chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Discomfort, Hypersensitivity, Pruritus, Rash
Clinical narrative: have a rash; has burning like an allergic reaction; has burning like an allergic reaction; has some discomfort from her thighs; itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 10May2022 at 10:30 as dose 4 (booster), single (Lot number: FM9992) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Covid-19 vaccine first dose:, Manufacturer: Pfizer, NDC: Unknown, Lot: EL8982, Expiration: Unknown , Dose given: Unknown, Location: left arm, Time: afternoon, Location given: Civic Center), administration date: 27Jan2021, when the patient was 76-year-old, for COVID-19 immunization; covid-19 vaccine (Covid-19 vaccine second dose:, Manufacturer: Unknown, NDC: Unknown, Lot: EL9264, Expiration: Unknown, Dose given: Unknown, Anatomical Location: Left arm  , Location given: Civic Center , Time: Afternoon around 2:30), administration date: 17Feb2021, when the patient was 76-year-old, for COVID-19 immunization; covid-19 vaccine (Covid-19 vaccine third dose:, Manufacturer: Unknown, NDC: Unknown, Lot: FF2593, Expiration: Unknown, Anatomical Location: Left arm, Time given: Afternoon , Dose given: Unknown, Location given: (Pharmacy name) 17115), administration date: 04Nov2021, when the patient was 77-year-old, for COVID-19 immunization. The following information was reported: BURNING SENSATION (medically significant), HYPERSENSITIVITY (medically significant) all with onset 10May2022, outcome "unknown" and all described as "has burning like an allergic reaction"; DISCOMFORT (medically significant) with onset 10May2022, outcome "unknown", described as "has some discomfort from her thighs"; RASH (medically significant) with onset 10May2022, outcome "unknown", described as "have a rash"; PRURITUS (medically significant) with onset 10May2022, outcome "unknown", described as "itching". Therapeutic measures were taken as a result of rash, burning sensation, hypersensitivity, discomfort, pruritus.   Additional Information: It was reported that She said she seems to have a rash.  She said she has burning like an allergic reaction. Event date: started about 15 to 20 minutes ago.  She had the vaccination about 10:30 this morning on 10May2022.  She took some Benadryl and applied some lidocaine to her face and arms.  She said her symptoms doesn't seem to have worsened but has calmed down but she has some discomfort from her thighs.  She never had this before.  She said this was her fourth vaccine and no problems with the other vaccines. She said symptoms seem to be calming down.   Follow-Up (13May2022): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysstasia, Joint instability, Muscle disorder, Muscular weakness, Nervous system disorder
Clinical narrative: my leg muscles got extremely weak; i had great difficulty standing without my knee's buckling; i had great difficulty standing without my knee's buckling; severe neuro/muscular issues; severe neuro/muscular issues; 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 Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "idiopathic peripheral neuropathy" (unspecified if ongoing); "Charcot Marie Tooth disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Primary Immunization series, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, Primary Immunization series, MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: MUSCULAR WEAKNESS (non-serious), 2 weeks after the suspect product(s) administration, outcome "unknown", described as "my leg muscles got extremely weak"; DYSSTASIA (non-serious), JOINT INSTABILITY (non-serious), all with latency 2 weeks after the suspect product(s) administration, outcome "unknown" and all described as "i had great difficulty standing without my knee's buckling"; NERVOUS SYSTEM DISORDER (non-serious), MUSCLE DISORDER (non-serious), outcome "unknown" and all described as "severe neuro/muscular issues". The events "my leg muscles got extremely weak", "i had great difficulty standing without my knee's buckling" and "severe neuro/muscular issues" required physician office visit.  Additional information: Reporter wanted to ask if any patients who took the Covid booster experienced severe muscle pain in the legs. Patient had 3rd booster in Dec2021 and about two weeks later leg muscles got extremely weak and had great difficulty standing without knee's buckling. Patient had severe neuro/muscular issues. Patient had idiopathic peripheral neuropathy and Charcot Marie Tooth disease. Patient's neurologist told that other patients also experienced muscle pains.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Jun2021 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200696992 same reporter/drug/event, different pt
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid; Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received BNT162b2 (BNT162B2), in Jun2021 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: DRUG INEFFECTIVE (hospitalization, medically significant), COVID-19 (hospitalization, medically significant), outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Additional information: We both my husband and I got our vaccines a year ago in Jun and both have Covid. What compensation am I entitled too? He may be entering the hospital as of today. The lot number for the vaccine , BNT162B2 was not provided and will be requested during follow-up.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200696967 same reporter/drug/event, different pt
