chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Ear pruritus, Erythema, Feeling hot, Skin fissures
Clinical narrative: right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report from a contactable consumer (Patient) via Reporting system.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single, and via an unspecified route of administration on an unspecified date (Lot number: unknown) as dose 1, single for COVID-19 immunization. Medical History included auto-immune disorder. No concomitant medication was reported. It was reported that, about 10 (or 12 days as per reporter) days after receiving the first dose of the vaccine had right ear itching and burning and then the skin started to crack. These side effects lasted about 5 days. About a week after receiving the second dose reports her other ear was burning, red, felt hot and started cracking again. Getting a rash on skin after receiving the second dose, patient thinks the second dose was on or around 30Jun2021. Patient stated that same side effect happened to her sons wifes father and grandfather, that 4 different people from 4 different states have all experienced the exact same side effect after receiving the Pfizer COVID-19 vaccine. She also reported that her 91-year-old mother "hasnt felt right and has had no energy" since she received the Pfizer COVID-19 vaccine in March or April and would like to know if this was something that was being reported specifically with older people. Reporter stated that her mother was usually very active, and now she lays on the couch "50% of the time. The reporter stated that her mom has just been lethargic since her vaccine [Pfizer COVID-19] and something is just not right. Her blood tests are normal and no UTI (urinary tract infection) but she refuses to go back to the doctor, and asking what should she do about this. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear pruritus, Erythema, Feeling hot, Skin fissures
Clinical narrative: right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report from a contactable consumer or other non HCP. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single and received dose 2 via an unspecified route of administration on an unspecified date BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported) as dose 2, single both for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that after receiving the first dose of the vaccine on an unspecified date she had right ear itching and burning and then the skin started to crack. These side effects lasted about 5 days. About a week after receiving the second dose she reports her other ear was burning, red, felt hot and started cracking again. She reported to DSU that this same side effect happened to her son's wife's father and grandfather, both received the Pfizer COVID-19 vaccine per reporter, and she would like to know if this side effect was something new or if this was something normal. Sister had the same side effect as well. The caller stated that 4 different people from 4 different states have all experienced the exact same side effect after receiving the Pfizer COVID-19 vaccine. The outcome of all events was unknown.  Follow-up attempts are needed, Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Ear pruritus, Erythema, Feeling hot, Skin fissures
Clinical narrative: right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; right ear itching and burning and then the skin started to crack; her other ear was burning, red, felt hot and started cracking again; her other ear was burning, red, felt hot and started cracking again; This is a spontaneous report from a Pfizer-Sponsored Program COVAX US Support. A contactable consumer reported for a patient.  A female patient with unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 30Jun2021 as DOSE 2, SINGLE for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on unknown date as DOSE 1, SINGLE for COVID-19 immunization. Medical history included autoimmune disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date about 10 (or 12 days per caller) days after receiving the first dose of the vaccine, the patient experienced right ear itching and burning and then the skin started to crack which lasted for 5 days, after a week of vaccination another ear was burning, red, felt hot and started cracking again. Patient also experienced a rash on her skin after receiving the second dose. She reported to DSU that this same side effect happened to her son's wife's father and grandfather, both received the Pfizer COVID-19 vaccine per reporter, and she would like to know if this side effect is "something new or if this is something normal." Sister had the same side effect as well. The caller states that 4 different people from 4 different states have all experienced the exact same side effect after receiving the Pfizer COVID-19 vaccine. All events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Feeling abnormal, Lethargy
