chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: No report of patient experiencing symptoms from improperly stored and administered MMR II / No additional AE; Medical assistant calling to report adverse event with improperly stored and administered vaccine, MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 13-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, two dose series, administered as prophylaxis (lot number, expiration date, and route of administration were not provided) (Product storage error). No report of patient experiencing symptoms or adverse event from improperly stored and administered measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II).
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain 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 pain (Verbatim: Painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.   It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2023 This case was reported by a patient via interactive digital media. The patient was given the shingles vaccine and it was really painful, he/she imagined that the disease was much, much worse.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: can not move my shoulder; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In OCT-2022, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced mobility decreased (Verbatim: can not move my shoulder). The outcome of the mobility decreased was not resolved.   It was unknown if the reporter considered the mobility decreased to be related to Shingles vaccine.  It was unknown if the company considered the mobility decreased to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-JUL-2023 This case was reported by a patient via interactive digital media. The patient was given the shingles vaccine and he/she still could not move his/her shoulder properly.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 08-JUL-2023, the patient received the 1st dose of Shingles vaccine. On 08-JUL-2023, less than a day after receiving Shingles vaccine, the patient experienced injection site pain (Verbatim: Injection hurts). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUL-2023 This case was reported by a patient via interactive digital media. Any pharmacy could administer the shingles vaccine.  The patient's doctor recommended it to him/her.  The patient did not want to get it because some people said that they had a bad reaction to it, he told him/her it was preferable to have a reaction for a few days over the pain of having shingles for months, he/she followed his advice, he/she decided to get it at the time of reporting and the injection only hurt a bit.  The reporter stated that he/she think you were eligible after 50.  The patient took his advice and he/she would get the second one later.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: a lot of pain in my arm; I only had fever throughtout the day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 03-JUL-2023, the patient received Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: I only had fever throughtout the day) and pain in arm (Verbatim: a lot of pain in my arm). In JUL-2023, the outcome of the fever was resolved (duration 1 day) and the outcome of the pain in arm was resolved.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingles vaccine.  It was unknown if the company considered the fever and pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-JUL-2023 This case was reported by a patient via interactive digital media. The patient only had a fever throughout the day but it was just one day, a lot of pain in his/her arm but it was gone away now.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness; This non-serious case was reported by a physician via sales rep and described the occurrence of dizziness in a 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 dizziness (Verbatim: Dizziness). The outcome of the dizziness was not reported.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     It was unknown if the company considered the dizziness to be related to Shingrix.   Additional Information: GSK receipt date: 12-JUL-2023 It was reported that patient experienced dizziness especially when standing up after receiving 1st dose of Shingrix. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pain, Pyrexia
Clinical narrative: fever of 102; Feeling sore; Sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 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 fever (Verbatim: fever of 102), pain (Verbatim: Feeling sore) and sickness (Verbatim: Sick). The outcome of the fever, pain and sickness were not reported.   It was unknown if the reporter considered the fever, pain and sickness to be related to Shingrix.     It was unknown if the company considered the fever, pain and sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 12-JUL-2023 The patient received first Shingrix vaccine and had 102 fever. He/she was feeling sore and was sick. He/she asked if one vaccine dose was effective.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Iritis
