chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Magnetic resonance imaging
Clinical narrative: Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0061321A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Pain, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) for Pain, at an unspecified dose and frequency. On 17-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Magnetic resonance imaging: unknown (Inconclusive) A definite cause or diagnosis was not provided.         Symptoms: It was reported that the patient had not experienced any problems with her right arm where she received her 2nd dose of vaccine and no other adverse events were reported.  Lab test includes: other tests were performed. Treatment medication includes: Other prescribed pain medicine  No concomitant medications were reported   This case was linked to MOD-2021-408546 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Since he had heart Palpitation; He also Shortness of breath with activity but no chest pain; This spontaneous case was reported by an other health care professional and describes the occurrence of PALPITATIONS (Since he had heart Palpitation) and DYSPNOEA (He also Shortness of breath with activity but no chest pain) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced PALPITATIONS (Since he had heart Palpitation). In 2021, the patient experienced DYSPNOEA (He also Shortness of breath with activity but no chest pain). At the time of the report, PALPITATIONS (Since he had heart Palpitation) and DYSPNOEA (He also Shortness of breath with activity but no chest pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient received the 2nd dose on 11FEB2021, the lot number is 024M21A. No Concomitant and Treatment medication were reported.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Influenza like illness, Lymphadenopathy
Clinical narrative: Flu like symptoms; Swollen lymph node under left armpit; Along with a severe headache; After the second dose she experienced chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph node under left armpit), HEADACHE (Along with a severe headache) and CHILLS (After the second dose she experienced chills) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), LYMPHADENOPATHY (Swollen lymph node under left armpit), HEADACHE (Along with a severe headache) and CHILLS (After the second dose she experienced chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), HEADACHE (Along with a severe headache) and CHILLS (After the second dose she experienced chills) had resolved and LYMPHADENOPATHY (Swollen lymph node under left armpit) had not resolved.            No concomitant medications were reported. No treatment details were reported.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A, 001C21A and 020C21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL, TERBINAFINE, HYDROCHLOROTHIAZIDE and FLUTICASONE for an unknown indication.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. On 07 December 2021 the vial was taken out of freezer and placed into fridge. Expiry date of vaccine was on 06 December 2021. It was unknown that if patient was experiencing any symptoms.   This case was linked to MOD-2021-408558, MOD-2021-408476, MOD-2021-408490, MOD-2021-409258, MOD-2021-408598, MOD-2021-408547 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Feeling hot, Insomnia, Myalgia
Clinical narrative: up all night; head is warm; I ache so bad/it hurts; cough; congestion/congested; pretty fatigued; body aches go down my body and muscles/Where I am sore I can push on it and it intensifies; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (up all night), FEELING HOT (head is warm), PAIN (I ache so bad/it hurts), COUGH (cough) and NASAL CONGESTION (congestion/congested) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 040821A and 006821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced INSOMNIA (up all night), FEELING HOT (head is warm), PAIN (I ache so bad/it hurts), COUGH (cough), NASAL CONGESTION (congestion/congested), FATIGUE (pretty fatigued) and MYALGIA (body aches go down my body and muscles/Where I am sore I can push on it and it intensifies). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) for Cough and Congestion nasal, at an unspecified dose and frequency. At the time of the report, INSOMNIA (up all night), FEELING HOT (head is warm), PAIN (I ache so bad/it hurts), COUGH (cough), NASAL CONGESTION (congestion/congested), FATIGUE (pretty fatigued) and MYALGIA (body aches go down my body and muscles/Where I am sore I can push on it and it intensifies) outcome was unknown.            The patient had administered booster dose on 09-Dec-2021 . The patient  head was warm and the body aches go down the body and muscles.  Soreness intensified on pushing with pretty fatigued. When body aches, felt like thrash as hurt and gave a lot of ache. The patient stated that some side effect had relieved. The concomitant medication was not reported.   This case was linked to MOD-2021-408589, MOD-2021-408592 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain
Clinical narrative: up all night; head is warm; I ache so bad/it hurts; cough; congestion/congested; pretty fatigued; body aches go down my body and muscles/Where I am sore I can push on it and it intensifies; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (up all night), FEELING HOT (head is warm), PAIN (I ache so bad/it hurts), COUGH (cough) and NASAL CONGESTION (congestion/congested) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 040821A and 006821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced INSOMNIA (up all night), FEELING HOT (head is warm), PAIN (I ache so bad/it hurts), COUGH (cough), NASAL CONGESTION (congestion/congested), FATIGUE (pretty fatigued) and MYALGIA (body aches go down my body and muscles/Where I am sore I can push on it and it intensifies). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency and GUAIFENESIN (MUCINEX) for Cough and Congestion nasal, at an unspecified dose and frequency. At the time of the report, INSOMNIA (up all night), FEELING HOT (head is warm), PAIN (I ache so bad/it hurts), COUGH (cough), NASAL CONGESTION (congestion/congested), FATIGUE (pretty fatigued) and MYALGIA (body aches go down my body and muscles/Where I am sore I can push on it and it intensifies) outcome was unknown.            The patient had administered booster dose on 09-Dec-2021 . The patient  head was warm and the body aches go down the body and muscles.  Soreness intensified on pushing with pretty fatigued. When body aches, felt like thrash as hurt and gave a lot of ache. The patient stated that some side effect had relieved. The concomitant medication was not reported.   This case was linked to MOD-2021-408589, MOD-2021-408592 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Type IV hypersensitivity reaction
Clinical narrative: Had delayed hypersensitivity on the right arm  which swelled from shoulder to elbow; Which swelled from her shoulder to elbow; This spontaneous case was reported by a nurse and describes the occurrence of TYPE IV HYPERSENSITIVITY REACTION (Had delayed hypersensitivity on the right arm  which swelled from shoulder to elbow) and PERIPHERAL SWELLING (Which swelled from her shoulder to elbow) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, the patient experienced TYPE IV HYPERSENSITIVITY REACTION (Had delayed hypersensitivity on the right arm  which swelled from shoulder to elbow) and PERIPHERAL SWELLING (Which swelled from her shoulder to elbow). At the time of the report, TYPE IV HYPERSENSITIVITY REACTION (Had delayed hypersensitivity on the right arm  which swelled from shoulder to elbow) and PERIPHERAL SWELLING (Which swelled from her shoulder to elbow) 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.   Concomitant medications were not provided.  Treatment information was not provided. It was reported that seven days after her first dose in the right arm, she had delayed hypersensitivity on the right arm which swelled from her shoulder to elbow.   This case was linked to MOD-2021-408575 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-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 MYALGIA (Body aches). At the time of the report, MYALGIA (Body aches) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-408587, MOD-2021-408592.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity, Vaccination complication
Clinical narrative: sore arm; symptoms; upset stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (symptoms) and ABDOMINAL DISCOMFORT (upset stomach) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (symptoms) and ABDOMINAL DISCOMFORT (upset stomach). At the time of the report, PAIN IN EXTREMITY (sore arm), VACCINATION COMPLICATION (symptoms) and ABDOMINAL DISCOMFORT (upset stomach) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  The reporter reported that most of his friends had a sore arm, symptoms for a day, upset stomach after receiving Moderna COVID-19 vaccine.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Dec-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.   This case was linked to MOD-2021-408599 (Patient Link).
