chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Fatigue, Headache, Heart rate abnormal
Clinical narrative: Hers is high / total cholesterol is 217; high blood pressure; her glasses to provide lot number; irregular heart beat; Headache; body ache; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: FD0809) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "irregular heartbeat" (unspecified if ongoing), notes: Chronic; "high blood pressure" (unspecified if ongoing), notes: Takes metroprolol, Chronic; "Diabetes" (unspecified if ongoing), notes: It is under control with her diet. Diagnosed about 4 years ago. Her number has never been higher than 7 but the last time the number was 8.; "chronic arthritis" (unspecified if ongoing), notes: Sometimes she get steroid injection in her knees, For two or three months she gets very bad body; "she got kind of sick" (unspecified if ongoing), notes: but it went away. Concomitant medication(s) included: METOPROLOL taken for hypertension. The following information was reported: HEART RATE ABNORMAL (non-serious), outcome "unknown", described as "irregular heart beat"; HEADACHE (non-serious) with onset 13Sep2021, outcome "recovered" (Sep2021), described as "Headache"; PAIN (non-serious) with onset 13Sep2021, outcome "recovering", described as "body ache"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "Hers is high / total cholesterol is 217"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "her glasses to provide lot number"; FATIGUE (non-serious) with onset 13Sep2021, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that the time of the first vaccination was given in the morning around 09:30 or 09:45. She stated she has an irregular heartbeat but that has been for ages, and she takes metoprolol for high blood pressure. She stated this comes and goes sometimes after the vaccine, but she was having this way before the vaccine, it is chronic but not that bad. She has always had it. She stated she started getting body aches within an hour of the vaccine and they are still there but not as much. She also got a headache that began the same day and time as the body aches, but she has no more headache. She wants to know if the vaccine contains cholesterol. Hers is high, and she is concerned about that. States her total cholesterol is 217. She is tired and has been on the phone for a half hour trying to get her questions answered. No prior vaccinations within 4 weeks. Patient neither visited to emergency room nor physician office for AE.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pain, Visual impairment
Clinical narrative: Hers is high / total cholesterol is 217; high blood pressure; her glasses to provide lot number; irregular heart beat; Headache; body ache; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Sep2021 (Lot number: FD0809) at the age of 70 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "irregular heartbeat" (unspecified if ongoing), notes: Chronic; "high blood pressure" (unspecified if ongoing), notes: Takes metroprolol, Chronic; "Diabetes" (unspecified if ongoing), notes: It is under control with her diet. Diagnosed about 4 years ago. Her number has never been higher than 7 but the last time the number was 8.; "chronic arthritis" (unspecified if ongoing), notes: Sometimes she get steroid injection in her knees, For two or three months she gets very bad body; "she got kind of sick" (unspecified if ongoing), notes: but it went away. Concomitant medication(s) included: METOPROLOL taken for hypertension. The following information was reported: HEART RATE ABNORMAL (non-serious), outcome "unknown", described as "irregular heart beat"; HEADACHE (non-serious) with onset 13Sep2021, outcome "recovered" (Sep2021), described as "Headache"; PAIN (non-serious) with onset 13Sep2021, outcome "recovering", described as "body ache"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "unknown", described as "Hers is high / total cholesterol is 217"; HYPERTENSION (non-serious), outcome "unknown", described as "high blood pressure"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "her glasses to provide lot number"; FATIGUE (non-serious) with onset 13Sep2021, outcome "recovering", described as "tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that the time of the first vaccination was given in the morning around 09:30 or 09:45. She stated she has an irregular heartbeat but that has been for ages, and she takes metoprolol for high blood pressure. She stated this comes and goes sometimes after the vaccine, but she was having this way before the vaccine, it is chronic but not that bad. She has always had it. She stated she started getting body aches within an hour of the vaccine and they are still there but not as much. She also got a headache that began the same day and time as the body aches, but she has no more headache. She wants to know if the vaccine contains cholesterol. Hers is high, and she is concerned about that. States her total cholesterol is 217. She is tired and has been on the phone for a half hour trying to get her questions answered. No prior vaccinations within 4 weeks. Patient neither visited to emergency room nor physician office for AE.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Therapeutic response unexpected
