chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness at injection site; Hardness at injection site/Being a 2 inch circle around the injection site; Tenderness at injection site/ a continual ache; Swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th May 2022, the patient received the 1st dose of Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced injection site erythema, injection site induration, injection site pain and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site induration, injection site pain and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site induration, injection site pain and injection site swelling to be related to Shingrix.     Additional Information: GSK receipt date: 17-MAY-2022 Reporter's comment: The case was reported by patient. The patient received 1st dose of Shingrix in the left arm and experienced redness, hardness, tenderness, a continual ache, and swelling at the injection site. The patient said there being a 2  inch circle around the injection site. The patient said all symptoms were ongoing.  The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Completed suicide, Impaired gastric emptying
Clinical narrative: GASTROPARESIS; HUNG HERSELF WITH BATHROBE BELT(SUICIDE); This spontaneous report received from a consumer via a company representative via media concerned an 81 years old female of an unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 prophylactic vaccination.  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 gastroparesis (which had blown up in her and suffered from the same for 5 months). On 18-AUG-2021, the patient had hung herself with bathrobe belt (suicide) and died from the same. It was unspecified if an autopsy was performed. It was reported by consumer that, "My 81 year old mom committed suicide on August 18th after suffering a blowup of incurable gastroparesis after her poison shots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of hung herself with bathrobe belt(suicide) on 18-AUG-2021, and the outcome of gastroparesis was not reported. This report was serious (Death, and Other Medically Important Condition). This case is a duplicate of 20220527077. This case, from the same reporter is linked to 20220126450, 20220126177, 20220126708, 20220126582, 20220130063 and 20220528171.  Additional information was received from consumer on 12-MAY-2022. It was determined that Manufacturer Case Number 20220527077 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20220126211. The following information was updated and incorporated into the case narrative: Added reporter (company representative).  Upon review following information was amended: The case was made valid, batch number statement updated in narrative and social media captured in source.; Sender's Comments: V1:Follow up information in this version updated  It was determined that Manufacturer Case Number 20220527077 was a duplicate of this case. All relevant information regarding this case will be submitted under Manufacturer Case Number 20220126211. The following information was updated: reporter. Upon review following information was amended: The case was made valid, batch number statement updated in narrative and social media captured in source.The follow up information does not change the causality of the previous reported event.   20220126211-Covid-19 vaccine ad26.CoV-2.s. Hung herself with bathrobe belt (suicide), Gastroparesis.  This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: SUICIDE
Sex: F
Vaccine: COVID19
Symptoms: Death, Gait inability
Clinical narrative: DIED; COULD NEVER WALK AGAIN; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. 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 could never walk again. On 25-APR-2022, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of could never walk again was not reported. This report was serious (Death).; Sender's Comments: V0-20220519096-covid-19 vaccine ad26.cov2.s-.Died The event(s) 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(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacture Pfizer concerned a 64 year old male of unspecified race and ethnicity. Initial information was processed along with the additional information received on 16-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: overweight, and asthmatic. On an unspecified date, the patient previously received with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  On an unspecified date in NOV-2021, the patient additionally received booster covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D31A, expiry: unknown) 1 total, dose was not reported for prophylactic vaccination. Concomitant medications included ascorbic acid, ergocalciferol, and zinc.  On an unspecified date, patient experienced very mild symptoms as mild and itchy cough and was prescribed with Paxlovid. On 04-MAY-2022 (in the night, day before reporting), he had stuffy nose. The patient reported that he was out in some weather that was cold and raining that maybe aggravated the covid . The patient also reported that he had not started the Paxlovid till the time of reporting and he had a stuffy nose before starting the Paxlovid (confirmed covid-19 infection) (dose number in series 2). Laboratory data (dates unspecified) included: Covid-19 virus test positive (confirmed clinical vaccination failure) Positive (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000230986.; Sender's Comments: V0 : 20220523540-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company (Pfizer) concerned a 36 year old female. Initial information was processed along with the additional information received on 13-MAY-2022 and 18-MAY-2022. The patient's height, and weight were not reported. The patient's past medical history included: drug allergy, and concurrent conditions included: asthma, migraines, and seasonal allergies. The patient was not