Clinical narrative: hasn't felt right and has had no energy; hasn't felt right and has had no energy; lays on the couch 50% of the time/lethargic; This is a spontaneous report from contactable consumer (patients daughter) via a Pfizer sponsored program COVAX US support. A 91-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported) via unspecified route of administration and unspecified date in 2021 (at the age of 91 years old) as dose number unknown, single for covid-19 immunisation. Medical history was reported as none. Patient was not pregnant. There were no concomitant medications. It was reported that patient had not felt right and has had no energy since she received the Pfizer COVID-19 vaccine in March or April and the caller would like to know if this was something that was being reported specifically with older people. The reporter stated that patient was usually very active, like the energizer bunny and she laid on the couch 50% of the time as it was the total opposite of her and was not like her. The reporter stated that patient had just been lethargic since her vaccine and something was just not right. Her blood tests were normal on an unspecified date in 2021 and no UTI (urinary tract infection) but she refused to go back to the doctor. The patient was asking what to do about this. The reporter stated that it may be coincidence but she got the Pfizer vaccine and hasn't felt right and has had no energy since. Outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Biopsy, Pericarditis
Clinical narrative: Pericarditis; a-fib; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269) via an unspecified route of administration in the left arm on 09Feb2021 as single dose for Covid-19 immunization. Medical history included chronic lymphocytic leukemia, thyroid cancer, right lobe was removed. Concomitant medications included ibrutinib (IMBRUVICA) for chronic lymphocytic leukaemia, levothyroxine sodium (LEVOXYL) for thyroid cancer, vitamins. The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283) in the left arm on 19Jan2021 for Covid-19 immunization, with 0.3mg on the card. On 08Jun2021, the patient developed atrial fibrillation and pericarditis. 4 months after the second  COVID 19 vaccine, she developed pericarditis. Like the male guys get from the vaccine. She was just curious. The patient had heard that these can be side effects for young boys. She wanted to know if there's a report on atrial fibrillation and pericarditis for people belonging to her age group. At first they thought she had A-fib from one of her other pills, but they also had to pull 16oz bloody fluid off of her heart. They put her on pills for the A-fib. They think the A-Fib could be related to her other pill, but they couldn't figure out the fluid. The biopsy didn't answer the question. She was not on the medication that caused the A-fib anymore. That medication was Imbruvica for her CLL, Chronic lymphocytic leukemia. On that medication 5% of people can get A-fib. She was on it 2.5 years. Her Imbruvica was 140mg. She was no longer on it. She wanted to donate the ones she didn't use, but they wouldn't let her. Outcome of the event pericarditis was recovered in 2021, of the event a-fib was unknown.    Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blindness unilateral, Fatigue, Gait disturbance, Headache, Hypersomnia
Clinical narrative: I just went blind in my right eye for about 30 or 40 minutes; Headache; Fatigue; I was sleeping 12-14 hours/I slept for long time; I cannot reach my legs; I could not hardly walk; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. The patient stated had this Pfizer shot in Apr2021. Patient took the second Pfizer, the first shot patient had no problem. Patient got second shot, the same day the very same day patient just started getting headaches, started getting fatigue and for about 8-10 days patient was sleeping 12-14 hours. Patient cannot reach his/her legs, patient cannot walk and then patient went blind in his/her right eye. Patient thought that he/she had had physicals before the shot everything was excellent on his/her physical. Patient knew when he/she took the shot, he/she was like Oh man, what was going on? Patient meant it just gave him/her fatigue because of that patient could not hardly walk, patient couldn't reach legs, patient slept for long time and then patient just went blind in right eye for about 30 or 40 minutes. Outcome of events was unknown.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: I just went blind in my right eye for about 30 or 40 minutes; Headache; Fatigue; I was sleeping 12-14 hours/I slept for long time; I cannot reach my legs; I could not hardly walk; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not provided. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Apr2021 as single dose for COVID-19 immunization. The patient stated had this Pfizer shot in Apr2021. Patient took the second Pfizer, the first shot patient had no problem. Patient got second shot, the same day the very same day patient just started getting headaches, started getting fatigue and for about 8-10 days patient was sleeping 12-14 hours. Patient cannot reach his/her legs, patient cannot walk and then patient went blind in his/her right eye. Patient thought that he/she had had physicals before the shot everything was excellent on his/her physical. Patient knew when he/she took the shot, he/she was like Oh man, what was going on? Patient meant it just gave him/her fatigue because of that patient could not hardly walk, patient couldn't reach legs, patient slept for long time and then patient just went blind in right eye for about 30 or 40 minutes. Outcome of events was unknown.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Gait disturbance, Interchange of vaccine products, Muscular weakness
