chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Asthma, COVID-19, Insomnia, Pain
Clinical narrative: WORSE ASTHMA ISSUES; BODY ACHES; SLEEPLESSNESS; TASTE STILL OFF; SKIN IRRITATIONS; COVID 3 TIMES; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on unspecified date for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (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, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered 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 worse asthma issues never went away, body aches, sleeplessness, taste still off, skin irritations, and had Covid 3 times after vaccine (Dose number in series 2). As per the patient, "Had vaccine 2xs worse asthma issues never went away. Body aches, sleeplessness, taste still off, skin irritations etc the list goes on...had Covid 3xs after vaccine. Useless experiment on us all. Pfizer doses, J&J useless, Moderna gets you sick" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from worse asthma issues, and taste still off, and the outcome of body aches, sleeplessness, skin irritations and covid 3 times was not reported. This report was non-serious. This case, involving the same patient is linked to 20221238315. This report was associated with product quality complaint: 90000263666.
Sex: U
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: WORSE ASTHMA ISSUES; BODY ACHES; SLEEPLESSNESS; TASTE STILL OFF; SKIN IRRITATIONS; COVID 3 TIMES; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total, administered on unspecified date for covid-19 prophylaxis. It was unknown whether the patient experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (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, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered 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 worse asthma issues never went away, body aches, sleeplessness, taste still off, skin irritations, and had Covid 3 times after vaccine (Dose number in series 2). As per the patient, "Had vaccine 2xs worse asthma issues never went away. Body aches, sleeplessness, taste still off, skin irritations etc the list goes on...had Covid 3xs after vaccine. Useless experiment on us all. Pfizer doses, J&J useless, Moderna gets you sick" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from worse asthma issues, and taste still off, and the outcome of body aches, sleeplessness, skin irritations and covid 3 times was not reported. This report was non-serious. This case, involving the same patient is linked to 20221238315. This report was associated with product quality complaint: 90000263666.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer. 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 covid-19. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This report was associated with product quality complaint: 90000263702. This case, from the same reporter is linked to 20221238610.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: alpha tryptasemia (causes allergic reaction to many things). The patient was previously received Moderna covid 19 vaccine (elasomeran) (Dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose was not reported, administered on 2021 for covid-19 prophylaxis.  On an unspecified date in 2021, the patient experienced reactions (Dose number in series 1). The outcome of reactions was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 01 total, administered on 10-APR-2021 for covid-19 prophylaxis which was associated with off label dosing frequency (off label use) and revaccination with different covid-19 vaccine (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label dosing frequency and revaccination with different covid-19 vaccine was not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 01 total, administered on 29-OCT-2021 for covid-19 prophylaxis. The patient did not experienced any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 3). This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID MORE THAN ONCE; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 covid more than once. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid more than once was not reported. This report was non-serious. This report was associated with a product quality complaint.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: FEEL SICK AFTERWARD; 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 feel sick afterward. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feel sick afterward was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Eye discharge
Clinical narrative: WEEPING EYE; This spontaneous report received from a consumer 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced weeping eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of weeping eye was not reported. This report was non-serious. This case is a duplicate of 20221241285.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: TERRIBLE MIGRAINES; 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 terrible migraines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible migraines was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol, Pain
Clinical narrative: BURNING PAIN LOWER LEGS AND FEET; This spontaneous report received from a patient via a company representative via social media and concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid-19 (hospitalized for a serious case of covid-19 in JAN-2021). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 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 experienced burning pain lower legs and feet (dose number in series 1). Laboratory data (dates unspecified) included: Cholesterol Raised (2-3 weeks later). The reporter stated "I had J&J vax and booster, first vax was burning pain lower legs, feet, raised cholesterol levels 2-3 weeks later (all after hospitalized for a serious case of covid jan 2021 before vax availability)" The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 total, dose, start therapy date were not reported for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of burning pain lower legs and feet was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: PAIN IN UPPER ARMS; 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 pain in upper arms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pain in upper arms was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac disorder
Clinical narrative: COVID-19; HEART ISSUES; This spontaneous report received from a consumer via a company representative concerned a male 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 covid-19, and heart issues. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the covid-19 and heart issues was not reported. This report was non-serious. This report was associated with product quality complaint: 90000263898.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: GOTTEN COVID AND WORSE; This spontaneous report received from a consumer via a company representative concerned multiple patients. 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 gotten covid and worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from gotten covid and worse. This report was non-serious. This case was associated with product quality complaint: 90000263901
