chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Blood test, Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ), at 5 mg 2x/day (5 mg, 2x/day (twice daily)). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid vaccine (dose 1 and 2; manufacturer unknown), for COVID-19 immunisation, reaction(s): "COVID". The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "recovering", described as "Stroke".  Clinical course: The patient had COVID and she took the tofacitinib citrate and then she had a stroke. She is fine now. Just her deformity is off. She stated she has to say 2-3 names before she gets the right one. They took her off tofacitinib citrate for the time being. There is no proof that the tofacitinib citrate caused the stroke, but she did have two COVID vaccines and a booster shot. She got the sroke right after the booster dose. She didn't specify which COVID vaccine she received. They didn't know what caused it because her blood work was fine and the tofacitinib citrate was working great for her. The action taken for tofacitinib citrate was temporarily withdrawn.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: FLUR4
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Patient reported fever, diarrhea and vomiting lasting greater than 24 hours
Age: 33.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chest pain, Dizziness, Headache, Pain in extremity, Painful respiration
Clinical narrative: Headache, dizziness, arm soreness all started around 6:15pm on the same day; and chest pain while taking deep breaths started 09/10/2022 morning.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Injection site pain, Insomnia, Pain, Pain in extremity
Clinical narrative: I had an appointment on Sunday, Sept 4 at 11:40 am for a flu shot at the pharmacy.  I received a flu shot at approximately that time. The pharmacist was polite and professional. When she administered my flu shot, she stuck it extremely high on my arm, into the shoulder. I have never had anyone give me a shot that high before. It hurt far more than usual and it felt as if something was vibrating. I told her that, and said it hurt quite a lot. She replied that she put the needle exactly where it was supposed to be. She gave my husband a shot in the same place. Although he had no additional problems, my arm hurt far more than expected. It was centered on my shoulder. It throbbed and I had trouble sleeping. Moving my shoulder or lifting anything resulted in extreme pain. It is beginning to feel better after a week, although it's still very tender. I had a Covid vaccine today, where the pharmacist strongly suggested I make a complaint. The pharmacist was very nice but I really do think she needs retraining in exactly where in the arm to administer a vaccine. The pharmacist stuck the Covid vaccine in the deltoid muscle, where every other vaccine I've ever had went. The pharmacist stuck that flu shot much, much higher, at the very top of my arm into the shoulder.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Product administered at inappropriate site, Tenderness
Clinical narrative: I had an appointment on Sunday, Sept 4 at 11:40 am for a flu shot at the pharmacy.  I received a flu shot at approximately that time. The pharmacist was polite and professional. When she administered my flu shot, she stuck it extremely high on my arm, into the shoulder. I have never had anyone give me a shot that high before. It hurt far more than usual and it felt as if something was vibrating. I told her that, and said it hurt quite a lot. She replied that she put the needle exactly where it was supposed to be. She gave my husband a shot in the same place. Although he had no additional problems, my arm hurt far more than expected. It was centered on my shoulder. It throbbed and I had trouble sleeping. Moving my shoulder or lifting anything resulted in extreme pain. It is beginning to feel better after a week, although it's still very tender. I had a Covid vaccine today, where the pharmacist strongly suggested I make a complaint. The pharmacist was very nice but I really do think she needs retraining in exactly where in the arm to administer a vaccine. The pharmacist stuck the Covid vaccine in the deltoid muscle, where every other vaccine I've ever had went. The pharmacist stuck that flu shot much, much higher, at the very top of my arm into the shoulder.
Age: 53.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: so patient has no any symptoms
Age: 21.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: Approximately 2 hours after getting vaccines the patient's father called saying he could not breathe easily and was having trouble swallowing.  Instructed to go to the er ASAP.
