chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Dysphemia, Hypoaesthesia, Magnetic resonance imaging, Paraesthesia
Clinical narrative: started to feel tingly and numb and had stuttering and had to be laid down.; started to feel tingly and numb and had stuttering and had to be laid down.; started to feel tingly and numb and had stuttering and had to be laid down.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0150) for covid-19 immunisation. The patient's relevant medical history included: "Seizures", start date: 2000 (unspecified if ongoing), notes: Seizures; "She is very sensitive and allergic to stuff" (unspecified if ongoing); "Hernia" (unspecified if ongoing); "going through infertility treatment" (unspecified if ongoing); "knee surgery" (unspecified if ongoing). There were no concomitant medications.  The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious), DYSPHEMIA (non-serious), outcome "recovered" and all described as "started to feel tingly and numb and had stuttering and had to be laid down.". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, COVID-19, COVID-19 pneumonia
Clinical narrative: COVID-19; COVID-19 pneumonia; lost of taste and smell; lost of taste and smell; fever; cough; difficulty breathing; body aches; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3893794-00.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 06Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, all intramuscular 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 (hospitalization, medically significant) all with onset Dec2021, outcome "unknown" and all described as "COVID-19"; COVID-19 PNEUMONIA (non-serious), outcome "not recovered"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost of taste and smell"; PYREXIA (non-serious), outcome "unknown", described as "fever"; COUGH (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; PAIN (non-serious), outcome "unknown", described as "body aches". The patient was hospitalized for covid-19 (start date: Dec2021). The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Unknown results; SARS-CoV-2 test: (Dec2021) Positive.The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19 pneumonia; lost of taste and smell; lost of taste and smell; fever; cough; difficulty breathing; body aches; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3893794-00.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 06Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, all intramuscular 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 (hospitalization, medically significant) all with onset Dec2021, outcome "unknown" and all described as "COVID-19"; COVID-19 PNEUMONIA (non-serious), outcome "not recovered"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost of taste and smell"; PYREXIA (non-serious), outcome "unknown", described as "fever"; COUGH (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; PAIN (non-serious), outcome "unknown", described as "body aches". The patient was hospitalized for covid-19 (start date: Dec2021). The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Unknown results; SARS-CoV-2 test: (Dec2021) Positive.The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: COVID-19; COVID-19 pneumonia; lost of taste and smell; lost of taste and smell; fever; cough; difficulty breathing; body aches; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3893794-00.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 08Jul2021 as dose 1, single (Batch/Lot number: unknown) and on 06Aug2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, all intramuscular 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 (hospitalization, medically significant) all with onset Dec2021, outcome "unknown" and all described as "COVID-19"; COVID-19 PNEUMONIA (non-serious), outcome "not recovered"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "lost of taste and smell"; PYREXIA (non-serious), outcome "unknown", described as "fever"; COUGH (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing"; PAIN (non-serious), outcome "unknown", described as "body aches". The patient was hospitalized for covid-19 (start date: Dec2021). The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Unknown results; SARS-CoV-2 test: (Dec2021) Positive.The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Pain, Pain in extremity