Clinical narrative: sore arm; felt the best I've felt in a long time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (Comirnaty-COVID 19 Vaccine, mRNA-Solution for injection) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPRIN. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "felt the best I've felt in a long time".  Additional information: Caller states he experienced a sore arm with first and second dose of Pfizer BioNTech Covid-19 Vaccine, had no fever, and felt the best I've felt in a long time after getting both doses. Caller stated he was a 74 year old male who received his second dose of the Pfizer BioNTech Covid-19 Vaccine 6 months ago. Caller states he was planning on getting the booster dose of the Pfizer BioNTech Covid-19 Vaccine but he takes an 81mg aspirin 6 days a week. Caller asking if he should discontinue the aspirin for any particular amount of time prior to getting the booster dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (24-SEP-2021): New information received from a Pfizer-sponsored from a contactable consumer reported that includes HCP details, Products details, Verbatim and Event Description.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (08Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood culture, Cardiac stress test, Chest scan, Colonoscopy
Clinical narrative: metallic taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 13:00 (Lot number: EN6202) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Diagnosed 20-25 years ago; "smoker" (unspecified if ongoing), notes: He states he is not smoking, it has been about 5 months now. Has history of smoking 40 to 45 years. Concomitant medication(s) included: HUMALOG taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; NIFEDIPINE; EDARBYCLOR; ACEBUTOLOL; ATORVASTATIN taken for blood cholesterol increased. The following information was reported: DYSGEUSIA (non-serious) with onset 27Feb2021, outcome "not recovered", described as "metallic taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The day patient took the first dose he had a metallic taste in his mouth. He had a nasty taste in his mouth. It was still there. None of the serious stuff started happening until after 2nd dose. He had been able to walk and jog 2 -3 miles a day. The patient was Diabetic and had high blood pressure and was taking medication for that. He was also overweight. He stated they bounce his dose of high blood pressure medication around depending on his readings. The patient was taking metformin in the last 12 years. Humalog use was depended on his work if he can eat small meals working 12-16 hours. He may check 7 time a day and sometimes 3 days. Started 12 years. Nifedipine started over 10 years for High blood pressure. Patient was taking Edarbyclor for at least 12 years for high blood pressure Acebutolol was started 10-12 years ago. Atorvastatin was taking for 12 years. His Cholesterol has been like 114 for 3 years, so he dis not know why they still have him on it. No other Vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Echocardiogram, Endoscopy, Gastrointestinal examination, Magnetic resonance imaging abdominal
Clinical narrative: metallic taste in my mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Feb2021 13:00 (Lot number: EN6202) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing), notes: Diagnosed 20-25 years ago; "smoker" (unspecified if ongoing), notes: He states he is not smoking, it has been about 5 months now. Has history of smoking 40 to 45 years. Concomitant medication(s) included: HUMALOG taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; NIFEDIPINE; EDARBYCLOR; ACEBUTOLOL; ATORVASTATIN taken for blood cholesterol increased. The following information was reported: DYSGEUSIA (non-serious) with onset 27Feb2021, outcome "not recovered", described as "metallic taste in my mouth". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The day patient took the first dose he had a metallic taste in his mouth. He had a nasty taste in his mouth. It was still there. None of the serious stuff started happening until after 2nd dose. He had been able to walk and jog 2 -3 miles a day. The patient was Diabetic and had high blood pressure and was taking medication for that. He was also overweight. He stated they bounce his dose of high blood pressure medication around depending on his readings. The patient was taking metformin in the last 12 years. Humalog use was depended on his work if he can eat small meals working 12-16 hours. He may check 7 time a day and sometimes 3 days. Started 12 years. Nifedipine started over 10 years for High blood pressure. Patient was taking Edarbyclor for at least 12 years for high blood pressure Acebutolol was started 10-12 years ago. Atorvastatin was taking for 12 years. His Cholesterol has been like 114 for 3 years, so he dis not know why they still have him on it. No other Vaccines were administered on same date of the Pfizer Suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Blood iron decreased, Blood phosphorus decreased, Blood test, Investigation, Ultrasound scan
