chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
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) (Physician). The reporter is the patient.  A 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 67 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), 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 included: "drug allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: (30Jan2023) Positive; (31Jan2023) Positive; (unspecified date) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Clinical course: She have had 5 Pfizer vaccines. She is a physician and a patient who took Paxlovid orally from 26Jan2023 to 30Jan2023 as COVID 19 Treatment. Other medical history many too many to list, given shortage of time. known allergies: she have many drug allergies, but she do not think that she had an allergic reaction to Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: The reported COVID-19 positive after BNT162b2, BNT162b2 omi ba.4-5 immunization is considered ineffective of suspects, and the Company cannot completely exclude the possible causality between the reported events and BNT162b2, BNT162b2 omi ba.4-5 administration.
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Myocardial infarction
Clinical narrative: Heart attack; Appendicitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2 NOS), 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; APPENDICITIS (medically significant), outcome "unknown". Clinical course: Reporter wanted to know if there was a product that can alleviate the symptoms, or she enquired it just pushing the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
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 a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 15:00 as dose number unknown (booster), single (Lot number: GH9693) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Mixed connective tissue disease" (unspecified if ongoing). Concomitant medication(s) included: METHOTREXATE, start date: Jun2010; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE], start date: Jun2010; EFFEXOR, start date: Jun2012. Past drug history included: Sporanox, reaction(s): "known allergies: sporanox", notes: known allergies: sporanox. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (04Feb2023) Negative, notes: I tested negative for COVID in the morning of 04feb and 05Feb but tested positive this morning, 06Feb; (05Feb2023) Negative, notes: I tested negative for COVID in the morning of 04feb and 05Feb but tested positive this morning, 06Feb; (06Feb2023) Positive, notes: I tested negative for COVID in the morning of 04feb and 05Feb but tested positive this morning, 06Feb.  Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COVID; got COVID; This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group.  A 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Sep2022 as dose 4 (booster), single (Lot number: GJ6742) at the age of 42 years intramuscular, 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'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 04Feb2023, outcome "not recovered" and all described as "got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Feb2023) Negative, notes: Nasal Swab; (04Feb2023) Positive, notes: Nasal Swab; (05Feb2023) Positive, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported event drug ineffective and COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Pfizer COVID shots: got COVID; Pfizer COVID shots: got COVID; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 84-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 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 "Pfizer COVID shots: got COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: just the results that she had COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Ultrasound scan, Vaccination failure
Clinical narrative: I was diagnosed with Covid on 09Nov2022; I was diagnosed with Covid on 09Nov2022; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 29-year-old female patient received BNT162b2 (BNT162B2), on 30Jun2021 as dose 1, single (Lot number: EW0187), on 22Jul2021 as dose 2, single (Lot number: EW0187) and on 09Feb2022 as dose 3 (booster), single (Lot number: 084J21A) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Bipolar II disorder" (unspecified if ongoing); "Generalized Anxiety Disorder" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SEROQUEL, start date: 27Sep2021; LAMOTRIGINE, start date: 12Apr2021; LEVOTHYROXINE, start date: 12Jul2021.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 09Nov2022, outcome "unknown" and all described as "I was diagnosed with Covid on 09Nov2022". The event "i was diagnosed with covid on 09nov2022" required emergency room visit. The patient underwent the following laboratory tests and procedures: Ultrasound scan: (14Sep2022) Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid.; Sender's Comments: Based on the available information in the case, the causal association between the events vaccination failure, COVID-19 and the suspect drug cannot be excluded.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Ultrasound scan
