chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: U
Vaccine: COVID19, COVID19, FLUX
Symptoms: Blood immunoglobulin E, Urticaria chronic
Clinical narrative: Positive for Covid; Lethargy; Fever; Redness and pain at the injection site; Redness and pain at the injection site; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Positive for Covid), LETHARGY (Lethargy), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness and pain at the injection site) and VACCINATION SITE PAIN (Redness and pain at the injection site) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Lot No EP7533) on 02-Apr-2021 and Pfizer (Lot No ER8735) on 23-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced LETHARGY (Lethargy), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness and pain at the injection site) and VACCINATION SITE PAIN (Redness and pain at the injection site). On 14-Jun-2022, the patient experienced COVID-19 (Positive for Covid). In 2021, LETHARGY (Lethargy), PYREXIA (Fever), VACCINATION SITE ERYTHEMA (Redness and pain at the injection site) and VACCINATION SITE PAIN (Redness and pain at the injection site) had resolved. At the time of the report, COVID-19 (Positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jun-2022, SARS-CoV-2 test: (Positive) Positive.         Concomitant medications were not reported.  Patient had regular symptoms observed like fever, lethargy, redness and pain at the injection site for a couple of days. Patient had no allergic reactions in any of the vaccines before. Patient had symptoms as coughing and shortness of breath. Patient was not hospitalized or anything but had a rough case for a week and had to use an inhaler and other medications to improve coughing and shortness of breath.   This case was linked to MOD-2022-657728 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: Follow-up received contains no new information
Age: 1.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022; No adverse event; Received the Moderna COVID 19 vaccine after the 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event) in a 12-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Avocado).    On 11-Oct-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after the 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after the 30-day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Received the Moderna COVID 19 vaccine after the 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 07-Sep-2022 and administered on 11-Oct-2022).    No concomitant medications were reported.  The monovalent vaccine was initially stored on 07-Sep-2022. The vial size was 2.5 ml. The vial did not underwent any temperature excursions.   No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657633 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657633:Same Reporter
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID-19; Patient had one dose of J & J and one Moderna and no booster dose; Patient had one dose of J & J and one Moderna and no booster dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Patient had one dose of J & J and one Moderna and no booster dose) and COVID-19 IMMUNISATION (Patient had one dose of J & J and one Moderna and no booster dose) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of COVID-19 VACCINE NRVV AD26 (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Patient had one dose of J & J and one Moderna and no booster dose) and COVID-19 IMMUNISATION (Patient had one dose of J & J and one Moderna and no booster dose). At the time of the report, COVID-19 (COVID-19), INTERCHANGE OF VACCINE PRODUCTS (Patient had one dose of J & J and one Moderna and no booster dose) and COVID-19 IMMUNISATION (Patient had one dose of J & J and one Moderna and no booster dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  Patient was experiencing the exact same rebound like patient's wife and the rebound symptoms were diarrhea, upper and lower colds.  Patient thought patient had just gotten post-covid colds until tested.  Device Date was reported as 10-Oct-2022.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657738 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2022: The  live follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657738:MOD-2022-657738 - Wife's Case
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash after first primary shot; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash after first primary shot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in 2020 and Rash in 2020.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced RASH (Rash after first primary shot). At the time of the report, RASH (Rash after first primary shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported by the reporter. After the first shot, the patient had a rash similar to when she had COVID in 2020. She also mentioned that all her shots were of Moderna vaccine. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-658044 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medicine was reported. It was reported that the patient got 2nd booster dose as well after the all 3 doses. No treatment medicine was reported.   Reporter did not allow further contact
