chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: A large red around the inject site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (A large red around the inject site) 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 ERYTHEMA (A large red around the inject site). At the time of the report, VACCINATION SITE ERYTHEMA (A large red around the inject site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product administration interrupted, Product availability issue
Clinical narrative: Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.; Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.) and PRODUCT AVAILABILITY ISSUE (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.) and PRODUCT AVAILABILITY ISSUE (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine.) and PRODUCT AVAILABILITY ISSUE (Her mother had 1st dose and scheduled for 2nd dose but they ran out of the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Waited 5 months to get the second; 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 (Waited 5 months to get the second) 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 (Waited 5 months to get the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Waited 5 months to get the second) had resolved.            No concomitant medications were not reported.  No treatment medications were not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Moderna, 2nd dose Janssen; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna, 2nd dose Janssen) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 09-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna, 2nd dose Janssen). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose Moderna, 2nd dose Janssen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The Janssen Covid-19 vaccine was administered at 0.5ml, intramuscular on the right deltoid. Lot number 204A21A  The action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medication reported.  No treatment was provided.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms, Neuralgia, Paraesthesia
Clinical narrative: Tingling and spasms in my back muscles across my shoulder blades; Tingling and spasms in my back muscles across my shoulder blades; Nerve pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling and spasms in my back muscles across my shoulder blades), MUSCLE SPASMS (Tingling and spasms in my back muscles across my shoulder blades) and NEURALGIA (Nerve pain) 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.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 PARAESTHESIA (Tingling and spasms in my back muscles across my shoulder blades), MUSCLE SPASMS (Tingling and spasms in my back muscles across my shoulder blades) and NEURALGIA (Nerve pain). At the time of the report, PARAESTHESIA (Tingling and spasms in my back muscles across my shoulder blades), MUSCLE SPASMS (Tingling and spasms in my back muscles across my shoulder blades) and NEURALGIA (Nerve pain) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Formication, Paraesthesia, Pruritus, Rash
Clinical narrative: feels the tingling, prickly sensation; her legs are somehow red; Something is crawling beneath my skin; itchy skin more whenever she is on bed already; rashes on her arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (feels the tingling, prickly sensation), ERYTHEMA (her legs are somehow red), FORMICATION (Something is crawling beneath my skin), PRURITUS (itchy skin more whenever she is on bed already) and RASH (rashes on her arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced PARAESTHESIA (feels the tingling, prickly sensation), ERYTHEMA (her legs are somehow red), FORMICATION (Something is crawling beneath my skin), PRURITUS (itchy skin more whenever she is on bed already) and RASH (rashes on her arm). At the time of the report, PARAESTHESIA (feels the tingling, prickly sensation), ERYTHEMA (her legs are somehow red), FORMICATION (Something is crawling beneath my skin), PRURITUS (itchy skin more whenever she is on bed already) and RASH (rashes on her arm) outcome was unknown.            No concomitant and treatment information was reported.  Patient did not have any side effects with first dose of vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis
Clinical narrative: That night and the next morning I had hot flashes severe enough to cause me to change tshirts.; Since then, even sminimal exercise has also brought unusual amount of perspiration; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (That night and the next morning I had hot flashes severe enough to cause me to change tshirts.) and HYPERHIDROSIS (Since then, even sminimal exercise has also brought unusual amount of perspiration) 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 09-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced HOT FLUSH (That night and the next morning I had hot flashes severe enough to cause me to change tshirts.) and HYPERHIDROSIS (Since then, even sminimal exercise has also brought unusual amount of perspiration). At the time of the report, HOT FLUSH (That night and the next morning I had hot flashes severe enough to cause me to change tshirts.) and HYPERHIDROSIS (Since then, even sminimal exercise has also brought unusual amount of perspiration) outcome was unknown.            Concomitant medications were not reported  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Death, Product contamination physical
