chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced mild side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20221100231.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Condition aggravated, Rash, Skin disorder
Clinical narrative: DERMATOLOGY RELATED SKIN ISSUES; FLARE UP; RASH; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via another pharmaceutical company concerned a 39 year old male of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was not having any known allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number and expiry was not reported) dose was not reported, administered 1 in total, first dose on 25-MAR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 39 years old. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for drug used for unknown indication. The patient received booster dose of non-company suspect vaccine included: elasomeran (Moderna vaccine) (Dose number in series 2) (form of admin unknown, intramuscular, batch number and expiry was not reported) dose and frequency were not reported on 01-DEC-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On 01-DEC-2021, the patient experienced revaccination with different covid-19 vaccine (Dose number in series 2).  On an unspecified date, the patient experienced dermatology related skin issues, flare up, and rash following vaccination with elasomeran (Moderna vaccine) (Dose number in series 2). It was unknown if patient was enrolled in covid-19 vaccine trial. The action taken with covid-19 vaccine ad26.cov2.s, adalimumab, and elasomeran was not applicable. The outcome of the rash, dermatology related skin issues, flare up and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site hypersensitivity
Clinical narrative: SENSITIVE POINT AT INJECTION SITE; This spontaneous report received from a consumer concerned a 75 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 75 years old. No concomitant medications were reported. On MAR-2021, the patient experienced sensitive point at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sensitive point at injection site on 07-MAR-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Joint stiffness, Tremor
Clinical narrative: TREMORS IN HAND; JOINT STIFFNESS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced tremors in hand, and joint stiffness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tremors in hand and joint stiffness was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative through media concerned a 31 year old female of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) frequency 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The reporter stated that, "met a guy that lost his 31 year old daughter from your vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died from an unknown cause on an unspecified date. This report was serious (Death).; Sender's Comments: V0: 20221104412-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via Communication concerned a 32 year old male of an unspecified race and ethnicity.   The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. Age at time of vaccination 4 decade old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient died from unknown cause of death after receiving the vaccine. It was unspecified if an autopsy was performed or not. It was reported as "(32 years old) died less than 24 hours after receiving the Johnson and Johnson vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221106251- Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, race, ethnicity, and sex. Initial information was processed along with the additional information received on 04-NOV-2022.  The patient's height, and weight were not reported. The patient's concurrent conditions included: irritable bowel syndrome (IBS), leaking heart valve, gastroesophageal reflux disease (GERD), sulfa drug allergy, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 05-APR-2021 to left arm for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, 1 total administered on 27-OCT-2021 to left arm for covid-19 prophylaxis. Concomitant medications included chlorhexidine gluconate, levothyroxine sodium (levothyroxin), lisinopril, omeprazole, and pravastatin.  On an unspecified date in 2022, the patient experienced symptoms of runny nose and mild diarrhea (Dose number in series 2).  The patient received non company co-suspect Paxlovid (form of admin and route of administration were not reported, batch number: unknown, expiry: unknown) dose was not reported, administered from 13-OCT-2022 to 17-OCT-2022 for treatment of COVID-19.  On 21-OCT-2022, Laboratory data included: COVID-19 virus test Negative. On 23-OCT-2022 (2 days after testing negative), patient tested positive for covid-19. Thus patient had confirmed covid-19 infection and confirmed clinical vaccination failure (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000257968.; Sender's Comments: V0: 20221107596- confirmed clinical vaccination failure. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Currently in hospital with myocarditis; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Currently in hospital with myocarditis) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 MYOCARDITIS (Currently in hospital with myocarditis) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDITIS (Currently in hospital with myocarditis) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. As per social media, patient won't live past 30. Treatment information was not reported.  Company comment: This is a spontaneous case concerning a 25-years-old male patient with no reported medical history, who experienced the expected serious (hospitalization and medically significant) adverse event of special interests of myocarditis. The event occurred on unknown day after the unknown dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.     Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2022: Live Follow-up received include : Patient age added. On 04-Nov-2022: Live follow up received and updated patient information and details were added, reporter information also added.; Sender's Comments: This is a spontaneous case concerning a 25-years-old male patient with no reported medical history, who experienced the expected serious (hospitalization and medically significant) adverse event of special interests of myocarditis. The event occurred on unknown day after the unknown dose of mRNA-1273 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event was not resolved. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness assessed as reported.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Chills, Hyperhidrosis
