chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Pain in extremity, X-ray
Clinical narrative: Continuous sharp pain in right elbow/constant sharp pain in right elbow joint; pain was in entire right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 (Lot number: EN6199) at the age of 41 years as dose 1, single and administered in arm right, administration date 09Apr2021 (Lot number: EW0151) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: ARTHRALGIA (disability) with onset 13Mar2021, outcome "recovered with sequelae" (2021), described as "Continuous sharp pain in right elbow/constant sharp pain in right elbow joint"; PAIN IN EXTREMITY (disability) with onset 13Mar2021, outcome "recovered with sequelae" (2021), described as "pain was in entire right arm". The events "continuous sharp pain in right elbow/constant sharp pain in right elbow joint" and "pain was in entire right arm" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: unknown results; x-ray: unknown results. Therapeutic measures were taken as a result of arthralgia, pain in extremity. Clinical course: No known allergies, The patient experienced continuous sharp pain in right elbow. For the first day, the pain was in entire right arm due to the shot but slowly started turning into constant sharp pain in right elbow joint. Pain was slowly decreasing each week, but then came back again after 2nd shot. The pain lasted for several months and slowly started fading around 4 months after the 2nd dose shot. Treatment included pain and anti-inflammation meds post x-ray/MRI. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, the was not patient diagnosed with COVID-19.  Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Immunisation, Pain, Pyrexia
Clinical narrative: Dose Number : 3; Severe chills; body ache; mild fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04Dec2021 (Lot number: 3302680) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955), administration date: 27Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955), administration date: 12Apr2021, for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021, outcome "unknown", described as "Dose Number : 3"; CHILLS (non-serious) with onset 04Dec2021, outcome "recovering", described as "Severe chills"; PAIN (non-serious) with onset 04Dec2021, outcome "recovering", described as "body ache"; PYREXIA (non-serious) with onset 04Dec2021, outcome "recovering", described as "mild fever". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, pain, pyrexia.  Additional information: The patient experienced Severe chills, body ache and mild fever the night of the vaccination and the day after. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19 and since the vaccination, the patient not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP. A 50-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed herpes zoster/shingles, with outcome of unknown. The batch/lot number for BNT162B2 not provided and will be requested during follow-up. Sender's comments: Linked report(s): US-PFIZER INC-202101738950 same reporter/drug/event, different patient.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Immunisation, Myocarditis, Pericarditis
Clinical narrative: fear damaged heart lining Myocarditis and/or Pericarditis; fear damaged heart lining Myocarditis and/or Pericarditis; shortness of breath; Dose Number : 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 66 year-old patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) administration date 12Oct2021 (Batch/Lot number: unknown) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 2; Lot No: Unknown.), administration date: Mar2021, for COVID-19 Immunization; Covid-19 (Dose 1; Lot No: Unknown; Brand= Unknown), administration date: Feb2021, for covid-19 Immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccine within 4 weeks prior to the COVID-19 vaccine. The following information was reported: PERICARDITIS (medically significant), MYOCARDITIS (medically significant) all with onset Nov2021, outcome "unknown" and all described as "fear damaged heart lining Myocarditis and/or Pericarditis"; IMMUNISATION (non-serious) with onset 12Oct2021, outcome "unknown", described as "Dose Number : 3"; DYSPNOEA (non-serious) with onset Nov2021, outcome "unknown", described as "shortness of breath". The patient reported, shortness of breath, which I fear damaged heart lining myocarditis and/or pericarditis after mRNA COVID-19 vaccination. Therapeutic measures were not taken as a result of pericarditis, myocarditis, dyspnoea. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: blood sugar rose; This is a spontaneous report received from a non-contactable reporter(Consumer or other non HCP).  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar rose". Relevant laboratory tests and procedures are available in the appropriate section. Additional information:patient have blood sugar rise after she had the shots each time.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101742407 same patient, vaccine, AE and different dose;US-PFIZER INC-202101741528 same vaccine, AE and different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain in extremity
