chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VYVANSE; PROZAC; OMEPRAZOLE; KLONOPIN. 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 drug ineffective, covid-19.  Clinical course: Patient took Paxlovid treatment from 24Dec2022 to 29Dec2022. There was 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 known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration
Clinical narrative: "bit black and blue mark" on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Dec2022 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: VACCINATION SITE DISCOLOURATION (non-serious), outcome "not recovered", described as ""bit black and blue mark" on the injection site".  Additional information: This consumer is the patient who got the shot of Pfizer Booster for Covid 21Dec2022 and has had a big black and blue mark on their arm and it's still there. Yes the patient also the reporter.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Vaccination site mass
Clinical narrative: a lump on the shoulder where the injection was is considered normal or not; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 81-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Dec2022 as dose number unknown (booster), single (Lot number: GJ6739) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HIV positive" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, manufacturer unknown), for covid-19 immunization; Covid-19 vaccine (Dose 3 (booster), single, manufacturer unknown), for covid-19 immunization.  The following information was reported: VACCINATION SITE MASS (non-serious) with onset 29Dec2022, outcome "unknown", described as "a lump on the shoulder where the injection was is considered normal or not".  Additional Information: Caller asked about the Pfizer Covid19 booster shot, and if getting a lump on the shoulder where the injection was considered normal or not. Caller noted that he just got his shot yesterday and that was his 5th time and that has never happened before. Consumer stated, "Yesterday, he got his second booster shot (Clarified as COVID-19 Vaccine) and this morning he found that he had a lump on his shoulder. His arm bump being a little larger than normal. Wants to know if that is normal or not.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 at 08:45 as dose 3 (booster), single (Lot number: FF2587) at the age of 56 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: "GERD" (unspecified if ongoing), notes: GERD; "Known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: Known allergies: Sulfa antibiotics. Concomitant medication(s) included: EZETIMIBE, start date: Jan2020; LANSOPRAZOLE; FINASTERIDE.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received paxlovid treatment from 17Dec2022 to 21Dec2022. Recurrent Covid symptoms (worse than initial symptoms but still mild-moderate in severity) approximately 10 days after initial symptoms, and 2 days after completing paxlovid treatment. Paxlovid treatment had been started 48 hours after initial symptom onset.; Sender's Comments: Based on the known the information available the Causal relation between the events Drug ineffective, Covid 19 and suspect drug cannot be excluded completely
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses.; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 10Oct2021 as dose 3 (booster), single (Lot number: FH8020) at the age of 59 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Date: 22Dec2020, NDC number, lot number, expiration date: Just has lot number, EJ1685.), administration date: 22Dec2020, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses."; BNT162b2 (DOSE 2, SINGLE, Date: 12Jan2021, NDC number, lot number, expiration date: EK4176), administration date: 12Jan2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses.". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses.  Additional information: Reporter repotred that she tested positive for Covid for the first time on 24Dec2022 and was still positive on 26Dec2022. Caller's last vaccine was on 12Nov2022, she did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses. Just got the sore arm with the 5th dose. There is a product complaint to report; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201401445 similar report from same reporter;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 12May2022 as dose 4 (booster), single (Lot number: FM9992) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1:, Date: 22Dec2020, NDC number, lot number, expiration date: Just has lot number, EJ1685.), administration date: 22Dec2020, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Nausea", "Fatigue", "muscle aches", "chills", "transient SOB", "runny nose", "weird headaches or fullness", "weird headaches or fullness", "Insomnia", "Light headness", "total body aches"; BNT162b2 (Dose 2:, Date: 12Jan2021, NDC number, lot number, expiration date: EK4176), administration date: 12Jan2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Diarrhea", "swollen kness", "headaches", "Nausea", "Fatigue", "Chills", "Muscle aches", "Runny nose", "Sneezing", "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses"; BNT162b2 (Dose 3:, Date: 10Oct2021, NDC number, lot number, expiration date: Assuming FH8020, would be nice if stickers were put on vaccination card instead of handwriting on vaccination card.), administration date: 10Oct2021, when the patient was 59-year-old, for COVID-19 immunization, reaction(s): "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses.". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Caller did not get swollen lymph nodes with 5th dose like caller did with the prior 4 doses.".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201401432 similar report from same reporter;
