chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given 3 months after 1st; This case was reported by a other health professional via sales rep and described the occurrence of drug dose administration interval too short in a patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (received first dose 3 months prior to the vaccination).   On an unknown date, the patient received the 2nd dose of Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The reported that if the second dose was mistakenly given at 3 months instead of 6 months. The reporter asked that they need to repeat the dose or was the customer considered fully vaccinated. No further information was available. Nothing was clarified as this came in through a customer relationship management.  The reporter consented to follow-up. Additional supportive information: The patient received the second dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, HEP, MNQ, TDAP
Symptoms: Product storage error
Clinical narrative: Vx exposed to 24.9°F and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number patients who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.  Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men ACWY-CRM NVS (Menveo) for prophylaxis, HBV (Engerix B) for prophylaxis, hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received Boostrix, Boostrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Menveo, Engerix B, Engerix B Pre-Filled Syringe Device and DTaP vaccine. On an unknown date, unknown after receiving Boostrix, Boostrix Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Menveo, Engerix B, Engerix B Pre-Filled Syringe Device and DTaP vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-DEC-2022 Reporters comment: The nurse reported that Boostrix, Kinrix, Pediarix, Menveo, Engerix-B were exposed to 24.9 degree F and administered to patients. This excursion was initially called in on 27th June 2022, but the health care professional did not reported/mentioned that the vaccines were administered as no adverse event report could be found.  She also stated that a Dtap vaccine was listed as an administered vaccine but it did not verify as a GSK vaccine by the lot number provided. The health care professional had it under GSK vaccines when she initially called about the temperature excursion. she was not able to verify the lot numbers for the vaccines administered as health care professional stated that this happened before she got there. She did not have patient information or dates of admin and declines follow up. Additional Supportive information:The nurse reported that Boostrix, Kinrix, Pediarix, Menveo, Engerix-B and Dtap vaccine were exposed to 24.Degree F and administered to patients, which led to incorrect storage of drug.
Age: 31.0
Sex: M
Vaccine: RV1
Symptoms: Accidental exposure to product, Exposure via eye contact, Incorrect route of product administration, Product administered to patient of inappropriate age
Clinical narrative: Sprayed Rotarix into eyes; Sprayed Rotarix into eyes; Sprayed Rotarix into eyes; Sprayed in to eyes, 31YO; This case was reported by a other health professional via call center representative and described the occurrence of inadvertent exposure to vaccine in a 31-year-old male patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 14th December 2022, the patient received Rotarix lyophilized formulation (ocular) and Rotarix Oral Applicator Device. On 14th December 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inadvertent exposure to vaccine, exposure via eye contact, inappropriate route of vaccination and inappropriate age at vaccine administration. On an unknown date, the outcome of the inadvertent exposure to vaccine, exposure via eye contact, inappropriate route of vaccination and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-DEC-2022 Reporter's comments: The medical assistant had sprayed Rotarix into the eyes. The reporter had consented to follow-up. Additional supportive information: The reporter had sprayed Rotarix into the eyes of a 31-year old patient, which had led to inadvertent exposure to vaccine, exposure via eye contact, inappropriate route of vaccination and inappropriate age at vaccine administration.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Vx not reconstituted properly; Only liquid adjuvant was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 50-year-old male patient who received Herpes zoster (Shingrix) (batch number B2C9F, expiry date 11th February 2024) for prophylaxis.   On 14th December 2022, the patient received Shingrix. On 14th December 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 15-DEC-2022 Reporter's comment: The clinic manager reported that the patient received a dose of Shingrix yesterday (the day before reporting) and it had not been reconstituted properly and only the liquid adjuvant was given. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by email. Additional Supportive Information: The patient received only the liquid adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received 1st dose, uknown if received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The pharmacist reported that a patient received first dose of Shingrix, but does not remember if she received the second dose or not.   The patient went to a pharmacy that was no longer open, and there was no records available.   Date of first dose was unknown. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. In worst approach, the case was kept valid with incomplete course of vaccination event considering the the patient did not receive the second dose.
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: 11 YO received Bexsero instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number ABXCO888, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 14th December 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 14th December 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient went to a facility to receive a Menveo dose, but instead he received a Bexsero dose, which led to wrong vaccine administered.
