chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnic origin. Initial information was processed along with the additional information received on 16-AUG-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: spondyloarthropathy (seronegative), and allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 042A21 A, and expiry: unknown) dose was not reported, 1 in total was administered on 01-APR-2021 for covid-19 prophylaxis. The patient received additional booster dose non-company suspect vaccine Pfizer BioNtech covid-19 vaccine (tozinameran) (dose number in series 2), (suspension for injection, route of admin not reported, and batch number: 3203080, expiry: unknown) dose was not reported, administered on 25-OCT-2021 for covid-19 prophylaxis. Concomitant medications included ascorbic acid, famotidine, macrogol, melatonin, and omeprazole. The patient was treated with Paxlovid (form of administration and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 24-MAY-2022 to 28-MAY-2022 for treatment of COVID-19. The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. On 31-MAY-2022, the patient experienced a rebound Covid infection after taking Paxlovid, and tested positive again 03-JUN-2022 (confimed covid-19 infection) (dose number in series 2) which led to confirmed clinical vaccination failure (dose number in series 1).  On 03-JUN-2022, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable, Pfizer BioNtech covid-19 vaccine (tozinameran) was not applicable and with paxlovid was drug discontinued. The patient recovered from confirmed covid-19 infection on JUN-2022, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000246582.; Sender's Comments: V0: 20220832201-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINE FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a other company concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and allergy (Unspecified). The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, dose 1, 1 in total, administered in left arm on 23-APR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose was not reported, dose 2, 1 in total, administered in right arm on 13-NOV-2021 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 2022 (Date and month unspecified), the patient experienced covid and tested positive which was confirmed covid-19 infection and confirmed clinical vaccine failure (Dose number in series: 2). Laboratory data included: COVID-19 virus test Positive The patient received non-company suspect drug Paxlovid (form of admin, route of admin were not reported, batch number: Unknown and expiry: Unknown) dose was not reported, administered from 13-JUL-2022 to 17-JUL-2022 for treatment of COVID-19. On 2022 (Date and month unspecified), the patient tested negative 7 day (unspecified) after testing positive. Laboratory data included: COVID-19 virus test Negative. On 2022 (Date and month unspecified), the patient had rebound case which tested positive again 14 day (unspecified) after negative test. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Paxlovid was not reported. The patient was recovering from confirmed covid-19 infection, and the outcome of confirmed clinical vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint and reference number requested.; Sender's Comments: V0: 20220837895-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccine failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Influenza like illness, Pain in extremity
Clinical narrative: Was not feeling good/He was down; Felt like he had the flu; Had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm). At the time of the report, FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported by reporter.  Patient reported of not seen a doctor.  No treatment medication was reported by reporter.  Patient said he was sick for 2 days meaning he was down, wasn't feeling good, felt like he had the flu, & had a sore arm when he got the doses.   This case was linked to MOD-2022-629960 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Dyspepsia, Dyspnoea, Feeling abnormal
Clinical narrative: Was not feeling good/He was down; Felt like he had the flu; Had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm). At the time of the report, FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported by reporter.  Patient reported of not seen a doctor.  No treatment medication was reported by reporter.  Patient said he was sick for 2 days meaning he was down, wasn't feeling good, felt like he had the flu, & had a sore arm when he got the doses.   This case was linked to MOD-2022-629960 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Head injury, Headache, Hyperhidrosis, Influenza like illness, Loss of consciousness
Clinical narrative: Was not feeling good/He was down; Felt like he had the flu; Had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm). At the time of the report, FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported by reporter.  Patient reported of not seen a doctor.  No treatment medication was reported by reporter.  Patient said he was sick for 2 days meaning he was down, wasn't feeling good, felt like he had the flu, & had a sore arm when he got the doses.   This case was linked to MOD-2022-629960 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Palpitations, Prostatic disorder
Clinical narrative: Was not feeling good/He was down; Felt like he had the flu; Had a sore arm; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm). At the time of the report, FEELING ABNORMAL (Was not feeling good/He was down), INFLUENZA LIKE ILLNESS (Felt like he had the flu) and PAIN IN EXTREMITY (Had a sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported by reporter.  Patient reported of not seen a doctor.  No treatment medication was reported by reporter.  Patient said he was sick for 2 days meaning he was down, wasn't feeling good, felt like he had the flu, & had a sore arm when he got the doses.   This case was linked to MOD-2022-629960 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced UNDERDOSE (The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (The patient received 0.15 ml dose of the Moderna COVID-19 vaccine instead of 0.25 ml dose).    Concomitant drugs were not reported.  It was reported that they had an issue and they incorrectly drawled up the doses. The patient had received lower-than-authorized doses.  Treatment medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2022: Follow up received included significant information: Case report type was updated, reporter first name was updated, patient details were added, Suspect vaccine dose number was added, dose description was updated and narrative updated.
