chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Oral pain
Clinical narrative: "round like sore in mouth"; This spontaneous case was reported by a pharmacist and describes the occurrence of ORAL PAIN ("round like sore in mouth") in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-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 ORAL PAIN ("round like sore in mouth"). At the time of the report, ORAL PAIN ("round like sore in mouth") 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.   No concomitant medication provided.  No treatment medication provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Vaccination site bruising
Clinical narrative: pain in arm; I had a deep blue black bruise about the size of a quarter; Inappropriate schedule of vaccine administered; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm), VACCINATION SITE BRUISING (I had a deep blue black bruise about the size of a quarter) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) 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) (unknown route) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 29-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE BRUISING (I had a deep blue black bruise about the size of a quarter). At the time of the report, PAIN IN EXTREMITY (pain in arm) and VACCINATION SITE BRUISING (I had a deep blue black bruise about the size of a quarter) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.            No concomitant medication information was provided.  No treatment medication information was given.   This case was linked to MOD-2021-081474 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site was so painful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site was so painful) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high.    On 11-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 VACCINATION SITE PAIN (Injection site was so painful). At the time of the report, VACCINATION SITE PAIN (Injection site was so painful) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       High Blood Pressure Med was given as concomitant medication.  No treatment information was provided.   This case was linked to MOD-2021-275274 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: (2nd dose) residual aching legs very regularly; (2nd dose) swollen upper arm; (2nd dose) painful upper arm; Injection site was so painfull; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY ((2nd dose) residual aching legs very regularly), PERIPHERAL SWELLING ((2nd dose) swollen upper arm), PAIN IN EXTREMITY ((2nd dose) painful upper arm) and INJECTION SITE PAIN (Injection site was so painfull) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-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 PAIN IN EXTREMITY ((2nd dose) residual aching legs very regularly), PERIPHERAL SWELLING ((2nd dose) swollen upper arm), PAIN IN EXTREMITY ((2nd dose) painful upper arm) and INJECTION SITE PAIN (Injection site was so painfull). At the time of the report, PAIN IN EXTREMITY ((2nd dose) residual aching legs very regularly) had not resolved, PERIPHERAL SWELLING ((2nd dose) swollen upper arm) had resolved and PAIN IN EXTREMITY ((2nd dose) painful upper arm) and INJECTION SITE PAIN (Injection site was so painfull) outcome was unknown.            The unspecified concomitant medication was reported for high blood pressure.  On an unknown date, after the second vaccination, the patient had residual aching legs all the time. The patient had swollen upper arm which was painful after vaccination and lasted about an week.   This case was linked to MOD-2021-275262 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Pruritus
Clinical narrative: arm is still like a lump,there bump,; it's reddish; arm is itching; This spontaneous case was reported by a consumer and describes the occurrence of MASS (arm is still like a lump,there bump,), ERYTHEMA (it's reddish) and PRURITUS (arm is itching) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE, OLMESARTAN, COLECALCIFEROL (VITAMIN D3) and VITAMIN B12 NOS for an unknown indication.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jul-2021, the patient experienced MASS (arm is still like a lump,there bump,), ERYTHEMA (it's reddish) and PRURITUS (arm is itching). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MASS (arm is still like a lump,there bump,), ERYTHEMA (it's reddish) and PRURITUS (arm is itching) 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.   Other concomitant drug used by patient was Multivitamin.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysphonia, Headache, Nasal congestion
Clinical narrative: low grade fever after 2nd dose; intense headache after 2nd dose; lost sense of smell and taste; raspy voice; loss of taste; mild fever; headache; congestion; This spontaneous case was reported by an other health care professional and describes the occurrence of NASAL CONGESTION (congestion), ANOSMIA (lost sense of smell and taste), DYSPHONIA (raspy voice), AGEUSIA (loss of taste) and PYREXIA (mild fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced NASAL CONGESTION (congestion), PYREXIA (mild fever) and HEADACHE (headache). On 01-Aug-2021, the patient experienced ANOSMIA (lost sense of smell and taste), DYSPHONIA (raspy voice) and AGEUSIA (loss of taste). On an unknown date, the patient experienced PYREXIA (low grade fever after 2nd dose) and HEADACHE (intense headache after 2nd dose). At the time of the report, NASAL CONGESTION (congestion), ANOSMIA (lost sense of smell and taste), DYSPHONIA (raspy voice), AGEUSIA (loss of taste), PYREXIA (mild fever) and HEADACHE (headache) had not resolved and PYREXIA (low grade fever after 2nd dose) and HEADACHE (intense headache after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided by the reporter. Reporter stated she wanted to report she tested positive for COVID19 on 31Jul2021 and said as a healthcare provider herself her thought is "duration of effect, it has been 7-8 months now" "different strains".   This case was linked to MOD-2021-275074 (E2B Linked Report).; Sender's Comments:  MOD-2021-275074:dose 1
