chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (the patient). A 36-year-old male patient received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# FG3527), at the age of 36, on Nov 11, 2021, single dose, for COVID-19 immunisation. Vaccination history included the 1st and 2nd dose of the COVID-19 vaccine (batch/lot# unknown) for immunisation. Medical history not reported. Concomitant medication included: Nyquil, start date: May 6, 2022 and Tylenol, start date: May 7, 2022. The patient experienced suspected COVID-19 (medically significant) and ineffective drug/treatment of COVID-19 (medically significant), onset 2022, with outcome of unknown. Therapeutic measures were taken as a result of suspected COVID-19 and ineffective drug. Clinical course: Antiviral details: Product: COVID-19 treatment, Brand: Paxlovid, Treatment start date: May 7, 2022, batch/lot# GA3567; Indication: Treatment of COVID-19. Device date: May 9, 2022. No follow-up attempts possible. No further information expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, Product administered at inappropriate site
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; booster; offlabel use; Location of injection: Leg Left; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in left leg for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: PANTOPRAZOLE, start date: 01Feb2022; DESLORATADINE, start date: 01Aug2017; EFFEXOR, start date: 01Aug2021. Past drug history included: Zofran, reaction(s): "known allergies: Zofran"; Dilaudid, reaction(s): "known allergies: dilaudid". The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 07Apr2022, outcome "unknown", described as "Location of injection: Leg Left"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment"; IMMUNISATION (medically significant), outcome "unknown", described as "booster"; OFF LABEL USE (medically significant), outcome "unknown", described as "offlabel use". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously received a COVID-19 Vaccine.  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: Asthenia, Balance disorder, Bedridden, Fall, Fatigue
Clinical narrative: MS; legs were very tired; could not walk; very unbalanced; very weak; bedridden; fall; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4018565.  A female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; SIMVASTATIN; CALCIUM; VITAMIN 15; BIOCAL; PROBIOTIC 10; SKELAXINE; RELAFEN. Past drug history included: Kenalog allergy, reaction(s): "Allergy"; Cipro allergy, reaction(s): "Allergy". The following information was reported: BEDRIDDEN (non-serious) with onset 23Mar2021, outcome "recovered"; GAIT INABILITY (non-serious) with onset 23Mar2021, outcome "recovered", described as "could not walk"; FALL (non-serious) with onset 23Mar2021, outcome "recovered"; FATIGUE (non-serious) with onset 23Mar2021, outcome "recovered", described as "legs were very tired"; BALANCE DISORDER (non-serious) with onset 23Mar2021, outcome "recovered", described as "very unbalanced"; ASTHENIA (non-serious) with onset 23Mar2021, outcome "recovered", described as "very weak"; MULTIPLE SCLEROSIS (medically significant), outcome "recovered", described as "MS".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait inability, Multiple sclerosis
Clinical narrative: MS; legs were very tired; could not walk; very unbalanced; very weak; bedridden; fall; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 4018565.  A female patient received BNT162b2 (BNT162B2), on 23Mar2021 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; SIMVASTATIN; CALCIUM; VITAMIN 15; BIOCAL; PROBIOTIC 10; SKELAXINE; RELAFEN. Past drug history included: Kenalog allergy, reaction(s): "Allergy"; Cipro allergy, reaction(s): "Allergy". The following information was reported: BEDRIDDEN (non-serious) with onset 23Mar2021, outcome "recovered"; GAIT INABILITY (non-serious) with onset 23Mar2021, outcome "recovered", described as "could not walk"; FALL (non-serious) with onset 23Mar2021, outcome "recovered"; FATIGUE (non-serious) with onset 23Mar2021, outcome "recovered", described as "legs were very tired"; BALANCE DISORDER (non-serious) with onset 23Mar2021, outcome "recovered", described as "very unbalanced"; ASTHENIA (non-serious) with onset 23Mar2021, outcome "recovered", described as "very weak"; MULTIPLE SCLEROSIS (medically significant), outcome "recovered", described as "MS".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 13Apr2021 at 13:00 as dose 1, single (Lot number: EW0161), in left arm, on 04May2021 at 15:00 as dose 2, single (Lot number: EW0173), in left arm and on 22Nov2021 at 14:00 as dose 3 (booster), single (Lot number: FH8027) at the age of 49 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing), notes: seasonal allergies. Concomitant medication(s) included: ACETAMINOPHEN, start date: 25Apr2022, stop date: 01May2022; LORATADINE, start date: 01Apr2022, stop date: 09May2022. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 09May2022, outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive, notes: Rebound COVID. Started experiencing symptoms and tested positive 7 days after completing treatment. Therapeutic measures were taken as a result of covid-19, drug ineffective.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive after testing negative with antigen tests.; Tested positive after testing negative with antigen tests.