chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided. It was reported that 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated.  The total number of vials were 2. The vial was not initially stored in the refrigerator The vial did not undergo any temperature excursions   This case was linked to MOD-2022-582637, MOD-2022-582638, MOD-2022-582650 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided. It was reported that 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated.  The total number of vials were 2. The vial was not initially stored in the refrigerator The vial did not undergo any temperature excursions   This case was linked to MOD-2022-582637, MOD-2022-582638, MOD-2022-582650 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Reporter stated that 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated. Nurse confirmed that vaccine was administered to 7 patients on 2 different days. Number of doses/vials:2 The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-582650, MOD-2022-582638, MOD-2022-582644, MOD-2022-582637, MOD-2022-582613, MOD-2022-582613 (Patient Link).
Age: 58.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported. No treatment medication details was reported. Reporter stated that 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated. Nurse confirmed that vaccine was administered to 7 patients on 2 different days. Number of doses/vials:2 The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-582650, MOD-2022-582638, MOD-2022-582644, MOD-2022-582637, MOD-2022-582613, MOD-2022-582613 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to 6 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. It was reported that the 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated. The total number of vials were 2. The vial was not initially stored in the refrigerator. The vial did not undergo any temperature excursions. It was reported that patient did not reported adverse event. No treatment were reported.   This case was linked to MOD-2022-582650, MOD-2022-582640 (Patient Link).
Age: 60.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to 6 patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 6 patients) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant were reported. It was reported that the 2 vials were placed in the freezer on 18-Jan-2022, and was never stored in the refrigerated. The total number of vials were 2. The vial was not initially stored in the refrigerator. The vial did not undergo any temperature excursions. It was reported that patient did not reported adverse event. No treatment were reported.   This case was linked to MOD-2022-582650, MOD-2022-582640 (Patient Link).
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated; Vaccine administered after date of expiry to 1 patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 1 patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) in a 55-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 1 patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after date of expiry to 1 patient) and PRODUCT STORAGE ERROR (2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. It was reported that the 2 vials were placed in the freezer on 18Jan2022, and was never stored in the refrigerated. The total number of vials were 2. The vial was not initially stored in the refrigerator. The vial did not undergo any temperature excursions.   This case was linked to MOD-2022-582455, MOD-2022-582637, MOD-2022-582638, MOD-2022-582640, MOD-2022-582644 (Patient Link).
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives; This spontaneous case was reported by a patient and describes the occurrence of URTICARIA (hives) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L21A, 034F21A, 040B21A and 007B21A) for COVID-19 vaccination.     The patient had no known allergies. The patient neither had COVID positive test nor diagnosis.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced URTICARIA (hives). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Hives, at an unspecified dose and frequency; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Hives, at an unspecified dose and frequency; PREDNISONE for Hives, at an unspecified dose and frequency and HYDROXYZINE (ATARAX [HYDROXYZINE]) for Hives, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives) had not resolved.            Concomitant medications of the patient were unknown.  The patient had adverse reaction with the 2nd booster shot, as he had an allergic reaction where he had hives, a week after the 2nd booster dose. The patient stated that he started developing hives and it had been going on for 4 weeks now.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2022: Upon live follow-up reporter details (occupation, address and email address), patient details (DOB, gender, age and height), suspect drug dosing details and treatment medications were added. Reporter details (first name), patient details (initial (patient identifier)), details of concomitant medications, details of medical history and event details were updated. Event description was also updated.
Age: 60.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Immunisation reaction, Psoriasis
Clinical narrative: Psoriasis; Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (Psoriasis) and IMMUNISATION REACTION (Vaccination adverse reaction) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 06-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced PSORIASIS (Psoriasis) and IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, PSORIASIS (Psoriasis) and IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.            No concomitant medications were provided.  It was unknown if the patient was enrolled in a COVID-19 vaccine trial.  The causality between co-suspect Skyrizi and events Psoriasis and Vaccination adverse reaction was reported as not provided.  No treatment medications were provided.
