chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Injection site pain, Pruritus
Clinical narrative: ARM ITCHED; INJECTION SITE SLIGHTLY SORE/IT WAS ARM TO TOUCH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient experienced arm itched and injection site slightly sore/it was arm to touch when treated with influenza vaccine for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced arm itched, and injection site slightly sore/it was arm to touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site slightly sore/it was arm to touch and arm itched was not reported. This report was non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cervical dysplasia, Human papilloma virus test, Smear cervix abnormal
Clinical narrative: low grade squamous intraepithelial lesion; This spontaneous case was reported by a consumer and describes the occurrence of CERVICAL DYSPLASIA (low grade squamous intraepithelial lesion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 prophylaxis.    Co-suspect product included mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 prophylaxis.    The patient's past medical history included Body mass index high.   On 27-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced CERVICAL DYSPLASIA (low grade squamous intraepithelial lesion). At the time of the report, CERVICAL DYSPLASIA (low grade squamous intraepithelial lesion) had resolved with sequelae.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jun-2021, Human papilloma virus test: Positive. On 18-Jun-2021, Smear cervix abnormal: abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was provided by reporter.  No Treatment drug was provided by reporter.
Age: 25.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Headache, Pain
Clinical narrative: achy body; feeling exhausted; headache; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (achy body), FATIGUE (feeling exhausted) and HEADACHE (headache) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.    Co-suspect products included non-company products TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication, TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Previously administered products included for Product used for unknown indication: Influenza vaccine on 18-Nov-2022. Past adverse reactions to the above products included No adverse event with Influenza vaccine.   On 18-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form, second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced PAIN (achy body), FATIGUE (feeling exhausted) and HEADACHE (headache). At the time of the report, PAIN (achy body), FATIGUE (feeling exhausted) and HEADACHE (headache) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that patient was feeling exhausted, with an achy body and a terrible headache. It was unknown if the patient experienced any additional symptoms or events. No treatment medication were provided.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: got a very mild case of Covid19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (got a very mild case of Covid19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Sep-2022, the patient experienced COVID-19 (got a very mild case of Covid19). At the time of the report, COVID-19 (got a very mild case of Covid19) outcome was unknown.      No concomitant medication information was provided. Patient had received first dose of Moderna in January and second dose in July. Patient received the first two Moderna vaccines 6 months apart way back in 2021. Six months later patient took a Moderna booster in December2021. Patient not had another shot since then. Someone visited patient and patient got a very mild case of COVID-19 on 06-Sep-2022. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-675041, US-MODERNATX, INC.-MOD-2022-675042 (E2B Linked Report). This case was linked to MOD-2022-675038 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675041:MOD-2022-675040 (Patient 1 male booster dose case) US-MODERNATX, INC.-MOD-2022-675042:(Patient 1 male booster dose case)
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Insomnia, SARS-CoV-2 test
Clinical narrative: diagnosed to have Covid; unable to sleep; This spontaneous case was reported by a patient and describes the occurrence of INSOMNIA (unable to sleep) and COVID-19 (diagnosed to have Covid) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     The patient had no allergies to medications, food and other products.  The patient's past medical history included Asthma (just childhood asthma which already resolved).    On 24-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Oct-2022, the patient experienced INSOMNIA (unable to sleep). On 31-Oct-2022, the patient experienced COVID-19 (diagnosed to have Covid). The patient was treated with GUAIFENESIN (MUCINEX) at an unspecified dose and frequency; DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) ongoing since an unknown date at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (ZYRTEC DUO) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INSOMNIA (unable to sleep) and COVID-19 (diagnosed to have Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Oct-2022, SARS-CoV-2 test: (Positive) went to the physician and was diagnosed to have Covid..         In Apr-2021, the patient received first dose of Moderna COVID-19 vaccine.  In May-2021, the patient received second dose of Moderna COVID-19 vaccine.  In Oct-2021, the patient received third/first booster dose of Moderna COVID-19 vaccine.  On 24-Oct-2022, the patient received fourth/second booster dose of Moderna COVID-19 vaccine.  On 28-Oct-2022, the patient did not feel well.  On 29-Oct-2022, the patient felt worse.  On 30-Oct-2022, the patient had sore throat, cough and could not sleep. She was sick as a dog.  On 31-Oct-2022, she went to the physician and was diagnosed to have Covid. She was prescribed with Mucinex.  At the time of the call, the patient states that the patient was not getting better and felt to be beaten to death. She was still unable to sleep and was congested (as the patient was only able to sleep for 2-3 hours), and hence felt tired and exhausted. The patient had diarrhea in the morning of 18-Nov-2022.  The patient reported that she understands that she was old but it had been 3-4 weeks and she should be getting better. The symptoms had worsened.