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: heavy hair fall/hair falling out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "Hair loss".  The following information was reported: ALOPECIA (non-serious), outcome "not recovered", described as "heavy hair fall/hair falling out".  Additional information: The patient was a performance artist who had experienced hair loss after receiving the Pfizer COVID-19 vaccine, she had spent a lot of money trying to prevent that hair loss but had not managed to prevent it. The side effect started after receiving the first dose of the vaccine and then worsened with subsequent doses. She got her shots at and wanted to know what therapeutic alternative or what kind of help can be provided for her problems.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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: "Leukaemia" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; PEPCID [FAMOTIDINE]. The following information was reported: DRUG INEFFECTIVE (medically significant), 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: Unknown Results, notes: Covid rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: Other medication in 2 weeks product (Atorvastatin and Pepcid). No known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201400554 Same patient, different product and event;
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (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: ALOPECIA (non-serious), outcome "unknown", described as "hair loss".  Additional information: The patient is a performance artist who experienced hair loss after receiving the Pfizer COVID-19 vaccine, she had spent a lot of money trying to prevent hair loss but has not managed to prevent it. The side effect started after receiving the first dose of the vaccine and then worsened with subsequent doses. She wanted to know what therapeutic alternative or what kind of help can be provided for her problems.   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: Radiculitis brachial
Clinical narrative: Got barachial neurities; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 13-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Jan2022 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: Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: Unknown), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: Unknown), for COVID-19 immunization. The following information was reported: RADICULITIS BRACHIAL (non-serious) with onset 2022, outcome "unknown", described as "Got barachial neurities". The event "got barachial neurities" required physician office visit. Therapeutic measures were taken as a result of radiculitis brachial.  Additional information: The patient didn't taken any other vaccine in four weeks. Other medications in two weeks was unknown. Adverse event was treated with Steroids. No COVID prior to vaccination. No Known allergies.  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: Pain, Weight bearing difficulty
Clinical narrative: Couldn't bear weight on leg for 12 hours, shooting pain.  2-3 weeks after vaccination.; Couldn't bear weight on leg for 12 hours, shooting pain.  2-3 weeks after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), 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. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), for COVID-19 Immunization. The following information was reported: WEIGHT BEARING DIFFICULTY (non-serious), outcome "recovered", described as "Couldn't bear weight on leg for 12 hours, shooting pain. 2-3 weeks after vaccination."; PAIN (non-serious), outcome "recovered", described as "Couldn't bear weight on leg for 12 hours, shooting pain. 2-3 weeks after vaccination". Therapeutic measures were not taken as a result of weight bearing difficulty, pain.  Additional information: Facility type vaccine was reported as unknown. Patient did not receive any other vaccine in four weeks. Other medication in 2 weeks was reported as unknown. Patient did not have COVID prior vaccination. It was unknown if the patent tested positive post vaccination.  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: his is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "No adverse event" (unspecified if ongoing). Concomitant medication(s) included: CRESTOR, start date: 15Sep2022, stop date: 19Dec2022. Past drug history included: Codeine, reaction(s): "known allergies: Codeine", notes: known allergies: Codeine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) strong positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course:  Patient had received other medication in 2 weeks.Patient was treated with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 56.0
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 56-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Other medical history: Hypothyroidism, high cholesterol; "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID, on 22Apr2022; ROSUVASTATIN, on 22Apr2022. Past drug history included: Tetracycline, reaction(s): "known allergies: Tetracycline", notes: known allergies: Tetracycline; Lactose, reaction(s): "known allergies:Lactose", notes: known allergies:Lactose. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 72.0
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 contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Nov2022 at 12:00 as dose 5 (booster), single (Lot number: GJ3275) at the age of 72 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Apr2022 as dose 4 (booster), single (Lot number: FK9893), in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 19Oct2021 as dose 3 (booster), single (Lot number: FH8020), 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: "Known allergies: A few antibiotics" (unspecified if ongoing), notes: Known allergies: A few antibiotics. Concomitant medication(s) included: TYLENOL, start date: Nov2022, stop date: Dec2022. 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 with PAXLOVID.  Additional information: Anti-Viral Details: Product=COVID 19 Treatment, Brand=PAXLOVID, Treatment Start Date=01Dec2022, Treatment Stop Date=05Dec2022, Indication=Treatment Of COVID-19
