chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 75 year old female of an unspecified ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: food intolerance (wheat, dairy, soy, walnuts, pecans), penicillin allergy, and nitrofuratine allergy. The patient was not pregnant at the time of vaccination. The patient previously received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered 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, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 8 decade old. No concomitant medications were reported. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient additionally received non-company suspect vaccine elasomeran (Moderna) (Dose number in series 3) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered to left arm on 05-OCT-2022 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 3). On an unspecified date, the patient experienced suspected covid-19 infection (Dose number in series 3).  The patient was treated with Unspecified drug from Pfizer (form of admin was not reported, route of admin, batch number and expiry were not reported) dose was not reported, start therapy date were not reported for covid-19 treatment. On 25-JAN-2023 21:00, the patient experienced Covid rebound and had symptoms of head stuffed, sore top of mouth (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: INJECTION SITE PAIN; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. No concomitant medications were reported.  On an unspecified date, the patient experienced injection site pain (dose number in series 1). The outcome of injection site pain was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 in total, 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.  On an unspecified date, the patient experienced injection site pain (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious. This case, involving the same patient is linked to 20230211874.
Sex: U
Vaccine: COVID19
Symptoms: Limb injury, Pain
Clinical narrative: TERRIBLE BURNING PAIN FROM THE HAND ON SHOULDER; DAMAGE IN RIGHT ARM FROM THAT SHOT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced terrible burning pain from the hand on shoulder, and damage in right arm from that shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible burning pain from the hand on shoulder and damage in right arm from that shot was not reported. This report was non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A, 012A21A, 077C21B and 058A22-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA. Past adverse reactions to the above products included No adverse event with INFLUENZA. Concurrent medical conditions included Kidney failure. Concomitant products included INFLUENZA VACCINE (FLU VACCINE VII) from 18-Jan-2023 to an unknown date, LISINOPRIL (VEROXIL [LISINOPRIL]), L-THYROXIN [LEVOTHYROXINE], COLESTIPOL HCL, ATORVASTATIN, ALLOPURINOL (ADCO ALLOPURINOL) and LIOTHYRONINE SODIUM (LIOTHYRONINE SOD.) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) was resolving. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient reported back in September 2023 my wife and I traveled in September and when we came back we were diagnosed with Covid-19. On January 19, 2023 the patient got into bed and the room started spinning. The patient got so dizzy that he could not stand to get up. In the morning the patient took his blood pressure. The patient relaxed and self monitored his blood pressure throughout the day of January 20, 2023. On January 21, 2023 the patient blood pressure returned normal. No treatment medication information was reported.   This case was linked to MOD-2023-706791 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fibromyalgia, Gingival discolouration, Hyperaesthesia teeth
Clinical narrative: exacerbated fibromyalgia/extremely fatigued/constant full body pain/ Sleeping; gums changed color; teeth became sensitive to heat; This spontaneous case was reported by a patient and describes the occurrence of FIBROMYALGIA (exacerbated fibromyalgia/extremely fatigued/constant full body pain/ Sleeping), GINGIVAL DISCOLOURATION (gums changed color) and HYPERAESTHESIA TEETH (teeth became sensitive to heat) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concurrent medical conditions included Fibromyalgia.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced FIBROMYALGIA (exacerbated fibromyalgia/extremely fatigued/constant full body pain/ Sleeping), GINGIVAL DISCOLOURATION (gums changed color) and HYPERAESTHESIA TEETH (teeth became sensitive to heat). At the time of the report, FIBROMYALGIA (exacerbated fibromyalgia/extremely fatigued/constant full body pain/ Sleeping), GINGIVAL DISCOLOURATION (gums changed color) and HYPERAESTHESIA TEETH (teeth became sensitive to heat) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No Concomitant medication was reported.  Patient  reported vaccination exacerbated fibromyalgia that patient did not know he/she had. Patient reported it has taken over 1 year and thousands of dollars to get treated and this may be a debilitating and he/she may not be able to work in a few years. Patient noticed something was wrong when gums changed color and teeth became sensitive to heat had constant full body pain and extremely fatigued. Patient reported free time is spent at doctors and sleeping. Patient  reached out when first had the side effects. It was reported that the patient want help financially as all his/her money was going to control these symptoms for an incurable illness. No treatment information was provided.  Company comment: This spontaneous case reported by a patient concerns a patient of unknown age and gender with relevant underlying condition of fibromyalgia, who experienced the non-serious unexpected AESI of Fibromyalgia (exacerbated fibromyalgia) which occurred unknown days after administration of a dose of mRNA-1273 vaccine. Patient's gums changed color and teeth became sensitive to heat. Patient had constant full body pain and extremely fatigued. Underlying condition of fibromyalgia remains confounding. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: came down with Covid this past January 20; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (came down with Covid this past January 20) 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 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2023, the patient experienced COVID-19 (came down with Covid this past January 20). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. On 25-Jan-2023, COVID-19 (came down with Covid this past January 20) had resolved.            No concomitant medication was provided by reporter.  Patient received Dose 2 Moderna Covid vaccine in 2022. Patient received First booster dose of Moderna on 05-Feb-2022. Patient did not get the second booster and came down with Covid this past 20 Jan and recovered on 25 Jan with the help of Plaxovid.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Dose 1 and Dose 2 taken on 22-Jul-22 and 2-Sep-22, 42 days apart; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 22-Jul-22 and 2-Sep-22, 42 days apart) and NO ADVERSE EVENT (No adverse event) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 22-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 25 microgram. On 02-Sep-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 25 microgram. On 02-Sep-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 22-Jul-22 and 2-Sep-22, 42 days apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 22-Jul-22 and 2-Sep-22, 42 days apart) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 22-Jul-22 and 2-Sep-22, 42 days apart).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2023-697101 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Missed scheduled second dose; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     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, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (Missed scheduled second dose).    Concomitant medications were not reported.  Patient missed scheduled second dose. Patient asked if patient could still take second dose of Moderna Covid-19 vaccine. They initially unsure if 42 days had lapsed then said that had been less than 42 days. Treatment medications were not reported.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: she received an expired Bivalent booster; vial was kept in the refrigerator for 34 days prior to administering it; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she received an expired Bivalent booster), PRODUCT STORAGE ERROR (vial was kept in the refrigerator for 34 days prior to administering it) and NO ADVERSE EVENT (No adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (she received an expired Bivalent booster), PRODUCT STORAGE ERROR (vial was kept in the refrigerator for 34 days prior to administering it) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she received an expired Bivalent booster), PRODUCT STORAGE ERROR (vial was kept in the refrigerator for 34 days prior to administering it) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (she received an expired Bivalent booster) and PRODUCT STORAGE ERROR (vial was kept in the refrigerator for 34 days prior to administering it).    Concomitant medications were not reported.   Treatment medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Came down with COVID / Tested positive; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Came down with COVID / Tested positive) 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.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. 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 and second dose of COVID-19 VACCINE NRVV AD (CHADOX1 NCOV-19) (ASTRAZENECA COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Came down with COVID / Tested positive). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Came down with COVID / Tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.       No concomitant medication was reported.  Reportedly, the patient had primary doses of AstraZeneca and came down with COVID and was taking Paxlovid. Patient tested positive and confirmed had COVID prior to taking Paxlovid.  Patient had a total of 5 doses. All of patient's doses were AstraZeneca and Moderna.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: covid 19; patient never went back to receive the second dose in her Primary Series; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (covid 19) and PRODUCT DOSE OMISSION ISSUE (patient never went back to receive the second dose in her Primary Series) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    In 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 COVID-19 (covid 19) and PRODUCT DOSE OMISSION ISSUE (patient never went back to receive the second dose in her Primary Series). At the time of the report, COVID-19 (covid 19) and PRODUCT DOSE OMISSION ISSUE (patient never went back to receive the second dose in her Primary Series) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient never went back to receive the second dose in Primary Series of the Moderna Covid-19 vaccine. It would be more than 35 days between Moderna Covid-19 Primary Series doses. Treatment medications were not reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received Dose Number 1 on 15-MAR-2021 and Dose Number 2 on 5-APR-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose Number 1 on 15-MAR-2021 and Dose Number 2 on 5-APR-2021) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 036A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Egg allergy and Food allergy.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose Number 1 on 15-MAR-2021 and Dose Number 2 on 5-APR-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received Dose Number 1 on 15-MAR-2021 and Dose Number 2 on 5-APR-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Concomitant products were not reported.  It was reported that patient received dose 3 from Pfizer on 25-Oct-2021 batch number FF2593 at left arm. Dose 4 from moderna on 04-Apr-2022 batch number 027L21A at right arm. Dose 5 from Pfizer on 07-Sep-2022 batch number GH9695 at left arm. Patient received paxlovid from 23-Jan-2023 to 28-Jan-2023 batch number GF317.   Treatment medications were not reported.
