chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills; headache; vomiting; fever; fatigue; sleep disruption; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received BNT162b2 (BNT162B2), on 01Aug2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin; "High blood pressure" (ongoing), notes: High blood pressure. Concomitant medication(s) included: LISINOPRIL. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine", notes: Known allergies: Codeine. Vaccination history included: Covid-19 vaccine (Dose number: 3), for COVID-19 immunization; Covid-19 vaccine (Dose number: 2), for COVID-19 immunization; Covid-19 vaccine (Dose number: 1), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering"; FATIGUE (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering"; PYREXIA (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering"; SLEEP DISORDER (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering", described as "sleep disruption"; VOMITING (non-serious) with onset 01Aug2022 at 22:30, outcome "recovering". Therapeutic measures were not taken as a result of chills, headache, vomiting, pyrexia, fatigue, sleep disorder.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Also since vaccination, she had not been tested for COVID-19. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 2 weeks of vaccination, she received Lisinopril. She reported event such as chills, headache, vomiting, fever, fatigue, and sleep disruption.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: her brother who got a dose of the vaccine experienced rashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP)   A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "her brother who got a dose of the vaccine experienced rashes".  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: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 10Mar2021 at 12:30 as dose 1, single (Lot number: EN6199), in left arm, on 31Mar2021 as dose 2, single (Lot number: ER8732), in right arm, on 04Nov2021 at 16:00 as dose 3 (booster), single (Lot number: 302308D), in right arm and on 09Jun2022 at 15:30 as dose 4 (booster), single (Lot number: FJ4989) at the age of 65 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing); "Allergy" (unspecified if ongoing). Concomitant medication(s) included: NALTREXONE, start date: Oct2019; FISH OIL, start date: Jan2018; VITAMIN D [VITAMIN D NOS], start date: Dec2018; B COMPLEX [VITAMIN B COMPLEX], start date: Jul2019. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment. Device Date: 02Aug2022.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 03Nov2021 as dose 1, single (Batch/Lot number: unknown), on 17Dec2021 as dose 2, single (Batch/Lot number: unknown) and on 07Jan2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Clotrimazole, reaction(s): "Known allergies: Clotrimazole"; Tobramycin, reaction(s): "Known allergies: tobramycin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with Paxlovid from 29Jul2022 to 02Aug2022 for COVID-19. The patient received other medications/products within 2 weeks of starting COVID-19 treatment. Patient reported metallic taste (onset 45 minutes, duration 4-6 hours), insomnia (slept 3-4 hours first 2 nights versus 8 normally and more when she was sick, missed a dose last night and slept completely normally. She expected that this will reoccur tonight after her last night time dose.  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 known drug safety profile and temporal association, there is reasonable possibility of causal association reported between the events and the suspect drug BNT162B2
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 71-year-old female patient received BNT162b2 (BNT162B2), on 27Aug2021 as dose 3 (booster), single (Lot number: FZ318L) at the age of 70 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: "COPD" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: Yes. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 02Aug2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 and included Paxlovid.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Apr2021 as dose 2, single (Lot number: ew0161) at the age of 46 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa Drugs" (unspecified if ongoing), notes: Known allergies: Sulfa Drugs. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. 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=26Jul2022, treatment stop date=27Jul2022, lot number=1917015A, indication=Treatment of COVID-19.Other medication received in 2 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6204), in right arm, on 01Apr2021 as dose 2, single (Lot number: ER8734), on 08Sep2021 as dose 3 (booster), single (Lot number: FF2588), in right arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FJ4989) at the age of 21 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Immunocompromised" (unspecified if ongoing); "History of anorexia nervosa" (unspecified if ongoing); "History of anxiety" (unspecified if ongoing), notes: History of anxiety. Concomitant medication(s) included: MIRTAZAPINE, start date: 01Mar2019; SERTRALINE, start date: 01Jun2018; MIRENA, start date: 06Jan2021; SPIRONOLACTONE, start date: 17May2022; RITALIN, start date: 01Jun2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 2022, outcome "not recovered", COVID-19 (medically significant) with onset Jul2022, 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) Negative; (01Aug2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient took Paxlovid from 21Jul2022 to 26Jul2022 as treatment of covid-19. Clinical course: The patient administered other medications/products within 2 weeks of starting COVID-19 treatment. After taking Paxlovid from 21Jul2022 through 26Jul2022, she tested negative for COVID on an antigen test and was asymptomatic. This continued through 31Jul2022. On 01Aug2022 05:30 PM, she redeveloped symptoms and tested positive for COVID on antigen tests and patient was not treated for adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