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: low grade fever after 2nd dose; intense headache after 2nd dose; lost sense of smell and taste; raspy voice; loss of taste; mild fever; headache; congestion; This spontaneous case was reported by an other health care professional and describes the occurrence of NASAL CONGESTION (congestion), ANOSMIA (lost sense of smell and taste), DYSPHONIA (raspy voice), AGEUSIA (loss of taste) and PYREXIA (mild fever) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced NASAL CONGESTION (congestion), PYREXIA (mild fever) and HEADACHE (headache). On 01-Aug-2021, the patient experienced ANOSMIA (lost sense of smell and taste), DYSPHONIA (raspy voice) and AGEUSIA (loss of taste). On an unknown date, the patient experienced PYREXIA (low grade fever after 2nd dose) and HEADACHE (intense headache after 2nd dose). At the time of the report, NASAL CONGESTION (congestion), ANOSMIA (lost sense of smell and taste), DYSPHONIA (raspy voice), AGEUSIA (loss of taste), PYREXIA (mild fever) and HEADACHE (headache) had not resolved and PYREXIA (low grade fever after 2nd dose) and HEADACHE (intense headache after 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information not provided by the reporter. Reporter stated she wanted to report she tested positive for COVID19 on 31Jul2021 and said as a healthcare provider herself her thought is "duration of effect, it has been 7-8 months now" "different strains".   This case was linked to MOD-2021-275074 (E2B Linked Report).; Sender's Comments:  MOD-2021-275074:dose 1
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administration error
Clinical narrative: The patient received a third shot because "just thought it would be safe"; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (The patient received a third shot because "just thought it would be safe") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 010A21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) injection for COVID-19 vaccination.    The patient's past medical history included Hepatitis. Concurrent medical conditions included COPD and Hypertension.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Aug-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Aug-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (The patient received a third shot because "just thought it would be safe"). On 03-Aug-2021, PRODUCT ADMINISTRATION ERROR (The patient received a third shot because "just thought it would be safe") had resolved.            Concomitant product use was not provided by the reporter.    Reporter did not allow further contact
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety. Concomitant products included CLONAZEPAM for Anxiety, PARACETAMOL (TYLENOL) for an unknown indication.    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 TINNITUS (Tinnitus). On 16-Apr-2021, TINNITUS (Tinnitus) had resolved.            No treatment information was received.   This case was linked to MOD-2021-275381 (Patient Link).
Age: 30.0
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 20May2021 A customer received the 1st dose of the Moderna Covid-19 vaccine. They're wanting to get the 2nd dose today.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (20May2021 A customer received the 1st dose of the Moderna Covid-19 vaccine. They're wanting to get the 2nd dose today.) in a 30-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (20May2021 A customer received the 1st dose of the Moderna Covid-19 vaccine. They're wanting to get the 2nd dose today.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (20May2021 A customer received the 1st dose of the Moderna Covid-19 vaccine. They're wanting to get the 2nd dose today.) 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.   No concomitants medication were provided. No treatment medication were provided.    Reporter did not allow further contact
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Diarrhoea, Faeces soft
Clinical narrative: Loose stool; In the beginning it was just my bowel were a little soft they were like mud; Condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Loose stool), FAECES SOFT (In the beginning it was just my bowel were a little soft they were like mud) and CONDITION AGGRAVATED (Condition aggravated) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DIARRHOEA (Loose stool), FAECES SOFT (In the beginning it was just my bowel were a little soft they were like mud) and CONDITION AGGRAVATED (Condition aggravated). At the time of the report, DIARRHOEA (Loose stool), FAECES SOFT (In the beginning it was just my bowel were a little soft they were like mud) and CONDITION AGGRAVATED (Condition aggravated) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was reported.    This case was linked to MOD-2021-275346 (Patient Link).
