chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pneumonia, Suspected COVID-19, Vaccination failure
Clinical narrative: PNEUMONIA; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bipolar, diabetic, high cholesterol, penicillin allergy, and sulpha allergy. The patient experienced drug allergy when treated with lamotrigine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-SEP-2021, the patient experienced suspected clinical vaccination failure as patient test positive for Covid-19. On an unspecified date, the patient experienced pneumonia, could not move, and could not do anything. Treatment medications (dates unspecified) included: lorazepam, and mirtazapine. Patient was administered Ativan and also treated with Remeron for 2 weeks. On 05-SEP-2021, the patient experienced weakness, and suspected covid-19 infection, and was hospitalized. The patient was hospitalized for 14 days and discharged on 18-SEP-2021. Patient felt week and deconditioned. They tied patient to the bed for 2 weeks. Patient stated that she could not move and could not do anything for herself and still can't but patient was trying. They did a ton of blood work but patient didn't remember any. Patient mentioned that she was really sick. Patient was calling to try to get Levaquin for pneumonia. Laboratory data (dates unspecified) included: Blood test (NR: not provided) with unknown result , and on 05-SEP-2021, COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, pneumonia and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000194723.; Sender's Comments: V0: 20210950464- Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS  20210950464- Covid-19 vaccine ad26.cov2.s- Pneumonia, suspected covid-19 infection. 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: COVID-19, Vaccination failure
Clinical narrative: Suspected Clinical Vaccination Failure; COVID-19 INFECTION; This spontaneous report received from a patient 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 (suspension for injection, route of administration not reported, batch number: Unknown) dose was not reported, with frequency as 1 total, 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 23-SEP-2021, the patient tested positive for Covid (covid-19 infection). Physician would not order antibody as far as patient knew. Patient had green which was nasty and was congested all day (suspected clinical vaccination failure). Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine  was not applicable. The outcome of the suspected clinical vaccination failure and covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0. 20210950996-COVID-19 VACCINE - Suspected clinical vaccination failure. This event is considered not related. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: TWO STROKES; This spontaneous report received from a patient via social media  concerned a patient of unspecified age, sex, unknown 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  (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, 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 two strokes and felt that people only told the good stuff and no one told the bad stuff. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) no covid (negative). The action taken with covid-19 vaccine  was not applicable. The outcome of two strokes was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210950516.; Sender's Comments: V0-20210951067-Covid-19 vaccine - Two Stroke. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer (patient's niece) concerned a male of unspecified age, race and ethnic origin. 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 and expiry: unknown) dose, therapy start date were not reported, 1 total for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On JUL-2021 (two months prior), the patient experienced blood clots and died. 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: V0.20210951234-Covid-19 vaccine ad26.cov2.s -Blood clot. 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).; Reported Cause(s) of Death: BLOOD CLOTS
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle soreness/muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness/muscle pain) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced MYALGIA (Muscle soreness/muscle pain). At the time of the report, MYALGIA (Muscle soreness/muscle pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The muscle pain was not severe and in about 2 weeks they were getting less painful.   This case was linked to MOD-2021-259101 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received contains significant information of Patient demographics and vaccine start date were updated. Batch number, event start date, vaccination facility information were added.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: A little bit of sore arm, sore only when moving and elevating it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A little bit of sore arm, sore only when moving and elevating it) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced VACCINATION SITE PAIN (A little bit of sore arm, sore only when moving and elevating it). On 20-Jul-2021, VACCINATION SITE PAIN (A little bit of sore arm, sore only when moving and elevating it) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details not provided. Patient reported that he had virtually no reaction but did mention having a little bit of sore arm. It was after falling asleep on the side of injected arm. It was sore only when moving and elevating it.    Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: FU Received on 21 Sep 2021 and contains no new information but initial version missed to capture dose number as 1 and relevant information captured in inarrative.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient administered first dose of the Moderna COVID-19 vaccine at age of 13; This spontaneous case was reported by a dentist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of the Moderna COVID-19 vaccine at age of 13) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of the Moderna COVID-19 vaccine at age of 13). On 30-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Patient administered first dose of the Moderna COVID-19 vaccine at age of 13) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-271958 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up received on 20-Sep-2021 contains no new information , but action taken updated to not applicable single event of medication error reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: every part of his body hurt like he has been beaten with a bat; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (every part of his body hurt like he has been beaten with a bat) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN (every part of his body hurt like he has been beaten with a bat). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. On 13-Feb-2021, PAIN (every part of his body hurt like he has been beaten with a bat) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications reported.   This case was linked to MOD-2021-272289 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received contain no significant information but initial version missed to capture latency and onset date of event.
