chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9694), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 30Mar2021 at 13:00 as dose 1, single (Lot number: ER8734), in left arm, on 20Apr2021 as dose 2, single (Lot number: ER8734), in left arm, on 18Nov2021 as dose 3 (booster), single (Lot number: FH8030), in left arm and on 25Jun2022 as dose 4 (booster), single (Lot number: FM0173), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 12Jan2023. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Hypersomnia, Weight
Clinical narrative: slept unbelievably long period of time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EL1283) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "cancer survivor Cancer in 2021", start date: 2021 (unspecified if ongoing), notes: Comments: cancer survivor Cancer in 2021. The patient's concomitant medications were not reported. The following information was reported: HYPERSOMNIA (non-serious) with onset 26Feb2021, outcome "unknown", described as "slept unbelievably long period of time". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient took first shot in Mar2021. At that point, had unbelievable sleep reaction. Did not have any other problems, other than she slept unbelievably long period of time. Went ahead and reported that to Pfizer. On 26Feb2021 when that first reaction happened. Most people have reaction to second and she had reaction to first.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (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), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of  COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient did not received other medication in 2weeks. Anti viral details included COVID 19 Treatment, Paxlovid started on 20Jan2023 to 24Jan2023 and lot number GF3904.  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: States she took every single vaccination of all Pfizer/she thinks she had 3-4, she doesn't know/she just finished Paxlovid this morning; States she took every single vaccination of all Pfizer/she thinks she had 3-4, she doesn't know/she just finished Paxlovid this morning; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "States she took every single vaccination of all Pfizer/she thinks she had 3-4, she doesn't know/she just finished Paxlovid this morning". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient stated that she took every single vaccination of all Pfizer and had no idea this was going to happen to her. She did not know the names of the vaccines. She took those and the flu shot, it was a shock to her. Pfizer kept coming out with another and another, she thinks she had 3-4, she didn't know. She made sure they were all Pfizer, all the same other than Moderna. She stated that apparently, the variant out there was resistant to the vaccines. She took all the shots for nothing. There was something out that that skirts around vaccines. She asks what was the point. It scared the hell out of her that after all that she was still not covered. She was a little surprised. She doesn't go anywhere, had no idea where she got this.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; dose 1,2 MODERNA/ dose 3 Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 13Oct2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 55 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 02Nov2021 as dose 3 (booster), single (Lot number: FH8020) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 02Mar2021 as dose 1, single (Batch/Lot number: unknown), on 30Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 20May2022 as dose 4 (booster), single (Lot number: 049L21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 02Nov2021, outcome "unknown", described as "dose 1,2 MODERNA/ dose 3 Pfizer"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 07Jan2023.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; ATORVASTATIN CALCIUM; BUPROPION; DULERA; CHOLECALCIFEROL; FLUTICASONE; LORATADINE; TIZANIDINE; PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment medicine was Paxlovid.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER8727), in left arm, on 10Apr2021 as dose 2, single (Lot number: EP7533), in left arm and on 18Dec2021 as dose 3 (booster), single (Lot number: FD7218) at the age of 44 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 12Jan2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient started with sore throat and chills on Thursday, 12Jan2023. On Friday, 13Jan2023 at 8:00 am, the patient started throwing up. The patient went to (Clinic Name) on Saturday, 14Jan2023. The patient was still throwing up. From 14Jan2023 to 19Jan2023, the patient received nirmatrelvir; ritonavir (PAXLOVID) for COVID-19 treatment. The patient had no known allergies. The patient had no other medical history.