chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Mass, Rash, Rash erythematous, Skin warm
Clinical narrative: Rash; Rash is warm to the touch; Rash is a red circle; Lump under the rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th October 2022, the patient received Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. In October 2022, less than a week after receiving Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced rash, skin warm, red rash and mass. On an unknown date, the outcome of the rash, skin warm, red rash and mass were not recovered/not resolved.   It was unknown if the reporter considered the rash, skin warm, red rash and mass to be related to Fluarix Tetra 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.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: 18-OCT-2022  Reporter's Comment: The reporter reported that, patient received Fluarix Quadrivalent on Sunday, between 1:15 and 1:30pm.  The reporter stated that, patient reported becoming aware of rash at the time of reporting.  The reporter reported that, patient might have had rash yesterday, but only became aware of it at the time of reporting because it began bothering them.  The reporter reported that, patient stated rash was warm to the touch and had the appearance of a red circle, but did not elaborate on size of circle.  The reporter reported that, patient stated there was also a lump under the rash. The reporter reported that, patient reported no allergy to eggs or latex.  The reporter consented to follow up with HCP.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered expired doses; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   On 4th October 2022, the patient received Havrix. On 4th October 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: 18-OCT-2022 Reporter's comment: Medical assistance reported that a patient was administered expired dose of Havrix on different date. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional Supportive Information: The patient received a dose of Havrix which was already expired, which led to expired vaccine used. This case was one of the 4 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022149860:Same reporter US-GSK-US2022149858:Same reporter US-GSK-US2022149859:Same reporter
Sex: F
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: administered a Hib vaccine with the wrong diluent (non-supplied GSK) mixed; 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 Hib UNK (Hib vaccine) for prophylaxis.   On 18th October 2022, the patient received Hib vaccine. On 18th October 2022, unknown after receiving Hib vaccine, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 19-OCT-2022 Reporters comment:  The medical assistant called to inquire about any available information. The medical assistant reported that employee's grandchild was administered a Hib vaccine with the wrong diluent non-supplied GSK mixed yesterday (one day before the day of reporting). The reporter stated that they were not the ones who given the vaccine and it had nothing to do with their office and called to get something for the employee so did not had worry. The reporter mentioned not able to provide any details on vaccine brand, lot, expiration or patient details. The reporter did not consent to follow-up  Additional Supportive information: The grandchild was administered a Hib vaccine with the wrong diluent non-supplied GSK mixed, which led to wrong solution used in drug reconstitution.
Age: 44.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 44-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 4th March 2022, unknown after receiving Twinrix and Twinrix 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: 19-OCT-2022 Reporter's Comment: The reporter called to inquire if expiration date move and wanted to know how to proceed. The reporter wanted to know if patient would need to be revaccinated. The reporter stated that, they realized their Twinrix was expired and a few patients were administered. The reporter reported that, they inadvertently administered expired Twinrix doses to three separate patients.  All administered at their facility. The reporter did not consent to follow-up. Additional Supportive Information: The reporter stated that, they realized their Twinrix was expired and a patient was administered, which led to expired vaccine used. This was 1 of 3 cases, reported by the same reporter.; Sender's Comments:  GSK-US2022150646:Same reporter GSK-US2022150647:Same reporter
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received  pediatric dose; Adult received pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 43-year-old male patient who received HAV (Havrix 720) (batch number 4CY9H, expiry date unknown) for prophylaxis.   On 19th October 2022, the patient received Havrix 720. On 19th October 2022, unknown after receiving Havrix 720, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 19-Oct-2022 Reporter's comment: The registered nurse was at a family practice.  The reporter was looking for guidance if that dose should be disregarded and adult formulation (1ml) should be repeated or if an addition 0.5 ml should be administered. The Vaccine Administration Facility was the same as Primary Reporter. The inquiry was came in via chat, nurse did not had any information available at this time but could procedure that and chat was ended by the user. The reporter consented to follow up.  Additional supportive information: The adult patient received a dose of pediatric formulation of Havrix, which led to underdose and adult use of a child product. The case US2022150648 was identified as duplicate of US2022150649. The case US2022150648 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient
Sex: M
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Havrix pedriatric administered to adult; Havrix pedriatric administered to adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult male patient who received HAV (Havrix 720) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 20th October 2022, the patient received Havrix 720 and Havrix Pre-Filled Syringe Device. On 20th October 2022, unknown after receiving Havrix 720 and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     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: 20-Oct-2022 Reporter's comment: No additional patient demographics was available from the health care professional at the time of call. The reporter consented to follow-up. Additional supportive information: An adult patient received pediatric dose of Havrix, which led to underdose and adult use of a child product.
