chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: F
Vaccine: MMR, UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AEs; temperature excursion; This spontaneous report was received from a registered nurse and refers to a 4-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) subcutaneous injection, lot #U039549, expiration date: 14-DEC-2023, administered subcutaneously for prophylaxis (dose and strength were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #W018825, expiration date: 14-JUN-2024, administered subcutaneously for prophylaxis (dose and strength were not provided); diphtheria vaccine toxoid, pertussis vaccine acellular 1-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (DTaP-IPV), lot #G9N2M, expiration date: 14-APR-2024, administered intramuscularly (dose, strength, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA003061: US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007838:
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA, HIBV, PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: temperature excursion; No additional AEs; This spontaneous report was received from a registered nurse and refers to an 18-month-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 06-DEC-2022, the patient was vaccinated with improperly stored doses of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006595, expiration date: 10-OCT-2024, administered intramuscularly for prophylaxis (dose and strength were not provided); pneumococcal vaccine conj (PCV B) lot #FN5555, expiration date: 31-JUL-2024, administered intramuscularly (dose, strength, formulation, and indication were not provided); hepatitis a vaccine inact (HAVRIX), unk, lot #94H52, expiration date: 30-APR-2023, administered intramuscularly (strength, formulation, and indication were not provided); and  diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (DTAP) lot #Y4259, expiration date: 03-MAR-2024, administered intramuscularly (dose, strength, formulation, and indication were not provided) (product storage error).  On an unknown date, before the administration, the vaccines underwent temperature excursion for unknown period of time. There was no adverse event reported.  The reporter considered temperature excursion to be not related to suspect vaccines.; Sender's Comments:  US-009507513-2212USA007828: US-009507513-2212USA007829: US-009507513-2212USA007830: US-009507513-2212USA007831: US-009507513-2212USA007832: US-009507513-2212USA007833: US-009507513-2212USA007834: US-009507513-2212USA007835: US-009507513-2212USA007836: US-009507513-2212USA007837: US-009507513-2212USA003061:
Sex: U
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: no adverse event; HCP reported that GARDASIL 9 was administered to a patient on 12/23/2022 after a Temperature Excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 23-DEC-2022, the patient was vaccinated with improperly stored dose (Product storage error) of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, syringe, lot #W000189 (verified to be valid lot number), expiration date: 10-AUG-2024, administered for prophylaxis (exact dose, dose #, route of administration, and anatomical location were not provided). Administered dose of vaccine experienced the temperature excursion of above 47 degrees Fahrenheit (F) (52.9 F) for 2 hours 22 minutes and 0 seconds. No further information was provided to further clarify any details. No additional adverse events (AEs) (No adverse event) were reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AEs; it was reported multiple temperature excursion 16-NOV-2022 and 09-DEC-2022 and were administered PEDVAXHIB, ROTATEQ and VAQTA; This spontaneous report was received from a medical assistant and refers to an unspecified group of patients of unknown age and gender. Their medical history, concurrent conditions and concomitant therapies were not reported.  On 16-NOV-2022 and 09-DEC-2022, the patients were vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number: U029144 and expiration date: 31-MAR-2024; with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023; and with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot number: U038854 and expiration date: 20-APR-2023. The vaccines were administered only once for prophylaxis, but dosage regimens, route of administrations and anatomical locations were not reported.  It was reported that the vaccines were administered after multiple temperature excursions (product storage error). Temperature was above 47 Fahrenheit (F) degree (50.0 F) for 0 hours 12 minutes and 0 seconds on 16-NOV-2022 and above 47 F (47.6F) for 0 hours 15 minutes and 0 seconds. Time frame was total 27 minutes. Additionally, no previous temperature excursion was reported. No other adverse event was reported (no adverse event).  Follow-up information was received from the medical assistant on 28-DEC-2022. This report refers to a 17 month old patient who was vaccinated on 29-NOV-2022 with Hepatitis A Vaccine, Inactivated (VAQTA) lot number: W015191 and expiration date: 27-OCT-2023, intramuscular (IM). The primary thermometer displayed out of range temperature for less than 15 minutes. The back-up thermometer did not display max. that was out of range. Log was ran and the temperatures were within range. The primary thermometer was re-calibrated.  Patients' identifiers were missing in the previous report but have now been provided.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, No adverse event, Product administration error
