chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: No other adverse events reported; Caller reports that improperly stored vaccines were administered.; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions, and concomitant drugs were not reported.   On 23-FEB-2023, the patient was vaccinated with Hepatitis A Vaccine, inactivated (VAQTA) intramuscular injection (1 time dose, lot# was reported as 3397T1 but was not valid for Hepatitis A Vaccine, inactivated (VAQTA) and did not match any company product, expiration date was reported as 30-NOV-2023; strength, dose, route of administration, and anatomical location were not reported) for prophylaxis. The vaccine administered was improperly stored at -40F for 70 hours 5 minutes (product storage error). No other adverse events were reported (no adverse event).
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Mobility decreased, Pain
Clinical narrative: yes some days unable to lift arm above mid high not even to my shoulder height, sore to the touch hard to lift objects even at a light weight; yes some days unable to lift arm above mid high not even to my shoulder height, sore to the touch hard to lift objects even at a light weight; have had a sore upper arm fro 3 weeks after having shot; This non-serious case was reported by a consumer and described the occurrence of pain in a 65-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 06-MAY-2023, the patient received Shingles vaccine. In MAY-2023, less than 3 weeks after receiving Shingles vaccine, the patient experienced pain (Verbatim: have had a sore upper arm fro 3 weeks after having shot), mobility decreased (Verbatim: yes some days unable to lift arm above mid high not even to my shoulder height, sore to the touch hard to lift objects even at a light weight) and induration (Verbatim: yes some days unable to lift arm above mid high not even to my shoulder height, sore to the touch hard to lift objects even at a light weight). In MAY-2023, the outcome of the pain was resolved (duration 3 weeks). The outcome of the mobility decreased and induration were not reported.   It was unknown if the reporter considered the pain, mobility decreased and induration to be related to Shingles vaccine.     It was unknown if the company considered the pain, mobility decreased and induration to be related to Shingles vaccine.   Additional Information: GSK receipt date: 26-May-2023 The patient stated that some days unable to lift arm above mid high not even to her shoulder height, sore to the touch hard to lift objects even at a light weight. The reporter consented to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypokinesia, Injection site pain, Joint swelling, Peripheral swelling, Rheumatoid arthritis
Clinical narrative: it looks like rheumatoid arthritis.; Arm pain left arm (site of injection); Swelling of fingers on opposite hand and fingers/Unable to close right hand due to swelling; Unable to close right hand due to Swelling; appear abnormally swollen around the joints; This serious case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included autoimmune disorder.   On 22-MAY-2023 11:30, the patient received the 1st dose of Shingrix (left arm). In MAY-2023, an unknown time after receiving Shingrix, the patient experienced rheumatoid arthritis (Verbatim: it looks like rheumatoid arthritis.) (serious criteria GSK medically significant), injection site pain (Verbatim: Arm pain left arm (site of injection)), hand swelling (Verbatim: Swelling of fingers on opposite hand and fingers/Unable to close right hand due to swelling), movements reduced (Verbatim: Unable to close right hand due to Swelling) and swollen joints (Verbatim: appear abnormally swollen around the joints). The outcome of the rheumatoid arthritis, injection site pain, hand swelling, movements reduced and swollen joints were unknown.   It was unknown if the reporter considered the rheumatoid arthritis, injection site pain, hand swelling, movements reduced and swollen joints to be related to Shingrix.     It was unknown if the company considered the rheumatoid arthritis, injection site pain, hand swelling, movements reduced and swollen joints to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAY-2023. The patient's daughter reported that on 22 May 2023 at 11:30 AM the patient received 1st dose of Shingrix vaccine on and has experienced swelling of her fingers.  The patient was unable to close her hand.  It was abnormally swollen and unknown timeframe of when the swelling started.  Arm pain left arm (site of injection).  Swelling of fingers on opposite hand and fingers (right hand).  The hand and fingers appear abnormally swollen around the joints, it looks like rheumatoid arthritis.  The patient had an autoimmune issue as well. The reporter did consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: patient who received Twinrix first dose on 11/2/2022  and he has never received the 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 63-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (1st dose received on 2nd November 2022, batch number 4F3YY, expiry date 1st January 2023.).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: patient who received Twinrix first dose on 11/2/2022  and he has never received the second dose). The outcome of the incomplete course of vaccination 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: 24-MAY-2023 The reporter reported about a patient who received Twinrix first dose on and had never received the second dose.  The reporter did not consented to follow up.  Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via eye contact, Occupational exposure to product
Clinical narrative: vaccine prior to administer it to a patient a portion of the dose leaked on her eye; vaccine prior to administer it to a patient a portion of the dose leaked on her eye; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of exposure via eye contact in a female 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 exposure via eye contact (Verbatim: vaccine prior to administer it to a patient a portion of the dose leaked on her eye) and occupational exposure while administering product (Verbatim: vaccine prior to administer it to a patient a portion of the dose leaked on her eye). The outcome of the exposure via eye contact and occupational exposure while administering product were unknown.   Additional Information: GSK Receipt Date: 24-MAY-2023 The pharmacist reported that while she was holding a Shingrix vaccine prior to administer it to a patient a portion of the dose leaked on her eye.  The healthcare professional asked for safety information and she asked how to proceed.  The healthcare professional did not provide data about Shingrix dose. The reporter consented to follow up. A portion of the Shingrix dose leaked on the pharmacist eye, which led to exposure via eye contact and occupational exposure while administering product.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Hasn't been administered a 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 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (In 2019, received first dose). Concurrent medical conditions included immunocompromised.   