Clinical narrative: miscarried; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 28-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 22Jul2021 as dose 2, single (Lot number: EW0187) at the age of 28 years for covid-19 immunisation. The patient's relevant medical history included: "Subclinical Hypothyroidism" (unspecified if ongoing), notes: Subclinical Hypothyroidism diagnosed during pregnancy; "Bipolar II" (unspecified if ongoing); "Generalized Anxiety Disorder" (unspecified if ongoing); "Known allergies Penicillin" (unspecified if ongoing). Date of last menstrual period: 11Jun2021. The patient was 5 weeks pregnant at the time of exposure to BNT162b2. The patient was 6 weeks pregnant at the event onset. The patient is expected to deliver one baby(s) on 18Mar2022. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose product=COVID 19, brand=Pfizer, lot number=EW0187, date=30Jun2021, DOSE 1, SINGLE), administration date: 30Jun2021, when the patient was 28-year-old, for Covid-19 Immunization. The following information was reported: ABORTION SPONTANEOUS (medically significant) with onset 22Jul2021, outcome "unknown", described as "miscarried". The pregnancy resulted in spontaneous abortion. The patient underwent the following laboratory tests and procedures: Ultrasound scan: I had indeed miscarried, notes: At subsequent visits this was also true - this was done to confirm via ultrasound that I had indeed miscarried. Therapeutic measures were not taken as a result of abortion spontaneous.  Additional information: "I received my first dose of the Pfizer Covid-19 vaccine when I did not realize I was pregnant on 30Jun2021. I would then have my second dose on 22Jul2021 at exactly when my baby would have been 6 weeks old. When I went in for my first OBGYN appointment, my baby had stopped growing at 6 weeks. At subsequent visits this was also true - this was done to confirm via ultrasound that I had indeed miscarried." Patient did not had covid prior vaccination.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event miscarriage and the use of suspect product cannot be fully excluded. 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: 54.0
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) (Nurse). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Oct2022 as dose 5 (booster) single (Lot number: CJ3275) at the age of 54 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Jun2022 as dose 4 (booster), single (Lot number: FM0173), in right 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's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "GERD" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "Trigeminal Neuralgia" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Chronic Pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, 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: the patient received Paxlovid from 20Jan2023 to 24Jan2023 for COVID-19 treatment.; Sender's Comments: Based on the available information in the case, the causal association between the events drug ineffective COVID-19 and the suspect drugs cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, 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 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), in Oct2022 as dose 4 (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: "Crohn's disease" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Depression" (unspecified if ongoing); "known allergies: Cows milk" (unspecified if ongoing); "known allergies: Pennicillian" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE, start date: 10Mar2022. Past drug history included: Imuran, reaction(s): "known allergies: Imuran"; Ammoxicillian, reaction(s): "known allergies: Ammoxicillian"; Pentasa, reaction(s): "known allergies: Pentasa". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) 101.0+; SARS-CoV-2 test: (27Jan2023) Positive, notes: covid test positive 27Jan2023. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received Moderna Bi-Valent at 01:00 PM. Covid symptoms started 25Jan2023 with a sore throat, covid test positive 27Jan2023. Started Paxlovid 27Jan2023.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 58.0
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 non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Nov2022 as dose 5 (booster), single (Lot number: GJ6796) at the age of 58 years 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), 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (30Jan2023) Negative, notes: Tested negative for Covid-19 on 30Jan2023; (04Feb2023) Positive, notes: Tested positive again for Covid-19 on  04Feb2023. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with paxlovid from 25Jan2023 to 29Jan2023. The patient had no known allergies, did not report administration of any concomitant medication within 2 weeks of Paxlovid therapy.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300058285 Same patient, different product and event;
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9693) at the age of 63 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), 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 included: "Osteoporosis" (unspecified if ongoing), notes: other medical history: Osteoporosis; "known allergies: Can't take aspirin (1 kidney)" (unspecified if ongoing), notes: known allergies: Can't take aspirin (1 kidney). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Can't take aspirin (1 kidney)", notes: known allergies: Can't take aspirin (1 kidney). 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. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient received treatment with paxlovid from 27Jan2023 to 01Feb2023. The patient did report administration other medication as ORACEA (doxycycline) and vitamin D within 2 weeks of paxlovid therapy.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: l lost my friend; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 34-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "l lost my friend". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed.  Clinical Course: Reporter reported that, he lost his friend. He lost him at 34 years old, he was like a brother to him. (Caller would not let this agent speak, to find out if his friend had taken the Pfizer Covid 19 vaccine or not). Not sure this was related to Pfizer vaccine.    No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: l lost my friend
