chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Death, General physical health deterioration
Clinical narrative: ENDED UP PASSING AWAY; GOT WORSE AND WORSE; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, 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 were not reported) dose, start therapy date were not reported, 1 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 got worse and worse and on an unspecified date patient ended up passing away. It was reported that  "My husband got thanks j j shot too years ago and then he got worse and worse and ended up passing away". On an unspecified date, the patient died from unknown cause of death. It was unknown whether an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got worse and worse was not reported and on an unspecified date the patient ended up passing away. This report was serious (Death).; Sender's Comments: V0: 20221243958-Ended up passing away. 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: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via a company representative via social media 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, expiry: unknown) dose was not reported, 1 total 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 stroke. It was reported that, "same with my Mom. Her legs went out from under her to a stroke the week after shot. so sorry for your injuries." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221244092.; Sender's Comments: V0: 20221244027- Stroke. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a consumer via a company representative through social media (J & J corporate) concerned a female of unspecified age, 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) dose, start therapy date were not reported, 1 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, one week after vaccination, the patient experienced stroke and it was reported as "same with my Mom. Her legs went out from under her to a stroke the week after shot. so sorry for your injuries". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stroke was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221244027.; Sender's Comments: V0: 20221244092- Stroke.  The event has an compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Brain abscess
Clinical narrative: BRAIN ABSCESS; This spontaneous report received from a consumer via social media via company representative concerned a male of an unspecified age, race, and ethnic origin. 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 was not reported, 01 total was administered on an unspecified date 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 brain abscess and was hospitalized for a couple of months. The number of hospitalization days was not reported. The patient was discharged on an unspecified date. The patient did not had any seizures since returning to home and was taking medication. It was reported as, "I had the Pfizer shot and had no issues. My significant other got the Johnson & Johnson shot and wasn't so lucky. He ended up with an brain abscess and landed in the hospital for a couple of months. He is home now, and is still taking medication. He hasn't had any seizures since he came home. We are taking it one day at a time and thanking God that he is healing and functioning okay. We don't know for sure if the shots had anything to do with the brain abcess. His memory has a few holes in it, but he is functioning and thriving and that is what really counts." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from brain abscess. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221244141- brain abcess. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Illness, SARS-CoV-2 test
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SICKNESS; This spontaneous report received from a patient via social media via a company representative concerned a patient of an unspecified age, sex, race and ethnic origin. Initial information was processed along with additional information received on 21-DEC-2022. The patient's weight, height, and medical history were not reported. The patient was previously administered with two doses of covid-19 vaccine (Unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following 2 doses of covid-19 vaccine (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis which was associated with Revaccination with different covid-19 vaccine (Dose number in series 2). 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 in DEC-2022, the patient experienced sickness. On the day of reporting, the patient still had sickness since 11 days after the booster (Dose number in series 2). Laboratory data (dates unspecified) included: COVID-19 virus test results not reported, tested covid-19 multiple times. It was reported that, "I took two and a booster have been sick sense 11days after the booster and have had tested coved mulwt times". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sickness, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious. This report was associated with product quality complaint: 90000263936. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (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. 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 blood clots (Dose number in series 1). It was reported as "I got the blood clots too after one of the shots". The patient also received dose 2 with covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 2), (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered start therapy date were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221244261- blood clots . Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: DOWN FOR 2 TO 3 DAYS AFTER VACCINATION; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. It was unknown whether patient had any adverse event following 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 date were not reported) dose, start therapy date were not reported, 1 total was 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 down for 2 to 3 days after vaccination and the patient was dread of receiving the third dose although patient knew it would be helpful (dose number in series 2). The reporter stated that "yeah I'm down for 2 t 3 days after I take it, dread getting there 3rd. Although I know it helpful." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of down for 2 to 3 days after vaccination was not reported. This report was non-serious.