Age: 79.0
Sex: F
Vaccine: UNK
Symptoms: Expired product administered
Clinical narrative: Expired Flulaval administred; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 79-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 24Bm2, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 19th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The reporter consented to follow-up via email. Additional supportive information: The patient received an expired dose of Flulaval one day before the reporting date, which led to expired vaccine used.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 5-year-old female patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th October 2022, unknown after receiving Kinrix and Kinrix 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: 20-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Kinrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Syringe issue
Clinical narrative: may have been an underdose; vaccine leaked out onto the patient's arm; vaccine leaked out onto the patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a adult female patient who received Herpes zoster (Shingrix) (batch number NZ5E5, expiry date 23rd November 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter did not ask about follow-up and pharmacy contact information in health care professional's details. Additional supportive information: While administering Shingrix, the syringe malfunctioned and some of the vaccine leaked out onto the patient's arm so the dose might had been an underdose, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Adult received Engerix-B Pediatric; Adult received Engerix-B Pediatric; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 40-year-old female patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   On 13th October 2022, the patient received the 2nd dose of Engerix B pediatric (intramuscular). On 13th October 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: administered Havrix to a "4 days away from 3 months old pt"; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received HAV (Havrix) (batch number CN3G5, expiry date 19th November 2023) for prophylaxis.   On 20th October 2022, the patient received the 1st dose of Havrix. On 20th October 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: No other information was provided.  No additional adverse event or product quality complaint was reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The medical assistant was accidently administered Havrix on the day of reporting to a patient, which led to inappropriate age at vaccine administration.
Age: 0.25
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered DTAP+IPV instead of DTAP; administered DTAP+IPV to 2 month old child; This case was reported by a consumer via call center representative and described the occurrence of wrong vaccine administered in a 3-month-old female patient who received DTPa-IPV (DTPa-IPV) for prophylaxis.   On 20th October 2022, the patient received DTPa-IPV. On 20th October 2022, unknown after receiving DTPa-IPV, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The patient's mother reported that they could not identify the brand name of the vaccine. The Kinrix was only approved in patents from 4 to 6 years of age. The reporter did not consent to follow-up. Additional supportive information: The patient received DTAP+IPV instead of DTAP vaccine at inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration. Suspect was coded as per narrative information.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Exposed, below freezing, administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent. On an unknown date, unknown after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The pharmacy resident reported that Flulaval which was exposed to temperature below freezing (24.4 Fahrenheit) was administered to 5 employees. The vaccine administration facility was the same as primary reporter. The reporter did not had any other details but agreed to follow-up via email only. The reporter consented to follow-up. This is one of five linked cases reported by same reporter for different patients. Additional supportive information: The patient received Flulaval after temperature excursions, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022AMR152068:Same reporter US-GSK-US2022AMR152067:Same reporter US-GSK-US2022AMR152066:Same reporter US-GSK-US2022AMR152065:Same reporter
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Alopecia, Herpes zoster, Rash, Rash pruritic, Vaccination failure
Clinical narrative: Shingles 5 years after being fully vaccinated/ Suspected vaccination failure; Shingles; rash between legs and face, rash on their head; hair falling out; a rash on their head that is very itchy; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, 5 years after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash, hair loss and itchy rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, rash, hair loss and itchy rash were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, rash, hair loss and itchy rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comments: The reporter was the patient.  The patient reported experiencing diagnosed Shingles approximately 5 years after being fully vaccinated with Shingrix.  The reporter reported having a rash between their legs and on his face, which did not itch.  The patient reported diagnosed Shingles resolved.  The patient reported he believed he was experiencing a second case of Shingles since being vaccinated, was not yet been diagnosed.  The patient reported having a rash on their head that was very itchy, their hair was falling out when they comb it.  The reporter did not consent to follow up. Additional information: This case was considered as suspected vaccination failure as detail regarding laboratory confirmation was unknown at the time of reporting.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer stage IV
