chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) and POOR QUALITY PRODUCT ADMINISTERED (Received a refreeze vaccine once thawed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Apr-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Received a refreeze vaccine once thawed). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed). At the time of the report, PRODUCT STORAGE ERROR (Received a refreeze vaccine once thawed) and POOR QUALITY PRODUCT ADMINISTERED (Received a refreeze vaccine once thawed) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No information on concomitant medication was reported. It was reported that a thawed vial was stored in the freezer. Vial was initially stored on the 07-Apr-2022 at 41.6 degree F then the vial was moved to the freezer at -8.1 degree F. Then, they took it out from the freezer on the date when the doses were administered. This vial was again thawed and then administered to 4 patients. The doses applied were 2 second boosters and 2 first boosters on the 16-Apr-2022. The vial did not undergo any temperature excursions. No information on treatment medications was reported. This case was linked to MOD-2022-545266, MOD-2022-545269, MOD-2022-545270 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (each time soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient had no allergies to medications, food, and other products. The patient never had COVID + test or diagnosis. The patient didn't reported receiving any other vaccines within 1 month prior to Moderna COVID-19 vaccine. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (each time soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (each time soreness at the injection site) had resolved. For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant product use was reported. The patient stated that after receiving the Moderna primacy series doses (1st and 2nd) each time patient experienced soreness at the injection site. The patient reported they didn't had any other side effects from any of these doses. No treatment information was provided. This case was linked to MOD-2022-545276, MOD-2022-545265, MOD-2022-545278 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE PAIN (each time soreness at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced VACCINATION SITE PAIN (each time soreness at the injection site). At the time of the report, VACCINATION SITE PAIN (each time soreness at the injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No allergies were reported. Patient was never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. This case was linked to MOD-2022-545276, MOD-2022-545277, MOD-2022-545265 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Patient could hear her heartbeat in her ear/Patient could hear her heartbeat when laying down and even standing up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A and 010821A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Augmentin allergy), Asthma, Hypertension and High cholesterol. Concomitant products included LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TINNITUS (Patient could hear her heartbeat in her ear/Patient could hear her heartbeat when laying down and even standing up). At the time of the report, TINNITUS (Patient could hear her heartbeat in her ear/Patient could hear her heartbeat when laying down and even standing up) had resolved. Patient used inhalers for asthma, over the counter medication like calcium. Patient did not take any treatment medications. Patient did not have COVID-19 in the past. Patient had a office visit with HCP. The symptoms lasted 5-6 days.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Stated that her first dose was on 04-Mar-2021 and second dose was on 16-Apr-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Stated that her first dose was on 04-Mar-2021 and second dose was on 16-Apr-2021) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Allergies (medications, food and other products) was reported as no. The patient never had COVID positive test or diagnosis. The patient not had Medical history relating to mentioned adverse event and both acute and chronic illnesses at the time of vaccination.  Concurrent medical conditions included Allergic reaction to drug (Codeine, but does not have an allergy to Codeine).   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Stated that her first dose was on 04-Mar-2021 and second dose was on 16-Apr-2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Stated that her first dose was on 04-Mar-2021 and second dose was on 16-Apr-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that the patient had no health conditions and took no medication. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine was reported as no. It was reported that the patient had no reaction to any other of the shots.  No treatment information was reported.   This case was linked to MOD-2022-545322 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered with a dose of Moderna from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient was administered  with a dose of Moderna from a vial that had been punctured for more than 12 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057M21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered with a dose of Moderna from a vial that had been punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient was administered  with a dose of Moderna from a vial that had been punctured for more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered  with a dose of Moderna from a vial that had been punctured for more than 12 hours) and PRODUCT STORAGE ERROR (patient was administered  with a dose of Moderna from a vial that had been punctured for more than 12 hours) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that patient was administered with second booster dose. It was reported that Number of doses/vials administered were 3 doses. The vial was initially stored in the refrigerator on 15-Apr-2022. The vial was first punctured at 11:50AM on 19-Apr-2022. The vial was stored at room temperature post puncture. It was reported that the vial was left on countertop overnight. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was 24 hours. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2022-546072, MOD-2022-546074 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. It was unknown if the patient had any allergies (medications, food and other products). It was also unknown if the patient ever had COVID positive test or diagnosis. It was unknown if other vaccines given within 1 month prior to Moderna COVID-19 vaccine. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication of the patient was not reported. The events did not cause the patient to seek medical care (office visit, urgent care, ER, hospitalized). No treatment information was provided by the reporter. This case was linked to MOD-2022-545402, MOD-2022-545418 (Patient Link). Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up information included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Mobility decreased, Tremor, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I could barely lift my arm), TREMOR (shakes), DIZZINESS (real dizzy), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced TREMOR (shakes), DIZZINESS (real dizzy), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (shivers). On an unknown date, the patient experienced MOBILITY DECREASED (I could barely lift my arm). At the time of the report, MOBILITY DECREASED (I could barely lift my arm) outcome was unknown and TREMOR (shakes), DIZZINESS (real dizzy), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (shivers) had resolved. No concomitant medications were reported. No treatment medications were reported. The Adverse Events did not cause patient to seek medical care. This case was linked to MOD-2022-545345, MOD-2022-545418 (Patient Link). Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow Up received include no new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I could barely lift my arm), TREMOR (shakes), DIZZINESS (real dizzy), VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, the patient experienced TREMOR (shakes), DIZZINESS (real dizzy), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (shivers). On an unknown date, the patient experienced MOBILITY DECREASED (I could barely lift my arm). At the time of the report, MOBILITY DECREASED (I could barely lift my arm) outcome was unknown and TREMOR (shakes), DIZZINESS (real dizzy), VACCINATION SITE PAIN (pain at the injection site), VACCINATION SITE SWELLING (swelling at the injection site) and CHILLS (shivers) had resolved. No concomitant medications were reported. No treatment medications were reported. The Adverse Events did not cause patient to seek medical care. This case was linked to MOD-2022-545345, MOD-2022-545418 (Patient Link). Reporter did not allow further contact. Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow Up received include no new information.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: pain at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A, 014M20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-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 22-Oct-2021, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) had resolved.            No concomitant medications were reported.  Patient did not seek to medical care due to adverse events. Patient was experienced a similar event in past.  No treatment medications were reported.   This case was linked to MOD-2022-545402, MOD-2022-545345 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Contained no new information.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Patient felt sick; She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines; Patient had a fever; Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient felt sick), ALOPECIA (She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines), PYREXIA (Patient had a fever) and VACCINATION SITE PAIN (Sore right injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced MALAISE (Patient felt sick), ALOPECIA (She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines), PYREXIA (Patient had a fever) and VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, MALAISE (Patient felt sick), ALOPECIA (She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines), PYREXIA (Patient had a fever) and VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2022-545585, MOD-2022-54564.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Patient felt sick; She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines; Patient had a fever; Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient felt sick), ALOPECIA (She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines), PYREXIA (Patient had a fever) and VACCINATION SITE PAIN (Sore right injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced MALAISE (Patient felt sick), ALOPECIA (She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines), PYREXIA (Patient had a fever) and VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, MALAISE (Patient felt sick), ALOPECIA (She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines), PYREXIA (Patient had a fever) and VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2022-545585, MOD-2022-54564.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Malaise, Vaccination site pain
Clinical narrative: Patient felt sick; She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines; Patient had a fever; Sore right injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient felt sick), ALOPECIA (She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines), PYREXIA (Patient had a fever) and VACCINATION SITE PAIN (Sore right injection site arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced MALAISE (Patient felt sick), ALOPECIA (She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines), PYREXIA (Patient had a fever) and VACCINATION SITE PAIN (Sore right injection site arm). At the time of the report, MALAISE (Patient felt sick), ALOPECIA (She has lost a lot of hair since she received the first dose of the Moderna Covid-19 vaccines), PYREXIA (Patient had a fever) and VACCINATION SITE PAIN (Sore right injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications information was reported. No treatment medications were provided.   This case was linked to MOD-2022-545585, MOD-2022-54564.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received contains no new information.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Felt sick.; Sore right injection site arm.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick.) and VACCINATION SITE PAIN (Sore right injection site arm.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Felt sick.) and VACCINATION SITE PAIN (Sore right injection site arm.). At the time of the report, MALAISE (Felt sick.) and VACCINATION SITE PAIN (Sore right injection site arm.) outcome was unknown.            The patient received the vaccine in her right arm shoulder deltoid muscle. Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2022-545646, MOD-2022-545455 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received does not contain any new information.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Felt sick.; Sore right injection site arm.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick.) and VACCINATION SITE PAIN (Sore right injection site arm.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Felt sick.) and VACCINATION SITE PAIN (Sore right injection site arm.). At the time of the report, MALAISE (Felt sick.) and VACCINATION SITE PAIN (Sore right injection site arm.) outcome was unknown.            The patient received the vaccine in her right arm shoulder deltoid muscle. Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2022-545646, MOD-2022-545455 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received does not contain any new information.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Malaise, Vaccination site pain
