chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Developed rebound COVID/Very dark line positive test; Developed rebound COVID/Very dark line positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Apr2021 as dose 1, single (Lot number: ER8736), in left arm, on 18May2021 as dose 2, single (Lot number: EW0177), in left arm and on 31Dec2021 as dose 3 (booster), single (Lot number: FE3594) at the age of 62 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "PBC" (unspecified if ongoing); "Lupus like" (unspecified if ongoing), notes: undifferentiated connective tissue disease (lupus like); "RLS" (unspecified if ongoing); "OA" (unspecified if ongoing); "Sjogren's disease" (unspecified if ongoing); "FM" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "RA" (unspecified if ongoing); "undifferentiated connective tissue disease (lupus like)" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; URSODIOL; HYDROXYCHLOROQUINE; SINGULAIR; TRAMADOL; DULOXETINE; VITAMIN D NOS; CALCIUM; MYRBETRIQ; ROPINIROLE. Past drug history included: Doxycycline, reaction(s): "known allergies". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Developed rebound COVID/Very dark line positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown Results, notes: Treatment of COVID-19; (11May2022) Positive, notes: Very dark line positive test on day 1; (16May2022) Positive, notes: Repeated after Paxlovid on day 6 and line very faint; (20May2022) Positive, notes: Rechecked test on day 10 and was dark line positive again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient received other medications within two weeks.  Conclusion: The complaint for lack of effect of the Pfizer Biontech Covid-19 Vaccine Injectables lot ER8736, lot EW0177,lot FE3594 were investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot ER8736, fill lot EP8688, lot EW0177, fill lot EP8728 and lot FE3594, fill lot FF2555 and the formulated drug product lot EP8585, lot EP8609 and lot EY0909 respectively. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: Fatigue; General Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 9-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 at 19:00 as dose 3 (booster), single (Lot number: FL8094) at the age of 9 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Birth at 33.5 gestational weeks" (unspecified if ongoing); "Bilateral inguinal hernia" (unspecified if ongoing), notes: Bilateral inguinal hernia repair at 2 months and 4 years of age; "Left temporal lobe dermatoid cyst excision" (unspecified if ongoing), notes: Left temporal lobe dermatoid cyst excision at 1.5 years of age. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 04Dec2021, when the patient was 8-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 07Nov2021, when the patient was 8-year-old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 25May2022 at 15:00, outcome "not recovered"; MALAISE (non-serious) with onset 25May2022 at 15:00, outcome "not recovered", described as "General Malaise". Therapeutic measures were not taken as a result of fatigue, malaise.  Additional information: If covid prior vaccination: No. If covid tested post vaccination: No. Known allergies: No. Other medications in two weeks: daily vitamins  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Fatigue, Headache
Clinical narrative: Headache; Stomachache; Mild fever of 100.1 degrees Fahrenheit by oral thermometer; Fatigue; General Malaise; Mild diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 at 19:00 as dose 3 (booster), single (Lot number: FL8094) at the age of 6 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 04Dec2021, when the patient was 5-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 07Nov2021, when the patient was 5--old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 25May2022 at 13:45, outcome "not recovered"; MALAISE (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "General Malaise"; HEADACHE (non-serious) with onset 25May2022 at 13:45, outcome "not recovered"; DIARRHEA (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "Mild diarrhea"; PYREXIA (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "Mild fever of 100.1 degrees Fahrenheit by oral thermometer"; ABDOMINAL PAIN UPPER (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "Stomachache". The events "headache", "stomachache", "mild fever of 100.1 degrees Fahrenheit by oral thermometer", "fatigue", "general malaise" and "mild diarrhea" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, abdominal pain upper, pyrexia, fatigue, malaise, diarrhea.  Additional information: Facility type vaccine: Pharmacy or Drug Store. Other vaccine in four weeks: No. Other medication in two weeks: daily vitamins, daily children's Claritin or Benadryl. No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, SARS-CoV-2 test
Clinical narrative: Headache; Stomachache; Mild fever of 100.1 degrees Fahrenheit by oral thermometer; Fatigue; General Malaise; Mild diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 6-year-old male patient received BNT162b2 (BNT162B2), on 24May2022 at 19:00 as dose 3 (booster), single (Lot number: FL8094) at the age of 6 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Seasonal allergies" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 04Dec2021, when the patient was 5-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: FK5127, Route of Administration: Intramuscular), administration date: 07Nov2021, when the patient was 5--old, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 25May2022 at 13:45, outcome "not recovered"; MALAISE (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "General Malaise"; HEADACHE (non-serious) with onset 25May2022 at 13:45, outcome "not recovered"; DIARRHEA (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "Mild diarrhea"; PYREXIA (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "Mild fever of 100.1 degrees Fahrenheit by oral thermometer"; ABDOMINAL PAIN UPPER (non-serious) with onset 25May2022 at 13:45, outcome "not recovered", described as "Stomachache". The events "headache", "stomachache", "mild fever of 100.1 degrees Fahrenheit by oral thermometer", "fatigue", "general malaise" and "mild diarrhea" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, abdominal pain upper, pyrexia, fatigue, malaise, diarrhea.  Additional information: Facility type vaccine: Pharmacy or Drug Store. Other vaccine in four weeks: No. Other medication in two weeks: daily vitamins, daily children's Claritin or Benadryl. No covid prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