Clinical narrative: sore arm; back ache; fatigue; body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 21K-163-3893794-00.  A 48-year-old male patient received BNT162b2 (BNT162B2, solution for injection), on 08Jul2021 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "back ache"; PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "body aches"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Lot number: EN6199), in right arm, on 27Mar2021 as dose 2, single (Lot number: ER8730), in right arm and on 13Sep2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 04Apr2022 at 14:00 as dose 4 (booster), single (Lot number: 003K21-2A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "sleep apnea" (unspecified if ongoing), notes: sleep apnea treated with CPAP; "obese" (unspecified if ongoing). Concomitant medication(s) included: PRAVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 29Apr2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (29Apr2022) Positive, notes: Antigen and PCR(friday swab) positive on Saturday; (04May2022) Negative, notes: Antigen and PCR negative on Wednesday. Felt fine; (05May2022) Positive, notes: Antigen positive on Thursday after last PAXLOVID does; (29Apr2022) Positive, notes: Antigen and PCR(friday swab) positive on Saturday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever reached 103.5; COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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: "Seasonal Asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Apr2022, outcome "unknown" and all described as "COVID 19"; PYREXIA (non-serious) with onset 20Apr2022, outcome "recovered" (22Apr2022), described as "fever reached 103.5". The patient underwent the following laboratory tests and procedures: Pyrexia: 103.5, notes: my fever reached 103.5; SARS-CoV-2 test: Positive, notes: Now, 11 days after ending my course of treatment, 21 days after exposure and 17 days after symptom onset, I am still testing positive, albeit with a fading line and no symptoms; Symptomatic Covid. Therapeutic measures were taken as a result of covid-19, pyrexia.  Clinical course: On day 2 of symptomatic Covid, fever reached 103.5 and thus, patient began the 5-day course of Paxlovid that evening from 20Apr2022 to 25Apr2022 and ibuprofen from 19Apr2022 to 21Apr2022. Fever went away entirely in two days. According to tests, patient viral load already was fading during the course of treatment (a lightening line in RAT). However, three days (28Apr) after the course of treatment ended, that line rebounded. It became more pronounced in the week that followed.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: EN6208), in left arm and on 10Apr2021 as dose 2, single (Lot number: ER8729), in left arm for Covid-19 immunisation; CoviD-19 vaccine miRNA (miRNA 1273) (MODERNA COVID-19 VACCINE), on 12Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Crohn's Disease (asymptomatic)" (unspecified if ongoing), notes: other medical history- Crohn's Disease (asymptomatic); "Known allergies: Kiwi" (unspecified if ongoing), notes: known allergies- kiwi; "sulfa drugs" (unspecified if ongoing), notes: sulfa drugs. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, Covid-19. No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: abnormal periods since getting booster dose; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23-year-old female patient (not pregnant) received COVID-19 Vaccine - Manufacturer Unknown, in Jan2022 as dose 3 (booster), single (Lot number: FK9729) at the age of 23 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Known allergies: Seafood" (unspecified if ongoing); "shellfish" (unspecified if ongoing), notes: Known allergies: Seafood, shellfish, pineapple; "pineapple" (unspecified if ongoing), notes: Known allergies: Seafood, shellfish, pineapple. There were no concomitant medications. Vaccination history included: COVID-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, Prev dose product: COVID 19, Prev dose brand unknown: True, Prev dose brand name unknown: COVID19 Vaccine, Prev dose lot number: EN6201, Prev dose lot unknown: False , Prev dose administration date: Feb2021, Prev dose dose number: 2, Prev dose vaccine location: Left arm), administration date: Feb2021, when the patient was 22 years old, for COVID-19 immunization, reaction(s): "2 dose: pain in lungs for 24 hours after vaccine"; COVID-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN, Prev dose product: COVID 19, Prev dose brand unknown: True, Prev dose brand name unknown: COVID19 Vaccine, Prev dose lot number: FK4175, Prev dose lot unknown: False, Prev dose administration date: Jan2021, Prev dose number: 1, Prev dose vaccine location: Left arm), administration date: Jan2021, when the patient was 22 years old, for COVID-19 immunization, reaction(s): "1 dose: tightness of chest and pain in lungs for 28 hours", "1 dose: tightness of chest and pain in lungs for 28 hours". The following information was reported: MENSTRUAL DISORDER (non-serious) with onset Feb2022, outcome "unknown", described as "abnormal periods since getting booster dose". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: Other vaccine in four weeks and medications in two weeks were reported as no. COVID prior vaccination was no and patient was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer BioNTech Vaccine administered (patient also took paxlovid for covid-19 treatment after received BNT162b2); Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2); This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 50-year-old male patient received BNT162b2 (BNT162B2), on 02Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 50 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for 5 days and as dose 2, single (Batch/Lot number: unknown) for 5 days 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) with onset 18Apr2022, outcome "unknown", described as "PAXAES report with Pfizer BioNTech Vaccine administered (patient also took paxlovid for covid-19 treatment after received BNT162b2)"; COVID-19 (medically significant) with onset 18Apr2022, outcome "recovered" (01May2022), described as "PAXAES report with Pfizer BioNTech Vaccine administered(patient also took paxlovid for covid-19 treatment after received BNT162b2)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Covid positive; negative, notes: tested negative; positive, notes: then again at day 12 positive. Therapeutic measures were taken as a result of covid-19.  Additional information: Treatment: Anti-viral details Plaxovid, Treatment start date: 04Apr2022, Treatment stop date: 08Apr2022, Treatment of COVID-19, Administrator route: Oral. Adverse event: Covid positive tested with upper Respiratory symptoms: started plaxovid on day 2 of positive -treatment for 5 days - symptom free after day 3 - reoccurrence of symptoms at day 11 - in between tested negative, and then again at day 12 positive. Patient did not receive any medication two weeks prior vaccination. Patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive test; positive test; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 24Feb2022 at 11:30 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 03May2022, outcome "recovering", COVID-19 (medically significant) with onset 03May2022, outcome "not recovered" and all described as "positive test". Symptoms are much worse with the rebound infection. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive, notes: Tested negative 4 days after first positive test and 4 days into paxlovid treatment; (29Apr2022) Negative, notes: Tested negative 4 days after first positive test and 4 days into paxlovid treatment;(03May2022) Negative, notes: Returned to work and also had a negative test on a Tuesday (3 days after completing Paxlovid) the following day I tested positive again for Covid 19, confirmed by 2 tests; (03May2022) Positive, notes: Returned to work and also had a negative test on a Tuesday (3 days after completing Paxlovid) the following day I tested positive again for Covid 19, confirmed by 2 tests; (03May2022) Positive, notes: Returned to work and also had a negative test on a Tuesday (3 days after completing Paxlovid) the following day I tested positive again for Covid 19, confirmed by 2 tests. Therapeutic measures were not 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.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) cannot be ruled out.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient. A 65-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Jun2021 as dose 2, single (Batch/Lot number: unknown) and on 18Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years for Covid-19 immunisation. The patient's relevant medical history included: "Viral (non-Covid) pericarditis", start date: Nov2021 (unspecified if ongoing). Concomitant medication(s) included: KLONOPIN, stop date: 18Apr2022; ALLOPURINOL; VYTORIN, stop date: 18Apr2022; COLCHICINE, stop date: 18Apr2022; ASPIRIN LOW; VITAMIN C [CALCIUM ASCORBATE], stop date: 18Apr2022; GLUCOSAMINE, stop date: 18Apr2022; VITAMIN B-12; CENTRUM, stop date: 18Apr2022. Past drug history included: Known allergies: Keflex, reaction(s): "Known allergies: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 18Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 18Apr2022, outcome "recovered with sequelae" and all described as "Report with Pfizer BioNTech Vaccine administered(patient also took Paxlovid for Covid-19 treatment after received BNT162b2)". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (22Apr2022) Negative; (23Apr2022) Positive. Therapeutic measures were taken as a result of Covid-19. Clinical course included: Covid symptoms and positive rapid test resumed 1 day after completing Paxlovid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (Pfizer-BioNTech COVID-19), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 25Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN (in 2weeks). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of covid-19. Treatment start date: 23Apr2022, Treatment stop date: 28Apr2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 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. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), for Covid-19 immunization; Bnt162b2 (Dose 3), for Covid-19 immunization. The following information was reported: TINNITUS (non-serious), outcome "not recovered".  Additional information: The clinical course was reported as reporter stated, patient has been experiencing tinnitus and it has been worse since his last dose on 01Apr2022 (second booster dose). He has had 4 doses of the vaccine. Reporter also stated, he has had the Pfizer BioNTech Vaccines, the 2 doses and the 2 Booster Shots, his last Booster being 01Apr2022 and he has tinnitus. Reporter states he has read reports about side effects with tinnitus with the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Malaise
