chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus, Sinonasal obstruction
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (Red arm), PRURITUS (Itchy arm), INFLUENZA LIKE ILLNESS (Felt like coming down with the flu), NASAL CONGESTION (Most of the time she feels congestion) and COUGH (Cough mostly in the afternoon or when she exercises) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058421A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery in October 2021. Concurrent medical conditions included Pollen allergy, Allergy to molds and Blood cholesterol abnormal. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 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 fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (Red arm), PRURITUS (Itchy arm), INFLUENZA LIKE ILLNESS (Felt like coming down with the flu), NASAL CONGESTION (Most of the time she feels congestion), COUGH (Cough mostly in the afternoon or when she exercises), SINONASAL OBSTRUCTION (sinus are blocked), HEADACHE (Slight headache) and PAIN IN EXTREMITY (Patient felt her arm sore/Achy arm/sometimes it still hurts). At the time of the report, ERYTHEMA (Red arm), PRURITUS (Itchy arm), INFLUENZA LIKE ILLNESS (Felt like coming down with the flu), NASAL CONGESTION (Most of the time she feels congestion), COUGH (Cough mostly in the afternoon or when she exercises), SINONASAL OBSTRUCTION (sinus are blocked), HEADACHE (Slight headache) and PAIN IN EXTREMITY (Patient felt her arm sore/Achy arm/sometimes it still hurts) had not resolved. Concomitant medication included unspecified medication for her cholesterol. Patient never had COVID positive test or diagnosis. No vaccines were given within 1 month prior to Moderna COVID-19 vaccine. It was stated that symptoms were worse the last 3 days. Patient had not experienced a similar event in the past. No treatment was given for the events.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Incorrect route of product administration
Clinical narrative: Patient had a reaction after her first shot because it was given subcutaneously; Patient had a reaction after her first shot because it was given subcutaneously; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient had a reaction after her first shot because it was given subcutaneously) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had a reaction after her first shot because it was given subcutaneously) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient had a reaction after her first shot because it was given subcutaneously) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had a reaction after her first shot because it was given subcutaneously). At the time of the report, IMMUNISATION REACTION (Patient had a reaction after her first shot because it was given subcutaneously) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Patient had a reaction after her first shot because it was given subcutaneously) outcome was unknown.   The action taken with mRNA-1273 (Spikevax) (Subcutaneous) was unknown.   No concomitant medications were provided.  The patient stated that her second shot was better because it was not subcutaneous. The patient also stated that she called Moderna two years ago but did not have a case number.   No treatment medications were reported.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   Concomitant medication was not provided. Treatment information was not provided.   This case was linked to MOD-2022-566260, MOD-2022-566266 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up appended, contains no new information.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore left injection site arm.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm.) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A, 030C21A and 001J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left injection site arm.). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm.) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2022-565868, MOD-2022-566266 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2022: Follow-up received included no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain, that did not have immediately after the shot, and it past already; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Injection site pain, that did not have immediately after the shot, and it past already) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no known allergies (medications, food, and other products). The patient never had COVID positive test or diagnosis. No history related to mentioned AE and both acute and chronic illnesses at the time of vaccination. No other vaccines given within one month prior to Moderna COVID-19 vaccine.  Previously administered products included for COVID-19 vaccination: PFIZER BIONTECH COVID-19 VACCINE (primary series with Pfizer (Dose 1)), PFIZER BIONTECH COVID-19 VACCINE (First booster with Pfizer) and PFIZER BIONTECH COVID-19 VACCINE (primary series with Pfizer (Dose 2)). Past adverse reactions to the above products included No adverse reaction with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 01-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-2022, the patient experienced VACCINATION SITE PAIN (Injection site pain, that did not have immediately after the shot, and it past already). At the time of the report, VACCINATION SITE PAIN (Injection site pain, that did not have immediately after the shot, and it past already) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Moderna employee called to report that his mother in-law had an adverse event after receiving the second booster of the Moderna covid19 vaccine on the 01-May-2022. He stated that she had a primary series with Pfizer and the first booster with Pfizer, and that on the 08-May-2022 she had injection site pain, that did not have immediately after the shot, and it past already. The symptoms were improved. He gave consent to be follow by safety. Reported adverse event did not cause patient to seek medical care. The patient never experienced a similar event in the past.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Breast swelling, Gynaecological examination, Lymphadenopathy