Age: 74.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Injection site rash, Injection site warmth
Clinical narrative: arm redness, rash, warmth at injection site 2.5 X 3" site
Age: 61.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Vaccination site erythema, Vaccination site reaction
Clinical narrative: Patient noticed a red circular reaction on left arm where vaccines were administered. Asked the patient if it was warm or hard to the touch, patient declined any of these reactions.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Antiphospholipid antibodies, Blood thyroid stimulating hormone, C-reactive protein, Chest X-ray, Cough
Clinical narrative: had a cough; BNT162B2 dose 1 07Aug2021 Flu 07Aug2021; BNT162B2 dose 1 07Aug2021 Flu 07Aug2021; 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 patient received BNT162b2 (BNT162B2), on 07Aug2021 at 15:10 as dose 1, single (Lot number: FA7484), in right arm for covid-19 immunisation; influenza vaccine (FLU), on 07Aug2021 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "hypothyroidism", start date: 11Jul1997 (ongoing), notes: I take levothyroxine 88mcg; "Hashimotos Hypothyroidism" (unspecified if ongoing). The patient's family history included: "High blood pressure", start date: 11Sep2012 (ongoing), notes: I take bisoproplol 6.25mg, low dose aspirin, losartan 50mg; "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOCETIRIZINE taken for blood cholesterol increased, start date: Jun2022 (ongoing); BISOPROLOL;HYDROCHLOROTHIAZIDE taken for hypertension, start date: 2013 (ongoing); LOSARTAN taken for hypertension, start date: 2018 (ongoing); LEVOTHYROXINE taken for autoimmune thyroiditis, hypothyroidism, start date: 2002 (ongoing); ALPRAZOLAM (ongoing). The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Aug2021, outcome "unknown" and all described as "BNT162B2 dose 1 07Aug2021 Flu 07Aug2021"; COUGH (non-serious), outcome "recovered" (14Jul2022), described as "had a cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cough.  Additional information: Upon follow up information received on 02Sep2022, it was reported that patient received BNT162b2 on 28Aug2021, in afternoon as dose 2, single (lot number: FC3182) in arm for covid-19 immunization and also received dose 3 on 19Apr2022, in morning as dose 3 (booster), single in arm for covid-19 immunization. Booster dose due to a weekend immune system. Vaccine facility type: Doctors office/ Urgent care. Vaccine administered at military facility: No. Patient received "Shingles" vaccine on 19Apr2022 in arm, as prior vaccine (within 4 weeks). Patient had cough with onset date: 08Apr - 08Jul2022. Pertinent details: for cough Allergy meds helped.  Amendment: This follow up report is being submitted to amend previous information: added the event 'off label use'.  Follow-Up (17Aug2022): Follow-up attempts are completed. No further information is expected.  Follow-up (02Sep2022): New information received from a same contactable consumer in response to Non-Hcp follow-up letter sent in cross reference case. Updated information included that RMH was added, lab data added, concomitant drugs were added and new event (had a cough) added and clinical information added.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory, Full blood count, Lipids
Clinical narrative: had a cough; BNT162B2 dose 1 07Aug2021 Flu 07Aug2021; BNT162B2 dose 1 07Aug2021 Flu 07Aug2021; 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 patient received BNT162b2 (BNT162B2), on 07Aug2021 at 15:10 as dose 1, single (Lot number: FA7484), in right arm for covid-19 immunisation; influenza vaccine (FLU), on 07Aug2021 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "hypothyroidism", start date: 11Jul1997 (ongoing), notes: I take levothyroxine 88mcg; "Hashimotos Hypothyroidism" (unspecified if ongoing). The patient's family history included: "High blood pressure", start date: 11Sep2012 (ongoing), notes: I take bisoproplol 6.25mg, low dose aspirin, losartan 50mg; "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOCETIRIZINE taken for blood cholesterol increased, start date: Jun2022 (ongoing); BISOPROLOL;HYDROCHLOROTHIAZIDE taken for hypertension, start date: 2013 (ongoing); LOSARTAN taken for hypertension, start date: 2018 (ongoing); LEVOTHYROXINE taken for autoimmune thyroiditis, hypothyroidism, start date: 2002 (ongoing); ALPRAZOLAM (ongoing). The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Aug2021, outcome "unknown" and all described as "BNT162B2 dose 1 07Aug2021 Flu 07Aug2021"; COUGH (non-serious), outcome "recovered" (14Jul2022), described as "had a cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cough.  