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash papular
Clinical narrative: She noticed bumps on her knees today 03FEB2023; This spontaneous case was reported by a patient and describes the occurrence of RASH PAPULAR (She noticed bumps on her knees today 03FEB2023) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included MELOXICAM for an unknown indication.    On 02-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced RASH PAPULAR (She noticed bumps on her knees today 03FEB2023). At the time of the report, RASH PAPULAR (She noticed bumps on her knees today 03FEB2023) outcome was unknown.        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.   Patient stated that 5 days ago the doctor gave her Meloxicam daily regimen. Patient took a Meloxicam tablet prior to vaccination.  No treatment information was reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Booster after positive COVID test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Booster after positive COVID test) in a  patient of an unknown age and gender 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. On an unknown date, the patient experienced COVID-19 (Booster after positive COVID test). At the time of the report, COVID-19 (Booster after positive COVID test) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The reporter wanted to enquire what was the wait time to receive 2nd booster, after a positive COVID test.  No concomitant medication reported. No treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2023: Case MOD-2023-706687 was created with IRD 01-Feb-2023 and SRD 02-Feb-2023 which was received via portal however an Email was received from consumer to Media team of Moderna on 31-Jan-2023 which was forwarded to drug safety team on 03-Feb-2023, hence a new initial case was created capturing IRD as 31-Jan-2023 and SRD 03-Feb-2023 and FU was appended dated 01-Feb-2023 (which was received via portal) with ID MOD-2023-707437 hence case  MOD-2023-706687 with IRD 01-Feb-2023 and SRD 02-Feb-2023 was deleted from safety database and case MOD-2023-707437 was retained for further follow-up.