Clinical narrative: Felt sick.; Sore right injection site arm.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Felt sick.) and VACCINATION SITE PAIN (Sore right injection site arm.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 027K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced MALAISE (Felt sick.) and VACCINATION SITE PAIN (Sore right injection site arm.). At the time of the report, MALAISE (Felt sick.) and VACCINATION SITE PAIN (Sore right injection site arm.) outcome was unknown.            The patient received the vaccine in her right arm shoulder deltoid muscle. Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2022-545646, MOD-2022-545455 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received does not contain any new information.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Patient was sick again after the booster dose; Patient first noticed the hair loss; painful left arm after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient was sick again after the booster dose), ALOPECIA (Patient first noticed the hair loss) and VACCINATION SITE PAIN (painful left arm after the booster dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 011M20A and 027K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced MALAISE (Patient was sick again after the booster dose), ALOPECIA (Patient first noticed the hair loss) and VACCINATION SITE PAIN (painful left arm after the booster dose). At the time of the report, MALAISE (Patient was sick again after the booster dose), ALOPECIA (Patient first noticed the hair loss) and VACCINATION SITE PAIN (painful left arm after the booster dose) outcome was unknown.            No concomitant drug reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-545585 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received, contains No new information.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Patient was sick again after the booster dose; Patient first noticed the hair loss; painful left arm after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient was sick again after the booster dose), ALOPECIA (Patient first noticed the hair loss) and VACCINATION SITE PAIN (painful left arm after the booster dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 011M20A and 027K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced MALAISE (Patient was sick again after the booster dose), ALOPECIA (Patient first noticed the hair loss) and VACCINATION SITE PAIN (painful left arm after the booster dose). At the time of the report, MALAISE (Patient was sick again after the booster dose), ALOPECIA (Patient first noticed the hair loss) and VACCINATION SITE PAIN (painful left arm after the booster dose) outcome was unknown.            No concomitant drug reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-545585 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received, contains No new information.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Malaise, Vaccination site pain
Clinical narrative: Patient was sick again after the booster dose; Patient first noticed the hair loss; painful left arm after the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Patient was sick again after the booster dose), ALOPECIA (Patient first noticed the hair loss) and VACCINATION SITE PAIN (painful left arm after the booster dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A, 011M20A and 027K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, the patient experienced MALAISE (Patient was sick again after the booster dose), ALOPECIA (Patient first noticed the hair loss) and VACCINATION SITE PAIN (painful left arm after the booster dose). At the time of the report, MALAISE (Patient was sick again after the booster dose), ALOPECIA (Patient first noticed the hair loss) and VACCINATION SITE PAIN (painful left arm after the booster dose) outcome was unknown.            No concomitant drug reported. No treatment information was provided by the reporter.   This case was linked to MOD-2022-545585 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow-up received, contains No new information.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever after getting the 2nd dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (fever after getting the 2nd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever after getting the 2nd dose). At the time of the report, PYREXIA (fever after getting the 2nd dose) had resolved.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. It was reported that patient had fever for 7-10 days after getting the 2nd dose.   This case was linked to MOD-2022-545561 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Product storage error; Covid-19 vaccine that were given beyond the 30 day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (Product storage error) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2022 at 9:00 PM, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 09-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient Not contacted HCP about any reactions.  No concomitant medication information provided. No treatment medication information provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Covid-19 vaccine that were given beyond the 30 day use by date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 vaccination.     No Medical History information was reported.  On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Covid-19 vaccine that were given beyond the 30 day use by date.) outcome was unknown. Not Provided    For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  A series of patients at a clinic received their second booster dose with a vial of Moderna that went past 30 days at 7-8 degree Celsius. At the time of administration it was approx. 6-10 days past the 30 day window. At the time of report, no patient contacted about any reactions.  Treatment information was not provided.   This case was linked to MOD-2022-542869 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Moderna Covid-19 vaccine ere administered; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine ere administered) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient was never diagnosed or tested positive with COVID -19. Patient does not have any acute illness at the time of vaccination and up to one month before.  Concurrent medical conditions included COPD, Hypoxic respiratory failure (Respiratory failure with hypoxia) and Pulmonary contusion.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine ere administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Moderna Covid-19 vaccine ere administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided by reporter. It was reported that there were no other vaccine given on the same day as Moderna COVID-19 vaccine and other vaccine received within one month prior to any dose of Moderna COVID-19 vaccine. The date at which the vial was initially stored in the refrigerator was unknown. It was transferred from another source. The vial did not undergo any temperature excursions.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Tension
