chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Still feels not right; Hot sweats; Back ache; Cold sweats; Migraines; Fever; Horrible headache; Muscle ache/horrible aching; Joint pain; Extreme fatigue; A tiny bit of nausea but no vomiting; She felt like she was going through menopause again but worse; Worst flu she has ever had; This spontaneous case was reported by a consumer and describes the occurrence of MENOPAUSE (She felt like she was going through menopause again but worse), FEELING ABNORMAL (Still feels not right), HYPERHIDROSIS (Hot sweats), BACK PAIN (Back ache) and COLD SWEAT (Cold sweats) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 058F21A, 039B21A and 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA (Worst flu she has ever had). On 15-Nov-2021, the patient experienced MENOPAUSE (She felt like she was going through menopause again but worse), HYPERHIDROSIS (Hot sweats), BACK PAIN (Back ache), COLD SWEAT (Cold sweats), MIGRAINE (Migraines), PYREXIA (Fever), HEADACHE (Horrible headache), MYALGIA (Muscle ache/horrible aching), ARTHRALGIA (Joint pain), FATIGUE (Extreme fatigue) and NAUSEA (A tiny bit of nausea but no vomiting). On 22-Nov-2021, the patient experienced FEELING ABNORMAL (Still feels not right). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. On 05-Nov-2021, INFLUENZA (Worst flu she has ever had) had resolved. At the time of the report, MENOPAUSE (She felt like she was going through menopause again but worse), FEELING ABNORMAL (Still feels not right), HYPERHIDROSIS (Hot sweats), BACK PAIN (Back ache), COLD SWEAT (Cold sweats), MIGRAINE (Migraines), PYREXIA (Fever), HEADACHE (Horrible headache), MYALGIA (Muscle ache/horrible aching), ARTHRALGIA (Joint pain), FATIGUE (Extreme fatigue) and NAUSEA (A tiny bit of nausea but no vomiting) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the following the booster dose of the vaccine, the day after receiving the shot was not so bad.   This case was linked to MOD-2021-395936, MOD-2021-395951 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Headache, Illness, Lymphadenopathy
Clinical narrative: softball lymph node underneath their arm, this was brand new.; really really bad headache.; felt like someone was crushing their bones; a terrible terrible back ache; felt sick; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (felt like someone was crushing their bones), BACK PAIN (a terrible terrible back ache), ILLNESS (felt sick), LYMPHADENOPATHY (softball lymph node underneath their arm, this was brand new.) and HEADACHE (really really bad headache.) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031h21a) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced BONE PAIN (felt like someone was crushing their bones), BACK PAIN (a terrible terrible back ache), ILLNESS (felt sick) and HEADACHE (really really bad headache.). On 20-Nov-2021, the patient experienced LYMPHADENOPATHY (softball lymph node underneath their arm, this was brand new.). At the time of the report, BONE PAIN (felt like someone was crushing their bones), BACK PAIN (a terrible terrible back ache), ILLNESS (felt sick), LYMPHADENOPATHY (softball lymph node underneath their arm, this was brand new.) and HEADACHE (really really bad headache.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-395931 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 9 patients received expired vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (9 patients received expired vaccines) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given. No treatment information were given.   This case was linked to MOD-2021-395880 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-067714, MOD-2021-395932 (Patient Link).
