chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea not to be believed/umbearable nausea; Vomited for 6 hours/vomiting episode/unexplained vomiting it was so bad/threw up for straight 14 hours; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea not to be believed/umbearable nausea) and VOMITING (Vomited for 6 hours/vomiting episode/unexplained vomiting it was so bad/threw up for straight 14 hours) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (Dose 1, Lot No. EN6207) on 15-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose 2 and Lot No. EP7533) on 05-Apr-2021. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concurrent medical conditions included Insomnia, Drug allergy (Allergy to Vicodin), Depression, Anxiety and Drug allergy (Allergy to ziprol). Concomitant products included VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Anxiety and Depression, TEMAZEPAM for Insomnia.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Dec-2021, the patient experienced VOMITING (Vomited for 6 hours/vomiting episode/unexplained vomiting it was so bad/threw up for straight 14 hours). On an unknown date, the patient experienced NAUSEA (Nausea not to be believed/umbearable nausea). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea not to be believed/umbearable nausea) and VOMITING (Vomited for 6 hours/vomiting episode/unexplained vomiting it was so bad/threw up for straight 14 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) Results were okay. On an unknown date, Colonoscopy: normal (normal) Results were okay. On an unknown date, Computerised tomogram: normal (normal) Results were okay. On an unknown date, Endoscopy: normal (normal) Results were okay.         It was reported that patient has never been diagnosed or tested positive for COVID-19. The patient did not have any acute and chronic illnesses at the time of vaccination. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  On 04-Dec-2021 the patient vomited for 6 hours. The patient was feeling okay and then suddenly had this vomiting episode. It was really strange for the patient, it was unknown to the patient if it was a stomach flu, or if it was a food poison. Then the patient had this vomiting episode a couple more times on Dec-2021, Jan-2022, and the last one was on 07-Feb-2022. The patient stated that this last episode was an unexplained vomiting, it was so bad and patient threw up for straight 14 hours.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2022 at 11:54 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Feb-2022 at 11:54 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021 and administered on 12-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Vaccine went into 2-8 °C thaw state on or about 24-Dec-2021, this vaccine was administered up until its manufacturing expiry date of 4 April 2022.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-542869 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to the patient after exposure to room temperature for more than 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to the patient after exposure to room temperature for more than 24 hours) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 057M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022 at 4:00 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022 at 4:00 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to the patient after exposure to room temperature for more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered to the patient after exposure to room temperature for more than 24 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  A vial was taken out of the freezer on 23-Apr-2022 and was punctured at 24-Apr-2022, 11 A.M. The vial was left out in room temperature until a dose was given from the vial to the patient at 25-Apr-2022 4 P.M. The pharmacist would urgently like to know if the dose was appropriate that was administered.  The vial was initially stored in the refrigerator on 23-Apr-2022.  The vial did not undergo any temperature excursions.  The total amount of time for which the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius/46 degree Fahrenheit to 77 degree Fahrenheit) was 29 hours.  No treatment information was reported.   Reporter did not allow further contact
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient received a booster dose of Moderna Covid-19 vaccine 24.5 hrs after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received a booster dose of Moderna Covid-19 vaccine 24.5 hrs after first puncture) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received a booster dose of Moderna Covid-19 vaccine 24.5 hrs after first puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient received a booster dose of Moderna Covid-19 vaccine 24.5 hrs after first puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the half dose (booster dose) was administered to the patient after exposure to room temperature for more than 24 hours. The vial did not undergo any temperature excursions. It was unknown when the vial was initially stored in the refrigerator and it was received in thawed state.