chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 15Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 22Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELOXICAM, start date: 17Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Multivitamin other medication in 2 weeks brand Megafood. Covid "rebound" of symptoms 5 days after completing Paxlovid prescription.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Dec2020 as dose 1, single (Lot number: EH9899), in right arm, on 05Jan2021 as dose 2, single (Lot number: EK4176), in right arm and on 11Sep2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "multiple sclerosis" (unspecified if ongoing); "myotonic muscular dystrophy" (unspecified if ongoing), notes: myotonic muscular dystrophy; "Asthma" (unspecified if ongoing); "chronic sinusitis" (unspecified if ongoing). The known allergies reported as none. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient has taken Paxlovid form 29Jun2022 to 04Jul2022 as treatment of COVID-19. The patient has taken other medication within 2 weeks of starting COVID-19 treatment are Dimethyl Fumarate, omeprazole, montelukast, fexofenadine hydrochloride, progesterone, estradiol, acetaminophen, ibuprofen and vitamin D3. On 12Jul2022, the patient had Covid rebound (Fever, body aches, Cough, Headaches, stuffy nose) and it has been treated with prednisone. The patient is recovering.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 75-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN5318), as dose 2, single (Lot number: FN6201), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "diabetes" (ongoing), notes: She has diabetes and that is why the doctor suggested Paxlovid. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "she did end up getting COVID and that is why she got Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: She got a letter that says thank you for contacting Pfizer and that she indicated that the Pfizer vaccine was not efficacious. She called initially because she wanted to let Pfizer know about the packaging for Paxlovid. She called and reported that. She had one pack that had white pills and had one pack that had pink pills. At the end of the conversation, she said by the way she had all four vaccines, and she is a fan of Pfizer. Now she has received this letter that says she indicated the product was not efficacious and that is not true. The third bubble packet had white and pink. Caller sent those back to pharmacist. She had 4 packets and she couldn't see the bubble stuff and sent the 2 unopened ones back to the pharmacy. That was what the report was on. Caller states that she did end up getting COVID and that is why she got Paxlovid. Caller clarified that she didn't end up taking the Paxlovid and didn't end up getting sick. She is assuming she didn't end up getting sick because she had the vaccines. Caller confirmed that all of this has been previously reported and she is calling today to clarify that she did not complain about the vaccines. Product strength and count size dispensed: not provided. Additional lot numbers of Pfizer COVID vaccine: first dose: lot number: EN5318. Second dose: lot number: FN6201. There is another lot number and caller was not sure if it is for the third or fourth dose, lot number: FF2593. One of them she doesn't have a lot number. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Mar2021 at 09:15 as dose 1, single (Lot number: EP7534), in left arm, on 08Apr2021 at 09:45 as dose 2, single (Lot number: ER8729), in left arm and on 10Dec2021 at 18:00 as dose 3 (booster), single (Lot number: FE3594) at the age of 62 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing), notes: Other medical history: Obesity. Concomitant medication(s) included: VITAMIN C;  ZINC GLUCONATE; VITAMIN D3; PRESERVISION AREDS 2. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Jun2022, outcome "not recovered" and all described as "Tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Jun2022) positive, notes: Tested positive for Covid-19 on 29Jun2022 PM; (04Jul2022) negative, notes: tested negative on 04Jul2022, 05Jul2022, and 06Jul2022; (05Jul2022) negative, notes: tested negative on 04Jul2022, 05Jul2022, and 06Jul2022; (06Jul2022) negative, notes: tested negative on 04Jul2022, 05Jul2022, and 06Jul2022; (11Jul2022) positive, notes: tested positive 11Jul2022 AM. Therapeutic measures were taken as a result of vaccination failure, covid-19. Paxlovid, Treatment start date: 30Jun2022, Treatment stop date: 04Jul2022. Tested positive for Covid-19 on 29Jun2022 PM, chills, headache, fatigue, doctor prescribed Paxlovid 30Jun2022, tested negative on 04Jul2022, 05Jul2022, and 06Jul2022. Symptoms (different than first time now head cold symptoms) appeared 10Jul2022 PM, tested positive 11Jul2022.
