chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: contracted COVID-19 omicron; contracted COVID-19 omicron; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4262637-00 (Agency).  A 51 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 51 years as dose number unknown (booster), single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at citrate free and second regimen subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free for crohn's disease, rheumatoid arthritis. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown.), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Dec2021, outcome "recovered" (07Jan2022) and all described as "contracted COVID-19 omicron". The action taken for adalimumab was temporarily withdrawn. 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 contracted COVID-19 omicron with HUMIRA(ADALIMUMAB) was a reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN): The reporter's causality for the event(s) of contracted COVID-19 omicron with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN) was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information available a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Liver function test, Liver function test decreased, Pain, Suspected COVID-19
Clinical narrative: COVID SYMPTOMS; COVID SYMPTOMS; Liver count was down; Hurt all over; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4265597-00 (Agency).  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 20Jan2022 (Batch/Lot number: unknown) at the age of 65 years as dose 3 (booster), single, intramuscular, administration date 09May2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 18Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID SYMPTOMS"; LIVER FUNCTION TEST DECREASED (non-serious), outcome "unknown", described as "Liver count was down"; PAIN (non-serious), outcome "unknown", described as "Hurt all over". The patient underwent the following laboratory tests and procedures: liver function test: liver count was down. The action taken for upadacitinib was unknown.  Causality for RINVOQ(UPADACITINIB): The reporter's causality for the event(s) of liver count was down, covid symptoms and hurt all over was not provided.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN). The reporter's causality for the event(s) of liver count was down, covid symptoms was not reported and hurt all over was possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; 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 and Decreased LFT, Pain.
Age: 58.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: COVID-19
Clinical narrative: COVID-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4265658-00 (Agency).  A 57 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 10Jun2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at 40 mg (40 mg,1 in 2 wk). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), outcome "unknown", described as "COVID-19". The action taken for adalimumab was unknown.  Clinical Course: In Jan2020, the patient experienced contracted covid. In Jan2021, the patient experienced contacted covid. Pfizer biontech covid-19 vaccine (Tozinameran) was also considered suspect. The reporter's causality for the event(s) of contracted covid onset in Jan2020 and contracted covid onset. in Jan2021 with Humira (Adalimubab) was a reasonable possibility. Causality 1) COVID-19 (10084268) (COVID-19) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : Reasonable possibility Dechallenge : N/A 2) COVID-19 (10084268) (COVID-19) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine): Reasonable possibility Dechallenge : N/A Seq.No. : 2 Drug : Pfizer biontech covid-19 vaccine (Tozinameran)(Tozinameran),Unknown Route of Admin : 1) Intra-muscular Therapy Dates/Duration : 1) 10Jun2021 -10Jun2021 Causality 1) COVID-19 (10084268) (COVID-19) Action(s) taken with drug : Unknown Causality as per reporter (Drug/Vaccine) : Possible Dechallenge : N/A 2) COVID-19 (10084268) (COVID-19 (10084268)) [v.24.1] Action(s) taken with drug :  Unknown Causality as per reporter (Drug/Vaccine) : Possible Dechallenge : N/A  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Due to  the limited information in the case report ,  a possible causal relationship between the event and suspect drug BNT162B2 cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cataract
Clinical narrative: Cataract Surgery; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4254354-00 (Agency).  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), oral (Lot number: 1150525). The patient's relevant medical history and concomitant medications were not reported.The following information was reported: CATARACT (hospitalization, medically significant) with onset Mar2021, outcome "recovered", described as "Cataract Surgery". The action taken for upadacitinib was dosage permanently withdrawn. Causality for Rinvoq (Upadacitinib). The reporter's causality for the event(s) of Cataract Surgery was not provided. Agency's opinion is that there is no reasonable possibility that the events of Cataract Surgery. Pfizer Biontech Covid-19 Vaccine Tozinameran causality as per reporter not reported.   The reporter's assessment of the causal relationship of the event 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.  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, there is reasonable possibility of causal association between the Reported event Cataract and the suspect drug BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 42.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Anxiety, COVID-19, Condition aggravated, Fistula, Vaccination failure