Sex: F
Vaccine: COVID19
Symptoms: Colon cancer stage IV
Clinical narrative: I know a woman who has stage 4 colon cancer; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2 NOS), 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: COLON CANCER STAGE IV (medically significant), outcome "unknown", described as "I know a woman who has stage 4 colon cancer".  Clinical Course: The caller provided that he worked for the government in IT and he was very concerned because he had been researching products and the other day he saw PhD (Name withheld), professor with was an analytics professional in healthcare, provide a statement that said that was the worst roll out of a drug since the invention of drugs and should be stopped immediately. It was very dangerous. The caller stated that in 2016, the government took 200 thousand men and vaccinated them with mRNA, not containing a virus, in which the vaccine made their heart stop at least once. The caller stated that these drugs should not be allowed in the public. The drugs were making people infertile, causing myocarditis, pericarditis, blood clots and things like that. Those drugs carry the same load and those drugs had been seen before. The caller stated they stopped an entire flu over two dead German shepherds. The caller stated that Pfizer needed to fear for Private as they have made an article 1 that was published. Caller stated that he never saw a label for Comirnaty and the concoction did not pass legal ramifications in 49/50 stated as it had to pass two things. 1. It had to be made from the virus, and 2. it had to keep you from getting said virus, which it did not. Upon asking if caller had any MI questions, caller declined and then said yes. The caller know people who have had heart attacks, strokes, and died from it. The caller knew a woman who had stage 4 colon cancer. If they were a Christian person, you're going to burn in hell. MI agent asked caller for MI questions again, caller stated yes and continue to ramble on, with no MI questions. Caller was warned about disconnection, and caller proceeded to cuss at the agent. Disconnection was performed by MI agent. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 at 18:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 30 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's relevant medical history included: "Overweight (BMI around 28)" (unspecified if ongoing); "BMI around 28" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. 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: Positive, notes: first time testing since originally testing positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: product was COVID 19 Treatment, brand=Paxlovid, treatment start date at 29Jan2023, treatment stop date at 02Feb2023. other medication in 2 weeks: Yes. Known allergies: No.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Coma
Clinical narrative: coma; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 manufacturer unknown), for COVID-19 immunization. The following information was reported: COMA (medically significant), outcome "unknown".  Clinical information: Caller seemed upset regarding the Pfizer COVID 19 vaccine saying this is not truly a vaccine. That is just kicked you guys out and said that you're going to pay for his daughter who is in a coma since she took her second Pfizer shot. It doesn't even work, it doesn't prevent COVID. You don't even know what's in the vaccine.  No Follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: PNC20
Symptoms: Incorrect dose administered, Laboratory test abnormal
Clinical narrative: some labs that are 1 point outside of the normal range; second dose of Prevnar 20 vaccine was given to a patient; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team,.  An 80-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 31Jan2023 at 09:38 as dose 2, 0.5 ml single (Lot number: GL3699, Expiration Date: 31Jul2024) at the age of 80 years, in right deltoid for immunisation. The patient's relevant medical history included: "Pancreatic mass"; "stage 3 chronic kidney disease"; "Dermatitis"; "nodule of middle lobe of right lung"; "overweight", start date: 06Sep2022, notes: BMI 25-29; "Covid 19", start date: 04Jan2023; "acute cystitis", start date: 06Jan2023; "hematuria", start date: 06Jan2023; "obstructive sleep apnea on CPAP", notes: Obstructive sleep apnea on CPAP; "GERD"; "coronary artery disease"; "Mixed hyperlipidemia"; "Anxiety"; "type 2 diabetes"; "insomnia due to medical condition"; "coronary bypass graft of native heart without angina pectoris"; "CPAP". The patient's medical history, reported also as family history: "Primary hypertension". Concomitant medication(s) included: NEXIUM [ESOMEPRAZOLE SODIUM] oral taken for gastrooesophageal reflux disease (ongoing); AMLODIPINE oral taken for essential hypertension (ongoing); ASPIRIN [ACETYLSALICYLIC ACID] oral taken for coronary artery disease (ongoing); ATORVASTATIN oral taken for type v hyperlipidaemia, start date: 14Aug2017 (ongoing); BUSPIRONE oral taken for anxiety, start date: 16Apr1021 (ongoing); CHLORTHALIDONE oral taken for essential hypertension, start date: 27Aug2022 (ongoing); Q10+VIT.E, start date: 12Sep2017 (ongoing); GLIPIZIDE oral taken for type 2 diabetes mellitus, start date: 05Sep2017 (ongoing); LOSARTAN oral taken for essential hypertension, start date: 16Apr2021 (ongoing); METOPROLOL TARTRATE oral taken for essential hypertension, start date: 01Jul2017 (ongoing); JANUVIA oral taken for type 2 diabetes mellitus, start date: 15Jun2022 (ongoing); ZOLPIDEM oral taken for sleep disorder due to a general medical condition, start date: 15Aug2017 (ongoing). Vaccination history included: prevnar 13, administration date: 20Jul2018, for immunisation; prevnar 20 (DOSE 1, lot number: FW2328, 0.5 ml in left arm), administration date: 15Sep2022, for immunisation. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious) with onset 31Jan2023 at 09:38, outcome "unknown", described as "second dose of Prevnar 20 vaccine was given to a patient"; LABORATORY TEST ABNORMAL (non-serious), outcome "unknown", described as "some labs that are 1 point outside of the normal range". Relevant laboratory tests and procedures are available in the appropriate section.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Moderna Dose Number: 3, Date: 17Mar2022 ; Pfizer / BioNTech, Date: 23Oct2021; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Oct2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 64 years for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 11Jan2021 as dose 1, single (Lot number: 039K20A), on 08Feb2021 as dose 2, single (Batch/Lot number: unknown) and on 17Mar2022 as dose 4 (booster), single (Lot number: 026L21b) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Oct2021, outcome "unknown", described as "Moderna Dose Number: 3, Date: 17Mar2022 ; Pfizer / BioNTech, Date: 23Oct2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: had tested negative on day 9, then tested positive again after being negative for 2 days; Negative, notes: had tested negative on day 9, then tested positive again after being negative for 2 days; Positive, notes: then tested positive again after being negative for 2 days; Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: No other medical history and known allergies were reported. The patient did not receive other medication in 2 weeks. The patient received treatment with Paxlovid from 29Jan2023 to 04Feb2023.; Sender's Comments: Based on available information and the temporal association, a possible contributory role of Comirnaty vaccine cannot be excluded for the reported events of " INTERCHANGE OF VACCINE PRODUCTS "," DRUG INEFFECTIVE ' and "COVID-19 ".
Age: 77.0
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 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 at 10:30 as dose 5 (booster), single (Lot number: GH9694) at the age of 77 years, in left arm for covid-19 immunization; BNT162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 02Mar2021 as dose 2, single (Lot number: EN6201), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: FE3184), in left arm and on 03Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunization. The patient's relevant medical history included: "restless leg syndrome" (unspecified if ongoing); "Known allergies: yes - sulfa drugs" (unspecified if ongoing), notes: Known allergies: yes - sulfa drugs; "Known allergies: shrimp" (unspecified if ongoing), notes: Known allergies: shrimp; "Known allergies: yes - kiwi fruit" (unspecified if ongoing), notes: Known allergies: yes - kiwi fruit; "Known allergies: yes - hazelnuts" (unspecified if ongoing), notes: Known allergies: yes - hazelnuts; "Known allergies: yes - gluten" (unspecified if ongoing), notes: Known allergies: yes - gluten. Concomitant medication(s) included: PRAMIPEXOLE, start date: 01Jan2005, stop date: Feb2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), all with latency 4 months 23 days 6 hrs after the suspect product(s) administration, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Sex: F
Vaccine: PNC13
Symptoms: Chronic obstructive pulmonary disease, Disease recurrence, Drug ineffective, Pneumonia
Clinical narrative: I had 1 prevnar 13 shot around 2014. I have had pneumonia a couple of times; I had 1 prevnar 13 shot around 2014. I have had pneumonia a couple of times; I had 1 prevnar 13 shot around 2014. I have had pneumonia a couple of times; COPD on oxygen and use inhalers; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2014 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant), DISEASE RECURRENCE (medically significant), outcome "unknown" and all described as "I had 1 prevnar 13 shot around 2014. I have had pneumonia a couple of times"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (medically significant), outcome "unknown", described as "COPD on oxygen and use inhalers". Therapeutic measures were taken as a result of chronic obstructive pulmonary disease.  Additional information: Patient had 1 Prevnar 13 shot around 2014. Patient had pneumonia a couple of times and had COPD. Patient was on oxygen and use inhalers. Patient asked her PCP and her pulmonary doctor if she should have the pregnancy 20 shot (as reported) but neither of them could give an answer. Patient was asking what would be the recommendation.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Investigation