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphagia, Headache, Pyrexia
Clinical narrative: swallowing problems and it is hard for him to swallow pills; Headache; Very low fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DYSPHAGIA (swallowing problems and it is hard for him to swallow pills), HEADACHE (Headache) and PYREXIA (Very low fever) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced HEADACHE (Headache) and PYREXIA (Very low fever). On an unknown date, the patient experienced DYSPHAGIA (swallowing problems and it is hard for him to swallow pills). The patient was treated with PARACETAMOL (TYLENOL) for Headache and Fever, at an unspecified dose and frequency. At the time of the report, DYSPHAGIA (swallowing problems and it is hard for him to swallow pills), HEADACHE (Headache) and PYREXIA (Very low fever) outcome was unknown.            No concomitant medications were reported.  It was reported that patient experienced some adverse events after receiving the second booster dose of the Moderna Covid 19 vaccine. Patient received this 4th dose on May2022 and 24 hours after, he had a headache and very low fever.  Patient took a Tylenol for the symptom.  Patient has swallowing problems and it is hard for him to swallow pills.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Wrong product administered
Clinical narrative: Only pulled out to give the doses and then put back in the fridge; No adverse event; Dose administered over12 hours post puncture; 0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered over12 hours post puncture), PRODUCT STORAGE ERROR (Only pulled out to give the doses and then put back in the fridge), WRONG PRODUCT ADMINISTERED (0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster) and NO ADVERSE EVENT (No adverse event) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022 at 12:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Oct-2022 at 12:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered over12 hours post puncture) and WRONG PRODUCT ADMINISTERED (0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Only pulled out to give the doses and then put back in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered over12 hours post puncture), PRODUCT STORAGE ERROR (Only pulled out to give the doses and then put back in the fridge), WRONG PRODUCT ADMINISTERED (0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered over12 hours post puncture), PRODUCT STORAGE ERROR (Only pulled out to give the doses and then put back in the fridge) and WRONG PRODUCT ADMINISTERED (0.25 mL of Monovalent Moderna vaccine was given as a 3rd booster).    No concomitant medications were reported.  It was reported as one vial, 5.5 mL was first punctured on 10-OCT-2022 at 9:00 AM and the same vial was administered on 11-OCT-2022 at 12:30 PM and the vial was stored in fridge post puncture and vial doesn't undergo any temperature excursions. It was also reported that Total amount of time the vial was exposed to room temperature range (8 to 25 degree Celsius equals to 46 to 77 degree Fahrenheit) was less than 24 hours. Vial was only pulled out to give the doses and then put back in the fridge.  No treatment medications were reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Lymphadenopathy, Rash
Clinical narrative: Heartburn radiating from left to right of body; Rash; Lymph nodes on the side of Neck are swollen; This spontaneous case was reported by a patient and describes the occurrence of DYSPEPSIA (Heartburn radiating from left to right of body), RASH (Rash) and LYMPHADENOPATHY (Lymph nodes on the side of Neck are swollen) 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. AS7148B) for COVID-19 immunisation.     The patient's past medical history included COVID-19 in 2020.    On 21-Sep-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 21-Sep-2022, the patient experienced DYSPEPSIA (Heartburn radiating from left to right of body), RASH (Rash) and LYMPHADENOPATHY (Lymph nodes on the side of Neck are swollen). At the time of the report, DYSPEPSIA (Heartburn radiating from left to right of body), RASH (Rash) and LYMPHADENOPATHY (Lymph nodes on the side of Neck are swollen) outcome was unknown.            No concomitant medications were provided. No treatment medication was provided. The patient was screaming and asking, what vaccine did they give and did not want to speak health department.   This case was linked to MOD-2022-658039 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Patient felt very sleepy; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient felt very sleepy) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Patient felt very sleepy). At the time of the report, SOMNOLENCE (Patient felt very sleepy) outcome was unknown.     It was unknown if any treatment was given or if patient was under any concomitant or regular medication.