Clinical narrative: No additional AE details; incomplete dose of PEDVAX HIB was administered; a needle was not fully attached and squirted out during administration; This spontaneous report was received from a medical assistant and refers to a patient of unspecified age and gender. There was no information regarding the patient's medical history, concurrent condition and concomitant therapies details.  On 29-DEC-2022, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W015927, expiration date: 15-FEB-2025, administered for prophylaxis (strength, and route of administration were not provided). The reporter stated that incomplete dose of vaccine was administered (Incorrect dose administered) after a needle was not fully attached and squirted out during administration (Product administration error). No product quality complaint was reported since needle and syringe was not a company product. No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs or PQC reported.; Caller reported expired sterile Diluent used to reconstitute MMR II and was administered; This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.  On 28-DEC-2022, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (rHA, recombinant Human Albumin) (M-M-R II), lot number: U011995, expiration date: 15-APR-2023 (dose, dose number, route of administration and anatomical location were not reported) for prophylaxis, which was reconstituted with an expired sterile diluent, lot number: T014300, expiration date: 03-DEC-2022 (dose, strength, route of administration and formulation were not reported) (expired product administered). No additional adverse events (AEs) or product quality complaint (PQC) were reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles along my spine wrapped around my right side; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 16th December 2022, the patient received Shingles vaccine. In December 2022, less than a week after receiving Shingles vaccine, the patient experienced shingles and pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles and pain were recovered/resolved.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had the shot on a Friday and on Tuesday was at the doctor getting the anti viral drug broke out in shingles along spine wrapped around patients right side. The symptoms luckily stopped it before it got to bad, but was very painful. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm, like someone punched hard; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2022, the patient received the 1st dose of Shingrix. On 24th December 2022, less than 2 months after receiving Shingrix, the patient experienced pain in arm. On 24th December 2022, the outcome of the pain in arm was recovered/resolved.   The reporter considered the pain in arm to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 24-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got 1st dose last month and would get 2nd dose in January 2023. The patients arm was sore like someone punched hard for about half a day. The patient was ok after that. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: missing antigen, adjuvant-only used; missing antigen, adjuvant-only used; 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 Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's Comment: The health care professional (HCP) reported administering Shingrix adjuvant only (missing antigen) to patient, for whom she had no identifying information. The reporter consented to follow up. Additional Supportive Information: The reporter reported administering Shingrix adjuvant only (missing antigen) to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022193689:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193690:Same reporter US-GSK-US2022AMR194824:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193687:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: missing antigen, adjuvant-only used; Administration of adjuvant-only; 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 Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK Receipt Date: 28-DEC-2022 Reporter's comments: The Healthcare Professional (HCP) had called up to report about administering adjuvant-only via intramuscular route (missing antigen) to 3 patients, for whom she had no identifying information.  The reporter had also administered it to six other patients, with identifying information. The reporter had consented to follow-up. Additional supportive information: The patient had received a Shingrix vaccine which was not reconstituted with the lyophilized antigen component, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case was one of the nine case reported by the same reporter for different patient.; Sender's Comments:  US-GSK-US2022193689:Same reporter US-GSK-US2022193688:Same reporter US-GSK-US2022193690:Same reporter US-GSK-US2022193680:Same reporter US-GSK-US2022AMR194823:Same reporter US-GSK-US2022193682:Same reporter US-GSK-US2022193685:Same reporter US-GSK-US2022193687:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue
Clinical narrative: Shivering; Fatigue/tiredness; Upset stomach; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 27th December 2022, the patient received Shingrix. In December 2022, less than a week after receiving Shingrix, the patient experienced shivering, fatigue and upset stomach. On an unknown date, the outcome of the shivering, fatigue and upset stomach were not recovered/not resolved.   The reporter considered the shivering, fatigue and upset stomach to be related to Shingrix.     Additional Information: GSK receipt date: 28 DEC 2022 Reporters comment: The reporter was the patient. The patient reported that had a Shingrix shot yesterday (day before reporting) around mid-day. The patient experienced shivering, fatigue or tiredness, and upset stomach.  The reporter provided limited information.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: Bexsero administered instead of Trumemba; This case was reported by a physician via call center representative and described the occurrence of interchange of vaccine products in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number KL472, expiry date 30th September 2024) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 28th December 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 17th January 2022, the patient received the 1st dose of TRUMENBA. On 28th December 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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: 28-DEC-2022 Reporter's Comments: The physician stated that patient came in for second dose of Trumenba but the staff administered a dose of Bexsero instead of Trumenba.   