chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Product preparation issue, Rash papular
Clinical narrative: arm is sore at the injection site; Raised rash, below the injection site; red, below the injection site; had to use 3 vials of Shingrix to mix the dose; had to use 3 vials of Shingrix to mix the dose; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd November 2021, the patient received the 1st dose of Shingrix (intramuscular). On 3rd November 2021, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate dose of vaccine administered. On 5th November 2021, the patient experienced injection site pain, rash and erythema. On an unknown date, the outcome of the injection site pain, rash and erythema were not recovered/not resolved and the outcome of the inappropriate reconstitution technique and inappropriate dose of vaccine administered were unknown.   The reporter considered the injection site pain to be related to Shingrix. It was unknown if the reporter considered the rash and erythema to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received 1st dose of Shingrix in right arm.  2 days after receiving Shingrix, the patient experienced a rash that was raised and red about 1 inch below the injection site. Her arm was sore at the injection site.  The patient wanted to also report that, she was not comfortable with the immunizer at her pharmacy as he looked confused when mixing the Shingrix vaccine.  The immunizer told the patient that, he had to use 3 vials of Shingrix to mix the dose which led to inappropriate reconstitution technique and it made her felt like she did not get the correct vaccine which led to inappropriate dose of vaccine administered. The patient did not give permission to contact healthcare professional. The reporter did not consent to follow-up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: two doses of Shingrix on the same day; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number 57LJ9, expiry date 14th April 2023) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 5th November 2021, the patient received the 2nd dose of Shingrix. On 5th November 2021, unknown after receiving Shingrix and Shingrix, the patient experienced overdose. On an unknown date, the outcome of the overdose was recovered/resolved.  Additional details were reported as follows; The health care professional called to request information on how to proceed after the patient had been given two doses of the Shingrix vaccine on the same day, which led to overdose. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Gait inability, Mobility decreased, Myalgia
Clinical narrative: weakness was so severe; could not get out of bed and could not walk; Polymyalgia Rheumatica; muscle pain in her arms and biceps; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 cases of shingles in her life).   On 16th August 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. In August 2021, less than a week after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant) and muscle pain. On an unknown date, the patient experienced weakness and mobility decreased. On an unknown date, the outcome of the polymyalgia rheumatica, muscle pain, weakness and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the polymyalgia rheumatica, muscle pain, weakness and mobility decreased to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient received Shingrix vaccine into her left deltoid at her physician's office. Four to 5 days later, she reported muscle pain in her arms and biceps. The patient also mentioned in the first 4 weeks after the vaccine, she also reported that she had 2 separate episodes in which her weakness was so severe that she could not get out of bed and could not walk. The patient had never reported these symptoms prior to getting the Shingrix vaccine. The patient had blood tests done, which came back normal, but she was diagnosed with polymyalgia rheumatica.  The patient reported symptoms was currently unresolved. The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Polymyalgia rheumatica
Clinical narrative: weakness was so severe; could not get out of bed and could not walk; Polymyalgia Rheumatica; muscle pain in her arms and biceps; This case was reported by a consumer via call center representative and described the occurrence of polymyalgia rheumatica in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (2 cases of shingles in her life).   On 16th August 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 ug. In August 2021, less than a week after receiving Shingrix, the patient experienced polymyalgia rheumatica (serious criteria GSK medically significant) and muscle pain. On an unknown date, the patient experienced weakness and mobility decreased. On an unknown date, the outcome of the polymyalgia rheumatica, muscle pain, weakness and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the polymyalgia rheumatica, muscle pain, weakness and mobility decreased to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for herself. The patient received Shingrix vaccine into her left deltoid at her physician's office. Four to 5 days later, she reported muscle pain in her arms and biceps. The patient also mentioned in the first 4 weeks after the vaccine, she also reported that she had 2 separate episodes in which her weakness was so severe that she could not get out of bed and could not walk. The patient had never reported these symptoms prior to getting the Shingrix vaccine. The patient had blood tests done, which came back normal, but she was diagnosed with polymyalgia rheumatica.  The patient reported symptoms was currently unresolved. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: has recalled vaccines, can "continue" using the vaccines?; has recalled vaccines, can "continue" using the vaccines?; This case was reported by a other health professional via call center representative and described the occurrence of recalled product administered in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced recalled product administered and drug dispensing error. On an unknown date, the outcome of the recalled product administered and drug dispensing error 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 details were reported as follows: Age at administration was not reported. Practice Manager stated that she had some of the recalled vaccines and that they were accurately labeled asked could they continue to use them.  The decision to file an adverse event was made after disconnected the call and therefore there was no additional information and permission for follow up was not obtained.