Clinical narrative: received both the Moderna and Pfizer vaccine 18 days apart; received both the Moderna and Pfizer vaccine 18 days apart; more pronounced swelling in legs; weakness in her lower extremities; very weak; very difficult for her to walk; legs are really sore; really painful and tender in certain areas when touched; really painful and tender in certain areas when touched; more of the confusion; This is a spontaneous report from a non-contactable consumer reported for a female patient (reporter's mother). A 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 28Jun2021 (age at vaccination was unknown) as dose 2 (initial Pfizer dose), single for COVID-19 immunization. The patient received COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Jun2021 (age at vaccination was unknown) dose 1, single for COVID-19 immunization. Prior to vaccination, the patient had pneumonia and shortness of breath. She went into the hospital on 03Jun2021, was admitted on 04Jun2021, and discharged on 17Jun2021. She was given antibiotics during this time. Prior medical history included high blood pressure, asthma, heart problems, dementia, and swelling in legs. Concomitant medication included carvedilol, chlorothiazide, tiotropium bromide monohydrate (SPIRIVA), albuterol sulfate, pantoprazole, allopurinol, losartan and memantine HCL all taken for an unspecified indication. The caller stated there were other medications, but she did not have it. The caller reported an adverse event her mother experienced. She was notified on Friday that her mother received both the Moderna and Pfizer vaccine 18 days apart. The patient received the Moderna vaccine as a first dose on 10Jun2021 at the rehabilitation facility and the Pfizer vaccine on 28Jun2021. Since vaccination, patient had the following symptoms: more pronounced swelling in legs, weakness in her lower extremities, very weak, very difficult for her to walk, legs are really sore, really painful and tender in certain areas when touched, and more of the confusion. The patient did not receive any medications for these side effects. The caller asked if her mother's side effects were common. The caller asked if her mother was fully vaccinated as she received two different brands 18 days apart. She asked if it was commonly reported for patients to receive two different brands. The patient was not hospitalized for the reported events since the vaccination. No treatment was received for the adverse events. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: received both the Moderna and Pfizer vaccine 18 days apart; received both the Moderna and Pfizer vaccine 18 days apart; more pronounced swelling in legs; weakness in her lower extremities; very weak; very difficult for her to walk; legs are really sore; really painful and tender in certain areas when touched; really painful and tender in certain areas when touched; more of the confusion; This is a spontaneous report from a non-contactable consumer reported for a female patient (reporter's mother). A 84-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 28Jun2021 (age at vaccination was unknown) as dose 2 (initial Pfizer dose), single for COVID-19 immunization. The patient received COVID-19 vaccine MRNA (MRNA 1273) (MODERNA COVID-19 VACCINE, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 10Jun2021 (age at vaccination was unknown) dose 1, single for COVID-19 immunization. Prior to vaccination, the patient had pneumonia and shortness of breath. She went into the hospital on 03Jun2021, was admitted on 04Jun2021, and discharged on 17Jun2021. She was given antibiotics during this time. Prior medical history included high blood pressure, asthma, heart problems, dementia, and swelling in legs. Concomitant medication included carvedilol, chlorothiazide, tiotropium bromide monohydrate (SPIRIVA), albuterol sulfate, pantoprazole, allopurinol, losartan and memantine HCL all taken for an unspecified indication. The caller stated there were other medications, but she did not have it. The caller reported an adverse event her mother experienced. She was notified on Friday that her mother received both the Moderna and Pfizer vaccine 18 days apart. The patient received the Moderna vaccine as a first dose on 10Jun2021 at the rehabilitation facility and the Pfizer vaccine on 28Jun2021. Since vaccination, patient had the following symptoms: more pronounced swelling in legs, weakness in her lower extremities, very weak, very difficult for her to walk, legs are really sore, really painful and tender in certain areas when touched, and more of the confusion. The patient did not receive any medications for these side effects. The caller asked if her mother's side effects were common. The caller asked if her mother was fully vaccinated as she received two different brands 18 days apart. She asked if it was commonly reported for patients to receive two different brands. The patient was not hospitalized for the reported events since the vaccination. No treatment was received for the adverse events. The outcome of the events was unknown.  Information on batch/lot number has been requested.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Spondylitis
