chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose  9nov2018, 2nd never; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 9th November 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Sept-2022 Reporter's comment: The registered pharmacist called to inquired that how to proceed with Shingrix series. The patient never receive the second dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 94.0
Sex: M
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Paralysis
Clinical narrative: ADVANCING NEUROPATHY; PARALYSIS; This spontaneous report received from a consumer via a company representative via social media (J and J social media) concerned a 94 year old male of an unspecified race and ethnicity. 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, and expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Age at time of vaccination 94 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced advancing neuropathy, and paralysis. It was reported by consumer that, "Johnson and Johnson my father was 94 when he got his j and j. He has had advancing neuropathy and paralysis ever since. No boosters for this family". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the advancing neuropathy and paralysis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220962712-covid-19 vaccine ad26.cov2.s-Advancing neuropathy, Paralysis . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: DORMANT CROHNS DISEASE ATTACK ME; This spontaneous report received from a patient via a company representative via media concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: crohn's disease. 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, 1 total, for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced dormant crohns disease attack. The patient reported that "I wish I could sue you so badly for making dormant Crohn's disease attack me and ruin my life. "Its funny that u get a covid vax then a month later doctors suggest you should be taking an intravenous drug manufactured by who other than you. I will not be a slave to the medical industry or this disease." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dormant crohns disease attack me was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221000201-covid-19 vaccine ad26.cov2.s- dormant crohns disease attack me. The event(s) has an unknown/unclear 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: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis, Off label use
Clinical narrative: MYOCARDITIS; OFF LABEL USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a consumer concerned a male child. 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, 1 total administrated, for covid-19 prophylaxis which was associated with Off label use. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced myocarditis. On an unspecified date, following vaccination the patient was hospitalized. Number of days of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the myocarditis and off label use in unapproved age group was not reported. This report was serious (Hospitalization Caused / Prolonged. This case is a duplicate of 20221000309.  Additional information was received from consumer on 30-SEP-2022: It was determined that Manufacturer Case Number 20221000309 was a duplicate of case 20221000293. All relevant information regarding case 20221000309 will be submitted under Manufacturer Case Number 20221000293.; Sender's Comments: V0: 20221000293-covid-19 vaccine ad26.cov2.s- Myocarditis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Gastric disorder
Clinical narrative: STOMACH ISSUES FOR MONTHS; DIARRHEA FOR MONTHS; EXHAUSTED; This spontaneous report received from a consumer 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced stomach issues for months, diarrhea for months, and exhausted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stomach issues for months, exhausted and diarrhea for months was not reported. This report was non-serious. This case, involving the same patient is linked to 20221002915.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK AFTER THE VACCINATION; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sick after the vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick after the vaccination was not reported. This report was non-serious. This case, from the same reporter is linked to 20221003166.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Issues after receipt of vaccine; was hospitalized and has health issues now.; This spontaneous case was reported by a non-health professional and describes the occurrence of IMMUNISATION REACTION (Issues after receipt of vaccine; was hospitalized and has health issues now.) in a  patient of an unknown age and gender 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 IMMUNISATION REACTION (Issues after receipt of vaccine; was hospitalized and has health issues now.) (seriousness criterion hospitalization). At the time of the report, IMMUNISATION REACTION (Issues after receipt of vaccine; was hospitalized and has health issues now.) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported. Company comment-This spontaneous case concerns a patient of unknown gender and age with no medical history reported, who experienced the unexpected serious (Hospitalization) event of Immunisation reaction (reported as Issues after receipt of vaccine; was hospitalized and has health issues now) which occurred on an unknown date after receiving unspecified dose of mRNA-1273 vaccination in covid-19 vaccination series. No further information on clinical course, lab. reports, treatment received and details pertaining to vaccine doses was available in the report. Outcome of the event was not known at the time of report. 