Additional information: Upon follow up information received on 02Sep2022, it was reported that patient received BNT162b2 on 28Aug2021, in afternoon as dose 2, single (lot number: FC3182) in arm for covid-19 immunization and also received dose 3 on 19Apr2022, in morning as dose 3 (booster), single in arm for covid-19 immunization. Booster dose due to a weekend immune system. Vaccine facility type: Doctors office/ Urgent care. Vaccine administered at military facility: No. Patient received "Shingles" vaccine on 19Apr2022 in arm, as prior vaccine (within 4 weeks). Patient had cough with onset date: 08Apr - 08Jul2022. Pertinent details: for cough Allergy meds helped.  Amendment: This follow up report is being submitted to amend previous information: added the event 'off label use'.  Follow-Up (17Aug2022): Follow-up attempts are completed. No further information is expected.  Follow-up (02Sep2022): New information received from a same contactable consumer in response to Non-Hcp follow-up letter sent in cross reference case. Updated information included that RMH was added, lab data added, concomitant drugs were added and new event (had a cough) added and clinical information added.
Sex: U
Vaccine: COVID19, FLUX
Symptoms: Magnetic resonance imaging head, Off label use, Product use issue, Red blood cell sedimentation rate, Ultrasound scan
Clinical narrative: had a cough; BNT162B2 dose 1 07Aug2021 Flu 07Aug2021; BNT162B2 dose 1 07Aug2021 Flu 07Aug2021; 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 patient received BNT162b2 (BNT162B2), on 07Aug2021 at 15:10 as dose 1, single (Lot number: FA7484), in right arm for covid-19 immunisation; influenza vaccine (FLU), on 07Aug2021 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation. The patient's relevant medical history included: "hypothyroidism", start date: 11Jul1997 (ongoing), notes: I take levothyroxine 88mcg; "Hashimotos Hypothyroidism" (unspecified if ongoing). The patient's family history included: "High blood pressure", start date: 11Sep2012 (ongoing), notes: I take bisoproplol 6.25mg, low dose aspirin, losartan 50mg; "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: LEVOCETIRIZINE taken for blood cholesterol increased, start date: Jun2022 (ongoing); BISOPROLOL;HYDROCHLOROTHIAZIDE taken for hypertension, start date: 2013 (ongoing); LOSARTAN taken for hypertension, start date: 2018 (ongoing); LEVOTHYROXINE taken for autoimmune thyroiditis, hypothyroidism, start date: 2002 (ongoing); ALPRAZOLAM (ongoing). The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 07Aug2021, outcome "unknown" and all described as "BNT162B2 dose 1 07Aug2021 Flu 07Aug2021"; COUGH (non-serious), outcome "recovered" (14Jul2022), described as "had a cough". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of cough.  Additional information: Upon follow up information received on 02Sep2022, it was reported that patient received BNT162b2 on 28Aug2021, in afternoon as dose 2, single (lot number: FC3182) in arm for covid-19 immunization and also received dose 3 on 19Apr2022, in morning as dose 3 (booster), single in arm for covid-19 immunization. Booster dose due to a weekend immune system. Vaccine facility type: Doctors office/ Urgent care. Vaccine administered at military facility: No. Patient received "Shingles" vaccine on 19Apr2022 in arm, as prior vaccine (within 4 weeks). Patient had cough with onset date: 08Apr - 08Jul2022. Pertinent details: for cough Allergy meds helped.  Amendment: This follow up report is being submitted to amend previous information: added the event 'off label use'.  Follow-Up (17Aug2022): Follow-up attempts are completed. No further information is expected.  Follow-up (02Sep2022): New information received from a same contactable consumer in response to Non-Hcp follow-up letter sent in cross reference case. Updated information included that RMH was added, lab data added, concomitant drugs were added and new event (had a cough) added and clinical information added.