Age: 79.0
Sex: M
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 contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. An 80-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 at 12:00 as dose 1, single (Batch/Lot number: Unknown), in left arm, on 18Mar2021 at 13:00 as dose 2, single (Batch/Lot number: Unknown), in left arm, on 25Oct2021 at 14:30 as dose 3 (booster), single (Batch/Lot number: Unknown), in left arm and on 25May2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: Unknown) at the age of 79 years, in left arm for covid-19 immunisation. The patient relevant medical history included: "Kidney stone" (unspecified if ongoing), "L nephrectomy", start date: Sep1960 (unspecified if ongoing), notes: L nephrectomy, "HBP" (unspecified if ongoing), notes: HBP, "high cholesterol" (unspecified if ongoing). The patient concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jun2022) Positive; (26Jun2022) Positive, notes: I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 vaccine. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single at the age of 65 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: "Drug ending in-cillin" (unspecified if ongoing), notes: Drug ending in-cillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6205), in left arm and on 26Mar2021 as dose 2, single (Lot number: ER8727), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 03Dec2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: other medical history: Asthma. Concomitant medication(s) included: ADVAIR; FLUTICASONE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18May2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient treated with Paxlovid for COVID 19 Treatment. It was reported that patient was taking Birth control pills before vaccination. Patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient. A 27-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 years, in left arm for covid-19 immunization; 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 immunization. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient did not receive other medication in 2 weeks. Patient had no known allergies. Reported that 6 days after finishing treatment, she became very congested again and had nasal discharge. Patient received Paxlovid (anti viral treatment) from 01Jul2022 to 06Jul2022 for COVID-19 treatment.  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 known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 43.0
Sex: F
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 a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jul2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Paxlovid rebound. Symptoms returned worse after I completed. treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Anti-viral details: Product-COVID 19 Treatment, Brand-Paxlovid, Treatment start date-03Jul2022, Treatment stop date-08Jul2022 and Indication-Treatment of COVID-19. Symptoms returned worse after I completed treatment. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 79-year-old male patient received BNT162b2 (BNT162B2), on 18Jan2021 as dose 1, single (Lot number: EL3246), on 05Feb2021 as dose 2, single (Lot number: EN9581), on 26Sep2021 as dose 3 (booster), single (Lot number: FC3124) and on 04Apr2022 at 16:00 as dose 4 (booster), single (Lot number: FJ4991) at the age of 79 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Stable  CAD" (unspecified if ongoing). Concomitant medication(s) included: ASA, start date: 01Jan2020; AMLODIPINE, start date: 01Jan2020; TOPROL XL, start date: 01Jan2021; PANTOPRAZOLE, start date: 01Jan2020; HTZ, start date: 01Jan2020; HYTRIN, start date: 01Jan2020; PRAVASTATIN, start date: 01Jan2021, stop date: 24Jun2022. The following information was reported: VACCINATION FAILURE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (03Jul2022) Negative, notes: Neg antigen; (10Jul2022) Negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: Covid rebound. Neg antigen 03Jul2022, negative 10Jul2022, positive 11Jul2022. Symptomatic 09Jul2022 minimally. Anti-Viral details: Product covid-19 Treatment Brand: Paxlovid Treatment start date: 24Jun022 Treatment Stop date: 28Jun2022 Indication: Treatment Covid-19  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and the suspect drug BNT162B2.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Scan thyroid gland, Thyroid mass
Clinical narrative: Rheumatoid arthritis flare up; Thyroid nodule; Dry skin; Painful nodule; Localized erythema;   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-163-4377018-00.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 01Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 01Feb2021 as dose 2, single (Batch/Lot number: unknown) at the age of 72 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Batch/Lot number: unknown) at citrate free, 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 "recovering", described as "Rheumatoid arthritis flare up"; THYROID MASS (non-serious), outcome "not recovered", described as "Thyroid nodule"; DRY SKIN (non-serious), outcome "not recovered"; NODULE (non-serious), outcome "recovering", described as "Painful nodule"; ERYTHEMA (non-serious), outcome "unknown", described as "Localized erythema". The patient underwent the following laboratory tests and procedures: Test: Five nodules on thyroid; Scan thyroid gland: Unknown Results. The action taken for adalimumab was unknown. Clinical course: Events of non-serious five nodules on thyroid/five nozzles in thyroids, dry skin, could not move or sleep due to painful nodules, rheumatoid arthritis/had flare up/affected left jaw and arm/rheumatoid arthritis flare up not as bad as before and finger and hand red at times with humira (adalimumab). 