pregnant at the time of reporting. On 11-NOV-2020, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 4381412, expiry: unknown) dose was not reported, 1 total administered to right arm for prophylactic vaccination. The age at time of vaccination was 35 years old. On 28-OCT-2021, the patient received non-company suspect elasomeran (Moderna vaccine) (dose number in series: 2) (form of admin and route of admin were not reported, batch number: 071F21A, expiry: unknown) dose was not reported, administered to left arm for prophylactic vaccination. No concomitant medications were reported. On 24-APR-2022, the patient experienced onset of covid-19 symptoms (dose number in series: 2). On the same day, the patient began treatment with Paxlovid (batch number: FX2740) for covid-19. On 28-APR-2022, the patient tested negative on a home antigen test. On 29-APR-2022, the patient took the last dose of Paxlovid. On 04-MAY-2022, the patient had symptoms and this corresponds to day 11 from initial symptom onset and tested positive for covid-19 (unspecified test) which indicated confirmed covid-19 infection (dose number in series: 2) and confirmed clinical vaccination failure (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000230965. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20220526665-covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure.The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 52 year old male. Initial information was processed along with additional information received on 16-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: tree nut allergy. The patient previously received covid-19 vaccine ad26.cov2.s 9 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805022 and expiry: unknown) dose was not reported, 1 total, administered on 08-MAR-2021 in right arm for prophylactic vaccination. Age at time of vaccination 51 years old. Concomitant medications included ibuprofen (advil), paracetamol (Tylenol) and Hammer Nutrition Tissue Rejuvenator and Race Cap. On an unspecified date in 2022, the patient experienced confirmed clinical vaccination failure (Dose number in series 1). The patient received non-company suspect vaccine Moderna covid-19 vaccine (elasomeran) (Dose number in series 2) (form of admin, route of admin was not reported, batch number: 071F21A, expiry: unknown) dose was not reported, administered on 09-NOV-2021 in right arm for prophylactic vaccination.  The patient reported that he tested negative for covid-19 after 10 days (date unspecified). Treatment medications for covid-19 included: ritonavir (Paxlovid) from 20-APR-2022 to 25-APR-2022. On 01-MAY-2022, patient reported more severe symptoms reoccurred (coded to confirmed covid-19 infection) (Dose number in series 2). Patient reported that he assumed the symptoms were something else and infected his partner as he was no longer isolating. Patient tested positive again on day 16 (date unspecified).  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable.  The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000231245; Sender's Comments: V0:20220530373-COVID-19 VACCINE Ad26.COV2.S-confirmed clinical vaccination failure  The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; ALLERGIC REACTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with additional information on 17-MAY-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, premature ventricular contractions, arrhythmia, several food allergy, and seasonal allergies. The patient was previously received two doses of Pfizer (tozinameran) (Dose number in series: 1) (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, administered first dose on 16-JAN-2021 12:00 on left arm and second dose on 19-FEB-2021 10:00 on left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with two doses of Pfizer (tozinameran) (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 16-NOV-2021 11:00 on left arm for prophylactic vaccination. 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 suspected covid-19 infection and had suspected clinical vaccination failure (Dose number in series: 2). Patient took Paxlovid (Ritonavir/nirmatrelvir) (batch number: FY6859) for covid-19 treatment first dose on 06-MAY-2022 and second dose on 07-MAY-2022. After 16 hours of first dose of Paxlovid which was on 07-MAY-2022, the patient experienced asthma like breathing problems, itching in throat, swelling in throat, itching in mouth, and swelling in mouth (allergic reaction) (Dose number in series: 2). It was stopped after taking 2 doses of Paxlovid. Treatment medications (dates unspecified) included: Benadryl (diphenhydramine hydrochloride), Zyrtec (cetirizine hydrochloride), PepsideAC (Peptides) and Albuterol (salbutamol). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from allergic reaction on 08-MAY-2022, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220526451.; Sender's Comments: V0- 20220530409 -COVID-19 VACCINE Ad26.COV2.S- Suspected Clinical Vaccination failure- The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Thrombosis
