chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: left side of her face swollen and droopy, warm to the touch; left side of her face swollen and droopy, warm to the touch; left side of her face swollen and droopy, warm to the touch; dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer; dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer; dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 44-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 04Jan2022 12:30 (Lot number: 33130BA) at the age of 44 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Erythromycin, reaction(s): "Known Allergies: Erythromycin". Vaccination history included: Moderna covid-19 vaccine (Dose Number: 1, Batch/Lot No: 025B21A, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 31Mar2021, when the patient was 43 years old, for COVID-19 Immunization; Moderna covid-19 vaccine (Dose Number: 2, Batch/Lot No: 009C21A, Location of injection: Arm Right, Route of Administration: Intramuscular), administration date: 26Apr2021, when the patient was 43 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), IMMUNISATION (non-serious) all with onset 04Jan2022 12:30, outcome "unknown" and all described as "dose number=1/dose number=2: Moderna; dosenumber=3: Pfizer"; SWELLING FACE (non-serious), SENSORY DISTURBANCE (non-serious), FEELING HOT (non-serious) all with onset 05Jan2022 06:00, outcome "not recovered" and all described as "left side of her face swollen and droopy, warm to the touch". Therapeutic measures were not taken as a result of swelling face, sensory disturbance, feeling hot.  Additional information: She got the booster (dose 3) on 04Jan2022 and woke up the next morning (05Jan2022) with left side of her face swollen and droopy, warm to the touch. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Birth control pill within 2 weeks of vaccination. The patient was not tested since the vaccination. The patient was not diagnosed with COVID-19 prior to vaccination.  Follow-Up: Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use
Clinical narrative: Moderna vaccine, 2nd dose was Pfizer; Moderna vaccine, 2nd dose was Pfizer; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 04Jan2022 (Lot number: FL3209) as dose 2,  single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1), for Covid-19 immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "Moderna vaccine, 2nd dose was Pfizer". No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Immunisation
Clinical narrative: recent flare ups; joint pain tends to increase; booster shot; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP) for a Pfizer sponsored program.  A 33 year-old female patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 33 years as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "booster shot"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "recent flare ups"; ARTHRALGIA (non-serious), outcome "unknown", described as "joint pain tends to increase".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Drug ineffective, Headache, Immunisation
Clinical narrative: booster dose; people who have gotten after receiving the vaccine; people who have gotten after receiving the vaccine; back pain; leg pain; Headaches; not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose number unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "people who have gotten after receiving the vaccine"; BACK PAIN (non-serious), outcome "unknown", described as "back pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg pain"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; ASTHENIA (non-serious), outcome "unknown", described as "not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events suspected covid19, drug ineffective and immunization cannot be totally excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Suspected COVID-19
Clinical narrative: booster dose; people who have gotten after receiving the vaccine; people who have gotten after receiving the vaccine; back pain; leg pain; Headaches; not feeling well; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP) from medical information team.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer, Dose number unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "booster dose"; SUSPECTED COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "people who have gotten after receiving the vaccine"; BACK PAIN (non-serious), outcome "unknown", described as "back pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg pain"; HEADACHE (non-serious), outcome "unknown", described as "Headaches"; ASTHENIA (non-serious), outcome "unknown", described as "not feeling well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events suspected covid19, drug ineffective and immunization cannot be totally excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood test, Gait disturbance, Inflammation, Joint stiffness
