chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4
Symptoms: Inappropriate schedule of product administration
Clinical narrative: flulaval on October 18th 2023 and 2nd dose on October 30th (less than 4 weeks gap; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 12-month-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2023-2024 season) for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLULAVAL QUADRIVALENT).   On 30-OCT-2023, the patient received the 2nd dose of FluLaval Quadrivalent 2023-2024 season. On 30-OCT-2023, an unknown time after receiving FluLaval Quadrivalent 2023-2024 season, the patient experienced drug dose administration interval too short (Verbatim: flulaval on October 18th 2023 and 2nd dose on October 30th (less than 4 weeks gap). The outcome of the drug dose administration interval too short 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: 01-NOV-2023 The pharmacist asked about what was the next step. The patient received 2nd dose of Flulaval earlier than recommended interval (less than 4 weeks gap as per schedule), which led to shortening of vaccination schedule. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received only the diluent portion of Shingrix; patient received only the diluent portion of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old male patient who received Herpes zoster (Shingrix) (batch number 7X5Y9, expiry date 22-NOV-2025) for prophylaxis.   On 31-OCT-2023, the patient received Shingrix. On 31-OCT-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the diluent portion of Shingrix) and inappropriate dose of vaccine administered (Verbatim: patient received only the diluent portion of Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The reporter reported that the patient received only the diluent portion of Shingrix. The reporter gave by error Shingrix diluent portion only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: She was age 67 when she received the immunization; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 67-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy (Splenectomy (spleen removal )) and distal pancreatectomy. Concomitant products included MENQUADFI and insulin aspart (Insulin Novolog).   On 14-AUG-2023, the patient received Bexsero. On 14-AUG-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: She was age 67 when she received the immunization). The outcome of the inappropriate age at vaccine administration 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: 01-NOV-2023 The reporter was the patient. The reporter reported that she did not have the lot number of Bexsero. The reporter reported that Bexsero was approved for use in individuals aged 10 through 25 years and she was over the recommended age.  The reporter did not want to share her doctor of medicine (MD) contact information with GlaxoSmithKline. The patient received a dose of Bexsero above the recommended age schedule, which led to inappropriate age at vaccine administration. The reporter did not consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received a dose of Arexvy without reconstitution (liquid portion only); received a dose of Arexvy without reconstitution (liquid portion only); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 85-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: received a dose of Arexvy without reconstitution (liquid portion only)) and inappropriate dose of vaccine administered (Verbatim: received a dose of Arexvy without reconstitution (liquid portion only)). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 01-NOV-2023 The pharmacist reported that patient might had received a dose of Arexvy without reconstitution (liquid portion only), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was not in the office, did not provide further information. The Vaccine Administration Facility is the same as Primary Reporter. The reporter did not consent to follow-up.
Age: 67.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Havrix on 31AUG2023 and 2nd dose of Havrix on 01NOV2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received HAV (Havrix 1440 adult) (batch number T9TL9, expiry date 05-DEC-2025) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX 1440 ADULT).   On 01-NOV-2023, the patient received the 2nd dose of Havrix 1440 adult (intramuscular). On 01-NOV-2023, an unknown time after receiving Havrix 1440 adult, the patient experienced drug dose administration interval too short (Verbatim: 1st dose of Havrix on 31AUG2023 and 2nd dose of Havrix on 01NOV2023. Lot# and Expiration dates are same for both doses of vaccines). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 1-Nov-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received 2nd dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 43.0
Sex: M
Vaccine: HEP, HEPAB
Symptoms: Inappropriate schedule of product administration, Wrong product administered
Clinical narrative: Engerix B instead of Twinrix third dose; Late 2nd dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 43-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Twinrix (1st dose of Twinrix received on 02 March 2018).   In NOV-2019, the patient received the 2nd dose of Twinrix. On 05-OCT-2023, the patient received Engerix B. In NOV-2019, an unknown time after receiving Twinrix and not applicable after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose). On 05-OCT-2023, the patient experienced wrong vaccine administered (Verbatim: Engerix B instead of Twinrix third dose). The outcome of the wrong vaccine administered and drug dose administration interval too long 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: 01-NOV-2023 The physician assistant called to report a patient received a first dose of Twinrix 02 March 2018, a second dose of Twinrix in November 2019. Then on 05 October 2023 Engerix B was administered instead of third dose of Twinrix which led to wrong vaccine administered. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccinations schedule. (Drug dose administration interval too long) plus 7 days. The reporter consented to follow up via mail. No lot number reported.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error, Product preparation issue
