chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.            Concomitant medications were not reported. Treatment information was not provided.   This case was linked to MOD-2021-272823 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: What are the side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are the side effects) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are the side effects). At the time of the report, VACCINATION COMPLICATION (What are the side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. No treatment details were provided.   Reporter did not allow further contact
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dental caries
Clinical narrative: Her teeth started crumbling out after receiving 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DENTAL CARIES (Her teeth started crumbling out after receiving 2nd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included ZOLPIDEM TARTRATE (AMBIEN), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) and ALPRAZOLAM (XANAX) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced DENTAL CARIES (Her teeth started crumbling out after receiving 2nd dose). At the time of the report, DENTAL CARIES (Her teeth started crumbling out after receiving 2nd dose) outcome was unknown.            No treatment medication was provided by reporter.   This case was linked to MOD-2021-273887 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: heat on the injection site; soreness and heat on the injection site; soreness and heat on the injection site, and it also itches; 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 SITE WARMTH (heat on the injection site), VACCINATION SITE PAIN (soreness and heat on the injection site) and VACCINATION SITE PRURITUS (soreness and heat on the injection site, and it also itches) 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 20-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (heat on the injection site), VACCINATION SITE PAIN (soreness and heat on the injection site) and VACCINATION SITE PRURITUS (soreness and heat on the injection site, and it also itches). At the time of the report, VACCINATION SITE WARMTH (heat on the injection site), VACCINATION SITE PAIN (soreness and heat on the injection site) and VACCINATION SITE PRURITUS (soreness and heat on the injection site, and it also itches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This report consists of multiple patients. Concomitant medication information was not provided. Treatment information was not provided.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Gingivitis, Herpes zoster, Vaccination complication
Clinical narrative: Severe reaction; Gingivitis; About 10-13 days ago, he was diagnosed with shingle; at first, they thought it was a bug bite since it started out as little pimples; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Severe reaction), GINGIVITIS (Gingivitis) and HERPES ZOSTER (About 10-13 days ago, he was diagnosed with shingle; at first, they thought it was a bug bite since it started out as little pimples) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 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 VACCINATION COMPLICATION (Severe reaction), GINGIVITIS (Gingivitis) and HERPES ZOSTER (About 10-13 days ago, he was diagnosed with shingle; at first, they thought it was a bug bite since it started out as little pimples). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) ongoing since an unknown date for Shingles, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Severe reaction), GINGIVITIS (Gingivitis) and HERPES ZOSTER (About 10-13 days ago, he was diagnosed with shingle; at first, they thought it was a bug bite since it started out as little pimples) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient intakes unknown blood pressure medications and antibiotics for shingles as reported by the reporter.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Groin pain, Pain in extremity
Clinical narrative: Severe pain in his thigh; Severe pain in his groin; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Severe pain in his thigh) and GROIN PAIN (Severe pain in his groin) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Severe pain in his thigh) and GROIN PAIN (Severe pain in his groin). The patient was treated with OXYCODONE for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Severe pain in his thigh) and GROIN PAIN (Severe pain in his groin) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: negative (Negative) still negative for kidney stone. and negative (Negative) negative for kidney stone.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.   This case was linked to MOD-2021-273688 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Heat on the injection site; Soreness and heat on the injection site, and it also itches; Soreness and heat on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Heat on the injection site), VACCINATION SITE PRURITUS (Soreness and heat on the injection site, and it also itches) and VACCINATION SITE PAIN (Soreness and heat on the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concomitant products included IBUPROFEN for Arthritis, VITAMINS NOS for an unknown indication.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced VACCINATION SITE WARMTH (Heat on the injection site), VACCINATION SITE PRURITUS (Soreness and heat on the injection site, and it also itches) and VACCINATION SITE PAIN (Soreness and heat on the injection site). At the time of the report, VACCINATION SITE WARMTH (Heat on the injection site), VACCINATION SITE PRURITUS (Soreness and heat on the injection site, and it also itches) and VACCINATION SITE PAIN (Soreness and heat on the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment includes anti-itching medicine (unspecified) and ice pack.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Mild Muscle pain in her left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Mild Muscle pain in her left injection site arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination.     No medical history was reported.     On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (Mild Muscle pain in her left injection site arm). At the time of the report, MYALGIA (Mild Muscle pain in her left injection site arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant include unspecified steroids and antibiotics. Treatment information was not reported.   This case was linked to MOD-2021-273492 (Patient Link).