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 patient of unknown gender and age with no medical history reported, who experienced the unexpected serious (Hospitalization) event of Immunisation reaction (reported as Issues after receipt of vaccine; was hospitalized and has health issues now) which occurred on an unknown date after receiving unspecified dose of mRNA-1273 vaccination in covid-19 vaccination series. No further information on clinical course, lab. reports, treatment received and details pertaining to vaccine doses was available in the report. Outcome of the event was not known at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick after the 1st dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ILLNESS (got sick after the 1st dose) in a 76-year-old female patient 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, the patient experienced ILLNESS (got sick after the 1st dose). At the time of the report, ILLNESS (got sick after the 1st dose) had not resolved.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2022-653555 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: swelling of their lips 10 days after 2nd shot; This spontaneous case was reported by a pharmacist and describes the occurrence of LIP SWELLING (swelling of their lips 10 days after 2nd shot) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIP SWELLING (swelling of their lips 10 days after 2nd shot). At the time of the report, LIP SWELLING (swelling of their lips 10 days after 2nd shot) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  It was reported that patient had 2 moderna COVID shots and had some swelling of their lips 10 days after 2nd shot and it was unclear if it was related to the shot.  No treatment medication reported by reporter.   Reporter did not allow further contact
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022; No adverse Event; A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022), EXPIRED PRODUCT ADMINISTERED (A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago) and NO ADVERSE EVENT (No adverse Event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044c22a) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022) and NO ADVERSE EVENT (No adverse Event). At the time of the report, PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022), EXPIRED PRODUCT ADMINISTERED (A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago) 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 (Date the vial was initially stored in the refrigerator on 22Aug2022, Date(s) of administration of vaccine on 30Sep2022) and EXPIRED PRODUCT ADMINISTERED (A patient received a first dose of the Moderna CVOID19 vaccine from a vial that was left in the fridge 40 days ago).    No concomitant medications were provided. The patient had 1st dose of the primary series with monovalent product. Vial size was 5.5ml. The vial did not undergo any temperature excursions. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Positive COVID; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive COVID) in a  patient of an unknown age and gender 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. In September 2022, the patient experienced COVID-19 (Positive COVID). At the time of the report, COVID-19 (Positive COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.  Patient tested positive COVID two weeks ago and asked how long patient need to wait to get bivalent vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Following vaccination with the 1st dose she was good, little things happened; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Following vaccination with the 1st dose she was good, little things happened) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy, Penicillin allergy (penicillin antibiotic for a sinus infection) and Blood pressure abnormal. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure, ROSUVASTATIN CALCIUM (CRESTOR) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Following vaccination with the 1st dose she was good, little things happened). At the time of the report, IMMUNISATION REACTION (Following vaccination with the 1st dose she was good, little things happened) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The patient's treatment included hot tea, consume more water, and was unable to take aspirin.   This case was linked to US-MODERNATX, INC.-MOD-2022-653962 (Linked Report). This case was linked to MOD-2022-654068, MOD-2022-654088, MOD-2022-654100 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-653962:Same reporter
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: No adverse event; dose administered from vial that underwent a temperature excursion; dose administered from vial that underwent a temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 4-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In September 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion). On 22-Sep-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion) 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 assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (dose administered from vial that underwent a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (dose administered from vial that underwent a temperature excursion).    No concomitant medications were reported.  It was reported that there was an temperature excursion on the 02-Sep-2022 for one hour and there were no remaining doses. The vials were under frozen condition at the time of the excursion and individual vials were in the box of vial size 2.5ml. The maximum temperatures reached was -12.5°C, the vials had not moved from freezer to refrigerator and there was no any vaccine state change found by visual inspection.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-654338 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2022: added patient initials, patients demographics and vaccine dose details.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654338:same reporter
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Tremor
