chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: got sick; fever; chills; swollen lymph nodes under left arm pits; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 56-year-old male patient received BNT162b2 (BNT162B2), on 15Oct2021 at 08:00 as dose 3 (booster), single (Lot number: EW0196) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TRADJENTA; LISINOPRIL; VIT D [COLECALCIFEROL]. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EL1284, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 28Dec2020, when the patient was 54-year-old, for Covid-19 Immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EL8982, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 15Jan2021, when the patient was 54-year-old, for Covid-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "recovering", described as "got sick"; PYREXIA (non-serious), outcome "recovering", described as "fever"; CHILLS (non-serious), outcome "recovering"; LYMPHADENOPATHY (non-serious), outcome "recovering", described as "swollen lymph nodes under left arm pits". The events "got sick", "fever" and "swollen lymph nodes under left arm pits" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After third and fourth doses got sick and had fever and chills and developed swollen lymph nodes under left arm pits. Patient had no other vaccine in four weeks. Patient had no Covid prior vaccination and tested covid post vaccination. Patient had no known allergies.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; vaccine brand other=Moderna; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "adhd" (unspecified if ongoing); "ptsd" (unspecified if ongoing); "immunosuppression for extra intestinal IBD symptoms" (unspecified if ongoing); "DALM w j pouch" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical Course: Patient received other medication in 2weeks. Patient did not have any known allergies. Treatment start date was 14Jan2023 and treatment stop date was 16Jan2023.  The information on the batch/lot number for [BNT162B2 NOS] has been requested and will be submitted if and when received.; Sender's Comments: Based on temporal association, there is reasonable possibility of causal association between the Reported events and the suspect drug.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, 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 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL9267), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6205), in left arm, on 28Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 29Mar2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Known allergies: PCN" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Relafen, reaction(s): "Known allergies: Relafen". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 including Paxlovid from 08Jan2023.  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.
Age: 76.0
Sex: F
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 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Jan2021 at 13:00 as dose 1, single (Lot number: EL8982), in right arm, on 11Feb2021 at 13:00 as dose 2, single (Lot number: EN6201), in right arm, on 22Oct2021 at 12:00 as dose 3 (booster), single (Lot number: FE3592), in left arm and on 20Mar2022 at 14:00 as dose 4 (booster), single (Lot number: FM0698) at the age of 76 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). The patient had no known allergy. 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". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2023) Positive, notes: Tested positive 11 days previous. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 07Jan2023.
Age: 57.0
Sex: M
Vaccine: COVID19, 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 58-year-old male patient received BNT162b2 (BNT162B2), on 18Apr2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 57 years, in right 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 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid (Lot number: GF1701) from 16Jan2023 to 18Jan2023.
Sex: F
Vaccine: COVID19, 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 a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Oct2022 as dose 3 (booster), single (Batch/Lot number: unknown), 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. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". 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 (Paxlovid from 16Jan2023 to 17Jan2023).  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Interchange of vaccine products, Investigation, Suspected COVID-19
Clinical narrative: three shots from Moderna and 4th booster was Pfizer; stroke; had whole bunch of long Covid issues come back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ3275) for covid-19 immunisation. The patient's relevant medical history included: "long covid " (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Moderna (Dose 1, single), for COVID-19 Immunization; Moderna (Dose 2, single), for COVID-19 Immunization; Moderna (Dose 3, single), for COVID-19 Immunization; Flu shot, for immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "three shots from Moderna and 4th booster was Pfizer"; CEREBROVASCULAR ACCIDENT (medically significant), 21 days after the suspect product(s) administration, outcome "unknown", described as "stroke"; SUSPECTED COVID-19 (non-serious), outcome "unknown", described as "had whole bunch of long Covid issues come back". The events "stroke" and "had whole bunch of long covid issues come back" required emergency room visit. The patient underwent the following laboratory tests and procedures: stomach test: Unknown results.  Clinical course: 21 days after the patient had the Pfizer Booster, the 4th booster, the patient had the stroke. A day after he had the vaccine he was in the emergency room, and had whole bunch of long Covid issues come back immediately when he had the Pfizer vaccine. The patient never had the Pfizer product before Moderna was only fine the booster he had. They all last to week emergency room said the patient must have the adverse reaction to vaccine and it stop after that and eventually the Pfizer anticipated.