Clinical narrative: COVID-19; COVID-19; Fistula crack; Anxiety attacks; Flare; This is a solicited report received from non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4269028-00 (Agency).  A 42 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 21Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single and intramuscular, administration date 01Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1155990) at unk (cf) for crohn's disease, colitis ulcerative. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "not recovered" and all described as "COVID-19"; FISTULA (non-serious), outcome "not recovered", described as "Fistula crack"; CONDITION AGGRAVATED (non-serious) with onset 2022, outcome "not recovered", described as "Flare"; ANXIETY (non-serious), outcome "not recovered", described as "Anxiety attacks". The action taken for adalimumab was unknown. 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 fistula crack, flare, anxiety attacks and covid-19 was not provided.  Causality for bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE (Tozinameran):  The reporter's causality for the event(s) of fistula crack, flare, anxiety attacks and covid-19  was possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The reported COVID-19 positive after both the doses of COVID-19 immunization is considered vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration. Based on the current available limited information in the case provided, the causal association between the events Fistula, Condition aggravated, anxiety and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4269846-00 (Agency).  A 62 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 25Feb2021 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single and intramuscular, administration date 01Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ) (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported.   The following information was reported: COVID-19 PNEUMONIA (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "recovering" and all described as "COVID-19 pneumonia". The action taken for upadacitinib was temporarily withdrawn.   Additional information: Patient had been in the hospital with Covid pneumonia for the last three weeks. Stopped Rinvoq for about two weeks, back on medication now  The reporter assessed the causality as no reasonable possibility between COVID-19 pneumonia and Rinvoq (Drug/vaccine). The reporter assessed the causality as possible between COVID-19 pneumonia and Pfizer Biontech Covid-19 Vaccine (Tozinameran).   The company assessed the causality as no reasonable possible between COVID-19 pneumonia and Rinvoq (Drug/vaccine). The company assessed the causality as not reported between COVID-19 pneumonia and Pfizer Biontech Covid-19 Vaccine (Tozinameran)  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events: Drug ineffective, COVID-19 Pneumonia and the suspect drug BNT162B2 cannot be completely excluded.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID/had Covid positive diagnosis; COVID/had Covid positive diagnosis; A Lot Of Pain; MARKETING PROGRAM NOT AVAILABLE  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4232687-00 (Agency).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 22Aug2021 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single, intramuscular, administration date 21Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date 31Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; upadacitinib (RINVOQ), first regimen oral (Batch/Lot number: unknown) and second regimen oral from 31Jan2022 (Batch/Lot number: unknown) to 31Jan2022 for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "COVID/had Covid positive diagnosis"; PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "A Lot Of Pain". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. The action taken for upadacitinib was temporarily withdrawn on 31Jan2022. The patient was started Rinvoq yesterday, had Covid positive diagnosis and in a lot of pain. She was off of Rinvoq per doctors orders for two weeks. Rinvoq stored with other medications in reminder holder, resolved with nurse ambassador. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The events of "Rinvoq stored with other medications" and "in a lot of pain" were added.  Causality for RINVOQ(UPADACITINIB) The reporter's causality for the event(s) of Covid and Rinvoq stored with other medications with Rinvoq(Upadacitinib) was a reasonable possibility. the reporter's causality for the event(s) of in a lot of pain was not provided. Causality: COVID-19 (COVID-19): Causality as per reporter (Drug/Vaccine) : Possible.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Nerve block, Peripheral swelling