Clinical narrative: occurred on 6/25/19 vaccinated, 7/25/19 iritis initially occurred, vaccinated sec; This non-serious case was reported by a physician via call center representative and described the occurrence of iritis in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-JUN-2019, the patient received the 1st dose of Shingrix. On 25-JUL-2019, 30 days after receiving Shingrix, the patient experienced iritis (Verbatim: occurred on 6/25/19 vaccinated, 7/25/19 iritis initially occurred, vaccinated sec). The outcome of the iritis was not reported.   It was unknown if the reporter considered the iritis to be related to Shingrix.   It was unknown if the company considered the iritis to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR097564   Additional Information: GSK receipt Date: 14-JUL-2023 The patient was vaccinated with Shingrix and iritis initially occurred, The doctor would like to be contacted by email by medical information to discuss his condition. The reporter agreed to follow up from GlaxoSmithKline. For tolerance of 2nd dose of Shingrix, refer case US2023AMR097564.; Sender's Comments:  US-GSK-US2023AMR097564:Same patient. second dose
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Iritis, Vaccine positive rechallenge
Clinical narrative: vaccinated second was 11/12/19, iritis flared up again on 12/12/19; This non-serious case was reported by a physician via call center representative and described the occurrence of iritis in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of iritis (received 1st dose on 25th June 2019, for tolerance of 1st dose , refer case  US2023AMR097538).   On 12-NOV-2019, the patient received the 2nd dose of Shingrix. On 12-DEC-2019, 30 days after receiving Shingrix, the patient experienced iritis (Verbatim: vaccinated second was 11/12/19, iritis flared up again on 12/12/19). Rechallenge with Shingrix was positive. The outcome of the iritis was not reported.   It was unknown if the reporter considered the iritis to be related to Shingrix.  It was unknown if the company considered the iritis to be related to Shingrix.   Linked case(s) involving the same patient:US2023AMR097538   Additional Information: GSK Receipt Date: 14-JUL-2023 The patient was vaccinated with Shingrix and iritis flared up again. The doctor would like to be contacted by email by medical information to discuss his condition. The reporter agreed to follow up from GlaxoSmithKline.; Sender's Comments:  US-GSK-US2023AMR097538:Same patient, first dose
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Skin discharge
Clinical narrative: Spots starting oozing a discharge yesterday; spots on both of his legs that were very itchy; His arm was sore; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included warfarin sodium (Coumadin).   In JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 02-JUL-2023, less than a month after receiving Shingrix, the patient experienced pruritus (Verbatim: spots on both of his legs that were very itchy). On 06-JUL-2023, the patient experienced skin discharge (Verbatim: Spots starting oozing a discharge yesterday). On an unknown date, the patient experienced pain in arm (Verbatim: His arm was sore). The patient was treated with white soft paraffin (Vaseline). The outcome of the pruritus and skin discharge were not resolved and the outcome of the pain in arm was resolved (duration 4 days).   It was unknown if the reporter considered the pruritus, pain in arm and skin discharge to be related to Shingrix.     It was unknown if the company considered the pruritus, pain in arm and skin discharge to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-JUL-2023 The reporter was a patient. The reporter reported that he received Shingrix vaccine and starting the evening of the vaccine or the next morning, his arm was sore and remained sore for about 4 days (no specific dates provided). The patient also reports that, he noticed he had spots on both of his legs that were very itchy, randomly spaced, some close together and others 5 to 6 inches apart and, these spots starting oozing a discharge. Patient reports these spots itch more at night than during the day, and he put vaseline on them because he thought they might be bug bites. The reporter reported that he still had the spots, itching and discharge to the reporting day. Patient also mentioned he was on Coumadin 7.5MG and Coumadin 3.75MG (pre existing medication before the Shingrix Vaccine). The patient did not had any lot/expiry information. The reporter did consent to follow up.