Clinical narrative: BLOOD CLOTS IN LEGS; BLOOD CLOTS IN LUNG; This solicited report received from a patient via PPSCVM000808: Janssen for XARELTO concerned an adult male of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was treated with rivaroxaban (film-coated tablet, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported for an unspecified indication.  The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots in legs, and blood clots in lung. Patient also mentioned the doctor advised he had blood clots way too often. Patient took off of Xarelto for 3 days frequently to donate blood. On first occasion of donating blood patient was still actively taken Xarelto and once needle was placed in arm, blood shot everywhere. The action taken with covid-19 vaccine ad26.cov2.s, and rivaroxaban was not applicable. The outcome of the blood clots in legs and blood clots in lung was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and blood clots in legs, and blood clots in lung was not related; and between rivaroxaban, and blood clots in legs, and blood clots in lung was not related.  This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220534253.; Sender's Comments: V0-20220530488-covid-19 vaccine ad26.cov2.s-Blood clots in legs, Blood clots in lung. The event(s) 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(s). Therefore, this event(s) is considered not related.  20220530488-Rivaroxaban-Blood clots in legs, Blood clots in lung. The event(s) is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. Therefore, this event(s) is considered not related.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 50-year-old female of unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown expiry: unknown) dose was not reported, 1 total administered on 25-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at the time of vaccination was 49 years. Concomitant medications included hydrochlorothiazide, and losartan potassium.  On 29-APR-2022, Covid symptoms (suspected covid-19 infection and suspected clinical vaccination failure) returned a week after patient stopped taking paxlovid, without lung issues. Treatment medication included Paxlovid from 18-APR-2022 to 22-APR-2022 for covid 19 treatment. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000231595.; Sender's Comments: V0: 20220531795-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 38 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: azithromycin (rash), alcohol user (consumes beer or wine once or twice a week), and non smoker, and other pre-existing medical conditions included: There was no drug abuse or illicit drug usage. The patient was previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 043A21A, expiry date: unknown) dose was not reported, 1 total, administered on 06-APR-2021 for a prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822809, expiry date: 04-AUG-2022) dose was not reported, 1 total, administered in left arm on 26-OCT-2021 for prophylactic vaccination. Age at time of vaccination 38 years old. No concomitant medications were reported.  On 06-JAN-2022, the patient experienced flu-like symptoms (confirmed covid-19 infection) (dose number in series 2). On 07-JAN-2022, covid-19 polymerase chain reaction (PCR) test was performed. On 08-JAN-2022, the result came back as positive (confirmed clinical vaccination failure) (dose number in series 2). Reporter stated that, she had flu like symptoms for two days before she got tested positive for Covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000231351.; Sender's Comments: V0-20220532722-Covid-19 vaccine ad26.CoV-2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: OUT OF SPECIFICATION PRODUCT USE; INCORRECT PRODUCT STORAGE AT FLUCTUATED TEMPERATURE BETWEEN 19 TO 43 FAHRENHEIT; This spontaneous report received from a health care professional concerned multiple patients. No past medical history or concurrent conditions were 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 prophylactic vaccination. 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 out of specification product use, and incorrect product storage at fluctuated temperature between 19 to 43 Fahrenheit. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use and incorrect product storage at fluctuated temperature between 19 to 43 Fahrenheit was not reported. This report was non-serious. This case, from the same reporter is linked.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use
Clinical narrative: OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 73 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient additionally received first booster dose with covid-19 vaccine ad26. cov2.s (dose number in series 2) (unspecified manufacturer) (suspension for injection, route of admin and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first booster dose of covid-19 vaccine ad26. cov2.s (dose number in series 2).  The patient received second booster dose with covid-19 vaccine ad26.cov2.s (dose number in series 3) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, dose and start therapy date were not reported for prophylactic vaccination which was off label use and inappropriate schedule of vaccine administered (dose number in series 3). Age at time of vaccination 73 years old. The batch number was not reported. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. No concomitant medications were reported. The patient was fine after third dose of vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: SORE ARM; This spontaneous report received from a patient concerned a 51 year old adult male. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol use (occasional, 1 per month), and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient had no history of drug abuse or illicit drug use. Diagnostic data of the patient was not available. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of administration, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on an unspecified date for prophylactic vaccination. No adverse events were reported following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total was administered on an unspecified date in OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 51 years old. No concomitant medications were reported.  On an unspecified date in 2021, next day of vaccination, the patients arm was sore and was noticeably sore, especially with movement, for just over a month in duration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on an unspecified date in 2021 after just over a month duration. This report was non-serious. This case, involving the same patient is linked to 20210407672.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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 prophylactic vaccination. 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 unspecified adverse event. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Pericarditis