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL USE IN UNAPPROVED AGE GROUP (VACCINE ADMINISTERED TO 15 YEAR OLD); This spontaneous report received from a pharmacist concerned a 15 year old of unspecified 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 not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, administered on 19-DEC-2022 for covid-19 prophylaxis. The drug was associated with Off label use. Age at time of vaccination 15 years old. No concomitant medications were reported.  On 19-DEC-2022, the patient experienced off label use in unapproved age group (vaccine administered to 15 year old). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label use in unapproved age group (vaccine administered to 15 year old) was not reported. This report was non-serious. This case, involving the same patient is linked to 20220355536.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure
Clinical narrative: HEART FAILURE; This spontaneous report received from a consumer via a company representative via social media concerned a 18 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, 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 heart failure. It was unspecified if an autopsy was performed. The reporter stated that  "No, you do not have the data. Because injuries are not being reported into VAERS. I had 1 coworker whose lips and tongue went numb after his vaccine, and he nearly died. 2 others had severe tinnitus. One had hands so painful he sat there rubbing them nearly crying. Another had he and his wife both experiencing numb hands with loss of grip. Another coworker's wife has myocarditis. My supervisor's daughter had her 18 year old best friend die of heart failure after his vaccine. These adverse events are not rare, look in every comment section about Covid vaccines. And do not give me that "anecdotal" stuff. Big pharma can not hide behind that lie forever ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20221243340, 20221243356, 20221243261, 20221243606, 20221245881 and 20221245969.; Sender's Comments: V0: 20221245816- Heart failure.  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: HEART FAILURE
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: NUMB HANDS WITH LOSS OF GRIP; 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 numb hands with loss of grip.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of numb hands with loss of grip was not reported. This report was non-serious. This case, from the same reporter is linked to 20221243340, 20221243356, 20221243261, 20221245816, 20221245969 and 20221243606.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Oxygen saturation, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a health care professional (Nurse) concerned a 63 year old female of an unspecified ethnicity. The patient's weight, height, and medical history were not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin and batch number were not reported, and expiry: Unknown) dose was not reported, 1 total, dose 1 was administered on an unspecified date in MAR-2021 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 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin and batch number were not reported, and expiry: Unknown) dose was not reported, 1 total, dose 2 was administered on an unspecified date in NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 62 years old. No concomitant medications were reported. On 16-SEP-2022, the patient experienced symptoms of covid included regular cold, blowing nose, worst sore throat which felt like swallowing razor blades, nasal congestion and fever which was suspected covid-19 infection (Dose number in series 2). The patient kept checking oxygen and blood pressure results were not reported. The patient was started on antivirals (unspecified) given by doctor, and then the patient tested negative on an unspecified date. After testing negative the patient experienced feeling in her chest for about 3 months that went away, heart rate increased, nose kept draining and draining while wearing a mask, and had short of breath (Dose number in series 2). These were side effects after testing negative or long covid. Laboratory data (dates unspecified) included: Blood pressure not reported, COVID-19 virus test Negative, Heart rate increased, and Oxygen saturation not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Grip strength decreased, Hypoaesthesia
Clinical narrative: LOSS OF HAND GRIP; NUMB HANDS; 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 loss of hand grip, and numb hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the numb hands and loss of hand grip was not reported. This report was non-serious. This case, from the same reporter is linked to 20221243261, 20221243356, 20221243340, 20221245816, 20221245881 and 20221243606.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: EVERYONE I KNEW THAT GOT IT HASN'T BEEN OK; 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 everyone i knew that got it hasn't been ok. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of everyone i knew that got it hasn't been ok was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: BELLS PALSY; This spontaneous report received from a consumer via social media a company representative concerned a male of unspecified age, 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 and expiry date 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 bells palsy. Reporter stated, "My son took the shot and got bells palsy." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221246567-bells palsy. The event has an unknown/unclear temporal relationship, and is labeled. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 2.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022) and NO ADVERSE EVENT (No adverse event) in a 2-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)) for COVID-19 prophylaxis.     No Medical History information was reported.    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)) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022) 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 ACCIDENTAL OVERDOSE (a patient was given a double dose of the bivalent booster (0.4ml instead of 0.2ml). The vaccine adminstration was today, 15Dec2022).    No concomitant medicine were reported. No treatment medicine were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Skin lesion
Clinical narrative: 1st Lesion seen the day after 2nd booster/Lesions were now on both arms; This spontaneous case was reported by a patient and describes the occurrence of SKIN LESION (1st Lesion seen the day after 2nd booster/Lesions were now on both arms) in a 69-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: MODERNA COVID-19 VACCINE (First booster) in 2021; for Product used for unknown indication: INFLUENZA VACCINE in October 2022. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE and MODERNA COVID-19 VACCINE. Concurrent medical conditions included Breast cancer (Treated with chemo, surgical lumpectomy and currently approximately 1/2 way through 6-months of every 3-weeks of infusions) since 2022. Concomitant products included LETROZOLE from 2022 to an unknown date for Breast cancer.    On 30-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 01-Dec-2022, the patient experienced SKIN LESION (1st Lesion seen the day after 2nd booster/Lesions were now on both arms). At the time of the report, SKIN LESION (1st Lesion seen the day after 2nd booster/Lesions were now on both arms) outcome was unknown.        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.   It was reported that patient had the 1st lesion on the day after 2nd booster on same arm the booster was given which was a year after the first booster and 2 months after Oct 2022 flu shot and the lesions were now on both arms.  It was unknown if the patient experienced any additional symptoms/events.