Age: 29.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HAV (Havrix 1440 adult) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2022, the patient received the 1st dose of Havrix 1440 adult (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. On 15th December 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The caller consented to follow-up from GlaxoSmithKline, was transferred to medical information for next steps. Additional supportive information: The patient received an expired dose of Havrix vaccine in left deltoid, which led to expired vaccine used.
Age: 3.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Administered to the interior thigh subcutaneously; Administered to the interior thigh subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 3-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 997A5, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2022, the patient received Fluarix Quadrivalent 2022-2023 season (subcutaneous) and Fluarix Tetra Pre-Filled Syringe Device. On 15th December 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The adverse event contains all reported information. The reporter consented to follow-up. The case was linked with case US2022188027, reported by same reporter for different patient. Additional supportive information: The patient was administered a Fluarix vaccination to the interior thigh via inappropriate route, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site.; Sender's Comments:  US-GSK-US2022188027:Same reporter
Age: 8.0
Sex: F
Vaccine: UNK
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Administered to the interior thigh subcutaneously; Administered to the interior thigh subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 8-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 997A5, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2022, the patient received Fluarix Quadrivalent 2022-2023 season (subcutaneous) and Fluarix Tetra Pre-Filled Syringe Device. On 15th December 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The adverse event contains all reported information. The reporter consented to follow-up. The case was linked with case US2022188026, reported by same reporter for different patient. Additional supportive information: The patient was administered a Fluarix vaccination to the interior thigh via inappropriate route, which led to intramuscular formulation administered by other route and vaccine administered at inappropriate site.; Sender's Comments:  US-GSK-US2022188026:Same reporter
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Infanrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th December 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 15th December 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Infanrix, which led to expired vaccine used.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA751A, expiry date 31st October 2024) for prophylaxis.   On 15th December 2022, the patient received Menveo. On 15th December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 15-Dec-2022 Reporter's comment: The address of vaccination facility was not known by the healthcare professional. The reporter consented to follow-up. Additional supportive information: The patient only received the diluent of Menveo on the day of reporting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ALMOST DIED; This spontaneous report received from a consumer concerned a male of an 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, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient almost died, and he was within wheelchair now and disabled now. The patient had visited clinic two times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from almost died. This report was serious (Disability Or Permanent Damage). This case, from the same reporter is linked to 20210540143.; Sender's Comments: V0: 20221238334- almost died. Follow-up received regarding Clinical Details. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Idiopathic pulmonary fibrosis
Clinical narrative: IDIOPATHIC PULMONARY FIBROSIS (IPF); This spontaneous report received from a patient via a company representative via social media concerned a patient of an unspecified age, sex, 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 for months later, the patient was diagnosed with idiopathic pulmonary fibrosis (IPF) and the patient was on oxygen 24/7 since JAN-2022. It was reported that "I had the J and J and for months later I was diagnosed with IPF and have been on on oxygen 24/7 since Jan 2022". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from idiopathic pulmonary fibrosis (ipf). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221242058- idiopathic pulmonary fibrosis (IPF). Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Hypoaesthesia oral
Clinical narrative: NEARLY DIED; LIPS AND TONGUE WENT NUMB; 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 nearly died, and lips and tongue went numb. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lips and tongue went numb and nearly died was not reported. This report was non-serious. This case, from the same reporter is linked to 20221243340, 20221243606, 20221243356, 20221245881, 20221245816 and 20221245969.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Cerebrovascular disorder, Dizziness, Fall
