chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 47 year old was administrated Infanrix.; meant to receive Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 47-year-old male patient who received DTPa (Infanrix) (batch number 49tm3, expiry date 28th May 2022) for prophylaxis.  Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.  On 12th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 12th August 2021, unknown after receiving Infanrix and Infanrix 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 was meant to receive a dose of Boostrix but inadvertently administrated with Infanrix, which led to wrong vaccine administered and inappropriate age at vaccine administration. No further events was reported The reporter consented to follow up. The HCP (Health care professional) agreed to be contacted for follow up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose administered 06/11/2021. Second dose not yet given.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received in 11th June 2021).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported 2nd dose of Engerix-B greater than one month and 2nd dose not yet given till the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 46.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Twinrix in Nov 2020, the second dose was given in June 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 46-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in November 2020, batch number 75C72, expiry date 13th June 2022).   In June 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In June 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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: A Pharmacist reported that a male adult patient received the 2nd dose of Twinrix later than recommended schedule which led to lengthening of vaccination schedule and had not received the 3rd dose yet till the time of reporting. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Palpitations, Pyrexia, Rash erythematous
Clinical narrative: Fever 100 degrees Fahrenheit; Heart palpitations; Given subcutaneously / incorrectly administered/ incorrectly administered SQ (subcutaneously) instead of IM (intramuscularly); Reaction / Very large / Red rash on arm/ red rash 5 inches in diameter; This case was reported by a consumer via call center representative and described the occurrence of red rash in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis.   On 24th August 2021, the patient received the 1st dose of Shingrix (subcutaneous) .5 ml. In August 2021, less than a week after receiving Shingrix, the patient experienced red rash. On 24th August 2021, the patient experienced fever, palpitation and intramuscular formulation administered by other route. The patient was treated with doxycycline. On an unknown date, the outcome of the red rash and palpitation were not recovered/not resolved and the outcome of the fever and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the red rash, fever and palpitation to be related to Shingrix.  Additional details were reported as follows: The patient self-reported this case. The patient received Shingrix and after the dose she had heart palpitations, fever 100 degrees Fahrenheit, and a red rash 5 inches in diameter on the underside of the arm that she received the vaccine.  She still had a very large rash underneath her arm, not at the injection site. She was incorrectly administered subcutaneously (SQ) instead of intramuscularly (IM), which led to intramuscular formulation administered by other route.  The reporter indicated that her doctor had prescribed doxycycline for the rash and she took some doxycycline last night (26th August 2021) but had not taken any yet today (on the day of reporting). She indicated that she was still having palpitations. (She said she was planning on donating blood but would not be able to donate blood now due to the adverse event).
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: patient was administered Kinrix twice; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 5-year-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (1st dose received on 28th December 2020, at the age of 4 year old).   On 16th August 2021, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 16th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. The action taken with Kinrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the extra dose 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 details were provided as follows: The registered nurse reported that, the patient was administered Kinrix twice, additional dose received on 16th August 2021, which led to extra dose administered. The registered nurse mentioned patient did not had any other vaccines for the Dtap and or IPV just Kinrix. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Woke-up with a rash; This case was reported by a consumer via call center representative and described the occurrence of rash in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (several previous cases of shingles prior to 14th April 2021).   On 14th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 27th August 2021, 135 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient reported that, she received her first Shingrix vaccine in the left arm.  The patient woke-up with a rash on her right ear lobe and believed it was shingles.  The patient reported that, she had several previous cases of shingles prior to 14th April 2021 and was pretty sure this rash is leading to another case of shingles.  The reporter referred to health care professional. The patient was scheduled to receive her second Shingrix vaccine on the day of reporting.. The reporter did not consent to follow-up. The reporter did not gave permission to contact health care professional.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: wrong vaccine given; child (4 years old) received a  Boostrix dose; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 4-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 575HC, expiry date 28th February 2023) for prophylaxis.   On 27th August 2021, the patient received Boostrix (intramuscular). On 27th August 2021, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The health care professional reported that, the 4 years old patient received a Boostrix dose instead of an Infanrix dose in the right thigh, which led to wrong vaccine administered and inappropriate age at vaccine administration.  The reporter transferred to medical informer for further assistance. The reporter consented to follow up. The reporter gave permission to contact from GlaxoSmithKline. The case had been link with US2021156430, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021156430:same reporter
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Only the adjuvant was given; Only the adjuvant was given; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate dose of vaccine administered in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 7C4B3, expiry date 14th November 2022) for prophylaxis.   On 20th August 2021, the patient received Shingrix. On 20th August 2021, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The reporter stated that, the patient received only the adjuvant portion of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was linked with cases US2021182201, US2021182199, reported by same reporter for differnt patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021182199:Same reporter US-GLAXOSMITHKLINE-US2021182201:Same reporter
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 16Jul2021 and second dose 26Aug2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number KF4T7, expiry date 14th November 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 26th August 2021, the patient received the 2nd dose of Shingrix. On 26th August 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, 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 details were provided as follows: The pharmacist reported that, the patient received 2nd dose of Shingrix, late than the recommended time interval, which led to shortening of vaccination schedule. The pharmacist stated patient was not immunocompromised. Both doses were administered at the same facility.  The pharmacist provided lot number of GL79C for first dose but did not have expiration date. The reporter consented to follow up.