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 1, single (Lot number: ER8730), in left arm, on 15Apr2021 as dose 2, single (Lot number: EW0158), in left arm and on 13Nov2021 at 12:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 34 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "high BMI" (unspecified if ongoing); "diabetes" (unspecified if ongoing). The patient's family history included: "family history of high blood pressure" (unspecified if ongoing), notes: family history of high blood pressure. Concomitant medication(s) included: FLUOXETINE, start date: 19May2021; DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: 24Feb2022. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 2022, outcome "unknown" and all described as "Tested positive after testing negative with antigen tests.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative; (2022) Positive, notes: Tested positive after testing negative. Therapeutic measures were taken as a result of covid-19, vaccination failure.  Clinical Course: Patient received previously Covid Vaccine and patient taking any other medications/products within 2 weeks of starting COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jan2021 as dose 1, single (Batch/Lot number: unknown) and on 26Feb2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Dairy" (unspecified if ongoing); "vaccine dose number=3 Pfizer, vaccine dose number=2, 1 Moderna" (unspecified if ongoing), notes: vaccine dose number=3 Pfizer, vaccine dose number=2, 1 Moderna. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "vaccine_brand=Pfizer / BioNTech/product=COVID 19 Treatment, brand=Paxlovid". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had treatment Paxlovid from 27Apr2022 to 02May2022 as treatment of COVID-19. The patient received other medication in two weeks as birth control pills.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information in the case report, a possible causal relationship between reported events and suspect drug BNT162B2 cannot be excluded
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Jan2021 at 12:00 as dose 1, single (Lot number: EK9231), in left arm, on 26Jan2021 at 14:30 as dose 2, single (Lot number: EL3248), in left arm and on 25Oct2021 at 14:30 as dose 3 (booster), single (Lot number: FF2593) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: 01Sep2015, stop date: 09May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course:  No Seriousness criteria-results in death, life threatening, prolonged hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Report about COVID treatment. Vaccine was received.  There was other medication in 2 weeks. She began feeling better 12 hrs after 2nd Paxlovid dose. Felt normal by day 7 and returned to work. 3 days after finishing Paxlovid the symptoms came back as an-other bad sinus head cold. No treatment for AE. No Known allergies.; Sender's Comments: Based on the available information in the case, the causal association between the events Vaccination failure, COVID-19 and the suspect drug BNT162B2 cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier (s): MOD22-013231. A 67-year-old male patient received BNT162b2 (BNT162B2), on 06Feb2021 as dose 2, single (Lot number: EL9262) for Covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZOLPIDEM; AMITRIPTYLINE; LISINOPRIL; METOPROLOL; MONTELUKAST; SENNA [SENNA SPP.]; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B3; LUBRICANT. Vaccination history included: BNT162b2 (Dose: 01, Batch Number: EL3246, Route: Intramuscular), administration date: 17Jan2021, for COVID-19 Immunization. The following information was reported: BLINDNESS (medically significant) with onset 2021, outcome "recovered" (2021), described as "he lost eye sight for 3 months". Patient had his first Pfizer COVID-19 booster vaccine (lot number: 301348A) on 26Sep2021 at the facility in contact 4 and stated he blew a blood vessel in the left eye after this. No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: PMR; 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 number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POLYMYALGIA RHEUMATICA (medically significant), outcome "unknown", described as "PMR".  Clinical course: Patient experienced Polymyalgia Rheumatica (PMR) and how patient feel it was directly linked to the Covid-19 vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Neuralgia, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: WEIGHT DECREASED (medically significant), outcome "unknown", described as "lost 20 lbs."; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; ILLNESS (non-serious), outcome "unknown", described as "extremely sick"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown", described as "chill"; HEADACHE (non-serious), outcome "unknown", described as "severe headache". After the booster shot of Covid-19 vaccine have been extremely sick from it (body aches, chill, lost 20 lbs., severe headache, nerve pain). The patient wanted to know if someone can contact the patient. The patient underwent the following laboratory tests and procedures: Weight: lost 20 lbs. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Weight, Weight decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: WEIGHT DECREASED (medically significant), outcome "unknown", described as "lost 20 lbs."; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; ILLNESS (non-serious), outcome "unknown", described as "extremely sick"; PAIN (non-serious), outcome "unknown", described as "body aches"; CHILLS (non-serious), outcome "unknown", described as "chill"; HEADACHE (non-serious), outcome "unknown", described as "severe headache". After the booster shot of Covid-19 vaccine have been extremely sick from it (body aches, chill, lost 20 lbs., severe headache, nerve pain). The patient wanted to know if someone can contact the patient. The patient underwent the following laboratory tests and procedures: Weight: lost 20 lbs. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from contactable other HCP (the patient). A 66-year-old female patient received the 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 303135BA), at the age of 65, in left arm, on Sep 26, 2021, single dose, for COVID-19 immunization. Vaccination history included the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL3248), in left arm, on Feb 5, 2021, and the 1st dose of Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, on Jan 14, 2021; both single dose, for COVID-19 immunization. No medical history. The patient's concomitant medications not reported. The patient experienced vaccination failure (medically significant) and COVID-19/suspected COVID-19 (medically significant), onset 2022, with outcome of unknown. Therapeutic measures were taken as a result of suspected COVID-19. No follow-up attempts needed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, Pyrexia, SARS-CoV-2 test
Clinical narrative: bad cold type symptoms; Fever; 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 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 at 12:45 as dose 3 (booster), single (Lot number: EW0187) at the age of 66 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: "High blood pressure" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Overweight" (unspecified if ongoing); "Low thyroid" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXIN, start date: 01May1994; HYDROCHLOROTHIAZIDE, start date: 30Aug2019; LOSARTIN, start date: 30Aug2019; FLUOXETINE, start date: 17May2012; NYQUIL, start date: 26Apr2022; PEPTO-BISMOL, start date: 28Apr2022; ROBITUSSIN [AMYLMETACRESOL;DICHLOROBENZYL ALCOHOL], start date: 05Apr2022, stop date: 05Apr2022. The following information was reported: PYREXIA (non-serious) with onset 08May2022, outcome "recovered" (08May2022), described as "Fever"; NASOPHARYNGITIS (non-serious) with onset 08May2022 at 12:00, outcome "not recovered", described as "bad cold type symptoms"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (May2022) Negative; (May2022) Negative; (May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of nasopharyngitis, pyrexia.  Clinical information: The patient was taking other medications/products within 2 weeks of starting COVID-19 treatment. The patient previously receive a COVID-19 Vaccine. A bad cold type symptoms returned after about 7 days of feeling better. And 3 negative tests. A fever came and went on 08May. Adverse event start date: 08May2022. Adverse event start time: 12:00 PM. Patient start treatment with Paxlovid (From 29Apr2022 to 03May2022).  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: he blew a blood vessel in the left eye after this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD22-013231 (Moderna).  A 67-year-old male patient received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Lot number: 301348A) for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: ZOLPIDEM; AMITRIPTYLINE; LISINOPRIL; METOPROLOL; MONTELUKAST; SENNA [SENNA ALEXANDRINA LEAF]; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B3. Vaccination history included: BNT162b2 (Dose 1, Batch Number: EL3246, Route: Intramuscular, Indication: COVID-19 vaccine), administration date: 17Jan2021, for Covid-19 Immunization; BNT162b2 (Dose 2, Lot number of the second Pfizer COVID-19 vaccine: EL9262, Expiration of the second Pfizer COVID-19 vaccine: Unknown), administration date: 06Feb2021, for Covid-19 Immunization, reaction(s): "he lost eye sight for 3 months". The following information was reported: EYE HAEMORRHAGE (medically significant), outcome "unknown", described as "he blew a blood vessel in the left eye after this". Clinical course: He had the first Pfizer COVID-19 vaccine on 17Jan2021 at the facility in contact 3. He had the second Pfizer COVID-19 vaccine on 06Feb2021 at the facility in contact 4 stating he lost his eye sight for 3 months. He had his first Pfizer COVID-19 booster vaccine on 26Sep2021 at the facility in contact 4 and stated he blew a blood vessel in the left eye after this.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Coronary artery bypass, Expired product administered, Gastrooesophageal reflux disease, Illness, Transient ischaemic attack
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 76-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose number unknown (booster), single (Lot number: FF2589, Expiration Date: 31Mar2021) at the age of 76 years for Covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Breathing" (unspecified if ongoing), notes: He is on Breo Ellipta inhaler for breathing. Concomitant medication(s) included: CRESTOR taken for blood cholesterol; BREO ELLIPTA taken for dyspnoea. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 30Sep2021, outcome "unknown", described as "received the first booster dose on 30Sep2021. On the label on our vaccine card the expiration date is listed as 31Mar21"; TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "ministroke"; CORONARY ARTERY BYPASS (non-serious), outcome "unknown", described as "Quadruple bypass"; ILLNESS (non-serious), outcome "unknown", described as "sick"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "we were heavier when we got the shot"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "GERD". Therapeutic measures were taken as a result of transient ischaemic attack, gastrooesophageal reflux disease. Clinical course: The reporter stated that her 76-year-old husband had some serious things happen to him after he received his booster dose of the Pfizer COVID-19 vaccine on 30Sep2021. When asked about the Lot FF2589, the reporter received response that the date of manufacture is 09Jul2021 and the expiration date is 31Mar2022. The patient received booster Pfizer dose and received it at the end of Sep, and when looking at there immunization card over the weekend and realized that the sticker that they put on the card said that, that particular drug lot that they receive had expired 31Mar2021, and received it on 30Sep, six months later, so their concern was that they received expired medication. Reporter stated, her husband has been sick since this happened. He was 6' and was 188 pound. That's what they currently are, and they were heavier when got the shot. They haven't had any vaccines since the booster. He was on a heart tablet twice a day for Metoprolol Tartrate and he has GERD and he's on Nexium (Treatment). He had ministroke and he had quadruple bypass all of which he did not had before the shot. Follow-Up (12May2022): Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200687387 as same reporter/drug/event, different patient.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Weight decreased
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 76-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose number unknown (booster), single (Lot number: FF2589, Expiration Date: 31Mar2021) at the age of 76 years for Covid-19 immunisation. The patient's relevant medical history included: "Cholesterol" (unspecified if ongoing); "Breathing" (unspecified if ongoing), notes: He is on Breo Ellipta inhaler for breathing. Concomitant medication(s) included: CRESTOR taken for blood cholesterol; BREO ELLIPTA taken for dyspnoea. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 30Sep2021, outcome "unknown", described as "received the first booster dose on 30Sep2021. On the label on our vaccine card the expiration date is listed as 31Mar21"; TRANSIENT ISCHAEMIC ATTACK (medically significant), outcome "unknown", described as "ministroke"; CORONARY ARTERY BYPASS (non-serious), outcome "unknown", described as "Quadruple bypass"; ILLNESS (non-serious), outcome "unknown", described as "sick"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "we were heavier when we got the shot"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "GERD". Therapeutic measures were taken as a result of transient ischaemic attack, gastrooesophageal reflux disease. Clinical course: The reporter stated that her 76-year-old husband had some serious things happen to him after he received his booster dose of the Pfizer COVID-19 vaccine on 30Sep2021. When asked about the Lot FF2589, the reporter received response that the date of manufacture is 09Jul2021 and the expiration date is 31Mar2022. The patient received booster Pfizer dose and received it at the end of Sep, and when looking at there immunization card over the weekend and realized that the sticker that they put on the card said that, that particular drug lot that they receive had expired 31Mar2021, and received it on 30Sep, six months later, so their concern was that they received expired medication. Reporter stated, her husband has been sick since this happened. He was 6' and was 188 pound. That's what they currently are, and they were heavier when got the shot. They haven't had any vaccines since the booster. He was on a heart tablet twice a day for Metoprolol Tartrate and he has GERD and he's on Nexium (Treatment). He had ministroke and he had quadruple bypass all of which he did not had before the shot. Follow-Up (12May2022): Follow-up attempts are completed. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-202200687387 as same reporter/drug/event, different patient.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Loss of personal independence in daily activities, Nausea
Clinical narrative: couldn't do her normal activities.; extreme fatigue; body aches; she was up all night; fever of 102 degrees; chills; extreme nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US069854_NC.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE number unknown; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 29Apr2022, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 29Apr2022, outcome "recovering"; NAUSEA (non-serious) with onset 29Apr2022, outcome "recovering", described as "extreme nausea"; PYREXIA (non-serious) with onset 29Apr2022, outcome "recovering", described as "fever of 102 degrees"; SLEEP DISORDER (non-serious) with onset 29Apr2022, outcome "recovering", described as "she was up all night"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovering", described as "couldn't do her normal activities."; FATIGUE (non-serious), outcome "recovering", described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: Event: Patient reported she received the Pfizer booster on Friday 29Apr2022 and a fever of 102 degrees started that night along with chills, extreme nausea and body aches and she was up all night. Her symptoms lasted through Saturday and Saturday night and she also stated that she had extreme fatigue and couldn't do her normal activities.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Sleep disorder