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Myalgia, Vaginal haemorrhage
Clinical narrative: Abnormal vaginal bleeding (3 weeks earlier than her expected period); Abdominal cramping; Sore arm; This spontaneous case was reported by a nurse and describes the occurrence of VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding (3 weeks earlier than her expected period)), ABDOMINAL PAIN (Abdominal cramping) and MYALGIA (Sore arm) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In July 2021, the patient experienced ABDOMINAL PAIN (Abdominal cramping) and MYALGIA (Sore arm). On 30-Jul-2021, the patient experienced VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding (3 weeks earlier than her expected period)). At the time of the report, VAGINAL HAEMORRHAGE (Abnormal vaginal bleeding (3 weeks earlier than her expected period)), ABDOMINAL PAIN (Abdominal cramping) and MYALGIA (Sore arm) 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.   No relevant concomitant medications were reported.  No treatment information was provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: Consumer had to get a gall bladder surgery after receiving the 1st dose of the vaccine and advised to wait on 2nd dose by MD,not got the 2nd dose yet.; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Consumer had to get a gall bladder surgery after receiving the 1st dose of the vaccine and advised to wait on 2nd dose by MD,not got the 2nd dose yet.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Back pain (It was due to stones in his bladder before receiving the vaccine), Gallbladder stones (before receiving the vaccine) and Gallbladder operation (after receiving the 1st dose of the vaccine). Concomitant products included PREDNISONE for an unknown indication.    On 15-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 OFF LABEL USE (Consumer had to get a gall bladder surgery after receiving the 1st dose of the vaccine and advised to wait on 2nd dose by MD,not got the 2nd dose yet.). At the time of the report, OFF LABEL USE (Consumer had to get a gall bladder surgery after receiving the 1st dose of the vaccine and advised to wait on 2nd dose by MD,not got the 2nd dose yet.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Blood calcium, Blood test, Diarrhoea, Protein total
Clinical narrative: shortly after the second vaccine she got a UTI; After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.; If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (shortly after the second vaccine she got a UTI), DIARRHOEA (After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.) and ABDOMINAL DISTENSION (If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-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 URINARY TRACT INFECTION (shortly after the second vaccine she got a UTI), DIARRHOEA (After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.) and ABDOMINAL DISTENSION (If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol). At the time of the report, URINARY TRACT INFECTION (shortly after the second vaccine she got a UTI) outcome was unknown, DIARRHOEA (After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.) had not resolved and ABDOMINAL DISTENSION (If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood calcium: High. On an unknown date, Blood test: (abnormal) patient stated that her blood came with high on couple of things and another things. On an unknown date, Protein total: high (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Antibiotics for UTI, Probiotics (Women's health one and then the digestive one).   This case was linked to MOD-2021-275324 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: shortly after the second vaccine she got a UTI; After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.; If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (shortly after the second vaccine she got a UTI), DIARRHOEA (After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.) and ABDOMINAL DISTENSION (If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 039B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-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 URINARY TRACT INFECTION (shortly after the second vaccine she got a UTI), DIARRHOEA (After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.) and ABDOMINAL DISTENSION (If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol). At the time of the report, URINARY TRACT INFECTION (shortly after the second vaccine she got a UTI) outcome was unknown, DIARRHOEA (After the antibiotics and probiotics, the diarrhea was more severe/ severe severe diarrhea.) had not resolved and ABDOMINAL DISTENSION (If I eat anything it is like blowing through me , anything processed: meat, dairy, alcohol) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood calcium: High. On an unknown date, Blood test: (abnormal) patient stated that her blood came with high on couple of things and another things. On an unknown date, Protein total: high (High) high.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information included Antibiotics for UTI, Probiotics (Women's health one and then the digestive one).   This case was linked to MOD-2021-275324 (Patient Link).