Sex: F
Vaccine: COVID19, UNK
Symptoms: COVID-19, Drug ineffective, Feeling abnormal, SARS-CoV-2 test
Clinical narrative: COVID-19; COVID-19; BRAIN FOG; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2K-163-4518641-00 (Agency).  A 59-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 15Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; adalimumab (HUMIRA), (ongoing) (Lot number: 1160830), subcutaneous for hidradenitis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset Aug2022, outcome "not recovered", described as "BRAIN FOG"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2022, outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. The action taken for adalimumab was dosage not changed. Patient was with events of non-serious brain fog and COVID-19 with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date in Aug2022, the patient experienced brain fog. In Aug2022, the patient experienced COVID-19. COVID-19 VACCINE and MODERNA COVID-19 VACCINE (ELASOMERAN) were also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality details for HUMIRA (ADALIMUMAB) included the reporter's causality for the events of brain fog and COVID-19 was not provided. Ongoing HUMIRA (Solution for injection in Pre-filled pen) (ADALIMUMAB) via subcutaneous route of administration for moderate to severe Hidradenitis Suppurativa. COVID-19 Vaccine (COVID-19 Vaccine) (COVID-19 Vaccine) as single dose as solution for injection for COVID-19 vaccination. Drug causality for drug Humira with the event Foggy feeling in head (Feeling abnormal) was not reported and action taken with drug was dose not changed. Drug causality for drug Humira with the event COVID-19 was not reported with action taken with drug was dose not changed. Drug causality for drug COVID-19 vaccine and MODERNA vaccine with the event Foggy feeling in head (Feeling abnormal) and COVID-19 was possible with the action taken as unknown.   The reporter considered "covid-19" and "brain fog" related to BNT162b2.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Amendment: This follow-up report is being submitted to allow appropriate reporting to FDA with the correct Emergency Use Authorization number 027034 for BNT162B2.; Sender's Comments: Based on available information in the case the reported events Covid-19, Drug ineffective and feeling abnormal are assessed as related to suspect drug .
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug ineffective, Immunodeficiency, Suspected COVID-19
Clinical narrative: Immune system down; COVID with HUMIRA (ADALIMUMAB); COVID with HUMIRA (ADALIMUMAB); This is a solicited report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4518942-00 (Agency).  A 30-year-old female patient received BNT162b2 (BNT162B2), on 03Sep2021 as dose 1, single (Batch/Lot number: unknown) and on 24Sep2021 as dose 2, single (Batch/Lot number: unknown) at the age of 29 years, all intramuscular for covid-19 immunisation; adalimumab (HUMIRA), (Batch/Lot number: unknown), subcutaneous. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "recovered", described as "Immune system down"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID with HUMIRA (ADALIMUMAB)". The action taken for adalimumab was dosage permanently withdrawn.  Clinical course: On unknown dates, the patient experienced immune system down and COVID. On an unknown date, immune system down resolved. Pfizer BioNTech COVID-19 vaccine (Tozinameran) was also considered suspect. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter considered "immune system down" and "covid with humira (adalimumab)" related to BNT162b2.  The reporter's causality for the event(s) of immune system down with Humira (Adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of COVID was not provided.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: the patient has been having all kinds of issues with her mensuration  and everything; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2022NVX-US-000003008.  A female patient received BNT162b2 (COMIRNATY), 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: MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "the patient has been having all kinds of issues with her mensuration and everything".  Additional information: On 16Aug2022, it was reported that a patient started treatment on an unspecified date with mRNA Covid-19 Vaccine or (Name withheld) as unknown dose for unknown indication. It was reported the patient has been having all kinds of issues with her mensuration and everything. No further follow-up is anticipated.   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: Alanine aminotransferase, Aldolase, Antibody test, Aspartate aminotransferase, Blood creatine phosphokinase