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: Hasn't been administered a second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2023 Physician assistant called to report a patient had not been administered a second dose. First dose was given at a different facility so no information on lot number, vaccination date for the vaccine. The reporter did consent to follow up. Till the time of reporting the patient had not received the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Expired dose given; 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 male patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29-APR-2023) for prophylaxis.   On 23-MAY-2023, the patient received Infanrix. On 23-MAY-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: Expired dose given). 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: 24-May-2023 The medical assistant called to report that an expired dose of Infanrix was accidentally given, wished to know how to proceed.  The information about vaccine, patient and event collected. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. The patient was administered an expired dose of Infanrix, which led to expired vaccine used.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: an expired dose of Pediarix was administered to a patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 6-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number Z4R9R, expiry date 14-MAY-2023) for prophylaxis.   On 24-MAY-2023, the patient received Pediarix. On 24-MAY-2023, an unknown time after receiving Pediarix, the patient experienced expired vaccine used (Verbatim: an expired dose of Pediarix was administered to a patient). 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: 24-MAY-2023 The reporter consented to follow up via email. The patient received expired dose of Pediarix, which led to expired vaccine used.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose of Kinrix; This non-serious case was reported by a nurse 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 H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 24-MAY-2023, the patient received the 1st dose of Kinrix. On 24-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: 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: 25-May-2023 and 26-May-2023 The nurse explained that this would be patient's 4th dose of Polio and 5th dose of Dtap. The reporter consented to follow-up via email. The patient received an expired dose of Kinrix, which led to expired vaccine used.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: received the Shingrix first dose subcutaneously; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number 597C4, expiry date 04-AUG-2024) for prophylaxis.   On 24-MAY-2023, the patient received the 1st dose of Shingrix (subcutaneous, left deltoid). On 24-MAY-2023, an unknown time after receiving Shingrix, the patient experienced intramuscular formulation administered by other route (Verbatim: received the Shingrix first dose subcutaneously). The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2023 The reporter called to enquired that any recommendation if Shingrix was administered subcutaneously instead of Intramuscularly. The reporter reported the patient might have received the Shingrix but it had not been verified if it was.  The reporter stated they believed it was not administered subcutaneously but the patient stated it was.  The reporter did not consent to follow up.  The patient received Shingrix subcutaneously, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: doesn't get the second dose; 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 (received 1st dose over a year).   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: doesn't get the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2023 The reporter submitted the following for a physician. The reporter enquired that the patient got one dose of Shingrix and did not get the second dose and it's had been over a year, did they have to start the 2 series dose over again. The reporter consented to follow up with the sales representative for more information. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received expired first dose of Engerix-B; 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 45-year-old female patient who received HBV (Engerix B) (batch number K329E, expiry date 24-APR-2023) for prophylaxis.   On 25-MAY-2023, the patient received the 1st dose of Engerix B. On 25-MAY-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Patient received expired first dose of Engerix-B). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2023 The patient received expired first dose of Engerix B which led to expired vaccine used. The patient was still on the office and was going to get revaccinated again on the day of reporting. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pediatric dose of Engerix-B was given to an adult; Underdose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult use of a child product in a 25-year-old female patient who received HBV (Engerix B pediatric) (batch number CM294, expiry date 19-APR-2024) for prophylaxis.   On an unknown date, the patient received Engerix B pediatric. On an unknown date, an unknown time after receiving Engerix B pediatric, the patient experienced adult use of a child product (Verbatim: Pediatric dose of Engerix-B was given to an adult) and underdose (Verbatim: Underdose). The outcome of the adult use of a child product and underdose 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: 25-MAY-2023 It was reported that a pediatric dose of Engerix-B was given to an adult. The Vaccine Administration Facility was the same as Primary Reporter. The call dropped before transfer could be made. Adverse event information was provided by another agent who spoke with the HCP when she called back. The reporter consented to follow up via postal.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: will like to know if the patient has to restart the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 6th March 2022 in left arm with batch number 42YY3 and expiry date 28th May 2024).   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: will like to know if the patient has to restart the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 25-MAY-2023 The pharmacist would like to know if the patient had to restart the series. The reporter 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: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Kinrix 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 male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 07-MAY-2023) for prophylaxis.   On 12-MAY-2023, the patient received Kinrix. On 12-MAY-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Kinrix expired dose). 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: 25-MAY-2023 An expired dose of Kinrix was administered to a patient which led to expired vaccine used. The reporter consented to follow up via mail.
