chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th October 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 5th October 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient received expired Bexsero vaccine. The reporter did consent to follow up. Additional supportive information: The patient received a Bexsero which was already expired, which led to expired vaccine used.  This case has been linked to the US2022144895 case reported by the same reporter.; Sender's Comments:  US-GSK-US2022144895:same reporter
Age: 0.5
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 6 month old received an adult dose; 6 month old received an adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 6-month-old male patient who received HBV (Engerix B adult) (batch number TB3KN, expiry date 3rd December 2023) for prophylaxis.   On 10th October 2022, the patient received the 3rd dose of Engerix B adult. On 10th October 2022, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 10-Oct-2022 Reporter's comment: A nurse reported that the patient received an adult 1 ml dose of Engerix. No symptoms were reported.  The reporter consented to follow up. Additional Supportive Information: The 6 months old patient received an adult 1 ml dose of Engerix, which led to overdose and adult product administered to child.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac failure, Enzyme level test, Loss of consciousness, Vomiting
Clinical narrative: HEART FAILURE; VOMITING; PASSED OUT; This spontaneous report received from a patient concerned female unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: HPA secondary hypothalamic- pituitary adrenal insufficiency (since she was a kid). On an unspecified date, The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 063A21A  expiry: UNKNOWN) dose was not reported, 1 total for covid-19 prophylaxis.  The patient experienced pain in arm when treated with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 29-DEC-2021 for covid-19 prophylaxis. No concomitant medications were reported.  On DEC-2021, since she received the booster, she passed out, 3 times in total (Dose number in series 2). On an unspecified date, the patient experienced vomiting for 3 months since 4AM-5AM in the morning until 2PM-3PM in the afternoon about 2-3 times a day, every hours. She also mentioned having trouble breathing, she saw her doctor and they did a blood work and find out that she had a heart problem, early stage of heart failure. Heart failure was worst around March and April 2022. Her doctor explained to her that her enzymes were really low and they were causing her heartbeat to be slower (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and the outcome of heart failure and passed out was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20221024078.; Sender's Comments: V0: 20221022922-COVID-19 VACCINE AD26.COV2.S- Heart failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY- HPA secondary hypothalamic- pituitary adrenal insufficiency. Therefore, this event(s) is considered not related.  V0: 20221022922-COVID-19 VACCINE AD26.COV2.S- Passed Out. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caregiver stated that the patient received both Moderna vaccines, but still got Covid.; This spontaneous case was reported by an other caregiver and describes the occurrence of COVID-19 (Caregiver stated that the patient received both Moderna vaccines, but still got Covid.) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Anorgasmia (No orgasms), Paralyzed, Optic neuritis, COVID-19 and Coma. Concurrent medical conditions included Forgetfulness (Forgetting everything), Pain, Burning sensation and Weight gain. Concomitant products included OCRELIZUMAB (OCREVUS) and OXYGEN for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caregiver stated that the patient received both Moderna vaccines, but still got Covid.) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Caregiver stated that the patient received both Moderna vaccines, but still got Covid.) had resolved.            Ocrevus stops working. Concurrent conditions reported: lesions, location not provided  No treatment information was provided.  Patient had Medically history of lesions.  Company Comment: This is a spontaneous case concerning an adult female patient (exact age unknown) with no relevant medical history, who experienced the serious (due to hospitalization) unexpected, event of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The outcome was reported as recovered. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning an adult female patient (exact age unknown) with no relevant medical history, who experienced the serious (due to hospitalization) unexpected, event of COVID-19. The event occurred on an unknown date after the second dose of mRNA-1273 vaccine. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. The outcome was reported as recovered. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Hyperthyroidism, Adrenal insufficiency and Blindness. Concurrent medical conditions included Melanoma (Melanoma of the eye), Hypertension and Asthma.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No relevant concomitant medications were reported. No treatment medication reported.