Clinical narrative: three people died; the flakes of rubber and little pieces of steel found in the vials; 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 DEATH (three people died ) and PRODUCT CONTAMINATION PHYSICAL (the flakes of rubber and little pieces of steel found in the vials) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEATH (three people died) (seriousness criteria death and medically significant) and PRODUCT CONTAMINATION PHYSICAL (the flakes of rubber and little pieces of steel found in the vials) (seriousness criterion death). The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant product was reported. No treatment medication was reported.  This case concerns a patient with no details on age, gender and past medical history, who presented with unexpected event of death on an unknown date after receiving the second dose of mRNA 1273 vaccine. It is unknown if an autopsy was performed. Product contamination physical was considered as an additional event. The event was considered related to the product per the reporter's assessment. The benefit risk relationship of vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a patient with no details on age, gender and past medical history, who presented with unexpected event of death on an unknown date after receiving the second dose of mRNA 1273 vaccine. It is unknown if an autopsy was performed. Product contamination physical was considered as an additional event. The event was considered related to the product per the reporter's assessment. The benefit risk relationship of vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue
Clinical narrative: has not received a second dose of the vaccine.; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) and PRODUCT DOSE OMISSION ISSUE (has not received a second dose of the vaccine.) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced MYALGIA (Sore arm). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received a second dose of the vaccine.). On 29-Apr-2021, MYALGIA (Sore arm) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received a second dose of the vaccine.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Greater than 35 days between Moderna Covid-19 vaccinations.; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    In March 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 PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that the caller would like to know if the patient should get his second dose of Moderna covid-19 vaccine as it has been more than 35 days between Moderna covid-19 vaccination. No treatment medications were reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site swelling
Clinical narrative: Arm swelled up at the injection site; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Arm swelled up at the injection site) and FATIGUE (Felt tired) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high and Type 2 diabetes mellitus.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Arm swelled up at the injection site) and FATIGUE (Felt tired). On 10-Mar-2021, VACCINATION SITE SWELLING (Arm swelled up at the injection site) and FATIGUE (Felt tired) had resolved.            No Concomitant medication was reported. No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Sore lower back; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sore lower back) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Sep-2021, the patient experienced BACK PAIN (Sore lower back). At the time of the report, BACK PAIN (Sore lower back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Still painful; 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 PAIN (Still painful) 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 PAIN (Still painful). At the time of the report, PAIN (Still painful) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia
Clinical narrative: extreme body aches/less body aches; running high fever; headaches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (extreme body aches/less body aches), PYREXIA (running high fever) and HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 MYALGIA (extreme body aches/less body aches). an unknown date, the patient experienced PYREXIA (running high fever) and HEADACHE (headaches). At the time of the report, MYALGIA (extreme body aches/less body aches), PYREXIA (running high fever) and HEADACHE (headaches) outcome was unknown.            No Concomitant medications were reported. No Treatment information was reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: 2 episodes of seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (2 episodes of seizures) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy (on the seizure medication and not had any seizure since last 23 years until 22Aug2021.).    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, the patient experienced SEIZURE (2 episodes of seizures) (seriousness criteria hospitalization and medically significant). At the time of the report, SEIZURE (2 episodes of seizures) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was on  seizure medication for Epilepsy.  On 22Aug2021, Caller experienced 2 episodes of seizures for which he had to go the emergency room. Caller mentioned that he had been on the seizure medication for Epilepsy. Caller believed that vaccine must have potentially triggered the seizure since he had not had any seizure since last 23 years until 22Aug2021.  Company Comment: This case concerns a 50-year-old, male subject with a history of epilepsy, who experienced the unexpected event of seizure. The event occurred 4-days after the first dose of Moderna covid-19 vaccine. The rechallenge is unknown for this case. The event was not provided as per the reporter's assessment. The medical history of epilepsy remains a confounder.The benefit-risk relationship of the vaccine is not affected by this report; Sender's Comments: This case concerns a 50-year-old, male subject with a history of epilepsy, who experienced the unexpected event of seizure. The event occurred 4-days after the first dose of Moderna covid-19 vaccine. The rechallenge is unknown for this case. The event was not provided as per the reporter's assessment. The medical history of epilepsy remains a confounder.The benefit-risk relationship of the vaccine is not affected by this report