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 36-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Nov2022 as dose 4 (booster), single (Lot number: GJ3277) at the age of 36 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Apr2021 as dose 1, single (Lot number: Er8729), in left arm, on 02May2021 as dose 2, single (Lot number: Ew0179), in left arm and on 11Dec2021 as dose 3 (booster), single (Lot number: Fj1611), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: TIROSINT, start date: 03Dec2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures paxlovid from 10Jan2023 were taken as a result of vaccination failure, covid-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: got COVID at end of Aug2022; got COVID at end of Aug2022; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team and product quality group. The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 21Jan2021 as dose 1, single (Lot number: EL3249), on 11Feb2021 as dose 2, single (Lot number: EM4810), on 02Aug2022 as dose 4 (booster), single (Lot number: FP7138) at the age of 72 years, in left deltoid and on 13Sep2021 as dose 3 (booster), single (Lot number: EW0172) for covid-19 immunisation. The patient's relevant medical history included: "Thyroid stuff" (unspecified if ongoing), notes: Concomitant Products/Medical Conditions: Not really, has thyroid stuff but not anything crazy. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "unknown" and all described as "got COVID at end of Aug2022". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Aug2022) Positive, notes: Caller tested positive for COVID 26Aug2022. Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Additional information: Patient had to get another booster because they were going on a cruise and flew to withheld to visit family. Husband got sick first and tested positive 24Aug2022.; Sender's Comments: The reported COVID-19 positive after appropriately spaced doses of BNT162b2 immunization is considered as vaccination failure of BNT162B2, and the Company cannot completely exclude the possible causality between the reported events and BNT162B2 administration.,Linked Report(s) : US-PFIZER INC-202300038491 same reporter/drug/event, different patient;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Took paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer; Took paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; 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 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 "Took paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient and her husband took Paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300038590 same reporter/product/event, different patients;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: took paxlovid as they had covid-19 even though they have the 2 vaccines and a booster from Pfizer; took paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single for covid-19 immunisation; 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "took paxlovid as they had covid-19 even though they have the 2 vaccines and a booster from Pfizer"; COVID-19 (medically significant), outcome "unknown", described as "took paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19. Consumer also stated: that her husband had a mild headache but he took aspirin. She also took Paxlovid and had a headache and the also took an aspirin for it. She states that she suffers from headaches from time to time, but not her husband even though he I 78-years-old. He is always in good shape. They both took Paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300038589 same reporter/product/event, diff patients;
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 14Oct2022 as dose 5 (booster), single (Lot number: GJ6939) at the age of 69 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Feb2021 as dose 1, single (Lot number: EN9581), in left arm, on 24Feb2021 as dose 2, single (Lot number: EN6198), in left arm, on 03Oct2021 as dose 3 (booster), single (Lot number: 30145BA), in left arm and on 02Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "Insomnia" (unspecified if ongoing); "A-fib corrected" (unspecified if ongoing); "chemo induced neuropathy" (unspecified if ongoing). The patient has no known allergies. Concomitant medication(s) included: LYRICA, start date: 01Jun2017. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: Positive at home test; (Jan2023) Positive, notes: positive rapid test at Urgent. Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid treatment on 15Jan2023 to 19Jan2023.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 01Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Bladder cancer" (unspecified if ongoing). Concomitant medication(s) included: FAMOTIDINE; ESOMEPRAZOLE; LEVOCETIRIZINE. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "recovering" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 09Jan2023 to 13Jan2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Dec2022 as dose 4 (booster), single (Lot number: GJ6738) at the age of 41 years, in left arm for covid-19 immunisation; 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 immunisation. The patient's relevant medical history included: "Migraines" (unspecified if ongoing); "sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: NORTRIPTYLINE; ZOLMITRIPTAN. Past drug history included: Keflex, reaction(s): "Drug Allergy: Keflex". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 (Paxlovid taken from 16Jan2023 to 21Jan2023, lot number: GF4000).