Clinical narrative: Low iron and phosphate; Low iron and phosphate; Loss of bladder control/Cannot hold urine at all/Often urinate in my clothing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 15:00 (Lot number: EW0179) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stiff neck", start date: 1998, stop date: 1998, notes: Pinched nerve in neck, Onset date: 20Apr2021; "Pinched nerve in neck" (unspecified if ongoing); "Knee pain", start date: 2003 (ongoing), notes: Twisted knee/continued pain/X-rays. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Time: 15:00, Anatomical site of injection: Left arm , Batch/lot no: ER8729), administration date: 10Apr2021, when the patient was 53 years old, for COVID-19 Immunization, reaction(s): "Lower body numbness", "Very poor balance", "Pain in my legs", "Pain in my legs and abdomen", "cannot walk up steps or stairs", "muscle spasms/Leg spasms". The following information was reported: URINARY INCONTINENCE (non-serious) with onset 19May2021, outcome "not recovered", described as "Loss of bladder control/Cannot hold urine at all/Often urinate in my clothing"; BLOOD IRON DECREASED (non-serious), BLOOD PHOSPHORUS DECREASED (non-serious) all with onset 25May2021, outcome "unknown" and all described as "Low iron and phosphate". The event "loss of bladder control/cannot hold urine at all/often urinate in my clothing" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urinary incontinence. Therapeutic measures were taken as a result of blood iron decreased, blood phosphorus decreased.  Additional information: Patient often urinate in clothes if patient cannot get to a bathroom immediately, Once starts, patient cannot stop it.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Urinary incontinence, X-ray
Clinical narrative: Low iron and phosphate; Low iron and phosphate; Loss of bladder control/Cannot hold urine at all/Often urinate in my clothing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 15:00 (Lot number: EW0179) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Stiff neck", start date: 1998, stop date: 1998, notes: Pinched nerve in neck, Onset date: 20Apr2021; "Pinched nerve in neck" (unspecified if ongoing); "Knee pain", start date: 2003 (ongoing), notes: Twisted knee/continued pain/X-rays. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01, Time: 15:00, Anatomical site of injection: Left arm , Batch/lot no: ER8729), administration date: 10Apr2021, when the patient was 53 years old, for COVID-19 Immunization, reaction(s): "Lower body numbness", "Very poor balance", "Pain in my legs", "Pain in my legs and abdomen", "cannot walk up steps or stairs", "muscle spasms/Leg spasms". The following information was reported: URINARY INCONTINENCE (non-serious) with onset 19May2021, outcome "not recovered", described as "Loss of bladder control/Cannot hold urine at all/Often urinate in my clothing"; BLOOD IRON DECREASED (non-serious), BLOOD PHOSPHORUS DECREASED (non-serious) all with onset 25May2021, outcome "unknown" and all described as "Low iron and phosphate". The event "loss of bladder control/cannot hold urine at all/often urinate in my clothing" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urinary incontinence. Therapeutic measures were taken as a result of blood iron decreased, blood phosphorus decreased.  Additional information: Patient often urinate in clothes if patient cannot get to a bathroom immediately, Once starts, patient cannot stop it.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Photophobia, SARS-CoV-2 test, Tinnitus
Clinical narrative: 2ND DOSE: I'm having constant noise in my right ear; Eyes are sensitive to light; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19Sep2021 (Batch/Lot number: unknown) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pemphigus Vulgaris" (unspecified if ongoing), notes: affects mucosa areas; "morphine" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "2ND DOSE: I'm having constant noise in my right ear"; PHOTOPHOBIA (non-serious) with onset 2021, outcome "not recovered", described as "Eyes are sensitive to light". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of tinnitus, photophobia.  Additional Information: After 2ND DOSE: Patient was having constant noise in her right ear for 5 days now, sounds like was standing in a field of loud crickets. Eyes were sensitive to light. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications the patient received within 2 weeks of vaccination: MSM with glucosamine, omega 3, vitamins. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19.  Conclusion of Previously Completed Investigation: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE INJECTABLE lot FC3183 was investigated. The investigation included reviewing manufacturing and packaging batch records, deviation investigations, analytical release test results, and an analysis of the complaint history for the reported lot. The final scope was determined to be the reported finished goods lot FC3183, fill lot EY0555, and the bulk formulated drug product lot EP8657. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality. No root cause or CAPA were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, SARS-CoV-2 test, Speech disorder, Visual impairment
Clinical narrative: dizziness; distortion of vision; migraine headache accompanied by vomiting; migraine headache accompanied by vomiting; distortion of Speech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 08:30 (Lot number: FD0809) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Allergy: erythromycin", notes: Allergy: erythromycin; Hydroxychloroquine, reaction(s): "Allergy: hydroxychloroquine", notes: Allergy: hydroxychloroquine. The following information was reported: DIZZINESS (non-serious) with onset 31Aug2021, outcome "recovered" (2021), described as "dizziness"; VISUAL IMPAIRMENT (non-serious) with onset 31Aug2021, outcome "recovered" (2021), described as "distortion of vision"; MIGRAINE (non-serious), VOMITING (non-serious) all with onset 31Aug2021, outcome "recovered" (2021) and all described as "migraine headache accompanied by vomiting"; SPEECH DISORDER (non-serious) with onset 31Aug2021, outcome "recovered" (2021), described as "distortion of Speech". The events "dizziness", "distortion of vision", "migraine headache accompanied by vomiting", "migraine headache accompanied by vomiting" and "distortion of speech" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, visual impairment, migraine, vomiting, speech disorder.  