chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Pain, Rash pruritic, Rash vesicular
Clinical narrative: malaise; tiredness; painful itchy circular blister like rash on her back at the base of her spine; painful itchy circular blister like rash on her back at the base of her spine; painful circular blister; This case was reported by a consumer via call center representative and described the occurrence of malaise in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th May 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced malaise, tiredness, itchy rash, blistery rash and pain. On an unknown date, the outcome of the malaise and tiredness were recovered/resolved and the outcome of the itchy rash, blistery rash and pain were not recovered/not resolved.   It was unknown if the reporter considered the malaise, tiredness, itchy rash, blistery rash and pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JUN-2022  Reporter's Comments: The patient had her a dose of Shingrix and experienced malaise, tiredness, and a painful itchy circular blister like rash on her back at the base of her spine.  The reporter was given medical disclaimer.  Referred to health care professional (HCP).  Spoke per package insert (PI) and content.  Offered after call survey. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received first dose in 2019, back to get 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received first dose of Shingrix on 16th October 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-June-2022 Reporter's Comments: Pharmacist stated that the patient was back to get the 2nd dose. Consented to follow up via postal Additional Supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: COVID-19, Dyspnoea, Gait disturbance, Guillain-Barre syndrome, Headache
Clinical narrative: Guillain-Barre Syndrome; had numbness in feet all the way up to knees; hard to walk; hard time breathing; COVID-19; headache for 5 days; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 58-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than 2 years after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), numbness in leg (serious criteria hospitalization), walking difficulty (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), covid-19 and headache. On an unknown date, the outcome of the guillain barre syndrome, numbness in leg, walking difficulty, difficulty breathing and covid-19 were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome, numbness in leg, walking difficulty, difficulty breathing, covid-19 and headache to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comment: The case was reported by the patient. The patient reported that, he received the flu shot in December 2020 or January 2021. He stated that, he had a headache for 5 days and did not thought anything of it.  He stated that, he also was diagnosed with Covid shortly thereafter.  He stated that, one morning after that, he had numbness in his feet all the way up to his knees.  It was getting hard to walk and harder to breathe.  He stated that, he was diagnosed with GBS (Guillain-barre syndrome) and was hospitalized for 5 days.  He did not remember which flu vaccine it was and did not remember any of the dates at this time.  The reporter did not consent to follow-up.
Age: 58.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia
Clinical narrative: Guillain-Barre Syndrome; had numbness in feet all the way up to knees; hard to walk; hard time breathing; COVID-19; headache for 5 days; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 58-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, less than 2 years after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), numbness in leg (serious criteria hospitalization), walking difficulty (serious criteria hospitalization), difficulty breathing (serious criteria hospitalization), covid-19 and headache. On an unknown date, the outcome of the guillain barre syndrome, numbness in leg, walking difficulty, difficulty breathing and covid-19 were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome, numbness in leg, walking difficulty, difficulty breathing, covid-19 and headache to be related to Flu vaccine.     Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comment: The case was reported by the patient. The patient reported that, he received the flu shot in December 2020 or January 2021. He stated that, he had a headache for 5 days and did not thought anything of it.  He stated that, he also was diagnosed with Covid shortly thereafter.  He stated that, one morning after that, he had numbness in his feet all the way up to his knees.  It was getting hard to walk and harder to breathe.  He stated that, he was diagnosed with GBS (Guillain-barre syndrome) and was hospitalized for 5 days.  He did not remember which flu vaccine it was and did not remember any of the dates at this time.  The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received shingrix 2 years ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient received 1st dose of Shingrix 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 10-JUN-2022 Reporter's Comment: The reporter would like to know if the patient had to restart the series or not. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 30.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received INFANRIX instead of BOOSTRIX; adult received dose of INFANRIX; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 30-year-old male patient who received DTPa (Infanrix) (batch number ak443, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd June 2022, the patient received Infanrix .5 ml and Infanrix Pre-Filled Syringe Device. On 3rd June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The health care professional reported that the patient received wrong vaccine. The patient was an adult who received Infanrix instead of Boostrix. The reporter consented to follow up. Additional Supportive Information: The health care professional reported that a patient received Infanrix vaccine instead of Boostrix at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. The case US2022092462 was identified as duplicate of this case. The case US2022092462 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: administrated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa (Infanrix) (batch number 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 13th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On 13th June 2022, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The nurse reported that a dose of Infanrix was given to the patient and it was already expired.  The nurse reported that no adverse event was reported. The Vaccine Administration Facility was the same as primary reporter. No patient's identifiers provided. The reporter consented to follow up. Additional Supportive Information: The patient received Infanrix dose which was already expired on 28th May 2022, which led to expired vaccine used.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with a diluent other than the liquid conjugate portion; Reconstituted with a diluent other than the liquid conjugate portion; 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 female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA605A, expiry date 31st May 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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 Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comments: The medical assistant reported that a patient received a dose of Menveo that had been reconstituted with a diluent other than the liquid conjugate portion of Menveo. The Vaccine Administration Facility was the same as primary reporter. The reporter consented to follow up by email. Additional supportive information: The use of Menveo dose that had been reconstituted with a diluent other than the liquid conjugate portion of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 32.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 32-year-old patient who received HAV (Havrix) (batch number G99R4, expiry date 20th May 2022) for prophylaxis.   On 13th June 2022, the patient received Havrix. On 13th June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's comments: The reporter was Health Care Professional from primary care clinic. The reporter stated that a patient was given a dose of Havrix. The reporter does not know if the dose was the patient's first or second dose in the series. The reporter did not had any patient information, aside from date of birth. At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The reporter stated that a patient received an expired dose of Havrix which led to, expired vaccine used.
