chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took the shot but did not protect me/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Took the shot but did not protect me/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The patient was treated with intravenous fluid (nos) (Infusion). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine but the vaccine did not protect him or her. The patient stated that he or she have shingles for six months. The patient took infusion to improve his or her immune system. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received vaccine I also got the shingles/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Received vaccine I also got the shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 10-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced shingles. The patient stated that he or she never take another vaccine again. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: HEPAB
Symptoms: Therapeutic response unexpected
Clinical narrative: everyday headache was gone/ no migraine; This non-serious case was reported by a consumer and described the occurrence of unexpected therapeutic effect in a 58-year-old female patient who received HAB (Twinrix adult) for prophylaxis.   The patient's past medical history included migraine (had suffered from migraines for over 50 years) and headache (everyday).   In OCT-2022, the patient received the 1st dose of Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult, the patient experienced unexpected therapeutic effect (Verbatim: everyday headache was gone/ no migraine). The outcome of the unexpected therapeutic effect 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: 08-JUN-2023 The patient self-reported this case. The patient received 1st dose of Twinrix adult and a couple days later noticed everyday her headache was gone.  Then after the patient received 2nd dose it stayed and gone.  Patient received 3rd dose in March 2023, and it had been a month without a migraine.  Patient reported that only thing she could contribute to migraines leaving was the Twinrix.  Patient stated nothing else had ever helped her and she did not change her lifestyle in anyway. Patient just wanted to know if this was a side effect, getting rid of her migraines.  Patient wished if she had received the shot years ago. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: husband got his first ever shingles shot and than got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: husband got his first ever shingles shot and than got shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 08-JUN-2023 The case was received from the patient's wife interactive digital media. The patient got his first ever Shingles shot and then got shingles. The reporter's mother had shingles, but reporter was not afraid of getting it because of her active healthy lifestyle. But that was not the case at all little did she know shingles varies from person to person. The reporter stated that for her it started with four days of neck pain. The pain kept getting worse.  Then a rash developed, and her physician diagnosed her with shingles.  The pain was so intense that she was not able to work for days. Even after the rash went away, she had pain that lasted for five months, and reporter wished that she would not have waited to learn more about shingles. The reporter stated that did not wait talk to a physician or pharmacist on the day of reporting, about shingles prevention for those over 50. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-FEB-2023, the patient received the 1st dose of Shingrix. On 02-APR-2023, 59 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and experienced mild case of Shingles. The patient stated that he or she was recovered from shingles and now been 6 weeks since being diagnosed. The reporter wanted to know when should he or she receive the second dose of Shingrix after he or she recovered from shingles. Follow-up would not possible as no contact details were available.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Glycosylated haemoglobin increased, Hypersomnia, Loss of personal independence in daily activities
Clinical narrative: HbA1c level was one point higher; Stay home for 2 days, because of the shot; Sleeping for 2 days; Exhausted; This non-serious case was reported by a consumer via call center representative and described the occurrence of exhaustion in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, dietary control (the past 3 months or so  had been dieting because preparing for surgery so  expecting HbA1c to go down, not up) and drug allergy (had a allergy to several unspecified medications).   In MAY-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On 07-JUN-2023, less than 2 weeks after receiving Shingrix, the patient experienced hba1c increased (Verbatim: HbA1c level was one point higher). On an unknown date, the patient experienced exhaustion (Verbatim: Exhausted), activities of daily living impaired (Verbatim: Stay home for 2 days, because of the shot) and sleep excessive (Verbatim: Sleeping for 2 days). The outcome of the exhaustion, activities of daily living impaired and sleep excessive were resolved (duration 2 days) and the outcome of the hba1c increased was unknown.   The reporter considered the exhaustion, activities of daily living impaired and sleep excessive to be related to Shingrix. It was unknown if the reporter considered the hba1c increased to be related to Shingrix.     The company considered the exhaustion, activities of daily living impaired and sleep excessive to be related to Shingrix. It was unknown if the company considered the hba1c increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-JUN-2023 The reporter was a patient. The patient received Shingrix shot about 2 weeks ago from the date of reporting but she did not have the exact date of the shot or the lot number. She provided her pharmacy's name who would had that data on file. The patient reported that she had to stay home for 2 days, because of the shot, due to being exhausted and resting and sleeping for 2 days. The patient also reported that she had her blood drawn and the results show that her HbA1c level was one point higher than her previous score. The reporter did consent to follow up.