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: got a double booster making it a full shot; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (got a double booster making it a full shot) in a male patient of an unknown age 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (got a double booster making it a full shot). At the time of the report, ACCIDENTAL OVERDOSE (got a double booster making it a full shot) outcome was unknown. Patient stated that for his first booster shot, he got a double booster making it a full shot. He wanted to know can he get the second booster dose. No concomitant medications details were reported. No treatment medications details were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Beyond the 30 day use by date, 22Apr2022; Inadvertently administered to a patient an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered to a patient an expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Beyond the 30 day use by date, 22Apr2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered to a patient an expired dose of the Moderna COVID-19 vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Beyond the 30 day use by date, 22Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered to a patient an expired dose of the Moderna COVID-19 vaccine) and PRODUCT STORAGE ERROR (Beyond the 30 day use by date, 22Apr2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  The vaccine was administered to the patient around lunch time on 25-Apr-2022 probably at 12 noon. The vial was stored in refrigerator on 23-Mar-2022. The vial doesn't undergone any temperature excursion.  It was reported that it would be the second dose of vaccine.  No treatment medications was reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood test, Chills, Influenza like illness, Malaise
Clinical narrative: flu like symptom's; Ache in neck; Ache in back; pain in arm; have been sick/ she does not feel great; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom's), NECK PAIN (Ache in neck), BACK PAIN (Ache in back), PAIN IN EXTREMITY (pain in arm) and MALAISE (have been sick/ she does not feel great) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 048C21A, 022M2014 and 031LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Consumer reported no pre-existing condition nor allergy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom's), NECK PAIN (Ache in neck), BACK PAIN (Ache in back), PAIN IN EXTREMITY (pain in arm), MALAISE (have been sick/ she does not feel great) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom's), NECK PAIN (Ache in neck), BACK PAIN (Ache in back), PAIN IN EXTREMITY (pain in arm), MALAISE (have been sick/ she does not feel great) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Blood test: did not find anything (normal) Did not find anything. In April 2022, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided by the reporter.  Patient started to experience symptoms in the evening of vaccine receipt and have been sick for week and half.  It was reported that symptoms are somehow ongoing.  Treatment information was not provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: flu like symptom's; Ache in neck; Ache in back; pain in arm; have been sick/ she does not feel great; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptom's), NECK PAIN (Ache in neck), BACK PAIN (Ache in back), PAIN IN EXTREMITY (pain in arm) and MALAISE (have been sick/ she does not feel great) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 048C21A, 022M2014 and 031LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Consumer reported no pre-existing condition nor allergy.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptom's), NECK PAIN (Ache in neck), BACK PAIN (Ache in back), PAIN IN EXTREMITY (pain in arm), MALAISE (have been sick/ she does not feel great) and CHILLS (Chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptom's), NECK PAIN (Ache in neck), BACK PAIN (Ache in back), PAIN IN EXTREMITY (pain in arm), MALAISE (have been sick/ she does not feel great) and CHILLS (Chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Blood test: did not find anything (normal) Did not find anything. In April 2022, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant product use was not provided by the reporter.  Patient started to experience symptoms in the evening of vaccine receipt and have been sick for week and half.  It was reported that symptoms are somehow ongoing.  Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Insomnia
Clinical narrative: difficulty breathing; difficulty sleeping; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing) and INSOMNIA (difficulty sleeping) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056M21A) 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) (Intramuscular) 1 dosage form. On 20-Apr-2022, the patient experienced DYSPNOEA (difficulty breathing) and INSOMNIA (difficulty sleeping). At the time of the report, DYSPNOEA (difficulty breathing) and INSOMNIA (difficulty sleeping) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Apr-2022, Heart rate: elevated (abnormal) elevated.         Concomitant medications was not provided by the reporter.  Treatment information was not provided.