Age: 67.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 67 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FP4554) 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: "Hypercholesterolaemia" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 04Jan2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (04Jan2023) positive; (10Jan2023) negative; (10Jan2023) negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid treatment from 05Jan2023 to 10Jan2023.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Pyrexia, Tremor
Clinical narrative: high fevers; uncontrollable body shakes; teeth chattering; Intense headaches; chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Apr2021 as dose 1, single (Lot number: EW0161) at the age of 29 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fevers"; TREMOR (non-serious), outcome "unknown", described as "uncontrollable body shakes"; CHILLS (non-serious), outcome "unknown", described as "teeth chattering"; HEADACHE (non-serious), outcome "unknown", described as "Intense headaches"; CHEST PAIN (non-serious), outcome "unknown". Therapeutic measures were not taken as a result of pyrexia, tremor, chills, headache, chest pain.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300024971 same reporter/patient/product, different dose/AE;
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Headache, Nasopharyngeal swab, Pyrexia
Clinical narrative: high fevers; uncontrollable body shakes; teeth chattering; Intense headaches; chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2021 as dose 2, single (Lot number: EW0171) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: Ew0161; anatomical location: Left arm), administration date: 15Apr2021, when the patient was 29-year-old, for COVID-19 Immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fevers"; TREMOR (non-serious), outcome "unknown", described as "uncontrollable body shakes"; CHILLS (non-serious), outcome "unknown", described as "teeth chattering"; HEADACHE (non-serious), outcome "unknown", described as "Intense headaches"; CHEST PAIN (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, tremor, chills, headache, chest pain.  Additional information: the patient had no other vaccine in four weeks. She had no prior COVID prior to vaccination, and was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300024971 same reporter/patient/product, different dose/event;
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: high fevers; uncontrollable body shakes; teeth chattering; Intense headaches; chest pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2 (BNT162B2), on 06May2021 as dose 2, single (Lot number: EW0171) at the age of 29 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Fatty liver" (unspecified if ongoing); "Known allergies: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: Ew0161; anatomical location: Left arm), administration date: 15Apr2021, when the patient was 29-year-old, for COVID-19 Immunization, reaction(s): "high fevers", "uncontrollable body shakes", "teeth chattering", "Intense headaches", "chest pain". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "high fevers"; TREMOR (non-serious), outcome "unknown", described as "uncontrollable body shakes"; CHILLS (non-serious), outcome "unknown", described as "teeth chattering"; HEADACHE (non-serious), outcome "unknown", described as "Intense headaches"; CHEST PAIN (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, tremor, chills, headache, chest pain.  Additional information: the patient had no other vaccine in four weeks. She had no prior COVID prior to vaccination, and was tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : PFIZER INC-202300024971 same reporter/patient/product, different dose/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 5 (booster), single (Lot number: GJ3277), 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: "known allergies: Sulfa" (unspecified if ongoing). The patient's 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 Treatment". 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.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 74 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: "Prostate Cancer in remission 6 years" (unspecified if ongoing). The patient's 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 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: UNK
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Dec2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (18Dec2022) positive, notes: I tested positive on 18Dec2022; (15Jan2023) positive, notes: 15Jan2023 I tested positive again. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 19Dec20022 to 24Dec2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Musculoskeletal stiffness
Clinical narrative: It is in my neck muscle/had a stiff neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 15Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, Manufacturer unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, Manufacturer unknown), for COVID-19 Immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset Oct2022, outcome "unknown", described as "It is in my neck muscle/had a stiff neck". The event "it is in my neck muscle/had a stiff neck" required physician office visit.  Additional Information: It was reported that patient had the Pfizer bivalent booster on 15Sep2022. This would be my 5th Pfizer shot. Since Oct, had a stiff neck and other issues on the left side where patient had the shots. Patient had paid out so much money to get to the bottom of it and was going for trigger point shots at the end of Jan. At this point, the Ortho specialist feels it was in patient neck muscle. We thought it could be from raking leaves and other yard work but patient had never had any issues before. Going to contact the CDC next.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: She might have had a stroke in the past; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "She might have had a stroke in the past ".  Clinical course: The caller mentioned that she is 58-year-old and has had two shots of the Pfizer COVID-19 vaccine. She never got her booster; she was supposed to get it, but she never did. She also asked if she had a stroke in the past, should worry about getting the booster shot. Resolutions: - Gathered the caller's concern or inquiry -Gathered the caller's demographics (unable to verify the caller's name since we were not allowed to spell out their name back) -Privacy statement has been provided. -informed her that PMI is closed but she can call them during the weekdays -Provided the PMI and HOO numbers -End call - Precautionary AE form: (Withheld) She might have had a stroke in the past and she did not get her booster. Medical Information: Forwarded to MI: Yes, medical inquiry was forwarded to MI.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Bell's palsy, Facial paralysis