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 12 weeks of horrible pain from the 2 doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (12 weeks of horrible pain from the 2 doses) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis and Psoriatic arthritis.   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. In August 2021, the patient experienced PAIN (12 weeks of horrible pain from the 2 doses). At the time of the report, PAIN (12 weeks of horrible pain from the 2 doses) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  This is a spontaneous case concerning a 56-year-old patient of an unknown gender with relevant concurrent medical conditions of Psoriasis and Psoriatic arthritis, who experienced non serious unexpected event of Pain. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Concurrent medical conditions of Psoriasis and Psoriatic arthritis remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-395930 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 56-year-old patient of an unknown gender with relevant concurrent medical conditions of Psoriasis and Psoriatic arthritis, who experienced non serious unexpected event of Pain. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Concurrent medical conditions of Psoriasis and Psoriatic arthritis remain confounders. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 77-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 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 PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No concomitant medications were reported   No treatment information was provided   This case was linked to MOD-2021-395969, MOD-2021-395983, MOD-2021-395969 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19  immunization. No medical history reported. On Nov 19, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In November 2021, patient experienced headache. At the time of the report, headache outcome: unknown. Patient wanted to know if could take an ibuprofen for his headache. No concomitant medication or treatment information reported. This case linked to MOD-2021-396027, MOD-2021-396028 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Other side effects with the first and second dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-Nov-2021 and was forwarded to Moderna on 22-Nov-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other side effects with the first and second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION COMPLICATION (Other side effects with the first and second dose). At the time of the report, VACCINATION COMPLICATION (Other side effects with the first and second dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2021-396011, MOD-2021-396028 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pruritus, Rash
Clinical narrative: next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone; next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone; during waiting period at the vaccination she found it hard to breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (during waiting period at the vaccination she found it hard to breath), PRURITUS (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone) and RASH (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 001A21A) for COVID-19 vaccination.     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. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (during waiting period at the vaccination she found it hard to breath). On 26-Mar-2021, the patient experienced PRURITUS (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone). On an unknown date, the patient experienced RASH (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone). At the time of the report, DYSPNOEA (during waiting period at the vaccination she found it hard to breath) and RASH (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone) outcome was unknown and PRURITUS (next day over 12 hours later her tailbone was itching then stopped and then there was a rash at the tailbone) had resolved.            No concomitant medications were reported. No treatment medications were reported. It was reported that tailbone itching was stopped and then rash was started at the tailbone. Patient wants to know that if she should get the booster.   This case was linked to MOD-2021-395902 (Patient Link).
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Injection site pain, Vaccination complication
Clinical narrative: "maybe a sore arm"; "normal things"; Dose administered after expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE PAIN ("maybe a sore arm"), VACCINATION COMPLICATION ("normal things") and EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903 and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date). On an unknown date, the patient experienced INJECTION SITE PAIN ("maybe a sore arm") and VACCINATION COMPLICATION ("normal things"). On 19-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after expiration date) had resolved. At the time of the report, INJECTION SITE PAIN ("maybe a sore arm") and VACCINATION COMPLICATION ("normal things") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided by the reporter.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: axillary lymph nodes are the size of softballs; This spontaneous case was reported by an other health care professional and describes the occurrence of LYMPHADENOPATHY (axillary lymph nodes are the size of softballs) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Nov-2021, the patient experienced LYMPHADENOPATHY (axillary lymph nodes are the size of softballs). At the time of the report, LYMPHADENOPATHY (axillary lymph nodes are the size of softballs) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Pyrexia
Clinical narrative: still having fever off and on day 12; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Nov-2021 and was forwarded to Moderna on 24-Nov-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (still having fever off and on day 12) 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 November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced PYREXIA (still having fever off and on day 12). At the time of the report, PYREXIA (still having fever off and on day 12) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2021, Blood test: negative (Negative) Had a fever work-up, blood cultures and everything have been negative after day 7 post-vaccine..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Illness, Pyrexia
Clinical narrative: got real sick; headache; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got real sick), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (got real sick), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever). At the time of the report, ILLNESS (got real sick), HEADACHE (headache), CHILLS (chills) and PYREXIA (fever) had resolved.            No concomitant medication were reported. No treatment information was provided by the reporter.  The patient got real sick: fever, headache, and chills for a day.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product, Eye irritation
Clinical narrative: Vaccine squirted in the eyes of the patient; eye felt normal outside of the irritation; This spontaneous case was reported by a pharmacist and describes the occurrence of EYE IRRITATION (eye felt normal outside of the irritation) and ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine squirted in the eyes of the patient) 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 21-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced EYE IRRITATION (eye felt normal outside of the irritation). On 21-Nov-2021, the patient experienced ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine squirted in the eyes of the patient). On 21-Nov-2021, ACCIDENTAL EXPOSURE TO PRODUCT (Vaccine squirted in the eyes of the patient) had resolved. At the time of the report, EYE IRRITATION (eye felt normal outside of the irritation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  Reporter stated that the vial was kept under Moderna recommended temperature range the entire time. There was nothing else wrong except that the vaccine was administered beyond the manufacturer's expiration date.   This case was linked to MOD-2021-396165, MOD-2021-396184 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations in my heart after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations in my heart after second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 491B21A and 019D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-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 PALPITATIONS (Palpitations in my heart after second dose). The patient was treated with PREDNISONE for Adverse event, at a dose of 1 dosage form. At the time of the report, PALPITATIONS (Palpitations in my heart after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-396037, MOD-2021-396143 (Patient Link).