Age: 57.0
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 a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Borderline asthma" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN B12 NOS, start date: 01Apr2022, stop date: 10May2022. Past drug history included: Amoxicillin, reaction(s): "Allergy:Amoxicillin"; Alleve, reaction(s): "Allergy:Alleve"; Advil, reaction(s): "AllergyAdvil". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Adverse event: Bitter taste 24/7 for full 5 days. Return of mild Covid symptoms 6-8 days after completing treatment (minor sore throat, cough, minor lung congestion)  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis; 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-163-4383284-00 (AbbVie).  A 48-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 48 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since May2019 (Batch/Lot number: unknown) at 40 mg 2x/week (40 mg, 1 in 2 week), subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant), outcome "unknown". The action taken for adalimumab was unknown.  The reporter considered "rheumatoid arthritis" possibly related to BNT162b2.  Causality for Humira 40MG/0.4ML (Adalimumab) The reporter's causality for the event(s) of signs and sympytoms of Rheumatoid arthritis was not provided.  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 events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 40.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old male patient received BNT162b2 (BNT162B2), on 06Nov2021 at 22:00 as dose 3 (booster), single (Lot number: 3Q155BA) at the age of 40 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA 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: "Eosinophilic oesophagitis" (unspecified if ongoing); "Full dose of Moderna followed by Pfizer booster" (unspecified if ongoing), notes: Full dose of Moderna followed by Pfizer booster. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Apr2022) Negative; (07May2022) Positive, notes: continue to test positive through 07May2022; (May2022) Positive, notes: continue to test positive through 07May2022. Therapeutic measures were taken as a result of covid-19. Clinical course: Treatment of Covid-19 was started on 21Apr2022 and stopped on 26Apr2022. Adverse event start date and time was provided as 02May2022 11:45 PM. Patient stated that after testing negative on an at-home rapid test on 26Apr2022, and following the isolation and masking protocols, I had an impaction of food in my esophagus due to eosinophilic esophagitis on 02May2022. During the hospital stay, I tested positive on a rapid test and continue to test positive through 07May2022. Symptoms were mild, including lingering cough and some nasal congestion. (Full dose of Moderna followed by Pfizer booster, but the site wouldn't let me enter the Moderna vaccine info.).  No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19/Drug Ineffective; Covid-19; 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 (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown), on 09Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: dust" (unspecified if ongoing); "Known allergies: poison ivy" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: 08Feb2022; OXYBUTYNIN, start date: 08Feb2022; VOLTAREN [DICLOFENAC], start date: 08Feb2022; ACID CONTROLLER. Past drug history included: Percocet, reaction(s): "Known allergies: Percocet". The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Covid-19/Drug Ineffective"; COVID-19 (medically significant), outcome "unknown". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Negative; Negative; Unknown results. Therapeutic measures were taken as a result of covid-19. Patient received the vaccine. Patient received other medications in 2 weeks which included atorvastatin, oxybutynin and voltaren all taken from 08Feb2022. Other medication in 2 weeks also included acid controller. After quick improvement of respiratory symptoms and mild fever, she tested negative twice and ventured out into the world. Then awful nausea/diarrhea for two days followed by full body rash, which Benadryl helped quell after two days. Lingering cough and chills. Still was glad she took Paxlovid and am not certain the later symptoms were related. As of yesterday cough and chills were gone. Tested negative again. PA put me on antibiotic 04May2022 to make sure cough did not go into Covid pneumonia. Patient received treatment which included 2 Benadryl every 4 hours, later antibiotic. Patient known allergies including Poison Ivy, Dust, Percocet. Other medical history included recovering from hip surgery 07Feb2022 (as reported).   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Hip surgery, Off label use, SARS-CoV-2 test