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 a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old male patient received BNT162b2 (BNT162B2), on 09Mar2021 at 14:00 as dose 1, single (Lot number: El9269), in right arm, on 30Mar2021 at 14:00 as dose 2, single (Lot number: En6205), in right arm and on 14Jan2022 at 13:00 as dose 3 (booster), single (Lot number: FJ6369) at the age of 39 years, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications.  The following information was reported: VACCINATION FAILURE (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: (2022) Negative, notes: After completing 5 days of paxlovid and testing negative on antigen test; (unspecified date) Positive, notes: COVID 19 Treatment; (2022) Positive, notes: symptoms returned and I tested positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: The patient did not receive any other medication in 2 weeks. The patient received treatment with Paxlovid (Lot number: GD8744) from 26Jul2022 to 30Jul2022 for Covid-19.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 1, single (Lot number: EW0151), on 28Apr2021 as dose 2, single (Lot number: EW0171) and on 16Nov2021 as dose 3 (booster), single (Lot number: FJ1620) at the age of 43 years for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid from 17Jul2022 to 21Jul2022 for treatment of COVID-19.  Clinical course: The patient had allergies like symptoms: headache, dry throat, runny and stuffy nose from 31Jul2022 which were recovering. The patient did not received other medication in 2weeks. The patient had no know allergies.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 02Jan2021 as dose 1, single (Lot number: EL1283) and on 22Jan2021 as dose 2, single (Lot number: EL9261) at the age of 41 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 15Nov2021 as dose 3 (booster), single (Lot number: 069F21A) for covid-19 immunisation. The patient's relevant medical history included: "asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: allergies; "varicose veins" (unspecified if ongoing); "suspicious thyroid nodule( w/u pending)" (unspecified if ongoing), notes: suspicious thyroid nodule( w/u pending); "known allergies: sulfa" (unspecified if ongoing). Concomitant medication(s) included: ASMANEX, start date: 31Dec2017; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 01Jan2015. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received treatment with Paxlovid from 24Jul2022 to 28Jul2022 for treatment of Covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Sex: F
Vaccine: PPV
Symptoms: Illness
Clinical narrative: Has had 2 Pneumonia shots and has been sick 3 times this year; 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 received pneumococcal 13-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), as dose 2, single (Batch/Lot number: unknown) for pneumonia, immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumococcal 13-val conj vac (dipht crm197 protein) (Dose 1, single), for immunization. The following information was reported: ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "Has had 2 Pneumonia shots and has been sick 3 times this year".  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 13Jul2022 as dose 3 (booster) single (Batch/Lot number: unknown) at the age of 61 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 "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID-19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: No other medication received in 2 weeks. No known allergy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 61-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 06Apr2021 as dose 1, single (Batch/Lot number: unknown), on 04May2021 as dose 2, single (Batch/Lot number: unknown) and on 12Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: after testing negative 10 days prior; Positive, notes: Rebound positive home antigen tests x 4 days after testing negative 10 days prior. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received anti viral treatment with Paxlovid from 15Jul2022 to 19Jul2022 (route of administration: oral) for covid-19. Patient experienced rebound positive home antigen tests x 4 days after testing negative 10 days prior (Mild symptoms). No known allergies reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
Age: 68.0
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).  A 69-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no known allergies. Patient had no other medical history. Patient did not have other medication in 2 weeks. Patient started Paxlovid from Jul2022 to Jul2022 for COVID 19 Treatment. The adverse event stated was relapsed after testing negative on 02Aug2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