Clinical narrative: went to get a booster last year, she received a third dose instead.; felt super tense and hipper after the third dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of TENSION (felt super tense and hipper after the third dose.) and ACCIDENTAL OVERDOSE (went to get a booster last year, she received a third dose instead.) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 9399021, 031L20A and 011C20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (allergic to codeine) and Latex allergy.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ACCIDENTAL OVERDOSE (went to get a booster last year, she received a third dose instead.). In August 2021, the patient experienced TENSION (felt super tense and hipper after the third dose.). At the time of the report, TENSION (felt super tense and hipper after the third dose.) had resolved and ACCIDENTAL OVERDOSE (went to get a booster last year, she received a third dose instead.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No medical history was reported.   No concomitant medications were reported.  Patient was never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. The patient was not immunocompromised.  No treatment medications were reported.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ischaemic stroke
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of ISCHAEMIC STROKE (Acute ischemic stroke) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: First report of COVID-19 vaccine included flare of compensated congenital thrombotic thrombocytopenic purpura. Blood Coagul Fibrinolysis; 33(1). No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ISCHAEMIC STROKE (Acute ischemic stroke) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (Acute ischemic stroke) 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 considered ISCHAEMIC STROKE (Acute ischemic stroke) to be related. No concomitant medication was reported. No treatment medication was reported. Company Comment: This is a Literature-non-study case, concerning a 50-year-old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant), and AESI of Ischaemic stroke. The event occurred on an unknown date after a dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a Literature-non-study case, concerning a 50-year-old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant), and AESI of Ischaemic stroke. The event occurred on an unknown date after a dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ischaemic stroke, Thrombocytopenia, Thrombotic thrombocytopenic purpura
Clinical narrative: This literature-non-study case was reported in a literature article and describes the occurrence of ISCHAEMIC STROKE (Acute ischemic stroke) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: First report of COVID-19 vaccine included flare of compensated congenital thrombotic thrombocytopenic purpura. Blood Coagul Fibrinolysis; 33(1). No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ISCHAEMIC STROKE (Acute ischemic stroke) (seriousness criterion medically significant). At the time of the report, ISCHAEMIC STROKE (Acute ischemic stroke) 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 considered ISCHAEMIC STROKE (Acute ischemic stroke) to be related. No concomitant medication was reported. No treatment medication was reported. Company Comment: This is a Literature-non-study case, concerning a 50-year-old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant), and AESI of Ischaemic stroke. The event occurred on an unknown date after a dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report. Sender's Comments: This is a Literature-non-study case, concerning a 50-year-old female patient, with no medical history reported, who experienced the unexpected, serious (medically significant), and AESI of Ischaemic stroke. The event occurred on an unknown date after a dose of mRNA-1273. Clinical course, diagnostic tests and treatment details were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dispensed 28 doses of expired Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient has never been diagnosed or tested positive for COVID-19 No acute illness reported at the time of vaccination and up to one month before it.  Concurrent medical conditions included Peripheral vascular disease, Congestive heart failure and Arteriosclerotic heart disease.    On 06-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dispensed 28 doses of expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.  The date in which vial was initially stored in the refrigerator was Unknown. It was transferred from another store. The vial did not undergo any temperature excursions. No adverse events reported. It was reported that the stability studies came back fine from Moderna.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Patients have been administered from vaccines that experienced a T excursion; Patients have been administered from vaccines that experienced a T excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) in a 63-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 027L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 23-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patients have been administered from vaccines that experienced a T excursion) and POOR QUALITY PRODUCT ADMINISTERED (Patients have been administered from vaccines that experienced a T excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The patient did not have any adverse events post injection. It was reported that the storage condition at the time of the excursion was at refrigerator. Maximum temperature reached was 64-degree Fahrenheit, and excursion duration was approximately 7 hours. The vials were returned to the refrigerator. No changes in visual inspection. Pertinent details: At the time they were unpunctured. It was reported as Tran date as 23-Mar-2022 No treatment medication information was given.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2022: Follow up received contains no new information. On 20-Apr-2022: Follow up received contains patient information and dose number.