chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Tiredness; Headache; Muscle ache at the infection area -right upper arm; Pain in the right armpit; Muscle ache at the infection area -right upper arm; sore arm; Lymph node in the right armpit; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 17Feb2022 17:45 (Lot number: FJ6369) at the age of 53 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: Comirnaty (Dose 2, Lot number: EL3247, Administration time: 10:00 AM , Dose vaccine location: Left arm), administration date: 22Mar2021, when the patient was 52 years old, for Covid-19 immunization; Comirnaty (Dose 1, Lot number: EL3247, Administration time: 09:30 AM , Dose vaccine location: Left arm), administration date: 01Mar2021, when the patient was 52 years old, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 18Feb2022 06:00, outcome "not recovered", described as "Tiredness"; HEADACHE (non-serious) with onset 18Feb2022 06:00, outcome "not recovered", described as "Headache"; MYALGIA (non-serious), INFECTION (non-serious) all with onset 18Feb2022 06:00, outcome "not recovered" and all described as "Muscle ache at the infection area -right upper arm"; AXILLARY PAIN (non-serious) with onset 18Feb2022 06:00, outcome "not recovered", described as "Pain in the right armpit"; LYMPHADENOPATHY (non-serious) with onset 18Feb2022, outcome "not recovered", described as "Lymph node in the right armpit"; PAIN IN EXTREMITY (non-serious) with onset 18Feb2022 06:00, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, axillary pain, lymphadenopathy, infection.  Additional information: The patient had not received any other vaccine in 4 weeks. The patient had not other medications in 2 weeks. Patient had not covid prior vaccination and had not covid tested post vaccination. Patient had received the booster on (thursday) 17Feb around 17:45, and and events occurred was (friday) 18Feb. In early morning, around 6:00AM patient was experienced headache, sore arm etc. The lymph nodes part was a bit later during the day.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ovulation disorder
Clinical narrative: started ovulating and having periods again; 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 female patient received bnt162b2 (BNT162B2) (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: Covid-19 vaccine (Primary Immunization series completed but manufacturer unknown), for covid 19 immunization. The following information was reported: OVULATION DISORDER (non-serious), outcome "unknown", described as "started ovulating and having periods again".  Additional information: After receiving 3rd COVID 19 vaccine the patient's reproductive system had gone into reverse. She had not experienced a period for almost a year. But since receiving 3rd vaccine she had started ovulating and having periods again. It was also reported that she know of 2 other women of her age who had also experienced similar events.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chloasma
Clinical narrative: after I got the first dose of the vaccine COVID 19 from Pfizer I got a dark spot on my neck like melasmas; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (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: CHLOASMA (non-serious), outcome "unknown", described as "after I got the first dose of the vaccine COVID 19 from Pfizer I got a dark spot on my neck like melasmas".  Additional information: After patient  got the first dose of the vaccine COVID 19 from Pfizer patient  got a dark spot on my neck like melasmas and with the second one it has grown and does not disappear, a few days ago in a video of a dermatologist on the social media platform. He talked about spots on the skin and I read several comments where they said they knew or have relatives who after vaccination they got dark spots, and I want to know if you have reported cases.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Dizziness, Menstrual disorder
Clinical narrative: I'm still light headed, dizzy, and a little confused sometimes.; I'm still light headed, dizzy, and a little confused sometimes.; I'm still light headed, dizzy, and a little confused sometimes.; The second round was 3 days ago; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2022 11:30 (Lot number: fl3209) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Avocado" (unspecified if ongoing); "Bipolar 2" (unspecified if ongoing); "Depression" (unspecified if ongoing); "GAD" (unspecified if ongoing); "PMDD" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: LAMICTAL. Vaccination history included: Bnt162b2 (Dose 1, Single, lot number: FJ5682,, administration time: 10:30AM, vaccine location: Left arm), administration date: 16Jan2022, when the patient was 29 years old, for COVID-19 Immunization, reaction(s): "monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round", "monthly cycle started 2 weeks early, was much worse than usual, experienced excessive blood clots with the first round", "Light headed/dizzy", "A little confused sometimes". The following information was reported: DIZZINESS (non-serious), DIZZINESS (non-serious), CONFUSIONAL STATE (non-serious) all with onset Feb2022, outcome "not recovered" and all described as "I'm still light headed, dizzy, and a little confused sometimes."; MENSTRUAL DISORDER (non-serious) with onset Feb2022, outcome "unknown", described as "The second round was 3 days ago".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, Weight, Weight decreased