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Drug ineffective, Incomplete course of vaccination
Clinical narrative: Patient only had one dose; asthma was acting out despite having Nucala; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included mepolizumab (Nucala) powder for injection for eosinophilic asthma.   Previously administered products included Shingles vaccine (Patient had 1st dose a years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On 14-JUN-2023, the patient started Nucala. On an unknown date, an unknown time after receiving Shingles vaccine and an unknown time after starting Nucala, the patient experienced incomplete course of vaccination (Verbatim: Patient only had one dose) and lack of drug effect (Verbatim: asthma was acting out despite having Nucala). The action taken with Nucala was unknown. The outcome of the incomplete course of vaccination and lack of drug effect were unknown.   It was unknown if the reporter considered the lack of drug effect to be related to Nucala.     It was unknown if the company considered the lack of drug effect to be related to Nucala.   Additional Information: GSK Receipt Date: 07-JUL-2023 The patient stated she started Nucala on June 14th by a nurse.  Patient had the vial presentation of Nucala.  Patient stated that last week she felt like her asthma was acting out despite having Nucala (lack of drug effect).  During the conversation patient stated that she had a shingles vaccine years ago but she only had one dose.  Patient could not remembered the presentation of the vaccine and whether it was a GSK vaccine.  Filed reported of underdose of shingles vaccine.  Patient did not want to be associated with this report and wanted to file it as anonymous. The reporter did not consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Red arm; swollen arm; Itchy arm after first dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number 55HA3, expiry date 02-JUL-2024) for prophylaxis.   On 01-MAY-2023, the patient received the 1st dose of Shingrix. On 02-MAY-2023, 1 days after receiving Shingrix, the patient experienced erythema of extremities (Verbatim: Red arm), swelling arm (Verbatim: swollen arm) and itchy upper limbs (Verbatim: Itchy arm after first dose of Shingrix). The outcome of the erythema of extremities, swelling arm and itchy upper limbs were resolved (duration 5 days).   It was unknown if the reporter considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, swelling arm and itchy upper limbs to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter called to report that the patient received Shingrix vaccine and day after vaccination she had a red, swollen, itchy arm for 5 days. The reporter did consent to follow up via email.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 74-year-old male patient who received Herpes zoster (Shingrix) (batch number X9KC7, expiry date 25-OCT-2024) for prophylaxis.   Previously administered products included Shingrix (1st and 2nd dose received on an unknown date).   On 10-JUL-2023, the patient received the 3rd dose of Shingrix. On 10-JUL-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: 3rd dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 10-JUL-2023 Pharmacist called to inform that earlier that day, a patient received a 3rd dose of Shingrix.  The Vaccine Administration Facility was the same as Primary Reporter. Consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: she did not reconstitute the SHINGRIX antigen with the adjuvant; she did not reconstitute the SHINGRIX antigen with the adjuvant; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUL-2023, the patient received Shingrix (left deltoid). On 11-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: she did not reconstitute the SHINGRIX antigen with the adjuvant) and inappropriate dose of vaccine administered (Verbatim: she did not reconstitute the SHINGRIX antigen with the adjuvant). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 11-JUL-2023 Pharmacist reported that she did not reconstitute the Shingrix antigen with the adjuvant. Reporter stated that she injected only the adjuvant into the patient's left deltoid.  Pharmacist reported adverse event to GlaxoSmithKline 15 minutes after adverse event occurred. (AE filed).  The patient was asymptomatic without harm at present time. The reporter was transferred to medical information for further instructions. Consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix potential administration error/only 2 vials of Powder in it; Shingrix potential administration error/only 2 vials of Powder in it; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Shingrix potential administration error/only 2 vials of Powder in it) and inappropriate dose of vaccine administered (Verbatim: Shingrix potential administration error/only 2 vials of Powder in it). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date:12-Jul-2023 The Intern said that they found a box of Shingrix with only two vials of powder in it.  The reporter was looking if they could a two extra diluent for it.  The reporter could be due to administration error not sure. No other information was available. The reporter consented to follow up. The Intern said that they found a box of Shingrix with only two vials of powder in it, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 1.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 19-month-old male patient who received DTPa (Infanrix) (expiry date 10-JUN-2023) for prophylaxis.   On 11-JUL-2023, the patient received Infanrix. On 11-JUL-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-JUL-2023 The reporter reported that expired dose of Infanrix was administered to a patient which led to expired vaacine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: male adult who received Shingrix first dose 2/27/2020 and he has never received second dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (on 27-FEB-2020, the patient received the 1st dose of Shingrix,batch number 3L3PR, expiry date 01-DEC-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: male adult who received Shingrix first dose 2/27/2020 and he has never received second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 13 Jul 2023: The pharmacist technician had patient who received Shingrix first dose and he had never received second dose. The reporter consented to followup via email. Till the time of reporting the patient did not  received 2nd dose which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Not received 2nd dose 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 male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2022).   