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination complication
Clinical narrative: My wife for 23 days was never the same after the shot on 1/9/2023; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (My wife for 23 days was never the same after the shot on 1/9/2023) in a female 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 09-Jan-2023, 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. In January 2023, the patient experienced VACCINATION COMPLICATION (My wife for 23 days was never the same after the shot on 1/9/2023). At the time of the report, VACCINATION COMPLICATION (My wife for 23 days was never the same after the shot on 1/9/2023) had resolved.            No concomitant medication information provided.  It was reported that reporter's wife for 23 days was never the same after the shot, went to urgent care and her doctor. Stated due to this she would never take another covid shot.  No treatment information provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was stored in the refrigerator in-between use; No adverse event; vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vial was stored in the refrigerator in-between use), EXPIRED PRODUCT ADMINISTERED (vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023 at 8:00 AM, 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 24-Jan-2023 at 8:00 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was stored in the refrigerator in-between use) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (vial was stored in the refrigerator in-between use), EXPIRED PRODUCT ADMINISTERED (vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (vial was stored in the refrigerator in-between use) and EXPIRED PRODUCT ADMINISTERED (vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM.).    No relevant concomitant medications were reported.   Refrigerator expiration date was reported 02-Mar-2023. The vial was punctured at approximately 9:00 AM on 23-Jan-2023, and the dose was given on 24-Jan-2023 at approximately at 8:00 AM. The vial was stored in the refrigerator in-between use.   No treatment information was provided.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid 19) in an adult female patient 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 fifth 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 experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had resolved.            No concomitant medications were reported.  The patient had received 5 doses of the COVID-19 vaccine, but still got COVID. The reporter stated that, she was doing better now. The reporter did not know if she had received the Moderna COVID-19 vaccine or Pfizer.   No treatment medications were reported.   Reporter did not allow further contact
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023; no adverse event; beyond the manufacturer expiration date and the 30 BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023), EXPIRED PRODUCT ADMINISTERED (beyond the manufacturer expiration date and the 30 BUD) and NO ADVERSE EVENT (no adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 051C22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (beyond the manufacturer expiration date and the 30 BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023), EXPIRED PRODUCT ADMINISTERED (beyond the manufacturer expiration date and the 30 BUD) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was placed in the refrigerator on 09-Nov-2022 and administered on 01-Feb-2023) and EXPIRED PRODUCT ADMINISTERED (beyond the manufacturer expiration date and the 30 BUD).    No relevant concomitant medications were reported.  Manufacturer expiration date was 13-Jan-2023 and the initial date the vaccine was placed in the refrigerator was on 09-Nov-2022.  No adverse reactions were reported by the patients. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Drug interaction, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; Patient had cross reactivity of Darbepoetin to the Moderna vaccine; diarrhea; fatigue; muscle aches; fever; headache; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (shortness of breath), DRUG INTERACTION (Patient had cross reactivity of Darbepoetin to the Moderna vaccine), DIARRHOEA (diarrhea), FATIGUE (fatigue) and MYALGIA (muscle aches) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DARBEPOETIN ALFA for Anaemia NOS.    Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Anemia.  Concurrent medical conditions included Anaemia NOS.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DARBEPOETIN ALFA (unknown route) at an unspecified dose. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), DRUG INTERACTION (Patient had cross reactivity of Darbepoetin to the Moderna vaccine), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath), DRUG INTERACTION (Patient had cross reactivity of Darbepoetin to the Moderna vaccine), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported that, in their medical records, there was a flagged report on a patient who had gotten the Moderna COVID-19 in Apr-2021 who was on Darbepoetin for anemia who came down with fatigue, muscle aches, fever of 103, diarrhea, headache and shortness of breath. It was not considered as an allergy but a cross reactivity to the vaccine.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: shortness of breath; Patient had cross reactivity of Darbepoetin to the Moderna vaccine; diarrhea; fatigue; muscle aches; fever; headache; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (shortness of breath), DRUG INTERACTION (Patient had cross reactivity of Darbepoetin to the Moderna vaccine), DIARRHOEA (diarrhea), FATIGUE (fatigue) and MYALGIA (muscle aches) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product DARBEPOETIN ALFA for Anaemia NOS.    Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Anemia.  Concurrent medical conditions included Anaemia NOS.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started DARBEPOETIN ALFA (unknown route) at an unspecified dose. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), DRUG INTERACTION (Patient had cross reactivity of Darbepoetin to the Moderna vaccine), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache). At the time of the report, DYSPNOEA (shortness of breath), DRUG INTERACTION (Patient had cross reactivity of Darbepoetin to the Moderna vaccine), DIARRHOEA (diarrhea), FATIGUE (fatigue), MYALGIA (muscle aches), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The pharmacist reported that, in their medical records, there was a flagged report on a patient who had gotten the Moderna COVID-19 in Apr-2021 who was on Darbepoetin for anemia who came down with fatigue, muscle aches, fever of 103, diarrhea, headache and shortness of breath. It was not considered as an allergy but a cross reactivity to the vaccine.  No treatment medications were reported.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: product storage error; No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Feb-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 06-Feb-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medication information provided. Individual vials or intact cartons: Intact cartons vial size was 5.5 ml.  Date the vial was initially stored in the refrigerator was 11-JAN-2023.  It was unknown if the vial had undergone any temperature excursions. No treatment information provided.