Clinical narrative: Breasts were swollen; Stomach also felt as if she was pre-menstrual; Swelling of the lymph nodes under her both arms; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAST SWELLING (Breasts were swollen), ABDOMINAL DISCOMFORT (Stomach also felt as if she was pre-menstrual) and LYMPHADENOPATHY (Swelling of the lymph nodes under her both arms) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 031L20A) for COVID-19 vaccination.     It was reported that patient had not tested positive for COVID or diagnosis.  The patient's past medical history included Menopause (menopause at 62 years old). Concurrent medical conditions included Lactose intolerant, Drug allergy (Allergy to Meclizine), Sarcoidosis (Sarcoidosis which was remission) and Hot flushes. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Prophylaxis, PROGESTERONE for an unknown indication.   On 28-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 BREAST SWELLING (Breasts were swollen), ABDOMINAL DISCOMFORT (Stomach also felt as if she was pre-menstrual) and LYMPHADENOPATHY (Swelling of the lymph nodes under her both arms). At the time of the report, BREAST SWELLING (Breasts were swollen) and ABDOMINAL DISCOMFORT (Stomach also felt as if she was pre-menstrual) outcome was unknown and LYMPHADENOPATHY (Swelling of the lymph nodes under her both arms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Gynaecological examination: normal (normal) Normal-was okay.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Hot flushes.  Patient went to her OB-Gynaecologist who did an internal examination and informed her that she was okay.  Treatment information was not provided.   This case was linked to MOD-2022-566478 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: having severe joint pain after the Moderna booster; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (having severe joint pain after the Moderna booster) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A, 039K20A and 012A21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Osteoarthritis (Many years ago) and Allergic reaction to antibiotics (Ciprofloxacin).   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (having severe joint pain after the Moderna booster). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Joint pain, at a dose of treatment around November 2021 and TROLAMINE SALICYLATE (ASPERCREME [TROLAMINE SALICYLATE]) for Joint pain, at an unspecified dose and frequency. At the time of the report, ARTHRALGIA (having severe joint pain after the Moderna booster) was resolving.            The patient had never been diagnosed with/ tested positive for COVID-19. Patient did not received any other vaccine within 1 month prior to Moderna COVID-19 vaccine. The patient did not experience a similar event in the past. On 05-Nov-2021, patient received first booster dose of Moderna COVID-19 Vaccine. The patient reports taking Medrol dose-pack as treatment around November 2021. He tried Aspercreme on the joints a day or two after he got the shot.   This case was linked to MOD-2022-566607 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The pharmacist stated that they inadvertently administered and expired dose of the Moderna Covid-19 vaccine to 18 patients - 9 doses administered on 09May2022 and 9 doses administered on 11May2022. Lot number 084J21A;expiration 05May2022. No patient has reported adverse reaction No treatment medication were provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Shots gave her typical side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Shots gave her typical side effects) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 969905, 002B21A and 007M20A) for COVID-19 vaccination.     The patient's past medical history included Ear infection (ear infection once 20 years ago). Concurrent medical conditions included Blood pressure high and Penicillin allergy.   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (Shots gave her typical side effects). At the time of the report, IMMUNISATION REACTION (Shots gave her typical side effects) outcome was unknown. No concomitant medications were provided.  Patient stated that all of her shots gave her typical side effects.  No treatment medications were reported.   This case was linked to MOD-2022-566651, MOD-2022-566656, MOD-2022-566657 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: all of her shots gave her typical side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (all of her shots gave her typical side effects) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 007M20A) for COVID-19 vaccination.     Patient never had COVID positive test or diagnosis. The patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not have any Acute and Chronic illnesses relating to mentioned AE at the time of vaccination.  The patient's past medical history included Ear infection (once 20 years ago). Concurrent medical conditions included Blood pressure high and Penicillin allergy (pencillin).   On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced IMMUNISATION REACTION (all of her shots gave her typical side effects). At the time of the report, IMMUNISATION REACTION (all of her shots gave her typical side effects) outcome was unknown.      