chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Moderna / Dose Number: 4 Pfizer / BioNTech / Dose Number: 5; Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2022 at 14:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 61 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Jan2021 as dose 1, single (Lot number: 042L2UA), in left arm, on 23Feb2021 as dose 2, single (Lot number: 023M20A), in left arm, on 21Aug2021 as dose 3 (booster), single (Lot number: C52E21A), in left arm and on 10Apr2022 as dose 4 (booster), single (Lot number: 001M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HBP" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Melanoma" (unspecified if ongoing); "Vascular disease." (unspecified if ongoing); "No spleen" (unspecified if ongoing); "Partial pancreatectomy" (unspecified if ongoing). Concomitant medication(s) included: METFORMINE [METFORMIN HYDROCHLORIDE], start date: 01Jan2015; EZETIMIBE & SIMVASTATIN, start date: 01Jan2003, stop date: 27Nov2022; BUPROPION, start date: 01Jan2001; LOSARTAN, start date: 01Jan2010; BABY ASPIRIN, start date: 01Jan2000; VITAMIN D 2000, start date: 01Feb2020. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 19Sep2022 at 14:00, outcome "unknown", described as "Moderna / Dose Number: 4 Pfizer / BioNTech / Dose Number: 5". Therapeutic measures were taken as a result of drug ineffective, covid-19. From 27Nov2022 to 01Dec2022, the patient received Paxlovid as treatment of COVID-19. The patient had no known allergies.
Age: 56.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) 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), 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: "type 1 diabetes" (unspecified if ongoing), notes: type 1 diabetes; "Contrast dye allergy" (unspecified if ongoing), notes: known allergies: Contrast dye. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Vaccine was received. Other medications in 2 weeks was noted as no. Treatment noted as COVID 19 Treatment of Pfizer. Treatment start date was noted as 30Nov2022 and treatment stop date was noted as 05Dec2022. Indication noted as treatment of 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.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Lightheadedness when she gets up and walk around; 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 80-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: DIZZINESS (non-serious), outcome "unknown", described as "Lightheadedness when she gets up and walk around".  Additional information: It was also reported that patient was asking for how long does side effects from bivalent COVID booster for adults would last. She said that she wanted to know specifically about lightheadedness when she gets up and walk around.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, Vaccination failure
Clinical narrative: Drug ineffective; COVID-19; Pfizer / BioNTech Dose Number: 3 Moderna Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 as dose 1, single (Lot number: EN5318), in right arm, on 19Feb2021 as dose 2, single (Lot number: EL9264), in right arm and on 24Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 66 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 03Apr2022 as dose 4 (booster), single (Lot number: 065K21A), in right arm and on 06Oct2022 as dose 5 (booster), single (Lot number: B050D22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3, start date: 06Sep2022; VITAMIN C [ASCORBIC ACID], start date: 06Sep2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 03Apr2022, outcome "unknown", described as "Pfizer / BioNTech Dose Number: 3 Moderna Dose Number: 4"; VACCINATION FAILURE (medically significant), outcome "unknown", described as "Drug ineffective"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient received Paxlovid (Lot number: 2692131) as treatment of COVID-19 from 29Nov2022 to 04Dec2022.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 11Dec2021 as dose number unknown, single (Lot number: EW0217) at the age of 44 years, in right arm 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 "COVID 19 Treatment". It was reported that patient's sore throat and body ache came back after those were gone. The test results became positive after being negative.The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive; and SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: caller already had the Pfizer Covid vaccine primary series and had Covid; caller already had the Pfizer Covid vaccine primary series and had 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 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 "caller already had the Pfizer Covid vaccine primary series and had Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: had Covid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Caller took paxlovid a month and half ago and asked is there any reason he can't get the pfizer booster shot after taking Paxlovid a month and half ago. - Gathered caller's Name- unable to verify spelling of name - Warm transferred to another line- ( Created and submitted Manual AE form Precautionary because caller already had the Pfizer Covid vaccine primary series and had Covid, causing caller to take Paxlovid. Also unable to ask if caller already took the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I got covid; I got COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Nov2022 as dose 3 (booster), single (Batch/Lot number: unknown) and on 06Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 09Dec2022, outcome "unknown", described as "I got COVID"; DRUG INEFFECTIVE (medically significant) with onset 09Dec2022, outcome "unknown", described as "I got covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10Dec2022) Positive, notes: Nasal Swab. It was unknown if 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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201366310 Same reporter/patient, different AE.;