Clinical narrative: Nerve block; Constant pain in back/Back pain (with radiation); Swelling shoot down left leg; Foot went numb; FACILITATED COLLECT This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4267029-00 (AbbVie).  A 55 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at citrate free for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVE BLOCK (medically significant), outcome "unknown", described as "Nerve block"; BACK PAIN (medically significant), outcome "not recovered", described as "Constant pain in back/Back pain (with radiation)"; PERIPHERAL SWELLING (medically significant), outcome "recovering", described as "Swelling shoot down left leg"; HYPOAESTHESIA (medically significant), outcome "recovering", described as "Foot went numb". The action taken for adalimumab was unknown. Patient got a steroid shot nerve blocker in conjunction with HUMIRA injection. After that, she experienced Constant pain in back and swelling shooting down left leg and foot went numb. She reported improvement and thought it was triggered by the Covid shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality with bnt162b2 for the event(s) Nerve block, Back pain, swelling, Numbness in feet was possible. The reporter's causality with adalimumab for the event(s) Nerve block was Reasonable possibility, Back pain, swelling, Numbness in feet was not reported. The causality as per Mfr. with adalimumab for the event(s) Nerve block, Back pain, swelling, Numbness in feet was No reasonable possibility.  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 current available limited information in the case provided, the causal association between the events, Nerve block, Back pain, Peripheral swelling, Hypoesthesia and the use of suspect product BNT162B2 cannot be fully excluded. However, as the patient got a steroid shot nerve blocker in conjunction with HUMIRA injection, the reported events can be due to that also.   The case will be reassessed once further information is 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 58.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4269128-00 (Agency).  A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single, intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The action taken for adalimumab was unknown.  Clinical information: Solicited report by a consumer of an adult female with an event of non-serious COVID-19 with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced COVID-19. 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). It was not reported if events did abate after stopping drug or reappear after reintroduction.  The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was no reasonable possibility and for PFIZER BIONTECH COVID-19. VACCINE(TOZINAMERAN) causality was reported as possible for the event(s) of COVID-19.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events drug ineffective and COVID-19 cannot be totally excluded.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dizziness, Musculoskeletal stiffness, Nasopharyngitis
Clinical narrative: Fever 99.8; Cold; Stiff muscles; Dizzy; Weak; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Feb2022 (Lot number: unknown) at the age of 29 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 10Feb2022, outcome "unknown", described as "Fever 99.8"; NASOPHARYNGITIS (non-serious) with onset 10Feb2022, outcome "unknown", described as "Cold"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 10Feb2022, outcome "unknown", described as "Stiff muscles"; DIZZINESS (non-serious) with onset 10Feb2022, outcome "unknown", described as "Dizzy"; ASTHENIA (non-serious) with onset 10Feb2022, outcome "unknown", described as "Weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, it was unknown whether the patient was 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever 99.8; Cold; Stiff muscles; Dizzy; Weak; This is a spontaneous report from a non-contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09Feb2022 (Lot number: unknown) at the age of 29 years as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset 10Feb2022, outcome "unknown", described as "Fever 99.8"; NASOPHARYNGITIS (non-serious) with onset 10Feb2022, outcome "unknown", described as "Cold"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 10Feb2022, outcome "unknown", described as "Stiff muscles"; DIZZINESS (non-serious) with onset 10Feb2022, outcome "unknown", described as "Dizzy"; ASTHENIA (non-serious) with onset 10Feb2022, outcome "unknown", described as "Weak". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, it was unknown whether the patient was 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.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Drug ineffective, Incorrect dose administered, Pneumonia