Sex: F
Vaccine: COVID19
Symptoms: Melanocytic naevus
Clinical narrative: Was diagnosed with Halo Nevi; This spontaneous case was reported by a patient and describes the occurrence of MELANOCYTIC NAEVUS (Was diagnosed with Halo Nevi) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 001A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy (Allergy since patient was a kid.).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MELANOCYTIC NAEVUS (Was diagnosed with Halo Nevi). At the time of the report, MELANOCYTIC NAEVUS (Was diagnosed with Halo Nevi) outcome was unknown.            Patient's birth year was provided as 1959.  No concomitant medication were given.  Halo Nevi which patient said was an auto immune disease in which white spots around the moles and skin eats the moles.   No treatment information were given.   This case was linked to MOD-2022-629961 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; apparently for her 3rd shot patient received a booster instead of a full dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (apparently for her 3rd shot patient received a booster instead of a full dose) and NO ADVERSE EVENT (No adverse event) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (gluten), Sjogren's syndrome, Polyarthropathy, Allergic reaction to antibiotics (Sulfas), Drug allergy (Amlodipine), Drug allergy (Cymbalta), Drug allergy (Lyrica), Drug allergy (Atorvastatin), Allergy to vaccine (influenza vaccine), Drug allergy (Gabapentin), Allergic reaction to analgesics (Hydrocodone), Drug allergy (Lisinopril), Drug allergy (NSAIDs), Allergic reaction to analgesics (Oxycodone), Allergic reaction to analgesics (Tolmetin) and Allergic reaction to analgesics (Tramadol). Concomitant products included LEFLUNOMIDE (ARAVA) and HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) for Immunosuppression.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In November 2021, the patient experienced ACCIDENTAL UNDERDOSE (apparently for her 3rd shot patient received a booster instead of a full dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (apparently for her 3rd shot patient received a booster instead of a full dose) 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 ACCIDENTAL UNDERDOSE (apparently for her 3rd shot patient received a booster instead of a full dose).    It was reported that an immunocompromised patient asked for her 4th dose of the Moderna COVID-19 Vaccine, but apparently for patient's 3rd shot patient received a booster instead of a full dose.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Cardiac disorder, Dyspnoea
Clinical narrative: Heart affected; breathing difficulty long hauler; energy was affected; This spontaneous case was reported by an other health care professional and describes the occurrence of CARDIAC DISORDER (Heart affected), DYSPNOEA (breathing difficulty long hauler) and ASTHENIA (energy was affected) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart affected) (seriousness criterion hospitalization), DYSPNOEA (breathing difficulty long hauler) (seriousness criterion hospitalization) and ASTHENIA (energy was affected) (seriousness criterion hospitalization). At the time of the report, CARDIAC DISORDER (Heart affected), DYSPNOEA (breathing difficulty long hauler) and ASTHENIA (energy was affected) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported the patient stated Moderna reaction nearly made patient hospital inpatient. Treatment information was not provided.  Company comment: This spontaneous case concerns a female patient of unspecified age with no reported medical history who was hospitalized due to the unexpected events of cardiac disorder (described as heart affected), dyspnoea and asthenia which occurred at an unknown interval after receiving a dose of mRNA1273. The events in this case may be related to each other.  Further details regarding the clinical course, hospital admission, other diagnostic or imaging test done, concomitant medications and treatment were not provided. Information regarding other COVID-19 vaccines were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unspecified age with no reported medical history who was hospitalized due to the unexpected events of cardiac disorder (described as heart affected), dyspnoea and asthenia which occurred at an unknown interval after receiving a dose of mRNA1273. The events in this case may be related to each other.  Further details regarding the clinical course, hospital admission, other diagnostic or imaging test done, concomitant medications and treatment were not provided. Information regarding other COVID-19 vaccines were not reported. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 17-Aug-2022, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It was unknown if patient was under any concomitant or regular medication.  Patient asked if she could take Tylenol for fever.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: The patient could not remember if received second primary dose 28 days later; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The patient could not remember if received second primary dose 28 days later) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The patient could not remember if received second primary dose 28 days later) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The patient could not remember if received second primary dose 28 days later) 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 PRODUCT ADMINISTRATION INTERRUPTED (The patient could not remember if received second primary dose 28 days later).    