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Unknown cause of death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Unknown cause of death) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication was reported. No treatment medication was reported.  Company comment- This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced an unexpected, medically significant death, which occurred at an unknown time with regards to vaccination with a dose of mRNA-1273.222. No further information was provided. Latency between vaccination and the event could not be assessed since vaccination date and onset date of event was not provided. The cause of death is unknown and no autopsy result was disclosed.  The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a male patient of unknown age with no reported medical history, who experienced an unexpected, medically significant death, which occurred at an unknown time with regards to vaccination with a dose of mRNA-1273.222. No further information was provided. Latency between vaccination and the event could not be assessed since vaccination date and onset date of event was not provided. The cause of death is unknown and no autopsy result was disclosed.  The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial").    No concomitant medications were reported.  The adult patient (above 18) inadvertently received Bivalent booster dose from a Moderna "for booster dose only vial" which was intended for pediatric primary series age group 6-11 years old.  No treatment medications were reported.  This case contains information for the 1st of 4th adult patients described by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site induration, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Her arm is still hurting a lot to even lift it.; It's hard in the area and hurting all the way to her shoulder; Arm is still hurting a lot to even lift it; Hurting all the way to shoulder; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Her arm is still hurting a lot to even lift it.), VACCINATION SITE INDURATION (It's hard in the area and hurting all the way to her shoulder), VACCINATION SITE PAIN (Arm is still hurting a lot to even lift it) and ARTHRALGIA (Hurting all the way to shoulder) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 014H22A) for COVID-19 prophylaxis.     Patient had no allergies. Patient had never tested COVID-19 positive.  Previously administered products included for Product used for unknown indication: Janssen (Dose number 1) on 08-May-2021. Past adverse reactions to the above products included No adverse event with Janssen. Concurrent medical conditions included Type II diabetes mellitus, Blood pressure high (High blood pressure) and Spinal osteoarthritis (Arthritis in the spine).    On 17-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 17-Nov-2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Her arm is still hurting a lot to even lift it.), VACCINATION SITE INDURATION (It's hard in the area and hurting all the way to her shoulder), VACCINATION SITE PAIN (Arm is still hurting a lot to even lift it) and ARTHRALGIA (Hurting all the way to shoulder). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Her arm is still hurting a lot to even lift it.), VACCINATION SITE INDURATION (It's hard in the area and hurting all the way to her shoulder), VACCINATION SITE PAIN (Arm is still hurting a lot to even lift it) and ARTHRALGIA (Hurting all the way to shoulder) had not resolved.            No concomitant medications were reported. It was reported that the pain started the night of the injection. AE did not caused patient to seek medical care. Patient had not experienced a similar event in the past. Symptoms were worsened. No treatment details were reported.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose approximately 20 days early; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 32-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event.   On 4th November 2022, the patient received the 2nd dose of Havrix. On 4th November 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 14-NOV-2022. Reporter's Comments:  The nurse had reported the patient received dose two of Havrix approximately 20 days early. The reporter had consented to follow-up Additional supportive information: The patient had received her 2nd dose of Havrix prior to the recommended interval, which had led to shortening of vaccination schedule.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; 4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial"). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial") and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (4 patients inadvertently received  Bivalent booster dose from a Moderna "for booster dose only vial").    No concomitant medications were reported.  The adult patient (above 18) inadvertently received Bivalent booster dose from a Moderna "for booster dose only vial" which was intended for pediatric primary series age group 6-11 yrs old.  No treatment medications were reported.  This case contains information for the 2nd of 4 adult patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-675704, US-MODERNATX, INC.-MOD-2022-675671 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675704:Patient 4 US-MODERNATX, INC.-MOD-2022-675671:Patient 1
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Covid after Moderna Covid-19 vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid after Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced COVID-19 (Covid after Moderna Covid-19 vaccine). At the time of the report, COVID-19 (Covid after Moderna Covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2022, SARS-CoV-2 test: Positive. The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-675643, US-MODERNATX, INC.-MOD-2022-675742 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-675643:Reporter's case US-MODERNATX, INC.-MOD-2022-675742:Crosslink(Other people case) same reporter.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Myocarditis, Wrong product administered