Clinical narrative: had pneumonia three times; had pneumonia three times; received 3 doses of Prevnar 13; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. Other Case identifier(s): US-PFIZER INC-202200276208 (Pfizer).  An 83 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), administration date Oct2020 (Batch/Lot number: unknown) as dose 3, single, administration date 2018 (Batch/Lot number: unknown) as dose 2, single and administration date 2016 (Batch/Lot number: unknown) as dose 1, single for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23), administration date 2008 (Batch/Lot number: unknown) as dose 1, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), outcome "unknown" and all described as "had pneumonia three times"; INCORRECT DOSE ADMINISTERED (non-serious), outcome "unknown", described as "received 3 doses of Prevnar 13".  The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: my arm was heavy and painful to lift; my arm was heavy and painful to lift; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 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: PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious), outcome "unknown" and all described as "my arm was heavy and painful to lift".  Additional information: Caller stated On Wednesday, 09Feb2022, I got the booster dose and the next day my armpit was swollen and painful. I got it on the left-hand side, the injection site is tender but my under my armpit is painful. After I got the first and second dose and I did not have this, but my arm was heavy and painful to lift, which I know others experience that too, my husband had it too after the first and second dose. Is what I'm experiencing now (after booster) normal and how long does it last.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Lab data Jan2022 - COVID Positive.; Lab data Jan2022 - COVID Positive.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date Jan2021 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single, administration date Jan2021 (Batch/Lot number: unknown) at the age of 68 years as dose 2, single, and administration date Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 3 (booster), single, for covid-19 immunisation. Relevant medical history included: "Covid-19", start date: Aug2021, stop date: Aug2021, notes: Covid + in Aug2021- Received Monoclonal antibodies infusion; "heart disease" (unspecified if ongoing); "COPD" (unspecified if ongoing); "polio" (unspecified if ongoing). The patient took concomitant medications (unspecified statin medication). Past drug history included: Monoclonal antibodies infusion. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2022, outcome "unknown" and all described as "Lab data Jan2022 - COVID Positive.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Aug2021) positive; (Jan2022) positive. Therapeutic measures were taken as a result of covid-19 and included the patient was prescribed Paxlovid, 3 tabs- twice a day from 06Jan2022 to 12Jan2022. Clinical course: The patient was fully Vaccinated with Pfizer In Jan2021- Pfizer Booster received Sep2021 and the patient was Covid positive in Aug2021 for which the patient received Monoclonal antibodies infusion, the patient was Covid positive again Jan2022 and was prescribed the Paxlovid.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200051641 same patient, drug, event, different dose;US-PFIZER INC-202200187584 same patient, different drug and event
Age: 54.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bone pain, COVID-19, Drug ineffective, Dry skin, Incorrect route of product administration
Clinical narrative: COVID-19; COVID-19; Achy bones; Two dry patches; incorrect route of administration; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4267780-00 (Agency).  A 54 year-old female patient received bnt162b2 (BNT162B2), subcutaneous (Batch/Lot number: unknown) at the age of 54 years as dose 3 (booster), single, subcutaneous (Batch/Lot number: unknown) as dose 2, single and subcutaneous (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; risankizumab (SKYRIZI [RISANKIZUMAB]), subcutaneous (Batch/Lot number: unknown) for psoriasis. Relevant medical history included: "Dry patches" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INCORRECT ROUTE OF PRODUCT ADMINISTRATION (medically significant), outcome "unknown", described as "incorrect route of administration"; DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19"; BONE PAIN (non-serious), outcome "not recovered", described as "Achy bones"; DRY SKIN (non-serious), outcome "not recovered", described as "Two dry patches". The action taken for risankizumab was unknown.  Clinical information: Solicited report from a consumer of an adult female with events of non-serious COVID, ACHY BONES and DRY PATCHES with SKYRIZI (RISANKIZUMAB). The patient had a relevant medical history of DRY PATCHES. On unknown dates, the patient experienced COVID, ACHY BONES and DRY PATCHES. PFIZER BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect. The patient got sick from booster, got covid, achy bones, and two dry patches that came back. No concomitant drugs were taken. No adverse event Information was provided by patient related to covid vaccine. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No Known allergies  Causality for SKYRIZI(RISANKIZUMAB): The reporter's causality for the event(s) of COVID, ACHY BONES and DRY PATCHES was not provided. Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN): The reporter's causality for the event(s) of COVID, ACHY BONES and DRY PATCHES was provided as possible.