Clinical narrative: couldn't do her normal activities.; extreme fatigue; body aches; she was up all night; fever of 102 degrees; chills; extreme nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): NUS2022US069854_NC.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 29Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 65 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE number unknown; MANUFACTUERER UNKNOWN), for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 29Apr2022, outcome "recovering", described as "body aches"; CHILLS (non-serious) with onset 29Apr2022, outcome "recovering"; NAUSEA (non-serious) with onset 29Apr2022, outcome "recovering", described as "extreme nausea"; PYREXIA (non-serious) with onset 29Apr2022, outcome "recovering", described as "fever of 102 degrees"; SLEEP DISORDER (non-serious) with onset 29Apr2022, outcome "recovering", described as "she was up all night"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovering", described as "couldn't do her normal activities."; FATIGUE (non-serious), outcome "recovering", described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Clinical course: Event: Patient reported she received the Pfizer booster on Friday 29Apr2022 and a fever of 102 degrees started that night along with chills, extreme nausea and body aches and she was up all night. Her symptoms lasted through Saturday and Saturday night and she also stated that she had extreme fatigue and couldn't do her normal activities.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Age: 68.0
Sex: F
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(s) (Physician). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Dec2020 as dose 1, single (Lot number: EK5730), in left arm, on 08Jan2021 as dose 2, single (Lot number: EL1283), in left arm and on 05Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 68 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07May2022) Positive; (2022) Negative. Therapeutic measures were taken as a result of covid-19. The patient received treatment for COVID-19 with Paxlovid (lot number=FX2741) from 28Apr2022 to 02May2022. Clinical course: On an unreported date in 2022 the patient experienced COVID-19 and started treatment with Paxlovid on 28Apr2022. The patient had a relapse Covid infection after Paxlovid. The patient took 8 of the 10 doses over 5 days, then felt completely recovered. Also tested negative on the Abbott at home test. 3-4 days later (Day 10 from onset of symptoms on 27Apr2022) patient got sick again on 07May2022 and tested positive. Nasal congestion, cough, myalgias. Seems like a relapse, otherwise the patient was healthy with no medical problems.; 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 vaccination failure cannot be ruled out.
Age: 70.0
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(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old male patient received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EN6201), in right arm, on 28Feb2021 as dose 2, single (Lot number: EN6201), on 27Sep2021 as dose 3 (booster), single (Lot number: EW0185) and on 06Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ATORVASTATIN, stop date: 24Apr2022. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: soon after completing the Paxlovid, I testing positive again; (03May2022) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient received other medication in 2 weeks. Patient had no known allergies. Several days after completing Paxlovid therapy, very minor sore throat, cough, and scalp sensitivity reoccurred. Even though I got a negative (home) test soon after completing the Paxlovid, I testing positive again.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist). An elderly male patient received BNT162b2 (BNT162B2), in Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) for Covid-19 immunisation; CoviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for Covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for COVID on Apr24". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Apr2022) Positive, notes: My Father-In-Law tested positive for COVID on Apr24; (04May2022) Negative, notes: On Day 10 after testing positive, he tested negative and symptoms resolved; (08May2022) Positive, notes: On around Day 14, he started having symptoms again (e.g. sore throat, runny nose) and tested positive for COVID again. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Additional information: If vaccine received reported as Yes. Other medication in 2weeks reported- No. My Father-In-Law tested positive for COVID on Apr24. He is in his late 70s. Symptoms were generally mild. He started a course of Paxlovid as directed the next day. On Day 10 after testing positive, he tested negative and symptoms resolved. On around Day 14, he started having symptoms again (e.g. sore throat, runny nose) and tested positive for COVID again. I would suggest you re-evaluate the narrative that rebound COVID after Paxlovid use is "rare". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid 19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (the patient). A 70-year-old female patient received the 4th (booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# F59943), at the age of 70, left arm, on Apr 5, 2022, single dose, for COVID-19 immunization. Vaccination history included the 3rd (booster) of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# 30145BA), in left arm, on Oct 4, 2021, the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL9267), in left arm, on Feb 17, 2021, and the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN5318), on Jan 27, 2021; all single dose, for COVID-19 immunization. Medical history not reported. Concomitant medication included escitalopram, start date: Jun 12, 2019. The patient experienced vaccination failure (medically significant) and COVID-19 (medically significant), with outcome of unknown. Therapeutic measures were taken as a result of vaccination failure and COVID-19. Additional information: COVID-19 treatment included Paxlovid. Treatment start date: Apr 28, 2022. Treatment stop date: May 2, 2022: Treatment of COVID-19. No follow-up attempts possible. No further information expected.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse). A 57-year-old patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: EL3247), on 24Feb2021 as dose 2, single (Lot number: EL3247) and on 29Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 57 years 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 25Apr2022, outcome "unknown" and all described as "Covid test result: Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25Apr2022) Positive, notes: Covid test name post vaccination=AG. It was unknown if therapeutic measures were taken as a result of vaccination failure, Covid-19. No follow-up attempts are possible. No further information is expected. Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events vaccination failure and COVID-19 cannot be totally excluded.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (the patient). A 77-year-old male patient received the 3rd booster dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 76, in left arm, on Sep 9, 2021, at 15:00, single dose, for COVID-19 immunization. Vaccination history included the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, on Feb 9, 2021, at 17:00, and received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), in left arm, on Jan 19, 2021, at 17:00; both single dose, for COVID-19 immunization. Medical history included chronic heart disease (unspecified if ongoing). Concomitant medication included metoprolol; isosorbide mononitrate; irbesartan; atorvastatin; levothyroxine; vitamin D 2000. The patient experienced ineffective drug (medically significant), with outcome of unknown and COVID-19/initial COVID-19 bout (medically significant), with outcome of recovered. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results; negative antigen test, notes: After recovery from initial bout with COVID-19 and a negative antigen test, there was a complete rebound of symptoms and positive antigen testing. Therapeutic measures were taken as a result of COVID-19. Clinical course: Other medication in 2 weeks: One-A-Day multivitamin and turmeric tab. The patient has no known allergies. The information on the batch/lot number for  BNT162B2 requested and will be submitted if and when received.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 81-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 as dose 1, single (Lot number: EK9231), in left arm, on 25Jan2021 as dose 2, single (Lot number: EL8982), in left arm, on 08Nov2021 as dose 3 (booster), single (Lot number: 30155BA), in right arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 81 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "recurrent sinuisitis" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LATANOPROST OPTIC; FINASTERIDE; ATORVASTATIN, start date: 25Apr2022, stop date: 26Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Apr2022, outcome "unknown", COVID-19 (medically significant) with onset 28Apr2022, outcome "recovering", and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: RADT antigen test became positive. Other medication in 2weeks was reported as Yes. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Age group: Elderly (65+ Years).  No follow up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive on a PCR; tested positive on a PCR; 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 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Oct2021 at 19:30 as dose 1, single (Lot number: FH8028) at the age of 48 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Apr2022, outcome "unknown" and all described as "tested positive on a PCR". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Apr2022) Positive. Therapeutic measures were taken as a result of covid-19.  No follow-up attempts are possible. No further information is expected
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: 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 female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0172), in left arm and on 18Dec2021 as dose 3 (booster), single (Lot number: 3310308A) at the age of 45 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "known allergies: sulfa drugs" (unspecified if ongoing), notes: known allergies: sulfa drugs. Concomitant medication(s) included: Amlodipine Besylate; Montelukast Sodium; Cetirizine Hydrochloride. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 4 months 11 days after the suspect product(s) administration, 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 vaccination failure, covid-19. Clinical course: The patient had received Paxlovid on 29Apr2022 for treatment of COVID-19 and stop on 03May2022. Other medication in 2weeks brand was Berkley Jensen.