: LEVOTHYROXINE; CYCLOSPORINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19"; DISEASE RECURRENCE (medically significant) with onset 30Aug2022 at 19:00, outcome "recovering", described as "Patient began experiencing symptoms on day 10 and tested positive on day 11". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (Aug2022) positive, notes: 14 hours after testing positive on a rapid test; (27Aug2022) Negative, notes: negative on days 7 and 8; (28Aug2022) Negetive, notes: negative on days 7 and 8; (31Aug2022) positive, notes: tested positive on day 11. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Additional information: Anti viral details: Product: COVID 19 Treatment, Brand: Paxlovid, Treatment start date: 21Aug2022, Treatment stop date: 26Aug2022, Indication: Treatment of COVID-19, Other medication in 2 weeks product: Levothyroxine 50 MCG, Cyclosporine Opthalmic Solution .05% Emulsion (Restasis), Patient started a course of Paxlovid about 14 hours after testing positive on a rapid test. Patient had been experiencing mild symptoms about 36 hours before that. Felt much better within a day and tested negative on days 7 and 8. Patient began experiencing symptoms on day 10 and tested positive on day 11. Patient am currently experiencing symptoms (a little more congestion than before).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive yesterday 28Aug2022 via PCR test; tested positive yesterday 28Aug2022 via PCR test; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 2-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 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) all with onset 28Aug2022, outcome "unknown" and all described as "tested positive yesterday 28Aug2022 via PCR test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Aug2022) Positive.  Clinical information: The patient was exposed to covid Wednesday 24Aug2022, and tested positive yesterday 28Aug2022 via PCR test, and is doing quite well. Patient has some Covid symptoms but nothing too bad. The patient has a runny nose and a cough (upper respiratory, not a lower chest cough) so the physician feels he was relatively well protected from more severe Covid symptom by getting the vaccine.   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.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; Flu like symptoms; This is a  report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Batch/Lot number: unknown), in 2021 as dose 2, single (Batch/Lot number: unknown) and in 2021 as dose 3 (booster), single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Lot number: 1160362) at unk (cf) and second regimen since 2015 (Lot number: 1160362) at weekly (unk unk, weekly (cf dose increased (1 in 1 wk))), all subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown", described as "Rheumatoid arthritis flare up"; INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu like symptoms". The action taken for adalimumab was dosage increased.  The reporter's assessment of the causal relationship of "rheumatoid arthritis flare up" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. The reporter considered "flu like symptoms" related to BNT162b2.  Clinical Course: On unknown dates, the patient experienced Rheumatoid arthritis flares and flu Like symptoms with covid vaccine. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a covid-19 vaccine trial.  Causality for Humira (Adalimumab): The reporter's causality for the event(s) of rheumatoid arthritis flares and flu like symptoms with Humira vaccine was not provided. Causality for covid-19 vaccine (Tozinameran): The reporter's causality for the event(s) of rheumatoid arthritis flares was not provided and for flu like symptoms was provided as Possible with covid-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information available , a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of rheumatoid arthritis flare up" ,flu like symptoms. 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, COVID19, UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP).  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown) at unk (citrate free), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset Jul2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Jul2022, outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jul2022) Positive, notes: In Jul2022, the patient experienced COVID. The action taken for adalimumab was dosage permanently withdrawn.  Clinical course: In Jul2022, the patient experienced covid. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. There was no reported medical history. It was unknown if patient was enrolled in a covid-19 vaccine trial. The reporter's causality for the event(s) of COVID with HUMIRA (Adalimumab) was a reasonable possibility/ probable.  The reporter's assessment of the causal relationship of "drug ineffective" and "covid-19" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events
Sex: U
Vaccine: PNC13
Symptoms: Chronic respiratory disease