Clinical narrative: Face paralysis; Bell's palsy; 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FACIAL PARALYSIS (medically significant), outcome "recovered", described as "Face paralysis"; BELL'S PALSY (medically significant), outcome "recovered", described as "Bell's palsy".  Clinical course: Patient reported that I had face paralysis after my COVID vaccine. Bell's palsy. Only lasted about a week. Could that be due to Pfizer COVID vaccine?.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: tachycardia; 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TACHYCARDIA (non-serious), outcome "unknown". The event "tachycardia" required physician office visit. Additional information: the patient had no previous heart problems before and had a cardiologist visit for the event. The patient was not sure if the event was due to the BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: UNK
Symptoms: Cerebrovascular accident, Headache, Neurological symptom
Clinical narrative: stroke-like symptoms; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  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: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke-like symptoms". The event "stroke-like symptoms" required emergency room visit.  Clinical course: Pharmacist said that a patient has been in the ER for 3 days now after experiencing stroke-like symptoms (ex. headaches). The doctor told the patient it was from the vaccine and patient blamed pharmacy. Pharmacist did not disclose further information  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the event and suspect drug BNT162B2 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.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Syncope
Clinical narrative: fainted; fell to floor briefly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 81-year-old male patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose 4 (booster), single (Lot number: FM7553) at the age of 81 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot number: EK41F4, Anatomical site of location: Arm, Route of administration: Intramuscular), administration date: 14Jan2021, when the patient was 79-year-old, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE, Lot number: EL324F, Anatomical site of location: Arm, Route of administration: Intramuscular), administration date: 04Feb2021, when the patient was 79-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: FF2590, Anatomical site of location: Arm, Route of administration: Intramuscular), administration date: 14Oct2021, when the patient was 80-year-old, for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant) with onset 30Jun2022, outcome "recovered", described as "fainted"; FALL (non-serious) with onset 30Jun2022, outcome "recovered", described as "fell to floor briefly".  Clinical Course: Fourth dose, the next morning fainted; fell to floor briefly than recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Off label use, Product use issue
Clinical narrative: she got COVID shot and flu shot; she got COVID shot and flu shot; feel tired; cough; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), on 05Jan2023 as dose number unknown, single (Batch/Lot number: unknown) at the age of 57 years for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), till 09Jan2023 at 11 mg; influenza vaccine (FLU VACCINE VII), on 05Jan2023 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 05Jan2023, outcome "unknown" and all described as "she got COVID shot and flu shot"; COUGH (non-serious) with onset Jan2023, outcome "unknown"; FATIGUE (non-serious) with onset Jan2023, outcome "unknown", described as "feel tired". The action taken for tofacitinib citrate was dosage permanently withdrawn on 09Jan2023.  Additional information: the patient was taking medication regularly. However, she got COVID shot and flu shot on 05Jan2023, and she started to feel tired along with experiencing cough.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Despite getting the COVID shot, I still got COVID/ cold like symptoms; Despite getting the COVID shot, I still got COVID/ cold like symptoms; 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 (COMIRNATY), on 23Dec2020 as dose 1, single (Batch/Lot number: unknown) and on 08Apr2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Despite getting the COVID shot, I still got COVID/ cold like symptoms". Clinical course: Despite getting the covid shot, the patient still got covid. She only had cold like symptoms and it wasn't as bad as her friends that got it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: got the flu shot and got a really bad case of the flu. Found out the shot is only 50 pct effective; got the flu shot and got a really bad case of the flu. Found out the shot is only 50 pct effective; Initial information received on 12-Jan-2023 regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who got the flu shot and got a really bad case of the flu. found out the shot is only 50 pct effective after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date: Unknown) via unknown route in unknown administration site for Flu.  On an unknown date the patient developed a serious event of got the flu shot and got a really bad case of the flu. found out the shot is only 50 pct effective (vaccination failure) (latency: unknown) following the administration of INFLUENZA VACCINE.  On an unknown date the patient developed a non-serious event of got the flu shot and got a really bad case of the flu. found out the shot is only 50 pct effective (influenza) (latency: unknown) following the administration of INFLUENZA VACCINE.Reportedly stated that It has not gotten any better through the years. So patient may not bother with it next year since it has not gotten more effective through the years.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome: Unknown for both events  Seriousness criteria: Medically significant for vaccination failure; Sender's Comments: Sanofi company comment dated 18-Jan-2023: This case involves an unknown age and unknown gender patient who got the flu shot and got a really bad case of the flu. found out the shot is only 50 pct effective after receiving vaccine INFLUENZA VACCINE. The time to onset is not reported with the role of the vaccine. Patient's past medical history was unknown. Additional information regarding condition at the time of vaccination, lab data, concurrent condition, Concomitant medication, past vaccination history excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of an individual vaccine cannot be assessed.