Clinical narrative: her son incorrectly received 1 dose of Trumenba on 13Apr2016. He was not prescribed Trumenba; myocarditis; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 16Nov2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  An 18-year-old male patient received meningococcal group b Rlp2086 (TRUMENBA), on 13Apr2016 as dose 1, single (Batch/Lot number: unknown) at the age of 18 years, in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: WRONG PRODUCT ADMINISTERED (non-serious) with onset 13Apr2016, described as "her son incorrectly received 1 dose of Trumenba on 13Apr2016. He was not prescribed Trumenba"; MYOCARDITIS (medically significant) with onset 2016. It was reported that the reporter's son had myocarditis after receiving the Trumenba vaccine. The reporter asked when might Pfizer begin conducting a study for cardia-related adverse events such as myocarditis for the Trumenba vaccine. Clarified that this event happened in 2016 and was reported to Pfizer by the doctor's office. The reporter also reported this to disease control. Also clarified that the patient incorrectly received one dose of Trumenba on 13Apr2016. The patient was not prescribed Trumenba, it was accidentally administered in place of a different meningitis booster he was supposed to get with an MMR he had received. When the patient had this horrible reaction which was myocarditis, the reporter brought the patient back to the facility and found out that they had given the patient Pfizer Trumenba instead of just a regular meningitis booster shot. The reporter called because she saw on the news that Pfizer and Moderna were going to begin a study of long-term effects of people who developed heart issues after receiving the COVID-19 shot, and specifically said Pfizer. The reporter was thrilled that Pfizer is going to do a study on their COVID-19 vaccine and the young men that have gotten heart problems after the COVID-19 shot because it could possibly give her an idea of what the patient needs to look forward to with this myocarditis even though she knows that Trumenba is a totally different product than the COVID-19 shots. The patient doesn't want vaccinations of any kind because of what happened. The patient was scared. The reporter also clarified that she had no first hand knowledge of any patients that developed heart issues or heart problems after the COVID-19 shot. She was just referring to what was said on the news regarding the study. Outcome of the events was unknown.   The information on the batch/lot number for meningococcal group b Rlp2086 has been requested and will be submitted if and when received.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I tested positive.; I tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Sep2022 at 10:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 72 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: "absence seizures" (unspecified if ongoing); "essential tremor" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE; LAMOTRIGINE; PROPRANOLOL. The following information was reported: COVID-19 (medically significant) with onset 2022, outcome "not recovered", described as "I tested positive"; DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "not recovered", described as "I tested positive.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: indication: Treatment of COVID-19; Negative, notes: Tested negative on Tuesday; positive, notes: The next Sunday my throat hurt again, I tested positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: The patient received treatment of Paxlovid for the reported condition.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 66.0
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 (consumer). 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 06Oct2022 at 12:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 66 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 24Mar2021 as dose 1, single (Lot number: ER2613, Expiration Date: 31Jul2021), in left arm, on 27Apr2021 as dose 2, single (Lot number: EW0175), in left arm, on 10Nov2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: FJ4989), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Known allergies: All Narcotics" (unspecified if ongoing). Concomitant medications included: SYNTHROID, start date: Jan2008; FISH OIL, start date: 10Oct2022, stop date: 18Nov2022; B12 [CYANOCOBALAMIN]; MAGNESIUM CALCIUM; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ASPIRIN BAYER; TURMERIC [CURCUMA LONGA]. Past drug history included: Juniper, reaction: "Known allergies: Juniper". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 07Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (07Nov2022) Positive, notes: A very faint line; (Nov2022) Unknown result, notes: Tested three days in a row; (17Nov2022) Positive, notes: A bright pink line. Therapeutic measures were taken as a result of vaccination failure, COVID-19.  Clinical course: The patient first tested positive for COVID on 07Nov2022 (a very faint line) and received the Paxlovid the same day. She completed the five-day course on 11Nov2022. She then tested three days in a row. But then on 16Nov2022, she began to sneeze and has a runny nose. She tested again on 17Nov2022 as the sneezing got worse and a small cough began; she tested positive again, a bright pink line this time. At the time of reporting, the sneezing and coughing were slightly worse.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Really messed up her cycle; Clarified she is losing a lot of blood and never ever experienced it before the COVID shot/ bleeding more than 7 days; 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 received BNT162b2 (BNT162B2), on 31Oct2021 as dose 1, single (Lot number: 30145BA) at the age of 31 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MENSTRUAL DISORDER (non-serious), outcome "not recovered", described as "Really messed up her cycle"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "not recovered", described as "Clarified she is losing a lot of blood and never ever experienced it before the COVID shot/ bleeding more than 7 days".  Additional Information: She did not have any prior vaccinations within 4 weeks. Ever since she got the COVID shot against her will, it was for her job to keep her job, it has really messed up her cycle. Her cycle usually comes on for 5 to 7 days. She was bleeding more than 7 days, might be up to 14 days or more. It did not start to happen until after she got the COVID shot. She did not have any investigations.
