chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: body aches; chills; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), CHILLS (chills) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds (mold), Allergy (mildew), Dust allergy (dust), Pollen allergy (pollen), Allergy to animal dander (pet dander), Perfume sensitivity (perfume), Chemical sensitivity (bleach), Type 1 diabetes mellitus (Start Date: 50 years ago Recent change in status such as improvement or worsening: Stable) and Celiac disease (Recent change in status such as improvement or worsening: Stable) since 2014.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 27-Mar-2021, PAIN (body aches), CHILLS (chills) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. Patient did nit seek medical care (office visit, Urgent care, ER, hospitalized). Patient did not experienced a similar event in the past. She felt like she had more traveling joint pains, muscle pain, and exhaustion lately.   This case was linked to MOD-2022-668645, MOD-2022-668643 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Chest discomfort, Chest pain, Chills
Clinical narrative: body aches; chills; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), CHILLS (chills) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds (mold), Allergy (mildew), Dust allergy (dust), Pollen allergy (pollen), Allergy to animal dander (pet dander), Perfume sensitivity (perfume), Chemical sensitivity (bleach), Type 1 diabetes mellitus (Start Date: 50 years ago Recent change in status such as improvement or worsening: Stable) and Celiac disease (Recent change in status such as improvement or worsening: Stable) since 2014.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 27-Mar-2021, PAIN (body aches), CHILLS (chills) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. Patient did nit seek medical care (office visit, Urgent care, ER, hospitalized). Patient did not experienced a similar event in the past. She felt like she had more traveling joint pains, muscle pain, and exhaustion lately.   This case was linked to MOD-2022-668645, MOD-2022-668643 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lethargy, Myalgia, Pyrexia
Clinical narrative: body aches; chills; headache; This spontaneous case was reported by a patient and describes the occurrence of PAIN (body aches), CHILLS (chills) and HEADACHE (headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to molds (mold), Allergy (mildew), Dust allergy (dust), Pollen allergy (pollen), Allergy to animal dander (pet dander), Perfume sensitivity (perfume), Chemical sensitivity (bleach), Type 1 diabetes mellitus (Start Date: 50 years ago Recent change in status such as improvement or worsening: Stable) and Celiac disease (Recent change in status such as improvement or worsening: Stable) since 2014.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 25-Mar-2021, the patient experienced PAIN (body aches), CHILLS (chills) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN at an unspecified dose and frequency. On 27-Mar-2021, PAIN (body aches), CHILLS (chills) and HEADACHE (headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications were not reported. Patient did nit seek medical care (office visit, Urgent care, ER, hospitalized). Patient did not experienced a similar event in the past. She felt like she had more traveling joint pains, muscle pain, and exhaustion lately.   This case was linked to MOD-2022-668645, MOD-2022-668643 (Patient Link).
Age: 15.0
Sex: M
Vaccine: COVID19-2
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; got 0.25 ml instead of the full 0.5 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (got 0.25 ml instead of the full 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 15-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-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) .25 milliliter. On 03-Nov-2022, the patient experienced ACCIDENTAL UNDERDOSE (got 0.25 ml instead of the full 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (got 0.25 ml instead of the full 0.5 ml) 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 ACCIDENTAL UNDERDOSE (got 0.25 ml instead of the full 0.5 ml).    Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Pain in extremity
Clinical narrative: arm is just a little sore; women that gave the injection, she said you might want to keep an eye on your arm it was bubbling up, came home and did a little research, it said that could mean that you didn't get a full dose; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm is just a little sore) and INCORRECT DOSE ADMINISTERED (women that gave the injection, she said you might want to keep an eye on your arm it was bubbling up, came home and did a little research, it said that could mean that you didn't get a full dose) in a 63-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-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. On 03-Nov-2022, the patient experienced PAIN IN EXTREMITY (arm is just a little sore) and INCORRECT DOSE ADMINISTERED (women that gave the injection, she said you might want to keep an eye on your arm it was bubbling up, came home and did a little research, it said that could mean that you didn't get a full dose). At the time of the report, PAIN IN EXTREMITY (arm is just a little sore) and INCORRECT DOSE ADMINISTERED (women that gave the injection, she said you might want to keep an eye on your arm it was bubbling up, came home and did a little research, it said that could mean that you didn't get a full dose) outcome was unknown.            No concomitant drug was reported. Patient did a little research and that said that could mean that patient did not got a full dose. Patient was further asking was that true. No treatment drug was reported.