Additional information: The patient did not receive any other vaccine in four weeks and other medications in two weeks. It was reported that shot received on Saturday (28Aug2021), Tuesday (31Aug2021) morning experienced dizziness distortion of vision and speech which accelerated into a migraine headache accompanied by vomiting. AE treatment with iv fluids and pain killer. The patient had no covid prior vaccination. The patient tested covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: dizziness; distortion of vision; migraine headache accompanied by vomiting; migraine headache accompanied by vomiting; distortion of Speech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Aug2021 08:30 (Lot number: FD0809) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Allergy: erythromycin", notes: Allergy: erythromycin; Hydroxychloroquine, reaction(s): "Allergy: hydroxychloroquine", notes: Allergy: hydroxychloroquine. The following information was reported: DIZZINESS (non-serious) with onset 31Aug2021, outcome "recovered" (2021), described as "dizziness"; VISUAL IMPAIRMENT (non-serious) with onset 31Aug2021, outcome "recovered" (2021), described as "distortion of vision"; MIGRAINE (non-serious), VOMITING (non-serious) all with onset 31Aug2021, outcome "recovered" (2021) and all described as "migraine headache accompanied by vomiting"; SPEECH DISORDER (non-serious) with onset 31Aug2021, outcome "recovered" (2021), described as "distortion of Speech". The events "dizziness", "distortion of vision", "migraine headache accompanied by vomiting", "migraine headache accompanied by vomiting" and "distortion of speech" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, visual impairment, migraine, vomiting, speech disorder.  Additional information: The patient did not receive any other vaccine in four weeks and other medications in two weeks. It was reported that shot received on Saturday (28Aug2021), Tuesday (31Aug2021) morning experienced dizziness distortion of vision and speech which accelerated into a migraine headache accompanied by vomiting. AE treatment with iv fluids and pain killer. The patient had no covid prior vaccination. The patient tested covid post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia oral
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 58-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Sep2021 09:00 (Lot number: FF2589) at the age of 58 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "lupus" (unspecified if ongoing), notes: lupus. There were no concomitant medications. Past drug history included: Erythromycin, reaction(s): "Drug allergy: erythromycin", notes: erythromycin; Hydroxychloroquine, reaction(s): "Drug allergy: hydroxychloroquine", notes: hydroxychloroquine. Vaccination history included: Bnt162b2 (Time: [Pfizer] 08:30 AM, Batch/lot number: FD0809, Anatomical Location: Arm Left, Dose Number: 1), administration date: 28Aug2021, when the patient was 58 years old, for Covid-19 immunization. The following information was reported: PARAESTHESIA ORAL (non-serious) with onset 21Sep2021 09:00, outcome "recovered" (Sep2021), described as "Tingling on tip of tongue"; DYSGEUSIA (non-serious) with onset 21Sep2021 09:00, outcome "recovered" (Sep2021), described as "Metallic taste". Therapeutic measures were not taken as a result of paraesthesia oral, dysgeusia. Additional information: Patient was not pregnant at time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bowel movement irregularity, Vomiting
Clinical narrative: irregular bowel movements; I puked a few times; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BOWEL MOVEMENT IRREGULARITY (non-serious), outcome "unknown", described as "irregular bowel movements"; VOMITING (non-serious), outcome "unknown", described as "I puked a few times".  Additional information: Stated he puked a couple of times after he received the vaccine and would like to know does that relinquish the effect of the vaccine or is the vaccine discarded throughout his body regurgitated or is it intact since it is in the blood stream. Caller declined to make a report stating he was wondering if it was still in his system or regurgitated. Caller declined to provide name of contact number. Suspect Product: Pfizer, the general vaccine base, states the card says Pfizer BioNTech Covid 19 vaccine. Caller declined to make a report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: Irregular unscheduled heavy and prolonged menstrual cycle lasting about 5-6 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 35-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 (Lot number: fa7484) at the age of 35 years as DOSE 2, SINGLE for covid-19 immunization. Relevant medical history included: "Covid-19" (unspecified if ongoing). Concomitant medication(s) included: LO LOESTRIN FE. Vaccination history included: Bnt162b2 (First dose, Anatomical Location: Arm left, Batch/lot number: fc3138), administration date: 13Aug2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 05Sep2021, outcome "recovered" (Sep2021), described as "Irregular unscheduled heavy and prolonged menstrual cycle lasting about 5-6 days". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of menstrual disorder.  Additional Information: The patient had Irregular unscheduled heavy and prolonged menstrual cycle lasting about 5-6 days. Her normal menstrual cycles were 2 days, not heavy and align with LO-LOESTRIN FE cycle. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications she received within 2 weeks of vaccination: LO-LOESTRIN Fe. No treatment was received for adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Investigation, Paraesthesia