Age: 55.0
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 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    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. Not Provided  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were taken by the patient. The vial did not undergo any temperature excursion and it was unknown when the vial initially stored in the refrigerator.  It was reported that patient did not experienced any adverse events from the vaccine on 08-Apr-2022.   Total number of vials/doses was 28 Treatment medications were not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after 30-day use by date or after manufacture date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day use by date or after manufacture date of expiry) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     It was reported that the patient did not have any acute illness at the time of vaccination and up to one month before. The patient had never been diagnosed with/ tested positive for COVID-19. The patient had no chronic or long-standing health conditions. 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 (Vaccine administered after 30-day use by date or after manufacture date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 30-day use by date or after manufacture date of expiry) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had no concomitant medications taken at time of vaccination and or at the time of the adverse event. It was reported that, 28 doses were administered after 30-day use by date or after manufacture date of expiry. The expiry date for the vaccine was given as 18-Mar-2022. The date of vial initially stored in refrigerator was unknown and vials were transferred from another store.  The vial did not undergo any temperature excursion.  Stability study was requested and the results showed full activity against COVID-19. No information on treatment medications was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The vial did not undergo any temperature excursions. Total number of vials/doses was 28. No treatment medication was reported.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired vaccine from 28 dispensed doses of expired Moderna Covid-19 on 08-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine from 28 dispensed doses of expired Moderna Covid-19 on 08-APR-2022) in a 55-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. Patient had no acute illness at the time of vaccination and up to one month before and does not have any acute illnesses or chronic and long standing health conditions at the time of vaccination and up to one month before.     On 08-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine from 28 dispensed doses of expired Moderna Covid-19 on 08-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine from 28 dispensed doses of expired Moderna Covid-19 on 08-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient reported no adverse events from the vaccine on 08-Apr-2022. It was reported that patient does not had any prescriptions, over-the counter medications, dietary supplements or herbal remedies taken at time of vaccination or at the time of adverse event. The date when the vial was initially stored in the refrigerator was unknown as it was transferred from another store. The vial did not undergo any temperature excursions. The vaccine had an expiration date of 18-Mar-2022 so a stability study was requested with Moderna. The results of the stability study show full activity against COVID-19. No treatment medications were reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; administer an expired vaccine to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer an expired vaccine to a patient) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 25-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer an expired vaccine to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer an expired vaccine to a patient) and PRODUCT STORAGE ERROR (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Patient's allergies (medications, food and other products) reported as unknown. Patient COVID positive test or diagnosis reported as unknown.  Date the vial was initially stored in the refrigerator 23Apr2022.  No concomitant medication was reported.    No treatment information was reported.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt lousy) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 013M20A) for COVID-19 vaccination. The patient's past medical history included Balance disorder (Balance issues). On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MALAISE (Felt lousy). On 04-Mar-2021, MALAISE (Felt lousy) had resolved. No concomitant medications were provided. After the first dose the patient did not have side effects. After the 2nd primary dose, the patient felt lousy. No treatment medications were reported. This case was linked to MOD-2022-549121, MOD-2022-548661 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a expired vaccine 16Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a expired vaccine 16Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  It was reported that the patient never had COVID positive test or diagnosis and patient didn't received any other vaccines within 1 month prior to Moderna COVID-19 vaccine.  No treatment medication information was provided.   This case was linked to MOD-2022-549135, MOD-2022-549157, MOD-2022-549136 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2022: Follow-up received on 25-Apr-2022:.Reporter information and patient details updated.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30-day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     Patient had no known allergies to medications, food and other. No patient had ever been diagnosed with positive for COVID-19. Patient did not receive prescription Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event. No acute illness was reported at the time of vaccination and up to one month before. Patient had no chronic or long-lasting health conditions.     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 (Dose administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The date when the vial was initially stored in the refrigerator was unknown as it was transferred from another store. The vial did not undergo any temperature excursions. The vaccine had an expiration date of 18-Mar-2022 so a stability study was requested with Moderna. The results of the stability study show full activity against COVID-19. No treatment medications were reported.   This case was linked to MOD-2022-541343 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site reaction