Clinical narrative: This is a literature report for the following literature source(s): "A Possible Case of COVID-19 Booster Vaccine-Associated Rhabdomyolysis and Acute Kidney Injury", Journal of Pharmacy Technology. A 69-year-old female patient received BNT162b2 (BNT162B2), on 03Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes mellitus" (unspecified if ongoing); "morbid obesity" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "mood disorder" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "pedal edema" (unspecified if ongoing); "asthma" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: remote history in remission. The patient's family history included: "polymyositis rheumatica" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rosuvastatin for hyperlipidemia; Furosemide; Losartan; Metformin. Vaccination history included: Covid-19 vaccine (DOSE number unknown; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: RHABDOMYOLYSIS (medically significant) with onset 13Oct2021, outcome "recovering". The event "rhabdomyolysis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (8-22): (13Oct2021) 211 IU/l; Aldolase (normal high range 8.1): (unspecified date) 18.2 IU/l; Antibody test: (unspecified date) negative; Aspartate aminotransferase (8-45): (13Oct2021) 235 IU/l; Blood creatine phosphokinase (25-190): (13Oct2021) 8394 IU/l; (19Oct2021) 855 IU/l; (20Oct2021) 467 IU/l; Blood creatinine (normal high range 0.8): (11Oct2021) 1.77 mg/dl; (13Oct2021) 2.51 mg/dl; (13Oct2021) 2.73 mg/dl; (19Oct2021) 2.04 mg/dl; (20Oct2021) 2.02 mg/dl; (16Dec2021) 1.16 mg/dl; Glucose-6-phosphate dehydrogenase: (unspecified date) unremarkable; SARS-CoV-2 test: (13Oct2021) negative. Therapeutic measures were taken as a result of rhabdomyolysis. Sender's Comments: As there is limited information in the case provided, the causal association between the event Rhabdomyolysis with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Glucose-6-phosphate dehydrogenase, Rhabdomyolysis, SARS-CoV-2 test
Clinical narrative: This is a literature report for the following literature source(s): "A Possible Case of COVID-19 Booster Vaccine-Associated Rhabdomyolysis and Acute Kidney Injury", Journal of Pharmacy Technology. A 69-year-old female patient received BNT162b2 (BNT162B2), on 03Oct2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "type 2 diabetes mellitus" (unspecified if ongoing); "morbid obesity" (unspecified if ongoing); "coronary artery disease" (unspecified if ongoing); "mood disorder" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "pedal edema" (unspecified if ongoing); "asthma" (unspecified if ongoing); "breast cancer" (unspecified if ongoing), notes: remote history in remission. The patient's family history included: "polymyositis rheumatica" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Rosuvastatin for hyperlipidemia; Furosemide; Losartan; Metformin. Vaccination history included: Covid-19 vaccine (DOSE number unknown; MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: RHABDOMYOLYSIS (medically significant) with onset 13Oct2021, outcome "recovering". The event "rhabdomyolysis" required physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: Alanine aminotransferase (8-22): (13Oct2021) 211 IU/l; Aldolase (normal high range 8.1): (unspecified date) 18.2 IU/l; Antibody test: (unspecified date) negative; Aspartate aminotransferase (8-45): (13Oct2021) 235 IU/l; Blood creatine phosphokinase (25-190): (13Oct2021) 8394 IU/l; (19Oct2021) 855 IU/l; (20Oct2021) 467 IU/l; Blood creatinine (normal high range 0.8): (11Oct2021) 1.77 mg/dl; (13Oct2021) 2.51 mg/dl; (13Oct2021) 2.73 mg/dl; (19Oct2021) 2.04 mg/dl; (20Oct2021) 2.02 mg/dl; (16Dec2021) 1.16 mg/dl; Glucose-6-phosphate dehydrogenase: (unspecified date) unremarkable; SARS-CoV-2 test: (13Oct2021) negative. Therapeutic measures were taken as a result of rhabdomyolysis. Sender's Comments: As there is limited information in the case provided, the causal association between the event Rhabdomyolysis with the suspect product BNT162b2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Has the patient ever tested positive for Covid 19? Yes/believes it was 2 months ago; Has the patient ever tested positive for Covid 19? Yes/believes it was 2 months ago; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): MOD22-022013 (Moderna).  A male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: FEA092681), on 09Apr2021 as dose 2, single (Lot number: ER8734) and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8028) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Aug2022 as dose 4 (booster), single (Lot number: 006M21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Has the patient ever tested positive for Covid 19? Yes/believes it was 2 months ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Has the patient ever tested positive for Covid 19? Yes.  Clinical course: Description of Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date. Event or Problem: Vaccine expired on 13Aug2022 and he received it on 17Aug2022. There were no allergies. The patient has tested positive for Covid 19, but HCP does not remember exact date. Believed it was 2 months ago.; Sender's Comments: Based on the information in the case, an association between the reported events vaccination failure and covid 19 and the suspect product bnt162b2 cannot be ruled out.