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling of body temperature change, Headache, Myalgia, Nausea
Clinical narrative: kept waking up; would be hot and then cold; felt like a truck running over him; fever; headache,head is hurting so bad; body ache,body hurt; nauseous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of POOR QUALITY SLEEP (kept waking up), FEELING OF BODY TEMPERATURE CHANGE (would be hot and then cold), FEELING ABNORMAL (felt like a truck running over him), PYREXIA (fever) and HEADACHE (headache,head is hurting so bad) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19, Pneumonia and Bypass surgery (Quadruple). Concurrent medical conditions included Headache (after Covid). Concomitant products included VALSARTAN, OMEPRAZOLE, METOPROLOL, ROSUVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced POOR QUALITY SLEEP (kept waking up), FEELING OF BODY TEMPERATURE CHANGE (would be hot and then cold), FEELING ABNORMAL (felt like a truck running over him), PYREXIA (fever), HEADACHE (headache,head is hurting so bad), MYALGIA (body ache,body hurt) and NAUSEA (nauseous). At the time of the report, POOR QUALITY SLEEP (kept waking up), FEELING OF BODY TEMPERATURE CHANGE (would be hot and then cold), FEELING ABNORMAL (felt like a truck running over him), PYREXIA (fever), MYALGIA (body ache,body hurt) and NAUSEA (nauseous) outcome was unknown and HEADACHE (headache,head is hurting so bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: kept waking up; would be hot and then cold; felt like a truck running over him; fever; headache,head is hurting so bad; body ache,body hurt; nauseous; This spontaneous case was reported by a patient family member or friend and describes the occurrence of POOR QUALITY SLEEP (kept waking up), FEELING OF BODY TEMPERATURE CHANGE (would be hot and then cold), FEELING ABNORMAL (felt like a truck running over him), PYREXIA (fever) and HEADACHE (headache,head is hurting so bad) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19, Pneumonia and Bypass surgery (Quadruple). Concurrent medical conditions included Headache (after Covid). Concomitant products included VALSARTAN, OMEPRAZOLE, METOPROLOL, ROSUVASTATIN and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced POOR QUALITY SLEEP (kept waking up), FEELING OF BODY TEMPERATURE CHANGE (would be hot and then cold), FEELING ABNORMAL (felt like a truck running over him), PYREXIA (fever), HEADACHE (headache,head is hurting so bad), MYALGIA (body ache,body hurt) and NAUSEA (nauseous). At the time of the report, POOR QUALITY SLEEP (kept waking up), FEELING OF BODY TEMPERATURE CHANGE (would be hot and then cold), FEELING ABNORMAL (felt like a truck running over him), PYREXIA (fever), MYALGIA (body ache,body hurt) and NAUSEA (nauseous) outcome was unknown and HEADACHE (headache,head is hurting so bad) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported. No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Cough, Feeling abnormal, Illness, Suspected COVID-19
Clinical narrative: i'm now sick with all the symptoms of covid; coughing is getting worse; I feel awful; With all the symptoms of covid; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (i'm now sick with all the symptoms of covid), COUGH (coughing is getting worse), FEELING ABNORMAL (I feel awful) and SUSPECTED COVID-19 (With all the symptoms of covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (i'm now sick with all the symptoms of covid), COUGH (coughing is getting worse), FEELING ABNORMAL (I feel awful) and SUSPECTED COVID-19 (With all the symptoms of covid). At the time of the report, ILLNESS (i'm now sick with all the symptoms of covid), COUGH (coughing is getting worse), FEELING ABNORMAL (I feel awful) and SUSPECTED COVID-19 (With all the symptoms of covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was reported No treatment medication information was reported
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Epistaxis, Neck pain, Oropharyngeal pain, Peripheral swelling
Clinical narrative: Neck (both sides) was swollen; Right side of the neck hurts; Throat is painful when she swallows; Pain inside ear; Bloody nose (both nostrils); Arm swelled up really bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up really bad), EPISTAXIS (Bloody nose (both nostrils)), SWELLING (Neck (both sides) was swollen), NECK PAIN (Right side of the neck hurts) and OROPHARYNGEAL PAIN (Throat is painful when she swallows) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02PR21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up really bad). On 10-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EPISTAXIS (Bloody nose (both nostrils)). On 31-Jul-2021, the patient experienced SWELLING (Neck (both sides) was swollen), NECK PAIN (Right side of the neck hurts), OROPHARYNGEAL PAIN (Throat is painful when she swallows) and EAR PAIN (Pain inside ear). In 2021, PERIPHERAL SWELLING (Arm swelled up really bad) outcome was unknown. At the time of the report, EPISTAXIS (Bloody nose (both nostrils)), SWELLING (Neck (both sides) was swollen), NECK PAIN (Right side of the neck hurts), OROPHARYNGEAL PAIN (Throat is painful when she swallows) and EAR PAIN (Pain inside ear) outcome was unknown.            No concomitant product use was provided by the reporter.  Patient placed a warm wash cloth on her neck to alleviate the pain as a treatment.   This case was linked to MOD-2021-275070 (E2B Linked Report).; Sender's Comments:  MOD-2021-275070:dose 1