Clinical narrative: Waking up shaking; Feeling very ill; Patient received first dose on 05-Aug-2021 and Second dose on 26-Aug-2021; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Waking up shaking), MALAISE (Feeling very ill) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 05-Aug-2021 and Second dose on 26-Aug-2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026a21a and 031m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Aspirin), Penicillin allergy, Allergy to antibiotic (Antibiotic for a sinus infection) and Blood pressure abnormal. Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure abnormal, ROSUVASTATIN CALCIUM (CRESTOR) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 05-Aug-2021 and Second dose on 26-Aug-2021). On an unknown date, the patient experienced TREMOR (Waking up shaking) and MALAISE (Feeling very ill). At the time of the report, TREMOR (Waking up shaking), MALAISE (Feeling very ill) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 05-Aug-2021 and Second dose on 26-Aug-2021) outcome was unknown.            Patient did not test positive for COVID-19 or diagnosed with it.  Patient was told to consume more water and hot tea. Patient was unable to take aspirin.   This case was linked to US-MODERNATX, INC.-MOD-2022-653962 (E2B Linked Report). This case was linked to MOD-2022-654032, MOD-2022-654088, MOD-2022-654100 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-653962:Same reporter
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: redness; no apatite; soreness in her arm; -2nd dose 26Aug2021 lot #026a21a and -3rd dose 23Nov2021 lot #013f21a; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (redness), DECREASED APPETITE (no apatite), PAIN IN EXTREMITY (soreness in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (-2nd dose 26Aug2021 lot #026a21a and -3rd dose 23Nov2021 lot #013f21a) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013f21a, 026a21a and 031m20a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy and Allergy to antibiotic (Antibiotic for sinus infection). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure high, ROSUVASTATIN CALCIUM (CRESTOR) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.   On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (-2nd dose 26Aug2021 lot #026a21a and -3rd dose 23Nov2021 lot #013f21a). On an unknown date, the patient experienced ERYTHEMA (redness), DECREASED APPETITE (no apatite) and PAIN IN EXTREMITY (soreness in her arm). At the time of the report, ERYTHEMA (redness), DECREASED APPETITE (no apatite), PAIN IN EXTREMITY (soreness in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (-2nd dose 26Aug2021 lot #026a21a and -3rd dose 23Nov2021 lot #013f21a) outcome was unknown.            Patient had no history relating to mentioned adverse event. Patient had no acute and chronic illnesses at the time of vaccination. Patient did not test positive for COVID-19 or diagnosed with it. Patient did not seek medical care . Patient did not have similar event in the past. Patient was told to consume more water and hot tea. Patient was unable to take aspirin.   This case was linked to US-MODERNATX, INC.-MOD-2022-653962 (E2B Linked Report). This case was linked to MOD-2022-654032, MOD-2022-654068, MOD-2022-654100 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-653962:Same reporter
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling cold, Feeling hot, Pyrexia
Clinical narrative: shaking so bad; feeling cold; feeling really warm; took her temperature 100.4°F and later 100.7°F; bad chills; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking so bad), FEELING COLD (feeling cold), FEELING HOT (feeling really warm), PYREXIA (took her temperature 100.4°F and later 100.7°F) and CHILLS (bad chills) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 7162b) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Drug allergy (Aspirin) and Penicillin allergy (penicillin antibiotic for a sinus infection). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure abnormal, ROSUVASTATIN CALCIUM (CRESTOR) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 28-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking so bad), FEELING COLD (feeling cold), FEELING HOT (feeling really warm), PYREXIA (took her temperature 100.4°F and later 100.7°F) and CHILLS (bad chills). At the time of the report, TREMOR (shaking so bad), FEELING COLD (feeling cold), FEELING HOT (feeling really warm) and PYREXIA (took her temperature 100.4°F and later 100.7°F) had not resolved and CHILLS (bad chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 F and 100.7 F.         No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient reported receiving antibiotic for a sinus infection in the past. Patient was not tested positive for COVID-19. Patient received the following doses of the Moderna COVID-19 vaccine -1st dose on 5Aug 2021 lot #031m20a,  2nd dose on 26Aug2021 lot #026a21a and 3rd dose on 23Nov2021 lot #013f21a. No treatment medications were reported. She consumed hot tea and more water, she also reported she was unable to take Aspirin.   This case was linked to MOD-2022-654032, MOD-2022-654068, MOD-2022-654088.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shaking so bad; feeling cold; feeling really warm; took her temperature 100.4°F and later 100.7°F; bad chills; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (shaking so bad), FEELING COLD (feeling cold), FEELING HOT (feeling really warm), PYREXIA (took her temperature 100.4°F and later 100.7°F) and CHILLS (bad chills) in a 71-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 7162b) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal, Drug allergy (Aspirin) and Penicillin allergy (penicillin antibiotic for a sinus infection). Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR) for Blood pressure abnormal, ROSUVASTATIN CALCIUM (CRESTOR) and LEVETIRACETAM (KEPPRA [LEVETIRACETAM]) for an unknown indication.    On 28-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (shaking so bad), FEELING COLD (feeling cold), FEELING HOT (feeling really warm), PYREXIA (took her temperature 100.4°F and later 100.7°F) and CHILLS (bad chills). At the time of the report, TREMOR (shaking so bad), FEELING COLD (feeling cold), FEELING HOT (feeling really warm) and PYREXIA (took her temperature 100.4°F and later 100.7°F) had not resolved and CHILLS (bad chills) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 F and 100.7 F.         