chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A little sore left shoulder injection site after 2nd booster) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A, 013F21A, 013F21A and 014M20A) for COVID-19 vaccination. Concurrent medical conditions included Lumbar disc disease (spinal problem (Spaces between L3 and L4)). On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2022, the patient experienced VACCINATION SITE PAIN (A little sore left shoulder injection site after 2nd booster). At the time of the report, VACCINATION SITE PAIN (A little sore left shoulder injection site after 2nd booster) outcome was unknown. It was reported that patient receives Steroid injections from time to time for long time medical condition with his spine in the lumbar region. The shots did not make his pre-existing spinal problem worse. After the first dose, he did not have any side effects. Patient does not recall if any side effects after second dose. No treatment medications were reported. This case was linked to MOD-2022-553179 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Polyps (polyps in duodenum) in October 2019 and Surgery (bile duct removal by surgery) in October 2019. Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot. Concurrent medical conditions included Drug allergy (Aleve allergy), Allergic reaction to analgesics (Codeine allergy), Allergic reaction to analgesics (allergic to Opioids), Cholesterol, Anxiety, Restless leg syndrome, Acid reflux (esophageal), Insomnia, Osteoporosis, and Hypothyroidism. Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PANTOPRAZOLE 40) for Acid reflux (esophageal), HYDROXYZINE HYDROCHLORIDE (ATARAX [HYDROXYZINE HYDROCHLORIDE]) for Allergy prophylaxis, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, COLESEVELAM for Cholesterol and Drug therapy, LEVOTHYROXINE for Hypothyroidism, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, DENOSUMAB (PROLIA) for Osteoporosis, CLONIDINE for Restless leg syndrome. 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 RASH (Rash) and PAIN IN EXTREMITY (sore arm). At the time of the report, RASH (Rash) and PAIN IN EXTREMITY (sore arm) outcome was unknown. Patient reported that there were no changes in medical history after vaccination. It was reported because of polyps in duodenum patient had a surgery in Oct-2019. Patient has completed the first booster dose. No treatment information was reported. This case was linked to MOD-2022-553214, MOD-2022-553295, MOD-2022-553296 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and PAIN IN EXTREMITY (sore arm) in a 73-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination. The patient's past medical history included Polyps (bile duct removal by surgery (no changes in medical history after vaccination)) in October 2019. Previously administered products included for Product used for unknown indication: flu shot (around the time of her 1st Moderna Covid-19 dose). Past adverse reactions to the above products included No adverse reaction with flu shot. Concurrent medical conditions included Drug allergy (allergies to Aleve (no changes in medical history after vaccination)), Drug allergy (allergies to Codeine (no changes in medical history after vaccination)), Drug allergy (allergies to Opioids (no changes in medical history after vaccination)), Blood cholesterol abnormal (no changes in medical history after vaccination), Anxiety (no changes in medical history after vaccination), Restless leg syndrome (no changes in medical history after vaccination), Acid reflux (esophageal) (no changes in medical history after vaccination), Insomnia (no changes in medical history after vaccination), Osteoporosis (no changes in medical history after vaccination) and Hypothyroidism (no changes in medical history after vaccination). Concomitant products included PANTOPRAZOLE for Acid reflux (esophageal), HYDROXYZINE HYDROCHLORIDE (ATARAX [HYDROXYZINE HYDROCHLORIDE]) for Allergy prophylaxis, CELECOXIB (CELEXA [CELECOXIB]) for Anxiety, ATORVASTATIN CALCIUM (LIPITOR) for Blood cholesterol abnormal, COLESEVELAM for Blood cholesterol abnormal and Biliary obstruction, LEVOTHYROXINE for Hypothyroidism, ZOLPIDEM TARTRATE (AMBIEN) for Insomnia, DENOSUMAB (PROLIA) for Osteoporosis, CLONIDINE for Restless leg syndrome. On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and PAIN IN EXTREMITY (sore arm). At the time of the report, RASH (Rash) and PAIN IN EXTREMITY (sore arm) outcome was unknown. For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments. Patient reported that there was no changes in medical history after vaccination. It was reported because of polyps in duodenum patient had a surgery on Oct 2019. It was reported patient was taking Colesevelam 1200 mg for Cholesterol and Bile Duct. No treatment information was reported. This case was linked to MOD-2022-553214, MOD-2022-553294, MOD-2022-553296 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received expired moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received expired moderna Covid-19 vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received expired moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received expired moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. It was reported that the vial did not undergo temperature excursion. The vial was initially stored in the refrigerator on 04-Apr-2022. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up received contains non-significant information: updated reporter contact details.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) 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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine was administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. The reporter stated that she had 22 forms (from the CDC) about patients that were administered expired vaccines, she was asking if they should revaccinate those patients. Number of doses/vials: 22 The date of vial initially stored in the refrigerator was unknown. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  Patient received his first booster in his left arm. Vials did not undergo any temperature excursions. No treatment information was reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported. In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 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 medications were reported.  The date of vial initially stored in the refrigerator was unknown.  Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 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 medications were reported. The date of vial initially stored in the refrigerator was unknown. It was reported that 22 patients received expired Moderna Covid-19 vaccine. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  The vial did not undergo any temperature excursions. No treatment information was reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 22 patients received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients received 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 medications were reported.  The date of vial initially stored in the refrigerator was unknown. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.  