Age: 32.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Oral candidiasis, Taste disorder
Clinical narrative: Developed oral thrush (yeast infection) on day 3.; Rancid taste in mouth developed within 60 mins of first dose; This spontaneous case was reported by a patient and describes the occurrence of ORAL CANDIDIASIS (Developed oral thrush (yeast infection) on day 3.) and TASTE DISORDER (Rancid taste in mouth developed within 60 mins of first dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product NIRMATRELVIR, RITONAVIR (PAXLOVID) for COVID-19 treatment.    Concurrent medical conditions included Allergy. Concomitant products included PARACETAMOL (TYLENOL), IBUPROFEN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and PSEUDOEPHEDRINE HYDROCHLORIDE (SUDAFED [PSEUDOEPHEDRINE HYDROCHLORIDE]) for an unknown indication.   On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2022, the patient started NIRMATRELVIR, RITONAVIR (PAXLOVID) (unknown route) at an unspecified dose. On 30-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TASTE DISORDER (Rancid taste in mouth developed within 60 mins of first dose). On 01-Jun-2022, the patient experienced ORAL CANDIDIASIS (Developed oral thrush (yeast infection) on day 3.). The patient was treated with NYSTATIN (oral) at an unspecified dose and frequency. At the time of the report, ORAL CANDIDIASIS (Developed oral thrush (yeast infection) on day 3.) and TASTE DISORDER (Rancid taste in mouth developed within 60 mins of first dose) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient was taking any other medications or products within 2 weeks of starting COVID-19 treatment and the patient previously received a COVID-19 Vaccine.  The patient experienced rancid taste in mouth developed within 60 mins of first dose. Reportedly, the patient developed oral thrush (yeast infection) on day 3.   The treatment received by the patient for the adverse event reported as Nystatin Oral Suspension.  The device date reported as 02-Jun-2022.
Age: 65.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Biopsy, Eczema, Psoriasis
Clinical narrative: Psoriasis showing up on both legs/arms and patch on the stomach; Eczema; This spontaneous case was reported by a patient and describes the occurrence of PSORIASIS (Psoriasis showing up on both legs/arms and patch on the stomach) and ECZEMA (Eczema) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical History information was reported.   On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced ECZEMA (Eczema). In May 2022, the patient experienced PSORIASIS (Psoriasis showing up on both legs/arms and patch on the stomach). At the time of the report, PSORIASIS (Psoriasis showing up on both legs/arms and patch on the stomach) had not resolved and ECZEMA (Eczema) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2022, Biopsy: psoriasis showing up on both legs, arms and patch Psoriasis showing up on both legs, arms and patch on stomach.         No concomitant medications were reported. As per HUMIRA, psoriasis causality was per reporter as probable, action taken was unknown and de challenge not applicable and for Eczema Causality as per reporter was not provided, action taken with drug unknown and de challenge was not applicable. No treatment medications were reported.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Just fatigue; Headache for a head; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (Just fatigue) and HEADACHE (Headache for a head) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received 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 FATIGUE (Just fatigue) and HEADACHE (Headache for a head). At the time of the report, FATIGUE (Just fatigue) and HEADACHE (Headache for a head) outcome was unknown.            No concomitant drug information was provided. The patient had reported did not have major side effects related to the Moderna vaccine. The first two were just fatigue and a headache for a head. Patient received booster dose on 03-Nov-2021 No treatment drug information was provided.   This case was linked to MOD-2022-579137, MOD-2022-583093 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Anaemia, Constipation, Vaccination site pain
Clinical narrative: Constipation; Anemia; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Constipation), ANAEMIA (Anemia) and VACCINATION SITE PAIN (Vaccination site pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products UPADACITINIB (RINVOQ) for Arthritis rheumatoid and IRON for Anaemia.    Concurrent medical conditions included Anaemia.   In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose and IRON (unknown route) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On an unknown date, the patient experienced CONSTIPATION (Constipation) and ANAEMIA (Anemia). At the time of the report, CONSTIPATION (Constipation), ANAEMIA (Anemia) and VACCINATION SITE PAIN (Vaccination site pain) outcome was unknown.            No concomitant medication was provided. It was reported that patient for anemic and for took Iron for that and experienced constipation.  The causality for the all events reported with respect to RINVOQ not reported and causality for the event with respect to Iron was probable for constipation and for vaccination site pain and anemia was not reported.  It was unknown if the patient was enrolled in COVID-19 vaccine trial.  No treatment medication was provided.