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 five nodules on thyroid/five nozzles in thyroids, dry skin, rheumatoid arthritis/had flare up/affected left jaw and arm/rheumatoid arthritis flare up not as bad as before and finger and hand red at times was not provided. The reporter's causality for the event(s) of could not move or sleep due to painful nodules with humira(adalimumab) was a reasonable possibility. The reporter considered "rheumatoid arthritis flare up", "thyroid nodule", "dry skin", "painful nodule" and "localized erythema" related to BNT162b2.  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 nature of the events Rheumatoid arthritis flare up ,dry skin,  thyroid nodule, erythema, painful nodule a causal relation between the reported events and the administration of the vaccine 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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 15Sep2021 as dose 2, single (Lot number: FC3183) intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypo" (ongoing); "Chronic pain" (ongoing); "CKD3" (ongoing). Concomitant medication(s) included: THYROID TINCTURE oral taken for hypothyroidism (ongoing). Vaccination history included: BNT162b2 (Dose: 1st, Time: 12:00 PM, Route of administration: Intramuscular, Anatomical Site of injection: Left upper arm, Lot: FC3183), administration date: 26Aug2021, for COVID-19 Immunization, reaction(s): "Pain". The following information was reported: PAIN (non-serious) with onset 15Sep2021, outcome "not recovered". The event "pain" required physician office visit. Therapeutic measures were not taken as a result of pain.  Additional information: The second dose of vaccine was administered on Right upper arm. No relevant tests were done. Specific relevant test for thromboembolic events with thrombocytopenia: None.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: swollen lymph in armpit breast; They ache randomly since this happened; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2), on 30Nov2021 at 12:30 as dose 3 (booster), single (Lot number: FJ1620) at the age of 39 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Mood disorder" (unspecified if ongoing); "Migraines" (unspecified if ongoing), notes: Migraines. Concomitant medication(s) included: BUPROPION oral taken for affective disorder, start date: 2018 (ongoing); SUMATRIPTAN oral taken for migraine, start date: 2016 (ongoing). Vaccination history included: BNT162b2 (Dose:1st, Time: 10:30, Site and Route of injection:, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: ER8737), administration date: 02Apr2021, for Covid-19 Immunization, reaction(s): "COVID-19"; BNT162b2 (Dose: 2nd, Time: 11:00, Site and Route of injection:, Anatomical site of injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EW0175), administration date: 23Apr2021, for Covid-19 Immunization, reaction(s): "COVID-19"; flucelvax (DOSE NUMBER UNKNOWN), administration date: 02Nov2021, for Immunization. The following information was reported: LYMPH NODE PAIN (non-serious) with onset 01Dec2021, outcome "unknown", described as "They ache randomly since this happened"; LYMPHADENOPATHY (non-serious) with onset 01Dec2021, outcome "recovering", described as "swollen lymph in armpit breast". The event "swollen lymph in armpit breast" required physician office visit. Therapeutic measures were not taken as a result of lymphadenopathy.  Additional Information: On day after booster vaccine (3 in the series), my lymph nodes in both armpits swelled. They ache randomly since this happened. Patient does not required the initiation of new medication/other treatment/procedure.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: positive effect of your vaccine injections on lesions of my classic Kaposisarcoma cancer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3302) at the age of 83 years for covid-19 immunisation. The patient's relevant medical history included: "Kaposi's sarcoma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "positive effect of your vaccine injections on lesions of my classic Kaposisarcoma cancer".  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Nausea, Pyrexia
Clinical narrative: fever; nausea; Lack of appetite; increased tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 8-month-old patient received BNT162b2 (COMIRNATY), 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: PYREXIA (non-serious), 3 hrs after the suspect product(s) administration, outcome "recovering", described as "fever"; NAUSEA (non-serious), 3 hrs after the suspect product(s) administration, outcome "recovering"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Lack of appetite"; FATIGUE (non-serious), outcome "unknown", described as "increased tiredness". Therapeutic measures were taken as a result of pyrexia, nausea.  Additional information: Symptoms reduced with dosage of Tylenol 2.5 ml. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pain