Age: 36.0
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 contactable reporter(s) (Nurse). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROGESTERONE, start date: 01Sep2021; ESTROGEN, start date: 01Sep2021; EFFEXOR. 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.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected drug cannot be completely excluded.
Sex: M
Vaccine: PNC20
Symptoms: Vaccination site pain
Clinical narrative: very slight pain at the injection site; This is a spontaneous report received from a contactable reporter (Consumer) from Agency. The reporter is the patient.  A 74-year-old male patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pneumovax 23, administration date: 2013, for Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "very slight pain at the injection site". Additional information: Reporter mentioned that he was 74 y/o and was injected with the Prevnar 20 five milliliters vaccine yesterday and said that he did not have any noticeable side effects. Just maybe for a half hour a very slight pain at the injection site but after a half hour it went away. Patient said that he was about to take Shingrix but he wants to know how long he should wait to get the Shingrix vaccine. Created a manual form because the patient mentioned that he experienced slight pain at the injection site after getting Prevnar vaccine.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC20
Symptoms: Asplenia, Circumstance or information capable of leading to medication error, Medication error, Spleen disorder, Splenectomy
Clinical narrative: spleen taken out; She just got Prevnar 20 and the doctor told her she needs a second dose in two months; This is a spontaneous report received from a contactable reporter (Pharmacist) from the Agency.  A 65-year-old female patient received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), as DOSE NUMBER UNKNOWN, SINGLE (batch/lot number: unknown) for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SPLEEN DISORDER (medically significant), outcome "unknown" described as "spleen taken out"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown" described as "She just got Prevnar 20 and the doctor told her she needs a second dose in two months." Therapeutic measures were taken as a result of spleen disorder.  Additional information: The reporter called about Prevnar 20. She has a patient who got her spleen taken out. She just got Prevnar 20 and the doctor told her she needs a second dose in two months. He also told her she is supposed to get another pneumonia vaccine every two years. She wanted to know what the recommendations are for this population. Spoke from the ACIP recommendations under Summary, which included patients with certain underlying conditions. Also spoke from 'Pneumococcal Vaccine Recommendations' Table 1 where it discusses certain underlying conditions, including asplenia. Offered all of these recommendations in writing for their evaluation. Referred to the CDC for further discussion as these are their recommendations that Pfizer is independent of. Explained that this would be looked further and if there is any additional information regarding this will be included in writing in the fulfillment.   The information on the batch/lot number for pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The spleen disorder requiring surgical intervention with splenectomy represents the patient's underlying medical condition unrelated to the vaccine use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Pneumonitis
Clinical narrative: it inflamed my lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; methotrexate sodium (METHOTREXATE SODIUM). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONITIS (medically significant), outcome "unknown", described as "it inflamed my lungs". The action taken for methotrexate sodium was dosage permanently withdrawn. Therapeutic measures were taken as a result of pneumonitis. Clinical course: the event was reported as non-serious. It was reported that patient has gotten the vaccine twice. The first one she was on Methotrexate and it didn't mix with that, it inflamed her lungs and was on oxygen for a year. The second one was on hydroxychloroquine, and it broke all the capillaries in her body. So she had to go off both.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 31Jan2023 at 10:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR; SERTRALINE. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 31Jan2023 at 17:00, outcome "recovering"; FATIGUE (non-serious) with onset 31Jan2023 at 17:00, outcome "recovering". Therapeutic measures were taken as a result of headache, fatigue.  Additional information: No other vaccine in four weeks. Treatment included Ibuprofen. No COVID prior vaccination: No. Not tested for COVID tested post vaccination. No known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.