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Fatigue, Malaise, Mobility decreased
Clinical narrative: Just haven't felt well; Very fatigued; Temperature of 101.9 F/ low-grade temperature in the 100s for two other days; Diarrhea; Could not move around at all; very painful; Aches; Very sore arm and it is sore right now; This spontaneous case was reported by a consumer and describes the occurrence of Diarrhea, malaise, Could not move around at all, pain, and aches in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included INSULIN for Diabetes.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced MYALGIA. On 25-Aug-2021, the patient experienced Diarrhea, Could not move around at all, pain, Aches, and PYREXIA. On an unknown date, the patient experienced MALAISE and Fatigued. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, Diarrhea, MALAISE, Very sore arm and it is sore right now, and Fatigued had not resolved and Could not move around at all, pain, Aches, and PYREXIA had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Oxygen saturation: 88 Low. On 25-Aug-2021, Body temperature: 101.9F High.     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.   Patient had COVID-19 back in January for which she was put with life support, and survived. After 1st dose patient also had 88 of O2 saturation, and couldn't make it go up for two weeks, so she was with oxygen machine. Concomitant medications included Hypertension medication and Fluid pill medication along with above mentioned medications. Patient's doctor recommended her not to take the second dose when she visited doctor on 08Sep2021.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oxygen saturation, Pain, Pyrexia
Clinical narrative: Just haven't felt well; Very fatigued; Temperature of 101.9 F/ low-grade temperature in the 100s for two other days; Diarrhea; Could not move around at all; very painful; Aches; Very sore arm and it is sore right now; This spontaneous case was reported by a consumer and describes the occurrence of Diarrhea, malaise, Could not move around at all, pain, and aches in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in January 2021. Concurrent medical conditions included Diabetes and Hypertension. Concomitant products included INSULIN for Diabetes.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced MYALGIA. On 25-Aug-2021, the patient experienced Diarrhea, Could not move around at all, pain, Aches, and PYREXIA. On an unknown date, the patient experienced MALAISE and Fatigued. The patient was treated with TYLENOL at an unspecified dose and frequency. At the time of the report, Diarrhea, MALAISE, Very sore arm and it is sore right now, and Fatigued had not resolved and Could not move around at all, pain, Aches, and PYREXIA had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Oxygen saturation: 88 Low. On 25-Aug-2021, Body temperature: 101.9F High.     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.   Patient had COVID-19 back in January for which she was put with life support, and survived. After 1st dose patient also had 88 of O2 saturation, and couldn't make it go up for two weeks, so she was with oxygen machine. Concomitant medications included Hypertension medication and Fluid pill medication along with above mentioned medications. Patient's doctor recommended her not to take the second dose when she visited doctor on 08Sep2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication (side effects after second vaccine) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication (side effects after second vaccine). At the time of the report, vaccination complication (side effects after second vaccine) outcome: unknown. No concomitant medications and treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Feeling the chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS 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 CHILLS. At the time of the report, CHILLS outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: Feeling weak after second shot; Feeling tired after second shot/Spent time in bed after second shot; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Feeling weak after second shot) and FATIGUE (Feeling tired after second shot/Spent time in bed after second shot) 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 23-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced ASTHENIA (Feeling weak after second shot) and FATIGUE (Feeling tired after second shot/Spent time in bed after second shot). On 24-Aug-2021, ASTHENIA (Feeling weak after second shot) and FATIGUE (Feeling tired after second shot/Spent time in bed after second shot) had resolved.            No treatment informations were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: Got COVID; moderna shot on May 13; I want the second shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 13-May-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 COVID-19 (Got COVID) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (moderna shot on May 13; I want the second shot). At the time of the report, COVID-19 (Got COVID) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (moderna shot on May 13; I want the second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Company Comment:  This report refers to a case of Product dose omission issue for mRNA-1273 (lot # unknown) with associated unexpected serious adverse event of COVID-19. The event onset occurred after the first vaccination dose, although time to onset was not specified. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.  It is not clear the root cause of the product omission issue.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273 (lot # unknown) with associated unexpected serious adverse event of COVID-19. The event onset occurred after the first vaccination dose, although time to onset was not specified. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.  It is not clear the root cause of the product omission issue.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: magnet sticking to their arm; 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 (magnet sticking to their arm) 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 (magnet sticking to their arm). At the time of the report, VACCINATION COMPLICATION (magnet sticking to their arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No treatment medication were reported.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Emotional distress, Erectile dysfunction, Sexual dysfunction