Clinical narrative: Dose Number 3: 13Sep2021; recovering from hip surgery 07Feb2022; 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 (not pregnant) received BNT162b2 (BNT162B2), on 13Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Dust" (unspecified if ongoing), notes: Known allergies: Dust. Concomitant medication(s) included: ATORVASTATIN; OXYBUTYNIN; VOLTAREN [DICLOFENAC], start date: 08Feb2022, stop date: 08Feb2022; ACID CONTROLLER. Past drug history included: Percocet, reaction(s): "Known allergies: percocet", notes: Known allergies: percocet; Poison ivy, reaction(s): "Known allergies: Poison Ivy", notes: Known allergies: Poison Ivy. Vaccination history included: BNT162b2 (vaccine_dose_number_unknown=Fals, e}, {vaccine_brand=Pfizer / BioNTech,, vaccine_brand_unknown=False,, vaccine_administration_date=09Mar, 2021, vaccine_lot_unknown=True,, vaccine_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, vaccine_dose_number=2,), administration date: 09Mar2021, for Covid-19 immunization; BNT162b2 (vaccine_dose_number_unknown=Fals, e}, {vaccine_brand=Pfizer / BioNTech,, vaccine_brand_unknown=False,, vaccine_administration_date=17Feb, 2021, vaccine_lot_unknown=True,, vaccine_lot_unknown_reason=Not, available/provided to reporter at the, time of report completion,, vaccine_dose_number=1,, vaccine_dose_number_unknown=Fals, e}]), administration date: 17Feb2021, for Covid-19 immunization. The following information was reported: HIP SURGERY (medically significant) with onset 07Feb2022, outcome "recovering", described as "recovering from hip surgery 07Feb2022"; OFF LABEL USE (non-serious), outcome "unknown", described as "Dose Number 3: 13Sep2021". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: tested negative twice/Tested negative again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Return of covid symptoms; Return of covid symptoms; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 07Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 08Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "acid reflux" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE], start date: 28Apr2022, stop date: 01May2022; TYLENOL, start date: 01Jan2022, stop date: 10May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Return of covid symptoms". Therapeutic measures were taken as a result of covid-19. Clinical information: Patient has received other medication in 2 weeks. It was reported that return of covid symptoms 5 days after completion of Paxlovid despite complete isolation.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 23Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 29Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2021) Positive, notes: On day 4; (2021) Positive, notes: On day 12. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient was received vaccine and other medication with in 2 weeks reported as no. Adverse event: On day 4 after testing + on a rapid antigen test, and after taking 5 Paxlovid pills, I discontinued taking them. I had almost no Covid symptoms leading up to taking Paxlovid but was told to take it due to my age, 74. After 5 days quarantine and 5 days wearing a mask I resumed full activities. On day 12 I tested + on a rapid test. This is the adverse event. I had a very mild sore throat. I have quarantined an additional 5 days and am on day 9. No Known allergies.  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 the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FJ1620) 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: "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04May2022) Negative; (07May2022) positive. Therapeutic measures were taken as a result of covid-19. Clinical course: Other medication details: other medication in 2weeks product=Simvastatin. Adverse event: Tested negative after Paxlovid course. 3 days later, tested positive. The next day (4th day post course completion) I was more positive (darker antigen band and relative to control band) and exhibiting some symptoms including nasal pressure and some muscle aches. Adverse event start date: 02May2022 If patient recovered: Not recovered If treatment ae: No Known allergies: Sulfa.  No follow-up attempts possible. No further information expected.; Sender's Comments: Based on the information available  a possible contributory role of the suspect  cannot be excluded for the reported events of covid-19 and drug ineffective.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 56-year-old male patient received BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 56 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "renal insufficiency" (unspecified if ongoing); "hypertension" (unspecified if ongoing). Concomitant medication(s) included: ATENOLOL. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative; (09May2022) Positive, notes: Rebound of COVID-19 infection. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Antiviral details was COVID 19 Treatment, brand: Paxlovid, treatment start date: 27Apr2022, treatment stop date: 02May2022, indication=Treatment of COVID-19, Administrator route was Oral, Other mediation in two weeks product was Atenolol. No known allergies. No AE treatment was received. Other medical history: renal insufficiency, age, hypertension, lipid.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current limited available information and the drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events drug ineffective and COVID-19 cannot be excluded.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: product=COVID 19 Treatment, brand=Paxlovid; product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old male patient received BNT162b2 (BNT162B2), on 05Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years 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: "High blood pressure" (unspecified if ongoing). No known allergies. Other medication in 02 weeks was unknown. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "product=COVID 19 Treatment, brand=Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested Negative on covid tests, on Day 10 of infection, symptoms came back and covid tests are positive again; Negative, notes: Tested Negative on covid tests, on Day 10 of infection, symptoms came back and covid tests are positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course; Adverse event was tested Negative on covid tests, on Day 10 of infection, symptoms came back and covid tests are positive again. start date was 07May2022 and start time was 12:00 PM patient was Recovering.  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 the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of drug ineffective,covid-19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 11Oct2021 as dose 2, single (Lot number: El3248), in left arm, on 05Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: FC9893) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing). There were no concomitant medications. The patient did not receive any other medications in 2 weeks. Past drug history included: Omeprazole, reaction(s): "Known allergies: Omeprazole". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19. It was reported that from 27Apr2022 to 01 May2022, the patient was given treatment for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes mellitus" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 29Apr2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive; (06May2022) Negative; (09May2022) Positive; (10May2022) Positive; (unspecified date) Unknown results. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: The patient became symptomatic on 29Apr2022. He had home antigen test Positive PCR test and started Paxlovid as anti-viral as treatment medication as lower renal dose due to diabetes from 29Apr2022 to 03May2022 . She retook home antigen test and was negative on 06May2022 and became symptomatic again on 09May2022, retook home antigen test and was positive 10May2022. Her symptoms include sore throat, runny nose which started on 09May2022 was recovering. She did not had know allergies and did not taken other medication in 2 weeks of vaccination.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
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 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 49 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 14Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 02Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL; FLOVENT. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Apr2022) Negative; (18Apr2022) Positive; (24Apr2022) Negative. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. The patient had not received other medication in 2 weeks. The patient was given COVID 19 Treatment with anti-viral medication from 09Apr2022 to 13Apr2022. Patient tested negative on 16Apr2022, and then cough, congestion, sore throat and exhaustion returned on 18Apr2022 with positive Covid test. Tested negative again on 24Apr2022..  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: Blood potassium, Blood potassium decreased, Investigation, Vomiting
Clinical narrative: dropping my k+ landed me in the hospital; vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in May2022 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 but unknown manufacturer), for Covid-19 immunization.  The following information was reported: BLOOD POTASSIUM DECREASED (hospitalization), outcome "unknown", described as "dropping my k+ landed me in the hospital"; VOMITING (non-serious), outcome "unknown". The patient underwent the following laboratory tests and procedures: Blood potassium: dropping my k+; other test: negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I took Paxlovoid after getting COVID 19; I took Paxlovoid after getting COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right 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 had no relevant medical history. There were no concomitant medications.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "I took Paxlovoid after getting COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive again; (2022) Positive, notes: tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Investigation, Migraine, Pain
Clinical narrative: I have been dealing with migraine and pain through my whole body; Pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (005570). The reporter is the patient.  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 and concomitant medications were not reported. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "I have been dealing with migraine and pain through my whole body"; PAIN (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Additional information: Was it possible for the covid vaccine to cause pain throughout my whole body ever since I got my 1st dose I had been dealing with migraine and pain through my whole body all my labs and testing come back normal my family Dr can't figure out what's wrong with me the only thing I had done was get vaccinated and now I'm like this.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Nov2021 at 10:30 as dose number unknown, single (Batch/Lot number: unknown) at the age of 43 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: sulfa drugs" (unspecified if ongoing); "Known allergies: asparagus" (unspecified if ongoing); "Known allergies: spinach" (unspecified if ongoing); "Known allergies: strawberries (mild)" (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 "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of covid-19. 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: Atrial fibrillation