Age: 42.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received a 1st dose with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old male patient who received HBV (Engerix B) (batch number 9P9B5, expiry date 7th February 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received the 1st dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: The reporter was medical assistant. The reporter reported that, a patient received Engerix-B with an expired dose. The reporter consented to follow up. Additional Supportive Information: A patient received a expired dose of Engerix-B, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient receiving the 1st dose on 08-feb-2019  2nd dose was never administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 8th February 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 13-JUN-2022 Reporter's Comment: Pharmacist reported that second dose was never administered yet. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Administered only the liquid component; Administered only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number Amxa656a, expiry date unknown) for prophylaxis.   On 13th June 2022, the patient received Menveo. On 13th June 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comment: Office manager reported that yesterday (day before reporting) a patient administered only the liquid component of Menveo. The reporter consented to follow-up via postal mail. Additional supportive information: The patient received only the liquid component of Menveo, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered. The lot number Amxa656a was provided, but GlaxoSmithKline could not find a match. This may need to be clarified.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: received expired dose; 11 YO received infanrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 11-year-old patient who received DTPa (Infanrix) (batch number unknown, 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 13th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-JUN-2022 Reporter's comment:  The patient received the Infanrix vaccine, which was expired on 28th May 2022 The reporter consented to follow up. Additional supportive information: The patient received Infanrix vaccine at 11 years of age, which led to inappropriate age at vaccine administration and expired vaccine used. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093050:Same reporter
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: Expired vaccine used; 11 YO patient received the vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 11-year-old patient who received DTPa (Infanrix) (batch number unknown, 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 13th June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-JUN-2022 Reporter's comment:  11 years patient received the infanrix vaccine, which was expired on 28th May 2022 The reporter consented to follow up. Additional supportive information: The patient received infanrix vaccine, which led to Inappropriate age at vaccine administration and expired vaccine used. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022093051:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 7 months ago, not yet received second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose approximately 7 months and one week ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2022 Reporter's Comments: The case was self reported by the patient. The patient reported that patient had not received second dose of Shingrix vaccine. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 0.17
Sex: U
Vaccine: DTAPHEPBIP, HEP
Symptoms: Overdose
Clinical narrative: Patient received both Pediarix (first dose) and Engerix-b (second dose) on the same day; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 2-month-old patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Engerix B pediatric, the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-June-2022 Reporter's comment: The pharmacist reported that the patient received both Pediarix (first dose) and Engerix-b (second dose) on the same day. HCP had no further information about the situation. The reporter consented to follow up. Additional Supportive Information: The patient received Pediarix and Engerix-b on the same day which led to overdose.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: This spontaneous report received from a consumer via social media (Johnson and Johnson Corporate) from a company representative concerned 4 adult male patients of an unspecified age, race and ethnic origin. 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, 01 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. It was reported that, on an unspecified date, "4 adult males who died supposedly of Covid/ died of the gain of function flu, but 3 were fully jabbed " and had suspected clinical vaccination failure. It was unspecified if an autopsy was performed. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient died of suspected Covid 19 infection / died of the gain of function flu on an unspecified date, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220126450, 20220126708, 20220126582 and 20220130063. This report was associated with product quality complaint: 90000211848. The suspected product quality complaint has been confirmed to be the reported allegation could not be confirmed. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed. Upon review, the following information was corrected: case corrected from invalid to valid and narrative updated accordingly, batch no statement updated as per recent update. Sender's Comments: V1- Upon review, the following information was corrected: case corrected from invalid to valid and narrative updated accordingly, batch no statement updated as per recent update. This updated information does not alter the causality of previously reported events. 20220126174-JANSSEN COVID-19 VACCINE Ad26.COV2.S-Suspected Covid 19 infection/ died of the gain of function flu. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20220126174-JANSSEN 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; Reported Cause(s) of Death: DIED SUPPOSEDLY OF COVID/DIED OF THE GAIN OF FUNCTION FLU.