Clinical narrative: weakness; sweating at night; chills; This spontaneous case was reported by a patient and describes the occurrence of ASTHENIA (weakness), HYPERHIDROSIS (sweating at night) and CHILLS (chills) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer on 21-Jan-2021, Pfizer on 11-Feb-2021 and Pfizer on 05-Oct-2021. Past adverse reactions to the above products included No adverse reaction with Pfizer, Pfizer and Pfizer.   On 31-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness), HYPERHIDROSIS (sweating at night) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), HYPERHIDROSIS (sweating at night) and CHILLS (chills) outcome was unknown.     No concomitant medications were reported. Patient received 4th dose of Moderna vaccine on 01-Jul-2022. After receiving Moderna Bivalent vaccine patient experienced chills, weakness and sweating at night. caller stated she was told that these side effects would be there for 2-3 days but its day 5.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (rash) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first 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.        mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.       No concomitant medications were reported.   It was reported that patient received 4 doses of Moderna vaccine and had a rash since first dose.  No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: Lump in mouth; This spontaneous case was reported by a consumer and describes the occurrence of MASS (Lump in mouth) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced MASS (Lump in mouth). At the time of the report, MASS (Lump in mouth) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The reporter's causality for the event of lump in mouth with Adalimumab Solution for Injection was not provided and assessed as reasonable possibility with Moderna COVID-19 vaccine (Elasomeran). No treatment details were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Dry mouth, Dysphagia, Lip swelling, Paraesthesia oral
Clinical narrative: tongue started to tingling; entire mouth got so dry; could not swallow; lips swelled; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA ORAL (tongue started to tingling), DRY MOUTH (entire mouth got so dry), DYSPHAGIA (could not swallow) and LIP SWELLING (lips swelled) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson & Johnson vaccine. Past adverse reactions to the above products included No adverse event with Johnson & Johnson vaccine. Concurrent medical conditions included Allergy.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA ORAL (tongue started to tingling), DRY MOUTH (entire mouth got so dry), DYSPHAGIA (could not swallow) and LIP SWELLING (lips swelled). The patient was treated with TRIAMCINOLONE ACETONIDE (KENALOG [TRIAMCINOLONE ACETONIDE]) at an unspecified dose and frequency and PREDNISONE at an unspecified dose and frequency. At the time of the report, PARAESTHESIA ORAL (tongue started to tingling), DRY MOUTH (entire mouth got so dry), DYSPHAGIA (could not swallow) and LIP SWELLING (lips swelled) outcome was unknown.            No concomitant medications were provided by the reporter.  It was reported that on the 27th at 5:40 PM at a local vaccine facility, patient had the Moderna booster.   Patient had the Johnson & Johnson before because they do have allergies. It was reported that within 2 minutes of taking the shots, their tongue started to tingling, entire month got so dry and could not swallow.   Patient waited for 45 minutes and went home. 2 hours later, lips swelled. Patient had got a Tenalog shot from the doctor the next day and a Prednisone pill. The Tenalog helped with the dryness, the prednisone did not help stopping it.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Nervousness, Productive cough, SARS-CoV-2 test
Clinical narrative: When he coughs it goes away; Phlegm in his lungs; Does not feel so bad nor nauseous but he is nervous; Tested positive for Covid; This spontaneous case was reported by a patient and describes the occurrence of COUGH (When he coughs it goes away), PRODUCTIVE COUGH (Phlegm in his lungs), NERVOUSNESS (Does not feel so bad nor nauseous but he is nervous) and COVID-19 (Tested positive for Covid) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no known allergies.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2022, the patient experienced COVID-19 (Tested positive for Covid). On an unknown date, the patient experienced COUGH (When he coughs it goes away), PRODUCTIVE COUGH (Phlegm in his lungs) and NERVOUSNESS (Does not feel so bad nor nauseous but he is nervous). At the time of the report, COUGH (When he coughs it goes away), PRODUCTIVE COUGH (Phlegm in his lungs), NERVOUSNESS (Does not feel so bad nor nauseous but he is nervous) and COVID-19 (Tested positive for Covid) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2022, SARS-CoV-2 test: Positive.         No concomitant medications was reported.  Patient had online doctor assistance. No treatment medications was reported.