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 71-year-old male patient received BNT162b2 (BNT162B2), on 12Feb2021 at 08:30 as dose 1, single (Lot number: EL9269), in left arm, on 05Mar2021 at 08:45 as dose 2, single (Lot number: EN6205), in left arm, on 06Jun2021 at 09:00 as dose 3 (booster), single (Lot number: FF2590), in left arm and on 18Apr2022 at 08:00 as dose 4 (booster), single (Lot number: FJ4989) at the age of 70 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), outcome "recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19. Patient did not take any other medication in 2weeks. COVID 19 Treatment start date was 15Jul2022. Treatment stop date was 20Jul2022. Indication was treatment of COVID-19. Paxlovid rebound effect 1 or 2 days after completing Paxlovid 5 day regimen. Mild symptoms, felt run down, nasal congestion, chills, left ear canal discomfort. Known allergies was None. Other medical history was none.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pancreatic carcinoma
Clinical narrative: 2 of her friends who took the vaccine got pancreatic cancer within 3 months after taking the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATIC CARCINOMA (medically significant), outcome "unknown", described as "2 of her friends who took the vaccine got pancreatic cancer within 3 months after taking the vaccine".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201032213 same reporter/drug/AE, different patient;
Sex: U
Vaccine: COVID19
Symptoms: Pancreatic carcinoma
Clinical narrative: 2 of her friends who took the vaccine got pancreatic cancer within 3 months after taking the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PANCREATIC CARCINOMA (medically significant), outcome "unknown", described as "2 of her friends who took the vaccine got pancreatic cancer within 3 months after taking the vaccine".  Clinical Course: Caller also mentions that she has not taken the Pfizer Covid 19 vaccine because she was fearful and because 2 of her friends who took the vaccine got pancreatic cancer within 3 months after taking the vaccine. Caller also mentions that her brother who got a dose of the vaccine experienced rashes. She asks if the Pfizer Covid 19 vaccine causes HIV and cancer (specifically pancreatic cancer).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201032212 same reporter/drug/AE, different patient;
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 69-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 69 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), 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) all with onset 19Jul2022, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient had no known allergies. He had no other medication in 2 weeks. Symptoms of COVID-19 began on 19Jul2022. He received COVID 19 treatment as Paxlovid, started from 21Jul2022 to 25Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 45.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593) at the age of 45 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: "Asthma" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: NORTREL [LEVONORGESTREL] taken for contraception; OMEPRAZOLE taken for gastrooesophageal reflux disease; WELLBUTRIN; CYMBALTA; TRAZODONE; CONCERTA; MIRALAX. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 19Jul2022, outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (19Jul2022) Positive; (24Jul2022) Negative; (26Jul2022) Negative; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient had received other medication in 2weeks. Patient had received Paxloid treatment from 19Jul2022 to 24Jul2022. Patient had no known allergies. It was reported that Tested positive on 19Jul2022. Started Paxloid in the evening Finished on 24Jul2022. Symptoms stopped 22Jul2022. Tested negative on 24Jul2022 and 26Jul2022. Runny nose and coughing on 29Jul2022. Home kit positive.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
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 contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose number unknown, single (Lot number: ER8732), in left arm and on 20Apr2021 as dose number unknown, single (Lot number: EW0164) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 28Dec2021 as dose number unknown, single (Lot number: 028K21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "penicillin allergy" (unspecified if ongoing); "back surgery" (unspecified if ongoing), notes: I had recent back surgery and knee surgery; "knee surgery" (unspecified if ongoing), notes: I had recent back surgery and knee surgery; "Asthma" (unspecified if ongoing), notes: I am a healthy, elite athlete. Compromised meaning asthma. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Drug allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 24Jul2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (24Jul2022) Positive, notes: Tested positive on 24Jul; immune compromised- 25Jul called my PCP, Rx Paxlovid; (31Jul2022) Positive, notes: 31Jul rebound - fully symptomatic and texted positive both rapid and a PCR; (31Jul2022) Positive, notes: 31Jul rebound - fully symptomatic and texted positive both rapid and a PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the Drug ineffective (LOE) and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: a fever for a number of days; 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 female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE , Caller adds that she got all the covid vaccines, they were all Pfizer,), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE , Caller adds that she got all the covid vaccines, they were all Pfizer,), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE , Caller adds that she got all the covid vaccines, they were all Pfizer,), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "a fever for a number of days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller adds that she got all the covid vaccines, they were all Pfizer, and the 4th one, clarifying the second booster, that gave her a fever for a number of days. When probed if she had dates, lot numbers, and expiry dates of all her covid vaccines, caller again stated that she prefers to provide this information on follow up, she was sure this information. Caller asked is it common that one can have a fever as a side effect. Caller declined transfer , stating that she was informed on how to get to the website, and look at it. Caller asked for drug safety's email to provide product details. Caller was informed that she would have to wait for follow up with her. Caller stated to not send her any physical mail, caller states that she would like to be contacted by Email.