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: other friend who also took Pfizer, he died suddenly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant) with onset 2022, outcome "fatal", described as "other friend who also took Pfizer, he died suddenly". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical course: It was reported that my other friend who also took Pfizer, he died suddenly 4 and a half weeks ago; He just died in his kitchen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: other friend who also took Pfizer, he died suddenly
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Blood test, COVID-19, Drug ineffective, Echocardiogram, Interchange of vaccine products
Clinical narrative: covid / first two dosage was last year that was moderna and the two booster was Pfizer; covid / first two dosage was last year that was moderna and the two booster was Pfizer; covid / first two dosage was last year that was moderna and the two booster was Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Infection" (unspecified if ongoing); "Immunity disorder" (unspecified if ongoing); "IGG immunity disorder" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). Concomitant medication(s) included: TAMIFLU; CEFDINIR taken for infection. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Dec2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid / first two dosage was last year that was moderna and the two booster was Pfizer". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Echocardiogram: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Blood test, Body temperature, Chills, Dyspnoea, Echocardiogram
Clinical narrative: covid / first two dosage was last year that was moderna and the two booster was Pfizer; covid / first two dosage was last year that was moderna and the two booster was Pfizer; covid / first two dosage was last year that was moderna and the two booster was Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Infection" (unspecified if ongoing); "Immunity disorder" (unspecified if ongoing); "IGG immunity disorder" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). Concomitant medication(s) included: TAMIFLU; CEFDINIR taken for infection. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Dec2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid / first two dosage was last year that was moderna and the two booster was Pfizer". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Echocardiogram: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: Fatigue, Hyperhidrosis, Nightmare, SARS-CoV-2 test
Clinical narrative: covid / first two dosage was last year that was moderna and the two booster was Pfizer; covid / first two dosage was last year that was moderna and the two booster was Pfizer; covid / first two dosage was last year that was moderna and the two booster was Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 63 years for covid-19 immunisation; BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Blood pressure high" (unspecified if ongoing); "Infection" (unspecified if ongoing); "Immunity disorder" (unspecified if ongoing); "IGG immunity disorder" (unspecified if ongoing); "Heart disease" (unspecified if ongoing). Concomitant medication(s) included: TAMIFLU; CEFDINIR taken for infection. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset Dec2021, outcome "unknown", DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "covid / first two dosage was last year that was moderna and the two booster was Pfizer". The patient underwent the following laboratory tests and procedures: Blood test: Unknown results; Echocardiogram: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19-2
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). A 61-year-old female patient (not pregnant) received BNT162B2, BNT162B2 OMI BA.4-5, as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; COVID-19 VACCINE, as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Vaccine brand was noted as Pfizer/BioNTech. Other medication in 2 weeks was noted as unknown. Paxlovid oral started on 07Dec2022 for Treatment of 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.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: I keep on getting hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (159558). 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: URTICARIA (non-serious), outcome "unknown", described as "I keep on getting hives".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Nausea, Wrong product administered
Clinical narrative: Severe nausea; headaches; weakness; Bivalent vaccine was administered for Dose 1; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 at 13:00 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in right arm for covid-19 immunisation. The patient didn't receive BNT162b2 (BNT162B2). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 22Nov2022 at 13:00, outcome "unknown", described as "Bivalent vaccine was administered for Dose 1"; NAUSEA (non-serious) with onset 22Nov2022 at 16:45, outcome "recovered" (2022), described as "Severe nausea"; HEADACHE (non-serious) with onset 22Nov2022 at 16:45, outcome "recovered" (2022), described as "headaches"; ASTHENIA (non-serious) with onset 22Nov2022 at 16:45, outcome "recovered" (2022), described as "weakness". Therapeutic measures were not taken as a result of nausea, headache, asthenia.  Additional information: It was also reported that there was no other vaccine in four weeks. There were no allergies and patient did not had covid prior vaccination and was not covid tested post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she got really sick with all three of the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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: ILLNESS (non-serious), outcome "unknown", described as "she got really sick with all three of the vaccines".  Additional Information: Daughter is 44 and she got really sick with all three of the vaccines. Daughter never said that to her before. Thinks a lot of people just don't say anything and don't report it. Will talk to her daughter about calling and filing a report.Thought she was feeling better. Its wearing off. Doesn't know how the symptoms work through the system exactly. Starting to feel a little bit better. Doesn't know that she will make it to her appt Wednesday though. She cant shower to get out of house. She walks and rides a bike everyday. So this has really put her our. Doesn't get sick very often at all.  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-202201369522 same reporter/patient/event, different doses.;US-PFIZER INC-202201353127 same reporter/patient/event, different doses.;