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: Not received 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-JUL-2023 Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient received an incorrectly reconstituted dose of Menveo/lyophilized portion was reconstituted with sterile diluent; patient received an incorrectly reconstituted dose of Menveo/lyophilized portion was reconstituted with sterile diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA859A, expiry date 31-JAN-2024) for prophylaxis.   On 13-JUL-2023, the patient received Menveo. On 13-JUL-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received an incorrectly reconstituted dose of Menveo/lyophilized portion was reconstituted with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: patient received an incorrectly reconstituted dose of Menveo/lyophilized portion was reconstituted with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 13 Jul 2023 A nurse reported that a patient received an incorrectly reconstituted dose of Menveo. The lyophilized portion was reconstituted with sterile diluent. The reporter consented to follow up via email. The patient received an incorrectly reconstituted dose of Menveo, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received a SHINGRIX dose by mistake today when he went for a Covid vaccine; received a SHINGRIX dose by mistake today when he went for a Covid vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13-JUL-2023, the patient received Shingrix (unknown arm). On 13-JUL-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: received a SHINGRIX dose by mistake today when he went for a Covid vaccine) and wrong vaccine administered (Verbatim: received a SHINGRIX dose by mistake today when he went for a Covid vaccine). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   Additional Information: GSK receipt date 13 Jul 2023: The reporter was the uncle of a patient and was concerned about possible harm.  The patient received a SHINGRIX dose by mistake when he went for a Covid vaccine. The patient was a healthy 15 year-old. The uncle did not know the pharmacy where the injection was received, nor did he know which arm it was received in. The reporter did not consent to follow-up. The 15 year-old patient received a SHINGRIX dose by mistake when he went for a Covid vaccine, which led to inappropriate age at vaccine administration and wrong vaccine administered.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: accidently administered an expired dose; 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 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 34l52, expiry date 06-JUL-2023) for prophylaxis.   On 14-JUL-2023, the patient received Shingrix. On 14-JUL-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: accidently administered an expired dose). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 14-July-2023 The reporter stated that the patient was accidently administered an expired dose of Shingrix on the day of reporting which led to expired vaccine used. The reporter consented to follow up.; Sender's Comments: GSK receipt date: 14-July-2023 The reporter stated that the patient was accidently administered an expired dose of Shingrix on the day of reporting which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient via a company representative 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 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: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine)) 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. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired product administered to adult patient received expired booster doses of Bivalent Moderna COVID-19 vaccine)).    No concomitant information was reported. Suspect product dosage text was reported as unknown. The 2.5ml vial was initially stored in the refrigerator on 07-JUL-2023 and date of administration of vaccine was 07-JUL-2023 there might be another date in June2023 but not sure and did not underwent any temperature excursions. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-732775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732775:master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, 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 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      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 (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine).    No concomitant medication was reported.  Date the vial was initially stored in the refrigerator on 07-JUL-2023. The vial did not undergo any temperature excursion. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732775 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732775:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine)) 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. 022H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 07-Jul-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 07-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine)). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine)) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired product administered (5 adult patients received expired booster doses of Bivalent Moderna COVID-19 vaccine)).    No concomitant medication was reported. Suspect vaccine was Bivalent BA.4-5 Blue Cap. It was reported that suspect vaccine might administer on another date in Jun-2023.  Vial size was reported as 2.5 ml.. Vial was initially stored in the refrigerator on 07-Jul-2023 which was less then 30 days of administration of vaccine. Vial did not undergo any temperature excursions. Expiry date was reported as 01-Jun-2023.  Suspect product dosage text was reported as unknown. Treatment information was not provided.  This case contains information about patient 4th out of 5 patients.      This case was linked to US-MODERNATX, INC.-MOD-2023-732775, US-MODERNATX, INC.-MOD-2023-732775 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732775:master case US-MODERNATX, INC.-MOD-2023-732775:case for Patient 4