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Product dose omission issue
Clinical narrative: Not able to get  her 2nd dose on the due date because she was sick; she was sick; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not able to get  her 2nd dose on the due date because she was sick) and MALAISE (she was sick) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis and Paralysis.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not able to get  her 2nd dose on the due date because she was sick) and MALAISE (she was sick). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not able to get  her 2nd dose on the due date because she was sick) had resolved and MALAISE (she was sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Oropharyngeal pain
Clinical narrative: Sore throat; Congestion; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and NASAL CONGESTION (Congestion) had not resolved.        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 medications were not provided.  Post vaccination patient experienced congestion and sore throat, these symptoms worsen in the morning and lasted for couple of weeks .Treatment information was not provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine administered to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) to be possibly related.    No concomitant medication details was reported. No treatment medication details was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: unable to receive scheduled second dose of the vaccine (23Jun2021); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (unable to receive scheduled second dose of the vaccine (23Jun2021)) 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 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (unable to receive scheduled second dose of the vaccine (23Jun2021)). On 23-Jun-2021, PRODUCT DOSE OMISSION ISSUE (unable to receive scheduled second dose of the vaccine (23Jun2021)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.   Patient was not able to get her scheduled second dose of vaccination due to lack of transport and family problems. No treatment medication was reported.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Neck mass, Pain
Clinical narrative: lump started to hurt with a slight twitch; lump started to hurt with a slight twitch; a lump between her clavicula and her neck on the left side; This spontaneous case was reported by a consumer and describes the occurrence of NECK MASS (a lump between her clavicula and her neck on the left side), PAIN (lump started to hurt with a slight twitch) and MUSCLE TWITCHING (lump started to hurt with a slight twitch) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004d21a) for COVID-19 vaccination.     Medical history information was not reported.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced NECK MASS (a lump between her clavicula and her neck on the left side). On 02-Aug-2021, the patient experienced PAIN (lump started to hurt with a slight twitch) and MUSCLE TWITCHING (lump started to hurt with a slight twitch). At the time of the report, NECK MASS (a lump between her clavicula and her neck on the left side), PAIN (lump started to hurt with a slight twitch) and MUSCLE TWITCHING (lump started to hurt with a slight twitch) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Limb injury
Clinical narrative: stepped on a rusty nail (left foot); This spontaneous case was reported by a consumer and describes the occurrence of FALL (stepped on a rusty nail (left foot)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced FALL (stepped on a rusty nail (left foot)). At the time of the report, FALL (stepped on a rusty nail (left foot)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant Medication information recorded. No Treatment information recorded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: received his second dose of the Pfizer Covid-19 vaccine instead of Moderna Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (received his second dose of the Pfizer Covid-19 vaccine instead of Moderna Covid-19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No Medical History information was reported.   On 22-Jul-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 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 22-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (received his second dose of the Pfizer Covid-19 vaccine instead of Moderna Covid-19 vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (received his second dose of the Pfizer Covid-19 vaccine instead of Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered vaccine that had been stored in the refrigerator for more than 30 days; Administered vaccine that had been stored in the refrigerator for more than 30 days and administered to 81 patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that had been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine that had been stored in the refrigerator for more than 30 days and administered to 81 patient) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) 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 PRODUCT STORAGE ERROR (Administered vaccine that had been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine that had been stored in the refrigerator for more than 30 days and administered to 81 patient). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that had been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (Administered vaccine that had been stored in the refrigerator for more than 30 days and administered to 81 patient) had resolved.        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.   No concomitant medications reported. No treatment medications reported.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient has not received 2nd dose of the vaccine in more than 6 months from the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of the vaccine in more than 6 months from the 1st dose) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025020A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of the vaccine in more than 6 months from the 1st dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose of the vaccine in more than 6 months from the 1st dose) had resolved.            No concomitant medication were reported. No treatment information was provided.   Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Rash pruritic
Clinical narrative: developed a papular rash over her trunk and upper thighs; rash was itchy; This spontaneous case was reported by a physician and describes the occurrence of RASH PAPULAR (developed a papular rash over her trunk and upper thighs) and RASH PRURITIC (rash was itchy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hyperlipidemia.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PAPULAR (developed a papular rash over her trunk and upper thighs) and RASH PRURITIC (rash was itchy). At the time of the report, RASH PAPULAR (developed a papular rash over her trunk and upper thighs) and RASH PRURITIC (rash was itchy) 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 product information was not provided.  As treatment the patient received some 'cor'.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site movement impairment