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster) and NO ADVERSE EVENT (No adverse event) in a 54-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer bivalent booster (34 days ago, patient received a Pfizer bivalent booster) and Pfizer (Pfizer primary series). Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer bivalent booster.    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 WRONG PRODUCT ADMINISTERED (patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (patient came in for a flu shot and was inadvertently given a Moderna COVID-19 Vaccine, Bivalent booster).    No concomitant information was reported. No treatment information was provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Feeling of relaxation, Illness, Nasopharyngitis
Clinical narrative: It made me sick; Got nervous; Back ache; Felt weak; laid back; Felt she had a cold; Running a temperature/fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (It made me sick), NERVOUSNESS (Got nervous), BACK PAIN (Back ache), ASTHENIA (Felt weak) and FEELING OF RELAXATION (laid back) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR4504B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Echocardiogram (leaky heart valve go every 6 months and they do echogram.). Concurrent medical conditions included Drug allergy (Hydrochlorothiazide), Blood pressure high, Hypercholesteremia and Heart valve disorders. Concomitant products included CARVEDILOL, IRBESARTAN, NIFEDIPINE and ATORVASTATIN for an unknown indication.    On 14-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ILLNESS (It made me sick), NERVOUSNESS (Got nervous), BACK PAIN (Back ache), ASTHENIA (Felt weak), FEELING OF RELAXATION (laid back), NASOPHARYNGITIS (Felt she had a cold) and PYREXIA (Running a temperature/fever). At the time of the report, ILLNESS (It made me sick), NERVOUSNESS (Got nervous), BACK PAIN (Back ache), ASTHENIA (Felt weak), FEELING OF RELAXATION (laid back), NASOPHARYNGITIS (Felt she had a cold) and PYREXIA (Running a temperature/fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2022, SARS-CoV-2 test: (Negative) Negative.         The patient had Dose 1(unknown date) with lot number 032L20A, dose 2 was on 22-Feb-2021 with lot number 030M20A and first  booster dose was on 04-Nov-2021 with lot number 076C21A.  Patient stated that she had the 2 shots and one booster and she never had any problems with them.  Patient never had COVID + test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE did not cause patient to seek medical care. The patient did not experienced a similar event in the past.  No treatment medications were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Pyrexia, SARS-CoV-2 test
Clinical narrative: It made me sick; Got nervous; Back ache; Felt weak; laid back; Felt she had a cold; Running a temperature/fever; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (It made me sick), NERVOUSNESS (Got nervous), BACK PAIN (Back ache), ASTHENIA (Felt weak) and FEELING OF RELAXATION (laid back) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AR4504B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Echocardiogram (leaky heart valve go every 6 months and they do echogram.). Concurrent medical conditions included Drug allergy (Hydrochlorothiazide), Blood pressure high, Hypercholesteremia and Heart valve disorders. Concomitant products included CARVEDILOL, IRBESARTAN, NIFEDIPINE and ATORVASTATIN for an unknown indication.    On 14-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced ILLNESS (It made me sick), NERVOUSNESS (Got nervous), BACK PAIN (Back ache), ASTHENIA (Felt weak), FEELING OF RELAXATION (laid back), NASOPHARYNGITIS (Felt she had a cold) and PYREXIA (Running a temperature/fever). At the time of the report, ILLNESS (It made me sick), NERVOUSNESS (Got nervous), BACK PAIN (Back ache), ASTHENIA (Felt weak), FEELING OF RELAXATION (laid back), NASOPHARYNGITIS (Felt she had a cold) and PYREXIA (Running a temperature/fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2022, SARS-CoV-2 test: (Negative) Negative.         The patient had Dose 1(unknown date) with lot number 032L20A, dose 2 was on 22-Feb-2021 with lot number 030M20A and first  booster dose was on 04-Nov-2021 with lot number 076C21A.  Patient stated that she had the 2 shots and one booster and she never had any problems with them.  Patient never had COVID + test or diagnosis. No other vaccines given within 1 month prior to Moderna COVID-19 vaccine. AE did not cause patient to seek medical care. The patient did not experienced a similar event in the past.  No treatment medications were reported.
Age: 6.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, No adverse event
Clinical narrative: Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent) and NO ADVERSE EVENT (No adverse event) in a 6-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 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL OVERDOSE (Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL OVERDOSE (Received 0.50mL instead of 0.25 mL from Moderna Covid 19 Bivalent).    No concomitant medications was reported. No treatment medications was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-659990.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-659990:Patient 1 case
Sex: M
Vaccine: COVID19
Symptoms: Near death experience
Clinical narrative: She is not sure if her son's vaccine was Moderna or Pfizer but he was at death's door.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis" (unspecified if ongoing), notes: myasthenia gravis for about 6 years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01 Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: NEAR DEATH EXPERIENCE (caused and prolonged hospitalization, medically significant, life threatening), outcome "unknown", described as "She is not sure if her son's vaccine was Moderna or Pfizer but he was at death's door".  Clinical course: The reporter son had his second vaccine and ended up in a medical crisis in the hospital for a month. Caller declined to complete report for her son and states she was not sure if he had the Pfizer or Moderna covid vaccine and has no lot, expiry date or NDC to provide for his vaccine but she was with him when he went into acute medical crisis and he was a very very sick man with myasthenia gravis, clarified her son had myasthenia gravis prior to the covid vaccine and it was under control but it was after the covid vaccine when he went into medical crisis. Her son had myasthenia gravis for about 6 years. Her son has myasthenia gravis and got his second shot on her birthday date and that day he ended up in the hospital for the total of a month in a medical crisis. She was not sure if her son's vaccine was Moderna or Pfizer but he was at death's door.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Nasal congestion
Clinical narrative: Her daughter had a period where she was sick and had scheduled for 01Aug for her second dose but had cough, congestion, and junk; Her daughter had a period where she was sick and had scheduled for 01Aug for her second dose but had cough, congestion, and junk; Her daughter had a period where she was sick and had scheduled for 01Aug for her second dose but had cough, congestion, and junk; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 3-year-old female patient received BNT162b2 (BNT162B2), on 11Jul2022 as dose 1 (maroon cap), 0.2 ml single (Lot number: FT9142) at the age of 3 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: COUGH (non-serious), ILLNESS (non-serious), NASAL CONGESTION (non-serious), outcome "unknown" and all described as "Her daughter had a period where she was sick and had scheduled for 01Aug for her second dose but had cough, congestion, and junk".