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: my flu symptoms were much less and a short duration; Initial information received on 13-Jan-2023 regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves Adult and unknown gender patient whose flu symptoms were much less and a short duration after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, dose, lot number: unknown) via unknown route in unknown administration site for Prophylactic vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of my flu symptoms were much less and a short duration (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, it's not about getting the flu people, it's about not being as miserable. It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE  was not applicable.  It was not reported if the patient received a corrective treatment for the event (my flu symptoms were much less and a short duration).  At time of reporting, the outcome was Recovered / Resolved on an unknown date.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: sick; Initial information received on 14-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who was sick after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, lot number and expiry date was unknown) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event of sick (illness) (latency: unknown) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown
Age: 53.0
Sex: M
Vaccine: TDAP
Symptoms: Incorrect route of product administration, Medication error, No adverse event
Clinical narrative: Adacel administered to a patient intravenously instead of intramuscularly, with no reported adverse event; Initial information received on 17-Jan-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 53-year-old male patient to whom DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] administered intravenously instead of intramuscularly, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 17-Jan-2023, the patient was administered 0.5ml total dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE Strength: standard (formulation, lot number and expiry date: not reported) via intravenously (iv) not otherwise specified (nos) route in unknown administration site for Immunization, instead of intramuscularly, with no reported adverse event (incorrect route of product administration) (latency: same day).  It was reported, caller asking for guidance moving forward and does not have additional information to provide since the patient is waiting at their clinic. Patient is being observed for 2 hours and is 30 minutes in at time of call. Product no longer available. Escalated for further assistance due to there not being an alternate route. Vial discarded, unknown by caller.   Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.) and NO ADVERSE EVENT (No adverse event) in a child 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. 215K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 14-Jan-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the 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 (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.) outcome was unknown and NO ADVERSE EVENT (No adverse event) had not resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patients given doses of the Moderna bivalent 6m-5y of age after the beyond use date.).    No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MODERNATX, INC.-MOD-2023-698291, MODERNATX, INC.-MOD-2023-698271 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-698291:first patient case MODERNATX, INC.-MOD-2023-698271:1st patient
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reports there have been no additional adverse experiences reported; Caller reports that an improperly stored vaccine was administered to a patient; This spontaneous report was received from a physician referring to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications and drug reaction/allergies were not reported.  On 12-JAN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (1 dose, lot #W021743, expiration date: 10-JUL-2024, strength, route of administration and anatomical site of administration were not provided) which improperly stored (product storage error) for prophylaxis. It was reported that it was stored in 10 degrees Celsius for 1 hour 28 minutes. There were no previous temperature excursion. There had been no additional adverse experiences reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; other zoster-related conditions; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 21-MAY-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. At the time of the patient's vaccination, the patient relied on the warning label affixed to zoster vaccine live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that zoster vaccine live (ZOSTAVAX) was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect, which induced the patient to be vaccinated. Alternatively, on or about 21-MAY-2014, the patient's pharmacist at the pharmacy, relied on the warning label affixed to the zoster vaccine live (ZOSTAVAX) vaccine and believed that it was effective in preventing shingles on a long-term or permanent basis, and that it did not carry any significant risks of adverse effects. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation (date not reported), the patient was treated by a physician for shingles and other zoster-related conditions. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the events shingles and other zoster-related conditions was not recovered. The causality assessment was considered as related by the lawyer.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Joint swelling, Pain, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: ankle swelling; foot swelling; shooting pains in feet; rashes on her back; This case was reported by a physician via sales rep and described the occurrence of ankle swelling in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th August 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix, the patient experienced ankle swelling, swelling of feet, foot pain and rash. The patient was treated with furosemide (Lasix) and gabapentin. On an unknown date, the outcome of the ankle swelling, swelling of feet and foot pain were not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the ankle swelling, swelling of feet, foot pain and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-JAN-2023 Reporter's Comment: The reporter reported that the Shingrix was given to patient by a different provider so only information available from patient was that she received 1 dose of Shingrix and the patient started to saw doctor in March 2022 and explained that she experienced foot and ankle swelling and shooting pains in feet and that it was on going since receiving the vaccine and complained of rashes on back. The physician did prescribe Lasix and Gabapentin to the patient. The doctor could not determine if adverse events were related to the Shingrix vaccine. The reporter agreed to follow up from GlaxoSmithKline.