Age: 0.58
Sex: F
Vaccine: RV1
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: received an expired dose of Rotarix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 7-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L5G93, expiry date 27th August 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 29th October 2021, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 29th October 2021, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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 details were reported as follows: The reporter was medical assistant. The patient received an expired dose of Rotarix that expired on 27th August 2021, which led to expired vaccine used. The patient had not developed any symptoms. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: Adult patient was administered a pediatric dose; Adult patient was administered a pediatric dose; This case was reported by a consumer via call center representative and described the occurrence of underdose in a patient who received HBV (Engerix B 10 mcg) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B 10 mcg. On an unknown date, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report.. The consumer reported that  patient was administered a pediatric dose of Engerix-B which led to adult use of a child product and under dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error, Product preparation issue
Clinical narrative: reconstituted with other diluent (MMR) and injected; reconstituted with other diluent (MMR) and injected; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a patient who received Herpes zoster (Shingrix) (batch number A4354, expiry date 30th March 2023) for prophylaxis.   On 8th November 2021, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate reconstitution technique and inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique and inappropriate reconstitution technique were unknown.  Additional details were reported as follows: The age at vaccination was not reported The patient received a dose of Shingrix which constituted other diluent (one with MMR), which led to inappropriate reconstitution technique and inappropriate reconstitution technique.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with sterile water and administered; Reconstituted with sterile water and administered; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 99E53, expiry date 9th April 2023) for prophylaxis.   On 9th November 2021, the patient received Shingrix. On 9th November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that, Shingrix was reconstituted with sterile water and administered to the patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Disability, Incomplete course of vaccination
Clinical narrative: Received one dose of Shingrix, have disabilities; one dose in 2019, never received second dose; This case was reported by a nurse via call center representative and described the occurrence of disability in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced disability (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the disability and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the disability to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient had received 1st dose of Shingrix vaccine back in 2019 and till the time of reporting, the patient did not receive the second dose, which led to incomplete course of vaccination and the patient had disabilities. The nurse stated that most of their patients were disabled and lives in residential houses. They live in group home settings and they all had disabilities. No information was available for lot number and expiration date at the moment of the call. The reporter consented to follow up by fax.
Age: 8.0
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received Boostrix, DOB: 04-JUL-2013; received Boostrix instead of Flu vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included COVID-19 VACCINE (COVID-19 VACCINE UNKNOWN).   On 9th November 2021, the patient received Boostrix .5 ml and Boostrix Pre-Filled Syringe Device. On 9th November 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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 details were reported as follows: The reporter stated that, the patient received Boostrix vaccine instead of Flu vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administration. The reporter consented to follow up. This is one of four cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021231230:SAME REPORTER US-GLAXOSMITHKLINE-US2021231231:SAME REPORTER US-GLAXOSMITHKLINE-US2021231229:SAME REPORTER
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: have received an expired dose of Flulaval QIV; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number DJ247, expiry date 30th June 2021) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th November 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On 5th November 2021, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra 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 details were provided as follows: The patient had received an expired dose of Flulaval quadrivalent vaccine on 5th November 2021 and the expiry date was on 30th June 2021 which led to expired vaccine used.  The consent to follow up granted and follow up was given on email. The reporter informed that there were 2 patients reported: 1 female patient that was reported on adverse event 71255 and other patient with no details available that was reported on this case adverse event 71258. The case was linked with US2021232167, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021232167:same reporter
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 2nd dose of Shingrix. In November 2021, less than 2 weeks after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's brother. The reporter stated that, his sister received 2nd dose of Shingrix and experienced 3 days of flu like symptoms. The reporter called to inquire on strategies for mitigating possible side effects for the second dose of Shingrix. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Pt got only adjuvant portion; Pt got only adjuvant portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number ce45h, expiry date 1st October 2022) for prophylaxis.   On 11th November 2021, the patient received Shingrix. On 11th November 2021, 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 details were provided as follows: The age at vaccination was not reported. The patient received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not mention if it was regarding 1st or 2nd dose of Shingrix. The reporter consented to follow up.