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore arm/arm is still a little sore; chills; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Lot number: GJ6742), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's 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. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 13Oct2022 at 20:00, outcome "recovering", described as "Sore arm/arm is still a little sore"; CHILLS (non-serious) with onset 13Oct2022 at 20:00, outcome "recovered" (14Oct2022). Therapeutic measures were not taken as a result of pain in extremity, chills.  Additional information: No prior vaccination for COVID-19. No post vaccination if the patient tested for COVID-19. No known allergies and other medical history. Sore arm and chills starting approximately 9 hours after vaccination at 20:00. The arm is still a little sore but the chills went away overnight on 14Oct2022. The outcome of the events was reported as recovering.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021325922 same reporter/patient, different AE/dose;US-PFIZER INC-202101578176 same reporter/patient, different AE/dose;US-PFIZER INC-202200792194 same reporter/patient, different AE/dose;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022.; They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 80-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Jan2021) Positive, notes: They have had Covid twice; (24Aug2022) Positive, notes: They have had Covid twice. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information included: The caller thanked Pfizer for the vaccinations and said she and her husband have taken them all, up to the first booster. They can't take the second booster until 3 months after the Covid from August. The caller stated she is doing very well for her age. They have had Covid twice, the first time in Jan2021 and the second time on 24Aug2022. She stated for her age, for the most part she does not have to take medications and she is not on any medications for any conditions.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiovascular disorder, Fear
Clinical narrative: I am extremely concerned and fearful; My circulatory side effects are worsening; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), 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: FEAR (non-serious), outcome "unknown", described as "I am extremely concerned and fearful"; CARDIOVASCULAR DISORDER (non-serious), outcome "not recovered", described as "My circulatory side effects are worsening".  Additional information: The patient would like to please speak with someone about severe side effects that patient have and continue to have after Pfizer CoV2 vaccine. The patient circulatory side effects are worsening and was extremely concerned and fearful. The side effects are worsening, and the patient need resolution.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: PNC20
Symptoms: Malaise, Vaccination site pain
Clinical narrative: I have not been feeling well; The vaccination site is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from agency. The reporter is the patient.  A 78-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), 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: MALAISE (non-serious), outcome "unknown", described as "I have not been feeling well"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The vaccination site is still sore".  Additional information: Patient received a Prevnar 20 vaccination on 06Oct. The vaccination site was still sore. She was not feeling well. She wanted to know that other side effects have lasted this long.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hip arthroplasty, Renal function test
Clinical narrative: The patient experienced right hip replacement; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): US-ABBVIE-22K-163-4252170-00.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Batch/Lot number: unknown) and on 17Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 77 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Lot number: 1158135) at 40 mg (40 mg (citrate free)), subcutaneous for psoriatic arthropathy. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HIP ARTHROPLASTY (medically significant) with onset Dec2021, outcome "recovered", described as "The patient experienced right hip replacement". The patient underwent the following laboratory tests and procedures: Renal function test: (2022) High, notes: Kidney numbers [Renal function test], 2022, High; (unspecified date) abnormal. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of hip arthroplasty.  Clinical course: It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  Causalities The reporter's causality for the event(s) of right hip replacement with Pfizer BioNTech COVID-19 vaccine (Tozinameran) was No Reasonable Possibility The reporter's causality for the event(s) of right hip replacement with Adalimumab Solution for Injection was Not Provided Alternative Etiology for right hip replacement with Adalimumab Solution for Injection: Surgical procedure performed; Most likely related to underlying Psoriatic arthritis in this elderly patient  Assessment Results Pfizer BioNTech COVID -19 vaccine Hip replacement,  Pfizer BioNTech COVID -19 vaccine Hip replacement, Non-Health Care Professional, Global Introspection, No Reasonable Possibility Humira Hip replacement, Global Introspection, No Reasonable Possibility Humira Hip replacement, Non-Health Care Professional, Global Introspection, Not Reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