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). An 82 years old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) at age of 81 years old (as reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation.  Medical history included Arthritis and cholesterol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient's concomitant medications were yes but unspecified. The patient experienced spinal inflammation on 03Jul2021. Event resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient was hospitalized and received treatment. The patient underwent lab tests and procedures which included COVID test nasal swab: negative on 03Jul2021. The outcome was not recovered.    The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Her parents contracted COVID-19 badly; her parents contracted COVID-19 badly; This is a spontaneous report from a Pfizer sponsored program COVAX Support via a contactable consumer. This consumer reported similar events for two patients (her parents). This is the second of two reports. A male patient (reporter's father) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as singe dose, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included hospitalized for 5-10 days in mid Feb2021. The patient had to receive antibiotics as well as plasma during treatment process. The patient's concomitant medications were not reported. The reporter stated the patient was, as of about 3 weeks ago, fully vaccinated with the Pfizer vaccine. She (reporter) was trying to be cautious since her parents contracted COVID-19 badly. The outcome of the event was unknown.  The lot number for the vaccine bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021887349 same reporter/drug/AE, different patient
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Urticaria
Clinical narrative: Hives; didn't feel well; she was feeling really tired; This is a spontaneous report from a Pfizer sponsored program via contactable consumer (patient). A 35-years-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 12Mar2021 (Time the Vaccination Was Given: thinks around noon) (Batch/Lot number was not reported) as DOSE 1, SINGLE to prevent from getting COVID. Patient Age at Time of Vaccination was 35 years. Medical history was none. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced hives on 25Mar2021, didn't feel well and she was feeling really tired on 16Mar2021. Reporter was calling because she said she got the first dose of Pfizer COVID 19 vaccine on 12Mar2021, doesn't have a schedule date for second dose, she was not done with the second dose, because she said she had hives and didn't feel well for 12 days right after the first dose, and she wanted to know if she will take the second dose, or if she needed to take the first dose again. Stated she didn't get any sort of anything until 4 days after she received the vaccine. The hives lasted four days. She has recovered completely. Didn't felt well started on 16Mar2021, lasted for like 12 days, states she was feeling really tired. She had recovered completely. When dose was queried, Reporter states she doesn't know, she sees her boyfriend's vaccine card and his card doesn't show dose. The events result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care was not reported. Lab tests was none reported. The outcome of event urticaria and malaise was unknown. The event fatigue recovered on unspecified date.  Information on Lot/Batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Heat illness, Skin fissures
Clinical narrative: on the other ear, she had burning, it was bright red and heat and the same thing with cracking; on the other ear, she had burning, it was bright red and heat and the same thing with cracking; on the other ear, she had burning, it was bright red and heat and the same thing with cracking; on the other ear, she had burning, it was bright red and heat and the same thing with cracking; This is a spontaneous report from a contactable consumer or other non-hcp. A male (for reporter sons wife's grandfather) patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 on an unspecified date for COVID-19 immunization; she took the vaccine and is having side effects of burning on top of her ear lobes and also after a week it started cracking and itching very bad. Agent relays that the daughter in law and father-in-law and grandfather are having the same side effect. Agent relays that the caller wanted to report it and wanted to know if this was new or if this is normal. It was stated it was the Pfizer vaccine. Caller states the 1st time this happened it was about 10 days after the 1st vaccine and it was the weirdest thing, the top of her, she believes, right ear at first it was itching and burning and then started to crack and that lasted 5 days. States she applied Neosporin and Vaseline on it and didn't think much of it. She stated that after the 2nd shot about 1 week in, on the other ear, she had burning, it was bright red and heat and the same thing with cracking. Caller states she thought it was sunburn, but she wears a hat, and her ears are covered. On an unspecified date the patient experienced on