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; given the same booster dose as last year; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (given the same booster dose as last year) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (given the same booster dose as last year). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (given the same booster dose as last year) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant products were reported. No treatment drugs were reported   Reporter did not allow further contact
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event; Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose) and NO ADVERSE EVENT (No adverse event) in a 41-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 060f22a) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Oct-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INCORRECT DOSE ADMINISTERED (Patient received one dose of the bivalent Moderna COVID19 vaccine as a second dose).    No concomitant medications were reported. No treatment details were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Underdose
Clinical narrative: No adverse event; patient received 0.25 ml of Moderna bivalent vaccine instead of 0.5 ml; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (patient received 0.25 ml of Moderna bivalent vaccine instead of 0.5 ml) and NO ADVERSE EVENT (No adverse event) in a 52-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027E22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 01-Oct-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 01-Oct-2022, the patient experienced UNDERDOSE (patient received 0.25 ml of Moderna bivalent vaccine instead of 0.5 ml). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient received 0.25 ml of Moderna bivalent vaccine instead of 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 UNDERDOSE (patient received 0.25 ml of Moderna bivalent vaccine instead of 0.5 ml).    No concomitant drug was reported. No treatment drug was reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; a 0.5ml bivalent booster dose instead of his primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (a 0.5ml bivalent booster dose instead of his primary series) and NO ADVERSE EVENT (No adverse event) in a 77-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 12-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (a 0.5ml bivalent booster dose instead of his primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (a 0.5ml bivalent booster dose instead of his primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (a 0.5ml bivalent booster dose instead of his primary series).    No concomitant medication details was reported. No treatment medication details was reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; administered the dose from a vial that was punctured 24 hours ago/doses administered >12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered the dose from a vial that was punctured 24 hours ago/doses administered >12 hours post puncture) and NO ADVERSE EVENT (No Adverse event) in a 57-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 059f22a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Oct-2022 at 2:30 PM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Oct-2022 at 2:30 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered the dose from a vial that was punctured 24 hours ago/doses administered >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 (administered the dose from a vial that was punctured 24 hours ago/doses administered >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 (administered the dose from a vial that was punctured 24 hours ago/doses administered >12 hours post puncture).    No concomitant medications were reported. The vials were Individual. Vial size was 2.5 ml. Vial was initially stored in the refrigerator on 06-Oct-2022 at 10:56 AM Date and time of the vial first punctured : 09-Oct-2022 10 AM Date and time of vaccine administration : 10-Oct-2022 2:30 PM The vial was stored in the fridge post puncture. The vial was not undergone any temperature excursions. Total amount of time the vial was exposed to room temperature range (8 to 25 degree C equals to 46 to 77 degree F): 30 minutes out of the Fridge. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-658091 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2022: Live Follow-up  Significant information accepted. Added patient details, reporter details and date of administration of vaccine.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-658091:MOD-2022-658091 (patient case)
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, No adverse event
Clinical narrative: No adverse event; Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-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 12-Oct-2022, the patient experienced ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster) 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 (Received 0.25 ml dose instead of 0.5 ml for Bivalent Booster).    Concomitant medications were not reported. No treatment information was provided by the reporter. This case contains information for the 6th adult patients out of 15 adult patients described by the reporter.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: feel sick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 77-year-old female patient received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 76 years for covid-19 immunisation. The patient's relevant medical history included: "AFib" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot: EN6201 NDC, Exp: Unknown), administration date: 15Feb2021, when the patient was 76-year-old, for Covid-19 Immunization, reaction(s): "positive for Covid after one dose vaccine"; BNT162b2 (DOSE 1, SINGLE, Lot: EN6201 NDC, Exp: Unknown), administration date: 15Feb2021, when the patient was 76-year-old, for Covid-19 immunization, reaction(s): "With the previous doses of Covid-19 vaccine, she felt sick after receiving them"; BNT162b2 (DOSE 2, SINGLE, Lot: EN9581 NDC, Exp: Unknown), administration date: 08Mar2021, when the patient was 76-year-old, for Covid-19 immunization, reaction(s): "With the previous doses of Covid-19 vaccine, she felt sick after receiving them". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "feel sick". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise.  Additional Information: It was reported that the other 2 boosters made her feel sick, but that did not last long. Report was not related to a study or programme. Takes something else for the heart. No Other Conditions, Investigations. Covid-19 vaccine was a Pfizer product. Treatment included just Tylenol. No prior vaccinations within 4 weeks. No family medical history relevant to AE, No emergency room visit and no physician office visit. There was a product complaint to report. Clarified that caller previously tested positive for Covid. Had it really bad, a long time there, she was really sick. Didn't want it again. Actually had Covid before, twice. The firs time, was down for 6 weeks, probably. Then went and got the shot for it. Afterwards, went back to the doctor because she was falling down. Tested again positive and it was not as bad as the first time, because she had the shot. Clarified further that caller had not had any Covid vaccines prior to first time testing positive for Covid. When she was positive for Covid the second time, she had received just one dose of the Covid vaccine, prior.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201210413 same patient, different vaccine dose/AE;US-PFIZER INC-202201209676 same reporter/patient/vaccine, different dose/AE;
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No Adverse event; monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine) and NO ADVERSE EVENT (No Adverse event) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR6965B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Oct-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Oct-2022, the patient experienced WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine) 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 (monovalent vaccine for 6 to 11 years old administered instead of bivalent vaccine).    Concomitant drugs were not reported. It was reported that the patient received 0.5 ml of the dark blue cap vaccine for 6 to 11 years old instead of the new bivalent vaccine. Treatment medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-657547, US-MODERNATX, INC.-MOD-2022-657560 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-657547: US-MODERNATX, INC.-MOD-2022-657560:Same reporter
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on trunk of body all the way up to the neck and under arm pits; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on trunk of body all the way up to the neck and under arm pits) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 026D21A, 004M20A and 011L20A) for COVID-19 vaccination.     The patient's past medical history included Illness (Cold) and Rash (mild rash on neck and abdominal area). Concurrent medical conditions included Diverticulitis. Concomitant products included PROBIOTICS NOS from 2020 to an unknown date for an unknown indication.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Rash on trunk of body all the way up to the neck and under arm pits). On 22-May-2022, RASH (Rash on trunk of body all the way up to the neck and under arm pits) had resolved.            It was reported that 1.5 days after second booster patient experienced rash on trunk of body all the way up to the neck and under arm pits which went away itself in 2.5 days. The patient did not inform any HCP. No treatment medications were taken.