Clinical narrative: noticed a huge bubble at the injection site; was given his dose of the Moderna Covid-19 Vaccine subcutaneously; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (noticed a huge bubble at the injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was given his dose of the Moderna Covid-19 Vaccine subcutaneously) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (First two primary doses (First dose)), PFIZER BIONTECH COVID-19 VACCINE (First booster dose) and PFIZER BIONTECH COVID-19 VACCINE (First two primary doses (Second dose)). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 22-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 22-Apr-2022, the patient experienced VACCINATION SITE REACTION (noticed a huge bubble at the injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was given his dose of the Moderna Covid-19 Vaccine subcutaneously). At the time of the report, VACCINATION SITE REACTION (noticed a huge bubble at the injection site) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (was given his dose of the Moderna Covid-19 Vaccine subcutaneously) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Patient had gotten first two primary doses & a first booster dose of the Pfizer Covid-19 Vaccine.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-549475 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: the vial was initially stored in the refrigerator on 25-Mar-2022 and vaccine was administred on 25-Apr-2022; gave an expired dose of a Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave an expired dose of a Moderna vaccine) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25-Mar-2022 and vaccine was administred on 25-Apr-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave an expired dose of a Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25-Mar-2022 and vaccine was administered on 25-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave an expired dose of a Moderna vaccine) and PRODUCT STORAGE ERROR (the vial was initially stored in the refrigerator on 25-Mar-2022 and vaccine was administered on 25-Apr-2022) outcome was unknown.    For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported Dose administered after manufacturer date of expiry. The vial does not undergo any temperature excursions. Treatment information was not reported
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Post-acute COVID-19 syndrome
Clinical narrative: long COVID; became very ill; developed COVID after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (developed COVID after being vaccinated), POST-ACUTE COVID-19 SYNDROME (long COVID) and ILLNESS (became very ill) in a 23-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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced COVID-19 (developed COVID after being vaccinated). On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (long COVID) and ILLNESS (became very ill). At the time of the report, COVID-19 (developed COVID after being vaccinated) had not resolved and POST-ACUTE COVID-19 SYNDROME (long COVID) and ILLNESS (became very ill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.  Company comment: This spontaneous case concerns a 23 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19 after receiving a dose of COVID -19 vaccination with mRNA-1273 vaccine (latency unknown). The patient also experienced Post-acute COVID-19 syndrome. No further information on clinical course, management of the event, vaccination schedule and its details were available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Apr-2022: Follow-up received and contains no new information; Sender's Comments: This spontaneous case concerns a 23 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19 after receiving a dose of COVID -19 vaccination with mRNA-1273 vaccine (latency unknown). The patient also experienced Post-acute COVID-19 syndrome. No further information on clinical course, management of the event, vaccination schedule and its details were available in the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Salivary gland pain
Clinical narrative: pain near Salivary gland on the left side; This spontaneous case was reported by a consumer and describes the occurrence of SALIVARY GLAND PAIN (pain near Salivary gland on the left side) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 025A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced SALIVARY GLAND PAIN (pain near Salivary gland on the left side). On 18-Mar-2021, SALIVARY GLAND PAIN (pain near Salivary gland on the left side) had resolved.     No concomitant medication reported. No treatment medication reported.   This case was linked to MOD-2022-549092 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: unauthorized age receive Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age receive Moderna) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age receive Moderna). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (unauthorized age receive Moderna) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  HCP stated that they accidentally administered 2 doses of the Moderna COVID-19 vaccine to a patient before they turned 18. Now, they are 18 years old and would like to receive a booster.  Treatment information was not provided.   This case was linked to MOD-2022-549081 (Patient Link).
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Hypoaesthesia