the other ear, she had burning, it was bright red and heat and the same thing with cracking. The clinical outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: Nauseous; legs became very achy; Chills; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number and Expiry Date: unknown), via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient Concomitant medications were not reported. On 12Jul2021, the patient experienced Chills, Nauseous, legs became very achy. It was reported that "I took the first shot yesterday and at about midnight last night my legs became very achy and I have chills but no fever and now today I felt a little bit nauseous so I was just wondering I thought that all was supposed to happen on the second shot not on the first shot." The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: passed away; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. The reporter felt people will get healthier with their own immune systems and that Covid was a cover up. She knew people that have died after getting vaccinated and the CDC had changed their guidelines many times now. She read if 50% were vaccinated and the other half combined with the virus but now that had changed to 70%. The body had been proven for antibodies to work and it's no different than the flu shot. The reporter had a 16 year old girl come to her door today letting her know that her neighbor passed away and she asked the 16-year-old if she could hug her and the little girl said "yes I've been vaccinated". It was unknown if autopsy was performed. Outcome of the event was fatal.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Neck pain, Vaccination site hypoaesthesia
Clinical narrative: had arm pain at injection site; her arm is numb to her hand on injection site side which is the left side.; From the injection site up to her neck is hurting; feels weak and tired; feels weak and tired; she can't feel her hand up to her fingers; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0198, Expiration Date: not reported) via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization (at the age 16-year-old). The patient's medical history and concomitant medications were not reported. The patient experienced had arm pain at injection site, her arm was numb to her hand on injection site side which was the left side, from the injection site up to her neck was hurting, not horrible pain just aching, feels weak and tired, feels weak and tired, she can't feel her hand up to her fingers on an unspecified date in Jul2021. It was reported that, it was patient's first vaccine and getting the second dose on 02Aug2021. The outcome of the events was unknown.  Information about lot/batch number is requested.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had arm pain at injection site; her arm is numb to her hand on injection site side which is the left side.; From the injection site up to her neck is hurting; feels weak and tired; feels weak and tired; she can't feel her hand up to her fingers; This is a spontaneous report from a contactable consumer (patient's mother). A 16-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EW0198, Expiration Date: not reported) via an unspecified route of administration on 12Jul2021 as dose 1, single for COVID-19 immunization (at the age 16-year-old). The patient's medical history and concomitant medications were not reported. The patient experienced had arm pain at injection site, her arm was numb to her hand on injection site side which was the left side, from the injection site up to her neck was hurting, not horrible pain just aching, feels weak and tired, feels weak and tired, she can't feel her hand up to her fingers on an unspecified date in Jul2021. It was reported that, it was patient's first vaccine and getting the second dose on 02Aug2021. The outcome of the events was unknown.  Information about lot/batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Lethargy, Movement disorder, Nausea
Clinical narrative: This is a spontaneous report from a contactable physician reported for male (patient). A male patient of an unspecified age received bnt162b2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: unknown) via an unspecified route of administration on an unspecified date as dose 1 single for covid-19 immunisation. Caller was a physician calling about the Covid 19 series of shots, the first 2. He called about the vaccine in general and mentioned a patient. This was the report for that one patient. Patient was unknown, caller stated it was a report he heard on a radio talk show. Caller stated it was even reported yesterday on the talk show about the shot series in LA, the host on the talk show who didn't represent anyone, he was a lawyer on the show for 3-4 years. Caller states he found out when the host had the second shot, on an unspecified date, he couldn't move for almost a whole day, he was lethargic, sick, nauseous and had a whole bunch of very bad effects. Caller stated when the reporter on radio couldn't move after the second shot and stayed in bed all day. Caller stated both were not talking about that. Outcome of the event was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Nerve injury, Neuralgia