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: safe for pregnant women/ may have received the Moderna COVID-19 Vaccine while pregnant or may be planning to do so; This spontaneous case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (safe for pregnant women/ may have received the Moderna COVID-19 Vaccine while pregnant or may be planning to do so) 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 MATERNAL EXPOSURE DURING PREGNANCY (safe for pregnant women/ may have received the Moderna COVID-19 Vaccine while pregnant or may be planning to do so). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (safe for pregnant women/ may have received the Moderna COVID-19 Vaccine while pregnant or may be planning to do so) had resolved.            Concomitant product use was unknown by the reporter. Treatment information was not provided.; Sender's Comments: This case concerns  a female patient with no age and  relevant medical history reported ,  who experienced the unexpected event of  maternal exposure during pregnancy. The onset of the event from the time from the vaccination with Moderna is unknown since date of the exact event and the dates  of the vaccination were not reported. The LMP and the EDD  was also not reported. The benefit-risk relationship of  Moderna is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, SARS-CoV-2 test
Clinical narrative: Second dose to be given more than 42 days from first dose; Tested positive for Covid after getting first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of SARS-COV-2 TEST (Tested positive for Covid after getting first dose) and INCOMPLETE COURSE OF VACCINATION (Second dose to be given more than 42 days from first dose) 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 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced SARS-COV-2 TEST (Tested positive for Covid after getting first dose). On 18-Sep-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Second dose to be given more than 42 days from first dose). On 18-Sep-2021, INCOMPLETE COURSE OF VACCINATION (Second dose to be given more than 42 days from first dose) outcome was unknown. At the time of the report, SARS-COV-2 TEST (Tested positive for Covid after getting first dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The pharmacist reported that the patient who got the first shot on 28-Mar-2021 but was not able to get the second dose because the patient tested positive for Covid.  Concomitant medications were not reported. No treatment information provided.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient of unknown age and gender, with unknown medical history who experienced the unexpected event of SARS-CoV-2 test: positive and incomplete course of vaccination. The event SARS-CoV-2 test: positive occurred approximately 1 day after the first dose of mRNA-1273 and 5 months and 22 days after the first dose of mRNA-1273. The benefit-risk relationship of Spikevax in not affected by this report. This case has been designated as invalid due to missing identifiers.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vial used, was opened more than 12 hours ago;  this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial used, was opened more than 12 hours ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, 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 (vial used, was opened more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial used, was opened more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow Up received contains updated reporter's email address.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash developed on her hand and feet 2days ago; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash developed on her hand and feet 2days ago) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported. On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Sep-2021, the patient experienced RASH (Rash developed on her hand and feet 2days ago). At the time of the report, RASH (Rash developed on her hand and feet 2days ago) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.  The patient took the Benadryl and hydrocortisone cream on 17-Sep-2021 as treatment.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Sleeping a lot more; More tired; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Sleeping a lot more) and FATIGUE (More tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Relapsing multiple sclerosis, Depression and Anxiety. Concomitant products included OCRELIZUMAB (OCREVUS), PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]), OXAZEPAM, VITAMIN D3 and ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]) for an unknown indication.    In May 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced HYPERSOMNIA (Sleeping a lot more) and FATIGUE (More tired). At the time of the report, HYPERSOMNIA (Sleeping a lot more) and FATIGUE (More tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No  treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Sep-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already). On 19-Sep-2021, EXPIRED PRODUCT ADMINISTERED (gotten the second dose of the Moderna COVID-19 vaccine, which was from a vial that has been punctured for more than 12 hours already) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter. Treatment medication was not given.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling, Vaccination site erythema
Clinical narrative: little redness today; little red dots about 8 inches around the injection site up to elbow; little bit of swelling/  5 inches wide swelling, raised swelling/ there is little bit of swelling today; great deal of pain; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (little bit of swelling/  5 inches wide swelling, raised swelling/ there is little bit of swelling today), PAIN (great deal of pain), ERYTHEMA (little redness today) and VACCINATION SITE ERYTHEMA (little red dots about 8 inches around the injection site up to elbow) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 17-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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. On 17-Sep-2021, the patient experienced SWELLING (little bit of swelling/  5 inches wide swelling, raised swelling/ there is little bit of swelling today), PAIN (great deal of pain) and VACCINATION SITE ERYTHEMA (little red dots about 8 inches around the injection site up to elbow). On 20-Sep-2021, the patient experienced ERYTHEMA (little redness today). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 500 milligram and CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING (little bit of swelling/  5 inches wide swelling, raised swelling/ there is little bit of swelling today), PAIN (great deal of pain), ERYTHEMA (little redness today) and VACCINATION SITE ERYTHEMA (little red dots about 8 inches around the injection site up to elbow) outcome was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Pyrexia, Urticaria