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix was administered to a 4 month old; Pt was supposed to get the polio vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) (batch number 237C4, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th November 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 10th November 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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 details were provided as follows: The patient received Kinrix at the age of 4 months old instead of Polio vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with sterile water; reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 67-year-old male patient who received Herpes zoster (Shingrix) (batch number 3BD9E, expiry date 6th April 2023) for prophylaxis.   On 11th November 2021, the patient received Shingrix. On 11th November 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Shingrix was reconstituted with sterile water prior to administration to patient, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: past due for dose two, dose one in 2019; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2019).   On an unknown date, the patient received 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 details were provided as fllows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: might have received only adjuvant portion; might have received only adjuvant portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 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 details were provided as follows: The age at vaccination was not reported. The patient received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. when the reporter was checking the box containing Shingrix noticed there were 1 powder vial missing so she assumed a patient only received adjuvant vial and no entire dose of Shingrix. The reporter was not sure if there was a patient actually vaccinated with only the adjuvant vial of Shingrix instead of the full dose of Shingrix. The reporter did not consent to follow up.
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death, Dyspepsia, Electrocardiogram, Inappropriate schedule of product administration, Off label use
Clinical narrative: DEATH; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; HEARTBURN; This spontaneous report received from a consumer concerned a 54-year-old white and non-Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included, non-alcoholic, and non-smoker. The patient had no known drug or non-drug allergies. The patient had a physical examination performed (in AUG-2021) a week or two before he received the Janssen Covid-19 vaccine and results were clear. He was pretty healthy, he rode his bike, and ate pretty well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, 01 total, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect vaccine included: Covid-19 vaccine (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had inappropriate schedule of vaccine administration (off label use). On 23-SEP-2021, the patient experienced chest pain/tightness. On 24-SEP-2021, he visited physician's office, the electrocardiogram (EKG) was performed and was diagnosed with heartburn. He did not feel comfortable with the diagnosis and booked another appointment for 25-SEP-2021. He did not make the appointment and on 25-SEP-2021, he died from unknown cause. He was not found for 2 days following his death. On an unspecified date, an autopsy was performed, one preliminary (unofficial) report with an undetermined cause of death from the funeral home was received and a more extensive autopsy was requested. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 25-SEP-2021, and the outcome of heartburn, off label use and inappropriate schedule of vaccine administration was not reported. This report was serious (Death).; Sender's Comments: V0: 20211103199-covid-19 vaccine ad26.cov2.s-Death. 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: UNKNOWN CAUSE OF DEATH
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Physical examination
Clinical narrative: DEATH; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; HEARTBURN; This spontaneous report received from a consumer concerned a 54-year-old white and non-Hispanic or Latino male. The patient's height, and weight were not reported. The patient's concurrent conditions included, non-alcoholic, and non-smoker. The patient had no known drug or non-drug allergies. The patient had a physical examination performed (in AUG-2021) a week or two before he received the Janssen Covid-19 vaccine and results were clear. He was pretty healthy, he rode his bike, and ate pretty well. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unkown) dose was not reported, 01 total, administered on 01-SEP-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Non-company suspect vaccine included: Covid-19 vaccine (form of admin, route of admin, and batch number were not reported), dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient had inappropriate schedule of vaccine administration (off label use). On 23-SEP-2021, the patient experienced chest pain/tightness. On 24-SEP-2021, he visited physician's office, the electrocardiogram (EKG) was performed and was diagnosed with heartburn. He did not feel comfortable with the diagnosis and booked another appointment for 25-SEP-2021. He did not make the appointment and on 25-SEP-2021, he died from unknown cause. He was not found for 2 days following his death. On an unspecified date, an autopsy was performed, one preliminary (unofficial) report with an undetermined cause of death from the funeral home was received and a more extensive autopsy was requested. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on 25-SEP-2021, and the outcome of heartburn, off label use and inappropriate schedule of vaccine administration was not reported. This report was serious (Death).; Sender's Comments: V0: 20211103199-covid-19 vaccine ad26.cov2.s-Death. 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: UNKNOWN CAUSE OF DEATH