Clinical narrative: Administration of the Rotarix Diluent Alone; Administration of the Rotarix Diluent Alone; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the Rotarix Diluent Alone) and inappropriate dose of vaccine administered (Verbatim: Administration of the Rotarix Diluent Alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152368:Different patient US-GSK-US2023152373:Different patient US-GSK-US2023152365:Different patient US-GSK-US2023152363:Different patient US-GSK-US2023152370:Different patient
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose of Shingrix has not been administered as of yet and is over the recommended 2nd dose schedule; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 19th April 2023).   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: second dose of Shingrix has not been administered as of yet and is over the recommended 2nd dose schedule). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 2-Nov-2023 The patient has not been administered second dose of Shingrix yet and was over the recommended 2nd dose schedule. Did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a third dose of Shingrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a male patient who received Herpes zoster (Shingrix) (batch number 4G95T, expiry date 23-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (received 2 doses on an unknown date).   On 01-NOV-2023, the patient received the 3rd dose of Shingrix. On 01-NOV-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 2-Nov-2023 Pharmacy intern reported that a patient received a third dose of Shingrix, which led to extra dose administered. The reporter did not provide initials and date of birth of the patient. No additional details were provided. The reporter consented to follow-up
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Device connection issue, Exposure via skin contact, Incorrect dose administered
Clinical narrative: needle was not well attached to the syringe and some of the vaccine leaked out and down the patient's arm.; some of the vaccine leaked out and down the patient's arm; some of the vaccine leaked out and down the patient's arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-NOV-2023, the patient received the 2nd dose of Shingrix. On 01-NOV-2023, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: needle was not well attached to the syringe and some of the vaccine leaked out and down the patient's arm.), exposure via skin contact (Verbatim: some of the vaccine leaked out and down the patient's arm) and inadvertent exposure to vaccine (Verbatim: some of the vaccine leaked out and down the patient's arm). The outcome of the incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine were unknown.   Additional Information: GSK receipt date: 02-NOV-2023 The pharmacist called with questions regarding a Shingrix vaccination. Her brother (patient) received his 2nd dose of Shingrix yesterday (day before reporting). The needle was not well attached to the syringe and some of the vaccine leaked out and down the patient's arm, which led to incomplete dose administered, exposure via skin contact and inadvertent exposure to vaccine. The reporter did not consent to follow-up.
Age: 70.0
Sex: F
Vaccine: RVX, VARZOS
Symptoms: Abdominal discomfort, Decreased appetite, Feeding disorder, Pain in extremity, Sleep disorder
Clinical narrative: anorexia/ unable to eat; upset stomach; sleep was interrupted; sore arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On 02-NOV-2023, the patient received the 1st dose of Shingrix (intramuscular, left deltoid) and RSV vaccine (intramuscular, left deltoid). On 02-NOV-2023, less than a day after receiving Shingrix and an unknown time after receiving RSV vaccine, the patient experienced pain in arm (Verbatim: sore arm). On 03-NOV-2023, the patient experienced anorexia (Verbatim: anorexia/ unable to eat), upset stomach (Verbatim: upset stomach) and sleep disturbance (Verbatim: sleep was interrupted). The outcome of the pain in arm, anorexia, upset stomach and sleep disturbance were not resolved.   It was unknown if the reporter considered the pain in arm, anorexia, upset stomach and sleep disturbance to be related to Shingrix and RSV vaccine.     It was unknown if the company considered the pain in arm, anorexia, upset stomach and sleep disturbance to be related to Shingrix and RSV vaccine.   Additional Information: GSK receipt date: 03-NOV-2023 The patient reported that on (Yesterday afternoon) she received her 1st Shingrix dose along with an RSV vaccine.  The manufacturer of the RSV vaccine is unknown.  Today (on the day of reporting) she stated that she has a sore arm and an upset stomach, she was unable to eat, and that her sleep was interrupted a few times last night. The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: RESPIRATORY ISSUES; This solicited report received from a patient: Call Center concerned a male of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient was treated with Simponi aria (golimumab) (solution for infusion, route of admin, and batch number were not reported) 50 mg, frequency, and therapy dates were not reported for rheumatoid arthritis. The batch number was not reported and has been requested. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total was administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced respiratory issues, and was hospitalized (date unspecified). The patient had spent 8 days in the hospital and discharge date was not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with golimumab was not reported. The outcome of respiratory issues was not reported. The reporter provided no causality assessment. Company causality between covid-19 vaccine ad26.cov2.s, and respiratory issues was not related; and between golimumab, and respiratory issues was not related. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20231078069-  covid-19 vaccine ad26.cov2.s-respiratory issues. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered not related. 20231078069-golimumab-respiratory issues. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 046A21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day). The patient was treated with VITAMIN D [VITAMIN D NOS] at an unspecified dose and frequency; CALCIUM at an unspecified dose and frequency; MAGNESIUM at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; IBUPROFEN ongoing since an unknown date for Joint surgery, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and NAPROXEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Every test that they took for blood sugar, Cholesterol, every test they had was in the normal range, there was nothing abnormal in the blood test..     The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  On 25-Sep-2023, the patient received TOZINAMERAN (COMIRNATY) for an unknown indication and on an unknown date, received INFLUENZA VACCINE for an unknown indication.  The patient reported for the Pfizer COVID-19 Vaccine. Received the dose on 25-Sep-2023 and 3 days after started experiencing joint pain which still has today at the time of report.  The patient was taking Vitamin supplements, Vitamin D, Calcium, Magnesium, Vitamin C and I am taking Ibuprofen and extra strength Tylenol.  Lab work: The patient had a complete physical about a week and half ago had a complete lab, for blood sample.  Treatment information included Ibuprofen and Naproxen which, 3 months ago he had a shoulder surgery that the doctor wanted patient to take the Ibuprofen as part of his therapy.  Anatomical location of administration was right arm.  This was the first vaccine gotten of Pfizer.  The patient has had several, had the original, then had a booster and then had another booster and this says that it was a Moderna COVID-19 vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-748655 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748655:Same repoter
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Syncope
Clinical narrative: fainted/Non responsive for short period of time; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SYNCOPE (fainted/Non responsive for short period of time) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 07-Nov-2023, the patient experienced SYNCOPE (fainted/Non responsive for short period of time) (seriousness criterion medically significant). On 07-Nov-2023, SYNCOPE (fainted/Non responsive for short period of time) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment medication information was not provided.  The patient received Flu and covid vaccines at the vaccination clinic offered at work. Reporter overheard saying her that, she laid down after she got the vaccinations but started feeling better, so she went back to her desk. She then went to get water and that is when she fainted. She was non-responsive for short amount of time. Paramedics arrived on site.  Company Comment   This spontaneous case concerns a patient of female patient of an unknown age with medical history of Co-suspect product INFLUENZA VACCINE who experienced the seriousness criterion medically significant unexpected event of syncope the same day after a dose of mRNA-1273.815 vaccine. Concomitant medication nor Treatment details were reported The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: after each one of the vaccines caller experienced an exacerbated rash; This spontaneous case was reported by a patient and describes the occurrence of RASH (after each one of the vaccines caller experienced an exacerbated rash) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 016M20A, 012F21A and 057M21A) for COVID-19 prophylaxis.     Patient had very long medical history.  The patient's past medical history included Transient global amnesia (patient already experienced 2 previous TGA episodes before getting any of the COVID-19 shots. 1st episode between 2011 and 2014 (he did not remember the exact year).), Transient global amnesia (patient already experienced 2 previous TGA episodes before getting any of the COVID-19 shots. 2nd episode happened on SEP2019.) in September 2019 and Rash.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (after each one of the vaccines caller experienced an exacerbated rash). The patient was treated with TRIAMCINOLONE at an unspecified dose and frequency. At the time of the report, RASH (after each one of the vaccines caller experienced an exacerbated rash) had resolved.            Concomitant product use was not provided by the reporter.  It was reported that after each one of the vaccines patient experienced an exacerbated rash that he had before because he was a veteran and was exposed to orange agent, the rash lasted approximately from a couple days to 1 week after each vaccine, and it was treated with Triamcinolone which is a steroid cream to treat topical rashes.   This case was linked to US-MODERNATX, INC.-MOD-2023-748572 (E2B Linked Report). This case was linked to MOD-2023-748572 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748572:Spikevax PFS case
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: She had been sick with a cold; This spontaneous case was reported by a patient and describes the occurrence of NASOPHARYNGITIS (She had been sick with a cold) in an 88-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On 16-Oct-2022, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (She had been sick with a cold). At the time of the report, NASOPHARYNGITIS (She had been sick with a cold) outcome was unknown. Not Provided      For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient received flu vaccination on 30-Oct-2023. No treatment information was provided.   This case was linked to MOD-2023-748585 (Patient Link).