Clinical narrative: Inappropriate schedule of vaccine administered; itchy hives,developed pop up hives on his thigh, back, stomach, & back end,Right now it's his eyelids; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (itchy hives,developed pop up hives on his thigh, back, stomach, & back end,Right now it's his eyelids), PYREXIA (fever), CHILLS (chills) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Cholesterol.   On 12-Feb-1900, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced URTICARIA (itchy hives,developed pop up hives on his thigh, back, stomach, & back end,Right now it's his eyelids), PYREXIA (fever) and CHILLS (chills). On 23-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 23-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, URTICARIA (itchy hives,developed pop up hives on his thigh, back, stomach, & back end,Right now it's his eyelids) outcome was unknown and PYREXIA (fever) and CHILLS (chills) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she had treated with Zyrtec Liquid.  Also stated that currently,  she was on like blood thinners.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse). The patient was treated with IBUPROFEN at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse) had not resolved.            No concomitant medication reported.  It was reported that in late August rash appeared everywhere in her legs and was ongoing.   This case was linked to MOD-2021-324028 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse). The patient was treated with IBUPROFEN at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, RASH (Rash appeared in her legs: thighs, ankles, behind the calves, back of the thighs after the second dose, her left side reacted worse) had not resolved.            No concomitant medication reported.  It was reported that in late August rash appeared everywhere in her legs and was ongoing.   This case was linked to MOD-2021-324028 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vaccination site reaction
Clinical narrative: Reactions/Some people had dermal fillings and received the vaccine; Caused dermal fillers to swell up / Swelling in the areas of dermal fillers; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine) and SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers) 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 SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine) and SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers). At the time of the report, VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine) and SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered SWELLING (Caused dermal fillers to swell up / Swelling in the areas of dermal fillers) to be related. No further causality assessment was provided for VACCINATION SITE REACTION (Reactions/Some people had dermal fillings and received the vaccine).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chills, Feeling abnormal, Pyrexia, Vaccination complication
Clinical narrative: He felt like he was getting COVID; strong reaction to both doses; He reported that he had bearable side effects; He had fever after 1st dose; He had chills; knocked me out/ bothered me; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (He felt like he was getting COVID), VACCINATION COMPLICATION (strong reaction to both doses), FEELING ABNORMAL (knocked me out/ bothered me), ADVERSE DRUG REACTION (He reported that he had bearable side effects) and PYREXIA (He had fever after 1st dose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (he had COVID-19 infection last year and became quite ill) in 2020.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced FEELING ABNORMAL (knocked me out/ bothered me). On an unknown date, the patient experienced FEELING ABNORMAL (He felt like he was getting COVID), VACCINATION COMPLICATION (strong reaction to both doses), ADVERSE DRUG REACTION (He reported that he had bearable side effects), PYREXIA (He had fever after 1st dose) and CHILLS (He had chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (He felt like he was getting COVID), VACCINATION COMPLICATION (strong reaction to both doses), FEELING ABNORMAL (knocked me out/ bothered me), ADVERSE DRUG REACTION (He reported that he had bearable side effects), PYREXIA (He had fever after 1st dose) and CHILLS (He had chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications includes BP (blood pressure) medications (unspecified). Treatment medication includes anti-histamines (unspecified).   This case was linked to MOD-2021-324087 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Significant Follow-up received on 20-Sep-2021 added new events and medical history
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Difficulties in the arm; Difficulties in the shoulder; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (Difficulties in the arm) and MUSCULOSKELETAL DISCOMFORT (Difficulties in the shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Multiple myeloma.    On 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Sep-2021, the patient experienced LIMB DISCOMFORT (Difficulties in the arm) and MUSCULOSKELETAL DISCOMFORT (Difficulties in the shoulder). At the time of the report, LIMB DISCOMFORT (Difficulties in the arm) and MUSCULOSKELETAL DISCOMFORT (Difficulties in the shoulder) outcome was unknown.            No concomitant product was provided by the reporter.  No adverse events after the first two vaccinations. The patient experienced "Difficulties in the arm" and "Difficulties in the shoulder" after third dose.  The patient was in treatment (unspecified) for multiple myeloma.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Oedema peripheral, Rash, Testicular swelling, Vaccination complication