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: expired dose of MENVEO was used; 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 15-month-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date 28-FEB-2023) for prophylaxis.   On 22-MAY-2023, the patient received Menveo. On 22-MAY-2023, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: expired dose of MENVEO was used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 25-MAY-2023. The patient received expired dose of MENVEO, which led to expired vaccine used. The reporter did consent to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Chills, Feeling hot, Nausea
Clinical narrative: FELT VERY HOT; CHILLS; NAUSEA; STOMACH CRAMPS; REALLY BAD BACK PAIN; This spontaneous report received from a patient 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 not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 29-APR-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 2021, the patient experienced stomach cramps, really bad back pain, and nausea. On 29-APR-2021, the patient experienced felt very hot, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt very hot, stomach cramps, really bad back pain, chills, and nausea on MAY-2021. This report was non-serious. This case, involving the same patient is linked to 20230562092. This case, from the same reporter is linked to 20230567770.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Limb mass
Clinical narrative: REALLY BIG BUMP ON HER ARM; SORE; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN) dose was not reported, 1 total administered in left arm on 29-APR-2021 for covid-19 prophylaxis. On 29-APR-2021, the patient did some weeding after the shot, and later that night the patient woke up and either had chills or felt very hot (dose number in series 1). The patient experienced nausea, stomach cramps, and really bad back pain (dose number in series 1). The patient compared all events to having really severe flu. The patient was fine after one week. The patient was recovered from chills, felt very hot, nausea, stomach cramps, and really bad back pain on MAY-2021. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 202F21A expiry: UNKNOWN) dose was not reported, 1 total administered in left arm on 17-SEP-2022 for covid-19 prophylaxis.  On an unspecified date, the patient experienced really big bump on her arm, and sore (dose number in series 2). The patient recently had the Shingles vaccines, and experienced all the side effects the second one. It was not further clarified what those other side effects were. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the really big bump on her arm and sore was not reported. This report was non-serious. This case, involving the same patient is linked to 20230562076 (case for dose number in series 1). This case, from the same reporter is linked to 20230567770.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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)) 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 10th of 24 patients described by the reporter.  Concomitant medication was not provided. Patient age was between 6 months to 5-years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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)) 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 11th of 24 patients described by the reporter.  Concomitant medication was not provided. Patient age was between 6 months to 5-years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated. It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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)) 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 12th of 24 patients described by the reporter.  No concomitant medications were reported. Patient age was between 6 months to 5-years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated. It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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)) 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    This case contains information for the 13th of 24 patients described by the reporter.  No concomitant medications were reported. The patient's were between 6 months to 5 years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated. It was reported that 24 patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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)) 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    Case corresponds patient 3 out of 24 patients reported by the reporter.  Concomitant products were not reported. Patient age was between 6 months to 5-years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated. It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment medications were not reported.     This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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)) 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    Concomitant medication was not provided.  Patient age was between 6 months to 5-years. The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated. It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose.  Treatment information was not provided.  This case contains information for the 5th of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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)) 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) .2 milliliter. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.) 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 WRONG PRODUCT ADMINISTERED (They received a 0.2 ml from the pink vial instead of the 0.25 ml from the blue cap vial.).    Patient age was between 6 months to 5-years. Concomitant medication was not reported.  The vaccination clinic received incorrect guidance from the Department of Health in regards to the vaccination, who instructed to order and administer the vials with pink top to 6month-5year previously unvaccinated patients when the switch from monovalent to bivalent happened. This resulted in 24 patients being under vaccinated.  It was reported that 24 pediatric patients were administered underdose bivalent vaccine doses for either their first or second doses. They received 0.2 ml dose from the pink vial instead of the 0.25 ml dose from the blue cap vial. The patients were being contacted and revaccinated with the correct dose. Treatment information was not provided.  This case contains information for the 7th of 24 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723339 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723339:Master case