Age: 41.0
Sex: F
Vaccine: COVID19-2
Symptoms: Mycobacterium tuberculosis complex test, No adverse event, Wrong product administered
Clinical narrative: No Adverse Event; bivalent first dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (bivalent first dose) and NO ADVERSE EVENT (No Adverse Event) in a 40-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     The patient had not received any of the doses of COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: Flu shot on 01-Nov-2022. Past adverse reactions to the above products included No adverse event with Flu shot.    On 03-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (bivalent first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, WRONG PRODUCT ADMINISTERED (bivalent first dose) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2022, Mycobacterium tuberculosis complex test: On 03-Nov-2022, no symptoms reported..     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (bivalent first dose).    The concomitant and treatment medication was not reported. No additional doses, medications or treatments.
Sex: U
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022) 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 (Patient received Moderna monovalent booster instead of Moderna bivalent after 8SEP2022).    No concomitant medications was reported. No treatment medications was reported.
Age: 15.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; patient received a bivalent Moderna COVID-19 vaccine as their first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID-19 vaccine as their first dose) and NO ADVERSE EVENT (No adverse event) in a 15-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 03-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID-19 vaccine as their first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID-19 vaccine as their first 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient received a bivalent Moderna COVID-19 vaccine as their first dose).    No concomitant medications was reported. No additional doses and symptoms was reported by patient. No treatment was received by the patient.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropod bite, Food allergy
Clinical narrative: Alpha-gal Syndrome (from a tick bite)/can't eat animals like lamb, pork, or beef/aking out all over stomach, under breast, itching and burning; Alpha-gal Syndrome (from a tick bite); This spontaneous case was reported by a patient and describes the occurrence of FOOD ALLERGY (Alpha-gal Syndrome (from a tick bite)/can't eat animals like lamb, pork, or beef/aking out all over stomach, under breast, itching and burning) and ARTHROPOD BITE (Alpha-gal Syndrome (from a tick bite)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 038A21A and 026A21A) for COVID-19 vaccination.     Concurrent medical conditions included Sulfonamide allergy (Sulfa allergy), Drug allergy (Steroids, Lipitor, Simvastatin), Allergy to antibiotic (Augmentin, Amoxi-Clav), Diabetic (controlled), Bladder disorder NOS (Bladder problem) and Irritable bowel syndrome.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient experienced FOOD ALLERGY (Alpha-gal Syndrome (from a tick bite)/can't eat animals like lamb, pork, or beef/aking out all over stomach, under breast, itching and burning) and ARTHROPOD BITE (Alpha-gal Syndrome (from a tick bite)). At the time of the report, FOOD ALLERGY (Alpha-gal Syndrome (from a tick bite)/can't eat animals like lamb, pork, or beef/aking out all over stomach, under breast, itching and burning) had not resolved and ARTHROPOD BITE (Alpha-gal Syndrome (from a tick bite)) outcome was unknown.            The patient never had COVID positive test or diagnosis. No other vaccines were given within 1 month prior to Moderna COVID-19 vaccine. No concomitant drug was reported. The patient was going to get the Moderna booster, but asked pharmacist if able to take that as the patient was diagnosed about 1 month ago with Alpha gal (from a tick bite) and could not eat animals like lamb, pork, or beef. It was reported that patient did not experience a similar event in the past. Patient visited Allergist and Dermatologist. No treatment was received.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired Bivalent Booster >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 69-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2022 at 8:57 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022 at 8:57 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture).    No concomitant medication was reported.   Patient received first Primary monovalent dose on unknown date,2nd Primary monovalent dose on unknown date, First Monovalent Booster dose on unknown date and unknown Lot number and expiry date.  vial size was 2.5ml Date the vial was initially stored in the refrigerator was 05OCT2022. Date and time vial was first punctured on 02-NOV-2022  at 4:58 PM. The vial did not undergo any temperature excursions. the vial was stored at room temperature in an amber pill vial after post puncture. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was reported 15 hours. No treatment information was reported.   This case was linked to MODERNATX, INC.-MOD-2022-668752 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2022-668752: Patient 1
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired Bivalent Booster greater than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2022 at 8:57 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture).    No concomitant medication was reported.   Date and time vial was first punctured on 02-NOV-2022  at 4:58 PM. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-668692 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668692:Patient 1
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    There was no reported medical history.    On an unknown date, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg /0.4 ml. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) was resolving.            On an unknown date, patient received  Dose 1 and Dose 2 of Moderna COVID-19 vaccine via Intra-muscular route.  The reporter's causality for the event of Sore arm with Adalimumab Solution for Injection was Not provided.  The other causality for the event of Sore arm with Adalimumab Solution for Injection and Moderna COVID-19 vaccine (Elasomeran) was Not provided.  No concomitant medication reported. No treatment medication reported.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Cardiac stress test, Chest X-ray, Chest pain, Choking sensation
Clinical narrative: Chest pains, trouble breathing, choking sensation, chronic burping. Given prescription Zantac for chronic burping.
