chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Headache, SARS-CoV-2 test, Vertigo
Clinical narrative: FELT DIZZY; VERTIGO (COULD NOT GET OUT OF THE BED AND THE WHOLE ROOM  WAS SPINNING AROUND); JOINT PAIN IN SHOULDER RADIATED TO LEGS; HEADACHE; This spontaneous report received from a patient concerned a 61 year old male. The patient's height, and weight were not reported. The patient's past medical history included: covid-19, and concurrent conditions included: type 2 diabetes. Patient was non smoker, and non alcohol user. The patient had no known allergies and no history of drug abuse or illicit drug usage. Concomitant medications included dulaglutide for type 2 diabetes, insulin aspart for type 2 diabetes, and insulin glargine for type 2 diabetes.  On 18-DEC-2020, Laboratory data included: SARS-CoV-2 test (NR: not provided) positive.  The patient was previously treated with paracetamol for body pain, dextromethorphan hydrobromide/guaifenesin/paracetamol/pseudoephedrine hydrochloride for body pain, dextromethorphan hydrobromide/doxylamine succinate/ephedrine sulfate/ethanol/paracetamol for body pain; and experienced dizziness, headache, joint pain and vertigo when treated with covid-19 vaccine ad26. cov2. s (Dose Number in Series: 1), administered on 06-MAY-2021 for prophylactic vaccination.  On 02-NOV-2021 the patient received booster dose and took paracetamol  (Tylenol PM). On 03-NOV-2021 patient experienced joint pain in the shoulder and radiated to his legs and felt dizzy. Joint pain was resolved on the same day.  On 04-NOV-2021 patient could not get out of the bed in the morning and the whole room was spinning around when he gets up. Patient reported that the dizziness went away by 11 AM on the same day. On 05-NOV-2021 the patient experienced the symptoms as the previous day, but the dizziness went away around 9 AM. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from dizziness and vertigo and recovered from joint pain and headache. This report was non-serious. This case, involving the same patient is linked to 20211122838.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LITTLE SORE ARM; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: epstein barr, exposed to covid twice, and pregnancy. Concurrent conditions included: allergies, and stress. On 12-APR-2021, the patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 201A21A), 1 in total, dose was not reported (dose number in series was 1), to right deltoid for prophylactic vaccination. On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced anxiety, stress and vision impaired (vision was 20/20 previously and now wears glasses). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: UNKNOWN) dose was not reported (dose number in series was 2), 1 total, administered to right arm on 26-OCT-2021 for prophylactic vaccination. Concomitant medications included guaifenesin for allergies. On 26-OCT-2021, following vaccination with booster dose of covid-19 vaccine ad26.cov2.s, the patient arm was a little sore. The patient stated it was located on her right dominant arm where she got vaccine. The reporter commented that "It nothing, really, she could blew it off" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from little sore arm. This report was non-serious. This case, involving the same patient is linked to 20211031414.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Confusional state, Memory impairment
Clinical narrative: CONFUSION; DIFFICULTY REMEMBERING NAMES; COVID-19; This spontaneous report received from a patient concerned an 85 year old female of unknown race and ethnicity.   Initial information was processed along with the additional information received on 19-NOV-2021 and 24-NOV-2021. The patient's weight was 127 pounds, and height was 66 inches. The patient's past medical history included: amputation below-knee amputation (bka) left leg, and concurrent conditions included: circulation psoriatic arthritis/ psoriasis, alcoholic (occasional), and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. Age at the time of vaccination was 84 years. Patient was not pregnant at the time of vaccination. The patient experienced drug allergy when treated with clopidogrel bisulfate.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: Unknown) dose was not reported, 1 total, administered on 10-MAR-2021 (dose number in series 1) for prophylactic vaccination. Patient contracted Covid-19 in May or June. On an unspecified date, the patient experienced confusion, difficulty remembering names (all events dose number in series 1). Patient recently received the Moderna Non-company suspect vaccine (mrna 1273) booster dose (dose number series 2) about 2 weeks ago (batch number: Unknown, expiry: Unknown, form of admin, route of admin, and were not reported) dose was not reported, administered on an unspecified date in 12-NOV-2021, for prophylactic vaccination. Concomitant medications included influenza vaccine (higher dose) for prophylactic vaccination, and Shingrix (varicella zoster vaccine rge (cho)) for prophylactic vaccination. She was reading her Tremfya literature and found the notes about if one is receiving vaccines should not take the Tremfya. Patient reported that she was continued to be confused and had difficulty remembering names since she had Covid-19. She stated it was getting better. She stated she received the booster to make sure to not get again. She talked with her doctor about the confusion and said he reported that patient was fine. Patient also said she was elderly so confusion might be a part of age. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confusion, difficulty remembering names, and covid-19. This report was non-serious. This report was associated with product quality complaint: 90000202894. The suspected product quality complaint has been confirmed to be the reported allegation was not confirmed and the root cause was determined to be not manufacturing related. based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: THROMBOSIS; This spontaneous report received from a consumer concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total, administered on 2021 for prophylactic vaccination. The batch number was not reported and has been requested (Dose number in series 1). No concomitant medications were reported.  On an unspecified date, the patient diagnosed with thrombosis thing adverse effect and it is because of the J&J vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20211163766-COVID-19 VACCINE AD26.COV2.S-Thrombosis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: UNEVALUABLE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced unevaluable event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unevaluable event was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: 19-SEP-2021) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211200956.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious. This case, involving the same patient is linked to 20211129919.
Sex: U
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: DIED FROM HEART ATTACK WITHING 24 HRS OF TAKING SHOT; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry- Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Dose number in series-1. No concomitant medications were reported.  On an unspecified date, as reporter stated, "his dad's coworker (patient) died from a heart attack within 24 hours of taking the Johnson & Johnson COVID shot". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0-20211165280-Covid-19 vaccine ad26.cov2.s- died from heart attack. This event(s) is considered unassessable. The event(s) has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: HEART ATTACK
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Oedema peripheral, Pain in extremity, Peripheral swelling
Clinical narrative: CALF WAS ENLARGED/CALF SWELLING; EDEMA OF ANKLES; CALF PAINS; This spontaneous report received from a patient concerned a 60 year old male. The patient's weight was 127 pounds, and height was 172.72 centimeters. The patient's past medical history included: respiratory issues, and other pre-existing medical conditions included: Patient was previously on a steroid breather to help with his breathing. The patient experienced drug allergy when treated with chloramphenicol for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. Concomitant medications included amlodipine for drug used for unknown indication, ibuprofen for drug used for unknown indication, losartan for drug used for unknown indication, and morniflumate for drug used for unknown indication. On an unspecified date, the patient experienced calf was enlarged/calf swelling, edema of ankles, and calf pains. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Clots did not show up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from calf pains, had not recovered from calf was enlarged/calf swelling, and the outcome of edema of ankles was not reported. This report was non-serious. This case, involving the same patient is linked to 20211122674.
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dyspnoea, Thrombosis
Clinical narrative: CLOT BLOOD; DEEP VEIN THROMBOSIS (DVT) IN LEFT LEG; SHORTNESS OF BREATH; This spontaneous report received from a parent concerned a 37 year old male The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker, and other pre-existing medical conditions included: The patient had no known drug allergies. The patient did not had asthma and he was active at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown), (Dose Number in Series: 1), dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter reported that patient got the vaccine some day in August or early September. 30 days later, both his leg swelled up (blew up) and he went to the hospital. He was hospitalized for the night and was told him that he is having a DVT (deep vein thrombosis) and blood clots. They gave him an unspecified intravenous (IV) injection and put him on anticoagulant (3 or 4 medications) and discharged him (duration of hospitalization was 1 day). He also developed shortness of breath at the same time as the DVT. As per reporter, 3 weeks later it seems that the clot resolved. He was going back and forth to the doctor. The reporter reported that patient could not walk well on his legs. Then after 45 days later he got another clot. Around 18-NOV-2021 or the 21-NOV-2021, patient woke up with severe extreme horrifying pain in his leg and left leg was Swollen. He went by ambulance to hospital. He was diagnosed with another DVT in the left leg. They treated him but didn't keep him in the hospital. They gave him unspecified intravenous (IV) injection and prescription and sent him home with a leg compression equipment to compress the leg due to the pain. The reporter mentioned that the clot was resistant to normal anticoagulants. As per reporter, patient was continuing to be unable to walk and he was not able to work. He need to lay down with his compression stocks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis (dvt) in left leg, and clot blood, and the outcome of shortness of breath was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20211165859-Covid-19 vaccine ad26.CoV-2.s-Clot blood, Deep vein thrombosis in left leg. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; CHILLS; FATIGUE; HEADACHE; RELATIVELY MILD FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (series 1) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, chills, fatigue, headache, and relatively mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue, headache, body aches, chills and relatively mild fever was not reported. This report was non-serious. This case, involving the same patient is linked to 20211150118.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: A PUNCTURED VIAL STORED IN THE REFRIGERATOR FOR MORE THAN 6 HOURS; ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: 20-MAR-2022) dose was not reported, administered on 29-NOV-2021 09:30 for prophylactic vaccination. No concomitant medications were reported.  On 29-NOV-2021, the patient experienced administration error. On an unspecified date, the patient experienced a punctured vial stored in the refrigerator for more than 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration error and a punctured vial stored in the refrigerator for more than 6 hours was not reported. This report was non-serious.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: THE PUNCTURED VIAL STORED IN THE REFRIGERATOR FOR 7 HOURS PRIOR TO ADMINISTRATION; INCORRECTLY STORED VACCINE ADMINISTERED/ DOSE OF VACCINE 1 HOUR PAST ITS  BEYOND USE TIME; This spontaneous report received from a health care professional concerned a 57 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A, and expiry: 11-APR-2022) dose was not reported, administered on 29-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 29-NOV-2021, the patient experienced the punctured vial stored in the refrigerator for 7 hours prior to administration. On 29-NOV-2021, the patient experienced incorrectly stored vaccine administered/ dose of vaccine 1 hour past its beyond use time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the punctured vial stored in the refrigerator for 7 hours prior to administration and incorrectly stored vaccine administered/ dose of vaccine 1 hour past its beyond use time was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-OCT-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211164584.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous report received from a consumer concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: seizure(has being treated with pharmacological agents), non-alcohol user, non-smoker, and arthritis, and other pre-existing medical conditions included: The patient had no history of drug abuse or illicit drug use. The patient experienced hives when treated with benzylpenicillin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: MOVED ARM AWAY BEFORE GETTING THE FULL DOSE; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: Alzheimer's disease. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 26-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 26-NOV-2021, the patient experienced moved arm away before getting the full dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of moved arm away before getting the full dose was not reported. This report was non-serious. This report was associated with product quality complaint: 90000204359. The suspected product quality complaint has been confirmed to be voided (did not meet pqc criteria) based on the PQC evaluation/investigation performed.
Sex: F
Vaccine: COVID19
Symptoms: Haemochromatosis, Neuropathy peripheral
Clinical narrative: her doctor reported to her that another female patient also had neuropathy in the feet; "hemochromatosis" 2 weeks after she received her 2nd moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose). At the time of the report, NEUROPATHY PERIPHERAL (her doctor reported to her that another female patient also had neuropathy in the feet) and HAEMOCHROMATOSIS ("hemochromatosis" 2 weeks after she received her 2nd moderna dose) outcome was unknown.            Company Comment- This is a spontaneous case concerning a female patient  of unknown age and unknown medical history, who experienced the unexpected  non serious event of Neuropathy peripheral and hemochromatosis. The event occurred after the second dose of mRNA 1273 vaccine. Event neuropathy peripheral was automatically upgraded as a serious event as per IME list. However, based on the information available and as per medical judgment it is classified as Non-serious.   The Benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.  No concomitant medication details provided. No treatment medication details provided.  The reporter stated that her doctor reported to her that another female patient also had neuropathy in the feet and hemochromatosis 2 weeks after she received her 2nd moderna dose as she stated that same thing happened to the other patient.; Sender's Comments: This is a spontaneous case concerning a female patient  of unknown age and unknown medical history, who experienced the unexpected  non serious event of Neuropathy peripheral and hemochromatosis. The event occurred after the second dose of mRNA 1273 vaccine. Event neuropathy peripheral was automatically upgraded as a serious event as per list. However, based on the information available and as per medical judgment it is classified as Non-serious.   The Benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: 7 year mistakenly getting Moderna vax instead of PFE/she was given a moderna covid vaccine instead of Pfizer for 5-11 year old; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTRATION ERROR (7 year mistakenly getting Moderna vax instead of PFE/she was given a moderna covid vaccine instead of Pfizer for 5-11 year old) in a 7-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (7 year mistakenly getting Moderna vax instead of PFE/she was given a moderna covid vaccine instead of Pfizer for 5-11 year old). At the time of the report, PRODUCT ADMINISTRATION ERROR (7 year mistakenly getting Moderna vax instead of PFE/she was given a moderna covid vaccine instead of Pfizer for 5-11 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The reporter was unsure of dosage as the pharmacy had not yet sent over the records.   