Clinical narrative: taste became more intense; I lost another 10 lbs. Total loss in 10 months 32 lbs.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 01Nov2021 (Lot number: FE2590) at the age of 69 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 1, SINGLE, Lot no# EN6207), administration date: 13Mar2021, when the patient was 68 years old, for Covid-19 immunization, reaction(s): "Had a metallic taste in her mouth", "That it is interfering with her eating", "lost 10 pounds/Have lost 22 lbs", "Smell/Taste Loss became worse", "Smell/Taste Loss became worse", "Smell/Taste Loss became worse", "Parosmia"; Bnt162b2 (DOSE 2, SINGLE, Lot no# EW0150), administration date: 06Apr2021, when the patient was 68 years old, for Covid-19 immunization, reaction(s): "parosmia became substantially worse", "metallic taste got so severe/metallic taste got worse / metallic taste in her mouth/ metallic/sour taste started in mouth", "metallic taste got so severe/metallic taste got worse / metallic taste in her mouth/ metallic/sour taste started in mouth", "Smell was completely gone", "Everything tastes awful", "she could barely eat/ interfering with her eating", "lost 10 pounds/ continued to lose weight/ have lost 22lbs".  The following information was reported: TASTE DISORDER (non-serious) with onset 01Nov2021, outcome "unknown", described as "taste became more intense"; WEIGHT DECREASED (non-serious) with onset 01Nov2021, outcome "unknown", described as "I lost another 10 lbs. Total loss in 10 months 32 lbs.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After booster taste became more intense and lost another 10lbs. Total less in 10 months 32lbs.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypoxia, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOXIA (death, medically significant), outcome "fatal", described as "8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions". The patient underwent the following laboratory tests and procedures: oxygen saturation: 60-80%; sars-cov-2 test: negative. There 8 patients total passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions. 5 were long term residents and 3 were short term residents. 5 of them passed within a two week period. The above patients' pulse oxygen saturation levels ranged 60-80%. The patient date of death was unknown. The reported cause of death was hypoxia. It was not reported if an autopsy was performed. The lot number for bnt162b2 was not provided and will be requested during follow up. Sender's Comments: Linked Report(s): US-PFIZER INC-202200376657 same reporter/drug, different event with similar event. Reported Cause(s) of Death: 8 patients total at his facility who passed within 6 months after getting the Pfizer Covid-19 vaccine from hypoxic conditions
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Dizziness, Dyspnoea, Exercise tolerance decreased, Flatulence
Clinical narrative: heart flutter; Shortness of breath; dizziness; near fainting; gas trapped in upper chest; exercise performance (running) has decreased significantly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 10:00 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, lot unknown, administration time: 09:00 AM , location: Left arm), administration date: 06Apr2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 09Jun2021 12:00, outcome "not recovered", described as "heart flutter"; DYSPNOEA (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "Shortness of breath"; DIZZINESS (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "dizziness"; PRESYNCOPE (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "near fainting"; FLATULENCE (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "gas trapped in upper chest"; EXERCISE TOLERANCE DECREASED (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "exercise performance (running) has decreased significantly". The events "heart flutter", "shortness of breath", "dizziness", "near fainting", "gas trapped in upper chest" and "exercise performance (running) has decreased significantly" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Sep2021) negative. Therapeutic measures were not taken as a result of cardiac flutter, dyspnoea, dizziness, presyncope, flatulence, exercise tolerance decreased. Clinical information: No other vaccine in four weeks and no other medications in last two weeks. Shortness of breath, dizziness (near fainting), heart flutter or gas trapped in upper chest. This has been going on since Jun2021. His exercise performance (running) has decreased significantly. When will this stop he was concerned. It was reported that, no covid prior vaccination. Tested positive post vaccination. No known allergies were reported. Other medical history reported as none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope, SARS-CoV-2 test