Patient weight was reported as 120 (Unit unspecified). Concomitant medication was not provided. Patient stated that all of her shots gave her typical side effects. No treatment medications were reported.   This case was linked to MOD-2022-566651, MOD-2022-566654, MOD-2022-566657 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: All of her shots gave her typical side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (All of her shots gave her typical side effects) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Ear infection (ear infection once ,20 years ago). Concurrent medical conditions included Blood pressure high and Penicillin allergy.    On 14-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 IMMUNISATION REACTION (All of her shots gave her typical side effects). At the time of the report, IMMUNISATION REACTION (All of her shots gave her typical side effects) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Patient weight reported as 120. Patient did not had COVID test or diagnosis  No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-566651, MOD-2022-566654, MOD-2022-566656 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: high dose; A "high dose J&J shot" on 20MAR2021 followed by a "high dose Moderna shot"; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (high dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A "high dose J&J shot" on 20MAR2021 followed by a "high dose Moderna shot") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: J&J shot on 20-Mar-2021. Past adverse reactions to the above products included No adverse event with J&J shot. Concurrent medical conditions included Immunocompromised.    On 03-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced ACCIDENTAL OVERDOSE (high dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A "high dose J&J shot" on 20MAR2021 followed by a "high dose Moderna shot"). At the time of the report, ACCIDENTAL OVERDOSE (high dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (A "high dose J&J shot" on 20MAR2021 followed by a "high dose Moderna shot") outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Rash
Clinical narrative: horrific reaction a rash started in his feet all the way up to scalp almost to eyes. States it looks like a permanent rash on his shin; received 3 full doses of the Moderna vaccine and is in his 80s, states he is not immunocompromised; This spontaneous case was reported by a consumer and describes the occurrence of RASH (horrific reaction a rash started in his feet all the way up to scalp almost to eyes. States it looks like a permanent rash on his shin) and EXTRA DOSE ADMINISTERED (received 3 full doses of the Moderna vaccine and is in his 80s, states he is not immunocompromised) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In August 2021, the patient 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. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced EXTRA DOSE ADMINISTERED (received 3 full doses of the Moderna vaccine and is in his 80s, states he is not immunocompromised). On an unknown date, the patient experienced RASH (horrific reaction a rash started in his feet all the way up to scalp almost to eyes. States it looks like a permanent rash on his shin). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA ALLERGY) for Rash, at an unspecified dose and frequency. At the time of the report, RASH (horrific reaction a rash started in his feet all the way up to scalp almost to eyes. States it looks like a permanent rash on his shin) and EXTRA DOSE ADMINISTERED (received 3 full doses of the Moderna vaccine and is in his 80s, states he is not immunocompromised) outcome was unknown.            No concomitant medication was reported.  It was reported patient in his 80s  Patient was not immunocompromised.   Treatment medication included 180 antihistamine   This case was linked to MOD-2022-566985 (Patient Link).   Reporter did not allow further contact
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: arm pain; possible administration of 2nd dose after >36 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (possible administration of 2nd dose after >36 days from 1st dose) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had not diagnosed or tested positive for Covid. Patient had no other vaccine given within one month prior to Moderna vaccine.  Concurrent medical conditions included Disability, Drug allergy (Lisinopril), Allergy to NSAIDs (Aspirin), Adhesive tape allergy (Adhesive) and Congestive heart failure (10 years ago. Recent change in status: Worsening) since 2012.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced PAIN IN EXTREMITY (arm pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (possible administration of 2nd dose after >36 days from 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and CELECOXIB (CELEBREX) for Adverse event, at an unspecified dose and frequency. In 2021, PAIN IN EXTREMITY (arm pain) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (possible administration of 2nd dose after >36 days from 1st dose) outcome was unknown.            Patient was on concomitant medications but declined to provide the names. Patient reported that arm pain was nothing compared to what patient experienced events after the 3rd dose. Patient did not have access to her vaccination card and therefore could not provide Moderna lot numbers or accurate dates of previous administrations. Patient had a similar reaction compared to 3rd dose of Moderna. However, it wasn't as bad as the 3rd dose and did not last for a week.   This case was linked to MOD-2022-566830 (Patient Link).