The patient received his Second booster in his right arm. The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received 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 medications were reported.  The date of vial initially stored in the refrigerator was unknown.  Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.   The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 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 medications were reported.  Patient received the first booster dose. The date of vial initially stored in the refrigerator was unknown.  Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022.   The vial did not undergo any temperature excursions.  No treatment information was reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 43-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial was initially stored in the refrigerator was unknown. Dates of administration of vaccine were reported as 2 doses on 05-Apr-2022, 13 doses on 06-Apr-2022, 2 doses on 07-Apr-2022 and 4 doses on 08-Apr-2022. The vial did not undergo any temperature excursions. Patient received first vaccine in primary series in Apr-2022, which was expired on 27-Mar-2022.  No treatment medications were reported.   This case was linked to MOD-2022-538058 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) 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. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 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 medications were reported.  The number of doses/vials was 22. The date of the vial was initially stored in the refrigerator was unknown. The vials did not undergo temperature excursion.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received 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 medications were reported.   The patient received second booster dose. It was not reported when the vial was initially stored in refrigerator. The vial did not undergo temperature excursion.  No treatment details were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Number of doses/vials: 22. Date the vial was initially stored in the refrigerator: Unknown. Date(s) of administration of vaccine: 2 doses 05Apr2022; 13 doses 06Apr2022; 2 doses 07Apr2022; 4 doses 08Apr2022. The vial did not undergo any temperature excursions. No treatment medications were reported.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine) in a 75-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received 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 reported.  Patient received the second booster dose. Date the vial was initially stored in the refrigerator was  Unknown. Date of administration of vaccine were noted as 2 doses 05 Apr 2022, 13 doses 06 Apr 2022, 2 doses 07 Apr 2022, 4 doses 08 Apr 2022. The vial did not undergo any temperature excursions. No treatment medication reported.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 22 patients received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (22 patients received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (22 patients received 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 product use was reported.  It was reported that dose was administered to patient after 30-day Use by Date or after manufacturer date of expiry. The date the vial was initially stored in the refrigerator was unknown. It was also reported that the vial didn't undergo any temperature excursions.  In Apr-2022, the patient received second booster dose which was expired on 27-Mar-2022.  No treatment information was reported.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was expired on 01-Apr-2022 and administered on 02-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 02-Apr-2022) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 02-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 01-Apr-2022 and administered on 02-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up document contains no new information.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022; Patient received the vaccine on 04-Apr-2022 but it had got expired on 01-Apr-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 04-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 04-Apr-2022 but it had got expired on 01-Apr-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine on 04-Apr-2022 but it had got expired on 01-Apr-2022) and PRODUCT STORAGE ERROR (Vial was expired on 01-Apr-2022 but initially stored in refrigerator on 04-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Pharmacist was calling to verify an expiration date for lot number 026L21B. The pharmacist said that he thought that the vaccine expired in Jun-2022 however the vaccine expired on 01-Apr-2022. Caller stated 155 patients were vaccinated with expired doses from 02-Apr-2022 to 19-Apr-2022 Date the vial was initially stored in refrigerator- 04-Apr-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received contains no new information to add.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: identical symptoms after second booster; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (identical symptoms after second booster) in a female 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (identical symptoms after second booster). At the time of the report, IMMUNISATION REACTION (identical symptoms after second booster) outcome was unknown.            No concomitant medications were reported No treatment medication was reported.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: she had localized pain on the injection site after receiving the 4 doses,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses,) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No information was provided regarding patients past Medical History, allergies or acute and chronic illnesses at the time of vaccination.  Concomitant products included CANNABIDIOL (CBD OIL), SIMVASTATIN and FAMOTIDINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses,). At the time of the report, VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine Patient has not yet diagnosed or tested positive with covid   This case was linked to MOD-2022-554212, MOD-2022-554220, MOD-2022-554221 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Immunisation reaction, Muscular weakness, Pain in extremity, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: she had localized pain on the injection site after receiving the 4 doses,; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses,) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No information was provided regarding patients past Medical History, allergies or acute and chronic illnesses at the time of vaccination.  Concomitant products included CANNABIDIOL (CBD OIL), SIMVASTATIN and FAMOTIDINE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses,). At the time of the report, VACCINATION SITE PAIN (she had localized pain on the injection site after receiving the 4 doses,) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were provided. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine Patient has not yet diagnosed or tested positive with covid   This case was linked to MOD-2022-554212, MOD-2022-554220, MOD-2022-554221 (Patient Link).