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Neck (both sides) was swollen; Right side of the neck hurts; Throat is painful when she swallows; Pain inside ear; Bloody nose (both nostrils); Arm swelled up really bad; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up really bad), EPISTAXIS (Bloody nose (both nostrils)), SWELLING (Neck (both sides) was swollen), NECK PAIN (Right side of the neck hurts) and OROPHARYNGEAL PAIN (Throat is painful when she swallows) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02PR21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up really bad). On 10-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EPISTAXIS (Bloody nose (both nostrils)). On 31-Jul-2021, the patient experienced SWELLING (Neck (both sides) was swollen), NECK PAIN (Right side of the neck hurts), OROPHARYNGEAL PAIN (Throat is painful when she swallows) and EAR PAIN (Pain inside ear). In 2021, PERIPHERAL SWELLING (Arm swelled up really bad) outcome was unknown. At the time of the report, EPISTAXIS (Bloody nose (both nostrils)), SWELLING (Neck (both sides) was swollen), NECK PAIN (Right side of the neck hurts), OROPHARYNGEAL PAIN (Throat is painful when she swallows) and EAR PAIN (Pain inside ear) outcome was unknown.            No concomitant product use was provided by the reporter.  Patient placed a warm wash cloth on her neck to alleviate the pain as a treatment.   This case was linked to MOD-2021-275070 (E2B Linked Report).; Sender's Comments:  MOD-2021-275070:dose 1
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: right shoulder hurt; This spontaneous case was reported by a non-health professional and describes the occurrence of ARTHRALGIA (right shoulder hurt) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     Concomitant products included METFORMIN, IRBESARTAN, AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PRAVASTATIN, INSULIN HUMAN INJECTION, ISOPHANE (HUMULIN N), INSULIN LISPRO (ADMELOG), TRAZODONE, GABAPENTIN, ESCITALOPRAM and HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced ARTHRALGIA (right shoulder hurt). At the time of the report, ARTHRALGIA (right shoulder hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not provided.    This case was linked to MOD-2021-275416 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypoaesthesia, Mobility decreased
Clinical narrative: Numbness on face that comes and goes; I am a lot better but still feel weird at times since vaccine; Lost use of my right arm on first shot for 36 h; Had severe headaches for almost 60 days; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness on face that comes and goes), MOBILITY DECREASED (Lost use of my right arm on first shot for 36 h), FEELING ABNORMAL (I am a lot better but still feel weird at times since vaccine) and HEADACHE (Had severe headaches for almost 60 days) 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-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness on face that comes and goes), MOBILITY DECREASED (Lost use of my right arm on first shot for 36 h), FEELING ABNORMAL (I am a lot better but still feel weird at times since vaccine) and HEADACHE (Had severe headaches for almost 60 days). At the time of the report, HYPOAESTHESIA (Numbness on face that comes and goes), MOBILITY DECREASED (Lost use of my right arm on first shot for 36 h), FEELING ABNORMAL (I am a lot better but still feel weird at times since vaccine) and HEADACHE (Had severe headaches for almost 60 days) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported by the reporter No treatment information was reported It was reported that the patient had taken the second dose of vaccine on 17 Feb 2021
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included ATENOLOL, ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 04-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details were not provided.   This case was linked to MOD-2021-275443 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: He got a positive diagnosis of COVID; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (He got a positive diagnosis of COVID) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In September 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In October 2020, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (He got a positive diagnosis of COVID). At the time of the report, SARS-COV-2 TEST POSITIVE (He got a positive diagnosis of COVID) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: positive (Positive) positive.         The patient wanted to reach out to someone about how "there should not be a covid patient driving their sample of saliva while they are sick." Concomitant medications were not provided. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Burning sensation, Erythema, Pruritus