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 a contactable reporter(s) (Physician).  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 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 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), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had no other medication in 2 weeks. The patient received therapy with anti viral product Oral Paxlovid for COVID 19 Treatment, which was started on 29Sep2022 and stopped on 04Oct2022. AE treatment with tylenol, ibuprofen, electrolytes. The patient had no Known allergies.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on possible temporal association the causal association of suspect  drug  BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5),BNT162b2 cannot be excluded for reported events-Drug ineffective and COVID-19
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; JANSSEN COVID-19 VACCINE on 17Mar2021 as dose 1 and BNT162b2 on 24Oct2021 as dose 2/Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 16:00 as dose 4 (booster), single (Lot number: cah9703) at the age of 27 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 24Oct2021 as dose 2 (booster), single (Lot number: 320308D), in right arm and on 05Jun2022 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 17Mar2021 as dose 1, single (Lot number: 1805025), in right arm for covid-19 immunisation. Patient was not pregnant at the time of vaccination.  The patient's relevant medical history included: "Asthma" (unspecified if ongoing), notes: Other medical history included asthma. Patient had no known allergies. Other medication in 2 weeks included NYQUIL COUGH DM + CONGESTION. Concomitant medication(s) included: NYQUIL COUGH DM + CONGESTION, start date: 28Sep2022, stop date: 01Oct2022. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 24Oct2021, outcome "unknown", described as "JANSSEN COVID-19 VACCINE on 17Mar2021 as dose 1 and BNT162b2 on 24Oct2021 as dose 2/Interchange of vaccine products"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2022, outcome "not recovered" and all described as "COVID 19 Treatment". 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. This report was about COVID-19 treatment. Patient received the vaccine. Patient received treatment for COVID-19 with Paxlovid from 28Sep2022 to 02Oct2022.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: redness / rash around injection site; redness / rash around injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Oct2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 52 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergy" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, on 28Sep2022 as dose 1, single; METFORMIN. Vaccination history included: Bnt162b2 (DOSE 4 (BOOSTER), SINGLE; Lot number: FM0698), for Covid-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE; Lot number: 32030BD), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0179), for Covid-19 immunization; Bnt162b2 (DOSE 1, SINGLE; Lot number: ER8731), for Covid-19 immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 11Oct2022 at 12:00, outcome "recovering", VACCINATION SITE RASH (non-serious) with onset 11Oct2022 at 12:00, outcome "recovering" and all described as "redness / rash around injection site". Therapeutic measures were not taken as a result of vaccination site erythema, vaccination site rash.  Additional information: Patient has not been diagnosed with covid-19 prior to vaccination and was not tested again for covid-19 after vaccination.  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-202201236504 same reporter/patient/product/dose; different events;
Age: 40.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Axillary pain, Burning sensation, Herpes zoster, Off label use, Product use issue
Clinical narrative: sharp pains and burning in the right armpit; sharp pains and burning in the right armpit; diagnosed with shingles/ developed a rash; off label use; Product use for unapproved combination; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 at 08:30 as dose number unknown (booster), single (Lot number: GH9702) at the age of 40 years intramuscular, in right arm for covid-19 immunisation; influenza vaccine (INFLUENZA), on 23Sep2022 as dose 1, single (Lot number: UT7744JA), in left arm for immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (primary immunization series complete; manufacturer unknown), for COVID-19 immunisation. The following information was reported: PRODUCT USE ISSUE (non-serious) with onset 23Sep2022, outcome "unknown", described as "Product use for unapproved combination"; OFF LABEL USE (non-serious) with onset 23Sep2022, outcome "unknown"; HERPES ZOSTER (non-serious) with onset 27Sep2022, outcome "recovering", described as "diagnosed with shingles/ developed a rash"; AXILLARY PAIN (non-serious), BURNING SENSATION (non-serious) all with onset 27Sep2022, outcome "recovering" and all described as "sharp pains and burning in the right armpit". The events "sharp pains and burning in the right armpit" and "diagnosed with shingles/ developed a rash" required physician office visit. Therapeutic measures were taken as a result of axillary pain, burning sensation, herpes zoster.  Additional information: Other vaccine received in four weeks was "Dynavax, Inc," (not further specified) on16Sep2022 as dose 1, single (Lot number: 938793) in left arm. Within a few days of receiving the COVID booster in the patient's right arm, she began to experience sharp pains and burning in her right armpit. She developed a rash that would not respond to diphenhydramine hydrochloride (BENADRYL), hydrocortisone, or steroid cream. She went to the doctor and was diagnosed with shingles. Treatment received included valacyclovir (VALTREX) on 04Oct2022 and topical ointment.