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), 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 "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment; Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: No other medication received in 2 weeks. Negative test then 4 days later positive.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: woke up with body aches and fever of 101/did home test and came positive; woke up with body aches and fever of 101/did home test and came positive; This is a spontaneous report received from a 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 12Feb2021 at 14:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 16Apr2021 at 13:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 19Jul2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Has mild Glaucoma" (unspecified if ongoing); "mild aortic regurgitation" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Jul2022, outcome "recovered" (Jul2022) and all described as "woke up with body aches and fever of 101/did home test and came positive". The patient underwent the following laboratory tests and procedures: Body temperature: (18Jul2022) 101; SARS-CoV-2 test: (18Jul2022) Positive, notes: did home test and came positive; (25Jul2022) Negative, notes: tested negative on seventh day; (28Jul2022) Positive, notes: tested again and it came very sharp red positive; (01Aug2022) Positive, notes: still positive but with lighter line. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient started feeling down after her daughter's family caught COVID. After three days, on 18Jul2022, she woke up with body aches and fever of 101. She did a home test and came positive. She called her PCP and asked for the anti-viral medicine as she is over 65 and has a very mild heart aortic regurgitation. She started taking the medicine on the 18th and continued for five days as prescribed, her symptoms improved in two days, and she was feeling back to normal on my fourth day. She tested negative on the seventh day but didn't do test on the sixth. After three days from testing negative, she started feeling a mild to medium sinus congestion and thought it was just her regular sinus issue that she got after she catch cold, but after watching the news about the rebound cases, she tested herself again and it came very sharp red positive. She didn't have any other symptoms but isolated herself again. She tested yesterday, 01Aug2022, and still showed positive but with lighter line. She will test herself tomorrow.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: covid-19; 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 65-year-old male patient received BNT162b2 (BNT162B2), on 13Mar2022 as dose number unknown (booster), single (Batch/Lot number: unknown), 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: "Bronchiectasis" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). The patient had no known allergies. The patient's concomitant medications were not reported. Other medication in 2 weeks reported as unknown. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "not recovered" and all described as "covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient was treated with anti-viral Paxlovid for COVID 19 treatment from 18Jul2022 to 23Jul2022. Paxlovid rebound; recurrence at approximately eight days following final treatment.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201032781 Same patient, different product and event;
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: has Covid 19; has Covid 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Aug2022, outcome "unknown" and all described as "has Covid 19". The event "has covid 19" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (01Aug2022) Positive, notes: he started with Covid yesterday His doctor this morning prescribed him the medication Paxlovid pills. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Caller has a question. He has Covid 19 and was being treated and he was vaccinated already. His doctor this morning prescribed him the medication Paxlovid pills. He started it now in the afternoon after he picked it up at the pharmacy. He was feeling pain since he started with Covid yesterday before he started the Paxlovid pills. His concern was can he take ibuprofen or Advil; would that make any trouble with Paxlovid. Caller declined to report as he was feeling pain in his joints and would like to ask about ibuprofen or Advil. Clarified that he had 2 Pfizer Covid vaccines and the Pfizer Covid booster.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Dose in Series Given Too Early-
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: covid vaccine breakthrough case  dose 1 Pfizer 1/19/21 EL3249 dose 2 Pfizer 2/158/21 EM9810