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; HCP stated that they gave the Booster shot with a temperature excursion to 5 patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) in a 59-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058H21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cholesterosis (Cholesterol). Concomitant products included LISINOPRIL for Cholesterosis, METFORMIN for Diabetes.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Dec-2021, the patient experienced PRODUCT STORAGE ERROR (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients). On 10-Dec-2021, PRODUCT STORAGE ERROR (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) and EXPIRED PRODUCT ADMINISTERED (HCP stated that they gave the Booster shot with a temperature excursion to 5 patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Storage condition at the time of the excursion was refrigerated. Maximum or minimum temperatures reached in between 2-8 Celsius degrees. Excursion duration is almost 24 to 30 hours and one vial is impacted. Treatment medication was not provided by the reporter.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 0034C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISINOPRIL, OXYBUTYNIN and OMEPRAZOLE for an unknown indication.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine). On 21-Apr-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment reported.   This case was linked to MOD-2021-408490, MOD-2021-408558, MOD-2021-408490, MOD-2021-408585, MOD-2021-408476, MOD-2021-408547 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Booster 1/2 dose administered/ should have received a full third dose for immunocompromised; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (Booster 1/2 dose administered/ should have received a full third dose for immunocompromised) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013F21A, 011A21A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 27-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 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, the patient experienced ACCIDENTAL UNDERDOSE (Booster 1/2 dose administered/ should have received a full third dose for immunocompromised). On 06-Dec-2021, ACCIDENTAL UNDERDOSE (Booster 1/2 dose administered/ should have received a full third dose for immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 antibody test
Clinical narrative: had fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (had fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0326210A, 037U21A and 021F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN ER), MAGNESIUM, LISINOPRIL and MELOXICAM for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-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 FATIGUE (had fatigue). At the time of the report, FATIGUE (had fatigue) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, SARS-CoV-2 antibody test: 756 (High) Showed 756 level of antibodies on SARS-COV-2 S protein quantitative test.. On 08-Dec-2021, SARS-CoV-2 antibody test: 246 (Low) Showed a level of 246 on SARS-COV-2 S protein quantitative test..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Symptoms: It was reported that the patient experienced event where her antibody levels were dropped to low level than they were prior receiving booster dose of Moderna COVID-19 vaccine, she wanted to know if she had to revaccinated.   No treatment medications were reported
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: felt sick; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick) and FATIGUE (tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Glaucoma. Concomitant products included LATANOPROST and DORZOLAMIDE for Glaucoma, GABAPENTIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILLNESS (felt sick) and FATIGUE (tired). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ILLNESS (felt sick) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       This case was linked to MOD-2021-408621, MOD-2021-408622 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain, Illness, Malaise, Rash
Clinical narrative: injection site became more warm; left breast hurt; sore left under arm; injection site became more tender; got worse and more red; Home sick; not feel well; rash on rib cage and stomach; oval rash on injection site of left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site became more warm), ILLNESS (Home sick), BREAST PAIN (left breast hurt), MALAISE (not feel well) and RASH (rash on rib cage and stomach) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included LATANOPROST and DORZOLAMIDE for Glaucoma, GABAPENTIN for an unknown indication.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MALAISE (not feel well), RASH (rash on rib cage and stomach) and VACCINATION SITE RASH (oval rash on injection site of left arm). On 10-Dec-2021, the patient experienced ILLNESS (Home sick). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site became more warm), BREAST PAIN (left breast hurt), AXILLARY PAIN (sore left under arm), VACCINATION SITE PAIN (injection site became more tender) and VACCINATION SITE ERYTHEMA (got worse and more red). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site became more warm), ILLNESS (Home sick), VACCINATION SITE PAIN (injection site became more tender) and VACCINATION SITE ERYTHEMA (got worse and more red) had not resolved, BREAST PAIN (left breast hurt), MALAISE (not feel well), AXILLARY PAIN (sore left under arm) and VACCINATION SITE RASH (oval rash on injection site of left arm) outcome was unknown and RASH (rash on rib cage and stomach) had resolved.            This case was linked to MOD-2021-408614, MOD-2021-408621 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site warmth