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 74-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). 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". The patient underwent the following laboratory tests and procedures: Laboratory test: (Jun2022) unknown results, notes: Laboratory test, consumer stated, "It happened while back it didn't happened recent, it happen in June. Therapeutic measures were taken as a result of covid-19.  Clinical course: It was reported that she wanted to report about bad side effect but she wanted to continue what else has happened this was like in June of last this past year, prior august, September. The patient reported that she was not 75 years old at the time she was 74 years old. Now she was 75 years. About product details she replied she threw it away. She did not have it. It would be on the insert that was in it or it would be on the outside of the package. She probably had the insert but she threw the package. The patient received unspecified concomitant medication which she was taking over the counter. Regarding laboratory test he patient stated It happened while back it did not happened recent, it happen in June. Not in two past week, no. The patient received Paxlovid treatment and she went to physical therapist three different times.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; Moderna, Dose Number: 1, Dose Number: 2; Pfizer / BioNTech, Dose Number: 3, Dose Number: 4; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Lot number: 9J6239) at the age of 41 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Dec2021 as dose 3 (booster), single (Lot number: FF2593), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Mar2021 as dose 1, single (Lot number: 039A21A), in left arm and on 24Apr2021 as dose 2, single (Lot number: 009C21A), in left arm. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Dec2021, outcome "unknown", described as "Moderna, Dose Number: 1, Dose Number: 2; Pfizer / BioNTech, Dose Number: 3, Dose Number: 4"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) positive, notes: COVID 19 Treatment; (07Feb2023) positive, notes: positive COVID test for myself. Therapeutic measures were taken as a result of drug ineffective, covid-19: the patient received Paxlovid from 24Jan2023 to 29Jan2023 for COVID-19 treatment. The patient had the following symptoms: congestion, runny nose, lethargic.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
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 67-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 29Sep2022 at 12:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), 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 had no relevant medical history. Concomitant medication(s) included: LEVOTHYROXINE, start date: May1999, stop date: 07Feb2023. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID 19 Treatment with Paxlovid, Treatment start date: 28Jan2023, Treatment stop date: 03Feb2023, Patient had no Known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 49 years for covid-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Hydromorphone, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant) with onset Jan2023, outcome "unknown", COVID-19 (medically significant) with onset Jan2023, outcome "recovering" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, COVID-19: the patient received Paxlovid from 28Jan2023 to 03Feb2023 for COVID-19 treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events with the suspect drug BNT162B2, BNT162B2 OMI BA.4-5 cannot be excluded. The case will be reassessed once new information is available.
Age: 66.0
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) from product quality group. The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Oct2022 at 10:00 as dose 4 (booster), single (Lot number: En3275) at the age of 66 years, in right 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's relevant medical history included: "allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19: Paxlovid. No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 76-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 29Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "Prediabetes" (unspecified if ongoing); "h/o TIA" (unspecified if ongoing); "Chronic cough" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (05Feb2023) Positive, notes: positive at home covid test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient taking any other medications/products within 2 weeks of starting COVID-19 treatment yes, patient previously receive a COVID-19 Vaccine yes, Product COVID 19 Treatment start date 24Jan2023, stop date 29Jan2023, Device Date 07Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2  to the reported events drug ineffective, COVID-19 cannot be ruled out.
Age: 76.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Oct2022 as dose 4 (booster), single at the age of 76 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 26Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 03Dec2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Obesity" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (31Jan2023) Negative, notes: Test negative 31Jan2023; (03Feb2023) Positive, notes: Tested positive 03Feb2023; (04Feb2023) Positive, notes: Tested positive 04Feb2023. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Additional information: Patient was treated with anti-viral PAXLOVID from 25Jan2023 to 29Jan2023. Test negative 31Jan2023. Felt sick again 02Feb2023, tested positive 03Feb2023 with stuffy nose, coughing, chills, body aches; Tested positive 04Feb2023 with all previous symptoms. 07Feb2023 feeling better but tired, coughing and short of breath after walking.   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
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 43-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history 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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid, Treatment start date: 27Jan2023, Treatment stop date: 31Jan2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.