Sex: U
Vaccine: COVID19
Symptoms: Arrhythmia, Cardiovascular disorder, Dizziness, Dyspnoea, Nervous system disorder
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MDEM22-02553 (Moderna). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Jul2021 as dose 2, 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 AstraZeneca (Dose 1), administration date: 17Apr2021, for Covid-19 immunization. The following information was reported: RESPIRATORY FAILURE (medically significant), outcome "unknown"; CIRCULATORY COLLAPSE (medically significant), outcome "unknown", described as "circulatory disorders"; ARRHYTHMIA (medically significant), outcome "unknown", described as "cardiac arrhythmia"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "nervous system dysfunction"; DIZZINESS (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown". 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: Respiratory failure, Tinnitus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): MDEM22-02553 (Moderna). A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 03Jul2021 as dose 2, 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 AstraZeneca (Dose 1), administration date: 17Apr2021, for Covid-19 immunization. The following information was reported: RESPIRATORY FAILURE (medically significant), outcome "unknown"; CIRCULATORY COLLAPSE (medically significant), outcome "unknown", described as "circulatory disorders"; ARRHYTHMIA (medically significant), outcome "unknown", described as "cardiac arrhythmia"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath"; NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "nervous system dysfunction"; DIZZINESS (non-serious), outcome "unknown"; TINNITUS (non-serious), outcome "unknown". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac imaging procedure, Palpitations, Syncope
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 33-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, Single), for COVID-19 immunization. The following information was reported: SYNCOPE (medically significant), outcome "unknown", described as "experienced fainting upon exertion"; PALPITATIONS (non-serious), outcome "unknown", described as "reoccurring symptoms of heart palpitations". The patient underwent the following laboratory tests and procedures: Cardiac imaging procedure: abnormal left side, notes: Recent heart imaging has shown abnormal left side; normal, notes: previous heart imaging was normal. Patient received the primary series vaccine. Since receiving the vaccine, he has developed reoccurring symptoms of heart palpitations and has experienced fainting upon exertion. Recent heart imaging had shown abnormal left side and previous heart imaging was normal. Patient was unsure if his condition was related or unrelated to the 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: Delirium, Drug ineffective, Suspected COVID-19
Clinical narrative: 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), as dose number unknown (booster), single (Batch/Lot number: unknown) and 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: DELIRIUM (hospitalization, medically significant), DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Hospitalized with delirium after I had Covid". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chest pain, Electrocardiogram normal
Clinical narrative: chest pains; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A 16-year-old female patient received meningococcal group b Rlp2086 (TRUMENBA), in Aug2022 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunization; meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), in Aug2022 as dose number unknown, single (Batch/Lot number: unknown), in different arm for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious) with onset Aug2022, 4 hrs after the suspect product(s) administration, outcome "recovered" (2022), described as "chest pains". The event "chest pains" required emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Four hours after receiving injection, patient complained of chest pains. Went to the ER. All findings EKG etc. were normal. By the end of ER visit symptom had resolved. A few days later symptoms came back and then resolved. Patient has not called back. Doctor assumed all symptoms are resolved as patient has not called back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, COVID-19, Drug ineffective, Heart rate, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 between doses of the Pfizer vaccine; Tested positive for COVID-19 between doses of the Pfizer vaccine; This is a literature report.  A 37-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "lupus nephritis" (ongoing), notes: on immunosuppressant therapy. The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (hospitalization, medically significant, life threatening), COVID-19 (hospitalization, medically significant, life threatening), outcome "unknown" and all described as "Tested positive for COVID-19 between doses of the Pfizer vaccine". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: normalized after overall, notes: resolution of her illness; Heart rate: normalized after overall, notes: resolution of her illness; SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on plausible dose -event relationship post vaccination and no other alternate explanation the causal role of BNT162B2 cannot be excluded for the reported LOE events.