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Neck pain, Pain in extremity
Clinical narrative: I could not turn my head/she couldn't turn her head or move her arm for over a week.; severe aches in my left arm, shoulder, and neck; severe aches in my left arm, shoulder, and neck; severe aches in my left arm, shoulder, and neck; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I could not turn my head/she couldn't turn her head or move her arm for over a week.), NECK PAIN (severe aches in my left arm, shoulder, and neck), PAIN IN EXTREMITY (severe aches in my left arm, shoulder, and neck) and ARTHRALGIA (severe aches in my left arm, shoulder, and neck) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient never had COVID positive test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Adhesive tape allergy, Drug allergy, Congestive heart failure (Started 10 years ago and recent change in status was worsening.), Drug allergy and Disability.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, the patient experienced MOBILITY DECREASED (I could not turn my head/she couldn't turn her head or move her arm for over a week.), NECK PAIN (severe aches in my left arm, shoulder, and neck), PAIN IN EXTREMITY (severe aches in my left arm, shoulder, and neck) and ARTHRALGIA (severe aches in my left arm, shoulder, and neck). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CELECOXIB (CELEBREX) at an unspecified dose and frequency. At the time of the report, MOBILITY DECREASED (I could not turn my head/she couldn't turn her head or move her arm for over a week.), NECK PAIN (severe aches in my left arm, shoulder, and neck), PAIN IN EXTREMITY (severe aches in my left arm, shoulder, and neck) and ARTHRALGIA (severe aches in my left arm, shoulder, and neck) was resolving.            No concomitant medications were provided by the reporter. It was mentioned that for all the reported AE s the patient did not cause to seek medical care and the patient had similar reactions after the 2nd dose of Moderna. However, AEs were not as bad as the 3rd dose and did not last for a week. Outcome for all the events were improved with residual effects.   This case was linked to MOD-2022-566790 (Patient Link).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (A stent was put in her leg after receiving the first dose of the Moderna Covid-19 vaccine) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The patient's past medical history included Stent placement. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes. On 16-Jun-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 IMMUNISATION REACTION (A stent was put in her leg after receiving the first dose of the Moderna Covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (A stent was put in her leg after receiving the first dose of the Moderna Covid-19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that there was no history of Myocarditis/pericarditis and patient was not experienced a similar event in the past. No treatment medications were reported. This case was linked to MOD-2022-566673 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 ; BUD:11-Feb-2022 and administered on 02-Mar-2022; administered 3 vaccines beyond the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered 3 vaccines beyond the beyond use date) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 ; BUD:11-Feb-2022 and administered on 02-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered 3 vaccines beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 ; BUD:11-Feb-2022 and administered on 02-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered 3 vaccines beyond the beyond use date) and PRODUCT STORAGE ERROR (Initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 ; BUD:11-Feb-2022 and administered on 02-Mar-2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to MOD-2022-566621 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Follow-up received contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 and administered on 10-Mar-2022; Administered 3 vaccines beyond the beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered 3 vaccines beyond the beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 and administered on 10-Mar-2022) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 3 vaccines beyond the beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 and administered on 10-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered 3 vaccines beyond the beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator possibly on 10-Jan-2022, 11-Jan-2022, or 12-Jan-2022 and administered on 10-Mar-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was not reported.  Vial did not undergo any temperature excursions.  No treatment medications were provided.   This case was linked to MOD-2022-566621 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Follow-up contains no new information.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   This case was linked to MOD-2022-566676 (Patient Link).
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: aches/pains; Tiredness; fever with the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches/pains), FATIGUE (Tiredness) and PYREXIA (fever with the second dose) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 003B21A) for COVID-19 vaccination.     No patient had never been diagnosed with/tested positive for COVID-19.  No acute illnesses at the time of vaccination and up to one month before. No chronic or long-standing health conditions.  Concurrent medical conditions included Egg allergy. Concomitant products included ETHINYLESTRADIOL, LEVONORGESTREL (ENPRESSE) for Birth control.   On 24-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. On an unknown date, the patient experienced PAIN (aches/pains), FATIGUE (Tiredness) and PYREXIA (fever with the second dose). At the time of the report, PAIN (aches/pains), FATIGUE (Tiredness) and PYREXIA (fever with the second dose) outcome was unknown.            No treatment medications were reported by the reporter.   This case was linked to MOD-2022-547111, MOD-2022-547115 (Patient Link).
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Cough, Dizziness, Fatigue, Headache, Rhinorrhoea
Clinical narrative: Sinus headache; Runny nose; Sneezing; Cough; Dizziness; Extreme exaustion/Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus headache), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Cough) and DIZZINESS (Dizziness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Concurrent medical conditions included Allergy to antibiotic (Bactrim).   On 01-Nov-2021 at 3:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 06-May-2022 at 3:00 PM, the patient experienced SINUS HEADACHE (Sinus headache), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Cough), DIZZINESS (Dizziness), FATIGUE (Extreme exaustion/Fatigue) and HEADACHE (Headache). At the time of the report, SINUS HEADACHE (Sinus headache), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Cough), DIZZINESS (Dizziness), FATIGUE (Extreme exaustion/Fatigue) and HEADACHE (Headache) was resolving.            No concomitant medication information provided.  Patient received no other medicines or products within two weeks of starting COVID-19 treatment. Device date was reported as 10-May-2022.  No treatment medication information provided.