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm at the site of the injection; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore arm at the site of the injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20-2A, 012M20A, 039D21A, 0661221A and 062F22A) for COVID-19 prophylaxis.     The patient's past medical history included Heart attack (before the vaccine), Lung cancer (2x (2019, 2021 not sure if after the first dose) and was radiated.) and Radiation therapy. Concurrent medical conditions included COPD (before the vaccine), Blood pressure high (before the vaccine) and Osteoporosis (diagnosed few months ago.).   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2022, received fifth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (sore arm at the site of the injection). At the time of the report, VACCINATION SITE PAIN (sore arm at the site of the injection) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748633 (E2B Linked Report). This case was linked to MOD-2023-748624 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748633:Husband's Case (Monovalent)
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: sore arm at the site of the injection; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (sore arm at the site of the injection) in a 62-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     The patient's past medical history included Heart attack ((before the vaccine)), Lung cancer (2x (2019, 2021 not sure if after the 1st dose)) and Radiation therapy. Concurrent medical conditions included COPD, Blood pressure high ((before the vaccine)) and Osteoporosis ((just diagnosed a few months ago)).    On 17-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In 2022, the patient experienced INJECTION SITE PAIN (sore arm at the site of the injection). At the time of the report, INJECTION SITE PAIN (sore arm at the site of the injection) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment information was provided.   This case was linked to MOD-2023-748633 (E2B Linked Report). This case was linked to MOD-2023-748624 (Patient Link).; Sender's Comments:  MOD-2023-748633:husband case
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day). The patient was treated with VITAMIN D NOS at an unspecified dose and frequency; CALCIUM at an unspecified dose and frequency; MAGNESIUM at an unspecified dose and frequency; VITAMIN C [ASCORBIC ACID] at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (I have gotten Moderna vaccines that I got, I had no side effects other than a minor sore arm for one day) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Every test that they took for blood sugar, Cholesterol, every test they had was in the normal range, there was nothing abnormal in the blood test..         Concomitant product use was not provided by the reporter.  On 25-Sep-2023, the patient received TOZINAMERAN (COMIRNATY) for an unknown indication and on an unknown date, received INFLUENZA VACCINE for an unknown indication. This was the first vaccine gotten of Pfizer.  The patient reported for the Pfizer COVID-19 Vaccine. Received the dose on 25-Sep-2023 and 3 days after started experiencing joint pain which still has today at the time of report.  The patient was taking Vitamin supplements, Vitamin D, Calcium, Magnesium, Vitamin C and I am taking Ibuprofen and extra strength Tylenol.  Lab work: The patient had a complete physical about a week and half ago had a complete lab, for blood sample.  Treatment information included Ibuprofen and Naproxen which, 3 months ago he had a shoulder surgery that the doctor wanted patient to take the Ibuprofen as part of his therapy.  Anatomical location of administration of Pfizer was right arm.  The patient has had several Moderna vaccinations, had the original, then had a booster and then had another booster and this says that it was a Moderna COVID-19 vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-747830 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-747830:Monovalent case
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Cardiac disorder
Clinical narrative: caller have a heart disease; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (caller have a heart disease) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (caller have a heart disease). At the time of the report, CARDIAC DISORDER (caller have a heart disease) outcome was unknown.            The case was created as Invalid as there was no Moderna product involved as a suspect.  No concomitant medications were reported.  The patient received vaccines, one from Pfizer vaccine, one from Moderna vaccine and another one from manual precautionary created vaccine.  The patient reported to have a heart disease.  No treatment medications were reported.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Pruritus, Urticaria