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient got a Moderna COVID19 vaccine bivalent as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient got a Moderna COVID19 vaccine bivalent as a second dose) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Nov-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 05-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient got a Moderna COVID19 vaccine bivalent as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient got a Moderna COVID19 vaccine bivalent as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient got a Moderna COVID19 vaccine bivalent as a second dose).    No concomitant medication details was reported. Date of administration of the primary series dose1, 08-Oct-2022 and lot number was unknown. Patient received COVID-19 vaccine bivalent as a second dose. Prior to this the patient only received one dose of the primary series. No treatment medication details was reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received the bivalent shot as their primary dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the bivalent shot as their primary dose) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 052D22A) for COVID-19 prophylaxis.     It was reported that the patient had no allergies to medications, food and other products. The patient did not have any medical history of acute and chronic illnesses at the time of vaccination. The patient had never been diagnosed or tested positive with COVID-19. No other vaccines were given to the patient within 1 moth prior to Moderna COVID-19 vaccination.     On 07-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 07-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the bivalent shot as their primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the bivalent shot as their primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the bivalent shot as their primary dose).    The patient was not taking any other medications. The patient's healthcare provider was aware of the incidents.  No treatment details was reported.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Influenza like illness, Lethargy
Clinical narrative: Had 2 Moderna vaccines and each time spent 3 days with flu Like symptoms; Lethargy; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Had 2 Moderna vaccines and each time spent 3 days with flu Like symptoms) and LETHARGY (Lethargy) in a 65-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Flu (Last had flu) in 1975.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Had 2 Moderna vaccines and each time spent 3 days with flu Like symptoms) and LETHARGY (Lethargy). At the time of the report, INFLUENZA LIKE ILLNESS (Had 2 Moderna vaccines and each time spent 3 days with flu Like symptoms) and LETHARGY (Lethargy) had resolved.            Concomitant product use was not provided by the reporter.  The patient had 2 Moderna vaccines and each time spent 3 days with flu like symptoms and lethargy. Kept trying to work it into calendar. Happened to be with her hypochondriac husband who goaded patient into getting the Omicron booster there on the spot! Pfizer Astounding - no reaction experienced.  The patient had not gotten yearly flu shots.  Treatment information was not provided.
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash erythematous, Rash pruritic, Tenderness
Clinical narrative: The fist size rash is sore to the touch; Fist size rash red and itchy rash/ fist size rash is sore to the touch and itches a lot.; Red and itchy rash; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (The fist size rash is sore to the touch), RASH PRURITIC (Fist size rash red and itchy rash/ fist size rash is sore to the touch and itches a lot.) and RASH ERYTHEMATOUS (Red and itchy rash) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 06-Nov-2022, the patient experienced TENDERNESS (The fist size rash is sore to the touch), RASH PRURITIC (Fist size rash red and itchy rash/ fist size rash is sore to the touch and itches a lot.) and RASH ERYTHEMATOUS (Red and itchy rash). At the time of the report, TENDERNESS (The fist size rash is sore to the touch), RASH PRURITIC (Fist size rash red and itchy rash/ fist size rash is sore to the touch and itches a lot.) and RASH ERYTHEMATOUS (Red and itchy rash) outcome was unknown.            Concomitant products were not reported.  It was reported that patient received previous all doses from Moderna vaccines but did not had lot numbers with her. This was her second booster, the last one was in Jan-2022.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2022: Live follow-up significant information received: reporter information, patient information, vaccination date and event onset updated.