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: weakness in hand; tingling in hand; This case was reported by a consumer and described the occurrence of hands weakness of in a 63-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 7th December 2022, the patient received Shingles vaccine. On 7th December 2022, less than a day after receiving Shingles vaccine, the patient experienced hands weakness of and tingling of extremity. On an unknown date, the outcome of the hands weakness of was not recovered/not resolved and the outcome of the tingling of extremity was unknown.   It was unknown if the reporter considered the hands weakness of and tingling of extremity to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 15th December 2022. Reporter's Comment:  This report was submitted via the online reporting system.  Expiry Date of Shingles vaccine was unknown. Weakness and tingling in hand were the symptoms and it was not treated. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022; This spontaneous case was reported by a pharmacist and describes the occurrence of NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7166B) for COVID-19 prophylaxis.     No Medical History information was reported.    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 09-Dec-2022, the patient experienced NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022). At the time of the report, NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 EXPIRED PRODUCT ADMINISTERED (administered with bivalent doses beyond use date/ Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022).    Moderna is authorized to communicate with the vaccine recipient's primary healthcare professional regarding this notification. Vaccines were stored in the fridge on 8Nov2022 and doses were administered on 9Dec2022 and 12Dec2022.  No Concomitant medication were provided by reporter. No Treatment medication was provided by reporter.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe body rash after second Moderna vaccination; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Severe body rash after second Moderna vaccination) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Allergies -Lisinopril Medical history Diabetes/Cholesterol /stroke 5 years ago Concomitant Medications Januvia 100 mg Crestor Plavix 75 mg every other day.  The patient's past medical history included Allergy and Stroke (5 years ago). Previously administered products included for COVID-19 prophylaxis: Spikevax on 01-Mar-2022. Past adverse reactions to the above products included No adverse event with Spikevax. Concurrent medical conditions included Diabetes, Cholesterol and Drug allergy. Concomitant products included SITAGLIPTIN PHOSPHATE (JANUVIA) and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication.    On 14-Apr-2020, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced RASH (Severe body rash after second Moderna vaccination). In November 2022, RASH (Severe body rash after second Moderna vaccination) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient had Dose 1 Lot number 04021A administered on 01Mar2022, Dose 3 Lot number 033F21A administered on 18Nov2022, Dose 4 Lot number 056M21A administered on 14May2022. Symptoms resolved November 2022 after taking Prednisone.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling; numbness in foot; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in foot) in a 40-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On 31-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 01-Nov-2022, the patient experienced PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in foot). At the time of the report, PARAESTHESIA (tingling) and HYPOAESTHESIA (numbness in foot) was resolving.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication list was not provided. It was reported that a patient reported to pharmacist today that experienced tingling and numbness in foot the next day after receiving his Moderna Bivalent booster dose. Treatment information was not provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Facial pain, Immunisation reaction, Ocular discomfort
Clinical narrative: had a weird side effect after he got the 2nd and the 1st booster dose of the Moderna Covid-19 vaccine; His left eye is now droopy; face pain under his left eye which eas very intense; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (face pain under his left eye which eas very intense), IMMUNISATION REACTION (had a weird side effect after he got the 2nd and the 1st booster dose of the Moderna Covid-19 vaccine) and OCULAR DISCOMFORT (His left eye is now droopy) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20 and 047C21A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Hypertension Ashtma Cholesterol allergies to sulfa (possibly).  Previously administered products included for an unreported indication: MODERNA COVID-19 VACCINE on 09-Feb-2021 and FLU VACCINE VII. Concurrent medical conditions included Hypertension, Asthma, Cholesterol and Sulfonamide allergy.   On 09-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2022, the patient experienced FACIAL PAIN (face pain under his left eye which eas very intense). On an unknown date, the patient experienced IMMUNISATION REACTION (had a weird side effect after he got the 2nd and the 1st booster dose of the Moderna Covid-19 vaccine) and OCULAR DISCOMFORT (His left eye is now droopy). At the time of the report, FACIAL PAIN (face pain under his left eye which eas very intense) was resolving and IMMUNISATION REACTION (had a weird side effect after he got the 2nd and the 1st booster dose of the Moderna Covid-19 vaccine) and OCULAR DISCOMFORT (His left eye is now droopy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided by reporter. No treatment medication was provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair loss; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss) 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 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 ALOPECIA (hair loss). At the time of the report, ALOPECIA (hair loss) outcome was unknown.            No concomitant product use was reported.  The patient received an additional booster dose.  The patient stated that the peoples on the internet are saying they got hair loss from taking the Moderna. Patient stated it could have been the first vaccine or any of them.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    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 COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. The patient reported  that her daughter developed COVID as well, She doesn't know which shot she got.                                    No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Temperature excursion occurred; No Adverse event; Temperature excursion occurred; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) and NO ADVERSE EVENT (No Adverse event) in an adult patient of an unknown gender 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 01-Dec-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. On 01-Dec-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) and NO ADVERSE EVENT (No Adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred), PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred) 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 assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Temperature excursion occurred) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred).    No concomitant drug information was provided.  It was reported that the temperature excursion of the vaccine had occurred on 29Nov2022. A total of 16 doses were administered.   Reportedly, Temperature excursion occurred on 29-Nov-2022. A total of 16 doses were administered on 29-Nov-2022 (5 doses), 30-Nov-2022 (4 doses), 01-Dec-2022 (2 doses), 02-Dec-2022 (2 doses), 03-Dec-2022 (1 doses) and 05-Dec-2022 (2 doses).  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication information was provided. The case is reported for one of the 2 adult patients who received the vaccine on 1Dec2022, as reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688061 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688061:1 adult patient (1DEC2022)