Clinical narrative: having problems with the nerves they were in my hips and in legs in my knees; nerve pains; it was my crippling where I couldn't stand; This is a spontaneous report from a non-contactable consumer or other non hcp (patient herself). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0179, Expiry date: Unknown), via an unspecified route of administration on an 06May2021 at the age of (65-years-old) as dose number unknown, single for COVID-19 immunisation. The patient medical history included he had back surgery in January of 2010 and he had little nerve damage after that, but it wasn't severe. The patient's concomitant medications were not reported. It was reported that he got that injection he guess about may be two months ago, second day after receiving the vaccine, he started problems with the nerves they were in his hips and in legs in his knees and he had previous problem with nerves but it was not anything that the medicine they gave me that could not handle (Not clear and not further clarified) but after he got the shot of the vaccine, he started getting nerve pains where it was his crippling where he could not stand and then he got the second one it got (unspecified). The outcome of the event was unknown.  No follow-up attempts are Possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Tuberculin test
Clinical narrative: Caller wanted to know if he got the right medication since the second dose "did not hurt"?/Caller mentioned he "did not have any response; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 72-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Right on 13Jul2021 as DOSE 2, SINGLE for covid-19 immunization. Previously the patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of ad-ministration, administered in Arm Right on an unknown date as DOSE 1, SINGLE for covid-19 immunization. Medical history included patient fall on an unknown date, limb injury from an unknown date. The patient's concomitant medications were not reported. On 13Jul2021, the patient wanted to know if he got the right medication since the second dose did not hurt caller mentioned he did not have any response. Patient also expressed concern if the dose was properly administered (feeling abnormal). On an unknown date in 2020, the patient underwent lab tests which included tuberculin test and result were unknown. The outcome of the event was reported as unknown at the time of report.  No follow up attempt was possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: mild urticaria covering whole body; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration on 07Jul2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history included hyperlipidaemia. She is not pregnant at time of vaccination. Concomitant medications included atorvastatin calcium; and esomeprazole sodium (NEXIUM [ESOMEPRAZOLE SODIUM]). The patient experienced mild urticaria covering whole body on 09Jul2021 with outcome of recovering. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The adverse event result in Doctor or other healthcare professional office/clinic visit. Treatment hydoxizine and famotidine were received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare, Rash
Clinical narrative: granuloma annulare (annular elastolytic granuloma-type) RASH as a possible side effect from the vaccine; granuloma annulare (annular elastolytic granuloma-type) RASH as a possible side effect from the vaccine; This is a spontaneous report received from a contactable other HCP. This Other HCP reported for a 78-year-old female (patient) that: A 78-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular on 15Mar2021 (at the age of 78-year-old) as single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included hx of total nephrectomy and Acid Reflux from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. The patient's concomitant medications were not reported. The patient previously took MACROBID [clarithromycin] and experienced drug Allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On unspecified date in Apr2021, the patient experienced granuloma annular (annular elastolysis granuloma-type) rash as a possible side effect from the vaccine. It was unknown that, since vaccination patient tested for COVID-19. Patient was not hospitalised for the events. Event resulted to visit Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events with topical steroid and oral antibiotic. The outcome of the events was reported as unknown.  Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Epstein-Barr virus infection, Haemophagocytic lymphohistiocytosis, Lyme disease