Clinical narrative: expired dose of the Pfizer-BioNTech COVID-19 Vaccine/ The paper said 30Apr2022, and yesterday was 05May2022; felt sick after getting the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73-year-old male patient received BNT162b2 (COMIRNATY), on 05May2022 as dose number unknown, single (Batch/Lot number: unknown, Expiration Date: 30Apr2022) at the age of 73 years for covid-19 immunisation. The patient's relevant medical history included: "severe diabetes" (ongoing), notes: he has severe diabetes and has other health issues; "He's had a stroke and a heart attack" (unspecified if ongoing); "He's had a stroke and a heart attack" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 05May2022, outcome "unknown", described as "expired dose of the Pfizer-BioNTech COVID-19 Vaccine/ The paper said 30Apr2022, and yesterday was 05May2022"; MALAISE (non-serious) with onset May2022, outcome "unknown", described as "felt sick after getting the shot".  Additional Information:Caller states that yesterday 05May2022 her husband (73 years old) received an expired dose of the Pfizer-BioNTech COVID-19 Vaccine."The paper said 30Apr2022, and yesterday was 05May2022.He felt sick after getting the shot.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Illness, Vomiting
Clinical narrative: Never felt sicker in my life; Vomiting; chills; sweats; 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 male patient received BNT162b2 (BNT162B2), on 06May2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. 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; Covid-19 vaccine (Dose: 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization.  The following information was reported: ILLNESS (non-serious) with onset 06May2022, outcome "not recovered", described as "Never felt sicker in my life"; VOMITING (non-serious) with onset 06May2022, outcome "not recovered"; CHILLS (non-serious) with onset 06May2022, outcome "not recovered"; HYPERHIDROSIS (non-serious) with onset 06May2022, outcome "not recovered", described as "sweats". Therapeutic measures were not taken as a result of illness, vomiting, chills, hyperhidrosis.  Additional information: Patient did not have known allergies. Patient did not receive any other vaccine within four weeks. No covid prior to vaccination was tested. Patient did not test covid post vaccination.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: EW0158), on 28Apr2021 as dose 2, single (Lot number: EW0171) and on 18Nov2021 as dose 3 (booster), single (Lot number: EW0181) at the age of 42 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 06May2022, outcome "recovering" and all described as "COVID-19". Therapeutic measures were not taken as a result of drug ineffective, suspected covid-19. Clinical course: The patient had no other medication in 2 weeks. The patient having rebound Covid after initial infection and treatment with Paxlovid from 27Apr2022 to 01May2022. The patient had no known allergies.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid on 6May2022 via at home test; Tested positive for Covid on 6May2022 via at home test; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 at 16:30 as dose 1, single (Lot number: EJ1685), in left arm, on 25Mar2021 at 16:00 as dose 2, single (Lot number: EK5730), in left arm and on 02Dec2021 at 14:30 as dose 3 (booster), single (Lot number: FJ1620) at the age of 31 years, in left arm, all intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AIMOVIG; BEYAZ; VYVANSE. Vaccination history included: afluria (Other vaccine 4weeks product: Afluria Quad 2021-2022 3yr Up Syringe), administration date: 22Nov2021, when the patient was 31-year-old, for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06May2022 at 10:00, outcome "recovering" and all described as "Tested positive for Covid on 6May2022 via at home test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (06May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19.  Clinical course- Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient receive Afluria Quad 2021-2022 3yr Up Syringe vaccines within 4 weeks prior to the COVID vaccine. There was list of any other medications Aimovig, Beyaz Birthcontrol pill, Vyvanse the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Death, Pneumonia
Clinical narrative: his death was weeks after getting the vaccine; pneumonia; This is a spontaneous report received from non-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), outcome "fatal", described as "his death was weeks after getting the vaccine"; PNEUMONIA (medically significant), outcome "unknown". The date and cause of death for the patient were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: his death was weeks after getting the vaccine