Age: 11.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix was given to a patient 11 years old instead of Boostrix; Infanrix was given to a patient 11 years old instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa (Infanrix) (batch number 7C9NS, expiry date 12-JAN-2024) for prophylaxis.   On 08-JUN-2023, the patient received Infanrix. On 08-JUN-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Infanrix was given to a patient 11 years old instead of Boostrix) and wrong vaccine administered (Verbatim: Infanrix was given to a patient 11 years old instead of Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 8-Jun-2023 The office manger asked that it was a valid dose. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received a dose of Infanrix instead of Boostrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Doses received more than 6 months apart; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In January 2020, received first dose in left arm.).   On 09-JUN-2023, the patient received the 2nd dose of Shingrix (right arm). On 09-JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Doses received more than 6 months apart). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2023 The reporter was a patient. The reporter reported that she received second dose of Shingrix more than 6 months apart from first dose. The reporter did consent to follow up. The patient received 2nd dose of Shingrix late than recommended time frame, which led to lengthening of vaccination schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of SHINGRIX 3 years ago, and not received second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of SHINGRIX 3 years ago, and not received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 09-JUN-2023 A pharmacist reported about a patient who received the first dose of SHINGRIX 3 years ago, and never received the second dose. The reporter did not consent to follow-up. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination. This case had been linked with case US2023081615 reported by same reporter.; Sender's Comments:  US-GSK-US2023081615:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient received the first dose of SHINGRIX 3 years ago second dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix 3 years ago.).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient received the first dose of SHINGRIX 3 years ago second dose not received yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 09-JUN-2023 A pharmacist reported about a patient who received the first dose of SHINGRIX 3 years ago, and never received the second dose. The reporter did not consent to follow-up. Till the time of reporting the patient had not received the second dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023081616:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: missed the 2-6 month window for their second dose of Shingrix; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: missed the 2-6 month window for their second dose of Shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2023 Sales representative submitted the following for a physician. The physician asked what to do if a patient missed the 2-6 month window for their 2nd dose of Shingrix. He asked if the patient should restart the 2nd dose series. They did not spoke with the health care provider. Till the day of reporting the patient did not received the second dose, which lead to incomplete course of vaccination. The reporter asked to follow up the Sales representative for more information.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received the second dose 4 years after the first; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years before 2nd dose of shingrix).   On 06-JUN-2023, the patient received the 2nd dose of Shingrix. On 06-JUN-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: received the second dose 4 years after the first). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-JUN-2023 The veterinarian called in to ask if their spouse had to restart their dosing schedule. They provided partial information about vaccine, event and patient. They also inquired about the recommendations of Shingrix in patients with prior episodes of shingles. The reporter consented to follow up. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The patient never got the 2nd dose of Shingrix. No other information was available. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. This was 1 of 2 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023082392:Same reporter, different patient
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: administered an expired Kinrix (exp:5/26/23); This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 5R3KX, expiry date 26-MAY-2023) for prophylaxis.   On 12-JUN-2023, the patient received Kinrix (left thigh). On 12-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: administered an expired Kinrix (exp:5/26/23)). 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: 12-Jun-2023 The medical physician called to inquired that how to proceed. The reporter did not consent to follow-up. The patient received an expire dose of Kinrix, which led to expired vaccine used.
