chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient received BNT162b2 (BNT162B2), on 24Apr2022 at 15:00 as dose number unknown, single (Lot number: FK9893) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Compazine, reaction(s): "Known allergies: Allergic to Compazine", notes: Known allergies: Allergic to Compazine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Other medication in 2weeks: No, Anti-viral details: Product-COVID 19 Treatment, Brand-Paxlovid, Treatment start date- 15Jun2022, Treatment stop date- 16Jun2022, Indication: Treatment of COVID-19.  Adverse event: Paxlovid severe diarrhea within 20 minutes of eating anything. Her doctor told her to stop taking it immediately. Known allergies: Allergic to Compazine  Follow-up attempts are completed. No further information is expected.
Age: 57.0
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 non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 57 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Jan2021 at 08:00 as dose 1, single (Batch/Lot number: unknown), in right arm, on 07Feb2021 at 08:15 as dose 2, single (Lot number: 010M20A), in right arm and on 31Oct2021 at 19:30 as dose 3 (booster), single (Lot number: B033F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroid" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing); "CAD" (unspecified if ongoing); "Interchange of vaccine products" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID; ROSUVASTATIN; NIACIN; ESTROGEN; ALOSETRON; ALPHA LIPOIC ACID; VITAMIN D3; PROGESTERONE. Past drug history included: Celecoxib, reaction(s): "known allergies: celecoxib". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (unspecified date) Negative; (16Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Additional information : Had recurrence of covid symptoms: headache , sorethroat, myalgia , etc four days after completing paxlovid and tested positive for covid after already testing negative for covid at the conclusion of the paxlovid treatment  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Jun2022 as dose 3 (booster), single (Lot number: FK9896) at the age of 65 years, in left arm for Covid-19 immunisation; Janssen CoviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 22Mar2021 as dose 1, single (Lot number: 1805031) and on 02Sep2021 as dose 2, single (Lot number: 206A21A) for Covid-19 immunisation. The patient's relevant medical history included: "Interchange of vaccine products" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Result; (13Jun2022) Negative; (17Jun2022) Positive. Therapeutic measures were taken as a result of drug ineffective, Covid-19. Clinical course: Other medication in 2weeks: No. No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Electrocardiogram, Electroencephalogram, Fluid wave test, Magnetic resonance imaging
Clinical narrative: a huge swollen armpit after 12 hrs, that moved down into a large watery lump on side of torso by May 1st; major tonic seizure; fainted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2022 at 17:00 as dose 3 (booster), single (Lot number: FK9893) at the age of 29 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DULOXETINE; SYNTHROID. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0181, Location of injection: Left arm), administration date: 22Jul2021, when the patient was 29-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0196, Location of injection: Arm Left), administration date: 28Jun2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 30Apr2022 at 09:30, outcome "recovering", described as "fainted"; TONIC CONVULSION (medically significant) with onset 30Apr2022 at 09:30, outcome "recovering", described as "major tonic seizure"; SWELLING (non-serious) with onset 01May2022, outcome "recovering", described as "a huge swollen armpit after 12 hrs, that moved down into a large watery lump on side of torso by May 1st". The events "major tonic seizure", "fainted" and "a huge swollen armpit after 12 hrs, that moved down into a large watery lump on side of torso by may 1st" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Electrocardiogram: Unknown results; Electroencephalogram: Unknown results; Fluid wave test: Unknown results; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of tonic convulsion, syncope, swelling.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Syncope, Tonic convulsion
Clinical narrative: a huge swollen armpit after 12 hrs, that moved down into a large watery lump on side of torso by May 1st; major tonic seizure; fainted; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old male patient received BNT162b2 (BNT162B2), on 28Apr2022 at 17:00 as dose 3 (booster), single (Lot number: FK9893) at the age of 29 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: DULOXETINE; SYNTHROID. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: EW0181, Location of injection: Left arm), administration date: 22Jul2021, when the patient was 29-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EW0196, Location of injection: Arm Left), administration date: 28Jun2021, when the patient was 29-year-old, for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 30Apr2022 at 09:30, outcome "recovering", described as "fainted"; TONIC CONVULSION (medically significant) with onset 30Apr2022 at 09:30, outcome "recovering", described as "major tonic seizure"; SWELLING (non-serious) with onset 01May2022, outcome "recovering", described as "a huge swollen armpit after 12 hrs, that moved down into a large watery lump on side of torso by May 1st". The events "major tonic seizure", "fainted" and "a huge swollen armpit after 12 hrs, that moved down into a large watery lump on side of torso by may 1st" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Computerised tomogram: Unknown results; Electrocardiogram: Unknown results; Electroencephalogram: Unknown results; Fluid wave test: Unknown results; Magnetic resonance imaging: Unknown results. Therapeutic measures were taken as a result of tonic convulsion, syncope, swelling.