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Have not had my period; Severely impacted my menstrual circle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Apr2021 at 16:00 as dose 1, single (Lot number: ER2613) at the age of 35 years, in left arm, on 03May2021 at 16:00 as dose 2, single (Lot number: EW0176), in left arm and on 21Mar2022 at 15:00 as dose 3 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN; LAMOTRIGINE; ROSUVASTATIN; OZEMPIC. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 12Apr2021, outcome "not recovered", described as "Have not had my period"; MENSTRUAL DISORDER (non-serious) with onset 12Apr2021, outcome "not recovered", described as "Severely impacted my menstrual circle". The events "have not had my period" and "severely impacted my menstrual circle" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder, menstrual disorder.  Additional information :The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19. List of any other medications the patient received within 2 weeks of vaccination: Wellbutrin, Lamotrigine, Rosuvastatin, Ozempic, NR .Patient have not had period since she got first two doses back in Apr/May of 2021. She is 36 and healthy without any hormonal or reproductive issues, and been checked out by Gynocologist. There is no other explanation other than the vaccine has severely impacted the menstrual cycle. She worries this may be permanent.Device Date was documented as 08May2022.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: testing positive; testing positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EM6205), on 24Mar2021 as dose 2, single (Lot number: ER8727) and on 31Aug2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Dose 1, 2, 3: Pfizer/ Dose 4: Moderna" (unspecified if ongoing), notes: Dose 1, 2, 3: Pfizer/ Dose 4: Moderna. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2022, outcome "unknown" and all described as "testing positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Mar2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity
Clinical narrative: redness; soreness to arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): EC-2022-113252.  A 78-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) intramuscular for covid-19 immunisation. The patient's relevant medical history included: "endometrial carcinoma" (unspecified if ongoing), notes: Endometrial Carcinoma; "Noted with fatigue" (unspecified if ongoing). Concomitant medication(s) included: LENVIMA, start date: 04Apr2022. Past drug history included: Keytruda, notes: formulation infusions. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "redness"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness to arm".  Additional information: Patient continues to take Lenvima 14 mg once daily. Stated blood pressure remains within normal limits. Denies nausea and diarrhea. Noted with fatigue. Unknown date of onset of symptoms. Stated received COVID-19 booster vaccine and noted with redness and soreness to arm. Unknown date of vaccine. Diagnosis Endometrial Carcinoma, Lenvima 14 mg once daily, start date 4/Apr/2022. Relevant history includes endometrial carcinoma, Keytruda infusions.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6204), in left arm, on 14Oct2021 as dose 3 (booster), single (Lot number: FE3540) at the age of 68 years, in left arm and on 29Mar2021 as dose 2, single (Lot number: EN6207), in left arm for covid-19 immunisation. The patient's relevant medical history included: "RA" (unspecified if ongoing), notes: other medical history: RA; "known allergies: penicillin" (unspecified if ongoing), notes: known allergies: penicillin. The patient's concomitant medications were not reported. Past drug history included: Pseudoephedrine, reaction(s): "Allergy: Pseudoephedrine", notes: known allergies: Pseudoephedrine. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19, vaccination failure.  Additional information: Anti viral details: [{product=COVID 19 Treatment, brand=Paxlovid, Treatment start date=26Apr2022, Treatment stop date=01May2022, Indication=Treatment of COVID-19}]. Other medications in two weeks: Methotrexate 2.5 mg x 10, Start date: 11Feb2022, Stop date: 06May2022. Tamsulosin HCL, Start date: 08Apr2022, Stop date: 25Apr2022. Trospium chloride, Start date: 08Apr2022, Stop date: 07May2022. Atorvastin calcium, Start date: 08Apr2022, Stop date: 26Apr2022. The patient previously receive a COVID-19 Vaccine. Reported Event: A runny nose, slightly elevated temperature, congestion, aches and pains, and a lot of coughing. Adverse event start date: 05May2022, Adverse event start time: 04:00 PM. The patient was recovering. Device Date was 07May2022.