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram, Dyspnoea, Electrocardiogram, Eructation
Clinical narrative: Chest pains, trouble breathing, choking sensation, chronic burping. Given prescription Zantac for chronic burping.
Age: 31.0
Sex: F
Vaccine: COVID19-2
Symptoms: Cheilitis, Lip swelling, Pruritus, Skin wound, Swelling
Clinical narrative: Continuous rash on lips, mild swelling, itching, broken skin. Brief blister/sore on first day of symptoms with significant swelling of upper and lower lip lasting for an hour or two.
Age: 18.0
Sex: M
Vaccine: COVID19-2, FLUX, SMALLMNK
Symptoms: Injection site discolouration, Injection site discomfort, Injection site erythema
Clinical narrative: site of monkeypox vaccine was red for two weeks following the injection and is currently black, with a green line (most likely a vein) seeming to run through it. no pain but somewhat discomforting
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: I got vaccinated, vaccines are painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR157095   Additional Information: GSK Receipt Date: 28-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient never suffered from shingles disease. The patient received the Shingles vaccine and stated although the vaccines were something painful. The patient thought it was better to get vaccinated than to have the disease, greetings and blessings.  Additional Supportive Information: The follow up would not possible as no contact details were available. This case had been linked with US2022AMR157095, reported by same reporter for same patient.; Sender's Comments:  US-GSK-US2022AMR157095:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: swelling arm,  have cellulitis?; Hotter arm, have cellulitis?; redder arm, have cellulitis?; This case was reported by a consumer via interactive digital media and described the occurrence of swelling arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced swelling arm, skin warm and erythema of extremities. On an unknown date, the outcome of the swelling arm, skin warm and erythema of extremities were not recovered/not resolved.   It was unknown if the reporter considered the swelling arm, skin warm and erythema of extremities to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: This case was received from the patient via interactive digital media. The patient had his /her vaccine 5 days ago from reporting and experienced all the common side effects. After a couple days the patient's arm started feeling better but on reporting day the swelling increased, and it was hotter and redder than it was before. The reported wanted to know do he/she had cellulitis. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the adjuvant; Patient received only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2022, the patient received the 2nd dose of Shingrix. On 27th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: The nurse report via web chat that she administered a dose of Shingrix to a patient and then discovered she had not reconstituted the dose, so the patient only received the adjuvant portion of Shingrix.   This was the patient's second dose in the series.   At the time of reporting, the second dose had not been re-administered.   The nurse ended the chat session before any further details could be obtained. The reporter consent to follow up. Additional Supportive Information: The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: 1st dose 2021, didn't require 2nd; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA728A, expiry date 20th September 2023) for prophylaxis.   Previously administered products included Menveo (1st dose received in 2021).   On 27th October 2022, the patient received the 2nd dose of Menveo. On 27th October 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: The health care professional reported that a patient received a Menveo dose on 2022, but this patient was already administered with the vaccine on 2021, so the patient did not require a second dose of Menveo. The reporter consent to follow up. Additional Supportive Information: The patient received extra Menveo dose, which led to extra dose administered.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Got it at pharmacy
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Took the shingles shot, got shingles after 3 years/Suspected vaccination failure; Got shingles; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. 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.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that the he/she received Shingles vaccine and they told him/her that it would be last for 5 years. The patient stated that he/she experienced Shingles after 3 years of receiving shingles vaccine. The patient reported that the medical business was fallen considerably just because of that they said we should take the vaccine and it did not guarantee it would work and he/she was a living proof. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 2nd round of (Shingles). And I've been vaccinated/Suspected vaccination failure; Recovering from (Shingles) second round; 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.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she had been vaccinated and he/she was recovering from his/her second round of shingles. The patient stated that you do not want this. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 28-OCT-2022 Reporter's Comments: The pharmacist called and ask for information about the administration of Flulaval to a staff member. The Flulaval vaccine that was administered were exposed to room temperature for a few weeks. The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the patient that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consent to follow up. Additional supportive information: The vaccine temperature exposed to temperatures higher than recommended, which led to incorrect storage of drug. This is 1 of the 7 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157002:Same reporter US-GSK-US2022AMR157003:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157008:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 21Dec2019, 2nd 30Jul2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number FA95N, expiry date 28th July 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st December 2019).   On 30th July 2022, the patient received the 2nd dose of Shingrix. On 30th July 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's comment: Pharmacist reported that a patient got first dose of Shingrix on 21st December 2019 and 2nd dose on 30th July 2022. The vaccine administration facility was the same as primary reporter. No information of the patient provided. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: COVID19