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19.; Treatment of COVID-19.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 17Mar2021 as dose 1, single (Batch/Lot number: unknown), on 07Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 05Dec2021 as dose 3 (booster), single (Lot number: FJ1611) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "esophagectomy from esophageal cancer" (unspecified if ongoing); "esophagectomy from esophageal cancer" (unspecified if ongoing); "Known allergies: Sulfa antibiotics" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS; METOPROLOL; PANTOPRAZOLE. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: tested positive for covid. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course of the events: Covid symptoms returned and tested positive for covid 6 days after completing 5 day Paxlovid regiment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Contracted Covid; Contracted Covid; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 50-year-old male patient received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: El3247), on 23Feb2021 as dose 2, single (Lot number: EL3247) and on 22Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 50 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 16Jun2022, outcome "recovering" and all described as "Contracted Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16Jun2022) Positive, notes: Covid test type post vaccination= Unknown. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: It was unknown if Covid prior vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information
Age: 61.0
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 61-year-old male patient received BNT162b2 (BNT162B2), on 03Jan2022 as dose number unknown (initial pfizer dose), single (Lot number: 3198) at the age of 61 years, in left arm for covid-19 immunisation; janssen coviD-19 vaccine (JANSSEN COVID-19 VACCINE), on 01Apr2021 as dose number unknown, single (Lot number: 042A21A), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: COVID-19 (medically significant) with onset 02Jun2022, outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jun2022) positive; (17Jun2022) positive. Therapeutic measures were taken as a result of covid-19.  Clinical course: He first tested positive for Covid Thursday morning 02Jun2022 after suffering with a high fever for 36 hours commencing Tuesday evening 31May. Was administered Paxlovid Thursday morning 02Jun. Completed the prescription Monday 06Jun and except for some minor wheezing, felt nearly 100% cured. By the following weekend, Saturday 11Jun, started to feel worse as my cough increased in my chest, and my head congestion increased. That was followed by a clogged eustachian tube this past week and fatigue. Hedon't believe I have redeveloped a fever, but I tested positive again for Covid as of my test Friday 17Jun.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm for 2 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breat cancer treatment", start date: Sep2017 (unspecified if ongoing), notes: Breast cancer treatment starting, September 2017. Concomitant medication(s) included: LETROZOLE; ZINC; QUERCITIN; VITAMIN C [ASCORBIC ACID]. Vaccination history included: pfizer / biontech (Dose 3 (Booster), single, Vaccine lot number: FF8839, vaccine location: Left arm), administration date: 26Sep2021, when the patient was 74-year-old, for COVID-19 Immunization; pfizer / biontech (Dose 2, single, Vaccine administration time: 12:45PM , vaccine lot number: EL9267 , vaccine location=Left arm), administration date: 25Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; pfizer / biontech (Dose1, single, Lot number: EL9269, vaccine location: Left arm), administration date: 04Feb2021, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Jun2022 at 08:00, outcome "not recovered", described as "Sore left arm for 2 months". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Patient had no known allergies. patient experienced Sore left arm for 2 months and Recurrence of illness with a positive test after testing negative with a 10 day isolation. No follow-up attempts are possible. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Sore left arm for 2 months; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breat cancer treatment", start date: Sep2017 (unspecified if ongoing), notes: Breast cancer treatment starting, September 2017. Concomitant medication(s) included: LETROZOLE; ZINC; QUERCITIN; VITAMIN C [ASCORBIC ACID]. Vaccination history included: pfizer / biontech (Dose 3 (Booster), single, Vaccine lot number: FF8839, vaccine location: Left arm), administration date: 26Sep2021, when the patient was 74-year-old, for COVID-19 Immunization; pfizer / biontech (Dose 2, single, Vaccine administration time: 12:45PM , vaccine lot number: EL9267 , vaccine location=Left arm), administration date: 25Feb2021, when the patient was 73-year-old, for COVID-19 Immunization; pfizer / biontech (Dose1, single, Lot number: EL9269, vaccine location: Left arm), administration date: 04Feb2021, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 16Jun2022 at 08:00, outcome "not recovered", described as "Sore left arm for 2 months". Therapeutic measures were not taken as a result of pain in extremity. Additional information: Patient had no known allergies. patient experienced Sore left arm for 2 months and Recurrence of illness with a positive test after testing negative with a 10 day isolation. No follow-up attempts are possible. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