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Potentially got the dose from a vial punctured longer than 12 hours ago; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got the dose from a vial punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were provided
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to 11 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients). On 16-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to 11 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Potentially got their doses from vials punctured longer than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.      This case was linked to MOD-2021-395701 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site erythema, Vaccination site swelling
Clinical narrative: the area was very red; the area was very big/ it's coming down now/ area was swollen/ She was surprised to see it big and swollen this time.; now she had chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (the area was very red), VACCINATION SITE SWELLING (the area was very big/ it's coming down now/ area was swollen/ She was surprised to see it big and swollen this time.) and CHILLS (now she had chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039FUA, 015M20A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VACCINATION SITE ERYTHEMA (the area was very red), VACCINATION SITE SWELLING (the area was very big/ it's coming down now/ area was swollen/ She was surprised to see it big and swollen this time.) and CHILLS (now she had chills). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 19-Nov-2021 for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE ERYTHEMA (the area was very red), VACCINATION SITE SWELLING (the area was very big/ it's coming down now/ area was swollen/ She was surprised to see it big and swollen this time.) and CHILLS (now she had chills) was resolving.            No concomitant medication details was provided.   Reporter did not allow further contact
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very mild Sore arm after second shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Very mild Sore arm after second shot) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (Very mild Sore arm after second shot). On 15-May-2021, PAIN IN EXTREMITY (Very mild Sore arm after second shot) had resolved.            No relevant concomitant medication was reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-395855, MOD-2021-396448 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Product temperature exersion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) 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 TEMPERATURE EXCURSION ISSUE (Product temperature exersion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Product temperature exersion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were provided. No treatment medications were provided. It was reported that 6 patients were administered a dose of the Moderna covid-19 vaccine after a temperature excursion at the frozen range reaching a temperature 50°C.   Most recent FOLLOW-UP information incorporated above includes: On 23-Nov-2021: Added patient demographic details.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysmenorrhoea, Muscle spasms, Muscle tightness, Nausea
Clinical narrative: Moderate to severe entire body muscle cramps; muscles were so tight I could barely extend my extremities; I could barely extend my extremities and sit up without pain; Subsequently, never having had menstrual cramps before, I experienced severe cramps at every menstrual cycle (3 cycles) since receiving the 2nd dose of the vaccine.; The cramps are so bad they make me nauseous and dizzy.; The cramps are so bad they make me nauseous and dizzy.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04May2021 08:00 (Lot number: EW0169) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar I" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number- EW0169, Administration time- 12:00 AM, Vaccine Location-Right arm, Route-Intramuscular, as dose 1, single administration date: 13Apr2021, when the patient was 33 years old, for Covid-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "Moderate to severe entire body muscle cramps"; MUSCLE TIGHTNESS (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "muscles were so tight I could barely extend my extremities"; PAIN (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "I could barely extend my extremities and sit up without pain"; DYSMENORRHOEA (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "Subsequently, never having had menstrual cramps before, I experienced severe cramps at every menstrual cycle (3 cycles) since receiving the 2nd dose of the vaccine."; NAUSEA (non-serious), DIZZINESS (non-serious) all with onset 04May2021 16:00, outcome "recovered with sequelae" and all described as "The cramps are so bad they make me nauseous and dizzy.". Therapeutic measures were taken as a result of muscle spasms, muscle tightness, pain, dysmenorrhoea, nausea, dizziness.  