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).; This spontaneous case was reported by an other health care professional and describes the occurrence of NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).) in a 75-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 010H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    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 14-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, NO ADVERSE EVENT (no adverse event) and EXPIRED PRODUCT ADMINISTERED (A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).) 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 EXPIRED PRODUCT ADMINISTERED (A patient got 1 dose of Moderna Bivalent BUD of 01Dec2022. Administered today (14Dec2022).).    No concomitant medicine were reported. No treatment medicine were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: side effects that she had from the 1st booster dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (side effects that she had from the 1st booster dose of the Moderna Covid-19 vaccine) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) 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, the patient experienced IMMUNISATION REACTION (side effects that she had from the 1st booster dose of the Moderna Covid-19 vaccine). At the time of the report, IMMUNISATION REACTION (side effects that she had from the 1st booster dose of the Moderna Covid-19 vaccine) outcome was unknown.            No concomitant product use was reported.  Reporter stated that while looking for Evushield, the medication that was prescribed to reporter to counteract the side effects that reporter had from the 1st booster dose of the Moderna Covid-19 vaccine (monovalent), reporter met 2 patients (no identifiers except their gender and age group) who was also had the same side effects as reporter had. There was no parental vaccine exposure.  No treatment information was provided for patient.  This report is for the 1st patient of 02.   This case was linked to US-MODERNATX, INC.-MOD-2022-687442 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-687442:Same reporter
Sex: U
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 018C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    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) .5 milliliter. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.) 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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (The pharmacist is unsure what vaccine he has with NDC 80777-275-05 and lot number 018C22A/ they have been administering 0.5 ml because it does say 0.5 on the vial.).    No concomitant medication information was provided. It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was accidentally administered the bivalent booster instead of the 2nd dose of the primary series.; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was accidentally administered the bivalent booster instead of the 2nd dose of the primary series.) 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 an unknown date, 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 an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Patient was accidentally administered the bivalent booster instead of the 2nd dose of the primary series.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was accidentally administered the bivalent booster instead of the 2nd dose of the primary series.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. On unknown date patient received 1st dose of Moderna COVID-19 vaccine. No treatment information was provided.   Reporter did not allow further contact
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; patient received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series) and NO ADVERSE EVENT (No Adverse event) in a 14-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 020h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-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) .5 milliliter. On 10-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series) 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 received a bivalent Moderna COVID19 vaccine as a 2nd dose of the primary series).    No concomitant medications were reported.  It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. On 04-Oct-2022, the patient received the 1st dose of Moderna COVID-19 vaccine (lot no: 063b22a).  No treatment medications were reported.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: he may have been given the Bivalent dose as the 1st dose.; No Adverse Event; This spontaneous case was reported by a consumer and describes the occurrence of WRONG PRODUCT ADMINISTERED (he may have been given the Bivalent dose as the 1st dose.) and NO ADVERSE EVENT (No Adverse Event) in a 48-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-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 an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (he may have been given the Bivalent dose as the 1st dose.) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (he may have been given the Bivalent dose as the 1st dose.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 (he may have been given the Bivalent dose as the 1st dose.).    No concomitant medication was reported. No treatment medication was reported. the patient attempted to schedule an appointment and asked to wait for 60 days. upon speaking with pharmacist, the patient was told to be administered with bivalent dose as the first dose. The patient received no other vaccine in the 4 weeks prior to COVID-19 vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 051d22a) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: COVID-19 VACCINE on 04-Mar-2021, COVID-19 VACCINE on 01-Apr-2021, COVID-19 VACCINE on 04-Nov-2021 and COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 15-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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 (Expired vaccine used).    NO Concomitant medication was provided by reporter. No Treatment medication was provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product temperature excursion issue
Clinical narrative: No adverse event; Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)/ 1 Patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)/ 1 Patient) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender 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 03-Dec-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. On 03-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)/ 1 Patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)/ 1 Patient) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (Temperature excursion occurred on 29Nov2022. A total of 16 doses were administered on 29Nov2022 (5), 30Nov2022 (4), 1Dec2022 (2), 2Dec2022 (2), 3Dec2022 (1), and 5Dec2022 (2)/ 1 Patient).    No concomitant medications were reported.  It was reported patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine as unknown.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient did not receive the second dose as she forgot to go get the 2nd; No adverse event; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose as she forgot to go get the 2nd) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose as she forgot to go get the 2nd) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose as she forgot to go get the 2nd) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient did not receive the second dose as she forgot to go get the 2nd).    No concomitant medications were reported.   Patient  took only the first dose of the Moderna COVID19 vaccine and patient's employer made a request in regards to vaccination process.  No treatment details were reported.