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 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 25Feb2021 at 12:45 as dose 2, single (Lot number: EL9267), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 years, in left arm for covid-19 immunisation. No known allergies. The patient's relevant medical history included: "Breat cancer treatment starting", start date: Sep2017 (unspecified if ongoing), notes: Breat cancer treatment starting, September 2017. Concomitant medication(s) included: LETROZOLE; ZINC; QUERCITIN; VITAMIN C [ASCORBIC ACID] were also other medication in 2weeks product. The following information was reported: DRUG NEFFECTIVE  (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: a positive test after testing negative with a 10 day isolation; Positive, notes: positive test after testing negative with a 10 day isolation. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  Clinical course: Sore left arm for 2 months and Recurrence of illness with a positive test after testing negative with a 10 day isolation.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from 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 04Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 25Feb2021 at 12:45 as dose 2, single (Lot number: EL9267), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 74 years, in left arm for covid-19 immunisation. No known allergies. The patient's relevant medical history included: "Breat cancer treatment starting", start date: Sep2017 (unspecified if ongoing), notes: Breat cancer treatment starting, September 2017. Concomitant medication(s) included: LETROZOLE; ZINC; QUERCITIN; VITAMIN C [ASCORBIC ACID] were also other medication in 2weeks product. The following information was reported: DRUG NEFFECTIVE  (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: a positive test after testing negative with a 10 day isolation; Positive, notes: positive test after testing negative with a 10 day isolation. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.  Clinical course: Sore left arm for 2 months and Recurrence of illness with a positive test after testing negative with a 10 day isolation.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 25Nov2021 as dose 3 (booster), single (Lot number: EN6200) at the age of 44 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis from Long Covid from first infection 15Sep2020" (unspecified if ongoing); "Rheumatoid arthritis from Long Covid from first infection 15Sep2020", start date: 15Sep2020 (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEXAPRO; HYDRALAZINE; TYLENOL; PEPCID AC. Past drug history included: Clindamycin, reaction(s): "Known allergies: clindamycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: anti viral details: product: COVID 19 Treatment, brand: Paxlovid: treatment start date: 03Jun2022, treatment stop date: 08Jun2022, indication: Treatment of COVID-19. The patient received other medication in 2 weeks product, Zyrtec, Lexapro, Hydralazine, Tylenol, Pepcid AC.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 51-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Mar2021 at 12:00 as dose 1, single (Lot number: 025A21A), on 02Apr2021 at 12:00 as dose 2, single (Lot number: 016B21A), in left arm, on 14Nov2021 at 13:00 as dose 3 (booster), single (Lot number: 065F2IA), in left arm and on 31May2022 at 15:45 as dose 4 (booster), single (Lot number: 049L2IA) at the age of 51 years, in left arm for Covid-19 immunisation. The patient's relevant medical history included: "Atopic dermatitis" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CLOBETASOL, start date: 12Jun2022, stop date: 14Jun2022. Past drug history included: Amoxicillin, reaction(s): "Known allergies: amoxicillin"; Erythromycin, reaction(s): "Known allergies: erythromycin". 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. Anti viral details: product: COVID 19 Treatment, brand: Pfizer, treatment start date: 15Jun2022, lot number: GCO470, indication=Treatment of COVID-19. Clinical course details: The patient received other medications in 2 weeks (Topical steroid). No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, Off label use, SARS-CoV-2 test
Clinical narrative: Off label use; Booster; COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hbp" (ongoing); "type 2 dm" (ongoing). The patient's concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; 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: Negative, notes: Had neg antigen test 1 day after completing medication; Positive, notes: Return of symptoms 6 days later and a positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient was treated with Paxlovid for treating COVID-19 from 08Jun2022 to 12Jun2022.  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 and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old male patient received BNT162b2 (BNT162B2), on 07Apr2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 27 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: On the 10th day of Covid. Therapeutic measures were taken with Paxlovid as a result of drug ineffective, covid-19. Clinical course: Patient received COVID 19 Treatment Paxlovid (lot number 1917018A) from 07Jun2022 to 12Jun2022. No other medication received in 2weeks. Patient had no known allergies and medical History. On the 10th day of Covid, symptoms returned with more mucus in upper chest and slight fever.  Clinical Course: The patient did not receive other medication in 2weeks. The patient received COVID 19 Treatment, (Paxlovid) from 07Jun2022 to 12Jun2022, for the treatment of COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Product use issue, Pyrexia