Clinical narrative: I have chronic lung issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), . The reporter is the patient.  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CHRONIC RESPIRATORY DISEASE (non-serious), outcome "unknown", described as "I have chronic lung issues".  Additional information: Description of Event Outcome: I had Prevnar 13 years ago. I have chronic lung issues can I receive Prevnar 20  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: experienced  a severe allergic reaction to the first dose of the Pfizer vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "experienced a severe allergic reaction to the first dose of the Pfizer vaccine".  Additional information: On 19Aug2022, it was reported that, a patient started treatment on an unspecified date with the Pfizer COVID-19 vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: It was reported the patient had a severe allergic reaction to the Pfizer shot; This is a spontaneous report received from 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 and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "It was reported the patient had a severe allergic reaction to the Pfizer shot".  Additional Information: On 16Aug2022, it was reported that a patient started treatment on an unspecified date with Pfizer-BioNTech COVID-19 vaccine at an unspecified dose, frequency and indication. It was reported the patient had a severe allergic reaction to the Pfizer shot and has been told not to get an mRNA vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Lethargy, Malaise
Clinical narrative: feeling sick; lethargic; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 20220508866.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feeling sick"; LETHARGY (non-serious), outcome "unknown", described as "lethargic". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A patient reported that their blood sugars were high and the reading were in the 200s mg/dL. Patient reported that blood sugar readings were in the 300s mg/dL before medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Dehydration, Diarrhoea, Diarrhoea haemorrhagic, Flatulence
Clinical narrative: bloody diarrhea, super bloody diarrhea; had severe ulcerative colitis; bad gas; diarrhea; dehydrated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). .  A 17-year-old male patient received BNT162b2 (BNT162B2), on 26May2021 as dose 1, single (Batch/Lot number: unknown) and on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA HAEMORRHAGIC (hospitalization, medically significant), outcome "unknown", described as "bloody diarrhea, super bloody diarrhea"; COLITIS ULCERATIVE (hospitalization, medically significant), outcome "unknown", described as "had severe ulcerative colitis"; FLATULENCE (hospitalization), outcome "unknown", described as "bad gas"; DIARRHOEA (hospitalization), outcome "unknown", described as "diarrhea"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydrated". The patient was hospitalized for flatulence, diarrhoea, dehydration (hospitalization duration: 35 day(s)). The patient underwent the following laboratory tests and procedures: Intestinal resection: remove his large intestine, notes: He had 3 surgeries. Therapeutic measures were taken as a result of diarrhoea haemorrhagic, colitis ulcerative, flatulence, diarrhoea, dehydration.  Clinical course: On 16Aug2022, it was reported that a he started treatment on 26May2021 (dose1) and 16Jun2021 (dose 2) with Pfizer Biontech COVID-19 Vaccine. It was reported the he had bad gas, diarrhea, bloody diarrhea, super bloody diarrhea and was dehydrated. He was in hospital for 35 days. They gave him IV and said he had severe ulcerative colitis. The only option was to remove his large intestine. He had 3 surgeries. They put in a J pouch instead of an ostomy bag.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Intestinal resection
Clinical narrative: bloody diarrhea, super bloody diarrhea; had severe ulcerative colitis; bad gas; diarrhea; dehydrated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). .  A 17-year-old male patient received BNT162b2 (BNT162B2), on 26May2021 as dose 1, single (Batch/Lot number: unknown) and on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 16 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA HAEMORRHAGIC (hospitalization, medically significant), outcome "unknown", described as "bloody diarrhea, super bloody diarrhea"; COLITIS ULCERATIVE (hospitalization, medically significant), outcome "unknown", described as "had severe ulcerative colitis"; FLATULENCE (hospitalization), outcome "unknown", described as "bad gas"; DIARRHOEA (hospitalization), outcome "unknown", described as "diarrhea"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydrated". The patient was hospitalized for flatulence, diarrhoea, dehydration (hospitalization duration: 35 day(s)). The patient underwent the following laboratory tests and procedures: Intestinal resection: remove his large intestine, notes: He had 3 surgeries. Therapeutic measures were taken as a result of diarrhoea haemorrhagic, colitis ulcerative, flatulence, diarrhoea, dehydration.  Clinical course: On 16Aug2022, it was reported that a he started treatment on 26May2021 (dose1) and 16Jun2021 (dose 2) with Pfizer Biontech COVID-19 Vaccine. It was reported the he had bad gas, diarrhea, bloody diarrhea, super bloody diarrhea and was dehydrated. He was in hospital for 35 days. They gave him IV and said he had severe ulcerative colitis. The only option was to remove his large intestine. He had 3 surgeries. They put in a J pouch instead of an ostomy bag.