Clinical narrative: cannot have an erection/penis cannot get hard/cannot perform his abilities; cannot have sex; very embarrassed/never had this before; worried; This spontaneous case was reported by a consumer and describes the occurrence of ERECTILE DYSFUNCTION (cannot have an erection/penis cannot get hard/cannot perform his abilities) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ERECTILE DYSFUNCTION (cannot have an erection/penis cannot get hard/cannot perform his abilities) (seriousness criterion medically significant), SEXUAL DYSFUNCTION (cannot have sex), EMOTIONAL DISTRESS (very embarrassed/never had this before) and ANXIETY (worried). At the time of the report, ERECTILE DYSFUNCTION (cannot have an erection/penis cannot get hard/cannot perform his abilities), SEXUAL DYSFUNCTION (cannot have sex), EMOTIONAL DISTRESS (very embarrassed/never had this before) and ANXIETY (worried) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter.   Treatment information was not provided.  Patient states he doesn't drink beer; he doesn't smoke; he doesn't know why this is happening.  Company Comment: This case concerns a 53- year-old, male subject with no medical history reported, who experienced the unexpected events of erectile dysfunction, sexual dysfunction, emotional distress and anxiety. It is not clear if the events occurred before or after receiving the vaccine. The rechallenge is not applicable in this case. The reporter's assessment is not provided.The benefit-risk relationship of the vaccine is not affected by this report; Sender's Comments: This case concerns a 53- year-old, male subject with no medical history reported, who experienced the unexpected events of erectile dysfunction, sexual dysfunction, emotional distress and anxiety. It is not clear if the events occurred before or after receiving the vaccine. The rechallenge is not applicable in this case. The reporter's assessment is not provided.The benefit-risk relationship of the vaccine is not affected by this report
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: breakthrough COVID-19; Lack of drug effect; breast cancer; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (breast cancer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced BREAST CANCER (breast cancer) (seriousness criterion medically significant). On 03-Sep-2021, the patient experienced COVID-19 (breakthrough COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with Surgery (right breast lumpectomy) for Breast cancer. At the time of the report, BREAST CANCER (breast cancer) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and COVID-19 (breakthrough COVID-19) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: negative (Negative) negative. On 05-Sep-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, Body temperature: 96.1 (Low) temperature starting going down three days before she showed symptoms of COVID-19. Her lowest temperature was 96.1 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. Patient received treatment to radiation treatment.  Company comment: This report refers to a case of COVID-19 and breast cancer occurring after 2 doses of vaccination with mRNA-1273. Based on the current available information, occurrence of COVID-19 infection is assessed as lack of effect for mRNA-1273. However, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, and hence causality for COVID-19 is considered as not applicable. Very limited information regarding the event breast cancer has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of COVID-19 and breast cancer occurring after 2 doses of vaccination with mRNA-1273. Based on the current available information, occurrence of COVID-19 infection is assessed as lack of effect for mRNA-1273. However, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination, and hence causality for COVID-19 is considered as not applicable. Very limited information regarding the event breast cancer has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: shoulder and injection site pain of both shoulders; shoulder and injection site pain of both shoulders/ left shoulder he has pain 10-20% of the time/ "feels like I was hit with brick"; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (shoulder and injection site pain of both shoulders) and ARTHRALGIA (shoulder and injection site pain of both shoulders/ left shoulder he has pain 10-20% of the time/ "feels like I was hit with brick") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (shoulder and injection site pain of both shoulders) and ARTHRALGIA (shoulder and injection site pain of both shoulders/ left shoulder he has pain 10-20% of the time/ "feels like I was hit with brick"). At the time of the report, VACCINATION SITE PAIN (shoulder and injection site pain of both shoulders) and ARTHRALGIA (shoulder and injection site pain of both shoulders/ left shoulder he has pain 10-20% of the time/ "feels like I was hit with brick") outcome was unknown.        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.   Concomitant medication was not provided.  Treatment medication include Advil, Tylenol. Ice and heat alternation.   This case was linked to MOD-2021-314550 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Product dose omission issue