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Dyspnoea, Headache, Hypoaesthesia, Nausea
Clinical narrative: Peripheral neuropathy; Metallic taste; Shortness of breath; Tingling in hands and feet; Nausea; Headache; Light sensitivity; Numbness; Permanent nerve damage; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Peripheral neuropathy"; DYSGEUSIA (non-serious), outcome "unknown", described as "Metallic taste"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling in hands and feet"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "Light sensitivity"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness"; NERVE INJURY (non-serious), outcome "unknown", described as "Permanent nerve damage". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nerve injury, Neuropathy peripheral, Paraesthesia, Photosensitivity reaction
Clinical narrative: Peripheral neuropathy; Metallic taste; Shortness of breath; Tingling in hands and feet; Nausea; Headache; Light sensitivity; Numbness; Permanent nerve damage; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: NEUROPATHY PERIPHERAL (medically significant), outcome "unknown", described as "Peripheral neuropathy"; DYSGEUSIA (non-serious), outcome "unknown", described as "Metallic taste"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; PARAESTHESIA (non-serious), outcome "unknown", described as "Tingling in hands and feet"; NAUSEA (non-serious), outcome "unknown"; HEADACHE (non-serious), outcome "unknown"; PHOTOSENSITIVITY REACTION (non-serious), outcome "unknown", described as "Light sensitivity"; HYPOAESTHESIA (non-serious), outcome "unknown", described as "Numbness"; NERVE INJURY (non-serious), outcome "unknown", described as "Permanent nerve damage". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Subcutaneous haematoma
Clinical narrative: death of patient's father from subdermal hematoma; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: SUBCUTANEOUS HAEMATOMA (death), outcome "fatal", described as "death of patient's father from subdermal hematoma". The patient date of death was unknown. Reported cause of death: "death of patient's father from subdermal hematoma". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: death of patient's father from subdermal hematoma
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (They have more or less 192 patients who had been administered with the Moderna vaccine (more or less 170 -monovalent and 20 bivalent) which were beyond the 30day beyond use date.).    Concomitant product use was not provided by the reporter.  lot 939902 reported with a BUD of 02-Sep-2021.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Live follow-up received included non significant information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: lot 042J21A should have been reported with a BUD of Feb 17, 2022.; No adverse event; lot 042J21A should have been reported with a BUD of Feb 17, 2022.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.), PRODUCT STORAGE ERROR (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and NO ADVERSE EVENT (No adverse event) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042J21A and 939902) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.), PRODUCT STORAGE ERROR (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (lot 042J21A should have been reported with a BUD of Feb 17, 2022.) and PRODUCT STORAGE ERROR (lot 042J21A should have been reported with a BUD of Feb 17, 2022.).    Concomitant products were not provided. Treatment medication were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704416 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2023: Follow-up contains no new information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704416:Master case
Age: 83.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm hurt but no big deal; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (my arm hurt but no big deal) in an 83-year-old 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 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (my arm hurt but no big deal). At the time of the report, PAIN IN EXTREMITY (my arm hurt but no big deal) outcome was unknown.            No concomitant information was provided.  Patient always got shots on time. Also patient had the moderna COVID-19 shots as soon as offered and had all the boosters. A couple times patient's arm hurt but no big deal. At the beginning a nurse told patient that after patient got any kind of shot they should rub it in a circular motion as long as feel like and patient rubbed it for half hour and doing it since patient never had a problem and it worked for patient.  No treatment medications was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: beyond the 30 days in the refrigerator on 24JAN2023; temperature excursion; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7171B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Jan-2023, 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 24-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion), EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (beyond the 30 days in the refrigerator on 24JAN2023), PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) and EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    No concomitant product reported by reporter.  Reporter stated that 4 adult patients received the Bivalent booster of Moderna COVID-19 vaccine beyond the 30 days in the refrigerator on 24-JAN-2023 with lot number AS7171B from intact cartons with vial size of 2.5ml. Vial was initially stored in the refrigerator 23-DEC-2022.  No treatment medication reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: had a stiff neck and stiff back; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (had a stiff neck and stiff back) 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 prophylaxis.    Co-suspect product included non-company product IBUPROFEN (ADVIL [IBUPROFEN]) for an unknown indication.    Previously administered products included for Drug use for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (received 2 regular), PFIZER BIONTECH COVID-19 VACCINE (and a booster dose of the pfizer vaccines) and PFIZER BIONTECH COVID-19 VACCINE (received 2 regular). Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.   On 15-Jan-2023, 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 started IBUPROFEN (ADVIL [IBUPROFEN]) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (had a stiff neck and stiff back). At the time of the report, MUSCULOSKELETAL STIFFNESS (had a stiff neck and stiff back) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   The patient had not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient got the booster shot last Sunday 15JAN2022. Patient had previously gotten pfizer shots Dec 2021.  Patient got dose in left arm and the next day had a stiff neck and stiff back.  First three days,  were really bad.  It was now 8 days later.  She had neck on the right side it had not subsided yet. She had rested her neck like she would do with a tightness, but it has not gone away. Patient was been taking advil. No treatment information was provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2023: Follow-up received include no new information.