Clinical narrative: SOME SMALL BLOOD VESSELS IN BRAIN HAD DIED; STARTED FALLING; FELT LIKE GOING TO PASS OUT/DIZZY; COVID MILD CASE; This spontaneous report received from a patient via a social media and by a company representative concerned a patient of unspecified age, sex, race and 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, first dose administered on an unspecified date for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, route of admin and batch number were not reported, and expiry: Unknown) dose was not reported, 1 total, second dose 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 following vaccination with second dose of covid-19 vaccine ad26.cov2.s, the patient started falling and was dizzy, and felt like going to pass out (Dose number in series: 2). On an unspecified date, the patient was found that some small blood vessels in brain had died (Dose number in series: 2). The patient also experienced covid mild case (date unspecified) (Dose number in series: 2). It was reported that "I took the first two shots of Covid. After the second one, I started falling was dizzy, felt like I was going to pass out. Come to find out some small blood vessels in my brain had died. I had Covid later on but it was a mild case" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the started falling, felt like going to pass out/dizzy, some small blood vessels in brain had died and covid mild case was not reported. This report was non-serious. This report was associated with a product quality complaint: 90000263914 and 90000263913.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case was assessed as non-serious
Sex: U
Vaccine: COVID19
Symptoms: Myasthenia gravis
Clinical narrative: SUFFERING WITH M G (MYASTHENIA GRAVIS); This spontaneous report received from a patient via a social media  through a company representative concerned a patient of unspecified age, sex, 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 and expiry: Unknown) dose was not reported, 1 total 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. The patient described that the vaccine doctor gave was nearly killed the patient. On an unspecified date, the patient had been suffering with M G (myasthenia gravis), and immune system even a wreck ever since. The patient had been treated by a neurologist and also had thymus removed and was performed with a series of plasmapheresis.  It was reported that "Your Johnson and Johnson COVID vaccine that my doctor gave me dam near killed me. I have been suffering with M.G. ever since. My immune system even a wreck ever since. I can not do anything about it. Yes I being treated by a neurologist. I also had my thymus removed, and a series of plasmapheresis performed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suffering with M G (myasthenia gravis). This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221244196-M G (myasthenia gravis). Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Electrocardiogram, Myocardial infarction, Suspected COVID-19
Clinical narrative: ANTEROSEPTAL INFARCTION; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via a company representative via social media concerned a 59 year old of an unspecified sex, race and ethnicity. Initial information was processed along with additional information received on 21-DEC-2022. The patient's height, and weight were not reported. The patient was always fit and exercised. 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. Age at time of vaccination 6 decade old. No concomitant medications were reported. On an unspecified date, 2 years after vaccination the EKG (electrocardiogram) picked up an inverted T wave and experienced anteroseptal infarction, and the patient had suspected covid-19 infection. It was reported that "Took 1 J&J covid vaccine...now 2 years later my EKG picked up an inverted T wave...Anteroseptal Infarction at 59 Y.O.. always fit and excercised. They lied to us...your god given immune system is far better than a toxic non effective vaccine developed in 9 months...no long term safety testing. J&J and Pfizer and Moderna...I'll never take any vaccine ever again as long as i am breathing. My god given immune system works...haven't been sick again with covid since having the alpha strain. BTW...this virus was man made...it did not cross over from a bat virus". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of anteroseptal infarction was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint. The suspected product quality complaint has been confirmed to be this customer preference case has been assessed and does not represent a product quality complaint. The disposition and root cause determination were documented properly based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20221244833-anteroseptal infarction. The event shows an incompatible temporal relationship. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: EXASPERATED DORMANT LUPUS; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: dormant lupus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 01 total administered, 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's dormant lupus exasperated. Reporter reported that, "1 j and j vac exasperated my dormant lupus. Never will vac again" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exasperated dormant lupus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221246304-exasperated dormant lupus. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: UNDERLYING DISEASE. Therefore, this event is considered inconsistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Intensive care
Clinical narrative: ADMITTED HER TO ICU; This spontaneous report received from a consumer via social media via a company representative 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 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, 45 minutes post vaccination the patient was admitted to intensive care unit (ICU), and she was hospitalized there for 2 weeks. Reporter stated, "my friend took the shot and 45 minutes later they had to admitted her to ICU. She was there 2 weeks. She pulled through but her doctor told her to never take a COVID shot again." The number of days of hospitalization was not reported and it was unsure if the patient was discharged from the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from admitted her to ICU. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221246595- Admitted her to ICU. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, COVID-19 immunisation