Sex: F
Vaccine: COVID19
Symptoms: Muscular dystrophy, Myalgia, Rhabdomyolysis
Clinical narrative: This is a literature report. An adolescent 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: RHABDOMYOLYSIS (medically significant), outcome "unknown", described as "Recurrent, non-traumatic, non-exertional rhabdomyolysis"; MYALGIA (non-serious), outcome "unknown"; MUSCULAR DYSTROPHY (non-serious), outcome "unknown", described as "dysferlinopathies". Sender's Comments: As there is limited information in the case provided, the causal association between the events RHABDOMYOLYSIS and the vaccine (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: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Investigation, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: fever; body aches; headaches; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 2-year-old female patient received BNT162b2 (BNT162B2), on 25Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Aug2022, outcome "recovered" (29Aug2022), described as "body aches"; HEADACHE (non-serious) with onset Aug2022, outcome "recovered" (29Aug2022), described as "headaches"; OROPHARYNGEAL PAIN (non-serious) with onset Aug2022, outcome "recovered" (29Aug2022), described as "sore throat"; PYREXIA (non-serious) with onset 25Aug2022, outcome "recovered" (29Aug2022), described as "fever".   Additional information: She had a fever that night (25Aug2022) which continued for 3+ days. She also had body aches, headaches, and sore throat. It progressively worsened, Saturday (27Aug2022) being the worst day. It started improving on Sunday (28Aug2022) and symptoms were resolved on Monday (29Aug2022). She was taken to urgent care on Sunday (28Aug2022) and was tested for COVID, flu, and strep, all of which were negative. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Streptococcus test
Clinical narrative: fever; body aches; headaches; sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 2-year-old female patient received BNT162b2 (BNT162B2), on 25Aug2022 as dose 1, single (Batch/Lot number: unknown) at the age of 2 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset Aug2022, outcome "recovered" (29Aug2022), described as "body aches"; HEADACHE (non-serious) with onset Aug2022, outcome "recovered" (29Aug2022), described as "headaches"; OROPHARYNGEAL PAIN (non-serious) with onset Aug2022, outcome "recovered" (29Aug2022), described as "sore throat"; PYREXIA (non-serious) with onset 25Aug2022, outcome "recovered" (29Aug2022), described as "fever".   Additional information: She had a fever that night (25Aug2022) which continued for 3+ days. She also had body aches, headaches, and sore throat. It progressively worsened, Saturday (27Aug2022) being the worst day. It started improving on Sunday (28Aug2022) and symptoms were resolved on Monday (29Aug2022). She was taken to urgent care on Sunday (28Aug2022) and was tested for COVID, flu, and strep, all of which were negative. Event took place after use of product.  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: Diabetes mellitus
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (Unknown). 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: DIABETES MELLITUS (medically significant), outcome "unknown", described as "diabetes". The event "diabetes" required physician office visit. Description of Event Outcome: Patient was trying to schedule her booster dose online and would like assistance in filling out information online and asking which should she select. She also mentioned that she was diagnosed with diabetes but with her recent visit with her physician she was advised that she is no longer prediabetic. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Chest X-ray, Electrocardiogram ST segment, Magnetic resonance imaging, Myocarditis