Clinical narrative: Patient developed new onset AFIB within days after administering the PFE vaccine; This is a spontaneous report received from non-contactable reporter(s) (Nurse) from a sales representative.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "Patient developed new onset AFIB within days after administering the PFE vaccine".  Clinical course: Description of Event reported as Patient developed new onset AFIB within days after administering the PFE vaccine. 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.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Atrial Fibrillation and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Jan2022 at 11:00 as dose 3 (booster), single (Lot number: FL3197) at the age of 44 years, in right 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: "Asthma" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Other medication in 2weeks: Yes. Anti-viral details: Product: COVID 19 Treatment. Brand: Paxlovid; Treatment start date: 29Apr2022; Treatment Stop date: 04May2022; Indication: Treatment of COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had Covid back in January this year even after getting the Pfizer Vaccine; I had Covid back in January this year even after getting the Pfizer Vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Low immune system" (unspecified if ongoing), notes: I have always had a low immune system; "surgery on my spine" (unspecified if ongoing), notes: I had had surgery on my spine. 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 "I had Covid back in January this year even after getting the Pfizer Vaccine".  Additional information: During inbound call: Patient stated, she had gone back to using the 5mg that she had left over from a year ago since she could not get the 11mg. She had Covid back in January this year even after getting the Pfizer Vaccine. She had had surgery on her spine and she have always had a low immune system. Patient was prescribed Xeljanz XR 11mg.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse), Program ID: (172086).  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. He had to get monoclonal antibodies. Told he has to wait three months until he can get his COVID-19 vaccine booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200695911 Same product and event, different patient
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Echocardiogram, Heart rate increased, Hypertension
Clinical narrative: fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: EW0162) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "stage I breast cancer" (unspecified if ongoing), notes: she had stage I breast cancer 10 years ago; "mastectomy" (unspecified if ongoing), notes: She had a mastectomy done. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200699539 same patient, same product, different dose, different events;US-PFIZER INC-202200700343 same patient, same product, different dose, different events
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Positron emission tomogram, Pyrexia, Ultrasound scan
Clinical narrative: fever; chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: (159558).  A 45-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: EW0162) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history included: "stage I breast cancer" (unspecified if ongoing), notes: she had stage I breast cancer 10 years ago; "mastectomy" (unspecified if ongoing), notes: She had a mastectomy done. The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "recovered", described as "fever"; CHILLS (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200699539 same patient, same product, different dose, different events;US-PFIZER INC-202200700343 same patient, same product, different dose, different events
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: possible Atrial Fibrillation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 47 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (prev dose product=COVID 19,, prev dose brand=Moderna,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=2,), for COVID-19 immunization; Moderna (prev dose product=COVID 19,, prev dose brand=Moderna,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Not available/provided to reporter at the time of report completion,, prev dose dose number=1), for COVID-19 immunization. The following information was reported: ATRIAL FIBRILLATION (medically significant), outcome "unknown", described as "possible Atrial Fibrillation". The event "possible atrial fibrillation" required physician office visit. It was unknown if therapeutic measures were taken as a result of atrial fibrillation.  Clinical Course: The patient had received the Moderna COVID vaccine initially and then received the Pfizer vaccine as a booster. subsequent to receiving the Pfizer booster, patients apple watch detected possible Atrial Fibrillation. Patient went to see his cardiologist who confirmed he has Atrial Fibrillation but was not concerned as he was generally healthy. Doctor or other healthcare professional office/clinic visit.  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: Toxicity to various agents
Clinical narrative: Poisoned booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (165141). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed., MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: TOXICITY TO VARIOUS AGENTS (non-serious), outcome "unknown", described as "Poisoned booster".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.