Clinical narrative: Low fever; chills; incredibly achy; exhaustion; other vaccine same date product=Prevnar 20; pain at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jun2022 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Jun2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "frequent sinus" (unspecified if ongoing); "ear infections" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; LAMOTRIGINE; DULOXETINE; L-METHYLFOLATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown, Unable to locate or read the details), administration date: Apr2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Unable to locate or read the details), administration date: Mar2021, for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 16Jun2022, outcome "unknown", described as "other vaccine same date product=Prevnar 20"; VACCINATION SITE PAIN (non-serious) with onset 16Jun2022, outcome "not recovered", described as "pain at injection site"; PYREXIA (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered", described as "Low fever"; CHILLS (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered"; FATIGUE (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered", described as "exhaustion"; PAIN (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered", described as "incredibly achy". Therapeutic measures were not taken as a result of pyrexia, chills, pain, vaccination site pain, fatigue.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Low fever; chills; incredibly achy; exhaustion; other vaccine same date product=Prevnar 20; pain at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Jun2022 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 30 years, in left arm for covid-19 immunisation; pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 16Jun2022 as dose 1, single (Batch/Lot number: unknown), in right arm for immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "frequent sinus" (unspecified if ongoing); "ear infections" (unspecified if ongoing). Concomitant medication(s) included: VYVANSE; LAMOTRIGINE; DULOXETINE; L-METHYLFOLATE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown, Unable to locate or read the details), administration date: Apr2021, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown, Unable to locate or read the details), administration date: Mar2021, for Covid-19 immunization. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 16Jun2022, outcome "unknown", described as "other vaccine same date product=Prevnar 20"; VACCINATION SITE PAIN (non-serious) with onset 16Jun2022, outcome "not recovered", described as "pain at injection site"; PYREXIA (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered", described as "Low fever"; CHILLS (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered"; FATIGUE (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered", described as "exhaustion"; PAIN (non-serious) with onset 17Jun2022 at 12:00, outcome "not recovered", described as "incredibly achy". Therapeutic measures were not taken as a result of pyrexia, chills, pain, vaccination site pain, fatigue.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: FK9262), in left arm, on 17Feb2021 as dose 2, single (Lot number: EN6201), in left arm, on 26Sep2021 as dose 3 (booster), single (Lot number: 30130BA), in left arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN controlled" (unspecified if ongoing); "GERD controlled" (unspecified if ongoing); "Hypercholesterolemia controlled" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; ATORVASTATIN; CHLORTHALIDONE; EXCEDRIN [ACETYLSALICYLIC ACID; CAFFEINE; PARACETAMOL; SALICYLAMIDE]; MAGNESIUM; OMEPRAZOLE; POTASSIUM; QUERCETIN; SWANSON 5-HTP; TURMERIC +; VIT D3. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jun2022) Negative; (18Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Antiviral details: Product: COVID 19 Treatment, brand: Pfizer, Treatment start date: 05Jun2022 and stop date: 09Jun2022, Lot number=FP6522, indication is used for treatment of COVID-19, Administrator route: Oral. The patient did not receive other medication in 2 weeks. The patient had Known allergies to NKA. Adverse event tested negative for COVID-19 13June 2022 after completing course of antiviral meds. New onset of sneezing with rhinorrhea 17June 2022. Tested positive for COVID-19 18June2022. No fever. No cough. No shortness of breath. No body aches. No Fatigue. The patient experienced adverse event on 16Jun2022. The patient tested negative for COVID-19 13June 2022 after completing course of antiviral meds. New onset of sneezing with rhinorrhea 17June 2022. Tested positive for COVID-19 18June2022. No fever. No cough. No shortness of breath. No body aches. No Fatigue. The patient did not receive treatment. The outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 1.83