Age: 51.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Ageusia, Nasopharyngeal swab, Off label use, Product use issue
Clinical narrative: I have lost my sense of taste.; Flucelvax quad: 15Nov2022, Pfizer Dose 4: 15Nov2022; Flucelvax quad: 15Nov2022, Pfizer Dose 4: 15Nov2022; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Nov2022 at 10:00 as dose 4 (booster), single (Lot number: G56796) at the age of 51 years, in right arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 15Nov2022 as dose 1, single (Lot number: 70461032203), in left arm for immunisation. The patient's relevant medical history included: "General Anxiety" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE; CLONAZEPAM; XYZAL. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: Unknown. Looks like ER8737, Location of injection: Arm Right), administration date: 05Apr2021, when the patient was 50-year-old, for COVID-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: Unknown. Looks Looks like, EW0173, Prev dose vaccine location= Right arm), administration date: 05May2021, when the patient was 50-year-old, for Covid-19 immunization; BNT162b2 (Dose Number: 3, Batch/Lot No: Unknown. Looks like, FK or HC then 9893, Location of injection: Arm Right), administration date: 08Apr2022, when the patient was 51-year-old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 15Nov2022, outcome "unknown" and all described as "Flucelvax quad: 15Nov2022, Pfizer Dose 4: 15Nov2022"; AGEUSIA (non-serious) with onset 17Nov2022 at 15:00, outcome "not recovered", described as "I have lost my sense of taste.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of ageusia.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise, Maternal exposure during pregnancy, Pain
Clinical narrative: Fever; sore arm; body aches; chills; joint pain; injection site pain; feel unwell; Patient is currently pregnant, she is 35 weeks; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 19Nov2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Pregnancy" (ongoing). Date of last menstrual period: 21Mar2022. The patient was 34 weeks pregnant at the time of exposure to BNT162b2. The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver a baby(s). Concomitant medication(s) included: METFORMIN; PRENATAL + DHA; VITAMIN D [ERGOCALCIFEROL]; WELLBUTRIN; INSULIN. Past drug history included: Tramadol, reaction(s): "Drug Allergy". The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 19Nov2022 at 12:00, outcome "unknown", described as "Patient is currently pregnant, she is 35 weeks"; PYREXIA (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered"; MALAISE (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "feel unwell"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "injection site pain"; ARTHRALGIA (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "joint pain"; PAIN IN EXTREMITY (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "sore arm". Therapeutic measures were not taken as a result of pyrexia, pain in extremity, pain, chills, arthralgia, vaccination site pain, malaise.  Additional information: Patient was pregnant at time of vaccination Patient did not receive any other vaccine in four weeks (as reported). Patient received other vaccine (not specified) on same date 19Nov2022 in right arm. If covid prior vaccination and if covid tested post vaccination reported as no. The gestation period of patient reported as 36.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Fever; sore arm; body aches; chills; joint pain; injection site pain; feel unwell; Patient is currently pregnant, she is 35 weeks; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 36-year-old female patient (pregnant) received BNT162b2 (BNT162B2), on 19Nov2022 at 12:00 as dose 1, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "asthma" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "Pregnancy" (ongoing). Date of last menstrual period: 21Mar2022. The patient was 34 weeks pregnant at the time of exposure to BNT162b2. The patient was 35 weeks pregnant at the event onset. The patient is expected to deliver a baby(s). Concomitant medication(s) included: METFORMIN; PRENATAL + DHA; VITAMIN D [ERGOCALCIFEROL]; WELLBUTRIN; INSULIN. Past drug history included: Tramadol, reaction(s): "Drug Allergy". The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 19Nov2022 at 12:00, outcome "unknown", described as "Patient is currently pregnant, she is 35 weeks"; PYREXIA (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "Fever"; PAIN (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "body aches"; CHILLS (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered"; MALAISE (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "feel unwell"; VACCINATION SITE PAIN (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "injection site pain"; ARTHRALGIA (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "joint pain"; PAIN IN EXTREMITY (non-serious) with onset 20Nov2022 at 04:00, outcome "not recovered", described as "sore arm". Therapeutic measures were not taken as a result of pyrexia, pain in extremity, pain, chills, arthralgia, vaccination site pain, malaise.  Additional information: Patient was pregnant at time of vaccination Patient did not receive any other vaccine in four weeks (as reported). Patient received other vaccine (not specified) on same date 19Nov2022 in right arm. If covid prior vaccination and if covid tested post vaccination reported as no. The gestation period of patient reported as 36.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Congestive cardiomyopathy, Gene mutation