Clinical narrative: injection site became more warm; left breast hurt; sore left under arm; injection site became more tender; got worse and more red; Home sick; not feel well; rash on rib cage and stomach; oval rash on injection site of left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site became more warm), ILLNESS (Home sick), BREAST PAIN (left breast hurt), MALAISE (not feel well) and RASH (rash on rib cage and stomach) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Glaucoma. Concomitant products included LATANOPROST and DORZOLAMIDE for Glaucoma, GABAPENTIN for an unknown indication.    On 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In November 2021, the patient experienced MALAISE (not feel well), RASH (rash on rib cage and stomach) and VACCINATION SITE RASH (oval rash on injection site of left arm). On 10-Dec-2021, the patient experienced ILLNESS (Home sick). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site became more warm), BREAST PAIN (left breast hurt), AXILLARY PAIN (sore left under arm), VACCINATION SITE PAIN (injection site became more tender) and VACCINATION SITE ERYTHEMA (got worse and more red). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (injection site became more warm), ILLNESS (Home sick), VACCINATION SITE PAIN (injection site became more tender) and VACCINATION SITE ERYTHEMA (got worse and more red) had not resolved, BREAST PAIN (left breast hurt), MALAISE (not feel well), AXILLARY PAIN (sore left under arm) and VACCINATION SITE RASH (oval rash on injection site of left arm) outcome was unknown and RASH (rash on rib cage and stomach) had resolved.            This case was linked to MOD-2021-408614, MOD-2021-408621 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: aches that evening; shakes; sore left injection site arm; fever; shivering; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches that evening), TREMOR (shakes), VACCINATION SITE PAIN (sore left injection site arm), PYREXIA (fever) and CHILLS (shivering) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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 an unknown date, the patient experienced PAIN (aches that evening), TREMOR (shakes), VACCINATION SITE PAIN (sore left injection site arm), PYREXIA (fever) and CHILLS (shivering). At the time of the report, PAIN (aches that evening), TREMOR (shakes), VACCINATION SITE PAIN (sore left injection site arm), PYREXIA (fever) and CHILLS (shivering) outcome was unknown.            No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-407924 (Patient Link).   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitants and Treatment medications were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer from 18-Mar-2021 to 15-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer.    On 10-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        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: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 28 patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine). On 10-Dec-2021, EXPIRED PRODUCT ADMINISTERED (28 patient received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary resection
Clinical narrative: had half of his lung removed; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY RESECTION (had half of his lung removed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer.    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 PULMONARY RESECTION (had half of his lung removed). At the time of the report, PULMONARY RESECTION (had half of his lung removed) outcome was unknown.            Concomitant product use was not provided by the reporter. No treatment information was provided.  The patient needed to receive a booster dose as he had cancer, received the Moderna COVID-19 vaccine and also had half of his lung removed.   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2021: The follow up document contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: immunocompromised patient given the booster dose (not the 3rd dose?); This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (immunocompromised patient given the booster dose (not the 3rd dose?)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 041A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced ACCIDENTAL UNDERDOSE (immunocompromised patient given the booster dose (not the 3rd dose?)). In August 2021, ACCIDENTAL UNDERDOSE (immunocompromised patient given the booster dose (not the 3rd dose?)) had resolved.            No concomitant medications were reported. No treatment information were reported.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Myalgia, Vaccination complication, Vaccination site pain
Clinical narrative: she had sore arm after first dose; received the first dose of Moderna COVID-19 vaccine while pregnant; feeling very worn out after first dose; body aches after first dose; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (feeling very worn out after first dose), VACCINATION SITE PAIN (she had sore arm after first dose), MYALGIA (body aches after first dose) and MATERNAL EXPOSURE DURING PREGNANCY (received the first dose of Moderna COVID-19 vaccine while pregnant) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Dec-2020 and the estimated date of delivery was 05-Oct-2021. On 02-Mar-2021, the patient experienced VACCINATION COMPLICATION (feeling very worn out after first dose) and MYALGIA (body aches after first dose). On 05-Mar-2021, the patient experienced VACCINATION SITE PAIN (she had sore arm after first dose) and MATERNAL EXPOSURE DURING PREGNANCY (received the first dose of Moderna COVID-19 vaccine while pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  tenth week of the pregnancy. The delivery occurred  on 01-Oct-2021, which was reported as Full-term. For neonate 1, The outcome was reported as Term Birth NOS. On 05-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (received the first dose of Moderna COVID-19 vaccine while pregnant) had resolved. At the time of the report, VACCINATION COMPLICATION (feeling very worn out after first dose), VACCINATION SITE PAIN (she had sore arm after first dose) and MYALGIA (body aches after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.  Patient reported that she did not had any other complications during pregnancy.   This case was linked to MOD-2021-407514, MOD-2021-407515 (Patient Link).