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
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 64 year old male. Initial information was processed with the additional information received on 09-NOV-2021. The patient's weight was 180 pounds, and height was 72 inches. 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: 1805025, expiry: UNKNOWN) dose was not reported, 1 total, administered on 09-MAR-2021 in left arm for prophylactic vaccination. Non-company suspect vaccine included: BNT 162 (form of admin, route of admin, and batch number were not reported) dose was not reported, administered on OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. It was reported that, the patient received a booster shot of Pfizer vaccine 4 days prior to reporting. On 26-OCT-2021, the patient developed symptoms of covid-19 such as flu-like symptoms, loss of taste and smell (confirmed covid-19 infection and confirmed clinical vaccination failure). On 29-OCT-2021, he received positive results for SARS-CoV-2 RT-PCR test (NR: not provided). Also, the patient would be treated with regeneron antibodies.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with BNT 162 was not reported. 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: 90000200093. The suspected product quality complaint has been confirmed to be disposition: undetermined. 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 - 20211103909- covid-19 vaccine ad26.cov2.s -Confirmed clinical vaccination failure. This event(s) is considered not related. 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
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pain in extremity, Paraesthesia
Clinical narrative: FEELING GENERAL WEAKNESS; MASSIVE HEADACHE WHEN GOT UP AFTER LYING DOWN; SHARP PAIN ON THE LEFT ARM (ENTIRE ARM); TINGLING ON THE LEFT ARM (ENTIRE ARM); This spontaneous report received from a patient concerned a 23 year old male. The patient's weight was 224 pounds, and height was 68 inches. 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: Unk) dose was not reported, administered on 03-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-NOV-2021, the patient experienced sharp pain on the left arm (entire arm). On 03-NOV-2021, the patient experienced tingling on the left arm (entire arm). On 04-NOV-2021, the patient experienced feeling general weakness. On 04-NOV-2021, the patient experienced massive headache when got up after lying down. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sharp pain on the left arm (entire arm), and tingling on the left arm (entire arm) on 03-NOV-2021, and feeling general weakness, and massive headache when got up after lying down on 05-NOV-2021. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: OUTSIDE OF REFRIGERATED TEMPERATURE 6 HOURS; This spontaneous report received from a pharmacist concerned multiple patients. 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: 1855194, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced outside of refrigerated temperature 6 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of outside of refrigerated temperature 6 hours was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pulmonary thrombosis
Clinical narrative: A BLOOD CLOT IN HER LUNG; VERY ILL; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number and expiry: unknown) dose was not reported, 1 total, therapy start date was not reported administered 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 a blood clot in her lung and very ill. On an unspecified date, patient was hospitalized. Number of days hospitalized and discharge information was not reported. It was reported from the consumer that "A dear friend with a large business, felt pressure to get the vaccine after having Covid and the obvious antibodies. She chose the Johnson and Johnson vaccine and now in the hospital very ill with a blood clot in her lung. This is not okay, vax mandates are not okay". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very ill and a blood clot in her lung was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211115177-Covid-19 vaccine ad26.cov2.s- A blood clot in her lung. This event is considered unassessable. The event 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. 20211115177- Covid-19 vaccine ad26.cov2.s-Very ill. This event is labeled and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: SKIN HAD BEEN CRAZY SINCE TAKEN VACCINE; 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 not reported, batch number: Unknown) 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 skin had been crazy since taken vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of skin had been crazy since taken vaccine was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Respiratory disorder
Clinical narrative: RESPIRATORY PROBLEMS; FLU-LIKE SYMPTOMS; This spontaneous report received from a consumer concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: ex smoker, and massive heart attack (on life support for 10 days), and concurrent conditions included: baseline breathing problems (requiring 4L of oxygen 24/7). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, 1 total, 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 after receiving covid-19 vaccine ad26.cov2.s the patient experienced flu-like symptoms after getting the vaccine and eventually required a CPAP(Continuous positive airway pressure). The reporter stated that, the patient used to smoke and have a baseline breathing problems (coded as respiratory problems) requiring 4 L of oxygen 24/7 at the time of report. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the flu-like symptoms and respiratory problems was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20211115315, 20211115081 and 20211115414.; Sender's Comments: V0: 20211115400-covid-19 vaccine ad26.cov2.s- flu-like symptoms. 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). 20211115400-Covid-19 vaccine ad26.cov2.s- respiratory problems . This event(s) is considered not related. 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: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: BODY ACHES; FEVER; HEADACHE; 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 not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced body aches, fever, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, fever, and headache. This report was non-serious. This case, involving the same patient is linked to 20211128598.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID VIRUS; This spontaneous report received from a consumer concerned a female of unspecified age. 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: 1805022 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On 08-NOV-2021, the patient experienced tested positive for covid virus. Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid virus was not reported. This report was non-serious. This case was associated with product quality complaint number: 90000201302.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 28 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known allergies and no past medical history was provided. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211129928.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: FELT ACHY; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 06-MAR-2021 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 felt achy, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt achy, and headache. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Asthenia, Chills, Gait inability, Headache
Clinical narrative: REALLY BAD SIDE EFFECTS; UNCONTROLLABLE SHAKING/SHIVERING; ACHED ALL OVER; RIBS ACHE; COULDN'T WALK; CHILLS; HEADACHE; NO ENERGY/LACK OF ENERGY; FEVER; 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: Patient was not using any medication, patient was very healthy, patient was very sensitive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced really bad side effects. On 28-APR-2021, the patient experienced chills. On 28-APR-2021, the patient experienced uncontrollable shaking/shivering. On 28-APR-2021, the patient experienced headache. On 28-APR-2021, the patient experienced ached all over. On 28-APR-2021, the patient experienced no energy/lack of energy. On 28-APR-2021, the patient experienced ribs ache. On 28-APR-2021, the patient experienced couldn't walk. On 28-APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really bad side effects, chills, uncontrollable shaking/shivering, couldn't walk, and fever on 28-APR-2021, headache on 29-APR-2021, and ached all over, no energy/lack of energy, and ribs ache on 01-MAY-2021. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Pain, Pyrexia, Tremor
Clinical narrative: REALLY BAD SIDE EFFECTS; UNCONTROLLABLE SHAKING/SHIVERING; ACHED ALL OVER; RIBS ACHE; COULDN'T WALK; CHILLS; HEADACHE; NO ENERGY/LACK OF ENERGY; FEVER; 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: Patient was not using any medication, patient was very healthy, patient was very sensitive. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 206A21A expiry: UNKNOWN) dose was not reported, administered on 27-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced really bad side effects. On 28-APR-2021, the patient experienced chills. On 28-APR-2021, the patient experienced uncontrollable shaking/shivering. On 28-APR-2021, the patient experienced headache. On 28-APR-2021, the patient experienced ached all over. On 28-APR-2021, the patient experienced no energy/lack of energy. On 28-APR-2021, the patient experienced ribs ache. On 28-APR-2021, the patient experienced couldn't walk. On 28-APR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from really bad side effects, chills, uncontrollable shaking/shivering, couldn't walk, and fever on 28-APR-2021, headache on 29-APR-2021, and ached all over, no energy/lack of energy, and ribs ache on 01-MAY-2021. This report was non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 58 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known allergies at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A expiry: 21-SEP-2021) dose was not reported, administered on 12-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-NOV-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211129841.