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the currently available information the possibility of causal association between the reported events and the suspect drug BNT162B2  cannot be ruled out. 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: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; Fever; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4267840-00 (AbbVie).  A 15 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 27Jan2022 (Batch/Lot number: unknown) at the age of 15 years as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (ongoing) (Batch/Lot number: unknown) at citrate free. 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 28Jan2022, outcome "recovered" (2022) and all described as "tested positive for COVID"; PYREXIA (non-serious) with onset 2022, outcome "unknown", described as "Fever". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Jan2022) positive. The action taken for adalimumab was dosage not changed.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of tested positive for covid and fever was not provided. Causality 1) COVID-19 virus test positive (SARS-CoV-2 test positive), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine) : Not Reported, Dechallenge: N/A 2) Fever (Pyrexia), Action(s) taken with drug: Dose Not Changed, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A 2) Pfizer BioNTech Covid-19 Vaccine (Tozinameran) (Tozinameran), Unknown, Unknown, Daily Dose: 1st dose (1 in - Route of administration: Intramuscular, Indication for use: Covid-19 vaccination, Therapy dates: Unk Seq.No. :2 Drug: Pfizer Biontech covid-19 vaccine (Tozinameran)(Tozinameran), Unknown, Unknown, Daily Dose: 1) 1st dose (1 in 1 Once), 2) Second Dose (1 in 1 Once), Route of Admin: 1) Intramuscular 2) Intramuscular, Therapy Dates/Duration: 2) 27Jan2022 - 27Jan2022 Causality: 1) COVID-19 virus test positive (SARS-CoV-2 test positive), Action(s) taken with drug: Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge: N/A 2) Fever (Pyrexia), Action(s) taken with drug:  Unknown, Causality as per reporter (Drug/Vaccine): Not Reported, Dechallenge:  N/A  The reporter's assessment of the causal relationship of the (drug ineffective, COVID-19, pyrexia) 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 lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: The events of Drug Ineffective, COVID-19 and pyrexia are related to the suspect product BNT162B2 based on temporal relationship.
Sex: F
Vaccine: COVID19
Symptoms: Aphonia, COVID-19, Chills, Cough, Drug ineffective
Clinical narrative: Tested positive for Covid; Tested positive for Covid; Headache; Sore throat; Congestion; Fever; Chills; Loss of voice; Aches; DUPIXENT MY WAY  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 2021SA431415 (Sanofi).  A 28 year-old female patient received bnt162b2 (BNT162B2), administration date 23Dec2020 (Batch/Lot number: unknown) as dose 1, single, administration date 13Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date 11Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for immunisation; dupilumab (DUPIXENT), first regimen from 04Sep2020 (Batch/Lot number: unknown) to 04Sep2020 at 2 DF (2 df, 2 injections of unknown dose, unknown route for the initial loading dose on 04sep2020) and second regimen (ongoing) (Batch/Lot number: unknown) at 300 mg (300 mg (qow)) for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 18Dec2021, outcome "not recovered" and all described as "Tested positive for Covid"; HEADACHE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Sore throat"; COUGH (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Congestion"; PYREXIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Chills"; APHONIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Loss of voice"; PAIN (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive; (18Dec2021) positive. The action taken for dupilumab was dosage not changed.  Reporter causality: not reported for all the events. Company causality: not reportable for all the events.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; Tested positive for Covid; Headache; Sore throat; Congestion; Fever; Chills; Loss of voice; Aches; DUPIXENT MY WAY  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 2021SA431415 (Sanofi).  A 28 year-old female patient received bnt162b2 (BNT162B2), administration date 23Dec2020 (Batch/Lot number: unknown) as dose 1, single, administration date 13Jan2021 (Batch/Lot number: unknown) as dose 2, single and administration date 11Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for immunisation; dupilumab (DUPIXENT), first regimen from 04Sep2020 (Batch/Lot number: unknown) to 04Sep2020 at 2 DF (2 df, 2 injections of unknown dose, unknown route for the initial loading dose on 04sep2020) and second regimen (ongoing) (Batch/Lot number: unknown) at 300 mg (300 mg (qow)) for dermatitis atopic. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 18Dec2021, outcome "not recovered" and all described as "Tested positive for Covid"; HEADACHE (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Headache"; OROPHARYNGEAL PAIN (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Sore throat"; COUGH (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Congestion"; PYREXIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Fever"; CHILLS (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Chills"; APHONIA (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Loss of voice"; PAIN (non-serious) with onset 18Dec2021, outcome "not recovered", described as "Aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (unspecified date) positive; (18Dec2021) positive. The action taken for dupilumab was dosage not changed.  Reporter causality: not reported for all the events. Company causality: not reportable for all the events.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Pain, Pain in extremity, Poor quality product administered