Age: 0.58
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: their daughter received an adult dose by mistake; Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (their daughter received an adult dose by mistake), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022) and NO ADVERSE EVENT (no adverse event) in a 7-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1414B, AS1414B and AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 30-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (their daughter received an adult dose by mistake), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022) and NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (their daughter received an adult dose by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022) outcome was unknown and NO ADVERSE EVENT (no adverse event) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for WRONG PRODUCT ADMINISTERED (their daughter received an adult dose by mistake) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 administered on 30-jun-2022 and Dose 1 administered on 21-Jul-2022).    No concomitant medication was reported. No treatment medication was reported.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysgeusia, Pruritus, Rhinorrhoea, Skin mass
Clinical narrative: tasted salty; coughing; runny nose; noticed welts of the size of a fingernail in her legs; Bumps; itchy/ itching around the neck line/ it started itching a little bit more; This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (Bumps), PRURITUS (itchy/ itching around the neck line/ it started itching a little bit more), DYSGEUSIA (tasted salty), URTICARIA (noticed welts of the size of a fingernail in her legs) and COUGH (coughing) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Leg injury. Previously administered products included for Product used for unknown indication: Johnson & Johnson (1st dose) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and MONTELUKAST for Asthma.    On 12-Dec-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 12-Dec-2022, the patient experienced SKIN MASS (Bumps). 12-Dec-2022, the patient experienced PRURITUS (itchy/ itching around the neck line/ it started itching a little bit more). On 14-Dec-2022, the patient experienced URTICARIA (noticed welts of the size of a fingernail in her legs). On 15-Dec-2022, the patient experienced DYSGEUSIA (tasted salty). 15-Dec-2022, the patient experienced COUGH (coughing) and RHINORRHOEA (runny nose). The patient was treated with PARACETAMOL (TYLENOL) on 13-Dec-2022 for Itching, at an unspecified dose and frequency. At the time of the report, SKIN MASS (Bumps) and PRURITUS (itchy/ itching around the neck line/ it started itching a little bit more) had not resolved, DYSGEUSIA (tasted salty) outcome was unknown and URTICARIA (noticed welts of the size of a fingernail in her legs), COUGH (coughing) and RHINORRHOEA (runny nose) was resolving.            It was reported that after the Moderna bivalent booster during the evening patient started itching around the neck line, next day patient took Tylenol and itch was not so bad, but on the next day before patient went to bed it started itching a little bit more and patient noticed welts of the size of a fingernail in the legs, next day around 12:30 patient started coughing and needed to drink water and then by 2 o clock patient had runny nose and tasted salty. Currently patient still had bumps and itchiness.   This case was linked to MOD-2022-689496 (Patient Link).
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: tasted salty; coughing; runny nose; noticed welts of the size of a fingernail in her legs; Bumps; itchy/ itching around the neck line/ it started itching a little bit more; This spontaneous case was reported by a patient and describes the occurrence of SKIN MASS (Bumps), PRURITUS (itchy/ itching around the neck line/ it started itching a little bit more), DYSGEUSIA (tasted salty), URTICARIA (noticed welts of the size of a fingernail in her legs) and COUGH (coughing) in an 88-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  The patient's past medical history included Leg injury. Previously administered products included for Product used for unknown indication: Johnson & Johnson (1st dose) on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with Johnson & Johnson. Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL (ALBUTEROL HFA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB) and MONTELUKAST for Asthma.    On 12-Dec-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 12-Dec-2022, the patient experienced SKIN MASS (Bumps). 12-Dec-2022, the patient experienced PRURITUS (itchy/ itching around the neck line/ it started itching a little bit more). On 14-Dec-2022, the patient experienced URTICARIA (noticed welts of the size of a fingernail in her legs). On 15-Dec-2022, the patient experienced DYSGEUSIA (tasted salty). 15-Dec-2022, the patient experienced COUGH (coughing) and RHINORRHOEA (runny nose). The patient was treated with PARACETAMOL (TYLENOL) on 13-Dec-2022 for Itching, at an unspecified dose and frequency. At the time of the report, SKIN MASS (Bumps) and PRURITUS (itchy/ itching around the neck line/ it started itching a little bit more) had not resolved, DYSGEUSIA (tasted salty) outcome was unknown and URTICARIA (noticed welts of the size of a fingernail in her legs), COUGH (coughing) and RHINORRHOEA (runny nose) was resolving.            It was reported that after the Moderna bivalent booster during the evening patient started itching around the neck line, next day patient took Tylenol and itch was not so bad, but on the next day before patient went to bed it started itching a little bit more and patient noticed welts of the size of a fingernail in the legs, next day around 12:30 patient started coughing and needed to drink water and then by 2 o clock patient had runny nose and tasted salty. Currently patient still had bumps and itchiness.   This case was linked to MOD-2022-689496 (Patient Link).