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 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: 6206), in left arm and on 01Apr2021 as dose 2, single (Lot number: ER8733) at the age of 22 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 01Dec2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Allergies (mostly seasonal and pets)" (ongoing); "Allergies (mostly seasonal and pets)" (ongoing). Concomitant medication(s) included: XYZAL taken for hypersensitivity; EQUATE ALLERGY RELIEF [FLUTICASONE PROPIONATE] taken for hypersensitivity. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin"; Azithromycin, reaction(s): "Known allergies: Azithromycin"; Clindamycin, reaction(s): "Known allergies: Clindamycin". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (09May2022) Positive; (25May2022) Positive, notes: Today on day 16 a dark line showed up again. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Patient had been testing positive for COVID-19 for the past 16 days on at home rapid tests. patient never experienced rebound symptoms after taking paxlovid and symptoms improved, but patient did want to share that have simply not tested negative since original positive test on 9May22. Sometimes the line is faint, but today on day 16 a dark line showed up again.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Fatigue
Clinical narrative: she was exhausted for 4 days and with the second shot, it was the same thing; a little confused and tired; a little confused and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient received BNT162b2 (BNT162B2), on 21Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 33 years for covid-19 immunisation. The patient's relevant medical history included: "allergic to amoxicillin and penicillin" (unspecified if ongoing), notes: NDC, LOT, EXP: Unknown; "She broke out into hives all over her body" (unspecified if ongoing), notes: NDC, LOT, EXP: Unknown; "Pregnancy" (unspecified if ongoing), notes: Pregnancy 22 weeks, 5 months pregnant. The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "allergic to amoxicillin", notes: NDC, LOT, EXP: Unknown. Vaccination history included: BNT162b2 (Dose: 1), administration date: 24Mar2021, when the patient was 33-year-old, for Covid-19 Immunization, reaction(s): "feeling dizzy", "extremely tired". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "she was exhausted for 4 days and with the second shot, it was the same thing"; CONFUSIONAL STATE (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "a little confused and tired".  Additional information: The other products were not reported. The patient had not the booster shot, she stated that she was going to be getting the booster shot. There was no prior vaccinations (within 4 weeks).   The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: malaise; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 69-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, 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 on 20May2022 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: MALAISE (non-serious), outcome "recovered".  Additional information: 69 years old male patient received 2nd booster experienced malaise for 4 hours after immunization. Recovered to baseline after resting without incident. No fever experienced. Similar previous reaction to covid vaccine. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experienced some arm soreness like all the previous doses; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 47-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 booster, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "experienced some arm soreness like all the previous doses". Additional information she received the second booster dose Pfizer BioNTech Covid vaccine on Monday afternoon around 215 and experienced some arm soreness like all the previous doses. However, she has also been experiencing other side effects such as excessive thirst, diarrhea and lost of appetite (she did not have these side effects with previous doses). Stated that she is not sure that some of the side effects of getting diarrhea. Stated that she did not get this before and wanted to know how long does it last. Wanted to know if this is a normal side effect, how long it lasts and how to treat it. Stated that she had major loss of appetite. Stated that she had the vaccine at 2:15 on Monday and had no side effects until last night. Stated that she had all other Pfizer vaccines.