Clinical narrative: Dilated Cardiomyopathy with mutated gene FLNC,; mutated gene FLNC; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old male patient received BNT162b2 (BNT162B2), on 02Apr2021 as dose 2, single (Lot number: ER8730) at the age of 43 years, in left arm for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6204, Location of injection: Arm Left), administration date: 12Mar2021, when the patient was 43-year-old, for COVID-19 immunization. The following information was reported: CONGESTIVE CARDIOMYOPATHY (hospitalization, medically significant) with onset 27Apr2022 at 13:15, outcome "not recovered", described as "Dilated Cardiomyopathy with mutated gene FLNC,"; GENE MUTATION (hospitalization) with onset 27Apr2022 at 13:15, outcome "not recovered", described as "mutated gene FLNC". The patient was hospitalized for congestive cardiomyopathy, gene mutation (hospitalization duration: 4 day(s)). The events "dilated cardiomyopathy with mutated gene flnc," and "mutated gene flnc" required emergency room visit. Therapeutic measures were taken as a result of congestive cardiomyopathy, gene mutation. Clinical information: Dilated Cardiomyopathy with mutated gene FLNC, the only thing that may of triggered the gene mutation how enlarged my heart is and the time frame sort of points to the vaccine because I really didn't have any other sickness, not totally saying it was the vaccine for sure but you also can't deny it wasn't. The adverse events treatment was Medication. Patient not received other vaccine in four weeks, other medications in not received in two weeks, no covid prior vaccination, no covid tested post vaccination. No history of known allergies.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
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 62-year-old male patient received BNT162b2 (BNT162B2), on 17Jun2022 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 61 years, in left arm, as dose number unknown (booster), single (Batch/Lot number: unknown), in right arm, as dose 2, single (Batch/Lot number: unknown), in left arm and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Lost spleen in 2001", start date: 2001 (unspecified if ongoing), notes: Lost spleen in 2001; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical courses: It was unknown if patient received other medication in 2 weeks. Treatment with anti-viral (Brand: Paxlovid) was started on 12Nov2022 and stopped on 16Nov2022 for COVID-19. Symptoms returned two days after second negative test.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; COVID vaccine details: Moderna Dose 4, Pfizer dose 1,2,3; 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 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Apr2021 as dose 1, single (Lot number: ER8729), in left arm, on 05May2021 as dose 2, single (Lot number: EW0173), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: fj8787) at the age of 48 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 06Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa antibiotics" (unspecified if ongoing), notes: Known allergies: Sulfa antibiotics. The patient's concomitant medications were not reported.  The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 06Sep2022, outcome "unknown", described as "COVID vaccine details: Moderna Dose 4, Pfizer dose 1,2,3"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) Positive, notes: Tested positive, again after 3 days of negative tests; (Nov2022) Negative, notes: Tested positive, again after 3 days of negative tests; (Nov2022) Negative, notes: Tested positive, again after 3 days of negative tests; (Nov2022) Negative, notes: Tested positive, again after 3 days of negative tests. Therapeutic measures were taken as a result of vaccination failure, covid-19. No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 at 10:00 as dose 5 (booster), single (Lot number: GH97034) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Lot number: GL8982), in left arm, on 04Feb2021 as dose 2, single (Lot number: En9581), in left arm, on 25Sep2021 as dose 3 (booster), single (Lot number: EW0187), in left arm and on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ACETAMINOPHEN, start date: 01Aug2022. The patient has no known allergies. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 79-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 14Jan2021 as dose 1, single (Batch/Lot number: unknown), on 04Feb2021 as dose 2, single (Batch/Lot number: unknown), on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 04Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hyperlipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "chronic anxiety" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: ESCITALOPRAM; HYDROCHLOROTHIAZIDE; ATORVASTATIN, stop date: 06Nov2022; LATANOPROST ophthalmic. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, 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.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect products BNT162b2, BNT162b2 omi ba.4-5 cannot be fully excluded.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 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's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with treatment start date was 09Nov2022 and stop date was 14Nov2022.  Clinical course: The patient did not receive other medications within 2 weeks. Vaccine lot unknown reason was not available/provided to reporter at the time of report completion,   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 in the case, the causal association between the events 'drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter (Consumer) from product quality group. The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 20Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 66 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 23Mar2021 as dose 1, single (Lot number: ER8730), in right arm, on 13Apr2021 as dose 2, single (Lot number: EW0164), in right arm and on 01Apr2022 as dose 3 (booster), single (Lot number: FJ9943), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: penicillin" (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 19Nov2022 at 07:30, outcome "not recovered" and all described as "COVID 19". Therapeutic measures were taken as a result of vaccination failure, covid-19.  No follow-up attempts are possible. No further information is expected.