Symptoms: Antiphospholipid antibodies, Antiphospholipid antibodies positive, Cardiolipin antibody, Cardiolipin antibody positive
Clinical narrative: HAD ANTIPHOSPHOLIPID ANTIBODY; ANTICARDIOLIPIN WENT HIGH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced had antiphospholipid antibody, and anticardiolipin went high. Laboratory data (dates unspecified) included: Anticardiolipin antibodies High, and had antiphospholipid antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the had antiphospholipid antibody and anticardiolipin went high was not reported. This report was non-serious.; Sender's Comments: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 Disease 3 months after the 2nd monovalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 Disease 3 months after the 2nd monovalent booster dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 Disease 3 months after the 2nd monovalent booster dose). At the time of the report, COVID-19 (COVID-19 Disease 3 months after the 2nd monovalent booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity, Vaccination site movement impairment
Clinical narrative: Sore Arm; He stated he lost 30% used in his right arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (He stated he lost 30% used in his right arm) and PAIN IN EXTREMITY (Sore Arm) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048L21A, 037F01A, 026A21A and 013L20A) for COVID-19 vaccination.     Patient had no tested positive or diagnosed. Patient had not taken any other vaccines within 1 month prior to Moderna covid-19 vaccine.  The patient's past medical history included Cardiac operation (7 years ago). Concurrent medical conditions included Drug addict. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 07-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) (Intramuscular) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore Arm). In April 2022, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (He stated he lost 30% used in his right arm). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (He stated he lost 30% used in his right arm) and PAIN IN EXTREMITY (Sore Arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: Negative.         Post vaccination patient's arm was sore and got worse. Patient lost 30% used in right arm. Patient went to see a general practitioner, had a blood test, Lyme and rheumatoid arthritis test done, and they all came back negative. The general practitioner stated that the side effects were common. Patient randomly mention yelling at wife. Patient went to see at a rheumatologist, and rheumatologist try to put patient on prednisone again. Patient went to see a bone doctor and bone doctor explained that side effects were not skeletal it was in the muscle in the arm. Patient was not mad and was a high risk patient . Patient also reported that his doctor want him to take 5 th dose.
Age: 76.0
Sex: M
Vaccine: COVID19-2, FLUX
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever of 101 degrees; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 101 degrees) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Patient reported of having no allergies. Patient did not have COVID positive test.    On 02-Nov-2022, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 02-Nov-2022 at 5:30 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PYREXIA (Fever of 101 degrees). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 101 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2022, Body temperature: 101 F.         Patient reported about Concomitant medication, but he did not specify on what medication.  Patient received the flu shot at the same. On 28-JAN-2021, patient received first dose, Lot no. unknown. On 25-FB-2021, patient received second dose, Lot no. unknown. On 25-OCT-2021, patient received third dose, Lot no. unknown.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Fall
Clinical narrative: Patient sat in chair. Was asked DOB, allergies, previous flu shot/ rxns, how feeling today - said he was fine today. Asked about his classmates  and why it took so long for them to return to class. He told me of previous flu shot at Pharmacy and "they lied to me". Tried to reassure him I'd be gentle as I could. used alcohol prep pad/ gauze gave shot in the left arm and he started to fall forward with his head.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Endotracheal intubation, Seizure
Clinical narrative: the child suffered a seizure and was admitted to the hospital; This spontaneous report was received from the patient's mother and refers to a 12-month-old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-OCT-2022, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, administered for prophylaxis (dose, strength, lot #, expiry date, and route of administration were not provided).  On 23-OCT-2022, the patient experienced a seizure and was admitted to the hospital. The patient was intubated for two days while on oxygen. Treatment also included unspecified steroids and antibiotics. On an unknown date in October 2022, the patient was discharged from the hospital. At the time of reporting, the patient had not recovered from the event of seizure.   The causal relationship between the seizure and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was unknown.  Upon internal review, the event seizure was determined to be medically significant. The reporter considered the event seizure to be life threatening.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: armpit to swell; This case was reported by a consumer via call center representative and described the occurrence of local swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 26th October 2022, the patient received Shingles vaccine. In October 2022, less than a week after receiving Shingles vaccine, the patient experienced local swelling. On an unknown date, the outcome of the local swelling was not recovered/not resolved.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comment: The patient got his/her shingles shot on Wednesday, the patient had to stay home yesterday the day before reporting with all the side effects happening. The patient was better on the day of reporting. The patient's armpit on the same side was swollen.  The reporter wanted to know if it was normal. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2019, 2nd not received; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-OCT-2022 Reporter's Comments: The patient born 1948 took first dose in 2019 and never got second dose. Chat disconnected before HCP provided details. During this interaction with HCP by chat, there was no opportunity to ask for permission to follow up since the HCP disconnected the chat immediately after getting medical information response. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.