The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. Additional Supportive Information: The patient received Bexsero instead of Trumenba, which led to interchange of vaccine products.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only the liquid component  used; Only the liquid component  used; 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 AMVA759A, expiry date 30th November 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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: 28-DEC-2022 Reporter's Comments: A health care professional reported that patient might received a partial dose of Menveo with only the liquid component. The reporter consented to follow up. Additional Supportive Information: The patient received partial dose of Menveo with only liquid component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is linked with US2022193713, reported by same reporter.; Sender's Comments:  US-GSK-US2022193713:same reporter
Age: 29.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old male patient who received HAV (Havrix) (batch number 2BA99, expiry date unknown) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th December 2022, the patient received the 1st dose of Havrix and Havrix Pre-Filled Syringe Device. On 29th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 29-DEC-2022 Reporter's comment: Nurse reported that a patient was inadvertently given an expired dose of Havrix by a medical assistant at a different site and wanted to know how to proceed.  They gave information relating to patient and incomplete information about the vaccine.  They did state that they could be contacted further on for clarification.  They declined to receive the medical information which was given verbally.  Medical information declined and they did not know the exact expiration date of the vaccine. The reporter was consented to follow up. Additional Supportive Information: The patient received expired Havrix, which led to expired vaccine used.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 06May2022, 2nd 30Jul2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received HAV (Havrix 1440) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX 1440).   On 30th July 2022, the patient received the 2nd dose of Havrix 1440 and Havrix Pre-Filled Syringe Device. On 30th July 2022, unknown after receiving Havrix 1440 and Havrix Pre-Filled Syringe Device, 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.   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: 29-DEC-2022 Reporter's Comment: The pharmacist called to report that a patient was erroneously given the second dose of Havrix, only 2 months after the first dose, which was given on 6th May 2022.  The patient looked up information about the recommended schedule and insisted that they needed a second dose.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient received the second dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose of Havrix was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 22-year-old female patient who received HAV (Havrix) (batch number 2BA99, expiry date 16th December 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th December 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 30th December 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-DEC-2022 Reporters comment: The pharmacist reported that on 30th December 2022 patient received the expired dose of Havrix . The reporter consented to follow-up via email. Additional Supportive information: The patient received the expired dose of havrix vaccine which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: a patient was inadvertently administered the Shingrix diluent component only without the lyophilized powder; a patient was inadvertently administered the Shingrix diluent component only without the lyophilized powder; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number K2YA4, expiry date 25th January 2024) for prophylaxis.   On 23rd December 2022, the patient received Shingrix. On 23rd December 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 30-DEC-2022 Reporters comment: The pharmacy intern called and reported that a patient was inadvertently administered the Shingrix diluent component only without the lyophilized powder. The reporter asked for any recommendation for this. Intern declined safety follow-up and to provide any patient details. The reporter did not consent to follow up. Additional Supportive information: The patient was inadvertently administered the Shingrix diluent component only without the lyophilized powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient was looking to finish their vaccination schedule for Shingrix, having had received the vaccine approximately 4 years prior; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received approximately 4 years ago).   On an unknown date, the patient did not 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 Information: GSK receipt date: 30-DEC-2022 Reporters comment: The pharmacist reported that patient was looking to finish their vaccination schedule for Shingrix, having had received the vaccine approximately 4 years prior. No other information was provided, even after having been solicited.  