Age: 56.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue
Clinical narrative: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose every two weeks. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to at an unspecified dose once a week. On an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown.            No concomitant medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for the event(s) of felt fatigued afterwards Moderna covid-19 vaccinations with Humira was reported as no reasonable possibility.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: failure to warn that it could happen again,and so it did with second booster; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (failure to warn that it could happen again,and so it did with second booster) in a  patient of an unknown age and gender 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, the patient experienced IMMUNISATION REACTION (failure to warn that it could happen again,and so it did with second booster). At the time of the report, IMMUNISATION REACTION (failure to warn that it could happen again,and so it did with second booster) outcome was unknown.            No concomitant and treatment medication were reported.   This case was linked to MOD-2022-563602 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: toothache; This case has been considered invalid as there is no indication that the consumer experienced an event under BNT162B2.  The initial case was missing the following minimum criteria: Other-Info not qualifying for AE reporting. Upon receipt of follow-up information on (01Jun2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (159558). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "low platelet count" (unspecified if ongoing), notes: She has a medical condition and low platelet count and is getting medication for it. The patient took concomitant medications. The following information was reported: TOOTHACHE (non-serious), outcome "unknown".  Additional information: Caller mentioned that she received both doses of the vaccine including the booster, she has a medical condition and low platelet count and is getting medication for it. She mentioned that she has a scheduled dentist appointment tomorrow because of toothache and wants to get the 2nd booster dose before getting to her dentist. Caller wants to confirm about what she heard from the news that there(s) an issue with the vaccine about blood clot and she wants to check if it is correct before she gets the 2nd booster dose of the vaccine. Medical questions were addressed by this program forwarded/referred to Medical Information. Customer and/or medical inquiry forwarded or referred to MI.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 5.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Overdose, Product preparation error, Swelling
Clinical narrative: redness; swelling; a 5 year old child who received an undiluted pfizer covid 19 vaccine; a 5 year old child who received an undiluted pfizer covid 19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 5-year-old patient received BNT162b2 (BNT162B2), on 12May2022 at 09:00 as dose 1, single (Batch/Lot number: unknown) at the age of 5 years intramuscular, in left arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: KINRIX intramuscular taken for immunisation, on 12May2022 as dose number unknown, single; PROQUAD subcutaneous, on 12May2022 as dose number unknown, single. The following information was reported: PRODUCT PREPARATION ERROR (non-serious), OVERDOSE (non-serious) all with onset 12May2022, outcome "unknown" and all described as "a 5 year old child who received an undiluted pfizer covid 19 vaccine"; ERYTHEMA (non-serious), outcome "recovered", described as "redness"; SWELLING (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of erythema.  Additional information: The caller was a pediatrician. He was requesting the possible side effects in a 05-year-old child who received an undiluted Pfizer COVID19 vaccine (orange cap). The patient provided information regarding the reported adverse event (s) with the use of the product. Pfizer/BioNTech Covid-19 Vaccine. Details: Dose: 1st anatomical site of injection: Left shoulder. Vaccination Facility Type: Doctor's office/Urgent care. Prior Vaccinations (within 4 weeks): Vaccine name: Proquand. Anatomical site of injection: L triceps. Date: 12May2022. Concomitant Drugs: None. Patient(s) Medical History (including any illness at time of vaccination): None. Family medical history relevant AE(S): None. Relevant Tests: None. Specific relevant test for thromboembolic events with thrombocytopenia: None. Patient mistakenly given undiluted dose of covid vaccine. continued patient's mother later that day to a test her. He contacted patient's family 10 days later to death on patient. mother reported that patient had redness & swelling not injection site. No treatment recommend by time of call.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (01Jun2022): This is a spontaneous follow-up report from a contactable Physician. This Physician reported in response to HCP letter sent which included updated information: new event (Redness, swelling) added. Event outcome and treatment receive added. Patient name, initial, age at vaccination added. Dosage Regimens (Route of Administration and Vaccine administration date, dose number, dose description). Vaccine Facility Information added.   The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID; COVID; The initial case was missing the following minimum criteria: valid adverse effect. Upon receipt of follow-up information on 23May2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An adult female received COVID-19 immunization at a local pharmacy/drug store with the first dose of intramuscular BNT162B2 (solution for injection; Lot EN5318 and expiry information not provided) as a single dose on 30Mar2021; the second dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose on 20Apr2021; and a third (booster) dose of intramuscular BNT162B2 (solution for injection; Lot FA7485 expiry 31Oct2021) as a single dose on 15Aug2021 (at 43-years-old). Relevant medical history included high risk of frequent institutional or occupation exposure to coronavirus. There were no concomitant medications reported. On 22May2022, the patient experienced a breakthrough case of COVID confirmed with positive SARS-CoV-2 test. Treatment details, if any, were not reported. The outcome of the event breakthrough case of COVID was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Acne
Clinical narrative: first shot caused her face to break out; 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 64-year-old female patient received BNT162b2 (BNT162B2), on 20May2021 as dose 1, single (Lot number: EW0183), in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ACNE (non-serious) with onset May2021, outcome "not recovered", described as "first shot caused her face to break out".  Additional information: Stated a week after the first shot and she said her poor body and she knows she is not suppose to scratch and she rubs it and it gets so intense.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200765005 same patient/product, different dose and events