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 08-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 08-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported. It was reported that the box of vials was received on 14-Oct-2021. It was frozen when it was received and was immediately placed in the clinic vaccine freezer. The vials remained frozen until the date of use and were thawed in the vaccine refrigerator prior to use. The vials remained in the refrigerator between uses and each vial was discarded after the final appointment of the day. Only 1 vial was used per day between the hours of 8:00am to 4:00pm.
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent reporting for son (patient).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "At first I thought I may just be allergic to a dye in the tablets but my son developed the same type of reaction after receiving his first covid vaccine".  Additional information: Developed an allergy to ibuprofen. Every time reporter take ibuprofen reporter develop "hives". Reporter get small, red circular bumps that are extremely itchy. At first reporter thought reporter might just be allergic to a dye in the tablets but the son (patient) developed the same type of reaction after receiving his first covid vaccine (and he takes a different brand of ibuprofen).  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Bronchospasm, Insomnia, Lacrimation increased, Pain
Clinical narrative: bronchospasm that has not quit and it hurts/it started in my back and its right up to the middle of my chest; I was in tears last night because of that; it hurts; I couldn''t even sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: BRONCHOSPASM (non-serious), outcome "not recovered", described as "bronchospasm that has not quit and it hurts/it started in my back and its right up to the middle of my chest"; INSOMNIA (non-serious) with onset 10Sep2021, outcome "unknown", described as "I couldn''t even sleep"; LACRIMATION INCREASED (non-serious), outcome "unknown", described as "I was in tears last night because of that"; PAIN (non-serious), outcome "not recovered", described as "it hurts".  Additional information: It was reported that Well 2 hours after I got it, it put me into a bronchospasm that has not quit and it hurts, I couldn't even sleep last night and I got that on 10Sep2021(Further not clarified hence not captured in tab). Why would I have that kind of reaction if it was FDA approved? And it started in my back and its right up to the middle of my chest. I was in tears last night because of that."  Follow-up attempts completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Body temperature, Body temperature abnormal, Headache
Clinical narrative: Blood pressure dropped to 78/52; body temp 92; debilitating head ache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 08:00 (Lot number: EW0186) at the age of 32 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gastrointestinal disorder" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: If Covid prior vaccination: Yes. There were no concomitant medications. Past drug history included: Sulfa salazine, reaction(s): "Allergies: sulfa allergy"; Allergies: keflex, reaction(s): "Allergies: keflex allergy"; Allergies: doxycycline, reaction(s): "Allergies: doxycycline allergy"; Allergies: nutrasweet, reaction(s): "Allergies: nutrasweet allergy". The following information was reported: BLOOD PRESSURE DECREASED (non-serious) with onset 04Aug2021 05:00, outcome "recovered" (2021), described as "Blood pressure dropped to 78/52"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 04Aug2021 05:00, outcome "recovered" (2021), described as "body temp 92"; HEADACHE (non-serious) with onset 04Aug2021 05:00, outcome "recovered" (2021), described as "debilitating head ache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of blood pressure decreased, body temperature abnormal, headache.  Additional information: The patient was not pregnant at the time of vaccination. The patient did not receive any other medications in two weeks. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient received bnt162b2 (BNT162B2), administration date 30Sep2021 08:00 (Lot number: unknown) at the age of 32 years as dose 2, single for covid-19 immunisation. The case was assessed as non-serious.  Follow-up attempts are completed. No further information is expected.