Clinical narrative: Received Covid booster on Monday; fatigue; sore arm; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 06Dec2021 (Batch/Lot number: unknown) as dose 3 (booster) single 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; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization, reaction(s): "fatigue", "body ache".  The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021, outcome "unknown", described as "Received Covid booster on Monday"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "fatigue"; PAIN IN EXTREMITY (non-serious) with onset Dec2021, outcome "unknown", described as "sore arm".  Additional information: Received Covid booster on Monday (06Dec2021) and experienced fatigue and sore arm on Monday/Tuesday (06Dec2021 or 07Dec2021) and event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021333169 same patient, different dose/event
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: She had to have a vein procedure to kill off a vein in her leg because she had a blood clot and the veins were reworking the wiring.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, First dose: given on 03Mar2021, lot number: EN6204, expiry: unknown, NDC: unknown, given in left arm.), administration date: 03Mar2021, when the patient was 59 years old, for COVID-19 Immunization. The following information was reported: THROMBOSIS (medically significant) with onset 08Nov2021, outcome "unknown", described as "She had to have a vein procedure to kill off a vein in her leg because she had a blood clot and the veins were reworking the wiring.". Therapeutic measures were taken as a result of thrombosis. Clinical course: The patient had to have a vein procedure to kill off a vein in her leg because she had a blood clot, and the veins were reworking the wiring. That was several weeks prior to booster on 08Nov2021 as she made sure it was more than 2.5 weeks. She was on Eliquis (NDC, lot number, and expiry date unknown), which is a blood thinner, for a week, from 08Nov2021 to 15Nov2021. Eliquis strength was reportedly a high level because the patient had a potential blood clot that the doctor wanted to make sure didn't get into deep vein and he (physician) was being aggressive.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid; tested positive for Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent(mother).  A 18 year-old female patient received bnt162b2 (Pfizer Covid-19 vaccine), administered in arm left(left forearm), administration date 26May2021 (Lot number: EW0183) at the age of 17 years as dose 2, 0.3 ml single and administered in arm left, administration date 03May2021 (Lot number: EW0172) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. No Vaccines Administered on Same Date of the Pfizer Suspect, no Prior Vaccinations (within 4 weeks), no Family Medical History.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 26Nov2021, outcome "unknown" and all described as "tested positive for Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (25Nov2021) negative, notes: on thanksgiving; (26Nov2021) positive for covid. Patient tested on thanksgiving and was negative. Then, she tested the day after holiday, 26Nov2021 with a PCR test that was positive for Covid after receiving both doses of the Pfizer Covid-19 vaccine and has come down with covid. There was no require a visit to: Emergency Room, no Physician Office.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101750087 Same reporter/drug/event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: came down with Covid after being vaccinated; came down with Covid after being vaccinated; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team.  A male patient in his 50's(this 50 something man) received bnt162b2 (Pfizer Covid-19 vaccine), administration date May2021 (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "came down with Covid after being vaccinated".  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101750040 Same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 (002191). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". Therapeutic measures were taken as a result of herpes zoster.  Additional information: Patient had not had the shingles vaccine. She took a seven day cycle of valacyclovir and she finished it seven days ago. Patient wanted to know if the effectiveness of the booster dose would be affected by the Valacyclovir or how long should she wait before having the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Arterial occlusive disease, Immunisation, Interchange of vaccine products, Off label use, Vasculitis
Clinical narrative: arterial closed and partially blocked; Vasculitis; Dose 1: Moderna; Dose 2: Moderna; dose received : 3 Pfizer; Dose 1: Moderna; Dose 2: Moderna; dose received : 3 Pfizer; dose received : 3 Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Oct2021 20:00 (Lot number: 32030BD) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "RA" (unspecified if ongoing); "Known allergies: sulfur drugs" (unspecified if ongoing). The patient took concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were other medications the patient received within 2 weeks of vaccination. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 044B21A, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 17Apr2021, when the patient was 60 years old, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 007B21A, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 20Feb2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: OFF LABEL USE (prolonged hospitalization, disability), INTERCHANGE OF VACCINE PRODUCTS (prolonged hospitalization, disability) all with onset 29Oct2021 20:00, outcome "unknown" and all described as "Dose 1: Moderna; Dose 2: Moderna; dose received : 3 Pfizer"; IMMUNISATION (prolonged hospitalization, disability) with onset 29Oct2021 20:00, outcome "unknown", described as "dose received : 3 Pfizer"; ARTERIAL OCCLUSIVE DISEASE (prolonged hospitalization, disability) with onset 04Nov2021 12:00, outcome "recovering", described as "arterial closed and partially blocked"; VASCULITIS (prolonged hospitalization, disability) with onset 04Nov2021 12:00, outcome "recovering", described as "Vasculitis". The patient prolonged hospitalization for off label use, interchange of vaccine products, immunisation, arterial occlusive disease, vasculitis (start date: 2021, discharge date: 2021, hospitalization duration: 7 day(s)). The events "arterial closed and partially blocked" and "vasculitis" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of arterial occlusive disease, vasculitis. Reported Event included Vasculitis, arterial closed and partially blocked. Digit #4 will have to be amputated, partial or 3/4. Treatment received for the adverse event included Steroids and Viagra. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: She had pneumonia for several weeks; 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 68 year-old female patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "severe eczema" (unspecified if ongoing), notes: she took Dupixent for severe eczema, which she has had before vaccinated. Concomitant medication(s) included: DUPIXENT taken for eczema. Vaccination history included: Bnt162b2 (Dose:1,single), administration date: Dec2020, for COVID-19 Immunization. The following information was reported: PNEUMONIA (medically significant) with onset 2021, outcome "recovered", described as "She had pneumonia for several weeks". She took Dupixent for severe eczema, which she has had before vaccinated. She received both doses more than 6 months ago and delayed the booster shot because she had pneumonia for several weeks. She had no problems after receiving the first two doses. The patient took Dupixent, a monoclonal antibody for eczema, and she took it every two weeks for severe eczema. Pneumonia, after second vaccine, delayed booster dose.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: diagnosed with Covid-19; Testing positive for Covid-19 after first dose of the purple cap Pfizer Covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team.  A 12 year-old male patient received bnt162b2 (COMIRNATY), administration date 30Sep2021 (Batch/Lot number: unknown) as dose 1, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 15Nov2021, outcome "unknown", described as "diagnosed with Covid-19"; COVID-19 (medically significant) with onset 15Nov2021, outcome "unknown", described as "Testing positive for Covid-19 after first dose of the purple cap Pfizer Covid-19 vaccine". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (15Nov2021) positive, notes: diagnosed with Covid-19 on 15NOV2021 via a PCR test. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the reported information ,a causal relationship between the events and suspected drug cannot be excluded.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: pass out; was drenched in sweat; she slept throughout the day and the next day she was okay.; chills; shaking; Headache; dizzy; 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 80 year-old female patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm left, administration date 22Feb2021 (Lot number: EN6202) at the age of 80 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOXYL taken for hypothyroidism (ongoing). No additional vaccines administered on same date of the Pfizer suspect. Vaccination history included: Bnt162b2 (First Dose , Date:  01Feb2021 , Lot- EL1283, Administered in left arm , AE(s) following prior vaccinations: None), administration date: 01Feb2021, when the patient was 80 years old, for COVID-19 immunisation, reaction(s): "None". The night she got the vaccine (22Feb2021), she had chills and shakes for over an hour that she could not stop. In the morning she got up, went to the bathroom and passed out. Her husband came in there and she was sweating, drenched in sweat. Her husband was finally able to get her up out the bathroom and put her to bed and she slept. The sweats went away by mid afternoon. However, she slept all day. By the next day she was okay. She commented she is in excellent health. Everything is perfect. She recently went to the doctor to have an annual physical. Her doctor gave her a little test first, this was in Dec2021. The blood test was to test to see how much antibodies she had in her system and she had antibodies. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 23Feb2021, outcome "recovered" (24Feb2021), described as "pass out"; CHILLS (non-serious) with onset 22Feb2021, outcome "recovered" (23Feb2021), described as "chills"; TREMOR (non-serious) with onset 22Feb2021, outcome "recovered" (23Feb2021), described as "shaking"; HYPERHIDROSIS (non-serious) with onset 23Feb2021, outcome "recovering", described as "was drenched in sweat"; HEADACHE (non-serious) with onset Feb2021, outcome "recovering", described as "Headache"; DIZZINESS (non-serious) with onset Feb2021, outcome "recovering", described as "dizzy"; SOMNOLENCE (non-serious) with onset 23Feb2021, outcome "recovered" (24Feb2021), described as "she slept throughout the day and the next day she was okay.". No Emergency Room. No Physician Office; Only went to doctor due to annual physical. The patient underwent the following laboratory tests and procedures: antibody test: (Dec2021) had antibodies.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Somnolence, Tremor