Clinical narrative: My arm is so sorry can't even hardly use it is this normal; My arm is so sorry can't even hardly use it; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (My arm is so sorry can't even hardly use it is this normal) and VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is so sorry can't even hardly use it) 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 01-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (My arm is so sorry can't even hardly use it is this normal) and VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is so sorry can't even hardly use it). At the time of the report, PAIN IN EXTREMITY (My arm is so sorry can't even hardly use it is this normal) and VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is so sorry can't even hardly use it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No Treatment information was provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Nerve injury
Clinical narrative: Nerve damage in my right arm and hand; This spontaneous case was reported by a consumer and describes the occurrence of NERVE INJURY (Nerve damage in my right arm and hand) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 048B21A) for COVID-19 vaccination.     The patient's past medical history included Heart attack on 15-May-2021 and Catheterization cardiac on 15-May-2021. Previously administered products included for an unreported indication: INFLUENZA (Arm Pain. Chest Pain and Vomiting and Sinusitis) on 07-Apr-2021. Concurrent medical conditions included Type 2 diabetes mellitus (Numbers improved slighty since Adverse event) since 17-Feb-2018 and Blood pressure high (Numbers are back to normal) since 17-Feb-2018. Concomitant products included INSULIN ASPART, INSULIN ASPART PROTAMINE (NOVOLOG MIX) from 10-Apr-2019 to an unknown date and DULAGLUTIDE (TRULICITY) from 12-Dec-2020 to an unknown date for an unknown indication.   On 13-May-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021 at 11:00 AM, 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 NERVE INJURY (Nerve damage in my right arm and hand). At the time of the report, NERVE INJURY (Nerve damage in my right arm and hand) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Catheterisation cardiac: (normal) Performed to check if heart was normal. Nothing abnormal was found.         Patient received Influenza Vaccine on 07-Apr-2021 and experienced vomiting. Treatment information was not provided.   This case was linked to MOD-2021-154215 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) 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 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 HERPES ZOSTER (Shingles). At the time of the report, HERPES ZOSTER (Shingles) outcome was unknown.            No concomitant medications are reported by reporter.  No treatment medications are reported by reporter.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: mixed series vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (mixed series vaccination) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: COVID-19 VACCINE on 08-Apr-2021. Concomitant products included LORAZEPAM from 26-Jan-2015 to an unknown date for Anxiety, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) from 29-Jun-2016 to an unknown date for Blood pressure, TRAZODONE from 23-Dec-2019 to an unknown date for Sleepy, MINOCYCLINE from 17-Feb-2020 to an unknown date and TESTOSTERONE from 16-Sep-2019 to an unknown date for an unknown indication.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (mixed series vaccination). On 26-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (mixed series vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up received and contains significant information updated reporter details, suspect product information route and anatomical site, vaccine facility information, concomitant medications, Events start date was updated.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: dose was administered greater than 12 hours after initial vial punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was administered greater than 12 hours after initial vial punctured) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was administered greater than 12 hours after initial vial punctured). On 01-Aug-2021, EXPIRED PRODUCT ADMINISTERED (dose was administered greater than 12 hours after initial vial punctured) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose was administered greater than 12 hours after initial vial punctured) to be possibly related.    No concomitant medication was given.   No treatment information was provided by the Reporter.   This case was linked to US-irms-MOD21-273539 (Linked Report).; Sender's Comments:  US-irms-MOD21-273539:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Vaccination site movement impairment, Vaccination site reaction
Clinical narrative: COVID arm; Could not move her arm; Urine infection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and URINARY TRACT INFECTION (Urine infection) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 027B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-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 VACCINATION SITE REACTION (COVID arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) and URINARY TRACT INFECTION (Urine infection). At the time of the report, VACCINATION SITE REACTION (COVID arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (Could not move her arm) had not resolved and URINARY TRACT INFECTION (Urine infection) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment information mentioned.  Patient reported taking both doses of vaccine. Patient went for for a urine infection prior to second dose. she had no insurance so did not go to the doctor at the time. The patient still had COVID arm and can't raise hand over head  Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-273598 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Didn't experience that much of side effects as he would have expected for his second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Didn't experience that much of side effects as he would have expected for his second dose) 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 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 VACCINATION COMPLICATION (Didn't experience that much of side effects as he would have expected for his second dose). At the time of the report, VACCINATION COMPLICATION (Didn't experience that much of side effects as he would have expected for his second dose) had resolved.            No concomitant medications were provided. No treatment medications were provided.  Patient wanted to double-check that he received Moderna's vaccine or other. Patient still unsure if the vaccine was real Moderna's or not.