No concomitant medications were reported. It was reported by the pharmacist that patient had received two primary series doses of Moderna COVID-19 vaccine. The patient had lost vaccination card and could not remember if ever received second dose of the Moderna COVID-19 vaccine. It was further stated that the patient believed to get second dose, but there was no record. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2022: Follow up received includes non-significant information.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: After the 2nd dose he says that he lost all hair from his body and it has not grown it back/by 3Apr2021 he was bald everywhere; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (After the 2nd dose he says that he lost all hair from his body and it has not grown it back/by 3Apr2021 he was bald everywhere) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced ALOPECIA (After the 2nd dose he says that he lost all hair from his body and it has not grown it back/by 3Apr2021 he was bald everywhere). At the time of the report, ALOPECIA (After the 2nd dose he says that he lost all hair from his body and it has not grown it back/by 3Apr2021 he was bald everywhere) had not resolved.            No concomitant medications were reported.  Patient reported that, he has not had COVID and that he had seen doctors for loss of hair but had not been given a diagnosis.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received the Moderna Covid-19 vaccine for her primary series and that 2 months ago she tested positive for Covid-19.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (received the Moderna Covid-19 vaccine for her primary series and that 2 months ago she tested positive for Covid-19.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (received the Moderna Covid-19 vaccine for her primary series and that 2 months ago she tested positive for Covid-19.). At the time of the report, COVID-19 (received the Moderna Covid-19 vaccine for her primary series and that 2 months ago she tested positive for Covid-19.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         The caller reports that she received the Moderna Covid-19 vaccine for her primary series and that 2 months ago she tested positive for Covid-19. The patient did not provide any dates of vaccination, lot numbers or expiration dates of vaccines. The patient did not provide her date of birth or age. No concomitant medication information were given. No treatment information were given.  Company comment- This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, non-serious AESI Covis-19 (with positive Sars-CoV test), which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced unexpected, non-serious AESI Covis-19 (with positive Sars-CoV test), which occurred at an unknown time with regards to the mRNA-1273 vaccination. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Headache, Lethargy, Nausea, Pain in extremity
Clinical narrative: pain at the injection site/It was more painful than the previous shots.; Received a mixed primary series first dose of pfizer and second dose of moderna; Received a mixed primary series first dose of pfizer and second dose of moderna; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site/It was more painful than the previous shots.), COVID-19 IMMUNISATION (Received a mixed primary series first dose of pfizer and second dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series first dose of pfizer and second dose of moderna) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis. The patient had no medical history, and no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 1). Past adverse reactions to the above products included Vaccination site pain with Pfizer. Concurrent medical conditions included Sulfonamide allergy (sensitivity to sulfa) and Penicillin allergy (sensitivity to penicillin).   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site/It was more painful than the previous shots.), COVID-19 IMMUNISATION (Received a mixed primary series first dose of pfizer and second dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series first dose of pfizer and second dose of moderna). At the time of the report, VACCINATION SITE PAIN (pain at the injection site/It was more painful than the previous shots.), COVID-19 IMMUNISATION (Received a mixed primary series first dose of pfizer and second dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series first dose of pfizer and second dose of moderna) outcome was unknown.            The patient height was reported as 5 feet 9.5 inches.  