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Around the shot, it is itching; It was sore/still sore when she touches it; Around the shot, it has been swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (Around the shot, it is itching), VACCINATION SITE PAIN (It was sore/still sore when she touches it) and VACCINATION SITE SWELLING (Around the shot, it has been swollen) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was reported that patient has never been diagnosed/tested positive for COVID-19.  Concurrent medical conditions included Tremor. Concomitant products included PRIMIDONE for Tremor, LISINOPRIL, METFORMIN, LEVOTHYROXINE, VITAMIN A [RETINOL], VITAMIN D [VITAMIN D NOS], FISH OIL, CALCIUM and VITAMINS NOS (MULTIVITAMINUM) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced VACCINATION SITE PRURITUS (Around the shot, it is itching), VACCINATION SITE PAIN (It was sore/still sore when she touches it) and VACCINATION SITE SWELLING (Around the shot, it has been swollen). At the time of the report, VACCINATION SITE PRURITUS (Around the shot, it is itching) and VACCINATION SITE SWELLING (Around the shot, it has been swollen) outcome was unknown and VACCINATION SITE PAIN (It was sore/still sore when she touches it) had not resolved.            No Medical History information was reported.  The vaccine patient received was second booster.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; The bivalent vaccine was given after the 30 day beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The bivalent vaccine was given after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) in a 30-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The bivalent vaccine was given after the 30 day beyond use date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The bivalent vaccine was given after the 30 day beyond use date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (The bivalent vaccine was given after the 30 day beyond use date).    No concomitant medications were provided. Patient has received first dose of the Moderna COVID-19 vaccine by intramuscular injection on 23-MAR-2021 ( lot number 008B21A, expiration date unknown), second dose of the Moderna COVID-19 vaccine by intramuscular injection on 20-APR-2021 ( lot number 039A21A, expiration date 4-SEP-2021), third dose of the Moderna COVID-19 vaccine by intramuscular injection on 16-NOV-2021 ( lot number 051F21A, expiration date 5-DEC-2021). Vial size was 2.5 mL. Date the vial was initially stored in the refrigerator was unknown. BUD expiration date was written as 5-NOV-2022. The vial did not undergo any temperature excursions. The pharmacy listed an expiration date on the vials of 5-NOV-2022. Reporter used the online expiration date tool which listed it as 19-MAY-2023.  The vaccine vials were thawed. Patient has no reported symptoms.  Patient has no additional doses, medications, or treatments.
Age: 44.0
Sex: M
Vaccine: COVID19-2
Symptoms: Asthenia, Malaise, Myalgia, Nausea
Clinical narrative: Feeling sick; No energy; Body hurts; Nauseated; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (Feeling sick), ASTHENIA (No energy), MYALGIA (Body hurts) and NAUSEA (Nauseated) in a 44-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient had no known allergies. The patient had no history relating to mentioned adverse event and both Acute and Chronic illnesses at the time of vaccination. The patient had tested negative for COVID-19.  Previously administered products included for Product used for unknown indication: Pfizer (Dose:1 Lot number: 101891872) on 19-May-2021, Pfizer (Dose: 2 Lot number: 101891872) on 09-Jun-2021, Pfizer (Dose:3 and First Booster Lot number: 101891872) on 13-Dec-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 04-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick), ASTHENIA (No energy), MYALGIA (Body hurts) and NAUSEA (Nauseated). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE (ASPIRIN EXTRA) at a dose of two generic aspirins extra strength. At the time of the report, MALAISE (Feeling sick), ASTHENIA (No energy), MYALGIA (Body hurts) and NAUSEA (Nauseated) was resolving.            No concomitant medications were reported. The patient was feeling adverse events 10 hours after getting the Moderna Booster shot. The adverse events did not cause patient to seek medical care (office visit, urgent care, ER, hospitalized). The patient had not experienced similar events in the past.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Did not receive their second vaccination; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Did not receive their second vaccination) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Dec-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 PRODUCT ADMINISTRATION INTERRUPTED (Did not receive their second vaccination) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Did not receive their second vaccination) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were provided. Patient would like to know if they can receive the second vaccination at the time of report. No treatment medications were reported.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Had Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had Covid) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (Had Covid). On 08-Oct-2022, COVID-19 (Had Covid) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: Positive. On 08-Oct-2022, SARS-CoV-2 test: Negative.         The concomitant medication was not reported by reporter. It was reported that patient had Covid at the beginning of September and tested negative on 08-Oct. Patient said he heard there was some waiting period of when you test negative and when you could get the Moderna Bivalent and patient wanted to know what that was. Patient did not have their vaccination card in front of them but got the first and second dose and then a booster dose. The treatment medication was not reported by reporter.