Information about vaccine was unknown or vaccination site. The healthcare provider wished to not be contacted by the safety team but did wish to receive medical information. The reporter did not consent to follow up. Additional Supportive information: The patient received the vaccine 4 years ago and she did not receive the 2nd dose yet which led to incomplete course of vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: TIA (TRANSIENT ISCHAEMIC ATTACK); This spontaneous report received from a patient via social media through a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2 (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2 (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, one week after second vaccine, the patient experienced TIA (transient ischaemic attack) (Dose number in series 2). It was reported as "Same thing happened to me with Vaccine and booster. I got a TIA one week after second vaccine- no more for me." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of TIA (transient ischaemic attack) was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20221257765. Sender's Comments: V0-20221257757-  TIA (transient ischaemic attack)- The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: BURNED ON THE WAY GOING INTO THE ARM; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced burned on the way going into the arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of burned on the way going into the arm was not reported. This report was non-serious. This case, from the same reporter is linked to 20210642390.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19 immunisation, Dizziness, Energy increased, Extrasystoles, Hospitalisation
Clinical narrative: HOSPITALIZED; UNSPECIFIED SYMPTOM; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SEIZURE-LIKE SYMPTOMS(THAT WAS NOT A SEIZURE,BUT A SURGE OF ENERGY); HE FELT LIKE HE WAS GOING TO PASS OUT; ELECTRICAL SHORT CIRCUIT FROM EXTRA HEART BEATS; This spontaneous report received from a consumer via other manufacturer Laboratories (Propharma group) concerned a 62 year old male of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 62 years old. On unspecified date in MAY-2021, the patient had a heart ablation due to an electrical short circuit from extra heart beats (Dose number in series 1). On unspecified date in JUN-2021, the patient experienced seizure-like symptoms (that was not a seizure, but a surge of energy) and he felt like he was going to pass out. It happened again on unspecified date in SEP-2021 and symptoms came and went in 30 seconds. (Dose number in series 1)  The patient additionally received non-company suspect vaccine included: Moderna (elasomeran) (Dose number in series 2) (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on DEC-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). No concomitant medications were reported. On unspecified date in JAN-2022, the patient experienced unspecified symptom. (Dose number in series 2) On unspecified date in MAR-2022, he experienced another rush of energy that was 10 seconds or less.(Dose number in series 2) On unspecified date in MAY-2022, the patient was hospitalized for 5 days and they couldn't find anything.(Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the electrical short circuit from extra heart beats, seizure-like symptoms (that was not a seizure, but a surge of energy), unspecified symptom, he felt like he was going to pass out, hospitalized and revaccination with different covid-19 vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20221260380-hospitalized. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221260380-Electrical short circuit from extra heart beats. 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. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nonspecific reaction
Clinical narrative: HOSPITALIZED; UNSPECIFIED SYMPTOM; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SEIZURE-LIKE SYMPTOMS(THAT WAS NOT A SEIZURE,BUT A SURGE OF ENERGY); HE FELT LIKE HE WAS GOING TO PASS OUT; ELECTRICAL SHORT CIRCUIT FROM EXTRA HEART BEATS; This spontaneous report received from a consumer via other manufacturer Laboratories (Propharma group) concerned a 62 year old male of an unspecified race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number and expiry date were not reported) dose was not reported, 1 total administered on MAR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 62 years old. On unspecified date in MAY-2021, the patient had a heart ablation due to an electrical short circuit from extra heart beats (Dose number in series 1). On unspecified date in JUN-2021, the patient experienced seizure-like symptoms (that was not a seizure, but a surge of energy) and he felt like he was going to pass out. It happened again on unspecified date in SEP-2021 and symptoms came and went in 30 seconds. (Dose number in series 1)  The patient additionally received non-company suspect vaccine included: Moderna (elasomeran) (Dose number in series 2) (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on DEC-2021 for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (Dose number in series 2). No concomitant medications were reported. On unspecified date in JAN-2022, the patient experienced unspecified symptom. (Dose number in series 2) On unspecified date in MAR-2022, he experienced another rush of energy that was 10 seconds or less.(Dose number in series 2) On unspecified date in MAY-2022, the patient was hospitalized for 5 days and they couldn't find anything.(Dose number in series 2) The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the electrical short circuit from extra heart beats, seizure-like symptoms (that was not a seizure, but a surge of energy), unspecified symptom, he felt like he was going to pass out, hospitalized and revaccination with different covid-19 vaccine was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20221260380-hospitalized. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  20221260380-Electrical short circuit from extra heart beats. 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. Therefore, the Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Maternal exposure before pregnancy