Age: 65.0
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 contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 65 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 was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "recovering", COVID-19 (medically significant), 9 days 13 hrs after the suspect product(s) administration, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Symptoms returned. Positive test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2 weeks reported as no. Paxlovid used for the treatment of covid 19. Known allergies reported as no.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201231877 Same patient, different product and event;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Apr2022 as dose number unknown, single (Lot number: FJ9943) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL, start date: Mar2021, stop date: Oct2022. Past drug history included: Gabapentin, reaction(s): "taking gabapentin for damaged femoral nerve", notes: taking gabapentin for damaged femoral nerve 600mg 3x daily(program would not allow more than one med) doubled vaxxed and double boosted; Tetanus toxoid, reaction(s): "Known allergies: Tetanus toxoid"; Gadolinium, reaction(s): "Known allergies: gadolinium". 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: Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested + for covid(home test)28Sep started Paxlovid 30Sep; Tested + for covid(home test) 28Sep started Paxlovid 30Sep; This is a spontaneous report received from a contactable reporter(s) (Nurse) from product quality group. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), on 03Jan2021 at 10:00 as dose 1, single (Lot number: EL0142), in left arm, on 24Jan2021 at 10:00 as dose 2, single (Lot number: EL3248), in right arm and on 12Oct2021 at 10:00 as dose 3 (booster), single (Lot number: 30145BA) at the age of 46 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "psoriasis" (unspecified if ongoing); "HTN" (unspecified if ongoing). Concomitant medication(s) included: HUMIRA, start date: 01Sep2015; NUVIGIL, start date: 01Sep2015; ATENOLOL, start date: 01Sep2015; PROTONIX [OMEPRAZOLE], start date: 01Sep2015. The following information was reported: COVID-19 (medically significant) with onset 28Sep2022, outcome "not recovered", described as "Tested + for covid (home test) 28Sep started Paxlovid 30Sep"; VACCINATION FAILURE (medically significant) with onset 28Sep2022, outcome "not recovered", described as "Tested + for covid (home test)28Sep started Paxlovid 30Sep". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Sep2022) Positive, notes: Tested + for covid (home test) 28Sep; (05Oct2022) Negative, notes: Tested negative 05Oct with no symptoms; (13Oct2022) Positive, notes: Tested +again 13Oct. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Paxlovid treatment start date 30Sep2022, stop date 05Oct2022. Tested negative 5Oct with no symptoms. Started getting sore throat and runny nose 09Oct. Tested positive again 13Oct with bad non productive cough and bad nasal congestion. The known allergies were none.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events vaccination failure, COVID-19 and the use of suspect product cannot be fully excluded.
Age: 58.0
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 non-contactable reporter(s) (Nurse). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Sep2022 at 11:00 as dose 5 (booster), single (Lot number: GH9702) at the age of 58 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: "Hyperlipidaemia" (unspecified if ongoing), notes: Other medical history Hyperlipidemia. Concomitant medication(s) included: PRAVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Oct2022) Positive, notes: Positive antigen test 6 days post Paxlovid treatment; (unspecified date) Positive, notes: Indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received COVID-19 treatment with Paxlovid from 01Oct2022 to 05Oct2022. Patient received other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Minor body aches; fever; headache; This is a spontaneous report received from a contactable reporter (consumer or other non-HCP). 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 12Oct2022 at 11:45 as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE (lot number: GJ6742) at the age of 54 years, administered in the left arm for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, (unknown manufacturer)), for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset 12Oct2022 at 22:30, outcome "recovered" (Oct2022), described as "Minor body aches"; PYREXIA (non-serious) with onset 12Oct2022 at 22:30, outcome "recovered" (Oct2022), described as "fever"; HEADACHE (non-serious) with onset 12Oct2022 at 22:30, outcome "recovered" (Oct2022). Therapeutic measures were not taken as a result of pain, pyrexia, and headache.  Additional information: Facility type vaccine is a Workplace clinic. Patient did not receive other vaccine in four weeks. Other medication in two weeks: N/A. If covid Prior vaccination: No. If covid tested post vaccination: No. Known allergies: N/A; Other medical history: N/A.