Clinical narrative: HLH; chronic lyme disease; an active EVB infection; This is a spontaneous report from a contactable consumer. This contactable consumer reported for a female patient of unspecified age (reporter's wife) that who received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration at single dose for COVID-19 immunization, first dose on an unspecified date and second dose on 19Mar2021. Medical history was not reported. Concomitant medications were not reported. The patient was currently in the ICU with a diagnosis of HLH. They noticed something going in in her bloodwork in Apr2021. She had chronic lyme disease which was an active EVB infection. There is a study in the public library for NIH, about HLH occurring in people with an active EVB infection. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: The fingers on my right hand began tingling about four hours after the shot and are still tingling. My right foot/toes also started tingling about a week ago and are still doing so.; This is a spontaneous report from a contactable consumer. This 33-year-old female consumer (patient) reported for herself.  A 33-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry Date was not reported), via an unspecified route of administration, administered in Arm Left at the age of 33-year-old on 24Jun2021 16:30 as single dose for covid-19 immunization. Medical history was reported as none. There were no concomitant medications. Patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Patient was not pregnant at the time of vaccination. On 24Jun2021 20:30 the patient experienced the fingers on my right hand began tingling about four hours after the shot and are still tingling, my right foot/toes also started tingling about a week ago and are still doing so. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for adverse event. The clinical outcome of event was not recovered.  Information on the Batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives on face; swelling of the throat; swallowing was difficult; This is a spontaneous report from a non-contactable consumer (patient). An adult non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 18May2021 as dose 2, single for covid-19 immunisation in hospital. Medical history included prior to vaccination, the patient was diagnosed with covid-19, and known allergies: antihistamines. Previously, the patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number was not reported), via an unspecified route of administration in arm left on 26Apr2021 as single for covid-19 immunisation. 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 Clindimicen. The patient stated that hives on face started 24 hours later (19May2021) after second shot, increased in intensity over 2 days with swelling of the throat. On 19May2021, breathing was somewhat normal, but swallowing was difficult. Went away 4 days after second shot. The events resulted in emergency room/department or urgent care. The patient lab test included covid-19 test was positive. Since the vaccination, the patient was not tested for COVID-19. Events considered as non-serious. No treatment medication was received for the adverse events. The outcome of the events was resolved on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Drug ineffective, Fatigue
Clinical narrative: contracted the Delta variant; contracted the Delta variant; sick/a general feeling of illness; fever; aches; head congestion; fatigue; brain fog; lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both dose via unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that had been double vaccinated early in Jan2021 with Pfizer and contracted the Delta variant from someone who also had the Pfizer. The person gave it to the patient. All of them got very sick with fever, aches, head congestion, fatigue, brain fog and a general feeling of illness. The patient had now lost taste and smell. This had been ongoing for 6 days. Outcome of the events was unknown.   Information about Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness, Pain, Pyrexia, Upper respiratory tract congestion
Clinical narrative: contracted the Delta variant; contracted the Delta variant; sick/a general feeling of illness; fever; aches; head congestion; fatigue; brain fog; lost taste and smell; lost taste and smell; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), both dose via unspecified route of administration in Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient reported that had been double vaccinated early in Jan2021 with Pfizer and contracted the Delta variant from someone who also had the Pfizer. The person gave it to the patient. All of them got very sick with fever, aches, head congestion, fatigue, brain fog and a general feeling of illness. The patient had now lost taste and smell. This had been ongoing for 6 days. Outcome of the events was unknown.   Information about Lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: Fast Heartbeat; Have difficulty with my chest pain and irritation; Difficulty breathing; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 26 year old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No any prior vaccination and no any family event history. The patient experienced increased heartbeat rate, had difficulty with chest pain and irritation, difficulty breathing on 10Jul2021. Patient stated she just had first Pfizer shot (Covid-19 Vaccine) she had very fast heartbeat few hours later and yesterday she felt like she have almost difficulty with my chest pain and irritation may be. she was not quite sure. Last night she had difficulty with her chest pain and difficulty in breathing. When probed if still having the problem (event) patient stated Last night she experienced again. Therapeutic measures were taken as a result of these events with one pill of Advil. The patient is scheduled for the second shot of covid-19 vaccination on 31Jul2021. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.