Clinical narrative: SPONTANEOUS ABORTION; VACCINE EXPOSURE BEFORE PREGNANCY; This spontaneous pregnancy report received from a consumer via media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was para 0, gravida 2.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had vaccine exposure before pregnancy. The pregnancy resulted in a spontaneous abortion. Reporter stated, " I tried to warned as many people that would listen to me, not to take those dangerous shots Very few people would listen to me, and some are dead now for not doing so. One lady (Not in my Sunday School Class, but is a church member), had two miscarriages after taking them. Everyone (53 members) in my Sunday School class took the shots, even though I warned them good not to take the shots Almost everyone in my class has had COVID since taking the shots They are now mighty quite about it all, when they announce that a member of our class now has COVID Some have had COVID the second time around, and they are filled up with those dangerous chemicals and man made viruses, that they allowed stupid doctors to give to them. When I was warning them, some of them said stupid things to me for not being protected, and risking other people's lives by catching it, and spreading it I don't hear a peep out of any of them now I did my research and I listened to "Real Doctors" Less ".  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the spontaneous abortion and vaccine exposure before pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20221258686. This case, from the same reporter is linked to 20221257674 and 20221257582.; Sender's Comments: V0: 20221260842- Spontaneous abortion. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.  20221260842-Vaccine exposure before pregnancy . The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a patient of unspecified age and sex. Initial information was processed along with additional information on 30-DEC-2022. The patient's height, and weight were not reported. The patient's concurrent conditions included: depression, and latex allergy. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on an unspecified date in left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse event following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 12-NOV-2021 in left arm for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included bupropion for depression.  On an unspecified date in 2022, the patient had COVID-19 infection (dose number in series 2) for which patient received non-company suspect Paxlovid (Nirmatrelvir) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on 30-NOV-2022 for covid-19 treatment. Date of last dose of administration was 05-DEC-2022. On 12-DEC-2022, the patient experienced rebound of covid-19 symptoms and positive antigen test following Paxlovid treatment (confirmed covid-19 infection) which resulted to confirmed clinical vaccination failure (dose number in series 2). Laboratory data included: COVID-19 antigen test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000265166.; Sender's Comments: V0: 20221260930-confirmed clinical vaccination failure. The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Death, Illness
Clinical narrative: DROP DEAD; VERY ILL; This spontaneous report received from a consumer via a company representative via media concerned multiple patients (unspecified number) of an unspecified age, sex, race and ethnicity.   The patient's weight, height, and medical histories were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry dates were not reported) dose, start therapy dates were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients were very ill and drop dead (death). The cause of death was not reported. It was unspecified if an autopsy was performed. As per reporter, "I have seen too many people drop dead or become very ill after getting the vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very ill was not reported. This report was serious (Death).; Sender's Comments: V0- 20221264046- Drop dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION (TIGHTNESS IN THROAT, DIARRHEA); This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy, and penicillin allergy, and other pre-existing medical conditions included: Patient was not pregnant at the time of vaccination. 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 16-APR-2021 13:00 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 57 years old. No concomitant medications were reported. On 19-DEC-2022 12:30, the patient experienced suspected covid-19 infection (tightness in throat, diarrhea). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from suspected covid-19 infection (tightness in throat, diarrhea). This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No adverse event; We had an excursion where Moderna product was stored in the fridge and experienced warm excursions; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced warm excursions), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041h22a) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Dec-2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced warm excursions) and PRODUCT STORAGE ERROR (Product storage error). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced warm excursions), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (We had an excursion where Moderna product was stored in the fridge and experienced warm excursions) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported. The vaccine was above 46F for a total of 215 hours and 45 minutes. The max temperature reached was 50.68F. Moderna COVID-19 vaccine, bivalent was delivered on 02-Dec-2022 and placed in the freezer upon delivery. Lot was relocated to fridge on 18-Dec-2022 and quarantined on 21-Dec-2022. All impacted product had been damaged. It was possible product might have been used after 18-Dec-2022. Product was not used after 21-Dec-2022.  Treatment information was not provided.