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Gait inability, Insomnia, Muscle discomfort, Pain in extremity, Walking aid user
Clinical narrative: her left leg hurt real bad/really bad side effects/the most painful; she was in a walker for a week; trouble to sleep due to pain; leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week; she can't even walk for a while; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her left leg hurt real bad/really bad side effects/the most painful), WALKING AID USER (she was in a walker for a week), GAIT INABILITY (she can't even walk for a while), INSOMNIA (trouble to sleep due to pain) and MUSCLE DISCOMFORT (leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Food allergy. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced GAIT INABILITY (she can't even walk for a while). On 18-Feb-2022, the patient experienced PAIN IN EXTREMITY (her left leg hurt real bad/really bad side effects/the most painful), WALKING AID USER (she was in a walker for a week), INSOMNIA (trouble to sleep due to pain) and MUSCLE DISCOMFORT (leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week). The patient was treated with TRAMADOL for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her left leg hurt real bad/really bad side effects/the most painful), WALKING AID USER (she was in a walker for a week), GAIT INABILITY (she can't even walk for a while), INSOMNIA (trouble to sleep due to pain) and MUSCLE DISCOMFORT (leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week) was resolving.            The concomitant medications were not reported.  Patient was approximately 50% recovered. Others treatment medication  was taken by patient, but was not able to report. She visited a pain medicine doctor.Patient was improving very slowly. Patient has not tested positive for Covid-19. Patient had not medical history related to events or any chronic illness at the time of vaccination.   This case was linked to MOD-2022-658243, MOD-2022-658249 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: her left leg hurt real bad/really bad side effects/the most painful; she was in a walker for a week; trouble to sleep due to pain; leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week; she can't even walk for a while; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (her left leg hurt real bad/really bad side effects/the most painful), WALKING AID USER (she was in a walker for a week), GAIT INABILITY (she can't even walk for a while), INSOMNIA (trouble to sleep due to pain) and MUSCLE DISCOMFORT (leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022J21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy and Food allergy. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced GAIT INABILITY (she can't even walk for a while). On 18-Feb-2022, the patient experienced PAIN IN EXTREMITY (her left leg hurt real bad/really bad side effects/the most painful), WALKING AID USER (she was in a walker for a week), INSOMNIA (trouble to sleep due to pain) and MUSCLE DISCOMFORT (leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week). The patient was treated with TRAMADOL for Pain, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (her left leg hurt real bad/really bad side effects/the most painful), WALKING AID USER (she was in a walker for a week), GAIT INABILITY (she can't even walk for a while), INSOMNIA (trouble to sleep due to pain) and MUSCLE DISCOMFORT (leg eggs really bad muscle you can hardly walk not even step down, pain she was in a walker for a week) was resolving.            The concomitant medications were not reported.  Patient was approximately 50% recovered. Others treatment medication  was taken by patient, but was not able to report. She visited a pain medicine doctor.Patient was improving very slowly. Patient has not tested positive for Covid-19. Patient had not medical history related to events or any chronic illness at the time of vaccination.   This case was linked to MOD-2022-658243, MOD-2022-658249 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in right arm and as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19. This report was about COVID-19 treatment. Patient received the vaccine. Other medications in 2 weeks were reported as No. Patient received anti-viral treatment from 30Sep2022 to 05Oct2022 for COVID-19 treatment. Known allergies included allergic to Bactrim. Other medical history was reported as none.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Measles, Oropharyngeal pain, Rhinorrhoea, Vaccination site pain