Clinical narrative: allergic reaction, whole body turned beet red, started on the scalp, started to itch and burn a little; redness in torso and back started on the scalp; itchy; burn a little; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (allergic reaction, whole body turned beet red, started on the scalp, started to itch and burn a little), ERYTHEMA (redness in torso and back started on the scalp), PRURITUS (itchy) and BURNING SENSATION (burn a little) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATENOLOL, ATORVASTATIN and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (allergic reaction, whole body turned beet red, started on the scalp, started to itch and burn a little), ERYTHEMA (redness in torso and back started on the scalp), PRURITUS (itchy) and BURNING SENSATION (burn a little). At the time of the report, ALLERGY TO VACCINE (allergic reaction, whole body turned beet red, started on the scalp, started to itch and burn a little), ERYTHEMA (redness in torso and back started on the scalp), PRURITUS (itchy) and BURNING SENSATION (burn a little) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information has provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-275407 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Vaccinated with a dose that was refrozen) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. Concurrent medical conditions included Hyperlipidemia, Hemiplegia, Edema and Prediabetes. Concomitant products included METFORMIN, CELECOXIB (CELEBREX), FUROSEMIDE and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication. On 02-Aug-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccinated with a dose that was refrozen). On 02-Aug-2021, PRODUCT STORAGE ERROR (Vaccinated with a dose that was refrozen) 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 PRODUCT STORAGE ERROR (Vaccinated with a dose that was refrozen) to be not related. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Additional information received on 06-AUG-2021 contains, updated the patient race, added medical history, added doctor and vaccine facility information, added concomitant medications information.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea
Clinical narrative: Since she got her vaccine, she has not gotten her period; This spontaneous case was reported by a consumer and describes the occurrence of AMENORRHOEA (Since she got her vaccine, she has not gotten her period) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0C9CZIA and 041C21A) 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 02-Jun-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 AMENORRHOEA (Since she got her vaccine, she has not gotten her period). At the time of the report, AMENORRHOEA (Since she got her vaccine, she has not gotten her period) outcome was unknown.            No Concomitant medications were reported.  No Treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Started getting bruising in leg,Bruising particularly under toenails; 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 CONTUSION (Started getting bruising in leg,Bruising particularly under toenails) 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, 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 CONTUSION (Started getting bruising in leg,Bruising particularly under toenails). At the time of the report, CONTUSION (Started getting bruising in leg,Bruising particularly under toenails) outcome was unknown.            No concomitant medications were provided by the reporter.   Treatment information was not provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccinated with a dose that was refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (vaccinated with a dose that was refrozen) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (vaccinated with a dose that was refrozen). On 02-Aug-2021, PRODUCT STORAGE ERROR (vaccinated with a dose that was refrozen) 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 were reported.  No treatment medications were reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: vaccinated with a dose that was refrozen; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (vaccinated with a dose that was refrozen) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (vaccinated with a dose that was refrozen). On 02-Aug-2021, PRODUCT STORAGE ERROR (vaccinated with a dose that was refrozen) had resolved.            No concomitant medications were reported. No treatment information was reported.