Clinical narrative: assuming I have RA; broke out in hives; struggled to walk in the mornings; joint pain; stiffness; slight swelling in (hips, ankles, feet, hands, wrists); pain grew worse over several months; couldn't put rings on my fingers; work shows elevated inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 12:00 (Lot number: ER8736) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPTONORM, start date: 23Apr2021. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand name unknown: False, Prev dose lot number: ER8733, Prev dose Lot unknown: False, Prev dose administration date: Mar2021, Prev dose administration time: 12:00 PM, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: Mar2021, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Jun2021, outcome "recovering", described as "assuming I have RA"; URTICARIA (non-serious) with onset Jun2021, outcome "recovering", described as "broke out in hives"; GAIT DISTURBANCE (non-serious) with onset Jun2021, outcome "recovering", described as "struggled to walk in the mornings"; ARTHRALGIA (non-serious) with onset Jun2021, outcome "recovering", described as "joint pain"; JOINT STIFFNESS (non-serious) with onset Jun2021, outcome "recovering", described as "stiffness"; JOINT SWELLING (non-serious) with onset Jun2021, outcome "recovering", described as "slight swelling in (hips, ankles, feet, hands, wrists)"; PAIN (non-serious) with onset Jun2021, outcome "recovering", described as "pain grew worse over several months"; PERIPHERAL SWELLING (non-serious) with onset Jun2021, outcome "recovering", described as "couldn't put rings on my fingers"; INFLAMMATION (non-serious) with onset Jun2021, outcome "recovering", described as "work shows elevated inflammation". The events "assuming i have ra", "broke out in hives", "struggled to walk in the mornings", "joint pain", "stiffness", "slight swelling in (hips, ankles, feet, hands, wrists)", "pain grew worse over several months", "couldn't put rings on my fingers" and "work shows elevated inflammation" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: elevated inflammation(crp marker). Therapeutic measures were not taken as a result of rheumatoid arthritis, urticaria, gait disturbance, arthralgia, joint stiffness, joint swelling, pain, peripheral swelling, inflammation.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pain, Peripheral swelling, Rheumatoid arthritis, Urticaria
Clinical narrative: assuming I have RA; broke out in hives; struggled to walk in the mornings; joint pain; stiffness; slight swelling in (hips, ankles, feet, hands, wrists); pain grew worse over several months; couldn't put rings on my fingers; work shows elevated inflammation; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01May2021 12:00 (Lot number: ER8736) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: LIPTONORM, start date: 23Apr2021. Vaccination history included: Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: Pfizer, Prev dose brand name unknown: False, Prev dose lot number: ER8733, Prev dose Lot unknown: False, Prev dose administration date: Mar2021, Prev dose administration time: 12:00 PM, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: Mar2021, for Covid-19 immunization. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset Jun2021, outcome "recovering", described as "assuming I have RA"; URTICARIA (non-serious) with onset Jun2021, outcome "recovering", described as "broke out in hives"; GAIT DISTURBANCE (non-serious) with onset Jun2021, outcome "recovering", described as "struggled to walk in the mornings"; ARTHRALGIA (non-serious) with onset Jun2021, outcome "recovering", described as "joint pain"; JOINT STIFFNESS (non-serious) with onset Jun2021, outcome "recovering", described as "stiffness"; JOINT SWELLING (non-serious) with onset Jun2021, outcome "recovering", described as "slight swelling in (hips, ankles, feet, hands, wrists)"; PAIN (non-serious) with onset Jun2021, outcome "recovering", described as "pain grew worse over several months"; PERIPHERAL SWELLING (non-serious) with onset Jun2021, outcome "recovering", described as "couldn't put rings on my fingers"; INFLAMMATION (non-serious) with onset Jun2021, outcome "recovering", described as "work shows elevated inflammation". The events "assuming i have ra", "broke out in hives", "struggled to walk in the mornings", "joint pain", "stiffness", "slight swelling in (hips, ankles, feet, hands, wrists)", "pain grew worse over several months", "couldn't put rings on my fingers" and "work shows elevated inflammation" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: elevated inflammation(crp marker). Therapeutic measures were not taken as a result of rheumatoid arthritis, urticaria, gait disturbance, arthralgia, joint stiffness, joint swelling, pain, peripheral swelling, inflammation.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Booster; tested positive for Covid recently.; tested positive for Covid recently.; 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.  A female patient in her 70's received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. Reporter reported that her sister-in-law received both primary doses of the Pfizer Covid-19 vaccine and the booster dose and tested positive for Covid recently. Reporter stated, "my sister-in-law has covid and she went to the hospital and they would not give her the monoclonal antibiotics because she has her shots and booster and they were only giving that to other people". "She's hacking her head off and no one can help her, she started having symptoms last Wednesday. She has diabetes and is elderly, but no one is helping her."  The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "Booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid recently.". The patient underwent the following laboratory tests and procedures: sars-cov-2 test positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Immunisation, Suspected COVID-19
Clinical narrative: My family had all 3 doses as early as we could get them; however, we now ALL have COVID; My family had all 3 doses as early as we could get them; however, we now ALL have COVID; My family had all 3 doses as early as we could get them; however, we now ALL have COVID; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My family had all 3 doses as early as we could get them; however, we now ALL have COVID". Additional information: "The web site states " Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage) while two doses show significantly reduced neutralization titers" My family had all 3 doses as early as we could get them; however, we now ALL have COVID. Not surprisingly, new strains are different enough to get past this immunity. The 2021-2022 flu vaccine is out, where is the updated COMIRNATY vaccine"  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Drug ineffective, Suspected COVID-19
Clinical narrative: My family had all 3 doses as early as we could get them; however, we now ALL have COVID; My family had all 3 doses as early as we could get them; however, we now ALL have COVID; My family had all 3 doses as early as we could get them; however, we now ALL have COVID; 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 patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant), DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "My family had all 3 doses as early as we could get them; however, we now ALL have COVID". Additional information: "The web site states " Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage) while two doses show significantly reduced neutralization titers" My family had all 3 doses as early as we could get them; however, we now ALL have COVID. Not surprisingly, new strains are different enough to get past this immunity. The 2021-2022 flu vaccine is out, where is the updated COMIRNATY vaccine"  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: covid 19 infection; covid 19 infection; 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 parent.  A 8 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2021 (Batch/Lot number: unknown) as dose 1 (tris), 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 "covid 19 infection".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dysgeusia, Headache, Rash, Thrombosis
Clinical narrative: possibility of blood clot; metal taste; rash around neck and hands; increase joint pain; Headaches; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date Dec2021 (Lot number: FH 80n8) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "thyroid low" (unspecified if ongoing); "Known allergy: Penicillin" (unspecified if ongoing); "Known allergy: skin care products with propylene glycol" (unspecified if ongoing); "Covid", start date: Dec2020, stop date: Dec2020, notes: if covid prior vaccination= Yes, COVID last Dec2020. Concomitant medication(s) included: SYNTHROID. The following information was reported: THROMBOSIS (medically significant) with onset Dec2021, outcome "recovered", described as "possibility of blood clot"; DYSGEUSIA (non-serious) with onset Dec2021, outcome "recovered", described as "metal taste"; RASH (non-serious) with onset Dec2021, outcome "recovered", described as "rash around neck and hands"; ARTHRALGIA (non-serious) with onset Dec2021, outcome "recovered", described as "increase joint pain"; HEADACHE (non-serious) with onset Dec2021, outcome "recovered", described as "Headaches". Therapeutic measures were not taken as a result of thrombosis, dysgeusia, rash, arthralgia, headache. Patient was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information provided, a causal association between reported events thrombosis, dysgeusia, rash, arthralgia, headache and the suspect BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Immunisation
Clinical narrative: stroke; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Dec2021 13:00 (Lot number: FL3197) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, LOT: EW0183, NDC, EXP: unknown, Route, Anatomical Location: right arm), administration date: 13May2021, for COVID-19 immunization; Bnt162b2 (Dose 2, LOT: EW0191, NDC, EXP: unknown, Route, Anatomical Location: right arm), administration date: 03Jun2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 29Dec2021 13:00, outcome "unknown", described as "Booster"; CEREBROVASCULAR ACCIDENT (hospitalization, medically significant) with onset 01Jan2022 12:23, outcome "unknown", described as "stroke". The patient was hospitalized for cerebrovascular accident (start date: 01Jan2022). The event "stroke" was evaluated at the emergency room visit. Therapeutic measures were taken as a result of cerebrovascular accident. Clinical course: The caller was the patients wife, reporting that her 55 years old husband who received the Pfizer covid vaccine Booster shot and 2 days later he had a stroke, he does not have any health issue, he was a very healthy person and doctors do not know the reason for stoke. She was calling to report it as advised by the doctor. She states that on Wednesday, they met with the doctor and they said there is no reason they can prove that this has something to do with her husband or his health. She states that he was perfectly fine and there was nothing wrong. She states that one of her friends who is a doctor, said to report this to Pfizer. Stroke occurred early Saturday morning at 12:23 in the morning. It was in the first few minutes of the new year, 01Jan2022. She states her husband is in critical condition and has been in the ICU since Saturday. He is not responsive and, they are saying his situation is getting very fast. Really bad things that usually go in like 6 days, is taking him hours. Treatment: Clarified that her husband has been in the hospital, in the ICU since 01Jan2022 and was still there now. She states she does not have any information with her regarding any treatments or mediations he has had. No prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Immunisation, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19 today; Tested positive for COVID-19 today; Dose Number: 3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  An adult patient received bnt162b2 (BNT162B2), administered in arm left, administration date Nov2021 (Lot number: EW0217) as dose 3 (booster), single, administered in arm left, administration date Feb2021 (Lot number: EL3247) as dose 2, single and administered in arm left, administration date Feb2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLOWMAX. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "Dose Number: 3"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 06Jan2022, outcome "not recovered" and all described as "Tested positive for COVID-19 today". The event "tested positive for covid-19 today" and "tested positive for covid-19 today" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of drug ineffective, covid-19. Additional information: No other vaccine received in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Immunisation, Rash, SARS-CoV-2 test
Clinical narrative: Dose Number: 3; Eczema-like lesions as well as red raised bumps on torso; entire body rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Dec2021 13:00 (Lot number: FD0809) at the age of 59 years as dose 3 (booster), single, administered in arm left, administration date 09Apr2021 13:30 (Lot number: EW0162) as dose 2, single and administered in arm left, administration date 19Mar2021 12:00 (Lot number: ER8727) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: IMMUNISATION (non-serious) with onset 10Dec2021, outcome "unknown", described as "Dose Number: 3"; ECZEMA (non-serious) with onset 25Apr2021, outcome "not recovered", described as "Eczema-like lesions as well as red raised bumps on torso"; RASH (non-serious) with onset 25Apr2021, outcome "not recovered", described as "entire body rash". The events "eczema-like lesions as well as red raised bumps on torso" and "entire body rash" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of eczema, rash.  Additional information: Patient was administered most recent Covid-19 vaccine in facility: Pharmacy or Drug store. Patient did not received any other vaccines within 4 weeks prior to the Covid-19 vaccine. Patient did not received any other medications within 2 weeks of vaccination. Patient was started experiencing events with the 1st dose, and escalating BADLY after the 2nd dose, it was Began to subside (though faintly with getting better and worse intermittently) and now EXTREMELY bad again after the booster. Patient have had treatments continuously including Prednisone, Cyclosporin, UV light treatments and multiple antihistamines. All to very little effect. Patient was not diagnosed with Covid-19 prior to vaccination. Patient was not tested for Covid-19 since vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Illness, Immunisation, Neck pain, Pain in extremity
Clinical narrative: booster dose; pain in left arm that is radiating to his shoulder and neck; pain in left arm that is radiating to his shoulder and neck; sick; pain in left arm that is radiating to his shoulder and neck; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 15Dec2021 (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 (1st dose), reaction(s): "Covid 19 immunization"; Bnt162b2 (2nd dose), reaction(s): "Covid 19 immunization". The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021, outcome "not recovered", described as "booster dose"; PAIN IN EXTREMITY (non-serious), ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset Dec2021, outcome "not recovered" and all described as "pain in left arm that is radiating to his shoulder and neck"; ILLNESS (non-serious) with onset Dec2021, outcome "unknown", described as "sick".  Additional information: The reporter reported he had booster dose of covid vaccine on 15Dec2021. He experienced pain in left arm that radiated to his shoulder and neck. He declined to provide any contact details. He was sick from the vaccination and could not wait to mail something to the legal department for compensation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Headache, Immunisation, Nasal congestion
Clinical narrative: chills; HA; ear pressure; congestion; scratchy; ST; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 49 years 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 Number: 2, Batch/Lot No: EL3247), administration date: 16Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 23Feb2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "booster"; CHILLS (non-serious) with onset 02Jan2022, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 02Jan2022, outcome "recovering", described as "HA"; EAR DISCOMFORT (non-serious) with onset 02Jan2022, outcome "recovering", described as "ear pressure"; NASAL CONGESTION (non-serious) with onset 02Jan2022, outcome "recovering", described as "congestion"; SCRATCH (non-serious) with onset 02Jan2022, outcome "recovering", described as "scratchy"; OROPHARYNGEAL PAIN (non-serious) with onset 02Jan2022, outcome "recovering", described as "ST". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chills, headache, ear discomfort, nasal congestion, scratch, oropharyngeal pain.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test, Scratch
Clinical narrative: chills; HA; ear pressure; congestion; scratchy; ST; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Oct2021 (Lot number: FF2589) at the age of 49 years 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 Number: 2, Batch/Lot No: EL3247), administration date: 16Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247), administration date: 23Feb2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Oct2021, outcome "unknown", described as "booster"; CHILLS (non-serious) with onset 02Jan2022, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 02Jan2022, outcome "recovering", described as "HA"; EAR DISCOMFORT (non-serious) with onset 02Jan2022, outcome "recovering", described as "ear pressure"; NASAL CONGESTION (non-serious) with onset 02Jan2022, outcome "recovering", described as "congestion"; SCRATCH (non-serious) with onset 02Jan2022, outcome "recovering", described as "scratchy"; OROPHARYNGEAL PAIN (non-serious) with onset 02Jan2022, outcome "recovering", described as "ST". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of chills, headache, ear discomfort, nasal congestion, scratch, oropharyngeal pain.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Hypertension, Immunisation, Peripheral swelling
Clinical narrative: my blood pressure goes into hypertensive levels; Even my legs are swelled up like before; my blood pressure goes into hypertensive levels and I fear its getting worse and worse; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 29Dec2021 (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), for COVID-19 immunization, reaction(s): "Even my legs are swelled up like before."; Bnt162b2 (Dose: 2), for COVID-19 immunization, reaction(s): "Even my legs are swelled up like before.". The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "booster"; HYPERTENSION (non-serious), outcome "unknown", described as "my blood pressure goes into hypertensive levels"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Even my legs are swelled up like before"; CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "my blood pressure goes into hypertensive levels and I fear its getting worse and worse".  Additional information: I have gotten the two shots of vaccine and the booster. I got the last booster on Wednesday 29Dec. The pattern is very clear to me as the week goes that my blood pressure goes into hypertensive levels and I fear its getting worse and worse. I can't afford another series of medical bills that examine my heart without any conclusions. Its like nobody cares what the side effects are with this vaccine. Even my legs are swelled up like before.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Drug ineffective, Immunisation, Oropharyngeal pain
Clinical narrative: mild cough; mild sore throat; tested positive on at-home rapid test for Covid-19 on 05Jan2022; tested positive on at-home rapid test for Covid-19 on 05Jan2022; Comirnaty booster; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). A 73-year-old male patient received BNT162B2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single; administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient had no relevant medical history (no underlying health conditions). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "Comirnaty booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "tested positive on at-home rapid test for Covid-19 on 05Jan2022"; COUGH (non-serious), outcome "unknown", described as "mild cough" and OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "mild sore throat". It was reported that the event took place after the use of product. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: at home.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: mild cough; mild sore throat; tested positive on at-home rapid test for Covid-19 on 05Jan2022; tested positive on at-home rapid test for Covid-19 on 05Jan2022; Comirnaty booster; This is a spontaneous report received from contactable reporters (Consumer or other non HCP). A 73-year-old male patient received BNT162B2 (COMIRNATY), administration date Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single; administration date 2021 (Batch/Lot number: unknown) as dose 2, single and administration date 2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient had no relevant medical history (no underlying health conditions). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset Nov2021, outcome "unknown", described as "Comirnaty booster"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 05Jan2022, outcome "unknown" and all described as "tested positive on at-home rapid test for Covid-19 on 05Jan2022"; COUGH (non-serious), outcome "unknown", described as "mild cough" and OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "mild sore throat". It was reported that the event took place after the use of product. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (05Jan2022) positive, notes: at home.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Pyrexia
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 3rd (booster) dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Jan 4, 2022, at 09:00, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st and 2nd dose of BNT162B2 (Comirnaty) for COVID-19 immunization. The patient had pyrexia/fever, onset Jan 2022, with outcome of not recovered. The lot number for BNT162B2 not provided and will be requested during follow-up.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Immunisation, Influenza like illness, Interchange of vaccine products
Clinical narrative: Flu-like symptoms; achy; Lethargic; pounding sensation when moving around; booster; Her first shot was J&J and she opted for a Pfizer booster; Her first shot was J&J and she opted for a Pfizer booster; pulse is 50% faster than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 05Jan2022 15:30 (Lot number: 33025BD) at the age of 80 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Johnson and johnson vaccine (First Dose, Lot: 206A21A), administration date: 03Aug2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022, outcome "unknown", described as "booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 05Jan2022, outcome "unknown" and all described as "Her first shot was J&J and she opted for a Pfizer booster"; HEART RATE INCREASED (non-serious) with onset 05Jan2022, outcome "unknown", described as "pulse is 50% faster than normal"; INFLUENZA LIKE ILLNESS (non-serious) with onset 06Jan2022, outcome "unknown", described as "Flu-like symptoms"; PAIN (non-serious) with onset 06Jan2022, outcome "unknown", described as "achy"; LETHARGY (non-serious) with onset 06Jan2022, outcome "unknown", described as "Lethargic"; PALPITATIONS (non-serious) with onset 06Jan2022, outcome "unknown", described as "pounding sensation when moving around". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that she had a booster shot yesterday. Her first shot was J&J and she opted for a Pfizer booster, that was the only thing being offered. The patient stated that everything was fine. It was totally painless, however last night she noticed her pulse was fast. The patient tested and took her pulse and it was like 50% faster than normal. Her pulse was around 88-90, but normally her pulse was very slow pulse like around 60. The patient stated she took her pulse again this morning and it was a little bit slower. Later in the morning, her pulse was like 80. She was feeling sort of like flu-like symptoms. She was achy, not severely achy, but just enough to be noticeable. She was feeling lethargic. The patient also stated that when she first got up she noticed when she was moving around, exercising a little bit, like walking around, she did had a pounding sensation. She stated she noticed this sensation today, but it was subsided.  The patient did not administered any additional vaccines on same date of Pfizer vaccine. The patient not received any other vaccine 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Off label use, Pain, Palpitations
Clinical narrative: Flu-like symptoms; achy; Lethargic; pounding sensation when moving around; booster; Her first shot was J&J and she opted for a Pfizer booster; Her first shot was J&J and she opted for a Pfizer booster; pulse is 50% faster than normal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 05Jan2022 15:30 (Lot number: 33025BD) at the age of 80 years as dose 2 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Johnson and johnson vaccine (First Dose, Lot: 206A21A), administration date: 03Aug2021, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 05Jan2022, outcome "unknown", described as "booster"; OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 05Jan2022, outcome "unknown" and all described as "Her first shot was J&J and she opted for a Pfizer booster"; HEART RATE INCREASED (non-serious) with onset 05Jan2022, outcome "unknown", described as "pulse is 50% faster than normal"; INFLUENZA LIKE ILLNESS (non-serious) with onset 06Jan2022, outcome "unknown", described as "Flu-like symptoms"; PAIN (non-serious) with onset 06Jan2022, outcome "unknown", described as "achy"; LETHARGY (non-serious) with onset 06Jan2022, outcome "unknown", described as "Lethargic"; PALPITATIONS (non-serious) with onset 06Jan2022, outcome "unknown", described as "pounding sensation when moving around". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient stated that she had a booster shot yesterday. Her first shot was J&J and she opted for a Pfizer booster, that was the only thing being offered. The patient stated that everything was fine. It was totally painless, however last night she noticed her pulse was fast. The patient tested and took her pulse and it was like 50% faster than normal. Her pulse was around 88-90, but normally her pulse was very slow pulse like around 60. The patient stated she took her pulse again this morning and it was a little bit slower. Later in the morning, her pulse was like 80. She was feeling sort of like flu-like symptoms. She was achy, not severely achy, but just enough to be noticeable. She was feeling lethargic. The patient also stated that when she first got up she noticed when she was moving around, exercising a little bit, like walking around, she did had a pounding sensation. She stated she noticed this sensation today, but it was subsided.  The patient did not administered any additional vaccines on same date of Pfizer vaccine. The patient not received any other vaccine within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.