No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient reported receiving antibiotic for a sinus infection in the past. Patient was not tested positive for COVID-19. Patient received the following doses of the Moderna COVID-19 vaccine -1st dose on 5Aug 2021 lot #031m20a,  2nd dose on 26Aug2021 lot #026a21a and 3rd dose on 23Nov2021 lot #013f21a. No treatment medications were reported. She consumed hot tea and more water, she also reported she was unable to take Aspirin.   This case was linked to MOD-2022-654032, MOD-2022-654068, MOD-2022-654088.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 25Aug2022, Date(s) of administration of vaccine on 28Sep2022; No adverse event; 1 dose of Moderna Covid-19 vaccine (Monovalent) was administered after the beyond use date of 21Sep2022.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was administered after the beyond use date of 21Sep2022.), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25Aug2022, Date(s) of administration of vaccine on 28Sep2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Sep-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was administered after the beyond use date of 21Sep2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25Aug2022, Date(s) of administration of vaccine on 28Sep2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose of Moderna Covid-19 vaccine (Monovalent) was administered after the beyond use date of 21Sep2022.), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25Aug2022, Date(s) of administration of vaccine on 28Sep2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) 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 (1 dose of Moderna Covid-19 vaccine (Monovalent) was administered after the beyond use date of 21Sep2022.) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 25Aug2022, Date(s) of administration of vaccine on 28Sep2022).    No concomitant medication information was provided. The patient received 1 dose of the moderna covid-19 vaccine with monovalent product. Vial size was 5.5ml. On 25 Aug 2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. No treatment medication information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: she also got a bad cough for 2 weeks after getting the second dose of the Moderna vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COUGH (she also got a bad cough for 2 weeks after getting the second dose of the Moderna vaccine) in a 70-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (she also got a bad cough for 2 weeks after getting the second dose of the Moderna vaccine). At the time of the report, COUGH (she also got a bad cough for 2 weeks after getting the second dose of the Moderna vaccine) had resolved.            It was reported that patient had health issues.  Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-651282 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-651282:Daughter's case
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022; No adverse event; Patient received vaccine after the 30 days beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 055A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the 30 days beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022) 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 (Patient received vaccine after the 30 days beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11AUG2022, vaccine administered on 26-SEP-2022).    No concomitant medication information was provided. The vial size was reported as 2.5 ml. It was reported that Lot 055A22A was moved from the freezer to the refrigerator on 11AUG2022.. It was reported that the vial did not undergo temperature excursions. They had multiple doses administered after the 30 days beyond use date. None of patients reported experiencing any symptoms after receiving those doses.  No additional doses, medications or treatments had been administered in response.   This case was linked to US-MODERNATX, INC.-MOD-2022-654159, US-MODERNATX, INC.-MOD-2022-654164 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-654159:Patient 6 (same reporter) US-MODERNATX, INC.-MOD-2022-654164:
Age: 1.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: No adverse event; First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine; First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 IMMUNISATION (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 12-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On 23-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2022, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 30-Sep-2022, the patient experienced COVID-19 IMMUNISATION (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, COVID-19 IMMUNISATION (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine), INTERCHANGE OF VACCINE PRODUCTS (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine) 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 assessments were provided for COVID-19 IMMUNISATION (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine) and INTERCHANGE OF VACCINE PRODUCTS (First dose of the Moderna COVID-19 vaccine and then received a dose of the Pfizer COVID-19 vaccine).    Concomitant product use was not provided by the reporter.  The patient had also received several other vaccines at the same time as the Pfizer vaccine.  No treatment information was provided.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: little localized reaction; a little red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (little localized reaction) and VACCINATION SITE ERYTHEMA (a little red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  Previously administered products included for Drug use for unknown indication: Skelaxin and Influenza vaccine (Gets the flu shot every year). Past adverse reactions to the above products included Hives with Skelaxin; and No adverse event with Influenza vaccine. Concurrent medical conditions included Drug allergy (Allergy to Reglan), Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to phenothiazines (Compazine, Mellaril)), Drug allergy (Allergy to codeine), Drug allergy (Allergy to Flexeril), Drug allergy (Allergy to Flagyl), Drug allergy (Allergy to hydrocodone), Drug allergy (Allergy to oxycodone), Drug allergy (Allergy to Skelaxin (hives)), Drug allergy (Allergy to Dilaudid) and Drug allergy (Allergy to Imitrex).