Sex: U
Vaccine: COVID19, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) 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. 024H22A) 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 EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) 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 EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022).    Concomitant medications were not reported.  They reported their beyond use date was on 12-Dec-2022 but they discovered it on 17-Dec-2022. This case contains information for the patient 2 out of 10 adult patients. Treatment medications were not reported.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022; No Adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) 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. 024H22A) 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 EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022) 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 EXPIRED PRODUCT ADMINISTERED (patients received the vaccines after the beyond use date/10 patients have received a bivalent Moderna COVID-19 vaccine after the 30 day BUD from 13DEC2022-17DEC2022).    Concomitant medications were not reported.  It was reported that their beyond use date was on 12-Dec-2022 but they discovered it on 17-Dec-2022. This case contains information for the patient 8 out of 10 adult patients. Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: a breakthrough case of COVID after receiving 4 shots; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (a breakthrough case of COVID after receiving 4 shots) 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)) (batch nos. AS7165b, 030l20a, 029a21a and 069721a) for COVID-19 prophylaxis.    Co-suspect product included non-company product LEVOTHYROXINE for an unknown indication.    Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine on 02-Feb-2021, Moderna COVID-19 Vaccine on 02-Mar-2021 and Moderna COVID-19 Vaccine on 19-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.   On 02-Feb-2021, 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 02-Mar-2021, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-Nov-2021, received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2022, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient started LEVOTHYROXINE (unknown route) at an unspecified dose. On 28-Nov-2022, the patient experienced COVID-19 (a breakthrough case of COVID after receiving 4 shots). At the time of the report, COVID-19 (a breakthrough case of COVID after receiving 4 shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Nov-2022, SARS-CoV-2 test: COVID test on 11/28/2022.     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.   It is unknown if any other vaccines in the 4 weeks prior to COVID-19 vaccine. Consumer reported that PAXLOVID for 5 days was taken which was consider a mistake CONCOMITANT levothyroxine. No Concomitant medication was provided by reporter. No Treatment medication was provided by reporter.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose) and NO ADVERSE EVENT (No adverse event) in a 6-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Aug-2022 at 11:00 AM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 16-Aug-2022 at 11:00 AM, the patient experienced WRONG PRODUCT ADMINISTERED (A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose) and NO ADVERSE EVENT (No adverse event) outcome 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 WRONG PRODUCT ADMINISTERED (A 6 year-old patient was given an adult vaccine instead of the children's vaccine for their second dose).    No concomitant medications were reported.  The vial/syringe was stored at room temperature for up to 3 hours. No reactions or follow-up documented from receiving the wrong dose.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was inadvertently given bivalent booster as first primary series dose; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient was inadvertently given bivalent booster as first primary series dose) and NO ADVERSE EVENT (No adverse event) 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.     No Medical History information was reported.    On an unknown date, 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 (Patient was inadvertently given bivalent booster as first primary series dose) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient was inadvertently given bivalent booster as first primary series 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 was inadvertently given bivalent booster as first primary series dose).    Concomitant product use was not provided by the reporter.   HCP (clinical services manager for pharmacy chain) reports that the patient was inadvertently given bivalent booster as first primary series dose and additional patient details were unknown to the reporting HCP at that time.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: Patient had original Moderna vaccine on 20-Sep-2021, enquired if needed a 2nd or booster dose and was told 2nd dose of Moderna Covid vaccine is no longer available; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient had original Moderna vaccine on 20-Sep-2021, enquired if needed a 2nd or booster dose and was told 2nd dose of Moderna Covid vaccine is no longer available) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O4SC21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-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 DOSE OMISSION ISSUE (Patient had original Moderna vaccine on 20-Sep-2021, enquired if needed a 2nd or booster dose and was told 2nd dose of Moderna Covid vaccine is no longer available) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient had original Moderna vaccine on 20-Sep-2021, enquired if needed a 2nd or booster dose and was told 2nd dose of Moderna Covid vaccine is no longer available) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported.  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Nodule
Clinical narrative: Developed 2 nodules 11DEC2022 to the marionette lines  approximately 2 cm and palpable; Inflamed; This spontaneous case was reported by a health care professional and describes the occurrence of NODULE (Developed 2 nodules 11DEC2022 to the marionette lines  approximately 2 cm and palpable) and INFLAMMATION (Inflamed) in a 67-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.    Co-suspect product included non-company product POLY-L-LACTIC ACID (SCULPTRA) injection for an unknown indication.    No Medical History information was reported.   On 04-Nov-2022, the patient started POLY-L-LACTIC ACID (SCULPTRA) (unknown route) at an unspecified dose. On an unknown date, 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, received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 11-Dec-2022, the patient experienced NODULE (Developed 2 nodules 11DEC2022 to the marionette lines  approximately 2 cm and palpable) and INFLAMMATION (Inflamed). The patient was treated with DOXYCYCLINE at an unspecified dose and frequency. At the time of the report, NODULE (Developed 2 nodules 11DEC2022 to the marionette lines  approximately 2 cm and palpable) and INFLAMMATION (Inflamed) had not resolved.        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.   No concomitant medication was provided.