Clinical narrative: Patient reported severe body ache; Out of energy; Very tired; Sleepy; Sore arm; Runny nose; when patient received this dose, vaccine vial had been at room temperature for about 31 hours; when patient received this dose, vaccine vial had been at room temperature for about 31 hours; This is a spontaneous report from a contactable reporter (pharmacist).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 11Feb2022 at 15:30 (lot number: FK9729) at the age of 60 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were reported as none. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FJ6369; Route of administration: Intramuscular; Anatomical site: Right arm; Administration time: 18:00), administration date: 19Jan2022, when the patient was 60 years old, for COVID-19 immunisation.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) and PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious); both with onset 11Feb2022 at 15:30, outcome "unknown", described as "when patient received this dose, vaccine vial had been at room temperature for about 31 hours"; PAIN (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Patient reported severe body ache"; ASTHENIA (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Out of energy"; FATIGUE (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Very tired"; SOMNOLENCE (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Sleepy"; PAIN IN EXTREMITY (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Sore arm"; RHINORRHOEA (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Runny nose". Therapeutic measures were taken as a result of pain, asthenia, fatigue, somnolence, pain in extremity and rhinorrhea.  Additional Information: The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. It was reported that when the patient received the second dose, the vaccine vial had been at room temperature for about 31 hours and it was also mentioned this was the reason for reporting these events even though they were generally seen in patients. Treatment received for reported events included Tylenol and Benadryl. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue, Rhinorrhoea, Somnolence
Clinical narrative: Patient reported severe body ache; Out of energy; Very tired; Sleepy; Sore arm; Runny nose; when patient received this dose, vaccine vial had been at room temperature for about 31 hours; when patient received this dose, vaccine vial had been at room temperature for about 31 hours; This is a spontaneous report from a contactable reporter (pharmacist).  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in right arm, administration date 11Feb2022 at 15:30 (lot number: FK9729) at the age of 60 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were reported as none. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: FJ6369; Route of administration: Intramuscular; Anatomical site: Right arm; Administration time: 18:00), administration date: 19Jan2022, when the patient was 60 years old, for COVID-19 immunisation.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) and PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious); both with onset 11Feb2022 at 15:30, outcome "unknown", described as "when patient received this dose, vaccine vial had been at room temperature for about 31 hours"; PAIN (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Patient reported severe body ache"; ASTHENIA (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Out of energy"; FATIGUE (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Very tired"; SOMNOLENCE (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Sleepy"; PAIN IN EXTREMITY (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Sore arm"; RHINORRHOEA (non-serious) with onset 12Feb2022 at 10:45, outcome "recovering", described as "Runny nose". Therapeutic measures were taken as a result of pain, asthenia, fatigue, somnolence, pain in extremity and rhinorrhea.  Additional Information: The patient had no known allergies. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. It was reported that when the patient received the second dose, the vaccine vial had been at room temperature for about 31 hours and it was also mentioned this was the reason for reporting these events even though they were generally seen in patients. Treatment received for reported events included Tylenol and Benadryl. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.