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Patient did not get the second dose in the series and was inquiring about getting the Moderna Bivalent booster today; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient did not get the second dose in the series and was inquiring about getting the Moderna Bivalent booster today) and NO ADVERSE EVENT (No adverse event) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient did not get the second dose in the series and was inquiring about getting the Moderna Bivalent booster today) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient did not get the second dose in the series and was inquiring about getting the Moderna Bivalent booster today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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 PRODUCT ADMINISTRATION INTERRUPTED (Patient did not get the second dose in the series and was inquiring about getting the Moderna Bivalent booster today).    No concomitant product reported by reporter. HCP reported a patient received the initial Moderna vaccine back in April of 2021. Patient did not get the second dose in the series and was inquiring about getting the Moderna Bivalent booster today. Caller would like to confirm that they need to finish the primary series before getting the second booster.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Two of my friends have ended up with heart problems; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, 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: CARDIAC DISORDER (non-serious), outcome "unknown", described as "Two of my friends have ended up with heart problems".  Additional Information: Reporter stated that two of their friends have ended up with heart problems and four are now on blood thinners for the rest of their lives.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300035000 same reporter/drug, different patient/event;US-PFIZER INC-202300035001 same reporter/drug, different patient/event;US-PFIZER INC-202300035009 same reporter/drug, different patient/event;US-PFIZER INC-202300035010 same reporter/drug, different patient/event;US-PFIZER INC-202300035011 same reporter/drug, different patient/event;
Sex: M
Vaccine: COVID19
Symptoms: Immune-mediated pancreatitis, Liver injury
Clinical narrative: IgG4-related autoimmune pancreatitis; Acute liver injury; This is a literature report.  A 63-year-old male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 (Dose 1, single (manufacturer unknown)), for COVID-19 immunisation. The following information was reported: IMMUNE-MEDIATED PANCREATITIS (medically significant), 1 month after the suspect product(s) administration, outcome "unknown", described as "IgG4-related autoimmune pancreatitis"; LIVER INJURY (medically significant), outcome "unknown", described as "Acute liver injury".  Clinical course:Acute liver injury and IgG4-related autoimmune pancreatitis following mRNA-based COVID-19 vaccination.; Sender's Comments: Based on the available information in the case, the causal association between the events immune mediated pancreatitis and acute liver injury  and the suspect drug BNT62B2  cannot be 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.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Illness, SARS-CoV-2 test
Clinical narrative: I have had 4 shots of COVID 19 vaccines. 2 of them Pfizer. I have tested positive for COVID 19; I have had 4 shots of COVID 19 vaccines. 2 of them Pfizer. I have tested positive for COVID 19; I am very sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose number unknown, 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), outcome "unknown" and all described as "I have had 4 shots of COVID 19 vaccines. 2 of them Pfizer. I have tested positive for COVID 19"; ILLNESS (non-serious), outcome "unknown", described as "I am very sick". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Clinical information: COVID-19 vaccines don't work. Patient had 4 shots of COVID-19 vaccines. 2 of them Pfizer. Patient had tested positive for COVID-19. Patient was very sick.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired healing, Joint range of motion decreased, Pain, Pain in extremity, Scar