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE details; TE evaluation states vaccines have been administered; This spontaneous report was received from a certified medical assistant and referring to a 22 months old male patient (also reported as 1-year-old). The patient's medical history, concomitant therapies and concurrent conditions were not provided. On 23-MAR-2022, the suspect vaccine underwent temperature excursion of -14 degrees Celsius (C) up to - 10C for 3 hours and -10C up to 8C for 1 hour and 30 minutes.   On 18-APR-2022, the patient was vaccinated with the first dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneously (lot # U025790 with expiration date: 19-AUG-2023; dose and strength were unknown) for prophylaxis (product storage error). No additional adverse event was reported (no adverse event).  There were no previous temperature excursions. It was an initial use of vaccine/vaccine-device. The operator of the vaccine/vaccine-device was healthcare professional. The vaccine/vaccine-device was not available for return/evaluation as it was given to the patient.   This is one of several cases received from the same reporter.; Sender's Comments:  US-009507513-2205USA003614: US-009507513-2205USA007821: US-009507513-2205USA007847: US-009507513-2205USA007852: US-009507513-2204USA009330: US-009507513-2205USA008004: US-009507513-2205USA008051: US-009507513-2205USA008008: US-009507513-2205USA008028: US-009507513-2205USA007982: US-009507513-2205USA008105: US-009507513-2205USA008106:
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered
Clinical narrative: Patient did not have any symptoms; Caller is a medical assistant who reports that an expired dose of VARIVAX was given to a patient.; This spontaneous report was received from the medical assistant and refers to a 48-year-old patient of an unknown gender. The patient's medical history, concomitant medications, and concurrent conditions were not reported.  On 01-JUN-2022, the patient was administered varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter once, lot #T010298, expiration date: 24-MAR-2022 (expired product administered) (strength, and route of administration were not provided) for varicella immunisation. The vaccine did not have any previous temperature excursions, and was used with the sterile diluent (lot number and expiry date not reported). The patient received varicella virus vaccine live (oka/merck) (VARIVAX), because had titers drawn and was not immune to varicella. It was unknown whether the patient was vaccinated against varicella before. On 06-JUN-2022, the medical assistant confirmed, that the patient did not have any adverse reaction to the expired vaccine. No further information was available.
Age: 71.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Myelitis transverse
Clinical narrative: Transverse myelitis after 2nd dose, currently in hospital; First dose 4/1/2022 - Second dose 4/11/2022; This case was reported by a consumer via call center representative and described the occurrence of myelitis transverse in a 71-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 11th April 2022, the patient received the 2nd dose of Shingrix. On 11th April 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On 28th April 2022, the patient experienced myelitis transverse (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the myelitis transverse and drug dose administration interval too short were unknown.   It was unknown if the reporter considered the myelitis transverse to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR094025   Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: The patient had transverse myelitis 17 days after second dose of Shingrix. The patient had stroke after 1st dose of vaccine and also found atrial fibrillation. The patient visit to doctor physically once a year and twice a year after the patient turn 65 year. The patient was in hospital. Additional Supportive Information: The patient received the 2nd dose of Shingrix early, which led to shortening of vaccination schedule.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR094025:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 18th Dec 2018, did not get the 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 18th December 2018 from batch number TP5E5, expiry date 15th November 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2022  Reporter's comment: The patient did not get the 2nd dose. The vaccine administration facility was the same as primary reporter for the 1st dose. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: gave Menveo to a 13-year-old pt who had been vaccinated with Menveo 2 years and 5 months ago; This case was reported by a non-health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA660A, expiry date 28th February 2023) for prophylaxis.   Previously administered products included Menveo (1st dose received 2 years and 5 months prior to the reporting).   On 16th June 2022, the patient received the 2nd dose of Menveo (intramuscular) .5 ml. On 16th June 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 16-JUN-2022  Reporter's comment: Caller was the store manager calling on behalf of the pharmacist on duty. Caller reported her pharmacy technician gave a Menveo vaccine on left arm to a 13-year-old patient who had previously been vaccinated with Menveo 2 years and 5 months prior to reporting. The pharmacist to MI for further instructions. The reporter consented to follow up. Additional supportive information: The patient received Menveo 2nd dose which led to extra dose administered.