Clinical narrative: NEARLY DIED; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously received two doses of covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, administered for covid-19 prophylaxis. On an unspecified date, the patient was nearly died within days after both her second dose (unspecified manufacturer) (Dose number in series 1). The outcome of the nearly died was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 1 total, administered 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, the patient was nearly died days after her booster and was hospitalized for unspecified number of days. (Dose number in series 2). It was reported that "My mother caretakes an old woman. She was hospitalized and nearly died within days after both her second dose and again days after her booster". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nearly died and revaccination with different covid-19 vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20221247101 and 20221247130.; Sender's Comments: V0: 20221247073- nearly died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via a company representative via social media concerned multiple (unspecified number) patients of an unspecified age, sex, race and ethnicity The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. 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 patients died. It was reported as "I could tell you about a 2hole bunch of people who died not too long after their covid vaccine". On an unspecified date, the patients 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. This report was serious (Death). This case, from the same reporter is linked to 20221247101 and 20221247073.; Sender's Comments: V0: 20221247130- died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Laboratory test, Thrombosis
Clinical narrative: BLOOD CLOT TO LEFT LEG; DAMAGED HEART MUSCLE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, 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 and expiry: Unknown) dose was not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced blood clot to left leg that damaged heart muscle. It was reported that the patient seen cardiologist where the patient was concluded after many tests (Lab test) and treatments, that the blood clot to left leg that damaged heart muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clot to left leg and damaged heart muscle was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221247202-blood clot to left leg. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: ROUGH TIME SINCE THEY GOT THEIR SHOT; This spontaneous report received from a consumer 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced rough time since they got their shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rough time since they got their shot. This report was non-serious. This case, from the same reporter is linked to 20221248771.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Balance disorder, Body temperature, Communication disorder, Dysgeusia
Clinical narrative: CAN NOT WORK; TIRED; DON NOT HAVE ENERGY ANYMORE ANYWAY; COMMUNICATION VERY HARD NOW A DAYS; EYE ROLLED BACK IN HEAD AND WAS NOT THERE; FUNNY TASTE IN MOUTH; TEMPERATURE CHANGE/TEMPERATURE THE NEXT DAY AFTER VACCINATION; LETHARGIC TYPE STUFF; FELT LIKE HAD A FLU BUG/FLU-EYE TYPE STUFF; OUT OF CONTROL SPASMS AND THEY WERE CLENCHING THE JAW TO SHUT AND ARCHING BACK AND MAKING NOT ABLE TO MOVE ARMS AND LEGS WHEN THEY CALM DOWN; VISION ISSUES; BALANCE ISSUES; MUSCLE ACHES; COULD NOT TYPE ANYMORE AND BRAIN DOES NOT FUNCTION IN NUMBERS ANY MORE; LARYNGEAL SPASMS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergic reactions to anything. The patient had no previous issues that would contribute. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old. No concomitant medications were reported. On 2021, the patient experienced could not type anymore and brain does not function in numbers any more, and laryngeal spasms. Laboratory data included: MRI not reported. On APR-2021, the patient experienced lethargic type stuff, felt like had a flu bug/flu-eye type stuff, out of control spasms and they were clenching the jaw to shut and arching back and making not able to move arms and legs when they calm down, vision issues, balance issues, and muscle aches. On 13-APR-2021, the patient experienced funny taste in mouth, and temperature change/temperature the next day after vaccination. Laboratory data included: Body temperature temperature change. On OCT-2021, the patient experienced eye rolled back in head and was not there. On 2022, the patient experienced communication very hard now a days, and don not have energy anymore anyway. Laboratory data included: Diagnostic ultrasound not reported. On an unspecified date, the patient experienced can not work, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from out of control spasms and they were clenching the jaw to shut and arching back and making not able to move arms and legs when they calm down, balance issues, communication very hard now a days, and laryngeal spasms, and the outcome of funny taste in mouth, lethargic type stuff, felt like had a flu bug/flu-eye type stuff, vision issues, muscle aches, could not type anymore and brain does not function in numbers any more, eye rolled back in head and was not there, don not have energy anymore anyway, tired, can not work and temperature change/temperature the next day after vaccination was not reported. This report was non-serious. This case, involving the same patient is linked to 20221248752.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Eye movement disorder, Fatigue, Feeling abnormal, Feeling of body temperature change, Impaired work ability