Clinical narrative: heart flutter; Shortness of breath; dizziness; near fainting; gas trapped in upper chest; exercise performance (running) has decreased significantly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 10:00 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single, lot unknown, administration time: 09:00 AM , location: Left arm), administration date: 06Apr2021, when the patient was 61 years old, for Covid-19 immunization. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 09Jun2021 12:00, outcome "not recovered", described as "heart flutter"; DYSPNOEA (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "Shortness of breath"; DIZZINESS (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "dizziness"; PRESYNCOPE (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "near fainting"; FLATULENCE (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "gas trapped in upper chest"; EXERCISE TOLERANCE DECREASED (non-serious) with onset 09Jun2021 12:00, outcome "not recovered", described as "exercise performance (running) has decreased significantly". The events "heart flutter", "shortness of breath", "dizziness", "near fainting", "gas trapped in upper chest" and "exercise performance (running) has decreased significantly" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Sep2021) negative. Therapeutic measures were not taken as a result of cardiac flutter, dyspnoea, dizziness, presyncope, flatulence, exercise tolerance decreased. Clinical information: No other vaccine in four weeks and no other medications in last two weeks. Shortness of breath, dizziness (near fainting), heart flutter or gas trapped in upper chest. This has been going on since Jun2021. His exercise performance (running) has decreased significantly. When will this stop he was concerned. It was reported that, no covid prior vaccination. Tested positive post vaccination. No known allergies were reported. Other medical history reported as none.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: swelling head to toe; lymph nodes and everything were swollen; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 60 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "leukemia" (unspecified if ongoing), notes:  He was a 60 year old male with the underlying medical condition of leukemia, which was in remission. The patient's concomitant medications were not reported. The following information was reported: SWELLING (hospitalization) with onset 2021, outcome "unknown", described as "swelling head to toe"; LYMPHADENOPATHY (hospitalization) with onset 2021, outcome "unknown", described as "lymph nodes and everything were swollen". The patient was hospitalized for swelling, lymphadenopathy (start date: 2021, discharge date: 2021).  Clinical course: Caller stated she wanted to stay anonymous but she knew a person who had the first dose of the Pfizer Covid vaccine and soon after had swelling head to toe. Caller stated that his lymph nodes and everything were swollen. Caller said he was a 60 year old male with the underlying medical condition of leukemia, which was in remission.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Nasal polyps, Neoplasm malignant, SARS-CoV-2 test, Shock
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 16:00 (Lot number: EN6205) at the age of 73 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Ovarian cancer" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Carbo platin, reaction(s): "Known allergies: carboplatin", notes: Carbo platin. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL 9266, Location of injection: Arm Left, Vaccine Administration Time: 04:00 PM), administration date: 18Feb2021, when the patient was 73 years old, for COVID-19 Immunization. The following information was reported: NEOPLASM MALIGNANT (disability, medically significant) with onset 15Mar2021, outcome "recovered with sequelae" (2021), described as "Same time Cancer detected after being cancer free for 2 and half years."; SHOCK (disability, medically significant) with onset 15Mar2021, outcome "recovered with sequelae" (2021), described as "shock like would travel from hamstrings to the toes of the right leg."; ARTHRALGIA (disability) with onset 15Mar2021, outcome "recovered with sequelae" (2021), described as "After the second dose developed severe pain in posterior right knee."; NASAL POLYPS (disability) with onset 15Mar2021, outcome "recovered with sequelae" (2021), described as "a polyp in my right nostril". The events "same time cancer detected after being cancer free for 2 and half years.", "shock like would travel from hamstrings to the toes of the right leg." and "after the second dose developed severe pain in posterior right knee." were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (23Dec2021) negative, notes: Covid test type post vaccination: Nasal Swab. Therapeutic measures were taken as a result of neoplasm malignant, shock, arthralgia, nasal polyps. As reported the patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 12:00 (Batch/Lot number: EW0198) as dose 3, single for Covid-19 immunization. No Covid prior vaccination was received by patient. On 23Dec2021, she had her Covid test done post vaccination as RTPCR as nasal swab and the test results was found to be negative. No follow-up attempts are possible. No further information is expected
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica, SARS-CoV-2 test
Clinical narrative: Pmr I. Remission for 4 years returned and also A heretic reaction landing me in the hospital; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 86 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Oct2021 12:00 (Batch/Lot number: unknown) at the age of 86 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "PMR" (unspecified if ongoing), notes: other medical history: PMR; "known allergies: Penicillin" (unspecified if ongoing), notes: known allergies: Penicillin; "known allergies: sulfa" (unspecified if ongoing), notes: known allergies: sulfa. Concomitant medication(s) included: LEXAPRO; ZETIA; PRAVACHOL; PRESERVISION; VIT D; CALCIUM. Past drug history included: Macrolides, reaction(s): "Allergy: macrolides", notes: known allergies: macrolides. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:00 AM), administration date: 03Mar2021, when the patient was 85 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 03Feb2021, when the patient was 85 years old, for Covid-19 Immunization. The following information was reported: POLYMYALGIA RHEUMATICA (hospitalization) with onset 01Nov2021, outcome "recovering", described as "Pmr I. Remission for 4 years returned and also A heretic reaction landing me in the hospital". The patient was hospitalized for polymyalgia rheumatica (hospitalization duration: 3 day(s)). The event "pmr i. remission for 4 years returned and also a heretic reaction landing me in the hospital" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (19Feb2022) negative, notes: Nasal Swab. Therapeutic measures were taken as a result of polymyalgia rheumatica. Clinical course: The patient did not receive any other vaccines within four weeks prior to the vaccination. Pmr I. Remission for 4 years returned and also a heretic reaction landing me in the hospital. Valtrex, cellcept received as treatment for the adverse event. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date was 09Mar2022.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Dyspnoea, Gait inability, Near death experience, Penile swelling
Clinical narrative: really almost died; swollen up again; penis, scrotum, stomach, legs and arms were swollen; penis, scrotum, stomach, legs and arms were swollen; penis, scrotum, stomach, legs and arms were swollen; penis, scrotum, stomach, legs and arms were swollen; unable to walk; short of breath; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 60 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2 , single for covid-19 immunisation. Relevant medical history included: "leukemia" (unspecified if ongoing), notes: underlying medical condition of leukemia, which is in remission. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "lymph nodes and everything were swollen", "swelling head to toe". The following information was reported: NEAR DEATH EXPERIENCE (hospitalization, medically significant), outcome "unknown", described as "really almost died"; SWELLING (hospitalization), outcome "unknown", described as "swollen up again"; PENILE SWELLING (hospitalization), SCROTAL SWELLING (hospitalization), ABDOMINAL DISTENSION (hospitalization), PERIPHERAL SWELLING (hospitalization), outcome "unknown" and all described as "penis, scrotum, stomach, legs and arms were swollen"; GAIT INABILITY (hospitalization), outcome "unknown", described as "unable to walk"; DYSPNOEA (hospitalization), outcome "unknown", described as "short of breath". Therapeutic measures were taken as a result of swelling, penile swelling, scrotal swelling, abdominal distension, peripheral swelling.  Clinical course: Reporter reported that the patient had a underlying condition but it was suggested that he take the vaccine anyways. The patient took the second dose and waited for 30 minutes. the reporter stated, by the time patient got home he had swollen up again and this time ended up hospitalized for 2 months. the reporter stated some of the swelling and shortness of breath still persist today and he was released from the hospital in Nov. the patient still had complication from the swelling, the patient had been placed on medication but the swelling still persist. Stated as, he really almost died. the patient's penis swelled to the size of a liter bottle and his scrotum swelled to the size of a cabbage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Scrotal swelling, Swelling
Clinical narrative: really almost died; swollen up again; penis, scrotum, stomach, legs and arms were swollen; penis, scrotum, stomach, legs and arms were swollen; penis, scrotum, stomach, legs and arms were swollen; penis, scrotum, stomach, legs and arms were swollen; unable to walk; short of breath; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 60 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2 , single for covid-19 immunisation. Relevant medical history included: "leukemia" (unspecified if ongoing), notes: underlying medical condition of leukemia, which is in remission. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 immunization, reaction(s): "lymph nodes and everything were swollen", "swelling head to toe". The following information was reported: NEAR DEATH EXPERIENCE (hospitalization, medically significant), outcome "unknown", described as "really almost died"; SWELLING (hospitalization), outcome "unknown", described as "swollen up again"; PENILE SWELLING (hospitalization), SCROTAL SWELLING (hospitalization), ABDOMINAL DISTENSION (hospitalization), PERIPHERAL SWELLING (hospitalization), outcome "unknown" and all described as "penis, scrotum, stomach, legs and arms were swollen"; GAIT INABILITY (hospitalization), outcome "unknown", described as "unable to walk"; DYSPNOEA (hospitalization), outcome "unknown", described as "short of breath". Therapeutic measures were taken as a result of swelling, penile swelling, scrotal swelling, abdominal distension, peripheral swelling.  Clinical course: Reporter reported that the patient had a underlying condition but it was suggested that he take the vaccine anyways. The patient took the second dose and waited for 30 minutes. the reporter stated, by the time patient got home he had swollen up again and this time ended up hospitalized for 2 months. the reporter stated some of the swelling and shortness of breath still persist today and he was released from the hospital in Nov. the patient still had complication from the swelling, the patient had been placed on medication but the swelling still persist. Stated as, he really almost died. the patient's penis swelled to the size of a liter bottle and his scrotum swelled to the size of a cabbage.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Hypersensitivity, Poisoning
Clinical narrative: Stated that he was severely intoxicated; Could not breath; Dizzy; Severe allergic reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 03May2021 (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: POISONING (medically significant), outcome "unknown", described as "Stated that he was severely intoxicated"; DYSPNOEA (non-serious), outcome "unknown", described as "Could not breath"; DIZZINESS (non-serious), outcome "unknown", described as "Dizzy"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Severe allergic reaction".  Additional Context: Caller stated that he was wondering, had a spat with the doctor's office and wanted to know what would be the treatment for severe allergic reaction. Stated that he had one in the office. Stated that she had the vaccine and had a visit and got the shot while he was in there. Stated that he was severely intoxicated, could not breathe and dizzy. Wanted to know if they should have put him on oxygen or anything. Wanted to know why they left him sitting in the hall for 30 minutes after saying they could perfectly handle any situation. Wanted to know the immediate response for someone having a severe allergic reaction. Is for the Pfizer Covid 19. Stated that this is his first dose. Stated that once he reported it that someone came out and basically held his hand and did not do anything. Stated that it has been almost a year and that he cannot get any answers from them and wanted to get some facts from Pfizer. Caller rambling on; unable to clarify details. Stated that he had the shot on 03May2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blindness, Limb discomfort
Clinical narrative: Lost eyesight in left eye; Leg weakness; have no balance and she cannot walk in a straight line; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administration date 15Sep2021 (Lot number: FC3182) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot Number / Expiry Date: FC3181/unknown, Route, Anatomical Location: right arm), administration date: 25Aug2021, when the patient was 61 years old, for Covid-19 Immunization.  The following information was reported: BLINDNESS (medically significant) with onset 01Oct2021, outcome "not recovered", described as "Lost eyesight in left eye"; LIMB DISCOMFORT (non-serious) with onset Sep2021, outcome "not recovered", described as "Leg weakness"; BALANCE DISORDER (non-serious) with onset Sep2021, outcome "not recovered", described as "have no balance and she cannot walk in a straight line". Patient stated that the events occurred after her second vaccine and she had the booster at a later time. Patient did not require a visit Emergency Room or Physician Office. The patient did not receive any other vaccines within four weeks prior to the vaccination and no AE(s) following prior vaccinations.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Fibrin D dimer, Peripheral swelling, Thrombosis
Clinical narrative: Potential blood clotting from skewed d-dimer test; Severe swollen arm; Asthma exacerbation; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Mar2022 10:00 (Lot number: FJ2614) at the age of 28 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination patient was diagnosed with COVID-19. Concomitant medication(s) included: EFFEXOR; ALBUTEROL [SALBUTAMOL]; ALLEGRA D. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fk9895, Location of injection: Arm Right, Vaccine Administration Time: 10:00 AM), administration date: 15Feb2022, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 09Mar2022 12:00, outcome "not recovered", described as "Potential blood clotting from skewed d-dimer test"; PERIPHERAL SWELLING (non-serious) with onset 09Mar2022 12:00, outcome "not recovered", described as "Severe swollen arm"; ASTHMA (non-serious) with onset 09Mar2022 12:00, outcome "not recovered", described as "Asthma exacerbation". The events "potential blood clotting from skewed d-dimer test", "severe swollen arm" and "asthma exacerbation" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: fibrin d dimer: (09Mar2022) potential blood clotting, notes: potential blood clotting from skewed d-dimer test. Therapeutic measures were taken as a result of thrombosis, peripheral swelling, asthma with anticoagulants, oral steroid, inhaled steroid.  Clinical course: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was albuterol inhaler. Since the vaccination the patient been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, COVID-19, Drug ineffective
Clinical narrative: a little of a month later we both got the Covid virus/Drug Ineffective; a little of a month later we both got the Covid virus; My joints are all aching; have no energy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "a little of a month later we both got the Covid virus/Drug Ineffective"; COVID-19 (medically significant), outcome "unknown", described as "a little of a month later we both got the Covid virus"; ARTHRALGIA (non-serious) with onset 2021, outcome "unknown", described as "My joints are all aching"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "have no energy". As a retired patient and wife took the 2 Pfizer shots thinking they were safe. Unfortunately, a little of a month later they both got the Covid virus. They talked to others who had gotten the Pfizer vaccines and they also got something with the same problems. For over a year now his joints were all aching and he had no energy. He had seen many doctors, but nobody seems to have the answer. What he thought was that Pfizer put something in the vaccines that affects older people. He thought we were working trying to kill seniors, so they have more money, because the pensions are gone, to sponsor insane money give away to other countries. What would happen was people will have another situation and kill every elected person and people that helped them. His life was on the line and it is too bad I did not live near. He almost gave his life and he would love to put bullets into Traitors. By killing people and others we not only save our country, we will protect the World. Maybe our first act was to talk to your creators of the vaccines to find out what they put in the vaccines and what can be done to correct it. If they did it on purpose they will be arrested and tried for Mass Murder World wide.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Illness, Immune system disorder
Clinical narrative: their immune system was off track; get sick all the time; their immune system was off track; get sick all the time; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a sales representative.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, (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: IMMUNE SYSTEM DISORDER (non-serious), ILLNESS (non-serious), outcome "unknown" and all described as "their immune system was off track; get sick all the time".  Additional information: The reporter was speaking to a doctor and the doctor made a statement in regard to the COVID vaccine. The doctor didn't specify if she was referring to Pfizer's Johnson and Johnson's or Moderna's vaccine. The doctor just made a brief comment. Again, The reporter states she does not know which manufacturer the reporter was referring to. The doctor mentioned the COVID vaccine and said she had three patients who had a bad immune system, she finally got the patients on track and states after the patients got their shot, their immune system was off track. The reporter asked the doctor if she reported this in VAERS or with Pfizer if it's Pfizer's vaccine, and the doctor didn't respond. The reporter asked the doctor which of the three manufacturers she was referring to and the doctor didn't clarify between the three manufacturers. The doctor only said the patients got off track and get sick all the time. The reporter mentions the patients did have comorbidities, but the reporter did not ask for any patient details. She believes that is a HIPAA violation.  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-202200402704 Same product and event, different patient;US-PFIZER INC-202200402705 Same product and event, different patient
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Reflux gastritis, SARS-CoV-2 test, Urticaria
Clinical narrative: After the 3rd injection I woke up with hives in my hands then next morning. The hives have become worse over time.; The reflux has become extreme and am now going in for endoscope.; 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 male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 21Dec2021 16:15 (Lot number: FJ8762) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies:Oats, mustard, Celery" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7534, Location of injection: Arm Left, Vaccine Administration Time: 07:45 AM), administration date: 24Mar2021, when the patient was 37 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0161 (Maybe a JW0161), Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 14Apr2021, when the patient was 37 years old, for COVID-19 Immunization. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient didn't diagnosed with COVID-19. The following information was reported: URTICARIA (disability, life threatening) with onset 22Dec2021 04:45, outcome "not recovered", described as "After the 3rd injection I woke up with hives in my hands then next morning. The hives have become worse over time." . The patient  have been diagnosed with Urticaria and am now on several treatments to calm it down; REFLUX GASTRITIS (disability, life threatening) with onset 22Dec2021 04:45, outcome "not recovered", described as "The reflux has become extreme and am now going in for endoscope.". The next treatment option is Xolair treatments as current treatment is not contained.  It took 8 weeks to get into an allergist at the beginning of all of this. The events "after the 3rd injection i woke up with hives in my hands then next morning. the hives have become worse over time." and "the reflux has become extreme and am now going in for endoscope." were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jan2022) negative, notes: covid test type post vaccination=Nasal Swab.  Therapeutic measures were taken as a result of urticaria, reflux gastritis: Steroid for 2 weeks, quad dosing of H1 and H2's. No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Acute kidney injury, Respiratory disorder, Septic shock
Clinical narrative: Septic shock; AKI; Respiratory Destress; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 19Mar2021 (Lot number: ER8737) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing); "allergies" (unspecified if ongoing), notes: Known allergies: Yes. No COVID prior vaccination. The patient took concomitant medications. No other vaccine in four weeks. There are other medications in two weeks. The following information was reported: SEPTIC SHOCK (hospitalization, medically significant, life threatening) with onset 20Mar2021, outcome "recovered with sequelae", described as "Septic shock"; ACUTE KIDNEY INJURY (hospitalization, medically significant, life threatening) with onset 20Mar2021, outcome "recovered with sequelae", described as "AKI"; RESPIRATORY DISORDER (hospitalization, life threatening) with onset 20Mar2021, outcome "recovered with sequelae", described as "Respiratory Destress". The patient was hospitalized for septic shock, acute kidney injury, respiratory disorder (hospitalization duration: 28 day(s)). Therapeutic measures were taken as a result of septic shock, acute kidney injury, respiratory disorder, reported as many treatment. No COVID tested post vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Inappropriate schedule of product administration, SARS-CoV-2 test negative
Clinical narrative: Stroke; 1st on 29Nov2021 / 2nd on 26Feb2022; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Feb2022 14:00 (Lot number: FK9895) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Shellfish" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fg3527, Location of injection: Arm Left), administration date: 29Nov2021, when the patient was 51 years old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization, disability, life threatening) with onset 12Mar2022 13:45, outcome "unknown", described as "Stroke"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 26Feb2022 14:00, outcome "unknown", described as "1st on 29Nov2021 / 2nd on 26Feb2022". The event "stroke" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test negative: (12Mar2022) negative. Therapeutic measures were taken as a result of cerebrovascular accident, inappropriate schedule of product administration.  Addition information: The patient was not received other vaccine in four weeks. Stroke 14 days after receiving covid vaccination in otherwise healthy adult without any other medical conditions. Physically active and healthy individual without any medical concerns prior.; 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 the reported event CEREBROVASCULAR ACCIDENT  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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 07Oct2021 (Lot number: FF2589) at the age of 64 years as dose 3 (booster), single, administration date 19Mar2021 (Lot number: EN6208) as dose 2, single and administration date 26Feb2021 (Lot number: EN6202) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "High BP" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM HCL, start date: Feb2020, stop date: 12Mar2022; ATORVASTATIN, start date: Sep2021, stop date: 08Mar2022; CENTRUM SILVER +50, start date: Sep2017, stop date: 08Mar2022; VIACTIV [CALCIUM], start date: Jan2019, stop date: 08Mar2022; WIXELA INHUB, start date: Feb2014, stop date: Mar2022; ALBUTEROL [SALBUTAMOL], start date: 01Mar2022, stop date: 12Mar2022. Past drug history included: Prednisone, reaction(s): "known allergies: Prednisone", notes: known allergies: Prednisone. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Product: COVID 19 Treatment: Paxlovid". Therapeutic measures were taken as a result of suspected Covid-19. Clinical comment: The COVID-19 treatment included Paxlovid from 09Mar2022 to Mar2022 (lot number: FW6344). No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.