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: she got really sick with all three of the vaccines; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  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): "she got really sick with all three of the vaccines". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "she got really sick with all three of the vaccines".  Additional information: Daughter was 44 and she got really sick with all three of the vaccines. Daughter never said that to her before. Thinks a lot of people just don't say anything and don't report it. Will talk to her daughter about calling and filing a report. Thought she was feeling better. Its wearing off. Doesn't know how the symptoms work through the system exactly. Starting to feel a little bit better. Doesn't know that she will make it to her appt Wednesday though. She can't shower to get out of house. She walks and rides a bike everyday. So this has really put her our. Doesn't get sick very often at all.  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-202201369512 same reporter/patient/event, different doses.;US-PFIZER INC-202201353127 same reporter/patient/event, different doses.;
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 27-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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: MYOCARDITIS (death, medically significant), outcome "fatal". The patient date of death was unknown. Reported cause of death: "died after he got the his Covid vaccine of myocarditis.". It was not reported if an autopsy was performed.  Clinical information: While reporting on her son, she reported that her friend's son who was 27-year-old died after he got the his Covid vaccine of myocarditis.  The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.; Reported Cause(s) of Death: died after he got the his Covid vaccine of myocarditis.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Pain, Suspected COVID-19
Clinical narrative: Lot of pain; Covid-19; Covid-19; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4180478 (Company).  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) and as dose number unknown, single (Batch/Lot number: unknown), all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1166040) till 2022 at single dose pen, subcutaneous for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "Covid-19"; PAIN (non-serious), outcome "unknown", described as "Lot of pain". The action taken for adalimumab was dosage permanently withdrawn in 2022.  The reporter's assessment of the causal relationship of "covid-19" and "lot of pain" with the suspect product(s) BNT162b2 was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality: The reporter's causality for the event of Covid-19 and Lot of pain with Adalimumab Solution for Injection was Not Provided. The reporter's causality for the event of Covid-19 and Lot of pain with Pfizer BioNTech Covid-19 vaccine (Tozinameran) was Not Provided. Company's opinion was that the causality for the event of Covid-19 and Lot of pain with Adalimumab Solution for Injection was Not Provided. Company's opinion was that the causality for the event of Covid-19 and Lot of pain with Pfizer BioNTech Covid-19 vaccine (Tozinameran) was Not Provided. Assessment Results: Humira-Covid-19, Non-Health Care Professional, Global Introspection, Not reported. Pfizer BioNTech Covid-19 vaccine-Pain, Non-Health Care Professional, Global Introspection, Not reported. Humira-Pain, Non-Health Care Professional, Global Introspection, Not reported. Pfizer BioNTech Covid-19 vaccine-Covid-19, Non-Health Care Professional, Global Introspection, Not reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As per the available information the events drug ineffective,suspected covid-19 and pain are possibly related to the suspect.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: facility administeredthe vaccine that was left out on the fridge on Friday and they accidentally administered it to two patients on Saturday; facility administeredthe vaccine that was left out on the fridge on Friday and they accidentally administered it to two patients on Saturday; This is a spontaneous report received from a contactable reporter(s) (Pharmacist), Program ID: (004756).  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: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "facility administeredthe vaccine that was left out on the fridge on Friday and they accidentally administered it to two patients on Saturday".  Additional information: Caller is a Pharmacist and one of the pharmacists on the facility administered the vaccine that was left out on the fridge on Friday and they accidentally administered it to two patients on Saturday. Caller would like to know how to handle this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid; covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; BNT162b2 (BNT162B2), 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: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Oct2022, outcome "not recovered" and all described as "covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Oct2022) positive; (03Nov2022) Unknown Results, notes: feeling better; (04Nov2022) Unknown Results, notes: feeling better; (07Nov2022) positive; (12Nov2022) negative; (13Nov2022) Positive, notes: testing strongly positive again; (unspecified date) Negative, notes: PCR came back negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: On 26Oct2022 COVID symptoms- congestion/body ache/headache. On 27Oct2022 self-test positive immediately. Started Paxlovid that day and tele-doc visit. On 31Oct2022 Paxlovid final day 5. 