Clinical narrative: Myocarditis; This is a literature report.  A 66-year-old male patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: MYOCARDITIS (hospitalization, medically significant), outcome "recovered". The patient underwent the following laboratory tests and procedures: Angiogram: normal; Chest X-ray: normal; Electrocardiogram ST segment: abnormal, notes: ST elevation; Magnetic resonance imaging: ant. septum in the mid-ventricular level, notes: Enhancement (myocardial and epicardial) along the ant. septum in the mid-ventricular level (LVEF: 44%).  Clinical information: Patient's presentation included Crushing substernal chest discomfort, diaphoresis, emesis.; 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: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Nodule, Pain, Pain of skin, Skin swelling
Clinical narrative: Pt came back in the next day after getting new Pfizer Bi-Valent booster.  Pt states tolerated prior doses fine. This dose arm started aching noticeably by bedtime (9pm'ish).  Woke up the morning of 9/10/22 and had a red slightly raised area oblong 2" wide aby 1" tall roughly. Warm to touch, some pain/tenderness, with a tight knot like feel.    Pt advised these are listed side effects of original vaccine and would apply to new booster.  Pt to try OTC pain relievers, antihistamine, ice pack. Was advised to notify Dr through exchange/after hours portal and follow up with them monday especially if hasn't subsided. If get's worse go to Urgent Care Clinic/ER.   Report any long term issues if any later through MD follow up.
Age: 85.0
Sex: F
Vaccine: COVID19-2
Symptoms: Skin tightness, Skin warm
Clinical narrative: Pt came back in the next day after getting new Pfizer Bi-Valent booster.  Pt states tolerated prior doses fine. This dose arm started aching noticeably by bedtime (9pm'ish).  Woke up the morning of 9/10/22 and had a red slightly raised area oblong 2" wide aby 1" tall roughly. Warm to touch, some pain/tenderness, with a tight knot like feel.    Pt advised these are listed side effects of original vaccine and would apply to new booster.  Pt to try OTC pain relievers, antihistamine, ice pack. Was advised to notify Dr through exchange/after hours portal and follow up with them monday especially if hasn't subsided. If get's worse go to Urgent Care Clinic/ER.   Report any long term issues if any later through MD follow up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Sleep disorder, Urticaria
Clinical narrative: Patient initially used J&J vaccine with no adverse effects. She developed hives about 6 weeks after mRNA booster. After three months working with her internist, she was referred to an allergist. She was told that the allergist has seen similar cases "almost every day" related to the mRNA covid boosters and recommended Xolair shots but could not say if or when they would be effective. Patient conferred with her internist and decided that the possible positive outcome did not overcome the potential for no relief or adverse response. Patient now on regimen of 2 Zyrtec twice a day plus refrigerated Sarna Sensistive, unable to wear clothes or sleep more than three hours at a time.
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pruritus, Rash
Clinical narrative: Rash at pressure points of body and severe itching
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received monovalent vaccine as opposed to expected bivalent vaccine
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Patient received monovalent vaccine as opposed to expected bivalent vaccine
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine as opposed to expected bivalent vaccine
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Infusion
Clinical narrative: CIDP IV infusions
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received monovalent vaccine as opposed to expected bivalent vaccine
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal discomfort, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: AFTER THE NEW PRIZER BOOSTER SHOT I WOKE UP IN EXTREME PAIN IE: WHOLE BODY INCLUDING ARMS , LEGS, HEADACHE, STOMACH UPSET . THIS LASTED FOR 5 - 6 HOURS.  EXPERIENCED FATIGUE THE WHOLE NEXT DAY.
Age: 23.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Progressively worsening redness, swelling, and itching over the course of the second day.
Age: 6.0
Sex: M
Vaccine: MMR, TDAP, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: no adverse event. Incorrect vaccine given: tdap instead of dtap