Clinical narrative: STAGE 4 BREAST CANCER; This spontaneous report received from a patient via a company representative concerned a female 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 was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, administered on 17-MAR-2021 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 had swelling of breast tissues and subsequent finding of stage four breast cancer.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stage 4 breast cancer was not reported. This report was serious (Other Medically Important Condition); Sender's Comments: V0:20221047274-covid-19 vaccine ad26.cov2.s-stage 4 breast cancer. 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: NATURE OF EVENT. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer via a company representative through social media concerned a patient of unspecified age, sex, race, and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2. s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots, and had surgery to remove blood clots.  It was reported that " My cousin also had the J and J covid vaccine and just had surgery to remove blood clots". The action taken with covid-19 vaccine ad26.cov2. s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0:20221047543-covid-19 vaccine ad26.cov2. s-blood clots. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. 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: Death, Malaise
Clinical narrative: DEATH; NOT FEELING GOOD; This spontaneous report received from a consumer through a social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. On an unspecified date (within a week of vaccination), patient was not feeling well and went to hospital, after two days stay in the hospital, patient died from unknown cause of death. It was unspecified if an autopsy was performed. It was reported that "My friend got shot, went in a week later not feeling good, died two days later in hospital."  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of death on an unspecified date, and the outcome of not feeling good was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20221048581- covid-19 vaccine ad26.cov2.s- Death. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.  20221048581- covid-19 vaccine ad26.cov2.s- not feeling good . This event(s) is labeled and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Seizure
Clinical narrative: A BRAIN CLOT; SEIZURES; This spontaneous report received from a consumer via a company representative via social media concerned a female 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 was not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient had a brain clot, and seizures. The reporter stated that " Their Covid-19 vaccine gave my daughter a brain clot and seizures ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a brain clot and seizures was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221049075-covid-19 vaccine ad26.cov2.s-seizures . 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. 20221049075-covid-19 vaccine ad26.cov2.s-brain clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a patient concerned a 65 year old male. 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 not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 05-MAY-2021 for covid-19 prophylaxis. Age at time of vaccination 64 years old. No concomitant medications were reported.  On 25-NOV-2021, the patient experienced tested positive for covid. Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, Gait inability
Clinical narrative: BROKEN DOWN HEAVILY; CAN NOT EVEN WALK A SHORT DISTANCE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 broken down heavily, and can not even walk a short distance. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from can not even walk a short distance, and broken down heavily. This report was non-serious.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022; No adverse event; Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 24-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 054B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. In October 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was given as first dose after the 30 day refrigeration mark) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 30-Aug-2022 and administered on 14-Oct-2022 and 15-Oct-2022).    No concomitant medication was reported.  The doses were administered on 14-OCT-2022 and 15-OCT-2022 for 2 different patient. Vial size was 2.5 milliliter. The vial did not undergo any temperature excursions. Per Moderna CMC lot analysis regarding doses administered on 14-Oct-2022 and 15-Oct-2022, Moderna cannot guarantee patients received full protection against the COVID-19 virus.  No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-661765 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2022: Live follow up received narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-661765:MOD-2022-661765 (patient case)
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Dyspnoea, Hypopnoea