Clinical narrative: general measles; Runny nose; sore arm at the sight of injection; sore throat; Loss of taste; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 53-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose number unknown (booster), single (Lot number: GJ6665) at the age of 53 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing), notes: I am taking hypertension medication . The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunisation. The following information was reported: AGEUSIA (non-serious) with onset 08Oct2022, outcome "not recovered", described as "Loss of taste"; MEASLES (medically significant), outcome "unknown", described as "general measles"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "sore arm at the sight of injection"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat". Therapeutic measures were not taken as a result of measles, ageusia, rhinorrhoea, vaccination site pain, oropharyngeal pain.  Additional information: The patient had question if its possible to get a loss of taste as a side effect from the new booster shot. Had just got the new booster, the bivalent booster on Friday and experienced some loss of taste as well and wondered if that was a possible side effect from the booster shot. The patient takes other hypertension medication. The patient took covid, the home test this morning and it was negative. The patient stated it's defiantly persistent because this morning her family, she make breakfast and everybody was saying it's too sweet and it didn't taste sweet to her that's why, thought that she had loss sense of taste and yesterday it was salty, didn't taste that too. Patient calling for loss of taste, runny nose and then sore arm at the sight of injection and for the sore throat from this also and just the general measles and nothing patient have you to worried  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the known information available  the event MEASLES and  is due to viral infection and not related to the suspect drug
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Chills; aches; pain; feverish; sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Lot number: ER8737) for covid-19 immunisation. The patient's relevant medical history included: "Other medical History: Chron's disease" (unspecified if ongoing), notes: Other medical History: Chron's disease; "Other medical History: autoimmune liver disease" (unspecified if ongoing), notes: Other medical History: autoimmune liver disease. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: EN6198), administration date: Mar2021, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "recovered"; PAIN (non-serious) with onset Mar2021, outcome "recovered", described as "aches"; PYREXIA (non-serious) with onset Mar2021, outcome "recovered", described as "feverish"; PAIN (non-serious) with onset Mar2021, outcome "recovered"; HYPERHIDROSIS (non-serious) with onset Mar2021, outcome "recovered", described as "sweating". It was unknown if therapeutic measures were taken as a result of chills, pain, pain, pyrexia, hyperhidrosis.  Additional Information: It was unknown if patient had known allergies. It was unknown if patient received other vaccine in four weeks. It was unknown if patient had covid prior vaccination and covid tested post vaccination.  Follow-Up (13Oct2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 10Oct2022, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "Latex Allergy" (unspecified if ongoing), notes: she just had a Latex Allergy awareness week and pressing to get vaccination and this is the issue; "Immunization" (unspecified if ongoing). Concomitant medication(s) included: FLU [INFLUENZA VACCINE] taken for immunisation as dose number unknown, single; PNEUMOCOCCAL VACCINE taken for immunisation as dose number unknown, single. The following information was reported: ANAPHYLACTIC REACTION (medically significant), outcome "unknown", described as "anaphylaxis". Therapeutic measures were taken as a result of anaphylactic reaction. Clinical course: The latex top she knows but need to know if risk for having a reaction and shouldn't be taking steroids if not necessary and may compromise the vaccine and have the steroid does she take another dose of old one or wait for the new COVID-19 Vaccine. Allergy reaction plan, take course of steroids, with antacid, take it before during and after, have an EpiPen. Told her if she would go fine with the first shot (covid vaccine) then she can go all three. I did have a reaction, but it is a very controlled reaction. I was able to have all three. She has a choice to take it, she was taking cetirizine and Pepcid. I should not take steroids unless necessary, because she has already immune issues. We don't want to compound and make the vaccine less effective or omicron reaction worst by taking more steroids. We need a very clear answer. My hospital pharmacist friend with latex allergy made me understand my allergy. She knew that the top of the vial is supposedly latex free but based on her experience with Shingrix vaccine, that was not the case.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.