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINE FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned multiple patients of an unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 14-JUN-2022. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, it was reported that, the patients who were fully vaccinated and boosted contracted the COVID-19, coded to suspected clinical vaccine failure, and suspected covid-19 infection (Dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. The patient received additional covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of administration, and batch number were not reported) dose was not reported, 1 total administered on unspecified date for prophylactic vaccination.  No adverse events were observed following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 2). This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000234975. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. A manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220618178-COVID-19 VACCINE AD26.COV2.S- SUSPECTED CLINICAL VACCINE FAILURE. 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. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Brain stem stroke, Paralysis
Clinical narrative: PARALYZED; STROKE/ BLOOD CLOT WAS IN BRAIN STEM AREA; This spontaneous report received from a consumer via a company representative via form and 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, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-APR-2021, the patient experienced stroke. The blood clot was in brain stem area. She was now paralyzed, could not speak, could not eat and swallow food. It was reported by consumer that patient must be feed and take her meds through the feeding tube. The patient was completely depended on her husband and daughter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke/ blood clot was in brain stem area and paralyzed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220620875 -covid-19 vaccine ad26.cov2.s- Stroke/ blood clot was in brain stem area, Paralyzed . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: 6 MALES WERE ADMINISTERED 0.3ML OF JANSSEN COVID 19 VACCINE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811 expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The drug was associated with Medication error. No concomitant medications were reported. On an unspecified date, the patient experienced 6 males were administered 0.3ml of janssen covid 19 vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 6 males were administered 0.3ml of janssen covid 19 vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20220626380.
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: stress. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 09-SEP-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 12-JUN-2022, the patient experienced headache. Laboratory data included: COVID-19 virus test Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of headache was not reported. This report was non-serious.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via a other manufacturer Pfizer concerned a 46 year old male. Initial information was processed with the additional information received on 14-JUN-2022. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on unspecified date in APR-2021 on left arm for prophylactic vaccination. Age at time of vaccination 45 years old. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered on unspecified date in NOV-2021 on left arm for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 46 years old. No concomitant medications were reported.  On 27-MAY-2022, patient was first tested positive for covid-19 and hence confirmed covid-19 infection and had confirmed clinical vaccination failure (Dose number in series 2). On same day, patient administered non company suspect drug: Paxlovid (form of admin, route of admin, batch number and expiry were not reported) dose was not reported, last administered on 31-MAY-2022 for covid-19. Patient's first negative test came on 31-MAY-2022, with additional negative test on 01-JUN-2022 and 02-JUN-2022. On 03-JUN-2022, at 06:30, patient again tested positive (twice) for covid-19. Patient also, reported he do not had any symptoms at time of reporting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and treatment with paxlovid was withdrawn on 31-MAY-2022. 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: 90000235726.; Sender's Comments: V0:20220627527-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypersensitivity, Nerve injury, Neurological examination
Clinical narrative: NERVE STUDY SHOWS DAMAGE; HYPERSENSITIVITY ON RIGHT SIDE; STROKE; This spontaneous report received from a consumer via social media through a company representative concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown, and expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date (a couple weeks after vaccination), the patient experienced hypersensitivity on right side. Patient wears a fleece jacket all the time because the air irritates his arm. On an unspecified date, the patient underwent nerve study Laboratory data included: nerve study which shows damage but doctors did not say that it was from the shot. On 02-JAN-2022, the patient experienced stroke and got into the emergency room (ER) in time to prevent permanent damage. Patient was on blood thinner for the rest of his life. Patient will be having magnetic resonance imaging (MRI) in a couple of weeks to check for multiple sclerosis (side effect of J and J). The patient visited to physician office and emergency room. Reporter stated that, "My husband started having hypersensitivity on his right side a couple weeks after his J and J. He wears a fleece jacket all the time because the air irritates his arm. Nerve study shows damage but doctors won't say it's from the shot but I sure will. He is having an MRI in a couple of weeks to check for Multiple Sclerosis (side effect of J and J). Then he had a stroke on Jan. 2. Got to the ER in time to prevent permanent damage that time, but is on blood thinner for the rest of his life". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the hypersensitivity on right side, stroke and nerve study shows damage was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220627822-covid-19 vaccine ad26.cov2.s-Stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Illness