Clinical narrative: developed a rash all over her body; blotchy black rash all over her torso; shortness of breath; shallow breathing; pressure in her chest; felt weak; In the night she had chills; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), HYPOPNOEA (shallow breathing), CHEST DISCOMFORT (pressure in her chest), ASTHENIA (felt weak) and CHILLS (In the night she had chills) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Auricular fibrillation, Allergy to antibiotic (Ciprofloxacin) and Sulfonamide allergy. Concomitant products included SOTALOL, VITAMIN C [ASCORBIC ACID], TIMOLOL and KETOROLAC for an unknown indication.    On 11-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced DYSPNOEA (shortness of breath), HYPOPNOEA (shallow breathing), CHEST DISCOMFORT (pressure in her chest), ASTHENIA (felt weak) and CHILLS (In the night she had chills). On 12-Oct-2022, the patient experienced RASH (developed a rash all over her body) and RASH MACULAR (blotchy black rash all over her torso). On 14-Oct-2022, RASH (developed a rash all over her body) and RASH MACULAR (blotchy black rash all over her torso) had resolved. At the time of the report, DYSPNOEA (shortness of breath), HYPOPNOEA (shallow breathing), CHEST DISCOMFORT (pressure in her chest), ASTHENIA (felt weak) and CHILLS (In the night she had chills) outcome was unknown.            Patient did not have COVID positive test. Patient did not have history of Myocarditis/pericarditis.  On 02-APR-2021 patient received First Moderna dose with Lot no.007C21A .  On 20-MAY-2021 patient received Second Moderna dose with Lot no.038C21A  . On 21-NOV-2021 patient received First Moderna Booster dose with Lot no.034F21A . On an unknown date patient received Second Moderna Booster dose with Lot no.056M21A .  No treatment information was reported.   This case was linked to MOD-2021-163805, MOD-2021-090452.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: developed a rash all over her body; blotchy black rash all over her torso; shortness of breath; shallow breathing; pressure in her chest; felt weak; In the night she had chills; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), HYPOPNOEA (shallow breathing), CHEST DISCOMFORT (pressure in her chest), ASTHENIA (felt weak) and CHILLS (In the night she had chills) in a 74-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Auricular fibrillation, Allergy to antibiotic (Ciprofloxacin) and Sulfonamide allergy. Concomitant products included SOTALOL, VITAMIN C [ASCORBIC ACID], TIMOLOL and KETOROLAC for an unknown indication.    On 11-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced DYSPNOEA (shortness of breath), HYPOPNOEA (shallow breathing), CHEST DISCOMFORT (pressure in her chest), ASTHENIA (felt weak) and CHILLS (In the night she had chills). On 12-Oct-2022, the patient experienced RASH (developed a rash all over her body) and RASH MACULAR (blotchy black rash all over her torso). On 14-Oct-2022, RASH (developed a rash all over her body) and RASH MACULAR (blotchy black rash all over her torso) had resolved. At the time of the report, DYSPNOEA (shortness of breath), HYPOPNOEA (shallow breathing), CHEST DISCOMFORT (pressure in her chest), ASTHENIA (felt weak) and CHILLS (In the night she had chills) outcome was unknown.            Patient did not have COVID positive test. Patient did not have history of Myocarditis/pericarditis.  On 02-APR-2021 patient received First Moderna dose with Lot no.007C21A .  On 20-MAY-2021 patient received Second Moderna dose with Lot no.038C21A  . On 21-NOV-2021 patient received First Moderna Booster dose with Lot no.034F21A . On an unknown date patient received Second Moderna Booster dose with Lot no.056M21A .  No treatment information was reported.   This case was linked to MOD-2021-163805, MOD-2021-090452.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19/ loss smell and taste/ have lingering stuff from COVID; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19/ loss smell and taste/ have lingering stuff from COVID) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048621A, 088D21A and 012M20A MTTDT) for COVID-19 vaccination.     No other vaccines given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Iodine allergy, Shellfish allergy and Bronchiectasis.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19/ loss smell and taste/ have lingering stuff from COVID). At the time of the report, COVID-19 (COVID-19/ loss smell and taste/ have lingering stuff from COVID) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2022, SARS-CoV-2 test: Positive.         Patient was taking other medication. Patient received first and second booster doses of Moderna COVID-19 Vaccine on 02-Nov-2021 and 30-Mar-2022 respectively. Patient's symptoms began on 05 or 06-Oct-2022. Patient isolated for 5 days as recommended by the CDC. No Hospitalization due to COVID-19. No treatment received.   This case was linked to US-MODERNATX, INC.-MOD-2022-662368 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662368:Husband case