Sex: M
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: lymphedema; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOEDEMA (lymphedema) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHOEDEMA (lymphedema). At the time of the report, LYMPHOEDEMA (lymphedema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: received the second Moderna dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna dose) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Jan-2021. Previously administered products included for an unreported indication: MMR in May 2020.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna dose). On 01-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the second Moderna dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive.         Reporter stated that he was prescribed an antibiotic.  Patient reported that he wears hearing aids  No concomitant medications were provided.   This case was linked to MOD-2021-029141 (Patient Link).
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: Severe Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe Headache) and PYREXIA (Fever) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced HEADACHE (Severe Headache) and PYREXIA (Fever). On 01-Aug-2021, PYREXIA (Fever) had resolved. At the time of the report, HEADACHE (Severe Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug was reported NO treatment medication was reported
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy
Clinical narrative: register pregnancy; vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PREGNANCY (register pregnancy) and EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-Feb-2021 and the estimated date of delivery was 12-Nov-2021. On 02-Aug-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). On an unknown date, the patient experienced PREGNANCY (register pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 02-Aug-2021, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. At the time of the report, PREGNANCY (register pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medications included prenatal vitamins and nausea medication.  No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Product dose omission issue, Vertigo
Clinical narrative: Dizziness/Light headedness; Some vertigo; Patient has not gotten 2nd dose after 1st dose more than 42 days later; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness/Light headedness), VERTIGO (Some vertigo) and PRODUCT DOSE OMISSION ISSUE (Patient has not gotten 2nd dose after 1st dose more than 42 days later) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 DIZZINESS (Dizziness/Light headedness) and VERTIGO (Some vertigo). an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not gotten 2nd dose after 1st dose more than 42 days later). At the time of the report, DIZZINESS (Dizziness/Light headedness) and VERTIGO (Some vertigo) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not gotten 2nd dose after 1st dose more than 42 days later) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  About 3 weeks after her 1st dose she experienced those above mentioned adverse events. The patient further stated that she was doing better and she had also been under doctor's care.  Company comment: Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: has not received his second dose as of today, it's been more than 42 days since he had received his first dose; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (has not received his second dose as of today, it's been more than 42 days since he had received his first dose) 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.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (has not received his second dose as of today, it's been more than 42 days since he had received his first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (has not received his second dose as of today, it's been more than 42 days since he had received his first dose) 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 product information was not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered 19 hours after vial was open/Exceeded 12 hours time frame; 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 EXPIRED PRODUCT ADMINISTERED (Dose administered 19 hours after vial was open/Exceeded 12 hours time frame) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 19 hours after vial was open/Exceeded 12 hours time frame). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered 19 hours after vial was open/Exceeded 12 hours time frame) had 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.   The pharmacist stated the vaccine did not have any excursions except that it was administered after it was expired. Visual inspection of the vial showed no change of vaccine state. Concomitant product information was not provided. Treatment information was not provided.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fatigue; Chills; Fever (101.4 degrees Fahrenheit); Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Fever (101.4 degrees Fahrenheit)) and HEADACHE (Headache) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE, LOSARTAN, POTASSIUM CITRATE and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Fever (101.4 degrees Fahrenheit)) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 500 mg. At the time of the report, FATIGUE (Fatigue), CHILLS (Chills), PYREXIA (Fever (101.4 degrees Fahrenheit)) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, Body temperature: 101.04 (High) 101.04.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Additional information received, new event Headache was added.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, SARS-CoV-2 test negative, Vaccination complication
Clinical narrative: Patient had symptoms; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (Patient had symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 013P1(2)20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (Patient had symptoms). The patient was treated with AZITHROMYCIN (oral) at a dose of 2 tablets a day then 1 tablet once daily. At the time of the report, VACCINATION COMPLICATION (Patient had symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Antibody test: negative (Negative) No antibodies present (negative) and not detected. In 2021, SARS-CoV-2 test negative: negative (Negative) COVID  nasal test, it was negative.         Concomitant product use was not provided by the reporter.