Clinical narrative: Heart attack; Greater than 35 days between Moderna Covid-19 vaccines/Did not get second shot, first on Apr 2021; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL, LISINOPRIL, METFORMIN and ATORVASTATIN for an unknown indication.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccines/Did not get second shot, first on Apr 2021). The patient was treated with TICAGRELOR (BRILINTA) for Heart attack, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] for Heart attack, at a dose of 81 mg and Surgery (Cardiac stents placed in JUL 2021) for Myocardial infarction. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccines/Did not get second shot, first on Apr 2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Company Comment: This case refers to a 68-year-old female patient with no known medical history but taking concomitantly Metoprolol, Lisinopril, Metformin and Atovarvastatin which are suggestive of an underlying medical condition. She experienced the unexpected event of Myocardial Infarction on an unspecified date after the first dose of Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 09-Sep-2021: Follow up received included reporter information, patient demographics, vaccination details, concomitant medications and treatment details.; Sender's Comments: This case refers to a 68-year-old female patient with no known medical history but taking concomitantly Metoprolol, Lisinopril, Metformin and Atovarvastatin which are suggestive of an underlying medical condition. She experienced the unexpected event of Myocardial Infarction on an unspecified date after the first dose of Moderna COVID-19 Vaccine. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired Moderna Covid-19 vaccine) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired Moderna Covid-19 vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was unknown.   This case was linked to MOD-2021-314567, MOD-2021-314573, MOD-2021-314570, MOD-2021-314793, MOD-2021-314805, MOD-2021-314810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Additional source document received contains NNI.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site reaction, Vaginal haemorrhage
Clinical narrative: vaginal bleeding/bleeding for 7 days; other typical stuff; sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of VAGINAL HAEMORRHAGE (vaginal bleeding/bleeding for 7 days), VACCINATION SITE REACTION (other typical stuff) and MYALGIA (sore arm) in a 38-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 VAGINAL HAEMORRHAGE (vaginal bleeding/bleeding for 7 days), VACCINATION SITE REACTION (other typical stuff) and MYALGIA (sore arm). At the time of the report, VAGINAL HAEMORRHAGE (vaginal bleeding/bleeding for 7 days), VACCINATION SITE REACTION (other typical stuff) and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient went through IVF in the past, but not right now. She is not on any other medications. She has an antibody titer of 28.5 on the Siemens test and worried about getting the second dose.  no treatment medications are provided.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: shoulder and injection site pain of both shoulders/ right shoulder he notices pain 40-50% of time/ pain comes and goes; shoulder and injection site pain of both shoulders; awkward movement of shoulder aggerate the pain; This spontaneous case was reported by a consumer and describes the occurrence of shoulder and injection site pain of both shoulders, right shoulder he notices pain 40-50% of time, pain comes and goes, shoulder and injection site pain of both shoulders, and awkward movement of shoulder aggerate the pain in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) 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 shoulder and injection site pain of both shoulders/ right shoulder he notices pain 40-50% of time/ pain comes and goes, shoulder and injection site pain of both shoulders and awkward movement of shoulder aggerate the pain. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, shoulder and injection site pain of both shoulders, right shoulder he notices pain 40-50% of time, pain comes and goes, shoulder and injection site pain of both shoulders, and awkward movement of shoulder aggerate the pain outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was mentioned. Treatment also includes Ice and heat alternation.   This case was linked to MOD-2021-314534 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Sep-2021 and was forwarded to Moderna on 09-Sep-2021.    This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-314570, MOD-2021-314573, MOD-2021-314793, MOD-2021-314805, MOD-2021-314810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: follow up received contain No New Information
Sex: F
Vaccine: COVID19
Symptoms: Post herpetic neuralgia
Clinical narrative: her post-herpetic neuralgia (PHN) pain became a lot worse, quite a bit worse, it went from 3-4-5 to 6-7-8; This spontaneous case was reported by a consumer and describes the occurrence of POST HERPETIC NEURALGIA (her post-herpetic neuralgia (PHN) pain became a lot worse, quite a bit worse, it went from 3-4-5 to 6-7-8) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Post herpetic neuralgia.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-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 POST HERPETIC NEURALGIA (her post-herpetic neuralgia (PHN) pain became a lot worse, quite a bit worse, it went from 3-4-5 to 6-7-8). At the time of the report, POST HERPETIC NEURALGIA (her post-herpetic neuralgia (PHN) pain became a lot worse, quite a bit worse, it went from 3-4-5 to 6-7-8) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment medications was reported.