03Nov2022 and 04Nov2022 the patient was feeling better and performed self-test hardly a line (same tests as before). 06Nov2022 lungs start to hurt/fatigue sets back. 07Nov2022 to 13Nov2022 COVID back and worsen than the first time, hit her lungs this time and congestion back testing strongly positive again. 14Nov2022 lungs recover by 12Nov2022 she was negative covid (again) on 26Nov2022, and still she was battling congestion in her ears sinus not blaming Paxlovid for that she hopes studies are being done on longer time on Paxlovid clearly 5days was not enough for her or her husband who also was sending you this form.  The information on the batch/lot number for [BNT162B2/ BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Interchange of vaccine products, Vertigo
Clinical narrative: She had terrible vertigo; She had terrible vertigo, was so dizzy; one Moderna, one Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-000004316 (Novavax).  A female 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 nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Meniere's disease" (unspecified if ongoing), notes: had a history of vertigo from Meniere's disease which she had for 6-7 years; "vertigo" (unspecified if ongoing), notes: had a history of vertigo from Meniere's disease which she had for 6-7 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 2), for COVID-19 Immunization; Bnt162b2 (Dose 1), for COVID-19 Immunization. The following information was reported: VERTIGO (non-serious), outcome "recovered", described as "She had terrible vertigo"; DIZZINESS (non-serious), outcome "recovered", described as "She had terrible vertigo, was so dizzy"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "one Moderna, one Pfizer".  Additional information: On 23Nov2022, it was reported that the patient started treatment on an unspecified date with Pfizer BioNTech COVID-19 Vaccine two primary doses and a booster for COVID-19 immunization. It was reported the patient was affected for months with side effects from the boosters she received (one Moderna, one Pfizer). Both side effects began 2 to 2.5 hours after receiving them. She had terrible vertigo, was so dizzy. But she also had a history of vertigo from Meniere's disease which she had for 6-7 years. She was now feeling back to the way she used to. The symptoms from the Pfizer booster only lasted 1 day. No further follow-up was anticipated.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Deafness, Dizziness, Nausea, Tinnitus
Clinical narrative: vestibular neuritis; some hearing loss; tinnitus; balance problems; nausea; Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 47-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 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: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant), outcome "unknown", described as "vestibular neuritis"; DEAFNESS (medically significant), outcome "not recovered", described as "some hearing loss"; TINNITUS (non-serious), outcome "not recovered"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "balance problems"; NAUSEA (non-serious), outcome "not recovered"; DIZZINESS (non-serious), outcome "not recovered", described as "Dizzy". Therapeutic measures were taken as a result of vestibular neuronitis, deafness, tinnitus, balance disorder, nausea, dizziness.  Clinical course: Reported as, 30-60 days later began to develop mild to moderate symptoms. By summer 2022 the symptoms had become severe. Dizzy, nausea, tinnitus, balance problems, some hearing loss. Diagnosed with vestibular neuritis. Patient was prescribed ondansetron and Valium. Attended Physical therapy for balance issues. Tried acupuncture. Event took place after use of product.  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: Vestibular neuronitis
Clinical narrative: vestibular neuritis; some hearing loss; tinnitus; balance problems; nausea; Dizzy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 47-year-old female patient received BNT162b2 (BNT162B2), in Dec2021 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: Covid-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: VESTIBULAR NEURONITIS (medically significant), outcome "unknown", described as "vestibular neuritis"; DEAFNESS (medically significant), outcome "not recovered", described as "some hearing loss"; TINNITUS (non-serious), outcome "not recovered"; BALANCE DISORDER (non-serious), outcome "not recovered", described as "balance problems"; NAUSEA (non-serious), outcome "not recovered"; DIZZINESS (non-serious), outcome "not recovered", described as "Dizzy". Therapeutic measures were taken as a result of vestibular neuronitis, deafness, tinnitus, balance disorder, nausea, dizziness.  Clinical course: Reported as, 30-60 days later began to develop mild to moderate symptoms. By summer 2022 the symptoms had become severe. Dizzy, nausea, tinnitus, balance problems, some hearing loss. Diagnosed with vestibular neuritis. Patient was prescribed ondansetron and Valium. Attended Physical therapy for balance issues. Tried acupuncture. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Had 2nd Covid booster (Pfizer) 30Sep22 and tested positive for Covid today.; Had 2nd Covid booster (Pfizer) 30Sep22 and tested positive for Covid today.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 08Dec2022, outcome "unknown" and all described as "Had 2nd Covid booster (Pfizer) 30Sep22 and tested positive for Covid today.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Dec2022) Positive, notes: tested positive for Covid today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors, However on conservative basis, the possible causality cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Myalgia, Nasal congestion