Age: 0.92
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: given to patient under 4 years old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-month-old female 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 27th August 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 27th August 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 nurse reported that, the patient was inadvertently administered a dose of Kinrix under 4 years, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult female patient who received Herpes zoster(Shingrix for prophylaxis.   Previously administered products included Shingrix (1st dose received on September 2020, 0.5ml, intramuscular route in an unknown arm).   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 preovided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter declined to provide demographic information or provide any other information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives for 7 months; This case was reported by a consumer via call center representative and described the occurrence of hives in a adult female patient who received Herpes zoster (Shingrix) (batch number ZM3D2, expiry date 3rd April 2022) for prophylaxis.   On 7th May 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In May 2020, 2 days after receiving Shingrix, the patient experienced hives. On an unknown date, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. This case was reported by the patient herself The patient had received Shingrix and 2 days later had hives, the hives lasted for 7 months then resolved (hives, resolved). The reporter initially provided some demographic information, then asked for it all to be deleted and would ask her pharmacy to file an adverse event report. The reporter did not consent to follow-up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2021, the patient received the 1st dose of Shingrix. On 30th August 2021, 32 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that, the patient who had received the first dose of Shingrix , started experiencing shingles on 30th August 2021.  The reporter consented to follow up.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered Menveo with sterile water; administered Menveo with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA581A, expiry date 31st August 2022) for prophylaxis.   On 31st August 2021, the patient received Menveo. On 31st August 2021, unknown after receiving Menveo, 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 was a Medical assistant. The patient was administered Menveo with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 9.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: administered Havrix that was activated the night before; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 9-year-old female patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2021 09:30, the patient received Havrix. On 31st August 2021, the patient started Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, 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 details were provided are as follows: Health care professional reported that the patient was inadvertently administered Havrix in left arm, which was activated (needle attached) the night before at 04:20 pm on 30th August 2021, which led to incorrect storage of drug. The reporter consented to follow-up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: noticed that the injection site is red like a light sunburn; noticed that the injection site kind of itches; noticed a lump at the injection site; her left arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (noticed a lump at the injection site), MYALGIA (her left arm hurt), VACCINATION SITE ERYTHEMA (noticed that the injection site is red like a light sunburn) and VACCINATION SITE PRURITUS (noticed that the injection site kind of itches) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Pulmonary fibrosis in 2010.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYALGIA (her left arm hurt). On 17-Aug-2021, the patient experienced VACCINATION SITE MASS (noticed a lump at the injection site). On 18-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (noticed that the injection site is red like a light sunburn) and VACCINATION SITE PRURITUS (noticed that the injection site kind of itches). At the time of the report, VACCINATION SITE MASS (noticed a lump at the injection site) had not resolved and MYALGIA (her left arm hurt), VACCINATION SITE ERYTHEMA (noticed that the injection site is red like a light sunburn) and VACCINATION SITE PRURITUS (noticed that the injection site kind of itches) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.  The reporter states that the patient took the booster dose as the patient is immunocompromised due to pulmonary fibrosis from chemotherapy in 2010.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Myalgia, Pyrexia
Clinical narrative: Feverish; ache all over; had my Third Booster Mederna shot; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Feverish), MYALGIA (ache all over) and EXTRA DOSE ADMINISTERED (had my Third Booster Mederna shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Feverish), MYALGIA (ache all over) and EXTRA DOSE ADMINISTERED (had my Third Booster Mederna shot). At the time of the report, PYREXIA (Feverish) and MYALGIA (ache all over) outcome was unknown and EXTRA DOSE ADMINISTERED (had my Third Booster Mederna shot) had resolved.            Concomitant medications were not reported. Treatment medications were not reported. Patient had Third Booster Moderna shot yesterday.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea
Clinical narrative: feel somewhat dizzy; slight chest cramp; slightly short of breathe; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel somewhat dizzy), CHEST PAIN (slight chest cramp) and DYSPNOEA (slightly short of breathe) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DIZZINESS (feel somewhat dizzy), CHEST PAIN (slight chest cramp) and DYSPNOEA (slightly short of breathe). At the time of the report, DIZZINESS (feel somewhat dizzy), CHEST PAIN (slight chest cramp) and DYSPNOEA (slightly short of breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.  The patient had first vaccine Friday. On Thursday, The patient felt somewhat dizzy, slight chest cramp and slightly short of breathe.   Reporter did not allow further contact
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Palpitations, Product dose omission issue
Clinical narrative: More than 36 days after the first dose without receiving the second dose.; high blood pressure,(blood pressure)  like 170; I am still having palpitations a little bit sometimes; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (high blood pressure,(blood pressure)  like 170), PALPITATIONS (I am still having palpitations a little bit sometimes) and PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included Supraventricular tachycardia (she was diagnosed by 5 years before), Palpitations and Blood pressure high.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, the patient experienced BLOOD PRESSURE INCREASED (high blood pressure,(blood pressure)  like 170) and PALPITATIONS (I am still having palpitations a little bit sometimes). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.). At the time of the report, BLOOD PRESSURE INCREASED (high blood pressure,(blood pressure)  like 170) outcome was unknown, PALPITATIONS (I am still having palpitations a little bit sometimes) had not resolved and PRODUCT DOSE OMISSION ISSUE (More than 36 days after the first dose without receiving the second dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Blood pressure measurement: 170 (High) Reported as blood pressure really high, like 170.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reported as patient takes medicines for her stomach, but stated that that doesn't cause palpitations. And also wanted to know if she can get Pfizer as the second dose. No medication treatment was taken.   Reporter did not allow further contact
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Dyspnoea, Hospice care, Pleural effusion, Pneumonia
Clinical narrative: pneumonia; couldn't catch her breath; She had fluid around her lungs; passed away; healthcare facility; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away), PNEUMONIA (pneumonia), DYSPNOEA (couldn't catch her breath) and PLEURAL EFFUSION (She had fluid around her lungs) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jul-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (couldn't catch her breath) (seriousness criterion hospitalization). On 27-Jul-2021, the patient experienced healthcare facility (healthcare facility). On an unknown date, the patient experienced PLEURAL EFFUSION (She had fluid around her lungs) (seriousness criterion medically significant). On 29-Jul-2021, PNEUMONIA (pneumonia), DYSPNOEA (couldn't catch her breath), PLEURAL EFFUSION (She had fluid around her lungs) and healthcare facility (healthcare facility) outcome was unknown. The patient died on 29-Jul-2021. The reported cause of death was Pneumonia, couldn't catch her breath, she had fluid around her lungs, she was on the floor and healthcare facility. It is unknown if an autopsy was performed.            Concomitant products were not provided. Treatment medication were not reported. The patient had pneumonia and couldn't catch her breath. She was on the floor, and then the emergency took her to the hospital on 25 Jul 2021. She had fluid around her lungs. The following day on 27 Jul 2021, the patient was sent to healthcare facility and then she died early morning on 29 Jul 2021.  Company comment: This is a case of death in a 82-year-old female patient who died 7 days after receiving first dose of vaccine. The patient experienced pneumonia, pleural effusion and dyspnoea due to which she was hospitalized but discharged to healthcare facility two days later where she passed away. Very limited information has been provided at this time. Further information will be requested.; Sender's Comments: This is a case of death in a 82-year-old female patient who died 7 days after receiving first dose of vaccine. The patient experienced pneumonia, pleural effusion and dyspnoea due to which she was hospitalized but discharged to healthcare facility two days later where she passed away. Very limited information has been provided at this time. Further information will be requested.; Reported Cause(s) of Death: pneumonia; couldn't catch her breath; She had fluid around her lungs; She was on the floor; healthcare facility