Age: 33.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Sinus headache, Sneezing
Clinical narrative: Sinus headache; Runny nose; Sneezing; Cough; Dizziness; Extreme exaustion/Fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus headache), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Cough) and DIZZINESS (Dizziness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19.    Concurrent medical conditions included Allergy to antibiotic (Bactrim).   On 01-Nov-2021 at 3:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 06-May-2022 at 3:00 PM, the patient experienced SINUS HEADACHE (Sinus headache), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Cough), DIZZINESS (Dizziness), FATIGUE (Extreme exaustion/Fatigue) and HEADACHE (Headache). At the time of the report, SINUS HEADACHE (Sinus headache), RHINORRHOEA (Runny nose), SNEEZING (Sneezing), COUGH (Cough), DIZZINESS (Dizziness), FATIGUE (Extreme exaustion/Fatigue) and HEADACHE (Headache) was resolving.            No concomitant medication information provided.  Patient received no other medicines or products within two weeks of starting COVID-19 treatment. Device date was reported as 10-May-2022.  No treatment medication information provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper
Clinical narrative: Severe stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Severe stomach pain) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049621A, 034F21A, 030B21A and 030M20A) for COVID-19 vaccination.     The patient neither had COVID positive test nor diagnosis.  Concurrent medical conditions included Vegetable allergy (night shade vegetables, red tomatoes, ripe potatoes) and Blood pressure abnormal.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ABDOMINAL PAIN UPPER (Severe stomach pain). At the time of the report, ABDOMINAL PAIN UPPER (Severe stomach pain) outcome was unknown.            Concomitant medication of the patient included unspecified blood pressure medication.  No treatment information was provided by the reporter.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna dose administered > 12 hours past vial puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna dose administered > 12 hours past vial puncture) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna dose administered > 12 hours past vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna dose administered > 12 hours past vial puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment information was not provided. The vial was punctured on 10-May-2022 and the vaccine administered on 11-May-2022 (Lot number: 059M21A, Expiration date: Unknown).None of the patients had reported any adverse reactions to the expired dose. HCP wanted to know if the vaccine was viable or should the patients be revaccinated   This case was linked to MOD-2022-567445 (Patient Link).
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with vaccine which was stored at room temp more than 24 hours; administered with vaccine which was punctured for more than 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was punctured for more than 12 hours) and PRODUCT STORAGE ERROR (administered with vaccine which was stored at room temp more than 24 hours) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 012L20A, 016M20A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022 at 9:30 AM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was punctured for more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered with vaccine which was stored at room temp more than 24 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with vaccine which was punctured for more than 12 hours) and PRODUCT STORAGE ERROR (administered with vaccine which was stored at room temp more than 24 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. The vial was pulled out of the refrigerator at 8:00 am on 12-May-2022, punctured around 8:15 am and left at room temp since then. The vial was initially stored in the refrigerator on 02-May-2022 in the morning. t It was reported that the vial did not undergo any temperature excursions. The patient does not have any side effects at the time of the call. No treatment were reported.
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: accidentally given a half dose (0.25 ml) for 2nd primary series dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (accidentally given a half dose (0.25 ml) for 2nd primary series dose) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (accidentally given a half dose (0.25 ml) for 2nd primary series dose). At the time of the report, ACCIDENTAL UNDERDOSE (accidentally given a half dose (0.25 ml) for 2nd primary series dose) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported. Patient received a second Moderna primary series four weeks after the first primary series dose.  Treatment medication details were not reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination. The patient had no known allergy. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 03-May-2022 at 2:00 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-May-2022 at 2:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) and PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose administered past manufactures expiration date/ Expired vaccine administered) to be related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vial expired on 02May2022, was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM). No concomitant product reported by reporter. It was unknown if patient had the ever been diagnosed with Covid-19. It was unknown if patient had acute illness at the time of vaccination as well as unknown for chronic health conditions. It was unknown if patient experienced similar adverse event in the past. Vaccine did not undergone any temperature excursion issue. Vaccine was pulled from freezer at 10AM on 03May2022 and was put in refrigerator until approximately 1:45 PM. Dose administered after 30 day Use By Date or after manufacturer date of expiry. No treatment medication reported by reporter.