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (PFIZER COVID-19 VACCINE), on 15Feb2021 as dose 2, single (Lot number: EL3247) at the age of 49 years, in left arm and on 26Jan2021 as dose 1, single (Lot number: EL3247), in left arm, all intramuscular for covid-19 immunisation. The patient had no relevant medical history. The patient had no known allergies. The patient did not diagnosed as COVID prior vaccination. There were no concomitant medications. The patient did not receive other vaccine in four weeks or other medications in two weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 25May2022 at 21:00, outcome "recovering" and all described as "Tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive, notes: test type: Nasal swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: and her whole body broke out and she experienced itching which is still persistin; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (COMIRNATY), on 10Jun2021 as dose 2, single (Lot number: EW0180), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Covid-19 first vaccine Manufacture: Pfizer BioNTech: Unknown Lot: EW0183 Expiration: Unknown, Dose given: Unknown;  , Time given: After 3:30 pm , Anatomical location: Right upper arm , Date given: 20May2021), administration date: 20May2021, for COVID-19 immunization, reaction(s): "first shot caused her face to break out.". The following information was reported: PRURITUS (non-serious) with onset Jun2021, outcome "not recovered", described as "and her whole body broke out and she experienced itching which is still persistin".; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200760970 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: discomfort; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Dec2020 as dose 1, single (Lot number: EH9899), in left arm, on 08Jan2021 as dose 2, single (Lot number: EL1284), in left arm and on 03Sep2021 as dose 3 (booster), single (Lot number: EW0151), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: INDERAL; LANSOPRAZOL; ROSUVASTATIN. The following information was reported: DISCOMFORT (non-serious), outcome "unknown".  Additional information: This is the first time that I got this side effects, the first three were great, just a little discomfort.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200764756 Same patient and drug, different event separated in time
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Covid; Covid; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: She also mentioned that both of them are immunocompromised. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Covid".  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-202200769678 Same reporter/vaccine/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: indication=Treatment of COVID-19; indication=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 56-year-old male patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 3 (booster), single (Lot number: EL0142), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Lactose intolerant" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Antibiotics, reaction(s): "some antibiotics get a rash", notes: some antibiotics get a rash. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  No follow-up attempts possible. No further information expected.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 11-year-old male patient received BNT162b2 (BNT162B2), on 05Nov2021 as dose 1, single (Lot number: FK5127) and on 07Dec2021 as dose 2, single (Lot number: FK5618) at the age of 11 years, all intramuscular for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts more than with previous doses.". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient had no known allergies. Patient was not allergic to latex. Prior to vaccination, the patient was not diagnosed with COVID -19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Post vaccination, the patient had not been tested for COVID-19.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Ag test positive; Ag test positive; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 32-year-old female patient received BNT162b2 (BNT162B2), on 15Jul2021 as dose 1, single (Lot number: FA7485) and on 05Aug2021 as dose 2, single (Lot number: EW0198) at the age of 31 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) with onset 26May2022, outcome "unknown", COVID-19 (medically significant) with onset 26May2022, outcome "unknown" and all described as "Ag test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (26May2022) Positive, notes: Nasal Swab; Body temperature: (26May2022) T 103.  Conclusion: This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes // Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the 'One and Done' business process according to in PQS Q1215 and/or Q1252. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the Pfizer biontech covid-19 vaccine injectable lot EW0198 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of complaint history for the reported lot. The final scope was determined to be the reported finished goods lot EW0198, fill lot ET8441, and the formulated drug product lot EP8623. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to 6149611 6148854 the release of the reported batch was within specifications.202200766131 7217670 compound bnt 162 covid-19 vaccine suspension for intramuscul ar 2ml multiple dose VIAL X 1 FM9992 'For this lot Adverse Event Safety Request For Investigation and/or Lack Of Effect was previously investigated. All analytical results were checked and were within registered limits.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events and BNT162B2.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 82-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL9261), in left arm, on 09Feb2021 as dose 2, single (Lot number: EL9264), in left arm, on 01Oct2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm and on 11Apr2022 as dose 4 (booster), single (Lot number: FK9893) at the age of 80 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LATANOPROST, start date: 11Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED 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: Unknown results, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of suspected covid-19.