Clinical narrative: CAN NOT WORK; TIRED; DON NOT HAVE ENERGY ANYMORE ANYWAY; COMMUNICATION VERY HARD NOW A DAYS; EYE ROLLED BACK IN HEAD AND WAS NOT THERE; FUNNY TASTE IN MOUTH; TEMPERATURE CHANGE/TEMPERATURE THE NEXT DAY AFTER VACCINATION; LETHARGIC TYPE STUFF; FELT LIKE HAD A FLU BUG/FLU-EYE TYPE STUFF; OUT OF CONTROL SPASMS AND THEY WERE CLENCHING THE JAW TO SHUT AND ARCHING BACK AND MAKING NOT ABLE TO MOVE ARMS AND LEGS WHEN THEY CALM DOWN; VISION ISSUES; BALANCE ISSUES; MUSCLE ACHES; COULD NOT TYPE ANYMORE AND BRAIN DOES NOT FUNCTION IN NUMBERS ANY MORE; LARYNGEAL SPASMS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergic reactions to anything. The patient had no previous issues that would contribute. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old. No concomitant medications were reported. On 2021, the patient experienced could not type anymore and brain does not function in numbers any more, and laryngeal spasms. Laboratory data included: MRI not reported. On APR-2021, the patient experienced lethargic type stuff, felt like had a flu bug/flu-eye type stuff, out of control spasms and they were clenching the jaw to shut and arching back and making not able to move arms and legs when they calm down, vision issues, balance issues, and muscle aches. On 13-APR-2021, the patient experienced funny taste in mouth, and temperature change/temperature the next day after vaccination. Laboratory data included: Body temperature temperature change. On OCT-2021, the patient experienced eye rolled back in head and was not there. On 2022, the patient experienced communication very hard now a days, and don not have energy anymore anyway. Laboratory data included: Diagnostic ultrasound not reported. On an unspecified date, the patient experienced can not work, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from out of control spasms and they were clenching the jaw to shut and arching back and making not able to move arms and legs when they calm down, balance issues, communication very hard now a days, and laryngeal spasms, and the outcome of funny taste in mouth, lethargic type stuff, felt like had a flu bug/flu-eye type stuff, vision issues, muscle aches, could not type anymore and brain does not function in numbers any more, eye rolled back in head and was not there, don not have energy anymore anyway, tired, can not work and temperature change/temperature the next day after vaccination was not reported. This report was non-serious. This case, involving the same patient is linked to 20221248752.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Laryngospasm, Lethargy, Magnetic resonance imaging, Muscle spasms
Clinical narrative: CAN NOT WORK; TIRED; DON NOT HAVE ENERGY ANYMORE ANYWAY; COMMUNICATION VERY HARD NOW A DAYS; EYE ROLLED BACK IN HEAD AND WAS NOT THERE; FUNNY TASTE IN MOUTH; TEMPERATURE CHANGE/TEMPERATURE THE NEXT DAY AFTER VACCINATION; LETHARGIC TYPE STUFF; FELT LIKE HAD A FLU BUG/FLU-EYE TYPE STUFF; OUT OF CONTROL SPASMS AND THEY WERE CLENCHING THE JAW TO SHUT AND ARCHING BACK AND MAKING NOT ABLE TO MOVE ARMS AND LEGS WHEN THEY CALM DOWN; VISION ISSUES; BALANCE ISSUES; MUSCLE ACHES; COULD NOT TYPE ANYMORE AND BRAIN DOES NOT FUNCTION IN NUMBERS ANY MORE; LARYNGEAL SPASMS; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no allergic reactions to anything. The patient had no previous issues that would contribute. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 12-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 62 years old. No concomitant medications were reported. On 2021, the patient experienced could not type anymore and brain does not function in numbers any more, and laryngeal spasms. Laboratory data included: MRI not reported. On APR-2021, the patient experienced lethargic type stuff, felt like had a flu bug/flu-eye type stuff, out of control spasms and they were clenching the jaw to shut and arching back and making not able to move arms and legs when they calm down, vision issues, balance issues, and muscle aches. On 13-APR-2021, the patient experienced funny taste in mouth, and temperature change/temperature the next day after vaccination. Laboratory data included: Body temperature temperature change. On OCT-2021, the patient experienced eye rolled back in head and was not there. On 2022, the patient experienced communication very hard now a days, and don not have energy anymore anyway. Laboratory data included: Diagnostic ultrasound not reported. On an unspecified date, the patient experienced can not work, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from out of control spasms and they were clenching the jaw to shut and arching back and making not able to move arms and legs when they calm down, balance issues, communication very hard now a days, and laryngeal spasms, and the outcome of funny taste in mouth, lethargic type stuff, felt like had a flu bug/flu-eye type stuff, vision issues, muscle aches, could not type anymore and brain does not function in numbers any more, eye rolled back in head and was not there, don not have energy anymore anyway, tired, can not work and temperature change/temperature the next day after vaccination was not reported. This report was non-serious. This case, involving the same patient is linked to 20221248752.