Age: 13.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: received on 2-8-2022, received another on 6-17-2022; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number MR5RK, expiry date 21st September 2023) for prophylaxis.   Previously administered products included Boostrix (1st dose received on 8th February 2022 in left arm).   On 17th June 2022, the patient received Boostrix (intramuscular) .5 mg/ml. On 17th June 2022, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 17-Jun-2022 Reporter's comments: This case was reported by the healthcare professional office for Boostrix administration error. The patient received a Boostrix on 8th February 2022 by their office. The same patient received another Boostrix vaccine on 17th June 2022 in the left arm at the same office. The consent to follow up was given. Additional Supportive Information: The patient received extra dose of Boostrix in error, which led to extra dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Breast swelling
Clinical narrative: SWOLLEN BREAST; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced swollen breast. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of swollen breast was not reported. This report was non-serious. This case, from the same reporter is linked to 20220635096 and 20220610772.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Headache, Lymphadenopathy
Clinical narrative: Extreme left lymph node swollen causing more than discomfort for a couple of weeks; Extreme left lymph node swollen causing more than discomfort for a couple of weeks; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Dec2021 at 14:00 as dose 3 (booster), single (Lot number: FJ8762) at the age of 54 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "no" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (prev dose product=COVID 19,, Prev dose brand=PFIZER,, prev dose brand unknown=False,, prev dose lot number=EW0170,, prev dose lot unknown=False,, prev dose administration date=26Apr2021,, prev dose administration time=12:00 PM,, prev dose dose number=2,, prev dose vaccine location=Right arm,), administration date: 26Apr2021, for COVID-19 immunization; BNT162b2 (prev dose product=COVID 19,, Prev dose brand=PFIZER,, prev dose brand unknown=False,, prev dose lot number=8743,, prev dose lot unknown=False,, prev dose administration date=05Apr2021,, prev dose administration time=02:00 PM,, prev dose dose number=1,, prev dose vccine location=Left arm), administration date: 05Apr2021, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), DISCOMFORT (non-serious) all with onset 07Dec2021 at 11:30, outcome "recovered" and all described as "Extreme left lymph node swollen causing more than discomfort for a couple of weeks"; HEADACHE (non-serious) with onset 07Dec2021 at 11:30, outcome "recovering". Therapeutic measures were not taken as a result of lymphadenopathy, discomfort.  No follow-up attempts are possible. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: My daughter tested positive for Covid-19, she has been vaccinated.; My daughter tested positive for Covid-19, she has been vaccinated.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the parent.  A 16-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EW0175), as dose 2, single (Lot number: EW0177) and on 07Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 15 years for covid-19 immunisation. The patient's relevant medical history included: "Birth control" (unspecified if ongoing). Concomitant medication(s) included: MILI [ETHINYLESTRADIOL;NORGESTIMATE] taken for contraception. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My daughter tested positive for Covid-19, she has been vaccinated.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical course: Pfizer colleague (Reporter) stated, so my daughter tested positive for Covid-19, she has been vaccinated. LOT: Pfizer colleague stated, "She had three different LOT for the the different shot. First one was EW0175. the second is EW0177 and the last one is 3303 I thinks this is 6 DD.''  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.