Clinical narrative: pass out; was drenched in sweat; she slept throughout the day and the next day she was okay.; chills; shaking; Headache; dizzy; 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 80 year-old female patient received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm left, administration date 22Feb2021 (Lot number: EN6202) at the age of 80 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LEVOXYL taken for hypothyroidism (ongoing). No additional vaccines administered on same date of the Pfizer suspect. Vaccination history included: Bnt162b2 (First Dose , Date:  01Feb2021 , Lot- EL1283, Administered in left arm , AE(s) following prior vaccinations: None), administration date: 01Feb2021, when the patient was 80 years old, for COVID-19 immunisation, reaction(s): "None". The night she got the vaccine (22Feb2021), she had chills and shakes for over an hour that she could not stop. In the morning she got up, went to the bathroom and passed out. Her husband came in there and she was sweating, drenched in sweat. Her husband was finally able to get her up out the bathroom and put her to bed and she slept. The sweats went away by mid afternoon. However, she slept all day. By the next day she was okay. She commented she is in excellent health. Everything is perfect. She recently went to the doctor to have an annual physical. Her doctor gave her a little test first, this was in Dec2021. The blood test was to test to see how much antibodies she had in her system and she had antibodies. The following information was reported: LOSS OF CONSCIOUSNESS (medically significant) with onset 23Feb2021, outcome "recovered" (24Feb2021), described as "pass out"; CHILLS (non-serious) with onset 22Feb2021, outcome "recovered" (23Feb2021), described as "chills"; TREMOR (non-serious) with onset 22Feb2021, outcome "recovered" (23Feb2021), described as "shaking"; HYPERHIDROSIS (non-serious) with onset 23Feb2021, outcome "recovering", described as "was drenched in sweat"; HEADACHE (non-serious) with onset Feb2021, outcome "recovering", described as "Headache"; DIZZINESS (non-serious) with onset Feb2021, outcome "recovering", described as "dizzy"; SOMNOLENCE (non-serious) with onset 23Feb2021, outcome "recovered" (24Feb2021), described as "she slept throughout the day and the next day she was okay.". No Emergency Room. No Physician Office; Only went to doctor due to annual physical. The patient underwent the following laboratory tests and procedures: antibody test: (Dec2021) had antibodies.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: She is having moments of periodic paralysis of all of her limbs that last for 5-10minutes at a time, almost on a daily basis. They said it can last days, weeks or even months at a time; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient (not pregnant) received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), administered in arm left, administration date 10Sep2021 17:00 (Lot number: FF2588) at the age of 15 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "A.D.D." (unspecified if ongoing); "Sprained ankle" (unspecified if ongoing). Prior to vaccination, the patient did not diagnose with COVID-19. She was absolutely healthy before. no surgeries, no medical issues other than a sprained ankle. Concomitant medication(s) included: ADDERALL. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3180, Location of injection: Arm Left, Vaccine Administration Time: 04:30 PM), administration date: 20Aug2021, when the patient was 15 years old, for COVID-19 immunization. She is having moments of periodic paralysis of all of her limbs that last for 5-10minutes at a time, almost on a daily basis. They said it can last days, weeks or even months at a time. She can no longer do sports and this is destroying her. The following information was reported: PARALYSIS (disability) with onset 17Nov2021 17:30, outcome "not recovered", described as "She is having moments of periodic paralysis of all of her limbs that last for 5-10minutes at a time, almost on a daily basis. They said it can last days, weeks or even months at a time". The event "she is having moments of periodic paralysis of all of her limbs that last for 5-10minutes at a time, almost on a daily basis. they said it can last days, weeks or even months at a time" was evaluated at the physician office visit and emergency room visit. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of paralysis. Potassium to see if raising her potassium helps.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: Myocarditis; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 42 year-old female patient (not pregnant) received bnt162b2 (COVID-19 MANUFACTURER UNKNOWN), intramuscular, administration date 15Jul2021 (Lot number: ER8735) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. No other vaccine in four weeks. The following information was reported: MYOCARDITIS (hospitalization) with onset 16Aug2021, outcome "recovering", described as "Myocarditis". The patient was hospitalized for myocarditis (hospitalization  from 2021 to 2021, duration: 1 day(s)). Therapeutic measure colchicine was taken as a result of myocarditis.; Sender's Comments: Based on the information available and temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available   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: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: I developed Guillain-Barre syndrome; partial numbness on left leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 12:00 (Lot number: FF8841) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6200, Location