Age: 37.0
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 37-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 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 was not reported. Concomitant medication(s) included: AMLODIPINE; CITALOPRAM; HYDROCHLOROTHIAZIDE. 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: UNKNOWN RESULT, notes: COVID 19 Treatment; POSITIVE, notes: Covid positive 20 days after recovery after paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product-COVID 19 Treatment, Brand- Paxlovid, Treatment start date: 30Apr2022, Treatment stop date: 04May2022, Indication: Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
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 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 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 and concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19. She was treated with paxlovid (start date- 16May2022 and stop date- 20May2022) for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: Treatment of COVID-19; COVID-19 Infection after immunization; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 28Feb2021 as dose 1, single (Lot number: EN 6202), in right arm, on 21Mar2021 as dose 2, single (Lot number: ER 8727), in right arm, on 09Oct2021 as dose 3 (booster), single (Lot number: FF 8841), in right arm and on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 62 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "afib" (unspecified if ongoing); "known allergies: Shellfish" (unspecified if ongoing), notes: known allergies: Shellfish. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered", described as "Treatment of COVID-19"; COVID-19 (medically significant), outcome "not recovered", described as "COVID-19 Infection after immunization". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear disorder
Clinical narrative: left ear started irritating; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 53-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04May2022 at 13:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 53 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, SINGLE, Manufacturer Unknown), for Covid-19 immunization. The following information was reported: EAR DISORDER (non-serious), outcome "recovered with sequelae", described as "left ear started irritating". It was unknown if therapeutic measures were taken as a result of ear disorder.  Clinical Course: It was reported that about 2 weeks after receiving the vaccine, the patient's left ear started irritating. The patient had not been diagnosed with the COVID prior vaccination. It was unknown if the patient tested for COVID post vaccination. It was unknown if the patient received any other vaccine within four weeks.  No follow-up attempts are possible. No further information expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Pfizer / BioNTech: 26Mar2021, 19Apr2021; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: 26Mar2021, 19Apr2021; Paxlovid: 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 48-year-old male patient received BNT162b2 (BNT162B2), on 26Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 19Apr2021 as dose 2, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 29Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "attention deficit disorder" (unspecified if ongoing); "History of severe bronchitis" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). No known allergies were reported Concomitant medication(s) included: DEXTROAMPHETAMINE [DEXAMFETAMINE], start date: 05Apr2022, stop date: 15May2022.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "not recovered" and all described as "Pfizer / BioNTech: 26Mar2021, 19Apr2021; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of COVID symptoms and positive COVID-19 test after taking a full course of Paxlovid; Negative, notes: testing negative form several days. Therapeutic measures were taken as a result of vaccination failure, covid-19. The Anti-viral Paxlovid was given to patient and the treatment was started on 16May2022 and stopped on 21May2022 for 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody 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 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and on 25Sep2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years, in left arm 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) all with onset 28May2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: Positive; Negative. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Clinical information: Paxlovid rebound. Tested negative for 2 days post-completion of 5 day course of Paxlovid. Tested positive again on post-Paxlovid day 3. The patient started COVID 19 treatment with Paxlovid (Lot number: GA1529) on 20May2022 till 25May2022. No other medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Haematuria
Clinical narrative: Gross hematuria; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 74-year-old male patient received BNT162b2 (BNT162B2), on 25May2022 at 03:45 as dose 3 (booster), single (Lot number: FK9896) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Fish" (unspecified if ongoing), notes: Known allergies: Fish; "COVID-19" (unspecified if ongoing), notes: prior vaccination. The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EK5730, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 22Dec2020, when the patient was 73-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL1283, Location of injection: Arm Left Vaccine Administration Time: 10:00 AM), administration date: 12Jan2021, when the patient was 73-year-old, for COVID-19 Immunization. The following information was reported: HAEMATURIA (medically significant) with onset 27May2022 at 15:00, outcome "unknown", described as "Gross hematuria".  Clinical course: Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. Received other medication within 2 weeks of the vaccination. Event was reported as non-serious, seriousness criteria reported as event was not resulted to death, nor it was life threatening. No prolonged hospitalization, Disabling/Incapacitating.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
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 non-contactable reporter(s) (Physician).  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Crohns disease" (unspecified if ongoing), notes: Crohns disease. The patient's concomitant medications were not reported and no other medications the patient received within 2 weeks of vaccination. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included oral Paxlovid. Clinical course was reported as rebound COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information and possible temporal association the causal relationship between the events and suspect  BNT162B2 cannot be excluded.The case will be reviewed further with FU information. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 60.0
Sex: M
Vaccine: 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 60-year-old male patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose number unknown, single (Lot number: FK9895) at the age of 60 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) all with onset May2022, outcome "unknown" and all described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course information: It was reported that the patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.  Follow-up attempts are completed, no further information is expected.