Clinical narrative: COVID-19; Pain; COVID-19; 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-163-4327066-00 (Company).  A 64-year-old male patient received BNT162b2 (BNT162B2), on 20Apr2021 as dose 1, single (Batch/Lot number: unknown) at the age of 63 years and on 18May2021 as dose 2, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 11463448) at citrate free, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2021, outcome "recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19"; PAIN (non-serious), outcome "not recovered". The action taken for adalimumab was unknown.  Clinical course: On an unknown date, the patient experienced PAIN/STILL HURT EVERYWHERE. In 2021, the patient experienced COVID-19. On 14Feb2022, the patient experienced COVID-19 and Pneumonia in left lung then entered right. In 2022, the COVID-19 and Pneumonia in left lung then entered right resolved. 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 COVID-19 onset 14Feb2022 and Pneumonia in left lung then entered right with HUMIRA (ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of COVID-19 onset in 2021 and Pain/still hurt everywhere was not provided.  Relevant Laboratory & Other Diagnostic Tests: 14Feb2022 COVID-19 TEST: positive. Change History: On 26Apr2022, received updates to event information, reporter opinion of causality, concomitant drug information and narrative description. On 29Jun2022, received updates to patient demographics, event information, reporter opinion of causality, suspect drug information, concomitant drug information and narrative description. The event of "Pain/still hurt everywhere" was added  The reporter's assessment of the causal relationship of "covid-19" and "pain" 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 possible temporal association the causal role of  reported events cannot be excluded for  suspect product  .Case will be reviewed further on receipt of FU information.
Sex: M
Vaccine: COVID19
Symptoms: Purpura
Clinical narrative: red purpura rash started to appear on lower parts of legs - not itching or painful at all; This is a spontaneous report received from contactable reporter(s) (Pharmacist).  A male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 2, single (Lot number: EN6204) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN oral taken for blood cholesterol, stop date: Apr2022; CLOPIDOGREL oral, stop date: Apr2022. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EN6205; Route of administration: Intramuscular; Anatomical site of injection: Arm Left), administration date: 24Feb2021, for Covid-19 immunization. The following information was reported: PURPURA (non-serious) with onset Jun2021, outcome "unknown", described as "red purpura rash started to appear on lower parts of legs - not itching or painful at all".
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Injection site irritation; Fever; Aches and pains; Headache; Felt sick; injection site pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; VACCINATION SITE IRRITATION (non-serious), outcome "unknown", described as "Injection site irritation"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Aches and pains"; HEADACHE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "Felt sick"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  The reporter considered the events as caused by the suspect product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site irritation, Vaccination site pain
Clinical narrative: Arm pain; Injection site irritation; Fever; Aches and pains; Headache; Felt sick; injection site pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (COMIRNATY), 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm pain"; VACCINATION SITE IRRITATION (non-serious), outcome "unknown", described as "Injection site irritation"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; PAIN (non-serious), outcome "unknown", described as "Aches and pains"; HEADACHE (non-serious), outcome "unknown"; MALAISE (non-serious), outcome "unknown", described as "Felt sick"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site pain".  The reporter considered the events as caused by the suspect product.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: body aches; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (COMIRNATY), 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: PAIN (non-serious), outcome "unknown", described as "body aches"; PYREXIA (non-serious), outcome "unknown", described as "fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient. A female patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Respondent and husband both got COVID-19 after getting the Pfizer Vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : PFIZER INC-202200944614 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: got covid; got covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; 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 immunization. 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 "got covid". Caller (consumer) needs some information on how long she will need to wait to get her 2nd booster dose when at a quarantine. She mentioned that she is due for the 2nd booster and got covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): MOD22-017955 (Moderna). A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Batch/Lot number: unknown), on 17Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 21Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body aches and pains"; PYREXIA (non-serious), outcome "unknown", described as "a little fever". Therapeutic measures were not taken as a result of headache, pain, pyrexia. Additional information: After receiving the dose of the Moderna vaccine, the patient experienced headache, body aches and pains, and a little fever. These symptoms were constant, and similar to what she experienced after the Pfizer vaccine. The patient had not taken any medications or treatments for symptoms.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Joint stiffness