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dehydration, Diarrhoea, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid after receiving the Pfizer Covid vaccines; diagnosed with Covid after receiving the Pfizer Covid vaccines; diarrhea; dehydrated; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "pregnancy" (unspecified if ongoing), notes: from her post pregnancy that was terminated due to other medical reasons. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (hospitalization, medically significant), DRUG INEFFECTIVE (hospitalization, medically significant), outcome "unknown" and all described as "diagnosed with Covid after receiving the Pfizer Covid vaccines"; DIARRHOEA (hospitalization), outcome "unknown", described as "diarrhea"; DEHYDRATION (hospitalization), outcome "unknown", described as "dehydrated". The events "diagnosed with covid after receiving the pfizer covid vaccines", "diarrhea" and "dehydrated" required emergency room visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN RESULT. Therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: patient is pregnant of 21 weeks and she has been diagnosed with Covid and prescribed Paxlovid.  He needs to know safety data on medication.  He said her first pregnancy was terminated around the same time frame and for similar medical reasons. Patient had severe side effects from Covid.  Patient has not started Paxlovid.  Patient was admitted to the hospital due to severe side effects of Covid and she had diarrhea and she was dehydrated. Emergency Room prescribed Paxlovid. Patient was vaccinated with series of two vaccines of Pfizer vaccines but not the booster.  Patient  received vaccines before being diagnosed with Covid.  He said she got pregnant and then this happened.  Caller declined to complete report.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202200762603 same patient/drug, different dose/event
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: got COIVID; got COIVID; 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 76-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "got COIVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: he was to get his second booster but got COIVID.  Clinical course: Caller states he just finished his regime of Paxlovid and had to stop taking his Crestor, Tamsulosin, Fenofibrate and hydrochlorothiazide. Caller states he has received the Pfizer COID-19 vaccine and one Pfizer booster he was to get his second booster but got COIVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Rebound symptoms and positive test; Rebound symptoms and positive test; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 as dose 1, single (Batch/Lot number: unknown), on 09Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "not recovered" and all described as "Rebound symptoms and positive test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive, notes: Rebound symptoms and positive test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient had no known allergies and she took no other medication in 2 weeks. The patient took COVID 19 Treatment with Paxlovid (Treatment start date=16May2022, Treatment stop date=20May2022).  The lot number for [BNT162b2], was not provided and will be requested during follow up.; Reporter's Comments: ~~~
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 47 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. Patient had no known allergies. There were no concomitant medications. The patient had no other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset May2022, outcome "recovered" (25May2022) and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results; (May2022) Negative, notes: I tested negative on day 8 and 9; (16May2022) Positive, notes: I retested positive on day 12; (25May2022) Negative, notes: I finally retested negative on day 21 (or day 10 from retest). Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid for COVID-19 from 05May2022 to 09May2022. Patient tested negative on day 8 and 9. She retested positive on day 12 (16May2022 07:00 AM). She developed body aches, mild cough, congestion, and rhinorrhea on days. She finally retested negative on day 21 (25May2022) (or day 10 from retest).; Sender's Comments: Based on the information in the case, an association between the reported events and the suspect product BNT162B2 cannot be ruled out.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received her 2nd Booster shot of the Pfizer Covid-19/ tested POSITIVE for COVID-19; received her 2nd Booster shot of the Pfizer Covid-19/ tested POSITIVE for COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (172086). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26May2022, outcome "unknown" and all described as "received her 2nd Booster shot of the Pfizer Covid-19/ tested POSITIVE for COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26May2022) Positive. Clinical course was reported as, a 72 year old female patient called about her prescription for PAXLOVID. She received her 2nd Booster shot of the Pfizer Covid-19 Vaccine 2 weeks ago, and she tested POSITIVE for COVID-19 (reported as today, that is on 26May2022). She was prescribed PAXLOVID. Reporter was asking is it advisable to take the PAXLOVID with just receiving the second Booster dose 2 weeks ago and added do not have information on a decrease in the efficacy of the vaccine if she take the PAXLOVID. Reporter states she thinks it takes about 2 weeks for the booster to reach it's full protective ability and confirms she is presently not taking Paxlovid, just asking a question.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; tested positive for Covid; 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 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 25May2022, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (25May2022) Positive, notes: Caller states she is 70 years old and tested positive for Covid yesterday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course included Patient states she is 70 years old and tested positive for Covid yesterday. Her doctor immediately prescribed Paxlovid for her but she now feels worse than she felt before she began taking the medication. She has Taken 3 doses and is debating the fourth dose. Caller says prior to beginning Paxlovid she had some congestion and weakness. Patient say she weighs 150lbs. and is very healthy. Patient says she plays pickleball 3-5 timer per weak. Patient says she's had all her vaccines and recommended boosters from Pfizer. number and Expiry Date of Pfizer COVID vaccine were not provided. The case was reported as non serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Nurse) from product quality group. A 50-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EL3247), on 23Mar2021 as dose 2, single (Lot number: EL3247) and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 50 years, all intramuscular for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 19May2022, outcome "unknown" and all described as "home Ag 22May2022 Positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22May2022) Positive, notes: Nasal Swab. Investigational report conclusion: Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for 'Lack of Effect' of the Pfizer BioNTech Covid-19 vaccine lot FF2589, EL3247 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FF2589, EL3247  fill lot FF2558, EL3230 and the bulk formulated drug product lot FE5318. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. No follow-up attempts are possible. No further information is expected.