Clinical narrative: scar tissue; it felt like she was being stabbed; Most painful vaccine she ever got; was in pain for a few weeks in the arm/getting more and more painful; got a "frozen shoulder"/Could not move arm much; Still is not completely healed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Froze arm" (unspecified if ongoing), notes: She has had a "Froze arm" before. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: SCAR (medically significant), outcome "recovered with sequelae", described as "scar tissue"; STAB WOUND (non-serious), outcome "recovered with sequelae", described as "it felt like she was being stabbed"; PAIN (non-serious), outcome "recovered with sequelae", described as "Most painful vaccine she ever got"; PAIN IN EXTREMITY (non-serious), outcome "recovered with sequelae", described as "was in pain for a few weeks in the arm/getting more and more painful"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "recovered with sequelae", described as "got a "frozen shoulder"/Could not move arm much"; IMPAIRED HEALING (non-serious), outcome "recovered with sequelae", described as "Still is not completely healed". The events "scar tissue", "it felt like she was being stabbed", "most painful vaccine she ever got", "was in pain for a few weeks in the arm/getting more and more painful", "got a "frozen shoulder"/could not move arm much" and "still is not completely healed" required physician office visit. Therapeutic measures were taken as a result of scar, stab wound, pain, pain in extremity, joint range of motion decreased, impaired healing.  Additional information: the pharmacist gave her the vaccine and as she gave it felt like was being stabbed. Most Painful vaccine she ever got. She was in pain for a few weeks in the arm and then she got a "frozen shoulder". From November - January it was getting more and more painful. Could not move arm much. She has had a "Froze arm" before. Went to PCP in February. Had A "Manipulation" where they put you to sleep and break the scar tissue. Went to physical therapy in early June. Resolved in Sep2022-Oct2022. Still is not completely healed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Stab wound
Clinical narrative: scar tissue; it felt like she was being stabbed; Most painful vaccine she ever got; was in pain for a few weeks in the arm/getting more and more painful; got a "frozen shoulder"/Could not move arm much; Still is not completely healed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient received BNT162b2 (BNT162B2), on 28Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation. The patient's relevant medical history included: "Froze arm" (unspecified if ongoing), notes: She has had a "Froze arm" before. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for COVID-19 immunization.  The following information was reported: SCAR (medically significant), outcome "recovered with sequelae", described as "scar tissue"; STAB WOUND (non-serious), outcome "recovered with sequelae", described as "it felt like she was being stabbed"; PAIN (non-serious), outcome "recovered with sequelae", described as "Most painful vaccine she ever got"; PAIN IN EXTREMITY (non-serious), outcome "recovered with sequelae", described as "was in pain for a few weeks in the arm/getting more and more painful"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "recovered with sequelae", described as "got a "frozen shoulder"/Could not move arm much"; IMPAIRED HEALING (non-serious), outcome "recovered with sequelae", described as "Still is not completely healed". The events "scar tissue", "it felt like she was being stabbed", "most painful vaccine she ever got", "was in pain for a few weeks in the arm/getting more and more painful", "got a "frozen shoulder"/could not move arm much" and "still is not completely healed" required physician office visit. Therapeutic measures were taken as a result of scar, stab wound, pain, pain in extremity, joint range of motion decreased, impaired healing.  Additional information: the pharmacist gave her the vaccine and as she gave it felt like was being stabbed. Most Painful vaccine she ever got. She was in pain for a few weeks in the arm and then she got a "frozen shoulder". From November - January it was getting more and more painful. Could not move arm much. She has had a "Froze arm" before. Went to PCP in February. Had A "Manipulation" where they put you to sleep and break the scar tissue. Went to physical therapy in early June. Resolved in Sep2022-Oct2022. Still is not completely healed.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.