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-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 VACCINATION SITE REACTION (little localized reaction) and VACCINATION SITE ERYTHEMA (a little red). At the time of the report, VACCINATION SITE REACTION (little localized reaction) and VACCINATION SITE ERYTHEMA (a little red) outcome was unknown.            No concomitant medications were reported. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient had a question about ingredients in the vaccine. She received the first two series of Moderna vaccine and had no real problem. She had a little localized reaction, a little red, but no fever. The patient explained that she gets the flu shot every year, and she's never had a reaction.  No treatment medications was reported.   This case was linked to MOD-2022-654193, MOD-2022-654194 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: little localized reaction; a little red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE REACTION (little localized reaction) and VACCINATION SITE ERYTHEMA (a little red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 025A21A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis.  Previously administered products included for Drug use for unknown indication: Skelaxin and Influenza vaccine (Gets the flu shot every year). Past adverse reactions to the above products included Hives with Skelaxin; and No adverse event with Influenza vaccine. Concurrent medical conditions included Drug allergy (Allergy to Reglan), Sulfonamide allergy (Allergy to sulfa), Drug allergy (Allergy to phenothiazines (Compazine, Mellaril)), Drug allergy (Allergy to codeine), Drug allergy (Allergy to Flexeril), Drug allergy (Allergy to Flagyl), Drug allergy (Allergy to hydrocodone), Drug allergy (Allergy to oxycodone), Drug allergy (Allergy to Skelaxin (hives)), Drug allergy (Allergy to Dilaudid) and Drug allergy (Allergy to Imitrex).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-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 VACCINATION SITE REACTION (little localized reaction) and VACCINATION SITE ERYTHEMA (a little red). At the time of the report, VACCINATION SITE REACTION (little localized reaction) and VACCINATION SITE ERYTHEMA (a little red) outcome was unknown.            No concomitant medications were reported. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  The patient had a question about ingredients in the vaccine. She received the first two series of Moderna vaccine and had no real problem. She had a little localized reaction, a little red, but no fever. The patient explained that she gets the flu shot every year, and she's never had a reaction.  No treatment medications was reported.   This case was linked to MOD-2022-654193, MOD-2022-654194 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: Little redness around the arm; A little sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Little redness around the arm) and VACCINATION SITE PAIN (A little sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 003B21A and 025A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu (The patient explained that she gets the flu shot every year and and she never had a reaction). Past adverse reactions to the above products included No adverse event with flu. Concurrent medical conditions included Drug allergy (Reglan), Drug allergy (phenothiazines (Compazine)), Drug allergy (phenothiazines (Mellaril)), Sulfonamide allergy (sulfa), Drug allergy (codeine), Drug allergy (Flexeril), Drug allergy (Flagyl), Drug allergy (hydrocodone), Drug allergy (oxycodone), Drug allergy (Skelaxin (hives)), Drug allergy (Dilaudid) and Drug allergy (Imitrex).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, 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 experienced VACCINATION SITE ERYTHEMA (Little redness around the arm) and VACCINATION SITE PAIN (A little sore arm). At the time of the report, VACCINATION SITE ERYTHEMA (Little redness around the arm) and VACCINATION SITE PAIN (A little sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that patient never had COVID + test or diagnosis.  No other vaccine was given within 1 month prior to Moderna Covid-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-654184, MOD-2022-654194 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Little redness around the arm; A little sore arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Little redness around the arm) and VACCINATION SITE PAIN (A little sore arm) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939901, 003B21A and 025A21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: flu (The patient explained that she gets the flu shot every year and and she never had a reaction). Past adverse reactions to the above products included No adverse event with flu. Concurrent medical conditions included Drug allergy (Reglan), Drug allergy (phenothiazines (Compazine)), Drug allergy (phenothiazines (Mellaril)), Sulfonamide allergy (sulfa), Drug allergy (codeine), Drug allergy (Flexeril), Drug allergy (Flagyl), Drug allergy (hydrocodone), Drug allergy (oxycodone), Drug allergy (Skelaxin (hives)), Drug allergy (Dilaudid) and Drug allergy (Imitrex).   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, 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 experienced VACCINATION SITE ERYTHEMA (Little redness around the arm) and VACCINATION SITE PAIN (A little sore arm). At the time of the report, VACCINATION SITE ERYTHEMA (Little redness around the arm) and VACCINATION SITE PAIN (A little sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  It was reported that patient never had COVID + test or diagnosis.  No other vaccine was given within 1 month prior to Moderna Covid-19 vaccine.  Treatment information was not provided.   This case was linked to MOD-2022-654184, MOD-2022-654194 (Patient Link).