Clinical narrative: tingling on left side of the body/tingling on my left side of the body near my arm and shoulder where the injection was given/tingling in my face, glutes and back; burning and tingling in her hands and feet; burning and tingling in her hands and feet; burning and tingling in her hands and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101267984 (Pfizer).  A female patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 15Apr2021, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (non-serious), outcome "recovered", described as "tingling on left side of the body/tingling on my left side of the body near my arm and shoulder where the injection was given/tingling in my face, glutes and back"; BURNING SENSATION (non-serious), BURNING SENSATION (non-serious), PARAESTHESIA (non-serious), outcome "unknown" and all described as "burning and tingling in her hands and feet". The events "tingling on left side of the body/tingling on my left side of the body near my arm and shoulder where the injection was given/tingling in my face, glutes and back", "burning and tingling in her hands and feet", "burning and tingling in her hands and feet" and "burning and tingling in her hands and feet" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: PQC was present. Patient presented AE after her 2nd shoot of Pfizer COVID 19 vaccine. Tingling on left side of the body, 2-3 days later it disappeared, 4 months after the 2nd shot she noticed tingling in feet, legs, arms and hands. Report was not related to a study or programme. NDC number of Covid-19 Vaccine was not provided. Expiry date of Covid-19 Vaccine was not provided. She was getting her symptoms evaluated by a neurologist. Patient was consulting a neurologist for a thorough evaluation of symptoms. Caller said that some of the tests that her neurologists has run have all come out normal. Other Products was not provided. Investigation assessment was not provided.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thinking abnormal
Clinical narrative: my thinking was off on that because it takes two weeks to develop immunity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cold" (unspecified if ongoing); "panicked" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Tetanus shot, for immunization. The following information was reported: THINKING ABNORMAL (non-serious), outcome "unknown", described as "my thinking was off on that because it takes two weeks to develop immunity". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was asking if the shape of the spike protein produced by the vaccine can prevent blood flow and lead to lots of tiny blood clots. Patient states her doctor told her that humans naturally have lots of cells with proteins on the surface. Patient asking if it is possible for the mRNA in the vaccine to malfunction and not be broken down after producing a spike protein and then circulate in the body forever and keep making spike proteins. Patient asking how long the vaccine is effective and if the antibodies circulate out of the body over time causing protection to diminish. Patient states, she don't do vaccines really ever. She was not an anti-vaxxer. She have taken a tetanus shot. But it was out of the ordinary for her to do vaccines. She developed a cold a while back and panicked a little. And got tested for Covid-19 and it was negative, but the next day she went and got the first dose of the Pfizer BioNTech Covid-19 Vaccine hoping she would develop antibodies immediately in case the cold turned into Covid-19, but it never did. She also realized her thinking was off on that because it takes two weeks to develop immunity. But she had such a problem mentally with the vaccine that she couldn't bring herself to get the second dose. She was hoping she didn't mess anything up though. Patient asking what negative effects could come from not getting the second dose of the Pfizer BioNTech Covid-19 Vaccine after getting the first dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: dizziness; Nausea; weakness; exhaustion; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 14:30 (Lot number: FC3180) at the age of 43 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; VITAMIN B; VITAMIN C [ASCORBIC ACID]; VITAMIN D; VITAMIN E; ZINC; MAGNESIUM. The following information was reported: DIZZINESS (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "dizziness"; NAUSEA (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "Nausea"; ASTHENIA (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "weakness"; FATIGUE (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "exhaustion"; HEADACHE (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "body aches". Therapeutic measures were not taken as a result of dizziness, nausea, asthenia, fatigue, headache, pain.  Additional Information: The patient had no known allergies. Other medical history included asthma. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications the patient received within 2 weeks of vaccination: Montelukast, vitamin B, C, D, E, zinc, magnesium. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: dizziness; Nausea; weakness; exhaustion; headache; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 43-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Sep2021 14:30 (Lot number: FC3180) at the age of 43 years as dose 1, single for covid-19 immunization. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; VITAMIN B; VITAMIN C [ASCORBIC ACID]; VITAMIN D; VITAMIN E; ZINC; MAGNESIUM. The following information was reported: DIZZINESS (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "dizziness"; NAUSEA (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "Nausea"; ASTHENIA (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "weakness"; FATIGUE (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "exhaustion"; HEADACHE (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "headache"; PAIN (non-serious) with onset 02Sep2021 23:00, outcome "recovered" (2021), described as "body aches". Therapeutic measures were not taken as a result of dizziness, nausea, asthenia, fatigue, headache, pain.  Additional Information: The patient had no known allergies. Other medical history included asthma. She did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Other medications the patient received within 2 weeks of vaccination: Montelukast, vitamin B, C, D, E, zinc, magnesium. No treatment received for adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test
Clinical narrative: Severe hair loss; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17May2021 (Lot number: Ew0179) at the age of 39 years as dose 1, single and administered in arm right, administration date 17May2021 (Lot number: Ew0182) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfur" (unspecified if ongoing), notes: Known allergies: Sulfur. There were no concomitant medications. The following information was reported: ALOPECIA (non-serious) with onset 12Jul2021, outcome "not recovered", described as "Severe hair loss". The event "severe hair loss" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Dizziness, Eye pain, Mass
Clinical narrative: body aches; Large welt on L. arm size of softball; arm weakness; pain behind eyes; dizzy/lightheaded; weak; diarrhea; shooting pain down arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 11:30 (Lot number: FF8839) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Thyroid cancer" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CYTOMEL; CETIRIZINE; ALBUTEROL SULFATE. Past drug history included: Gabapentin, reaction(s): "Allergies: Gabapentin", notes: known allergies: gabapentin; Nsaids, reaction(s): "Allergies: NSAIDS", notes: known allergies: NSAIDS. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: EW0191, Anatomical Location: Arm Left), administration date: 27Aug2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "body aches"; MASS (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "Large welt on L. arm size of softball"; MUSCULAR WEAKNESS (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "arm weakness"; EYE PAIN (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "pain behind eyes"; DIZZINESS (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "dizzy/lightheaded"; ASTHENIA (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "weak"; DIARRHOEA (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "diarrhea"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "shooting pain down arm". The events "body aches", "large welt on l. arm size of softball", "arm weakness", "pain behind eyes", "dizzy/lightheaded", "weak", "diarrhea" and "shooting pain down arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, mass, muscular weakness, eye pain, dizziness, asthenia, diarrhoea, pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: body aches; Large welt on L. arm size of softball; arm weakness; pain behind eyes; dizzy/lightheaded; weak; diarrhea; shooting pain down arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 11:30 (Lot number: FF8839) at the age of 42 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Thyroid cancer" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CYTOMEL; CETIRIZINE; ALBUTEROL SULFATE. Past drug history included: Gabapentin, reaction(s): "Allergies: Gabapentin", notes: known allergies: gabapentin; Nsaids, reaction(s): "Allergies: NSAIDS", notes: known allergies: NSAIDS. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/lot number: EW0191, Anatomical Location: Arm Left), administration date: 27Aug2021, when the patient was 42 years old, for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "body aches"; MASS (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "Large welt on L. arm size of softball"; MUSCULAR WEAKNESS (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "arm weakness"; EYE PAIN (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "pain behind eyes"; DIZZINESS (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "dizzy/lightheaded"; ASTHENIA (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "weak"; DIARRHOEA (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "diarrhea"; PAIN IN EXTREMITY (non-serious) with onset 22Sep2021 22:00, outcome "not recovered", described as "shooting pain down arm". The events "body aches", "large welt on l. arm size of softball", "arm weakness", "pain behind eyes", "dizzy/lightheaded", "weak", "diarrhea" and "shooting pain down arm" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain, mass, muscular weakness, eye pain, dizziness, asthenia, diarrhoea, pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Doctor's office/urgent care. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19.   Follow-up attempts are completed. No further information is expected.