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Moderna Covid-19 vaccine was administered via subcutaneous route; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Moderna Covid-19 vaccine was administered via subcutaneous route) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     It was unknown that whether patient had allergies to medications, food and other products. It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was having acute and Chronic illnesses at the time of vaccination.     On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 28-Apr-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Moderna Covid-19 vaccine was administered via subcutaneous route). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Moderna Covid-19 vaccine was administered via subcutaneous route) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medications were reported.   Patient received the second booster dose.  No treatment details were reported.   This case was linked to MOD-2022-554286, MOD-2022-554288.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow-up information included no new information.
Age: 68.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Moderna Covid-19 vaccine was administered to 3 patients via subcutaneous route on 28Apr2022.; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Moderna Covid-19 vaccine was administered to 3 patients via subcutaneous route on 28Apr2022.) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     It was unknown that whether patient had allergies to medications, food and other products. It was unknown if patient was diagnosed or tested positive for COVID-19. It was unknown if patient was having acute and Chronic illnesses at the time of vaccination.     On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 28-Apr-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Moderna Covid-19 vaccine was administered to 3 patients via subcutaneous route on 28Apr2022.). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Moderna Covid-19 vaccine was administered to 3 patients via subcutaneous route on 28Apr2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient received the second booster dose.  No treatment medications were reported.   This case was linked to MOD-2022-554283, MOD-2022-554288 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received included no new information.
Age: 76.0
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was administered to patient via subcutaneous route) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 28-Apr-2022, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was administered to patient via subcutaneous route). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine was administered to patient via subcutaneous route) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments. Patient received 2nd booster dose. No concomitant medication was provided by reporter. No treatment medication was provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received included no new information.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Whenever I lie down to go to bed, after about 10 or 15 minutes, I'll hear a sound & it goes across the back of my head.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Whenever I lie down to go to bed, after about 10 or 15 minutes, I'll hear a sound & it goes across the back of my head.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 007M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Joint replacement (Multiple orthopedic joint replacement surgeries). Concurrent medical conditions included Immunocompromised.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In September 2021, the patient experienced TINNITUS (Whenever I lie down to go to bed, after about 10 or 15 minutes, I'll hear a sound & it goes across the back of my head.). At the time of the report, TINNITUS (Whenever I lie down to go to bed, after about 10 or 15 minutes, I'll hear a sound & it goes across the back of my head.) had not resolved.            No concomitant medications were reported.  One week after the third dose the patient whenever lied down to go to bed, after about 10 or 15 minutes, patient would hear a sound and it went across the back of head. It kept going, unless patient sat upright. Had to sleep sitting upright in the living room. And if patient tried to sleep on  left side, it would start up right away. Went to see 4 different doctors, but everything was fine. It was unknown if the patient had allergies. It was unknown if the patient had been diagnosed with COVID or tested positive. Other vaccines given within 1 month prior to Moderna COVID-19 vaccine  was unknown.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up document contains no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing of the ears/Constant ringing of the ears; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing of the ears/Constant ringing of the ears) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903, 002A21A and 025L20A) for COVID-19 vaccination.     The patient had not tested positive for Covid.  Concurrent medical conditions included Seasonal allergy.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TINNITUS (Ringing of the ears/Constant ringing of the ears). At the time of the report, TINNITUS (Ringing of the ears/Constant ringing of the ears) had not resolved.            No concomitant product was provided by the reporter. Ever since the first booster dose, patient had a constant ringing of the ears No treatment medication was provided.