Clinical narrative: Hives and itchiness both sides of the body; Itchiness both sides of the body; She had bumps in the ears; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (Hives and itchiness both sides of the body), PRURITUS (Itchiness both sides of the body) and EAR SWELLING (She had bumps in the ears) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Patient had no medical conditions.     On 02-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced URTICARIA (Hives and itchiness both sides of the body), PRURITUS (Itchiness both sides of the body) and EAR SWELLING (She had bumps in the ears). At the time of the report, URTICARIA (Hives and itchiness both sides of the body), PRURITUS (Itchiness both sides of the body) and EAR SWELLING (She had bumps in the ears) was resolving.            It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  It was reported that couple of days after the fifth dose she started with hives and itchiness both sides of the body, which affected her face, eyes and ears, she had bumps in the ears, it was severe, not anaphylaxis but severe enough to go to hospital, she was given antiviral and antibiotics, and this was still ongoing at the time of reporting but was minimum compared to what it was earlier.   This case was linked to US-MODERNATX, INC.-MOD-2021-005967 (E2B Linked Report). This case was linked to MOD-2021-005967 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-005967:Monovalent dose
Age: 76.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19, Cough, Dysphonia, Fatigue, Headache
Clinical narrative: hoarse voice; sore throat; three and a half weeks later after vaccination got Covid for the first time ever; cough; runny nose; I was really sick(resp, fever, fatigue, headache); I was really sick(resp, fever, fatigue, headache); I was really sick(resp, fever, fatigue, headache); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (three and a half weeks later after vaccination got Covid for the first time ever), COUGH (cough), DYSPHONIA (hoarse voice), OROPHARYNGEAL PAIN (sore throat) and RHINORRHOEA (runny nose) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205F232A) for an unknown indication. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient's past medical history included Surgery (Huge heart surgery on 25Apr2023 involving two valves in the aorta) on 25-Apr-2023. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy.   On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 26-Oct-2023, the patient experienced PYREXIA (I was really sick(resp, fever, fatigue, headache)), FATIGUE (I was really sick(resp, fever, fatigue, headache)) and HEADACHE (I was really sick(resp, fever, fatigue, headache)). On 31-Oct-2023, the patient experienced RHINORRHOEA (runny nose). On 02-Nov-2023, the patient experienced COVID-19 (three and a half weeks later after vaccination got Covid for the first time ever) and COUGH (cough). On an unknown date, the patient experienced DYSPHONIA (hoarse voice) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, COVID-19 (three and a half weeks later after vaccination got Covid for the first time ever), RHINORRHOEA (runny nose), PYREXIA (I was really sick(resp, fever, fatigue, headache)), FATIGUE (I was really sick(resp, fever, fatigue, headache)) and HEADACHE (I was really sick(resp, fever, fatigue, headache)) outcome was unknown, COUGH (cough) had not resolved and DYSPHONIA (hoarse voice) and OROPHARYNGEAL PAIN (sore throat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient got really sick.  Patient was still coughing and she had not lost her sense of smell or taste.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow up received is non significant. On 03-Nov-2023: Live follow up received. PQC closed report and references added.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Oropharyngeal pain, Pyrexia, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: hoarse voice; sore throat; three and a half weeks later after vaccination got Covid for the first time ever; cough; runny nose; I was really sick(resp, fever, fatigue, headache); I was really sick(resp, fever, fatigue, headache); I was really sick(resp, fever, fatigue, headache); This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (three and a half weeks later after vaccination got Covid for the first time ever), COUGH (cough), DYSPHONIA (hoarse voice), OROPHARYNGEAL PAIN (sore throat) and RHINORRHOEA (runny nose) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 205F232A) for an unknown indication. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    The patient's past medical history included Surgery (Huge heart surgery on 25Apr2023 involving two valves in the aorta) on 25-Apr-2023. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy.   