Additional information: Vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no covid prior vaccination. The patient has not been tested for COVID-19 post vaccination. Patient had no known allergies. Patient received Ibuprofen, heat pack, muscle relaxer, massage as treatment of events.  Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Moderate to severe entire body muscle cramps; muscles were so tight I could barely extend my extremities; I could barely extend my extremities and sit up without pain; Subsequently, never having had menstrual cramps before, I experienced severe cramps at every menstrual cycle (3 cycles) since receiving the 2nd dose of the vaccine.; The cramps are so bad they make me nauseous and dizzy.; The cramps are so bad they make me nauseous and dizzy.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 33-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04May2021 08:00 (Lot number: EW0169) at the age of 33 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Bipolar I" (unspecified if ongoing); "Depression" (unspecified if ongoing); "anxiety disorder" (unspecified if ongoing); "ADHD" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot number- EW0169, Administration time- 12:00 AM, Vaccine Location-Right arm, Route-Intramuscular, as dose 1, single administration date: 13Apr2021, when the patient was 33 years old, for Covid-19 immunisation. The following information was reported: MUSCLE SPASMS (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "Moderate to severe entire body muscle cramps"; MUSCLE TIGHTNESS (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "muscles were so tight I could barely extend my extremities"; PAIN (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "I could barely extend my extremities and sit up without pain"; DYSMENORRHOEA (non-serious) with onset 04May2021 16:00, outcome "recovered with sequelae", described as "Subsequently, never having had menstrual cramps before, I experienced severe cramps at every menstrual cycle (3 cycles) since receiving the 2nd dose of the vaccine."; NAUSEA (non-serious), DIZZINESS (non-serious) all with onset 04May2021 16:00, outcome "recovered with sequelae" and all described as "The cramps are so bad they make me nauseous and dizzy.". Therapeutic measures were taken as a result of muscle spasms, muscle tightness, pain, dysmenorrhoea, nausea, dizziness.  Additional information: Vaccine was administered in Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no covid prior vaccination. The patient has not been tested for COVID-19 post vaccination. Patient had no known allergies. Patient received Ibuprofen, heat pack, muscle relaxer, massage as treatment of events.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Lymphadenopathy
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; severe muscle pain; Chills; Injection site swelling; Injection site redness; Feeling unwell; Swollen lymph nodes; my whole throat swelling; I can't get off the couch I'm in too much pain; Fever; the first shot in my leg; Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Lot number: FC3181) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: ENTYVIO taken for crohn's disease. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 18Aug2021, outcome "unknown", described as "the first shot in my leg; Left leg"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain; severe muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Injection site swelling"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Injection site redness"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "my whole throat swelling"; PAIN (non-serious), outcome "unknown", described as "I can't get off the couch I'm in too much pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, fatigue, headache, myalgia, chills, vaccination site swelling, vaccination site erythema, malaise, lymphadenopathy, pharyngeal swelling, pain, pyrexia.  Additional Information: Patient got a severe reaction to this vaccine. Patient took Tylenol and ice packs and CBD with turmeric and inflamed and Benadryl. No any other vaccine administered within four weeks prior to administration of first COVID shot.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Pain, Pharyngeal swelling, Product administered at inappropriate site
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; severe muscle pain; Chills; Injection site swelling; Injection site redness; Feeling unwell; Swollen lymph nodes; my whole throat swelling; I can't get off the couch I'm in too much pain; Fever; the first shot in my leg; Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Lot number: FC3181) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: ENTYVIO taken for crohn's disease. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 18Aug2021, outcome "unknown", described as "the first shot in my leg; Left leg"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain; severe muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Injection site swelling"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Injection site redness"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "my whole throat swelling"; PAIN (non-serious), outcome "unknown", described as "I can't get off the couch I'm in too much pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, fatigue, headache, myalgia, chills, vaccination site swelling, vaccination site erythema, malaise, lymphadenopathy, pharyngeal swelling, pain, pyrexia.  