No concomitant medications were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-629988 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site/It was more painful than the previous shots.; Received a mixed primary series first dose of pfizer and second dose of moderna; Received a mixed primary series first dose of pfizer and second dose of moderna; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site/It was more painful than the previous shots.), COVID-19 IMMUNISATION (Received a mixed primary series first dose of pfizer and second dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series first dose of pfizer and second dose of moderna) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis. The patient had no medical history, and no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 1). Past adverse reactions to the above products included Vaccination site pain with Pfizer. Concurrent medical conditions included Sulfonamide allergy (sensitivity to sulfa) and Penicillin allergy (sensitivity to penicillin).   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site/It was more painful than the previous shots.), COVID-19 IMMUNISATION (Received a mixed primary series first dose of pfizer and second dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series first dose of pfizer and second dose of moderna). At the time of the report, VACCINATION SITE PAIN (pain at the injection site/It was more painful than the previous shots.), COVID-19 IMMUNISATION (Received a mixed primary series first dose of pfizer and second dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series first dose of pfizer and second dose of moderna) outcome was unknown.            The patient height was reported as 5 feet 9.5 inches.  No concomitant medications were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-629988 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, Vaccination site pain
Clinical narrative: pain at the injection site/It was more painful than the previous shots.; Received a mixed primary series first dose of pfizer and second dose of moderna; Received a mixed primary series first dose of pfizer and second dose of moderna; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site/It was more painful than the previous shots.), COVID-19 IMMUNISATION (Received a mixed primary series first dose of pfizer and second dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series first dose of pfizer and second dose of moderna) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis. The patient had no medical history, and no other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Pfizer (Dose 1). Past adverse reactions to the above products included Vaccination site pain with Pfizer. Concurrent medical conditions included Sulfonamide allergy (sensitivity to sulfa) and Penicillin allergy (sensitivity to penicillin).   In January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site/It was more painful than the previous shots.), COVID-19 IMMUNISATION (Received a mixed primary series first dose of pfizer and second dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series first dose of pfizer and second dose of moderna). At the time of the report, VACCINATION SITE PAIN (pain at the injection site/It was more painful than the previous shots.), COVID-19 IMMUNISATION (Received a mixed primary series first dose of pfizer and second dose of moderna) and INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series first dose of pfizer and second dose of moderna) outcome was unknown.            The patient height was reported as 5 feet 9.5 inches.  No concomitant medications were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-629988 (Patient Link).
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Patient has not been feeling well since they received the second booster; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient has not been feeling well since they received the second booster) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Patient has not been feeling well since they received the second booster). At the time of the report, MALAISE (Patient has not been feeling well since they received the second booster) outcome was unknown.            No concomitant medication were reported.  It was mentioned in the emails subject that this inquiry was about the second booster No treatment information was provided by the reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Swelling
Clinical narrative: Shoulder is really red; Shoulder is real hot; Kind of itchy on her right shoulder; Shoulder has a Hump on it and look like it is swollen; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Shoulder is really red), BURNING SENSATION (Shoulder is real hot), PRURITUS (Kind of itchy on her right shoulder) and SWELLING (Shoulder has a Hump on it and look like it is swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061B22A) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included GABAPENTIN and CELECOXIB (CELEBREX) for an unknown indication.    On 15-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced ERYTHEMA (Shoulder is really red), BURNING SENSATION (Shoulder is real hot), PRURITUS (Kind of itchy on her right shoulder) and SWELLING (Shoulder has a Hump on it and look like it is swollen). At the time of the report, ERYTHEMA (Shoulder is really red), BURNING SENSATION (Shoulder is real hot), PRURITUS (Kind of itchy on her right shoulder) and SWELLING (Shoulder has a Hump on it and look like it is swollen) outcome was unknown.            Concomitant medication include 2 pain pills at 10 mg.  The dose patient received on 15-Aug-2022 was first booster dose.  Patient did not took any medication for side effects.