On 25-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 26-Oct-2023, the patient experienced PYREXIA (I was really sick(resp, fever, fatigue, headache)), FATIGUE (I was really sick(resp, fever, fatigue, headache)) and HEADACHE (I was really sick(resp, fever, fatigue, headache)). On 31-Oct-2023, the patient experienced RHINORRHOEA (runny nose). On 02-Nov-2023, the patient experienced COVID-19 (three and a half weeks later after vaccination got Covid for the first time ever) and COUGH (cough). On an unknown date, the patient experienced DYSPHONIA (hoarse voice) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, COVID-19 (three and a half weeks later after vaccination got Covid for the first time ever), RHINORRHOEA (runny nose), PYREXIA (I was really sick(resp, fever, fatigue, headache)), FATIGUE (I was really sick(resp, fever, fatigue, headache)) and HEADACHE (I was really sick(resp, fever, fatigue, headache)) outcome was unknown, COUGH (cough) had not resolved and DYSPHONIA (hoarse voice) and OROPHARYNGEAL PAIN (sore throat) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Nov-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Patient got really sick.  Patient was still coughing and she had not lost her sense of smell or taste.   Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Nov-2023: Live follow up received is non significant. On 03-Nov-2023: Live follow up received. PQC closed report and references added.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus, Urticaria
Clinical narrative: achy shoulder; itching all over/His chest, neck and back were covered/They are gone from his shoulders and chest but mid to lower back is still there; hives; This spontaneous case was reported by a patient and describes the occurrence of PRURITUS (itching all over/His chest, neck and back were covered/They are gone from his shoulders and chest but mid to lower back is still there), URTICARIA (hives) and ARTHRALGIA (achy shoulder) in a 75-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Cipro), Penicillin allergy, Pollen allergy and Ragweed allergy (and others that he cannot think of at the moment.).    On 04-Nov-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 04-Nov-2023, the patient experienced PRURITUS (itching all over/His chest, neck and back were covered/They are gone from his shoulders and chest but mid to lower back is still there) and URTICARIA (hives). On an unknown date, the patient experienced ARTHRALGIA (achy shoulder). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CLOBETASOL for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching all over/His chest, neck and back were covered/They are gone from his shoulders and chest but mid to lower back is still there) had not resolved, URTICARIA (hives) was resolving and ARTHRALGIA (achy shoulder) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. It was reported that patient had allergies to several things. He has had allergic reactions before like to cipro and the exact same thing happened, it was like Deja vu. His pharmacist said to take Benadryl and if it still gets worse then go to the doctor but it did not get worse. He had Clobetasol ointment which he used and it knocked the itch down quickly. They were gone from his shoulders and chest but mid to lower back was still there. He was currently at work at the time of reporting so he does not have information regarding his previous Moderna vaccinations.  .
Age: 68.0
Sex: M
Vaccine: COVID19, RVX
Symptoms: COVID-19, Confusional state, Respiratory syncytial virus infection
Clinical narrative: felt dazed and confused; RSV; Covid-19; This spontaneous case was reported by a patient and describes the occurrence of RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV), COVID-19 (Covid-19) and CONFUSIONAL STATE (felt dazed and confused) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product RSV VACCINE for an unknown indication.    Patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 vaccine and MODERNA COVID-19 VACCINE; for Product used for unknown indication: Influenza vaccine. Past adverse reactions to the above products included No adverse event with Influenza vaccine, MODERNA COVID-19 VACCINE and Moderna COVID-19 vaccine.   On 14-Oct-2023, the patient received third dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of RSV VACCINE (unknown route) 1 dosage form. On 04-Nov-2023, the patient experienced RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV) and COVID-19 (Covid-19). On an unknown date, the patient experienced CONFUSIONAL STATE (felt dazed and confused). The patient was treated with IBUPROFEN at a dose of 800 milligram every six hours and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) at an unspecified dose and frequency. At the time of the report, RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV), COVID-19 (Covid-19) and CONFUSIONAL STATE (felt dazed and confused) outcome was unknown.            No concomitant medication was reported. It was reported that patient had to go to the hospital for his wife on 2-NOV-2023. On 3-NOV-2023 he started to have a little runny nose, slight fever, a little cough, fatigue, and felt dazed and confused.