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  An 85-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK5730), in left arm, on 15Jan2021 as dose 2, single (Lot number: EL3248), in left arm, on 08Sep2021 as dose 3 (booster), single (Lot number: FC3182), in left arm and on 19Mar2022 as dose 4 (booster), single (Lot number: FJ9943) at the age of 85 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "mild hypertension" (unspecified if ongoing); "CA of prostate" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 05May2022, outcome "not recovered", VACCINATION FAILURE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: The reported Covid 19 positive after both the doses of  COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have suffered from peripheral neuropathy for over 15 years/overnight my symptoms disappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from License Party. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "peripheral neuropathy" (unspecified if ongoing), notes: peripheral neuropathy for over 15 years. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have suffered from peripheral neuropathy for over 15 years/overnight my symptoms disappeared". Additional Information: Patient reported, I am contacting you to tell you that I have suffered from peripheral neuropathy for over 15 years. After receiving 2 doses of the COVID vaccines and 1 booster, overnight my symptoms disappeared. That lasted for 6 months, then symptoms slowly returned. It was truly a miracle for me, I am planning to get my second booster next week to see if it helps my neuropathy pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 as dose 1, single (Lot number: EL3247), in left arm, on 11Feb2021 as dose 2, single (Lot number: EL9266), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: PC3182), in left arm and on 05Apr2022 at 15:30 as dose 4 (booster), single (Lot number: FJ4991) at the age of 69 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ESTRADIOL, start date: 01Nov2021, stop date: 29Apr2022; MEDROXYPROGESTERONE [MEDROXYPROGESTERONE ACETATE], start date: 01Nov2021, stop date: 29Apr2022; ATORVASTATIN, start date: 01Nov2021, stop date: 29Apr2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date: 07May2022. Patient had no known allergies and no other medical history.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EM9810), on 26Feb2021 as dose 2, single (Lot number: EMU198) and on 26Sep2021 as dose 3 (booster), single (Lot number: FC31E2) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "diabetic" (unspecified if ongoing). Concomitant medication(s) included: GLUMETZA, start date: Nov2020, stop date: May2022; BYDUREON BCISE, start date: Jul2018, stop date: May2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive.  Clinical course: Anti-Viral Details: Brand=Paxlovid, Treatment Start Date=14Apr2022, Treatment Stop Date=18Apr2022, Indication=Treatment of COVID-19}].  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). No known allergies noted. Concomitant medication(s) included: ESCITALOPRAM, start date: 01Dec2021, stop date: 06May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were not taken as a result of vaccination failure, covid-19. It was reported that patient received antiviral drug Paxlovid, from 24Apr2022 to 29Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema, Pruritus, SARS-CoV-2 test, Urticaria, Vaccination site mass
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Mild asthma" (unspecified if ongoing), notes: other medical history: Mild asthma; "hypertension" (unspecified if ongoing); "Allergic to cantaloupe" (unspecified if ongoing), notes: Known allergies: Allergic to cantaloupe; "moderate latex allergy" (unspecified if ongoing), notes: Known allergies: moderate latex allergy. Concomitant medication(s) included: NORVASC; LITHIUM. Past drug history included: Opiates for hives, reaction(s): "Allergy: Opiates", notes: Known allergies: Opiates give me hives and difficulty breathing.; Opiates for difficulty breathing, reaction(s): "Allergy: Opiates", notes: Known allergies: Opiates give me hives and difficulty breathing. Vaccination history included: Covid-19 vaccine (Dose 1, UNKNOWN MANUFACTURER), reaction(s): "Covid-19 Immunization"; Covid-19 vaccine (Dose 2, UNKNOWN MANUFACTURER), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 Booster, UNKNOWN MANUFACTURER), for Covid-19 Immunization. The following information was reported: PRURITUS (non-serious), ECZEMA (non-serious), VACCINATION SITE MASS (non-serious), URTICARIA (non-serious) all with onset 20Apr2022, outcome "not recovered" and all described as "Large deep red raised hard itchy lumps kind of like eczema and kind of like an insect bite but no bite. Started near infection site, have spread to legs, harms, hands, last 5-7 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pruritus, eczema, vaccination site mass, urticaria. Additional information: Reported Event: Large deep red raised hard itchy lumps kind of like eczema and kind of like an insect bite but no bite. Started near infection site, have spread to legs, arms, hands, last 5-7 days. Other like hives come and go. Started about 2 weeks after last injection. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, Prior to vaccination. The patient has been tested for COVID-19, since the vaccination. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.