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses) and NO ADVERSE EVENT (No adverse event) in an 11-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.15ml doses of the Moderna COVID19 vaccine instead of 0.25ml doses).    No concomitant medications were reported.  The patient received lower than authorized doses and received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml dose. The reporter stated that they had an issue and they incorrectly drawled up the doses.  No treatment information was provided by the reporter.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: no adverse event; patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses) and NO ADVERSE EVENT (no adverse event) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .15 milliliter. On 16-Aug-2022, the patient experienced ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (patient received 0.15ml doses of the Moderna COVID-19 vaccine instead of 0.25ml doses).    Concomitant medication list was not provided. It was reported that 5 patients received 0.15 ml doses of the Moderna COVID-19 vaccine instead of 0.25 ml doses from the same vial lot. The reporter stated they had an issue and they incorrectly drew up the doses. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Swelling on her knuckles; This spontaneous case was reported by a non-health professional and describes the occurrence of JOINT SWELLING (Swelling on her knuckles) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced JOINT SWELLING (Swelling on her knuckles). At the time of the report, JOINT SWELLING (Swelling on her knuckles) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Menstrual cycle came 7 days earlier; This spontaneous case was reported by a patient and describes the occurrence of MENSTRUAL DISORDER (Menstrual cycle came 7 days earlier) in a 31-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 052B22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in February 2021.    On 06-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In August 2022, the patient experienced MENSTRUAL DISORDER (Menstrual cycle came 7 days earlier). At the time of the report, MENSTRUAL DISORDER (Menstrual cycle came 7 days earlier) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient had no allergies and no other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Patient was not taking any concomitant medication. The patient told that she has a very regular cycle and never happened this to her. Her menstrual cycle came 7 days earlier and she was very concern about it. She said that was a red flag for her.  The AE did not cause patient to seek medical care at the moment but she will go. She did not experienced a similar event in the past, always been spread out. No treatment medication was provided.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity, Product preparation error
Clinical narrative: His leg was sore; Given undiluted dose of vaccine; Given undiluted dose of vaccine; This is a spontaneous report received from contactable reporter(s) (Pharmacist and Consumer or other non HCP) from medical information team, Program ID.  A 3-year-old male patient received BNT162b2 (BNT162B2), on 08Aug2022 as dose 1, single (Lot number: FT9142) at the age of 3 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), PRODUCT PREPARATION ERROR (non-serious) all with onset 08Aug2022, outcome "unknown" and all described as "Given undiluted dose of vaccine"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "His leg was sore".  Additional Information: The reporter was a pharmacist calling about the COVID-19 vaccine. The reporter reported that, it was administered to a patient without being diluted. Reporter came into the line and verified information received from the transferring agent. Reporter stated that the COVID 19 vaccine she was calling about had a dark red cap. Reporter stated that she was looking for guidance on this situation. Stated that she had not contacted the parents of the patient yet, she wanted to contact Pfizer first. Reporter began to cry and stated that she felt bad that this happened. The reporter was asking about a 3-year-old male patient who received his first dose of dark red cap vaccine, not diluted. She was looking for guidance. The pharmacist reported it was human error. The vaccines are too overwhelming. Every vaccine has different dosage amounts, different age groups, different dilution instructions, different dosages. It was too much and she goes slow when preparing but it was too many variations and calculations and the mistake happened with the overdose. The patient did not receive any prior vaccinations within 4 weeks. Information regarding concomitant drugs and medical history was reported as unknown. The reporter did call the mother after the overdose event and the mother was a physician which was helpful for monitoring the patient. The mother said he was fine but acting like his leg was sore but considered it a normal reaction. No other adverse events reported beyond that one.  Follow-up (10Aug2022): This is a spontaneous follow-up report received from a contactable consumer.  Updated information: reporter information (primary reporters email address and new secondary reporter added) and patient details (age at vaccination captured).  Follow-up (17Aug2022): This is a spontaneous follow-up report received from a contactable pharmacist. Updated Information: suspect drug (vaccine facility information added), reaction data (added new event of his leg was sore) and additional information updated with details of clinical course.
Sex: F
Vaccine: MENB
Symptoms: Interchange of vaccine products, Ocular discomfort
Clinical narrative: Caller states her eyes are not working right today; Started on Bexsero, got the 2nd dose as Trumenba; Started on Bexsero, got the 2nd dose as Trumenba; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), on 20Jul2022 as dose 2, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bexsero (DOSE 1, Deltoid Right, lot number: ABXA87AZ), administration date: 22Jul2021, for immunisation. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 20Jul2022, outcome "unknown" and all described as "Started on Bexsero, got the 2nd dose as Trumenba"; OCULAR DISCOMFORT (non-serious) with onset 12Aug2022, outcome "unknown", described as "Caller states her eyes are not working right today". Additional information: dose is not interchangeable so the patient will need to go back for the 2nd dose of Bexsero. A patient that started on Bexsero at the office and then was referred to a pharmacy and got the 2nd dose as Trumenba and not the Bexsero for their 2nd dose.   Follow-up attempts are completed. No further information is expected.