Sex: M
Vaccine: COVID19-2
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reaction; patient received 2 bivalent booster doses before approval; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (patient received 2 bivalent booster doses before approval) and NO ADVERSE EVENT (No adverse reaction) in an elderly male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 043H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose 1, route: intramuscular, Location of site: left deltoid, batch/lot number: 028L20A, expiration date: 09-Jul-2021) on 23-Jan-2021, Moderna (Dose 2, route: intramuscular, Location of site: left deltoid, batch/lot number: 013M20A, expiration date: 31-Jul-2021) on 23-Feb-2021, Moderna (Dose 3, route: intramuscular, Location of site: left deltoid, batch/lot number: 939904, expiration date: 24-Mar-2022) on 29-Oct-2021, Moderna (Dose 4, route: intramuscular, Location of site: right deltoid, batch/lot number: 002M21A and expiration date: 11-Sep-2022) on 13-Apr-2022; for Product used for unknown indication: Pfizer bivalent (Dose 5, Booster route: intramuscular, Location of site: left deltoid, batch/lot number: GJ5342 and expiration date: 30-Jun-2023) on 16-Sep-2022. Past adverse reactions to the above products included No adverse event with Moderna, Moderna, Moderna, Moderna and Pfizer bivalent.    On 22-Nov-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 22-Nov-2022, the patient experienced EXTRA DOSE ADMINISTERED (patient received 2 bivalent booster doses before approval). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXTRA DOSE ADMINISTERED (patient received 2 bivalent booster doses before approval) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.        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 reaction) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (patient received 2 bivalent booster doses before approval).    No concomitant medications were reported. It was reported that patient didn't experienced any adverse event.It was noticed that when patient come in for bivalent booster after cdc approval of 2 nd dose that he had already received 2 bivalent boosters. It was reported that patient history was not reviewed before entering or administering the vaccine No relevant lab tests or prior vaccinations with in 4 weeks were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, SARS-CoV-2 test
Clinical narrative: No adverse reaction; Dose 1 and Dose 2 taken on 29-Dec-2020 and 10-Jan-2021, 12 days apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 29-Dec-2020 and 10-Jan-2021, 12 days apart) and NO ADVERSE EVENT (No adverse reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004N20A and 026L20A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Codeine. Past adverse reactions to the above products included Allergy with Codeine.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 29-Dec-2020 and 10-Jan-2021, 12 days apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse reaction). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2023 to 17-May-2023 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 and Dose 2 taken on 29-Dec-2020 and 10-Jan-2021, 12 days apart) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2023, SARS-CoV-2 test: Positive.         No concomitant medications were reported. On 10-Nov-2021, the patient received 3rd dose of Moderna Covid-19 vaccine with batch/lot number: 053E21A on left arm.  On 01-Jul-2022, the patient received 4th dose of Moderna Covid-19 vaccine with batch/lot number: 017B22A on left arm. On 11-Oct-2022, the patient received 5th dose of Moderna Covid-19 vaccine with batch/lot number: 049D22A on left arm. It was reported that patuient had a symptoms of bad taste left in mouth that made everything taste bad.  On 13-May-2023, the patient was diagnosed with covid-19 at urgent care. Patient was tested on 21-May-2023. On 23-May-23, covid rebound symptoms were started. The device date was reported as 25-May-2023.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Retinal vein occlusion, Vision blurred, Visual impairment
Clinical narrative: My vision in my right eye over about 4 days became very blurred and blotchy with areas of  no vision.  I saw  my eye Dr and was referred to a retina specialist who I saw the next day.  Was diagnosed with CRVO during that appintment and was told  needed eye injections monthly for the rest of my life.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: bilateral pulmonary embolism
Age: 52.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Arterial occlusive disease, Blood test, Cardiac stress test, Chest pain, Coronary arterial stent insertion
Clinical narrative: Shortness of breath Chest pains Leg pains Heart Attack Timeline of Adverse Events: March 5, 2023: Went to the Emergency Room due to chest pain, discovered my right artery blockage and was having a heart attack. Had an emergency procedure to add stents to open passage way.  March 6, 2023: Had a second procedure to add another stent to the right artery.  (Hospitalized for one week) April 20, 2023: Had third procedure to add stent in the cx left artery done by Dr.