Clinical narrative: Feeling of pressure on the left abdomen after 2nd half dose booster; Numbness on the left side of the body after 2nd half dose booster; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Feeling of pressure on the left abdomen after 2nd half dose booster) and HYPOAESTHESIA (Numbness on the left side of the body after 2nd half dose booster) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001H21A, 004F21A, 025A21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, the patient experienced ABDOMINAL DISCOMFORT (Feeling of pressure on the left abdomen after 2nd half dose booster) and HYPOAESTHESIA (Numbness on the left side of the body after 2nd half dose booster). At the time of the report, ABDOMINAL DISCOMFORT (Feeling of pressure on the left abdomen after 2nd half dose booster) and HYPOAESTHESIA (Numbness on the left side of the body after 2nd half dose booster) outcome was unknown.            No concomitant medication reported. Patient received first booster dose on 10 Sep 2021 and received second booster dose on 20 Apr 2022.  No treatment medication reported. Reporter reported he visited doctor and ran tests in the hospital, then ruled out a stroke.   This case was linked to MOD-2022-549082 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2a) for COVID-19 vaccination.     The patient had never been tested positive or diagnosed with COVID-19 disease. The patient had no allergies to medications, food and other products.   The patient had no medical history related to mentioned adverse events and did not have any acute and chronic illnesses at the time of vaccination. The patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccination.     On 20-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  On 20-Apr-2022, the patient received the first booster dose of the vaccine.  No treatment information was provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Computerised tomogram, Disorientation, Dysstasia, Muscular weakness
Clinical narrative: Legs felt weaker and weaker one day after 2nd booster; Could not stand up one day after 2nd booster; Felt out of balance one day after 2nd booster; Swollen right arm after 2nd booster; Felt mildly dis-oriented a few hours after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen right arm after 2nd booster), DISORIENTATION (Felt mildly dis-oriented a few hours after 2nd booster), MUSCULAR WEAKNESS (Legs felt weaker and weaker one day after 2nd booster), DYSSTASIA (Could not stand up one day after 2nd booster) and BALANCE DISORDER (Felt out of balance one day after 2nd booster) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 939903 and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Balance difficulty (Balance issues).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced VACCINATION SITE SWELLING (Swollen right arm after 2nd booster) and DISORIENTATION (Felt mildly dis-oriented a few hours after 2nd booster). On 15-Apr-2022, the patient experienced MUSCULAR WEAKNESS (Legs felt weaker and weaker one day after 2nd booster), DYSSTASIA (Could not stand up one day after 2nd booster) and BALANCE DISORDER (Felt out of balance one day after 2nd booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 2 Tylenols. On 15-Apr-2022, DISORIENTATION (Felt mildly dis-oriented a few hours after 2nd booster) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swollen right arm after 2nd booster) outcome was unknown and MUSCULAR WEAKNESS (Legs felt weaker and weaker one day after 2nd booster), DYSSTASIA (Could not stand up one day after 2nd booster) and BALANCE DISORDER (Felt out of balance one day after 2nd booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal..         Patient didn't had side effects after First dose and First Booster dose. No concomitant medications were mentioned. It was reported that on15 April 2022, patient called an ambulance and was taken to the Hospital. Emergency Room. The doctor administered some IVs and discharged patient after 1 AM. Patient went home and was fine since then. Treatment medications included IVs along with above mentioned medication.   This case was linked to MOD-2022-548938, MOD-2022-548661 (Patient Link).
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Legs felt weaker and weaker one day after 2nd booster; Could not stand up one day after 2nd booster; Felt out of balance one day after 2nd booster; Swollen right arm after 2nd booster; Felt mildly dis-oriented a few hours after 2nd booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen right arm after 2nd booster), DISORIENTATION (Felt mildly dis-oriented a few hours after 2nd booster), MUSCULAR WEAKNESS (Legs felt weaker and weaker one day after 2nd booster), DYSSTASIA (Could not stand up one day after 2nd booster) and BALANCE DISORDER (Felt out of balance one day after 2nd booster) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002M21A, 939903 and 013M20A) for COVID-19 vaccination.     The patient's past medical history included Balance difficulty (Balance issues).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 14-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2022, the patient experienced VACCINATION SITE SWELLING (Swollen right arm after 2nd booster) and DISORIENTATION (Felt mildly dis-oriented a few hours after 2nd booster). On 15-Apr-2022, the patient experienced MUSCULAR WEAKNESS (Legs felt weaker and weaker one day after 2nd booster), DYSSTASIA (Could not stand up one day after 2nd booster) and BALANCE DISORDER (Felt out of balance one day after 2nd booster). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 2 Tylenols. On 15-Apr-2022, DISORIENTATION (Felt mildly dis-oriented a few hours after 2nd booster) had resolved. At the time of the report, VACCINATION SITE SWELLING (Swollen right arm after 2nd booster) outcome was unknown and MUSCULAR WEAKNESS (Legs felt weaker and weaker one day after 2nd booster), DYSSTASIA (Could not stand up one day after 2nd booster) and BALANCE DISORDER (Felt out of balance one day after 2nd booster) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) normal..         Patient didn't had side effects after First dose and First Booster dose. No concomitant medications were mentioned. It was reported that on15 April 2022, patient called an ambulance and was taken to the Hospital. Emergency Room. The doctor administered some IVs and discharged patient after 1 AM. Patient went home and was fine since then. Treatment medications included IVs along with above mentioned medication.   This case was linked to MOD-2022-548938, MOD-2022-548661 (Patient Link).