Clinical narrative: Swollen testicles; Covid feet; Worn out by it; Edema in my upper and lower legs; Skin rash on my shins and calves in both legs/ skin rash got worse; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (Edema in my upper and lower legs), TESTICULAR SWELLING (Swollen testicles), VACCINATION COMPLICATION (Covid feet), RASH (Skin rash on my shins and calves in both legs/ skin rash got worse) and FATIGUE (Worn out by it) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 048D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Skin rash on my shins and calves in both legs/ skin rash got worse). On 26-Jun-2021, the patient experienced OEDEMA PERIPHERAL (Edema in my upper and lower legs). On an unknown date, the patient experienced TESTICULAR SWELLING (Swollen testicles), VACCINATION COMPLICATION (Covid feet) and FATIGUE (Worn out by it). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Adverse event, at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (Edema in my upper and lower legs), TESTICULAR SWELLING (Swollen testicles), VACCINATION COMPLICATION (Covid feet), RASH (Skin rash on my shins and calves in both legs/ skin rash got worse) and FATIGUE (Worn out by it) had not resolved.            No concomitant product information was provided. Treatment medication includes vitamins, frozen water bottles.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up document include patient ,facility related details.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date";, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date") 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 EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date"). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave a Moderna Covid vaccine shot that was 1 day beyond it's "use by date") had resolved. Not Provided  No concomitant medication information available. No treatment medication information available.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea
Clinical narrative: Nausea, headache, malaise.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID-19
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Pyrexia, Vomiting
Clinical narrative: vomiting, fever, chills, injection site pain
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dysstasia, Mobility decreased, Nausea
Clinical narrative: not immunocompromised; couldn't stand up; didn't want food or liquids; she still has difficulty standing; too weak to walk; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't stand up), DECREASED APPETITE (didn't want food or liquids), DYSSTASIA (she still has difficulty standing), ASTHENIA (too weak to walk) and NAUSEA (nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 032L20A and 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced NAUSEA (nauseous). In September 2021, the patient experienced DYSSTASIA (she still has difficulty standing) and ASTHENIA (too weak to walk). On 19-Sep-2021 at 2:00 AM, the patient experienced MOBILITY DECREASED (couldn't stand up) and DECREASED APPETITE (didn't want food or liquids). On an unknown date, the patient experienced OFF LABEL USE (not immunocompromised). At the time of the report, MOBILITY DECREASED (couldn't stand up), DECREASED APPETITE (didn't want food or liquids) and NAUSEA (nauseous) outcome was unknown, DYSSTASIA (she still has difficulty standing) and ASTHENIA (too weak to walk) had not resolved and OFF LABEL USE (not immunocompromised) had resolved.            No concomitant medications were provided. Patient treatment include she went to the emergency room where they gave her 2 bags of IV fluids. Patient is not immunocompromised but got the shot because they heard Pfizer had authorized a third shot for people over 65.   This case was linked to MOD-2021-324298 (Patient Link).
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: not immunocompromised; couldn't stand up; didn't want food or liquids; she still has difficulty standing; too weak to walk; nauseous; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (couldn't stand up), DECREASED APPETITE (didn't want food or liquids), DYSSTASIA (she still has difficulty standing), ASTHENIA (too weak to walk) and NAUSEA (nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A, 032L20A and 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021 at 3:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced NAUSEA (nauseous). In September 2021, the patient experienced DYSSTASIA (she still has difficulty standing) and ASTHENIA (too weak to walk). On 19-Sep-2021 at 2:00 AM, the patient experienced MOBILITY DECREASED (couldn't stand up) and DECREASED APPETITE (didn't want food or liquids). On an unknown date, the patient experienced OFF LABEL USE (not immunocompromised). At the time of the report, MOBILITY DECREASED (couldn't stand up), DECREASED APPETITE (didn't want food or liquids) and NAUSEA (nauseous) outcome was unknown, DYSSTASIA (she still has difficulty standing) and ASTHENIA (too weak to walk) had not resolved and OFF LABEL USE (not immunocompromised) had resolved.            No concomitant medications were provided. Patient treatment include she went to the emergency room where they gave her 2 bags of IV fluids. Patient is not immunocompromised but got the shot because they heard Pfizer had authorized a third shot for people over 65.   This case was linked to MOD-2021-324298 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood potassium increased, Electrocardiogram T wave peaked, Hyperkalaemia
Clinical narrative: Patient presented to ER from doctors office after being found to be hyperkalemic, 4 days after COVID vaccine
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Breakthrough COVID
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: No second dose after the recommended time; 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 PRODUCT DOSE OMISSION ISSUE (No second dose after the recommended time) 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 PRODUCT DOSE OMISSION ISSUE (No second dose after the recommended time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (No second dose after the recommended time) had resolved.            concomitant medications were not reported. treatment medications were not reported.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NAUSEA (nauseous). At the time of the report, NAUSEA (nauseous) outcome was unknown.            Patient also received 3rd dose (Booster dose)  No concomitant medications were reported  No treatment information was provided   This case was linked to MOD-2021-324183.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A patient was given an expired vaccine; , this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient was given an expired 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 EXPIRED PRODUCT ADMINISTERED (A patient was given an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A patient was given an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported. Treatment details was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Ringing in ears. Concurrent medical conditions included Hearing loss.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE PAIN (Sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications was provided by the reporter. No treatment was provided by the reporter.   This case was linked to MOD-2021-324268 (Patient Link).