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 76 years intramuscular for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), first regimen (Batch/Lot number: unknown) till Jul2022 at citrate free and second regimen since 2022 (ongoing) (Lot number: 1162590) at citrate free, all subcutaneous for rheumatoid arthritis. 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 Jul2022, outcome "unknown" and all described as "COVID-19". The action taken for adalimumab was dosage permanently withdrawn.  The reporter considered "covid-19" related to BNT162b2.  Clinical information: In Jul2022, the patient experienced COVID. Moderna COVID-19 vaccine (Elasomeran) and Pfizer BioNTech COVID-19 Vaccine (Tozinameran) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Primary reporter did not have the lot number information, because the information was not available in the patient's file. Causality for Humira (Adalimumab) The reporter's causality for the event(s) of COVID was not provided. Change History On 25Aug2022, received updates to event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE)  and Covid-19 cannot be ruled out.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID; COVID; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4487476-00.  A 77-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Batch/Lot number: unknown), on 11Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 07Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 77 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at unk (citrate free), subcutaneous for crohn's disease. The patient had no relevant medical history. No Known Allergies. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Apr2022, outcome "unknown" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Apr2022) Positive, notes: On 01Apr2022, the patient experienced COVID. The action taken for adalimumab was dosage not changed. Clinical course as follows: Solicited report from the USA by a consumer of a 77-year-old male with events of covid with Humira (Adalimumab). On 01Apr2022, the patient experienced COVID. Pfizer BioNTech covid-19 vaccine (Tozinameran) was also considered suspect. he said he didn't know whether if it the Humira that's caused Covid. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for Humira (Adalimumab), The reporter's causality for the event covid was not provided. AbbVie's opinion is that there is no reasonable possibility that the events of covid is related to Humira (Adalimumab). Causality for Pfizer BioNTech Covid-19 Vaccine for event COVID-19, Causality as per reporter was Possible.  The reporter considered "covid" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the drug ineffective (LOE) and covid 19 cannot be ruled out.,Linked Report(s) : US-PFIZER INC-202201110935 same patient/vaccine different dose and AE;
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; 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 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Oct2021 as dose 3 (booster), single (Lot number: 30155BA) at the age of 41 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: "Diabetic type 2" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Aug2022) Positive, notes: Tested positive as of 30Aug2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the Pfizer BioNTech COVID-19 Vaccine was investigated. The investigation included reviewing incoming quality and manufacturing batch records, deviation investigations, an analysis of the complaint history for the reported lot and product type and final release assay testing. This product is received as preformulated bulk, and is manufactured, labeled, and packaged by Withheld. The final scope was determined to be lot 30155BA. No quality issues were identified during the investigation. There is no impact on product quality. An NTM was not issued for the complaint. No regulatory notification or SQRTs/AQRTs were held because of this complaint. The complaint condition of lack of effect was not confirmed, therefore, the root cause cannot be attributed to the manufacture or vendor processes as incoming quality component testing and all analytical tests performed at the time of lot release confirmed that the batch met potency specifications. No corrective or preventative actions are required as the complaint condition was not determined to be manufacture or vendor related and there are quality systems in place to detect defects prior to any lot being released to the market.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: MNQ
Symptoms: Diplopia, Multiple sclerosis, Photophobia
Clinical narrative: diagnosed with MS; developed photophobia; The light sensitivity turned to double vision; Initial information received on 24-Aug-2022 regarding an unsolicited valid serious case received from a patient's sister.  This case involves a 49-year-old male patient who had been diagnosed with multiple sclerosis (MS), developed photophobia, the light sensitivity turned to double vision after receiving vaccine Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This case is linked to case 2022SA355972(Menactra).   On an unknown date in Jun or Jul of this year 2022, the patient was doubted to received suspect Menquadfi vaccine at (unknown: formulation, strength, dose, lot number, route in unknown administration site) for immunization. Information regarding batch number requested.  