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date) 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. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-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) 1 dosage form. On 11-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/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 (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/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 (9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023/Dose administered after 30-day Use By Date).    Pharmacist was called to report that 9 adult patients (Not pregnant) received expired Bivalent Blue Cap booster doses of Moderna COVID-19 vaccine on 10JUN2023 through 24JUN2023. The dose administered after 30-day Use By Date.  The product was Bivalent BA.4-5 Blue Cap Lot number Lot-  AS7642B  and Exp. Date: 13JUL2023). The individual vials or intact cartons, the vial size was 2.5 ml. The date of the vial was initially stored in the refrigerator was 10MAY2023. The vial did not undergo any temperature excursions. This case contains information for the 2nd patient out of 9 patients described by the reporter. Concomitant medications were not reported.  No treatment information was provided by the reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-732805 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732805:Same report Patient 2
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: Caller reports her husband had Covid last August; 1st one: 04Feb2021 2nd dose: 26Oct2021 Next one: 04Mar2022 Next one: 01Apr2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Caller reports her husband had Covid last August) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st one: 04Feb2021 2nd dose: 26Oct2021 Next one: 04Mar2022 Next one: 01Apr2022) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history information were reported by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st one: 04Feb2021 2nd dose: 26Oct2021 Next one: 04Mar2022 Next one: 01Apr2022). In August 2022, the patient experienced COVID-19 (Caller reports her husband had Covid last August). At the time of the report, COVID-19 (Caller reports her husband had Covid last August) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st one: 04Feb2021 2nd dose: 26Oct2021 Next one: 04Mar2022 Next one: 01Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient workouts for 2 hours in the morning and very healthy. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733107, US-MODERNATX, INC.-MOD-2023-733118 (Linked Report). This case was linked to MOD-2023-733102 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733107:Same Reporter US-MODERNATX, INC.-MOD-2023-733118:Same Reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document) 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. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 15-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) 1 dosage form. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document) 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 (5 patients received expired Moderna Bivalent Covid-19 vaccine. 4 of the patients are included in this source document).    Concomitant product use was not provided by the reporter.  Treatment information was not provided.  This case contains information for the 3rd patient out of 4 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732810 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732810:Master case (Patient 3)
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 5 patients received expired Moderna Bivalent Covid-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine) 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. 044H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-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) 1 dosage form. On 15-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (5 patients received expired Moderna Bivalent Covid-19 vaccine) 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 (5 patients received expired Moderna Bivalent Covid-19 vaccine).    This case belongs to the 2nd patient out of 4 patients.  No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732810 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732810:Master case
Age: 3.0
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Body temperature, Expired product administered, No adverse event, Underdose
Clinical narrative: No adverse event; Vaccine administered after beyond use date; Patient administered 0.2 ml of moderna booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date), UNDERDOSE (Patient administered 0.2 ml of moderna booster dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 214K22A) for COVID-19 prophylaxis.     Patient had no known allergies.     On 14-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .2 milliliter. On 14-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and UNDERDOSE (Patient administered 0.2 ml of moderna booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date), UNDERDOSE (Patient administered 0.2 ml of moderna booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.0.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Vaccine administered after beyond use date) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient administered 0.2 ml of moderna booster dose).    Concomitant Medication use information was not provided by reporter.  The patient was not ever been diagnosed with/ tested positive for COVID-19.  Patient had no acute illnesses at the time of vaccination and up to one month before.  Patient had no chronic or long-standing health conditions.  Prescriptions, over the counter medications, dietary supplements or herbal remedies was not being taken by the patient at the time of vaccination and/or at the time of adverse event.  Treatment Medication use information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2023: Updated report type, added reporter information, patient demographics, suspect product dose details, new events (Expired vaccine used and vaccine underdose) and updated narrative.