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent) and NO ADVERSE EVENT (No adverse event) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 vaccination.     Patient had no allergies. Patient had no history relating to both Acute and Chronic illnesses at the time of vaccination.    On 05-Nov-2022, 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. On 05-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered with Moderna COVID-19 Vaccine from vial with blue cap and purple border Booster doses only presentation instead of the Moderna Bivalent).    It was unknown if patient was under any concomitant or regular medication. It was unknown whether patient ever had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. Patient did not report any adverse events after getting the vaccine. It was unknown if any treatment was given to patient.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received their second dose of Moderna Monovalent from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received their second dose of Moderna Monovalent from an expired vial) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 057A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Nov-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received their second dose of Moderna Monovalent from an expired vial). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received their second dose of Moderna Monovalent from an expired vial) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received their second dose of Moderna Monovalent from an expired vial).    No concomitant medications were reported.  Vial size was reported as 5.5 mL The vial was initially stored in the refrigerator on 04-Nov-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Never had a primary series at all and received 1 Bivalent dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Never had a primary series at all and received 1 Bivalent dose) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 06-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Never had a primary series at all and received 1 Bivalent dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Never had a primary series at all and received 1 Bivalent dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Never had a primary series at all and received 1 Bivalent dose).    No concomitant drug were reported.   The store administered a Moderna Bivalent booster dose yesterday to someone who has not completed a primary series. The patient never had a primary series at all and received 1 Bivalent dose.   No treatment drug were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: had COVID six weeks ago; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (had COVID six weeks ago) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049l21a, 065e21a, 038a21a and 030m20a) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) for an unknown indication.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2022, the patient experienced COVID-19 (had COVID six weeks ago). At the time of the report, COVID-19 (had COVID six weeks ago) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2022, SARS-CoV-2 test: (Positive) Patient had COVID six weeks ago.         It was reported that patient was expecting to receive a booster dose on Thursday and had COVID-19 infection six weeks ago. No treatment information was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Sore right arm for 5 days.; Right arm is red; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (Right arm is red) and VACCINATION SITE PAIN (Sore right arm for 5 days.) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Primary series). Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 03-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced VACCINATION SITE ERYTHEMA (Right arm is red). On 03-Nov-2022, the patient experienced VACCINATION SITE PAIN (Sore right arm for 5 days.). On 07-Nov-2022, VACCINATION SITE PAIN (Sore right arm for 5 days.) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (Right arm is red) outcome was unknown.            Patient received First Moderna booster dose on 20-Oct-2022 with lot no. 002S21A and Second Moderna booster dose on 19-Apr-2022 with lot no. 067H21A on left arm. No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2022-669858, MOD-2022-669857 (Patient Link).
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Malaise, Pain
Clinical narrative: He was a little off the next day with a little bit of achiness; He was a little off the next day with a little bit of achiness; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (He was a little off the next day with a little bit of achiness) and PAIN (He was a little off the next day with a little bit of achiness) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 024M201 and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jan-2021, the patient experienced MALAISE (He was a little off the next day with a little bit of achiness) and PAIN (He was a little off the next day with a little bit of achiness). At the time of the report, MALAISE (He was a little off the next day with a little bit of achiness) and PAIN (He was a little off the next day with a little bit of achiness) outcome was unknown.            No concomitant medication was reported.  On 17-Feb-2021, the patient received second dose of Moderna COVID-19 Vaccine.  On 18-Feb-2021, the patient was a little off with a little bit of achiness.  On 26-Oct-2021, the patient received third dose of Moderna COVID-19 Vaccine.  On 27-Oct-2021, the patient was a little off with a little bit of achiness.  No treatment medication was reported.   This case was linked to MOD-2022-669169 (Patient Link).