On unknown date in 2022 within 24 to 48 hours of receiving the vaccine, patient developed photophobia and the light sensitivity turned to double vision (diplopia). Patient had developed other significant symptoms and after lots of testing.  On unknown date in 2022, the patient developed a serious has been diagnosed with MS (multiple sclerosis) at unknown latency. This event was assessed as medically significant.  Action taken: Not applicable.  Corrective treatment: not reported.  At time of reporting, the outcome was Unknown for the events.; Sender's Comments: Sanofi company comment 02-Sep-2022: This case involves a 49-year-old male patient who experienced has been diagnosed with multiple sclerosis (MS), developed photophobia, the light sensitivity turned to double vision after receiving MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blister, Blister rupture, Chest pain
Clinical narrative: SHINGLES  delayed symptoms onset est 4-5 days after Second Pfizer Booster jab.First experierenved burning pain like a sunburn on back of neck and a subsequent raised welt. Then progressed  and scattered down neck on to  same side ushoulder,back and chest. Has now mostly  now fully blistered out and scabbing over breakage. Been suffering with the sharp intense pain for approx 4-5 days since initial burning symptom.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster, Neck pain, Pain, Scab, Urticaria
Clinical narrative: SHINGLES  delayed symptoms onset est 4-5 days after Second Pfizer Booster jab.First experierenved burning pain like a sunburn on back of neck and a subsequent raised welt. Then progressed  and scattered down neck on to  same side ushoulder,back and chest. Has now mostly  now fully blistered out and scabbing over breakage. Been suffering with the sharp intense pain for approx 4-5 days since initial burning symptom.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Inject site area is swollen-Medium, Additional Details: Patient says her arm is swollen and hot to the touch at injection site.  The swelling is as big as a fist.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Flushing, Hyperhidrosis, Injection site swelling
Clinical narrative: Site: Swelling at Injection Site-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Medium
Age: 75.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Mild
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Blood test, Febrile convulsion, Lethargy, Palpitations, Pyrexia
Clinical narrative: High fever, febrile seizure, lethargy, heart pounding hard with documented pulse rate over 120
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain
Clinical narrative: Headache, chills, body aches, joint pain, slight fever, fatigue and soreness in the arm.
Age: 41.0
Sex: M
Vaccine: COVID19-2
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Headache, chills, body aches, joint pain, slight fever, fatigue and soreness in the arm.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Headache, Myalgia, Nausea
Clinical narrative: Chills, headache, nausea, muscle pain, dizziness,
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: On the second day of administration, the symptoms began. The area reddened, warm to the touch, oozing, swelling, burning and ithiching.
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site warmth
Clinical narrative: On the second day of administration, the symptoms began. The area reddened, warm to the touch, oozing, swelling, burning and ithiching.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy
Clinical narrative: FLu like symptoms Large swollen nodes in the left armpit
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium decreased, COVID-19, Computerised tomogram head, Culture urine positive, Escherichia test positive
Clinical narrative: Admit Date:  7/28/2022   Discharge Date:   7/31/2022   Discharge Diagnosis:  Principal Problem:   Acute metabolic encephalopathy Active Problems:   Hyponatremia   UTI (urinary tract infection)   COVID-19 virus detected   Type 2 diabetes mellitus   Essential hypertension     Hospital Course:  75 year old female who was treated with Paxlovid on 7/18 for Covid-19 infection was admitted on 7/28 after developing encephalopathy from UTI. She also had hyponatremia. She did not require treatment with either Remdesivir or steroids. She has been on Rocephin since admission and mental status improved. Neurology saw her and ruled out stroke after MRI showed no acute findings. Urine culture grew pan sensitive Klebsiella and E coli. Na is stable at 130. She will be discharged home today in stable condition on oral antibiotic. Patient educated on appropriate level of care post-discharge. Follow up with Primary Care Doctor in 5-7 days.   Physical Exam on the day of discharge: Last Recorded Vital Signs: Temp: 97.2 °F (36.2 °C) Heart Rate (Monitor): 61 Pulse: 67 BP: 143/75 Respirations: 14 SpO2: 97 % O2 Flow Rate (l/min): 0 l/min General Appearance: no distress  Eyes: PERRLA ENT: moist mucus membranes, no adenopathy Lungs: clear to auscultation bilaterally  Heart: regular rate and rhythm Abdomen: soft, non-tender  Skin: No rashes or lesions  Extremities: full ROM Neuro: alert, normal strength and tone    Consults:  IP CONSULT TO NEUROLOGY IP CONSULT TO SOCIAL WORK   Significant Diagnostic Studies:   MRI head, CT head   Operations: none   Disposition:  Home    Discharge Condition:  Fair