Age: 41.0
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 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 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: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE; NUVARING. The following information was reported: DRUG INEFFECTIVE (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: (27May2022) Positive, notes: Symptoms came back, and have confirmed positive test (antigen/rapid) on 27May2022; (unspecified date) Unknown Results, notes: indication: Treatment of COVID-19; (23May2022) Negative, notes: After completing the full 5 day course, tested negative on Monday 23May2022. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Anti-viral product included Paxlovid for COVID 19 Treatment from 18May2022 to 22May2022. After completing the full 5 day course, the patient tested negative on Monday 23May2022. Symptoms came back, and patient have confirmed positive test (antigen/rapid) on 27May2022. The patient had other medication in 2 weeks included Jardiance and NuvaRing. No known allergies reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Covid-19; Covid-19; This is a spontaneous report from contactable consumer. The reporter is the patient. A 72-year-old male patient received BNT162b2, on 14Jan2021 as dose 1, single (Lot number: EL3247), in right arm, on 05Feb2021 as dose 2, single (Lot number: EM9810), in right arm, on 14Sep2021 as dose 3 (booster), single (Lot number: FC3183), in right arm and on 07Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "sarcoidosis", non-symptomatic sarcoidosis; "known allergies to sulfa drugs". The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), drug ineffective (medically significant), outcome "recovering" and all described as "Covid-19". Therapeutic measures were taken as a result of covid-19, drug ineffective, which included Pfizer Paxlovid from 17May2022 to 22May2022.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 27Feb2021 as dose 1, single (Lot number: EN6202), in left arm, on 21Mar2021 as dose 2, single (Lot number: ER2613), in left arm and on 30Sep2021 as dose 3 (booster), single (Lot number: FF2587) at the age of 68 years, in left arm for covid-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: ACETAMINOPHEN, start date: 01May2022, also reported as, other medication in 2 weeks. The following information was reported: VACCINATION FAILURE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, suspected covid-19 (Treatment start date: 12May2022, Treatment stop date: 17May2022). Clinical course was reported as, on 19May2022 the patient had rebound after Paxlovid. Patient was recovered and no treatment received for the event.; Sender's Comments:  As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 31.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: ER8729), in left arm and in May2021 as dose 2, single (Lot number: EW0173) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "Vaccine brand other: Moderna, Dose number:3/Vaccine brand: Pfizer/BioNTech, Dose number: 2 And 1." (unspecified if ongoing), notes: Vaccine brand other: Moderna, Dose number:3/Vaccine brand: Pfizer/BioNTech, Dose number: 2 And 1. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "recovered" (May2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (09May2022) Positive; (10May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 11May2022 to 16May2022.
Age: 32.0
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 33-year-old male patient received BNT162b2 (BNT162B2), on 07Nov2021 as dose 3 (booster), single (Lot number: Unknown) at the age of 32 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 29Apr2021 as dose 2, single (Lot number: Unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic (type 1 for 29 years, well controlled)" (unspecified if ongoing). Concomitant medication(s) included: HUMALOG taken for type 1 diabetes mellitus.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovering", and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received treatment from 18May2022 to 23May2022 for COVID-19. other medication in 2 weeks product was Insulin and brand was Humalog. Other medical history includes Diabetic (type 1 for 29 years, well controlled).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.