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SICK WITH COVID/ SUSPECTED COVID 19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a 91 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date in AUG-2021, the patient experienced suspected clinical vaccination failure. The patient was sick with suspected covid-19 infection.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sick with covid/ suspected covid 19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint. This case, from the same reporter is linked to 20210854979 and 20210855235.; Sender's Comments: V0: 20210855254-covid-19 vaccine ad26.cov2.s -Suspected 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
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; COVID-19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported; batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total, administered 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 covid-19 infection, and suspected clinical vaccination failure. On an unknown date, 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 the covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191088.; Sender's Comments: V0:  20210855314-Covid-19 vaccine ad26.cov2.s-Suspected 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
Sex: M
Vaccine: COVID19
Symptoms: Death, Seizure
Clinical narrative: DEATH; SEIZURES; This spontaneous report received from a consumer via a company representative via social media (twitter) concerned a male of an 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, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient developed seizure and then died. As per the reporter, "I know an hour after taking the vaccine this 100 percent healthy kid had seizures. Next thing the patient was dead." It was unknown if an autopsy was performed or not. The cause of death was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of seizures was not reported. This report was serious (Death).; Sender's Comments: V0: 20210855833-covid-19 vaccine ad26.cov2.s -Death, Seizures. 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
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling of body temperature change, Hyperhidrosis, Nausea, Pyrexia
Clinical narrative: SWEATS; HOT/COLD; SHIVERING; FEVER LIKE SYMPTOMS; NAUSEA; This spontaneous report received from a patient via a company representative 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: Unk) dose, start therapy date were not reported for prophylactic vaccination.  The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. No concomitant medications were reported. On an unspecified date, the patient experienced sweats, hot/cold, shivering, fever like symptoms, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sweats, hot/cold, shivering, fever like symptoms, and nausea. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Burning sensation, Impaired work ability, Influenza
Clinical narrative: FLU SYMPTOMS (6 HOURS AFTER VACCINATION); LEFT SHOULDER HURT ACUTELY/ SEVER PAIN IN HER SHOULDER; TINGLING WHICH CONTINUED FOR HOURS STARTED ON THE LEFT THEN MOVED TO THE RIGHT; RADIATION WHICH CONTINUED FOR HOURS STARTED ON THE LEFT THEN MOVED TO THE RIGHT; COULD NOT LEFT ARM MORE THAN 45 DEGREES; COULD NOT WORK OUT; BURNING SENSATION WHICH CONTINUED FOR HOURS STARTED ON THE LEFT THEN MOVED TO THE RIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk and expiry: unknown) dose was not reported, administered on 24-AUG-2021 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 AUG-2021, the patient experienced could not left arm more than 45 degrees. On AUG-2021, the patient experienced could not work out. On AUG-2021, the patient experienced burning sensation which continued for hours started on the left then moved to the right. On AUG-2021, the patient experienced tingling which continued for hours started on the left then moved to the right. On AUG-2021, the patient experienced radiation which continued for hours started on the left then moved to the right.  On 24-AUG-2021, the patient experienced flu symptoms (6 hours after vaccination). On 24-AUG-2021, the patient experienced left shoulder hurt acutely/ sever pain in her shoulder.  Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms (6 hours after vaccination), and shaking on 26-AUG-2021, had not recovered from left shoulder hurt acutely/ sever pain in her shoulder, and the outcome of could not left arm more than 45 degrees, could not work out, tingling which continued for hours started on the left then moved to the right, burning sensation which continued for hours started on the left then moved to the right and radiation which continued for hours started on the left then moved to the right was not reported. This report was non-serious.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: FLU SYMPTOMS (6 HOURS AFTER VACCINATION); LEFT SHOULDER HURT ACUTELY/ SEVER PAIN IN HER SHOULDER; TINGLING WHICH CONTINUED FOR HOURS STARTED ON THE LEFT THEN MOVED TO THE RIGHT; RADIATION WHICH CONTINUED FOR HOURS STARTED ON THE LEFT THEN MOVED TO THE RIGHT; COULD NOT LEFT ARM MORE THAN 45 DEGREES; COULD NOT WORK OUT; BURNING SENSATION WHICH CONTINUED FOR HOURS STARTED ON THE LEFT THEN MOVED TO THE RIGHT; This spontaneous report received from a patient concerned a 63 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Healthy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk and expiry: unknown) dose was not reported, administered on 24-AUG-2021 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 AUG-2021, the patient experienced could not left arm more than 45 degrees. On AUG-2021, the patient experienced could not work out. On AUG-2021, the patient experienced burning sensation which continued for hours started on the left then moved to the right. On AUG-2021, the patient experienced tingling which continued for hours started on the left then moved to the right. On AUG-2021, the patient experienced radiation which continued for hours started on the left then moved to the right.  