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: neurologic side effect; This spontaneous case was reported by a patient and describes the occurrence of NERVOUS SYSTEM DISORDER (neurologic side effect) in a 67-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Head injury.    On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (neurologic side effect). At the time of the report, NERVOUS SYSTEM DISORDER (neurologic side effect) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Height: Somewhere between 5feet 5 inches and 5feet 6 inches. Ethnicity was reported. Concomitant medications details were not reported by the reporter. Reporter began to clarify neurologic side effects after getting the Pfizer Covid-19 Bivalent 12 year plus vaccine. She had serious neck pain. The serious neck pain was so painful she had to use two pillows to sleep on to elevate her head. The pain was all around her entire neck; the pain was so bad. This started within the week of getting the vaccine. Reportedly, patient wondered and believed that she was having side effects from mixing both Modena and Pfizer vaccines.  Treatment details were not reported by the reporter.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; They gave her the incorrect shot, that they accidentally gave her the standard child's dose./received an incorrect vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (They gave her the incorrect shot, that they accidentally gave her the standard child's dose./received an incorrect vaccine) and NO ADVERSE EVENT (No Adverse Event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (They gave her the incorrect shot, that they accidentally gave her the standard child's dose./received an incorrect vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (They gave her the incorrect shot, that they accidentally gave her the standard child's dose./received an incorrect vaccine) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. No concomitant medication was provided by the reporter.  It was reported that patient was taken to the pharmacy to get the updated Moderna Bivalent booster. They gave patient the incorrect shot, that they accidentally gave patient the standard child's dose.  No treatment medication was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 24-Oct-2022: Live follow up received included significant information suspect product start date was added.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation reaction
Clinical narrative: previously reacted to Moderna/immediate reactions, to the Moderna COVID-19 Vaccine/worse side effects; feeling funky; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (previously reacted to Moderna/immediate reactions, to the Moderna COVID-19 Vaccine/worse side effects) and FEELING ABNORMAL (feeling funky) in a 75-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (previously reacted to Moderna/immediate reactions, to the Moderna COVID-19 Vaccine/worse side effects) and FEELING ABNORMAL (feeling funky). At the time of the report, IMMUNISATION REACTION (previously reacted to Moderna/immediate reactions, to the Moderna COVID-19 Vaccine/worse side effects) and FEELING ABNORMAL (feeling funky) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to MOD-2022-662621 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) 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)) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Oct-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 12-Oct-2022, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Oct-2022, SARS-CoV-2 test: (Positive) Positive. In October 2022, SARS-CoV-2 test: (Negative) Negative.         No concomitant medications were reported. Patient received Moderna bivalent booster dose on 10-Oct-2022 and on 12-Oct-2022 tested positive for Covid-19.  Currently Covid- negative but would like to ask as they had the virus and the vaccine almost at the same time, are they protected from getting Covid, for at least 6 months. No treatment information was reported.   Reporter did not allow further contact
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; First dose was administered on 19-Jan-2021 and second dose on 26-Mar-2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 19-Jan-2021 and second dose on 26-Mar-2021) and NO ADVERSE EVENT (No adverse event) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 4782590) for COVID-19 prophylaxis.     The patient's past medical history included Platelets increased in April 2020. Concurrent medical conditions included Tonsillectomy, Leukemia (Bone Marrow Biopsy) since January 2021, Leukemia (Bone Marrow Biopsy) since 01-Jan-2021, Allergic reaction to analgesics, Drug allergy, Ill-defined disorder, Physical therapy, Motor dysfunction, Walking difficulty and Strength loss of. Concomitant products included VENETOCLAX (VENCLEXTA) for Acute myeloblastic leukaemia, HYDROCODONE BITARTRATE and ACETAMINOPHEN for an unknown indication.    On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 19-Jan-2021 and second dose on 26-Mar-2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose was administered on 19-Jan-2021 and second dose on 26-Mar-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Reportedly, patient was not making progress with his hemoglobin.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-662671 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2022: Follow-up document contains updated patient demographics.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm after all 3 doses; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm after all 3 doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A, 037B21A and 022C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 14-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Dec-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm after all 3 doses). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm after all 3 doses) had resolved.            Concomitant medications details were not reported by the reporter.  Patient had sore arm after all 3 doses which went away.   Reporter did not allow further contact