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Dose 3: Pfizer/BioNTech, dose 4: Moderna bivalent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 30Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "MS" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE, start date: 25Oct2019; OCREVUS, start date: 25Oct2019. Past drug history included: Bactrim, reaction(s): "known allergies: Bacrtrim", notes: known allergies: Bacrtrim. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 30Sep2022, outcome "unknown", described as "Dose 3: Pfizer/BioNTech, dose 4: Moderna bivalent"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Dec2022) Negative, notes: Tested negative on day 7 with no symptoms remaining; (29Dec2022) Positive, notes: On day 10 had runny nose and fatigue and tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EL9261), in right arm, on 17Feb2021 as dose 2, single (Lot number: EN9581), in right arm and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 47 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "LPR (silent reflux)" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: No; "chronic sinusitis" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOLE, start date: 01Jan2020; CLARITINE, start date: 01Oct2021. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 20Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: tested negative twice; (unspecified date) Negative, notes: tested negative twice; (29Dec2022) Positive, notes: positive on day 9; (20Dec2022) Positive, notes: Positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Anti-viral details included Paxlovid from 20Dec2022 till 25Dec2022 for treatment of COVID-19. This was a report about covid treatment. Other medication in 2weeks product: Flonase with start date 01Oct2022. Adverse event: Covid rebound after finishing 5 day dose of Paxlovid. Sinus congestion, sore throat, problems breathing in both airways due to inflammation. Chills, low grade fever tested negative twice then positive on day 9 of positive test on 20Dec2022 Nausea. No appetite. Adverse event start date: 29Dec2022, start time: 01:15 PM. AE resulted in: [None of the above]. If patient recovered: Not recovered. If treatment ae: No.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Vaccine brand other=Moderna,; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FF2590), in right arm and on 18May2022 at 14:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 62 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 25Mar2021 at 14:00 as dose 1, single (Lot number: 001B21), in right arm, on 22Apr2021 at 14:00 as dose 2, single (Lot number: 038B21A), in right arm and on 27Oct2022 at 14:00 as dose 5 (booster), single (Lot number: 7167B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies: sulfa drugs" (unspecified if ongoing), notes: Known allergies: sulfa drugs. Concomitant medication(s) included: CRESTOR; VALTREX; ESTRING; FLAXSEED OIL; VITAMIN D NOS, Women's Senior Multivitamin.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Dec2021 at 14:00, outcome "unknown", described as "Vaccine brand other=Moderna,"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 16Dec2022 to 21Dec2022.
Age: 43.0
Sex: F
Vaccine: COVID19, 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) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 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: "Pre-diabetic" (unspecified if ongoing), notes: Pre-diabetic; "obesity" (unspecified if ongoing); "Known allergies: Yes, sulfas" (unspecified if ongoing), notes: Known allergies: Yes, sulfas; "Known allergies: cephalosporins" (unspecified if ongoing), notes: Known allergies: cephalosporins; "Known allergies: shellfish" (unspecified if ongoing), notes: Known allergies: shellfish; "Known allergies: peanuts" (unspecified if ongoing), notes: Known allergies: peanuts. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient took Paxlovid treatment from 27Dec2022 to 29Dec2022. Patient received other medication in 2 weeks.  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 available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of "DRUG INEFFECTIVE " and "COVID-19 ".
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment: Paxlovid; COVID 19 Treatment: Paxlovid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Sep2022 at 01:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "thyroid" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "diverticulitis" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Demerol, reaction(s): "Known allergies: Demerol"; Oxycoton, reaction(s): "Known allergies: Oxycoton". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment: Paxlovid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Positive, notes: I have diagnose with REBOUND Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had no other medication in 2weeks. The patient received treatment for COVID-19 with Paxlovid drug, Treatment start date was on 19Dec2022, Treatment stop date was on 23Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 36.0
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old male patient received BNT162b2 (BNT162B2), on 14Jun2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Occipital neuralgia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "known allergies: Bactrim", notes: known allergies: Bactrim. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment start date was 15Dec2022 and stop date was 19Dec2022. Clinical course: Vaccine lot unknown reason was Not available/provided to reporter at the time of report completion.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Fatigue