Additional Information: Patient got a severe reaction to this vaccine. Patient took Tylenol and ice packs and CBD with turmeric and inflamed and Benadryl. No any other vaccine administered within four weeks prior to administration of first COVID shot.  Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; severe muscle pain; Chills; Injection site swelling; Injection site redness; Feeling unwell; Swollen lymph nodes; my whole throat swelling; I can't get off the couch I'm in too much pain; Fever; the first shot in my leg; Left leg; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old patient received bnt162b2 (BNT162B2), administration date 18Aug2021 (Lot number: FC3181) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Crohn's disease" (unspecified if ongoing). Concomitant medication(s) included: ENTYVIO taken for crohn's disease. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 18Aug2021, outcome "unknown", described as "the first shot in my leg; Left leg"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; MYALGIA (non-serious), outcome "unknown", described as "Muscle pain; severe muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Injection site swelling"; VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown", described as "Injection site redness"; MALAISE (non-serious), outcome "unknown", described as "Feeling unwell"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "Swollen lymph nodes"; PHARYNGEAL SWELLING (non-serious), outcome "unknown", described as "my whole throat swelling"; PAIN (non-serious), outcome "unknown", described as "I can't get off the couch I'm in too much pain"; PYREXIA (non-serious), outcome "unknown", described as "Fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vaccination site pain, fatigue, headache, myalgia, chills, vaccination site swelling, vaccination site erythema, malaise, lymphadenopathy, pharyngeal swelling, pain, pyrexia.  Additional Information: Patient got a severe reaction to this vaccine. Patient took Tylenol and ice packs and CBD with turmeric and inflamed and Benadryl. No any other vaccine administered within four weeks prior to administration of first COVID shot.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Urticaria
Clinical narrative: Severe headache x3 days. Intially headache was over entire forehead, on day 2 and 3 radiated to right side of head with severe pain to right eye x3 days; Severe headache x3 days. Intially headache was over entire forehead, on day 2 and 3 radiated to right side of head with severe pain to right eye x3 days; Severe headache x3 days. Intially headache was over entire forehead, on day 2 and 3 radiated to right side of head with severe pain to right eye x3 days; On day 3 developed hives on right buttock which later spread to left buttock; This is a spontaneous report from a contactable nurse (patient).  A 43-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3182, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 25Aug2021 10:00 (at the age of 43 years old) as dose 2, single, dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0127, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 04Aug2021 (at the age of 43 years old) as dose 1, single for covid-19 immunisation at Pharmacy or drug store. Medical history included hypertension. Concomitant medication(s) included amlodipine besilate (AMLODIPINE). Known allergies included Ace and arbs. No other vaccine received in four weeks. Other medications received in two weeks included Amlodipine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced severe headache x3 days. Initially headache was over entire forehead, on day 2 and 3 radiated to right side of head with severe pain to right eye x3 days, on day 3 developed hives on right buttock which later spread to left buttock on an unspecified date. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Severe low back pain; This is a spontaneous report from a contactable physician (patient).   A 66-year-old male patient of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Lot number: 301308A) via an unspecified route of administration at left arm on 23Sep2021 at 15.00 (at the age of 66-years) as dose number unknown, single for COVID-19 immunization. The patient medical history included hypertension from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lisonpril taken for unknown date, start and stop date were not reported (within 2 weeks of vaccination). On 25Sep2021 at 08:00, the patient experienced severe low back pain. The patient was received muscle relaxant as treatment medication for the adverse event. The patient was advised to visit doctor or other healthcare professional office/clinic visit as result of the event. The case is assessed as non-serious. The physician reported Pfizer product had a casual effect to adverse event. The outcome of the event severe low back pain was recovering.  Follow-up attempts are completed. No further information is expected.