Clinical narrative: VERY SICK FOR EIGHT DAYS; SEVERE SIDE EFFECTS; This spontaneous report received from a patient via a company representative via social media (Social Listening) concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: severe allergies (Patient could not get Pfizer or Moderna vaccine due to severe allergies), and other pre-existing medical conditions included: Patient was told by doctor that it was too risky for health to get vaccinated for Covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced very sick for eight days, and severe side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very sick for eight days and severe side effects was not reported. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered expired vaccine to the patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered expired vaccine to the patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. It was reported as unknown when the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up document was received. Reporter details and patient details was updated. On 08-Jun-2022: Upon internal review on 15-Jun-2022, significant correction was performed. On 08-Jun-2022 case became valid but missed to tick the significant check box. Hence correction was performed to tick the significant check box for report submission.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer expired vaccine to 450 patients, after the manufacture date of expiration.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to 450 patients, after the manufacture date of expiration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported number of doses /vials given as 102 on 25Oct2021,26Oct2021, 27 Oct2021 ,29 Oct2021. It was unknown when the vial was stored in refrigerator. The vial did not undergo any temperature excursions.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received, reporter address and patient details was updated. On 08-Jun-2022: Upon internal review on 15-Jun-2022, significant correction was performed. On 08-Jun-2022 case became valid but missed to tick the significant check box. Hence correction was performed to tick the significant check box for report submission.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Diarrhoea, Rash, SARS-CoV-2 test
Clinical narrative: Covid-19; diarrhea for 4 hours; got a rash; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid-19), DIARRHOEA (diarrhea for 4 hours) and RASH (got a rash) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (Shrimps) and Meat allergy.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In December 2021, the patient experienced COVID-19 (Covid-19). On an unknown date, the patient experienced DIARRHOEA (diarrhea for 4 hours) and RASH (got a rash). At the time of the report, COVID-19 (Covid-19) outcome was unknown and DIARRHOEA (diarrhea for 4 hours) and RASH (got a rash) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2021, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported.  The patient experienced a similar event in the past because of some food. The symptoms were improved after 2 months.  No treatment information was reported.  Company Comment: This spontaneous case concerns a 52-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid-19 which occurred approximately 1 year after the first dose of mRNA-1273 vaccine. Incomplete course of vaccination is also noted as the nurse at the vaccination facility did not want to vaccinate the patient as the patient told them about the allergic reaction of rash and diarrhea she had after the first dose. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 52-year-old female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI of Covid-19 which occurred approximately 1 year after the first dose of mRNA-1273 vaccine. Incomplete course of vaccination is also noted as the nurse at the vaccination facility did not want to vaccinate the patient as the patient told them about the allergic reaction of rash and diarrhea she had after the first dose. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Heart rate
Clinical narrative: his wife had the Moderna vaccine and had A-Fib twice; his wife had the Moderna vaccine and had A-Fib twice; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) and the second episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced the first episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) (seriousness criterion medically significant) and the second episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) (seriousness criterion medically significant). At the time of the report, last episode of ATRIAL FIBRILLATION (his wife had the Moderna vaccine and had A-Fib twice) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 170 170.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   The patients husband performed Carotid massage but no impact. Then patient was taken to ER and treated for A-fib. patients heart rate was 170 when arrived in hospital. Both times A- fib happened 3 weeks after the Moderna vaccine. Concomitant medications was not provided.   Company Comment: This is a spontaneous case concerning an adult female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Atrial fibrillation which occurred twice 3 weeks after receiving a dose of mRNA-1273 Vaccine, dose number not specified. As reported, carotid massage was performed on patient, with no impact; thus, she was taken to the emergency room where heart rate was noted to be 170 beats per min. Unspecified treatment was done with unknown result. There was also no available information regarding diagnostic tests done and clinical course. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient of unknown age, with no reported medical history, who experienced the unexpected serious (medically significant) AESI of Atrial fibrillation which occurred twice 3 weeks after receiving a dose of mRNA-1273 Vaccine, dose number not specified. As reported, carotid massage was performed on patient, with no impact; thus, she was taken to the emergency room where heart rate was noted to be 170 beats per min. Unspecified treatment was done with unknown result. There was also no available information regarding diagnostic tests done and clinical course. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.