On 24-AUG-2021, the patient experienced flu symptoms (6 hours after vaccination). On 24-AUG-2021, the patient experienced left shoulder hurt acutely/ sever pain in her shoulder.  Laboratory data included: Body temperature (NR: not provided) 101.2 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flu symptoms (6 hours after vaccination), and shaking on 26-AUG-2021, had not recovered from left shoulder hurt acutely/ sever pain in her shoulder, and the outcome of could not left arm more than 45 degrees, could not work out, tingling which continued for hours started on the left then moved to the right, burning sensation which continued for hours started on the left then moved to the right and radiation which continued for hours started on the left then moved to the right was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: FEELING WEAK; This spontaneous report received from a consumer concerned a male 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 26-AUG-2021 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 26-AUG-2021, the patient experienced feeling weak. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling weak was not reported. This report was non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vertigo
Clinical narrative: DIZZINESS/DIZZINESS WHILE MOVING HEAD OR BODY; VERTIGO; FEELING RUN DOWN/GAS ME OUT OR MAKE ME FEEL FAINT; This spontaneous report received from a patient concerned a 54 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: possible penicillin allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient reported little to no reaction right after vaccine administration. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: 23-AUG-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. Concomitant medications included paracetamol. On APR-2021, the patient experienced feeling run down/gas me out or make me feel faint. On 10-APR-2021, the patient experienced dizziness/dizziness while moving head or body. On 10-APR-2021, the patient experienced vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dizziness/dizziness while moving head or body, and the outcome of feeling run down/gas me out or make me feel faint and vertigo was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SMALL NUMBER OF PEOPLE IT AFFECTED; 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced "small number of people it affected". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of small number of people it affected was not reported. This report was non-serious. This case, from the same reporter is linked to 20210857017.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: FEELING DIZZY; WEAKNESS; This spontaneous report received from a consumer concerned a male 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: Unk) dose was not reported, administered on 26-AUG-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On 27-AUG-2021, the patient experienced feeling dizzy. On 27-AUG-2021, the patient experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from weakness, and feeling dizzy. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Headache, Pyrexia
Clinical narrative: FEELING CLAMMY; HEADACHE AT NIGHT; FEVER; This spontaneous report received from a patient concerned a 41 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, administered on 18-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On AUG-2021, the patient experienced feeling clammy. On AUG-2021, the patient experienced headache at night. On AUG-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on AUG-2021, and the outcome of feeling clammy and headache at night was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: DOSE WAS ADMINISTERED AFTER BEING EXPIRED FOR AT LEAST 14 HOURS IN FRIDGE; VACCINE PLACED IN WRONG SHELF IN FRIDGE; This spontaneous report received from a pharmacist concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: 02-OCT-2021) dose was not reported, administered on 27-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-AUG-2021, the patient experienced dose was administered after being expired for at least 14 hours in fridge. On 27-AUG-2021, the patient experienced vaccine placed in wrong shelf in fridge. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose was administered after being expired for at least 14 hours in fridge and vaccine placed in wrong shelf in fridge was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer (patient's daughter) concerned a male 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 and expiry were unknown) dose was not reported, 1 total, therapy start date was not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient's s kidney transplant team recommended getting another shot of the Janssen covid-19 vaccine because the result of his antibody test was negative (suspected immunological vaccine failure).The reporter also wanted to know where to get the Janssen covid-19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000191377.; Sender's Comments: V0 20210858460-covid-19 vaccine ad26.cov2.s-Suspected Immunological Vaccine Failure. This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS