chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HEP
Symptoms: Maternal exposure before pregnancy, No adverse event
Clinical narrative: 8 Weeks Pregnant and Received Heplisav-B; Initial Report Received on 19-Oct-2022  This is a spontaneous report, received from a pregnant female patient, who received HEPLISAV-B for hepatitis B immunization.  There was no medical history reported.  Concomitant medications were not reported.  On 11-Oct-2022, dose 1 of HEPLISAV B (Lot #938793, expiration date 07-Oct2023, NDC # unknown), route not specified, was administered in the left deltoid for hepatitis B immunization.  The patient was 8 weeks pregnant with an estimated date of delivery 27-May-2023.   She did not experience any adverse reactions.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Pregnant and Received First Dose of Heplisav-B; Initial Report Received on 20-Oct-2022  This is a spontaneous report, received from a pharmacist regarding a 29-year-old pregnant female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 1 of HEPLISAV B (Lot #937234, expiration date 12-Sep-2023, NDC # unknown), route not specified, was administered in the left deltoid for hepatitis B immunization.  Pharmacist reported that the patient who received the dose was pregnant. Reporter did not provide any adverse reactions.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Given 3 Doses of Heplisav-B; Initial Report Received on 21-Oct-2022, 27-Oct-2022, 08-Nov-2022  This is a spontaneous report, received from a pharmacist regarding a 63-year-old male patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV B (Lot #937234, expiration date 12-SSep-2023, NDC # unknown), route not specified, was administered in the left deltoid for hepatitis B immunization.   The patient was given 3 doses of HEPLISAV B. No adverse reactions were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Given 3 Doses of Heplisav-B; Initial Report Received on 21-Oct-2022, 27-Oct-2022, 03-Nov-2022  This is a spontaneous report, received from a pharmacist regarding a 71-year-old male patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV B (Lot #937780, expiration date 14-Sep-2023, NDC # unknown), route not specified, was administered in the right deltoid for hepatitis B immunization.  The patient was given 3 doses of HEPLISAV B. No adverse reactions were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Given 3 Doses of Heplisav-B; Initial Report Received on 21-Oct-2022, 27-Oct-2022, 03-Nov-2022,   This is a spontaneous report, received from a pharmacist regarding a 40-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV-B (Lot #938793, expiration date 07-Oct-2023, NDC # unknown), route not specified, was administered in the right deltoid for hepatitis B immunization.   The patient was given 3 doses of HEPLISAV-B. No adverse reactions were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Given 3 Doses of Heplisav-B; Initial Report Received on 21-OCT-2022, 27-Oct-2022, 03-Nov-2022  This is a spontaneous report, received from a pharmacist regarding a 39-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV B (Lot #938233, expiration date 11-Mar-2023, NDC # unknown), route not specified, was administered in the left deltoid for hepatitis B immunization.   No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Second Dose as Engerix; Initial Report Received on 24-Oct-2022  This is a spontaneous report, received from a pharmacist regarding a 35-year-old female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On 19-Sep-2022, dose 1 of HEPLISAV-B (Lot #938794, expiration date 09-Oct-2023, NDC #43528-002-01), route not specified, was administered in the left arm for hepatitis B immunization.  On 24-Oct-2022, the patient received a 2nd dose of another manufacturer's vaccine, Engerix-B, in the right arm. The patient did not report any adverse reactions.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: HEP
Symptoms: Pyrexia, SARS-CoV-2 test negative, White blood cell count increased
Clinical narrative: Elevated WBCs; High Fever; Initial Report Received on 27-Oct-2022  This is a spontaneous report, received from a pharmacist regarding a male patient, aged 26 years, who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On 20-Apr-2022, dose 1 of HEPLISAV B (Lot #935840, expiration date 11-Sep-2022, NDC #43528-003-05), route not specified, was administered in the right arm for hepatitis B immunization.   On an unspecified date, a few days after having been vaccinated with HEPLISAV B, the patient went to urgent care with a high fever and elevated WBCs. The patient was given an antibiotic (name unknown), followed up with an ER visit 4-5 days post injection, and tested negative for COVID-19.  The physician instructed the patient not to get second dose.  No further information was available at the time of the report.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired Dose; Initial Report Received on 28-Oct-2022 and 14-Nov-2022 (report)  This is a spontaneous report, received from a nurse regarding a female patient, aged 32 years, who received HEPLISAV-B for hepatitis B immunisation. The report was also retrieved (Disease Control) (ID 2494169-1) on 14-Nov-2022 and was noted as being reported on 31-Oct-2022.   There was no medical history reported.  Concomitant medications were not reported.  On 20-Oct-2022, dose 1 of HEPLISAV B (Lot #935841, expiration date 17-Sep-2022, NDC #43528-003-05), route not specified, was administered intramuscularly in the right deltoid for hepatitis B immunisation.   The dose was 33 days past the expiration date.   On 28-Oct-2022, an attempt was made to contact the patient when the error was discovered but was unable to reach the patient.  On 31-Oct-2022, the patient was contacted and made aware of the error and the need to re-vaccinate. The patient denied any adverse reactions. She was re-vaccinated on the same day.  Action taken with HEPLISAV B was not reported.  The event was reported as recovered and as non-serious.   No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Heplisav-B as 1st Dose and Then Energix as 2nd Dose A Month Later; Initial Report Received on 31-OCT-2022  This is a spontaneous report, received from a pharmacist regarding a female patient, aged 69 years, who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On 02-AUG-2022, dose 1 of HEPLISAV B (Lot #937229, expiration date 03-SEP-2023, NDC # not reported), intramuscular in the left deltoid for hepatitis B immunization.   On 12-SEP-2022, 41 days after having been vaccinated with HEPLISAV B, the patient was vaccinated with Engerix as a second dose in the left deltoid.  No adverse events were reported.  No further information was available at the time of the report. The reporter did not want to be contacted for additional information.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Received An Expired Dose of Heplisav-B; Initial Report Received on 04-Nov-2022  This is a spontaneous report, received from a nurse regarding a male patient, aged 60 years, who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.   Concomitant medications were not reported.  On 31-OCT-2022, an unspecified dose of HEPLISAV B (Lot #935842, expiration date 29-OCT-2022, NDC #43528-003-05), route not specified, was administered in right arm for hepatitis B immunization.    The patient received an expired dose. The patient did not report any adverse reactions.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnant; Initial Report Received on 04-Nov-2022  This is a spontaneous report, received from a nurse regarding a female patient, aged 30 years, who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported. The patient was reported to have a low titer.  Concomitant medications were not reported.  On 03-NOV-2022, an unspecified dose of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # 43528-003-05), route and site not specified, was administered for hepatitis B immunization.   At the time of vaccination, the patient was 30+ weeks pregnant.  No further information was available at the time of the report.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: UNK
Symptoms: Accidental exposure to product
Clinical narrative: While getting a dose of BioThrax had some come out and a drop or two went into her mouth; A spontaneous report was received from the other healthcare professional on 23NOV2022.  It described a female patient who "while getting a dose of BioThrax (anthrax vaccine adsorbed) had some come out and a drop or two went into her mouth" (PT: Accidental exposure to product). It was reported that a while ago, when the patient was getting a dose of BioThrax, she had some come out (not confirmed at the time of reporting if she said if it was from the needle or not) but a drop or two went into her mouth, which was open (due to talking) and it tasted bad. The outcome of the reported event was not applicable.  Action taken with BioThrax with respect to the reported event was not applicable.  The concurrent conditions, medical history, and concomitant medications of the patient were not reported.  No additional information was reported.  Company comment: It was reported that a patient while getting a dose of BioThrax (anthrax vaccine adsorbed) had some come out and a drop or two went into her mouth (accidental exposure to product). Further information is limited. Considering the case information, the causality of accidental exposure to product is assessed as not applicable with BioThrax. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient while getting a dose of BioThrax (anthrax vaccine adsorbed) had some come out and a drop or two went into her mouth (accidental exposure to product). Further information is limited. Considering the case information, the causality of accidental exposure to product is assessed as not applicable with BioThrax. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Two shots 4 Y ago, then shingles again/Suspected vaccination failure; shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 28-Nov-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that after his/her first shingles, he/she had two shots 4 years ago and found out that had shingles again. The patient thought the vaccine was 95 percent effective. The patient was on antiviral medication now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Patient given expired fluarix vaccine; This case was reported by a other health professional and described the occurrence of expired vaccine used in a 6-year-old patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number CA599, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th November 2022, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 25th November 2022, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-Nov-2022 Reporter's comment: The reporter was reaching out to saw if they can get some guidance after administering an expired Flu vaccine to a pediatric patient.  The patient's guardian was a physician and would keep an eye out for adverse reactions. The reporter asked that what was next steps, the patient need to be revaccinated. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Fluarix quadrivalent, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-NOV-2022 Reporter's Comment: This case was reported by a patient via (Shingrix GSK) interactive digital media. The patient received a dose of Shingles vaccine and experienced swelling at injection site. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: feels like she has shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles 5 times).   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-NOV-2022 Reporter's Comment: The case was self reported by the patient. The patient received a dose of Shingrix a couple weeks ago and now felt like she had shingles again. The patient had shingles five times and her doctor recommended to get Shingrix.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: HAD COVID BAD TWO TIMES; This spontaneous report received from a parent concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced had covid bad two times. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had covid bad two times was not reported. This report was non-serious. This report was associated with product quality complaint 90000261380 The suspected product quality complaint has been confirmed to be voided (the reporter's daughter was vaccinated and had covid. there is no product quality issue described in the information reported as there is insufficient information to determine vaccination failure. there is no timeline for date of vaccination to contracting covid and no confirmatory test reported.) based on the PQC evaluation/investigation performed.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 29-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received first dose in primary series one day beyond manufacturer's expiration date of 11/28/2022).    Concomitant medication was not reported.  Patient received first dose in primary series one day beyond manufacturer's expiration date of 28-Nov-2022. Physician and patient was notified on 30-Nov-2022. Patient was not experiencing any adverse symptoms at that time. It was unknown if the patient experienced any additional symptoms/events. Treatment medication was not reported.  Vaers report submitted 01-Dec-2022.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: MUSCLE SPASMS; Muscle spasms; side effects from COVID-19 vaccination; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (MUSCLE SPASMS), MUSCULOSKELETAL STIFFNESS (Muscle spasms) and IMMUNISATION REACTION (side effects from COVID-19 vaccination) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Oral) 40 milligram. On an unknown date, the patient experienced MUSCLE SPASMS (MUSCLE SPASMS), MUSCULOSKELETAL STIFFNESS (Muscle spasms) and IMMUNISATION REACTION (side effects from COVID-19 vaccination). At the time of the report, MUSCLE SPASMS (MUSCLE SPASMS), MUSCULOSKELETAL STIFFNESS (Muscle spasms) and IMMUNISATION REACTION (side effects from COVID-19 vaccination) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment medications were provided by the reporter.  It was unknown if patient was enrolled in COVID-19-vaccine trial.  The reporter's causality for the events of Muscle spasm and side effects from COVID-19 vaccination with Adalimumab Solution for Injection was not provided.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022; No Adverse event; Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022), EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022) and NO ADVERSE EVENT (No Adverse event) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 prophylaxis.     It was unknown whether patient ever been diagnosed with or tested positive for COVID-19.     On 26-Sep-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022), EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Vaccine was stored on refrigerator on 22-Aug-2022 and vaccine was administered on 26-SEP-2022) and EXPIRED PRODUCT ADMINISTERED (Patient given vaccine after BUD date, expire beyond date 22-Sep-2022, vaccine administered 26-SEP-2022).    Concomitant Medication use information was not provided by reporter.  It was reported that vaccine coordinator was calling to report that some patients (Adults and Pediatrics) received expired Moderna COVID-19 vaccine after 30 days beyond use date 22-Sep-2022.  There were unbroken cartons. Vial size for 6 months to 5 years was 2.5 ml. The vial was initially stored in the refrigerator on 22-Aug-2022. The patient was given vaccine after BUD date.   The vial did not undergo any temperature excursions.  No reported adverse events.  Treatment Medication use information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 01-Dec-2022: Non significant follow up received contains no new information.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Received Monovalent booster instead of bivalent by mistake; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of bivalent by mistake) and NO ADVERSE EVENT (No Adverse event) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 075B22A, 067H21A, 003B21A and 011A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of bivalent by mistake). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of bivalent by mistake) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Received Monovalent booster instead of bivalent by mistake).    No concomitant medication information was provided.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022; No adverse event; Received doses after its beyond use date; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022) 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. 061f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Nov-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received doses after its beyond use date) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator on 11-Oct-2022 and administered on 30-Nov-2022).    Concomitant medication was not reported.  Reporter reported that the vial was individual vial and size was 2.5 ml. The vial was initially stored in refrigerator on 11-Oct-2022. The vial did not undergo any temperature excursion.  Treatment information was not reported.  This case contains information for the 7th patient out of 8 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-680810, US-MODERNATX, INC.-MOD-2022-680811, US-MODERNATX, INC.-MOD-2022-680808 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-680810:Samer Reporter US-MODERNATX, INC.-MOD-2022-680808:Samer Reporter US-MODERNATX, INC.-MOD-2022-680811:Samer Reporter
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; given an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (given an expired vaccine).    No concomitant medications were reported. The patient had not reported any adverse event at the time of the call. It was not asked if this were the patient's 1st or 2nd dose. No treatment medications were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Diagnosed with Covid; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Diagnosed with Covid) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. R506MZ119, 021B21A and 014M20A) for COVID-19 prophylaxis.     No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine.  Concurrent medical conditions included Food allergy (Green peppers), Arthritis and Gastroesophageal reflux.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, the patient experienced COVID-19 (Diagnosed with Covid). At the time of the report, COVID-19 (Diagnosed with Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.   On 22-Apr-2022, the patient received first booster dose of Moderna COVID-19 Vaccine. It was reported that the batch number was illegible-unsure.  Patient was tested positive for COVID-19 in early June. Patient had mild symptoms of COVID. The patient was not hospitalized.  The patient received infusion as treatment.   This case was linked to MOD-2022-681024, MOD-2022-680917 (Patient Link).
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; administered with an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 38-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 083B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (administered with an expired vaccine).    No concomitant medications were reported.  No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event; given the bivalent as the 1st dose; This spontaneous case was reported by a medical assistant and describes the occurrence of WRONG PRODUCT ADMINISTERED (given the bivalent as the 1st dose) 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. 0178H22A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 30-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (given the bivalent as the 1st dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (given the bivalent as the 1st dose) 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 (given the bivalent as the 1st dose).    No concomitant medication was reported.  On 30-Nov-2022, the bivalent booster dose was given to a patient who never had any Moderna Covid-19 shot. The patient was made to sit down for 15 minutes and left without reporting any side effects.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Rhinorrhoea
Clinical narrative: runny nose; cdoes not feel well after the shot; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and MALAISE (cdoes not feel well after the shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose) and MALAISE (cdoes not feel well after the shot). At the time of the report, RHINORRHOEA (runny nose) and MALAISE (cdoes not feel well after the shot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication was reported. No treatment medication was reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, COVID-19
Clinical narrative: COVID disease a long time after Moderna COVID shots; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID disease a long time after Moderna COVID shots) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In August 2022, the patient experienced COVID-19 (COVID disease a long time after Moderna COVID shots). At the time of the report, COVID-19 (COVID disease a long time after Moderna COVID shots) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, COVID-19: Positive. On an unknown date, Antibody test: 6.     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No concomitant information was reported. It was reported that patient wife antibody level was 25000. No treatment information was provided.   Reporter did not allow further contact
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; given an expired vaccine; given the monovalent vaccine as booster dose; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (given an expired vaccine), WRONG PRODUCT ADMINISTERED (given the monovalent vaccine as booster dose) and NO ADVERSE EVENT (No adverse event) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (batch no: EW0183) on 22-Aug-2021 and Pfizer (batch no: EW0191) on 12-Sep-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 25-Nov-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) and WRONG PRODUCT ADMINISTERED (given the monovalent vaccine as booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (given an expired vaccine), WRONG PRODUCT ADMINISTERED (given the monovalent vaccine as booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (given an expired vaccine) and WRONG PRODUCT ADMINISTERED (given the monovalent vaccine as booster dose).    No concomitant medication were reported.  Medical assistant reports that a co-worker accidentally administered an expired vaccine to the patient. Monovalent vaccine of Individual vials. Vial size was 5.5ml. The vial was initially stored in the refrigerator on 15-Nov-2022. The vial did not undergo any temperature excursions. No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-681150 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681150:Same reporter
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Given an expired vaccine; Given the monovalent vaccine as booster dose; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Given an expired vaccine), WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster dose) and NO ADVERSE EVENT (No adverse event) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013B22A, 029H21B, 025B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Given an expired vaccine) and WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Given an expired vaccine), WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Given an expired vaccine) and WRONG PRODUCT ADMINISTERED (Given the monovalent vaccine as booster dose).    The concomitant medication was not reported by reporter. The Medical assistant reports that a co-worker accidentally administered an expired vaccine. They wanted to know if there were certain risks if patient was revaccinated. Vial for 5.5 ml. On 15-Nov-2022, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-681148 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-681148:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate irregular
Clinical narrative: irregular heart beat; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEART RATE IRREGULAR (irregular heart beat) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE IRREGULAR (irregular heart beat). At the time of the report, HEART RATE IRREGULAR (irregular heart beat) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: irregular.   No concomitant medication was reported.  No treatment medication was reported.  Company Comment:  This is a spontaneous case concerning a male of unknown age, patient with no reported medical history, who experienced the unexpected non-serious AESI of heart rate irregular. The event is reported in relationship with a dose of mRNA-1273.222 vaccine, however latency could not be assessed due to lack of information. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2022-681153, US-MODERNATX, INC.-MOD-2022-680935 (E2B Linked Report).; Sender's Comments: This is a spontaneous case concerning a male of unknown age, patient with no reported medical history, who experienced the unexpected non-serious AESI of heart rate irregular. The event is reported in relationship with a dose of mRNA-1273.222 vaccine, however latency could not be assessed due to lack of information. No further information on clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273.222 Vaccine is not affected by this report. US-MODERNATX, INC.-MOD-2022-681153:Father-in-law US-MODERNATX, INC.-MOD-2022-680935:Stepdad
Sex: M
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Alopecia shortly after 2nd Primary dose/My Hair Is Gone after 2nd vaccine/Everyone is laughing at me post alopecia after 2nd vaccine; This spontaneous case was reported by a patient and describes the occurrence of ALOPECIA (Alopecia shortly after 2nd Primary dose/My Hair Is Gone after 2nd vaccine/Everyone is laughing at me post alopecia after 2nd vaccine) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced ALOPECIA (Alopecia shortly after 2nd Primary dose/My Hair Is Gone after 2nd vaccine/Everyone is laughing at me post alopecia after 2nd vaccine). At the time of the report, ALOPECIA (Alopecia shortly after 2nd Primary dose/My Hair Is Gone after 2nd vaccine/Everyone is laughing at me post alopecia after 2nd vaccine) outcome was unknown.            No concomitant medications were reported.  Adult patient was calling to file a complaint. He stated that he received 2 doses of Moderna COVID-19 vaccine in 2021. He stated that shortly after 2nd dose, he started having alopecia profanity and cursing Moderna employees. He stated that he has not wasted his time going to a doctor. patients hair was gone and everyone was laughing at patient, and patient can not even sue Moderna.  No treatment medications were reported.   Reporter did not allow further contact