of injection: Right Arm, Vaccine Administration Time: 12:30 PM), administration date: 25Feb2021, when the patient was 35 years old, for COVID-19 IMMUNIZATION; Bn2162b2 (Dose Number: 1, Batch/Lot No: EL8982, Location of injection: Right Arm, Vaccine Administration Time: 12:45 PM), administration date: 04Feb2021, when the patient was 35 years old, for COVID-19 IMMUNIZATION. The following information was reported: GUILLAIN-BARRE SYNDROME (disability) with onset 29Oct2021 13:00, outcome "recovering", described as "I developed Guillain-Barre syndrome"; HYPOAESTHESIA (disability) with onset 29Oct2021 13:00, outcome "recovering", described as "partial numbness on left leg". Patient developed Guillain-Barre syndrome. Spent a lot of money on testing. Still had partial numbness on left leg. Events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No other vaccine in four weeks. No treatment for events. No covid prior vaccination. No covid tested post vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune haemolytic anaemia, Blood potassium, Blood potassium increased, Haemolysis, Red blood cell abnormality
Clinical narrative: AIHA; Hemolysis; Elevated potassium levels; Damaged red blood cells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 15:00 (Lot number: ER8731) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Eng203, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: AUTOIMMUNE HAEMOLYTIC ANAEMIA (medically significant) with onset 07Dec2021, outcome "unknown", described as "AIHA"; HAEMOLYSIS (medically significant) with onset 07Dec2021, outcome "unknown", described as "Hemolysis"; BLOOD POTASSIUM INCREASED (non-serious) with onset 07Dec2021, outcome "unknown", described as "Elevated potassium levels"; RED BLOOD CELL ABNORMALITY (non-serious) with onset 07Dec2021, outcome "unknown", described as "Damaged red blood cells". The patient underwent the following laboratory tests and procedures: blood potassium: (07Dec2021) elevated; red blood cell count: (07Dec2021) damaged; Spit in cup: (17Aug2020) negative, notes: Other. Therapeutic measures were not taken as a result of autoimmune haemolytic anaemia, haemolysis, blood potassium increased, red blood cell abnormality. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Red blood cell count, SARS-CoV-2 test
Clinical narrative: AIHA; Hemolysis; Elevated potassium levels; Damaged red blood cells; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 15:00 (Lot number: ER8731) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Eng203, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 25Feb2021, when the patient was 50 years old, for COVID-19 Immunization. The following information was reported: AUTOIMMUNE HAEMOLYTIC ANAEMIA (medically significant) with onset 07Dec2021, outcome "unknown", described as "AIHA"; HAEMOLYSIS (medically significant) with onset 07Dec2021, outcome "unknown", described as "Hemolysis"; BLOOD POTASSIUM INCREASED (non-serious) with onset 07Dec2021, outcome "unknown", described as "Elevated potassium levels"; RED BLOOD CELL ABNORMALITY (non-serious) with onset 07Dec2021, outcome "unknown", described as "Damaged red blood cells". The patient underwent the following laboratory tests and procedures: blood potassium: (07Dec2021) elevated; red blood cell count: (07Dec2021) damaged; Spit in cup: (17Aug2020) negative, notes: Other. Therapeutic measures were not taken as a result of autoimmune haemolytic anaemia, haemolysis, blood potassium increased, red blood cell abnormality. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Headache, Immunisation, Lymphadenopathy
Clinical narrative: Left Ear ache; left lymphadenopathy; head ache; muscle & joint aches; muscle & joint aches; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Dec2021 15:30 (Lot number: FJ8762) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto autoimmune thyroid disease" (unspecified if ongoing), notes: Hashimoto autoimmune thyroid disease; "known allergies: Sulfa drugs" (unspecified if ongoing), notes: Hives with sulfa drugs. Concomitant medication(s) included: ESCITALOPRAM; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 06Apr2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021 15:30, outcome "unknown", described as "booster"; EAR PAIN (non-serious) with onset 05Dec2021 06:00, outcome "recovered" (Dec2021), described as "Left Ear ache"; LYMPHADENOPATHY (non-serious) with onset 05Dec2021 06:00, outcome "recovered" (Dec2021), described as "left lymphadenopathy"; HEADACHE (non-serious) with onset 05Dec2021 06:00, outcome "recovered" (Dec2021), described as "head ache"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 05Dec2021 06:00, outcome "recovered" (Dec2021) and all described as "muscle & joint aches". Therapeutic measures were not taken as a result of ear pain, lymphadenopathy, headache, arthralgia, myalgia.  Additional information: 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 not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.  Follow-Up (13Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Left Ear ache; left lymphadenopathy; head ache; muscle & joint aches; muscle & joint aches; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Dec2021 15:30 (Lot number: FJ8762) at the age of 51 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimoto autoimmune thyroid disease" (unspecified if ongoing), notes: Hashimoto autoimmune thyroid disease; "known allergies: Sulfa drugs" (unspecified if ongoing), notes: Hives with sulfa drugs. Concomitant medication(s) included: ESCITALOPRAM; LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 06Apr2021, when the patient was 50 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 50 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 04Dec2021 15:30, outcome "unknown", described as "booster"; EAR PAIN (non-serious) with onset 05Dec2021 06:00, outcome "recovered" (Dec2021), described as "Left Ear ache"; LYMPHADENOPATHY (non-serious) with onset 05Dec2021 06:00, outcome "recovered" (Dec2021), described as "left lymphadenopathy"; HEADACHE (non-serious) with onset 05Dec2021 06:00, outcome "recovered" (Dec2021), described as "head ache"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 05Dec2021 06:00, outcome "recovered" (Dec2021) and all described as "muscle & joint aches". Therapeutic measures were not taken as a result of ear pain, lymphadenopathy, headache, arthralgia, myalgia.  Additional information: 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 not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.  Follow-Up (13Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Myasthenic syndrome
Clinical narrative: myasthenia gravis symptoms; booster; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Aug2021 12:00 (Batch/Lot number: unknown) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "crps" (unspecified if ongoing); "Scoliosis" (unspecified if ongoing); "Epilepsy" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "known allergies: Some medication" (unspecified if ongoing). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication(s) included: SYNTHROID; FEMRING; PANTOPRAZOLE and medical canna. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left), for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Location of injection: Arm Left), for Covid-19 immunization. The following information was reported: IMMUNISATION (hospitalization, disability, medically significant) with onset 21Aug2021 12:00, outcome "unknown", described as "booster"; MYASTHENIC SYNDROME (hospitalization, disability, medically significant) with onset 25Aug2021, outcome "not recovered", described as "myasthenia gravis symptoms". The patient was hospitalized for immunisation, myasthenic syndrome (hospitalization duration: 3 day(s)). The event "myasthenia gravis symptoms" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of myasthenic syndrome. Treatment includes pyridostigmine, breathing, tests etc. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events 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.
Sex: M
Vaccine: COVID19
Symptoms: Bradycardia, Hypertensive heart disease, Neuropathy peripheral, Tachycardia
Clinical narrative: bradycardia; neuropathy; cardiovascular hypertensive crises; tachycardia; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team. The reporter is the patient.  A 65-year-old male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single and administration date Jan2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BRADYCARDIA (medically significant), outcome "recovering", described as "bradycardia"; NEUROPATHY PERIPHERAL (medically significant), outcome "recovering", described as "neuropathy"; HYPERTENSIVE HEART DISEASE (non-serious), outcome "recovering", described as "cardiovascular hypertensive crises"; TACHYCARDIA (non-serious), outcome "recovering", described as "tachycardia". Therapeutic measures were taken as a result of hypertensive heart disease. Patient received both doses of the Pfizer Covid 19 Vaccine back in Jan. He experienced devastating symptoms. He would have to double up on his blood pressure medication then after 3 or 4 days he would experience then also reported that he experienced. Things started to calm down in Nov. The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely 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: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Aura, Immunisation, Migraine
Clinical narrative: 3 migraine events/aura & migraine switches sides; booster; Aura/aura & migraine switches sides; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 20:00 (Lot number: 3303080) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high bp" (unspecified if ongoing); "pmdd" (unspecified if ongoing); "migraine w/aura" (unspecified if ongoing); "mal de debarquement" (unspecified if ongoing); "migraines" (unspecified if ongoing), notes: I have been getting migraines for the past 19 years.; "penicillin" (unspecified if ongoing); "sulfa" (unspecified if ongoing); "nightshades" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE; SERTRALINE; NORETHINDRONE [NORETHISTERONE]. Past drug history included: Erythromycin, reaction(s): "Reaction: Allergy"; Lanolin, reaction(s): "Reaction: Allergy"; Kaolin, reaction(s): "Reaction: Allergy". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0150, Location of injection: Arm Left), administration date: 15Apr2021, when the patient was 37 years old, for COVID-19 Immunization, reaction(s): "I got a migraine on day 2, 3 & 4."; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Right), administration date: 23Mar2021, when the patient was 37 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "booster"; MIGRAINE (non-serious) with onset 03Dec2021 14:15, outcome "not recovered", described as "3 migraine events/aura & migraine switches sides"; AURA (non-serious) with onset Dec2021, outcome "not recovered", described as "Aura/aura & migraine switches sides". Therapeutic measures were not taken as a result of migraine, aura.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.