Clinical narrative: PERICARDITIS; ALMOST HAD ANOTHER EVENT BEFORE; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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, start therapy date were not reported, 1 total administered on an unspecified date in 2021 prophylactic vaccination. 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, patient had pericarditis that started after he took his shot over a year ago and was taking ibuprofen but it was not helping. His doctor did not believe that it was due to the vaccine and they said because of patient's eating and patient was not healthy. Patient reported that he almost had another event before. Treatment medications (dates unspecified) included: ibuprofen.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pericarditis, and the outcome of almost had another event before was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220537184-covid-19 vaccine ad26.cov2.s-Pericarditis. The event(s) 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(s). Therefore, this event(s) is considered unassessable.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE (WAS REFROZEN AND ADMINISTERED); OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 27 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A, expiry: 20-MAY-2022) dose was not reported, administered on 09-DEC-2021 for prophylactic vaccination. Age at time of vaccination 27 years old. No concomitant medications were reported.  On 09-DEC-2021, the patient experienced incorrect storage of vaccine (was refrozen and administered) and out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of vaccine (was refrozen and administered) and out of specification product use was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537688, 20220538146, 20220537548, 20220538149 and 20220538210.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: THE JANSSEN COVID 19 VACCINE WAS REFROZEN AND ADMINISTERED TO PATIENT; PRODUCT STORAGE ERROR; This spontaneous report received from a health care professional concerned a 19 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286 expiry: 20-MAR-2022) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced the janssen covid 19 vaccine was refrozen and administered to subject, and product storage error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the the janssen covid 19 vaccine was refrozen and administered to patient and product storage error was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220538238, 20220537444, 20220537548 and 20220539045.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Diplopia, Gait disturbance, Intervertebral disc disorder
Clinical narrative: LEG CRAMPING; RIGHT AND LEFT FOOT DROP; DIFFICULTY WALKING; DIFFICULTY WITH FACIAL EXPRESSIONS/MOVEMENTS; BACK PAIN; PINCHED NERVE/NERVE PROBLEMS; DOUBLE VISION; DISC OUT; TINGLING SENSATIONS; WEAKNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was on thyroid medicine (not specified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204321A, expiry: UNKNOWN) dose was not reported, administered on SEP-2021 for prophylactic vaccination. Age at time of vaccination 69 years old. No concomitant medications were reported. On NOV-2021, the patient experienced leg cramping, right and left foot drop, difficulty walking, difficulty with facial expressions/movements, back pain, pinched nerve/nerve problems, double vision, disc out, tingling sensations, and weakness. Laboratory data included: MRI (NR: not provided) Abnormal (showed pinched nerve and disc out). Laboratory data (dates unspecified) included: Nerve stimulation test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramping, right and left foot drop, weakness, tingling sensations, difficulty walking, difficulty with facial expressions/movements, back pain, pinched nerve/nerve problems, double vision, and disc out. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Movement disorder, Muscle spasms, Nerve compression, Nerve stimulation test
Clinical narrative: LEG CRAMPING; RIGHT AND LEFT FOOT DROP; DIFFICULTY WALKING; DIFFICULTY WITH FACIAL EXPRESSIONS/MOVEMENTS; BACK PAIN; PINCHED NERVE/NERVE PROBLEMS; DOUBLE VISION; DISC OUT; TINGLING SENSATIONS; WEAKNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was on thyroid medicine (not specified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204321A, expiry: UNKNOWN) dose was not reported, administered on SEP-2021 for prophylactic vaccination. Age at time of vaccination 69 years old. No concomitant medications were reported. On NOV-2021, the patient experienced leg cramping, right and left foot drop, difficulty walking, difficulty with facial expressions/movements, back pain, pinched nerve/nerve problems, double vision, disc out, tingling sensations, and weakness. Laboratory data included: MRI (NR: not provided) Abnormal (showed pinched nerve and disc out). Laboratory data (dates unspecified) included: Nerve stimulation test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramping, right and left foot drop, weakness, tingling sensations, difficulty walking, difficulty with facial expressions/movements, back pain, pinched nerve/nerve problems, double vision, and disc out. This report was non-serious.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peroneal nerve palsy
Clinical narrative: LEG CRAMPING; RIGHT AND LEFT FOOT DROP; DIFFICULTY WALKING; DIFFICULTY WITH FACIAL EXPRESSIONS/MOVEMENTS; BACK PAIN; PINCHED NERVE/NERVE PROBLEMS; DOUBLE VISION; DISC OUT; TINGLING SENSATIONS; WEAKNESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was on thyroid medicine (not specified). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204321A, expiry: UNKNOWN) dose was not reported, administered on SEP-2021 for prophylactic vaccination. Age at time of vaccination 69 years old. No concomitant medications were reported. On NOV-2021, the patient experienced leg cramping, right and left foot drop, difficulty walking, difficulty with facial expressions/movements, back pain, pinched nerve/nerve problems, double vision, disc out, tingling sensations, and weakness. Laboratory data included: MRI (NR: not provided) Abnormal (showed pinched nerve and disc out). Laboratory data (dates unspecified) included: Nerve stimulation test (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg cramping, right and left foot drop, weakness, tingling sensations, difficulty walking, difficulty with facial expressions/movements, back pain, pinched nerve/nerve problems, double vision, and disc out. This report was non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: INCORRECT STORAGE OF VACCINE (VACCINE WAS REFROZEN); OUT OF SPECIFICATION PRODUCT USE (ADMINISTRATION OF REFROZEN VACCINE); This spontaneous report received from a health care professional concerned a 52 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, expiry: 20-MAR-2022) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. Age at time of vaccination 52 years old. No concomitant medications were reported. On 01-JUN-2021, the patient experienced out of specification product use (administration of refrozen vaccine). On an unspecified date, the patient experienced incorrect storage of vaccine (vaccine was refrozen). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect storage of vaccine (vaccine was refrozen) and out of specification product use (administration of refrozen vaccine) was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537356, 20220537532, 20220537683, 20220538238, 20220537444, 20220537548, 20220539045, 20220538425, 20220538428, 20220538297 and 20220538573.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: VACCINE WAS REFROZEN; ADMINISTRATION OF REFROZEN VACCINE; This spontaneous report received from a health care professional concerned a 48 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1821286, and expiry: 20-MAR-2022) dose was not reported, administered on 18-JUN-2021 for prophylactic vaccination. Age at time of vaccination 48 years old. No concomitant medications were reported.  On 18-JUN-2021, the patient experienced administration of refrozen vaccine. On an unspecified date, the patient experienced vaccine was refrozen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was refrozen and administration of refrozen vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220537683, 20220537356, 20220537444, 20220537507, 20220537532, 20220537548, 20220537683, 20220537683, 20220537688, 20220538146, 20220538149, 20220538210, 20220538292, 20220538297, 20220538347, 20220538379, 20220538316, 20220537341, 20220539045, 20220538425 and 20220538428.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 11-May-2022; administered with expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administered on 11-May-2022) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 11-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with expired vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and administerd on 11-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  It was reported that the patient had received expired dose after the 30 days use by date. The date the vial initially stored in the refrigerator was 11-Jan-2022 and was administered on 11-May-2022  The vaccine did not experience any temperature excursions. There were no adverse reactions reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2022: Follow up was received: Updated the primary reporter's additional contact information. On 17-May-2022: Significant follow-up was received: Report type updated into a valid case, patient details updated added patient's identifier, Suspect product dosages added batch number added, event verbatim updated and I-narrative updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: Developed blood clots after the second dose/got blood clots after the second shot; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) in a 7-decade-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) (seriousness criterion medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Developed blood clots after the second dose/got blood clots after the second shot) and CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided.  Company comment-This spontaneous case concerns an adult female patient (in 60s) with no reported medical history, who experienced the unexpected serious (medically significant) ADRs of Cerebrovascular accident and Thrombosis unknown days after administration of second dose of mRNA-1273 vaccine. Details regarding age of the patient, dates of vaccination, date of onset of events, medical history, concomitant medications, clinical course, investigations, and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-566820, MOD-2022-566822, MOD-2022-566828, MOD-2022-566808, MOD-2022-566718, MOD-2022-566821, MOD-2022-566839, MOD-2022-566813 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2022: Follow up received with Information as reporter information, verbatim for event thrombosis and new event stroke.; Sender's Comments: This spontaneous case concerns an adult female patient (in 60s) with no reported medical history, who experienced the unexpected serious (medically significant) ADRs of Cerebrovascular accident and Thrombosis unknown days after administration of second dose of mRNA-1273 vaccine. Details regarding age of the patient, dates of vaccination, date of onset of events, medical history, concomitant medications, clinical course, investigations, and treatment were not provided. The benefit-risk relationship of mRNA-1273 is not affected by this report.