Age: 54.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Underdose
Clinical narrative: Inappropriate dose administered; Inappropriate dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 54-year-old male patient who received HAV (Havrix 720) (batch number D7HA9, expiry date 27-OCT-2024) for prophylaxis.   On 07-JUN-2023, the patient received Havrix 720. On 07-JUN-2023, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: Inappropriate dose administered) and adult use of a child product (Verbatim: Inappropriate dose administered). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 12-JUN-2023 The reporter consented to follow-up. An adult patient received a dose of Havrix 720, which led to underdose and adult use of a child product.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: patient had received an expired dose of Kinrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26-MAY-2023) for prophylaxis.   On 12-JUN-2023, the patient received Kinrix. On 12-JUN-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: patient had received an expired dose of Kinrix). 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: 12-Jun-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was inadvertently given a dose of expired Havrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix) (expiry date JAN-2023) for prophylaxis.   On 12-JUN-2023, the patient received Havrix. On 12-JUN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: patient was inadvertently given a dose of expired Havrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 12-Jun-2023 The registered nurse did not had patient details or lot number to provide. The reporter consented to follow-up. The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired havrix vaccine administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 13-year-old female patient who received HAV (Havrix pediatric) (batch number gp75a, expiry date 04-OCT-2018) for prophylaxis.   On 20-NOV-2018, the patient received Havrix pediatric. On 20-NOV-2018, an unknown time after receiving Havrix pediatric, the patient experienced expired vaccine used (Verbatim: Expired havrix vaccine administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-JUN-2023 The reporter called to verify the expiration of a vaccine lot number and stated that vaccine was given one month after the supposed expiration date. The vaccine facility was the same as primary reporter. The reporter did consent to follow up. The patient received a Havrix pediatric which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: Late 3rd dose.; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 36-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received first two doses around 1996).   On an unknown date, the patient did not receive the 3rd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: Late 3rd dose.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-JUN-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the 3rd dose of Engerix-B, which led to incomplete course of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (COMIRNATY) for an unknown indication.    No Medical History information was reported.   On an unknown date, 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 and dose of TOZINAMERAN (COMIRNATY) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medication information was reported. Patient used over-the-counter cold medicine Alka-Seltzer Power Max Gels. The case was not severe and did not need a prescription.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was also reported that one of the patient had COVID-19 No concomitant medication was reported.  No treatment information was reported   This case was linked to US-MODERNATX, INC.-MOD-2023-728521, US-MODERNATX, INC.-MOD-2023-728530 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728530:Patient 3 US-MODERNATX, INC.-MOD-2023-728521:Patient 2
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday June 7/23 to 3 patients after the expiry date of June 1 2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received either the 4th or the 5th dose. No concomitant medication was reported.  The expiry date for the suspect was reported as 01-JUN-2023. It was also reported that one of the patient had COVID-19.  No treatment information was reported.  This case was reported for elderly patient out of 3 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-728519 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728519: Case(Patient 1)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Patient did not report any relevant medical history, conditions, allergy, concomitant diseases, and risk factor. It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 07-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 07-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Lot number 021H22A was accidentally administered yesterday 07-Jun-23 to patient after the expiry date of 01-Jun-2023).    Concomitant drugs were not reported. It was reported that the patients either received the expired vaccine as 4th or 5th dose.  It was also reported that one of the patient had COVID-19. Treatment medications were not provided.  This case was reported for elderly patient of total 3 patient.   This case was linked to US-MODERNATX, INC.-MOD-2023-728519 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728519. Case(Patient 1)
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Malaise
Clinical narrative: It almost kill me/I'd rather be dead than to deal with this; When I get up, I feel like I'm wearing a suit made of lead; It was sickening.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (It almost kill me/I'd rather be dead than to deal with this), DISCOMFORT (When I get up, I feel like I'm wearing a suit made of lead) and MALAISE (It was sickening.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (It almost kill me/I'd rather be dead than to deal with this), DISCOMFORT (When I get up, I feel like I'm wearing a suit made of lead) and MALAISE (It was sickening.). At the time of the report, FEELING ABNORMAL (It almost kill me/I'd rather be dead than to deal with this), DISCOMFORT (When I get up, I feel like I'm wearing a suit made of lead) and MALAISE (It was sickening.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. On 28-Mar-2021, patient got 1st shot of vaccine. It almost killed him. It ruined patient's life. Patient stated vaccine facility owe him 10 million dollars for what they did to his life. Patient used to be a triathlete just 3 days before. Nobody was trying to fix them & help them. They just want to take money from the government. It was sickening.  No treatment information was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral
Clinical narrative: peripheral neuropathy after the shot; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (peripheral neuropathy after the shot) 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 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 an unknown date, the patient experienced NEUROPATHY PERIPHERAL (peripheral neuropathy after the shot) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (peripheral neuropathy after the shot) had not resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) event of neuropathy peripheral. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event was not resolved. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.    Reporter did not allow further contact; Reporter's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no medical history reported, who experienced the unexpected serious (medically significant) event of neuropathy peripheral. The event occurred after a dose of mRNA-1273.222 vaccine. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, event was not resolved. The benefit-risk relationship of mRNA-1273.222 vaccine is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: Pregnancy; No adverse event; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnancy) and NO ADVERSE EVENT (No adverse event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022c21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-May-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 11-Nov-2022, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnancy) and NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnancy).    No concomitant medications were reported.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported. Company comment: This spontaneous case concerns a 34-year-old female patient, with no medical history reported, who got pregnant and the non-serious and unexpected event of MATERNAL EXPOSURE BEFORE PREGNANCY was reported with no adverse event associated. The exposure was reported one year and a half after the third dose of mRNA-1273 vaccine, and no details of other doses were reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 71.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 021H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (last dose (bivalent)) on 26-Oct-2022, SHINGRIX, PREVNAR 20 and BOOSTRIX. Past adverse reactions to the above products included No adverse reaction with BOOSTRIX, COVID-19 VACCINE, PREVNAR 20 and SHINGRIX.    On 08-Jun-2023, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 08-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    No concomitant medication was reported. It was reported  that the patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. HCP stated she was confused because they have a lot number that was received from another facility and they told them that the expiration for that lot number has been extended to 11JUL2023, but when she confirmed in the tracker the expiration date was 01JUN2023. HCP mentioned they already administered 1 dose to a patient. It was a intact cartons with the vial size 2.5 ml. The vial was initially stored in the refrigerator on 02-MAY-2023. The vial did not undergo any temperature excursions. No treatment medication was provided.
Age: 40.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023) and NO ADVERSE EVENT (No adverse event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7167B) for COVID-19 prophylaxis.     No relevant medical history/conditions, allergy, concomitant diseases and risk factor were reported.  Previously administered products included for Product used for unknown indication: COVID-19 VACCINE JANSSEN (Dose 1 and batch/lot number: Unknown); for COVID-19 prophylaxis: Spikevax (Dose 2 monovalent, batch/lot number: Unknown and administered 4 months ago). Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE JANSSEN and Spikevax.    On 08-Jun-2023, 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 08-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (Pharmacist is calling to ask if there is an extension to the expiration date of lot umber AS7167B. They checked on the vial expiration checker and the date came up as 07Jun2023).    No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: She got the first dose in 8Feb2022 but didn't get the second dose.; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (She got the first dose in 8Feb2022 but didn't get the second dose.) and NO ADVERSE EVENT (No adverse event) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (She got the first dose in 8Feb2022 but didn't get the second dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (She got the first dose in 8Feb2022 but didn't get the second dose.) 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 assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (She got the first dose in 8Feb2022 but didn't get the second dose.).    No concomitant drugs were reported.  No treatment drugs were reported.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: Vaccine administered that was 3 days past expiration for THAW time in the fridge. Thawed on 5/11/23, expired on 6/10/23. Vaccine administered on 6/13/23
Age: 0.17
Sex: M
Vaccine: UNK, UNK
Symptoms: Vomiting
Clinical narrative: Pt presented to clinic for 2-mo well child exam. Included in this were his 2-mo vaccinations. One of which was oral Rotateq. During admin of Rotateq, baby vomited. I checked with PCP regarding how to proceed and was instructed to re-administered the dose using a new vaccine. Followed provider's instructions with successful admin. .
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Loss of consciousness, Posture abnormal
Clinical narrative: Patient was seated when the shot was administered. Moments after administration the patient lost consciousness for about 10 to 15 seconds and slumped back in the chair. Patient came to and said she was fine. The patient refused EMS. The patient was monitored for 10 minutes and left with her caregiver. Patient does not drive and was instructed to go to ER if any other symptoms occur in the next 48 hours
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Blindness, Dizziness, Dyspnoea, Hyperhidrosis, Nausea
Clinical narrative: Pt became diaphoretic, vasovagal reaction loss of site for less than a minute occurring 10 minutes after vaccination administered in waiting room, nausea, SOB. BP 100/62, Pulse 77 4 minutes  reading. EMS called Paramedics arrived pt examined and reported at 19 minutes after  to be stable conscious with slight dizziness. Pt was initially placed on exam table supine with legs elevated.