Clinical narrative: extreme pain and stiffness in my joints; extreme pain and stiffness in my joints; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm 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: ARTHRALGIA (non-serious), JOINT STIFFNESS (non-serious) all with onset Feb2022, outcome "unknown" and all described as "extreme pain and stiffness in my joints".  Additional Information: Patient reported that since the day of vaccination had extreme pain and  stiffness in joints. Especially the left side of the body. The patient don't know what to do to get better.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Bell's palsy, Chest X-ray, Computerised tomogram, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: getting bells palsy after the first Pfizer injection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MOD22-017831.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1 , single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BELL'S PALSY (medically significant), outcome "unknown", described as "getting bells palsy after the first Pfizer injection". The patient underwent the following laboratory tests and procedures: Chest X-ray: (unspecified date) Unknown results, notes: chest x-ray to make sure they did not have pneumonia; Computerised tomogram: (unspecified date) Unknown results, notes: did not show any blood clots; Oxygen saturation: (unspecified date) Low, notes: still low in the 80's; SARS-CoV-2 test: (Nov2020) Positive, notes: had covid 19 back in Nov2020.  Clinical course: Caller said they initially took 2 Pfizer doses and 1 Pfizer booster. Caller reports getting bells palsy after the first Pfizer injection.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200945535 same patient/drug/AE, different dose number;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Infection with covid-19 was detected; Infection with covid-19 was detected; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and in Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09Jul2022, outcome "unknown" and all described as "Infection with covid-19 was detected". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09Jul2022) Infection with covid-19 was detected. Infection with covid-19 was detected 09Jul2022, 09Jul2022using BinaxNOW antigen self-test. Symptoms included sore throat, hoarse voice, cough, fatigue, nasal congestion, runny nose, headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 62-year-old male patient received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Infection with COVID-19". Symptoms: sore throat, hoarse voice, cough, fatigue, nasal congestion, runny nose and headache. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: infection with COVID-19. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: The causal association cannot be excluded between the reported events and suspect vaccine use based on known drug safety profile.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I had Covid six months ago and have not had my booster/ I had Covid twice already and I have had two vaccines. I had covid 6 months ago; I had Covid six months ago and have not had my booster/I had Covid twice already and I have had two vaccines. I had covid 6 months ago; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "I had Covid six months ago and have not had my booster/ I had Covid twice already and I have had two vaccines. I had covid 6 months ago"; COVID-19 (medically significant), outcome "unknown", described as "I had Covid six months ago and have not had my booster/I had Covid twice already and I have had two vaccines. I had covid 6 months ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: I had Covid twice already and I have had two vaccines. I had covid 6 months ago."  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Pyrexia
Clinical narrative: did not feel well; Aches; fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (173415). The reporter is the patient.  A male patient received BNT162b2 (COMIRNATY), 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: MALAISE (non-serious), outcome "unknown", described as "did not feel well"; PAIN (non-serious), outcome "unknown", described as "Aches"; PYREXIA (non-serious), outcome "unknown", described as "fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient reports COVID vaccine inefficacy/ I got COVID two weeks after I got my booster shot; Patient reports COVID vaccine inefficacy/ I got COVID two weeks after I got my booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient reports COVID vaccine inefficacy/ I got COVID two weeks after I got my booster shot".  Clinical information: Patient reported COVID vaccine inefficacy. Patient got COVID two weeks after he got his booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug Ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old patient received BNT162b2 (BNT162B2), 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: "skin issue" (unspecified if ongoing), notes: skin issue. Concomitant medication(s) included: PREDNISONE taken for skin disorder, start date: 27Jun2022. The following information was reported: COVID-19 (medically significant) with onset 10Jul2022, outcome "unknown", described as "tested positive for COVID"; DRUG INEFFECTIVE (medically significant) with onset 10Jul2022, outcome "unknown", described as "tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Jul2022) Positive. Clinical course: Patient reported that tested positive for COVID on the evening of Sunday (10Jul2022). Patient received three Pfizer-BNT vaccine shots to date. Symptoms were fatigue, sore throat, cough, sneezing/congestion. Patient was prescribed 5 days of prednisone the week of 27Jun2022 to treat a skin issue. Patient take no other medications.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.