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient daughter reported adverse effects on the phone and they already spoke to a doctor. pt was prescribed zyrtec.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Error: Wrong vaccine/Product administered.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Following administration patient had vasovagal syncope episode. This lasted for about 30 seconds. Patient regained full consciousness and alertness. Patient stayed in clinic room for 10 more minutes, stated he felt back to normal. He was asked to stay in the store for the next 15 minutes to ensure that this continued. Patient checked back into provider after 15 minutes and stated he had felt back to normal.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site extravasation
Clinical narrative: Error: Leaking from Injection Site-
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: Patient reported redness and swelling that is "warm to touch" at injection site on weekend after injection, not immediate reaction. Asked us to report.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: COVID vaccine breakthrough case
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Error: Expired Product Administered-
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Moderna 2/18/21 Lot# 038K20A;  Moderna 3/23/21 Lot# 010A21A;   Moderna 11/16/21 Lot# 939903
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Pruritus, Throat tightness
Clinical narrative: Immediately after receiving vaccine pt developed sensations of throat closing and pruritus. Pt has previous alergic rx to flu vaccine. RN at clinic administered epinephrine 0.3 mg IM into R thigh and was given benadryl 50 mg. Patient then went to ED via EMS. Patient was discarhed from ED.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case after two vaccines Moderna 6/20/21 Lot3 022B21A;  Moderna 7/18/21 Lot# 002B21A;
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 1 Janssen vaccine Janssen 5/13/21 Lot# 203A21A
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Chills, Dizziness, Fatigue
Clinical narrative: Headache X 3 days Severe Abdominal pain X 3 days Intermittent Nausea X 3 days Severe muscle and joint pain X 3 days Lightheadedness X 3 days Fatigue X 3 days Chills X 3 days Injection site red, hot, swollen and painful with itching and stinging sensation STILL CONTINUING TODAY WHICH IS DAY 4.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Headache X 3 days Severe Abdominal pain X 3 days Intermittent Nausea X 3 days Severe muscle and joint pain X 3 days Lightheadedness X 3 days Fatigue X 3 days Chills X 3 days Injection site red, hot, swollen and painful with itching and stinging sensation STILL CONTINUING TODAY WHICH IS DAY 4.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Myalgia, Nausea
Clinical narrative: Headache X 3 days Severe Abdominal pain X 3 days Intermittent Nausea X 3 days Severe muscle and joint pain X 3 days Lightheadedness X 3 days Fatigue X 3 days Chills X 3 days Injection site red, hot, swollen and painful with itching and stinging sensation STILL CONTINUING TODAY WHICH IS DAY 4.
Age: 41.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: Induration on the injection site. Arm still hurts 9 days after injection. There is a hard bump inside the skin, at injection site, that is painful when I rub it.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Moderna 1/8/21 Lot# 012L20A;  Moderna 2/5/21 Lot# 012L20A;  Moderna 11/23/21 Lot# 012H21B
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Balance disorder, Blood test, Computerised tomogram, Diplopia, Electromyogram
Clinical narrative: Muscle weakness, droopy eyes, double vision, unsteadiness
Age: 71.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eyelid ptosis, Muscular weakness
Clinical narrative: Muscle weakness, droopy eyes, double vision, unsteadiness
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Pfizer 3/19/21 Lot# ER8727; Pfizer 4/21/21 Lot# EW0164;  Pfizer 12/3/21 Lot# 33030BD
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Moderan 4/21/21 Lot# 043B21;  Moderan 5/19/21 Lot# 033B21A;  Moderna 2/1/22 Lot# 068H21A
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case after 4 vaccines Pfizer 2/2/21 Lot# EL9265;  Pfizer 2/23/21 Lot# EN6200;  Pfizer 10/25/21 Lot# FF8841;  Pfizer 5/2/22 Lot# FM9992
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines: Pfizer 1/27/2021 batch/lot# EL9264; Pfizer 2/17/2021 batch/lot# EN6201; Pfizer 10/2/2021 batch/lot# FC3183.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Moderna 3/31/21 Lot# 002B21A;  Moderna 4/29/21 Lot# 017C21A;  Moderna 11/10/21 Lot# 032F21A
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after three vaccines Pfizer 4/27/21 Lot# EW0176;  Pfizer 5/18/21 Lot#EW0177;  Pfizer 12/14/21 Lot#330308D
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Intentional medical device removal by patient
Clinical narrative: Patient pulled away when needle entered arm and same needle was used to reinject vaccine.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough case admission after 3 vaccines ; Moderna 1/27/21 Lot# 032H20A;  Moderna 1028/21 Lot# 076C21A;  Moderna 4/28/22 Lot# 048L21A
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Computerised tomogram abnormal, Dizziness, Dyspnoea, Fatigue, Pericardial effusion
Clinical narrative: Pro Air Inhaler Advair 500 Inhaler Dizziness difficulty catching my breathg fatigue
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death, Vaccine breakthrough infection
Clinical narrative: COVID-related death, breakthrough case
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested COVID positive after receiving 2 vaccines and one booster.