Clinical narrative: Chest pain; left side Joint ache; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Dec2022 at 12:30 as dose 4 (booster), single (Lot number: GJ6742) at the age of 48 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID" (unspecified if ongoing), notes: if COVID prior vaccination : Yes. Concomitant medication(s) included: INFLUENZA VACCINE taken for immunisation, on 28Dec2022 as dose 1, single; IBUPROFEN. Vaccination history included: Bnt162b2 (other vaccine same date product=Pfizer,, other vaccine same date lot number=Lot#EL3248,, other vaccine same date vaccine date=28Dec2022,, other vaccine same date dose number=1,), for COVID-19 immunization; Bnt162b2 (other vaccine same date product=Pfizer,, other vaccine same date lot number=Lot#EL3248,, other vaccine same date vaccine date=28Dec2022,, other vaccine same date dose number=2,), for COVID-19 immunization; Bnt162b2 (other vaccine same date product=Pfizer,, other vaccine same date lot number=Lot#FE3594,, other vaccine same date vaccine date=28Dec2022,, other vaccine same date dose number=3,), for COVID-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 28Dec2022 at 23:30, outcome "recovering"; FATIGUE (non-serious) with onset 28Dec2022 at 23:30, outcome "recovering"; ARTHRALGIA (non-serious) with onset 28Dec2022 at 23:30, outcome "recovering", described as "left side Joint ache". Therapeutic measures were not taken as a result of chest pain, arthralgia, fatigue.  Additional information: The patient had chest pain, left side Joint ache (recovering as of 29Dec2022 20:40) Fatigue (recovering as of 29Dec2022 20:40). Location of injection for vaccine received within 4 weeks PRIOR: Flu - right arm. Patient received ibuprofen within 2 weeks of vaccination. No treatment for Adverse event. Prior to vaccination, patient was diagnosed with COVID-19. It was unknown that since the vaccination, the patient been tested for COVID-19.
Age: 85.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 14Sep2022 as dose 5 (booster), single (Lot number: FM0699) at the age of 85 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Only moderate hypertension" (unspecified if ongoing), notes: Only moderate hypertension. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: Negative; (2022) Positive, notes: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: it was reported that case was non-serious. Patient was treated for COVID with anti-viral medication which started on 17Dec2022 to 22Dec2022. Other medication in 2 weeks was Lozartin. It was reported that rebound Covid. Test positive again one week after testing negative. No known allergies.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna/Dose number: 4/Dose number: 5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 53 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm and on 08Sep2022 as dose 5 (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's relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Sulfa and Biaxin" (unspecified if ongoing), notes: Sulfa and Biaxin; "Mold" (unspecified if ongoing), notes: Mold; "Dust mites" (unspecified if ongoing), notes: Dust mites. The patient's concomitant medications were not reported. Past drug history included: Sulfa and biaxin, reaction(s): "Allergy", notes: Sulfa and Biaxin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 07Apr2022, outcome "unknown", described as "Moderna/Dose number: 4/Dose number: 5"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Dec2022) Positive; (Dec2022) Negative; (Dec2022) Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Patient tested positive for COVID on home antigen test after two consecutive negative tests five days after completing a full course of Paxlovid treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 54.0
Sex: M
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old male patient received BNT162b2 (BNT162B2), on 20Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunization. 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 "recovering" 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; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Fever; Runny nose; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A 25-year-old patient received BNT162b2 (BNT162B2), on 16Jun2021 as dose 2, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE), administration date: 25May2021, when the patient was 25-year-old, for COVID-19 immunization, reaction(s): "Fever", "Runny nose". The following information was reported: PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; RHINORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "Runny nose".  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, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12May2021 as dose 2, single (Lot number: EW0183) at the age of 48 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated with Paxlovid started on 20Dec2022 and stopped on 25Dec2022. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient received COVID-19 Vaccine previously. No known allergies. No other medical history.
Sex: M
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 64-year-old male patient received BNT162b2 (BNT162B2), in Aug2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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 Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 16Dec2022 to 20Dec2022. Clinical course: Now Day 16 after start of symptoms and still have COVID Symptoms - runny nose, sneeze, cough, sore throat and also some bleeding from throat.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: bloody nose, right nostril; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Dec2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 82 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1st, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 2nd, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 3rd, Unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose: 4th, Unknown manufacturer), for Covid-19 immunization. The following information was reported: EPISTAXIS (non-serious) with onset 29Dec2022 at 20:00, outcome "recovered", described as "bloody nose, right nostril". Therapeutic measures were not taken as a result of epistaxis.  Additional information: Facility type vaccine was Pharmacy or Drug Store. The patient did not receive any other vaccine in four weeks. The patient did not have Covid prior to vaccination. The patient did not test for Covid post vaccination. The patient did not have any known allergies.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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 had no relevant medical history. There were no concomitant medications. 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: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment from 20Dec2022 to 25Dec2022.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.