Age: 100.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered as half dose (0.25ml) instead of full dose (0.5ml); 1st dose: 23Mar2022 ,2nd dose: 27Apr2022 .36 days; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (2nd dose administered as half dose (0.25ml) instead of full dose (0.5ml)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 23Mar2022 ,2nd dose: 27Apr2022 .36 days) in a 100-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 027L21A and 083J21A) 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 27-Apr-2022, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .25 milliliter. On 27-Apr-2022, the patient experienced ACCIDENTAL UNDERDOSE (2nd dose administered as half dose (0.25ml) instead of full dose (0.5ml)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 23Mar2022 ,2nd dose: 27Apr2022 .36 days). At the time of the report, ACCIDENTAL UNDERDOSE (2nd dose administered as half dose (0.25ml) instead of full dose (0.5ml)) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose: 23Mar2022 ,2nd dose: 27Apr2022 .36 days) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna that has BUD of 3/30/22 administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna that has BUD of 3/30/22 administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna that has BUD of 3/30/22 administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna that has BUD of 3/30/22 administered) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment reported  It was reported that the vial administered has an expiration of 5/20/22, and a BUD of 3/30/22 to one person this was done today which is 4/28/2022. The reported wanted to know if it was recommended for the individual to be revaccinated.
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Muscle spasms, Nerve injury, Neuralgia, Vaccination site reaction
Clinical narrative: Nerve damage in her arms and legs.; Nerve pain in her arms and legs; Hands start cramping up; COVID arm; She reported her arm was inflamed really bad; This spontaneous case was reported by a patient and describes the occurrence of NERVE INJURY (Nerve damage in her arms and legs.), NEURALGIA (Nerve pain in her arms and legs), MUSCLE SPASMS (Hands start cramping up), VACCINATION SITE REACTION (COVID arm) and INFLAMMATION (She reported her arm was inflamed really bad) in an adult 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NERVE INJURY (Nerve damage in her arms and legs.), NEURALGIA (Nerve pain in her arms and legs), MUSCLE SPASMS (Hands start cramping up), VACCINATION SITE REACTION (COVID arm) and INFLAMMATION (She reported her arm was inflamed really bad). At the time of the report, NERVE INJURY (Nerve damage in her arms and legs.), NEURALGIA (Nerve pain in her arms and legs) and MUSCLE SPASMS (Hands start cramping up) had not resolved and VACCINATION SITE REACTION (COVID arm) and INFLAMMATION (She reported her arm was inflamed really bad) had resolved.            No concomitant medication was provided by the reporter.  Patient received intramuscular 0.25ml of booster dose. Patient reported that after receiving the first Moderna primary series dose, patient did pretty good. Patient reported that sometime after receiving the second Moderna primary series dose, patient began experiencing nerve damage in arms and legs, the nerve pain does not occur every day, but patient could feel the nerve pain in arms and legs. Patient also reported that sometimes patient's hands start cramping up. No history or allergies were reported. It was not reported that patient had been diagnosed with/ tested positive for COVID-19. No acute illnesses at the time of vaccination and up to one month before was reported. Further in follow up its was reported that some folks went though a lot of misery after receiving their Moderna COVID-19 vaccination. No Consent was given for Safety follow-up.  No treatment medication was provided by the reporter.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received and narrative updated.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expiration date was yesterday and four shots were accidentally given out; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expiration date was yesterday and four shots were accidentally given out) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expiration date was yesterday and four shots were accidentally given out). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expiration date was yesterday and four shots were accidentally given out) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The reporter stated that the vaccine they had in stock said the expiration date was yesterday 28-Apr-2022 and four shots were accidentally given out. The date the vial was initially stored in the refrigerator was 26-Apr-2022. It was reported that the vial didn't undergo any temperature excursions. The doses administered were booster 0.25 mL doses.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2022: Follow up received contains no new information.