Clinical narrative: stuffy nose; flu-like symptoms; headache; muscle ache; 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), 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: NASAL CONGESTION (non-serious), outcome "recovered", described as "stuffy nose"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms"; HEADACHE (non-serious), outcome "recovered"; MYALGIA (non-serious), outcome "recovered", described as "muscle ache".  Additional information: With vaccine, patient ended up showing flu-like symptoms (headache, muscle ache, stuffy nose, etcetera) within 24 hours of receiving the vaccine. The symptoms went away within a day.   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): PFIZER INC-202201363305 same patient/event, different vaccine dose number; PFIZER INC-202201363306 same patient/event, different vaccine dose number;
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in 2022 as dose 3 (maroon cap), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD", start date: 13Jul2021 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1 (MAROON CAP), SINGLE; lot number: FT9142; time of administration: 08:54 AM; anatomical site of injection: Left thigh; route of administration: Intramuscular), administration date: 07Oct2022, when the patient was 24-month-old, for COVID-19 immunization, reaction(s): "She accidentally mixed the vial with 1.3 ml of diluent instead of 2.2 ml and realized this after she had administered 5 doses", "She accidentally mixed the vial with 1.3 ml of diluent instead of 2.2 ml and realized this after she had administered 5 doses", "fatigue"; pentacel (DOSE 3, SINGLE; Manufacture: Sanofi; Batch/lot: WJ641AAA; Route: IM; Anatomical site of injection: Left thigh.), administration date: 14Sep2022, for Immunization; prevnar 13 (DOSE 3, SINGLE; Manufacture: Pfizer; Batch/lot: FF7356; Route: IM; Anatomical site of injection: Right thigh.), administration date: 14Sep2022, for Immunization; fluzone (DOSE 2, SINGLE; Manufacture: Sanofi; Batch/lot: WT7680MA; Route: IM; Anatomical site of injection: Left thigh.), administration date: 14Sep2022, for Immunization; Bnt162b2 (DOSE 2 (MAROON CAP), SINGLE), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 2022, outcome "recovered" (2022).  Additional information: It was also reported that the patient provided information regarding the reported adverse event with the use of the product and considered Pfizer product had a causal effect to the adverse event. There were no relevant tests. Not having appropriate vaccine preparation and administration summary from CDC website in front of nurse when reconstituting vaccine/not being able to draw up all vaccine doses at one time before administering to patients/nurse fulfilling regular office Responsibilities (i.e. roaming patients taking recording vitals administering routine vaccines answering/triaging phone calls etc.) as well as running COVID vaccine clinic alone. Patient was fatigued the day after receiving the 3rd and final dose of the 6th month< 5 year  COVID vaccine, however return the baseline to the next day. No change in activity with 1st and 2nd dose Vs. 3rd dose. Patient made a full recovery. Parents contacted by patients PCP and notified of vaccine error of VAERS report having been submitted and full increased likelihood of reactogenicity.  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) : PFIZER INC-202201212961 same patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Post-acute COVID-19 syndrome
Clinical narrative: long COVID symptom; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID.  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: POST-ACUTE COVID-19 SYNDROME (disability), outcome "unknown", described as "long COVID symptom". Clinical course: Reporter have 2 friends with long COVID symptoms after they were vaccinated. Neither had COVID before but now they are battling with long COVID symptoms to the point of being disabled.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: allergic to something in the process and it has made me seriously ill in the past; allergic to something in the process; Initial information received on 08-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age male patient who was allergic to something in the process and it has made me seriously ill in the past , it involved vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer, with an unknown formulation and strength, ( lot number  and expiry date: not reported ) via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date , the patient was allergic to something in the mfg process and it has made me seriously ill in the past (illness) (allergy to vaccine) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken : not applicable.  Corrective treatment: not reported for the events  Outcome: unknown for both the events
Sex: U
Vaccine: FLUX
Symptoms: Cough, Illness, Influenza, Malaise
Clinical narrative: I can't quit coughing; so sick; got the flu; Initial information received on 10-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a patient of unknown demographics who can't quit coughing and so sick and got the flu while receiving vaccine INFLUENZA VACCINE.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (formulation, strength: unknown) lot number not reported in unknown administration site for prophylactic vaccination  On an unknown date the patient can't quit coughing (cough) and so sick (illness) and got the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE..  It was unknown if there were lab data/results available. It was unknown if the company suspect product inappropriately used as per local Marketing authorization  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event   At time of reporting, the outcome was Unknown for the event.