Most recent FOLLOW-UP information incorporated above includes: On 22-Nov-2021: Reference number was added.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (expired vials were used to provide 38 doses of of the Moderna Covid-19 Vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  The storage of refrigerator thawed and given on the same date but never stored in refrigerator.   No vial had undergone any temperature excursions.   There were no adverse reactions to the vaccine as reported by the patient.   This case was linked to MOD-2021-391439 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow up received contains Non significant information,added secondary reporter information.
Sex: U
Vaccine: COVID19
Symptoms: Dermatitis allergic
Clinical narrative: skin allergy; This spontaneous case was reported by a consumer and describes the occurrence of DERMATITIS ALLERGIC (skin allergy) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DERMATITIS ALLERGIC (skin allergy). At the time of the report, DERMATITIS ALLERGIC (skin allergy) had not resolved.            No concomitant medications were provided. No treatment medications were provided.  Patient was experiencing skin allergy for more than 2 weeks since the Moderna booster, and also stated that he never had an allergic reaction like this.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Instead of receiving the second dose I received the booster shot; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (Instead of receiving the second dose I received the booster shot) 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 22-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced ACCIDENTAL UNDERDOSE (Instead of receiving the second dose I received the booster shot). On 22-Nov-2021, ACCIDENTAL UNDERDOSE (Instead of receiving the second dose I received the booster shot) had resolved. Not Provided          No concomitant medication was reported. No treatment medication was reported.
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Migraine
Clinical narrative: Went 2 days without the medication and had a migraine; This spontaneous case was reported by an other health care professional and describes the occurrence of MIGRAINE (Went 2 days without the medication and had a migraine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ATOGEPANT tablet for an unknown indication and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In October 2021, the patient started ATOGEPANT (unknown route) 1 dosage form. In 2021, the patient experienced MIGRAINE (Went 2 days without the medication and had a migraine). At the time of the report, MIGRAINE (Went 2 days without the medication and had a migraine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information provided by the reporter. No treatment information provided by the reporter. It was reported that patient was taking the Qulipta for 12 days, and then she  started in mid October, she went 2 days without the medication and had a migraine. She had been back on it for 1 week.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had an issue after receiving the Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had an issue after receiving the Moderna vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had an issue after receiving the Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Had an issue after receiving the Moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Hypertension
Clinical narrative: anxiety; high blood pressure; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Nov-2021 and was forwarded to Moderna on 23-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety) and HYPERTENSION (high blood pressure) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ANXIETY (anxiety) and HYPERTENSION (high blood pressure). At the time of the report, ANXIETY (anxiety) and HYPERTENSION (high blood pressure) had not resolved. Not Provided. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) high. No treatment medication and concomitant medication was provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Given covid vacc booster from vial that was expired by a couple of hours; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours) and PRODUCT STORAGE ERROR (Product storage error) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for an unknown indication.     No Medical History information was reported.    On 19-Nov-2021 at 8:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 8:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours) and PRODUCT STORAGE ERROR (Product storage error). On 19-Nov-2021 at 8:15 AM, EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours) and PRODUCT STORAGE ERROR (Product storage error) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours) and PRODUCT STORAGE ERROR (Product storage error) to be not related.    No concomitant medication information was provided. A vial of Moderna vaccine was opened the day before and and then it was given on 19 Nov 2021. It was left in the refrigerator overnight. On 19 Nov 2021, a vaccine administrator used the same vial outside the recommended 12-hour vial puncture range. 8 patients received the doses.  No treatment medication information was provided.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Used the vial outside the recommended 12 hour vial puncture range; Vaccine opened and was left in refrigerator overnight; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Used the vial outside the recommended 12 hour vial puncture range) and PRODUCT STORAGE ERROR (Vaccine opened and was left in refrigerator overnight) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Vaccine opened and was left in refrigerator overnight). On 19-Nov-2021 at 11:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Used the vial outside the recommended 12 hour vial puncture range). On 19-Nov-2021, PRODUCT STORAGE ERROR (Vaccine opened and was left in refrigerator overnight) had resolved. On 19-Nov-2021 at 11:00 AM, EXPIRED PRODUCT ADMINISTERED (Used the vial outside the recommended 12 hour vial puncture range) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant and treatment information were not provided. The patient was given covid vaccine booster from vial that was expired by a couple of hours vial was refrigerated the whole time.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Given covid vacc booster from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.; Punctured vial left in refridgerator overnight outside the recommended 12 hour vial puncture range; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.) and PRODUCT STORAGE ERROR (Punctured vial left in refridgerator overnight outside the recommended 12 hour vial puncture range) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Punctured vial left in refridgerator overnight outside the recommended 12 hour vial puncture range). On 19-Nov-2021 at 10:15 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.). On 19-Nov-2021, PRODUCT STORAGE ERROR (Punctured vial left in refridgerator overnight outside the recommended 12 hour vial puncture range) had resolved. On 19-Nov-2021 at 10:15 AM, EXPIRED PRODUCT ADMINISTERED (Given covid vacc booster from vial that was expired by a couple of hours (vial was refrigerated the whole time). No adverse effect reported.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Vaccine used; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Product storage error). On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On 19-Nov-2021, PRODUCT STORAGE ERROR (Product storage error) had resolved. On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  No treatment medication were provided
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Expired Vaccine used; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 069F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021 at 10:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error). On 19-Nov-2021 at 10:00 AM, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and PRODUCT STORAGE ERROR (Product storage error) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Reporter stated that on 18-Nov-2021, Punctured vial left in refrigerator overnight outside the recommended 12 hour vial puncture range and was given as COVID-19 Vaccine booster dose from vial that was expired by a couple of hours on 19-Nov-2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cerebrovascular accident, Headache
Clinical narrative: Had several strokes; Memory loss; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had several strokes) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ATOGEPANT for Migraine.    The patient's past medical history included Migraine. Concomitant products included ERENUMAB AOOE (AIMOVIG [ERENUMAB AOOE]) for Migraine.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ATOGEPANT (unknown route) at an unspecified dose. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Had several strokes) (seriousness criterion medically significant), AMNESIA (Memory loss) and HEADACHE (Headache). At the time of the report, CEREBROVASCULAR ACCIDENT (Had several strokes) and AMNESIA (Memory loss) outcome was unknown and HEADACHE (Headache) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.  The start date of Qulipta (atogepant) was unknown, it was confirmed the patient did start samples, therapy was ongoing.  Company comment: This case concerns a 43-year-old, female patient with a history of migraine, who experienced the unexpected serious AESI event of CEREBROVASCULAR ACCIDENT (Had several strokes). The event occurred at an unknown date. The patient received two doses of mRNA-1273 vaccine, at an unknown date. The rechallenge was not applicable since it is unknown when the event occurred in relation to vaccination. The medical history of migraine remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to important medical event and medical judgement.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Follow up received contains email attachment which is non significant.; Sender's Comments: This case concerns a 43-year-old, female patient with a history of migraine, who experienced the unexpected serious AESI event of CEREBROVASCULAR ACCIDENT (Had several strokes). The event occurred at an unknown date. The patient received two doses of mRNA-1273 vaccine, at an unknown date. The rechallenge was not applicable since it is unknown when the event occurred in relation to vaccination. The medical history of migraine remains as a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as serious due to important medical event and medical judgement.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Vital signs measurement
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Vital signs measurement: normal (normal) Within normal limits.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Race: H   This case was linked to MOD-2021-391981 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Updated patient demographics