chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Product administration error, X-ray
Clinical narrative: still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown.  The information on the Batch/Lot number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: still a part of her forehead that feels like a live nerve; upper back started hurting/back was very tender and sensitive around the spine area; arm was a little sore; pharmacist had some left over in the vial and gave her that; has post traumatic neuralgia" related to her shingles; Shingles; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on 29Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from two contactable consumers via medical information team. A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date: unknown), via an unspecified route of administration on 28Jan2021 at a single dose for COVID-19 immunisation. Medical history included dental work/specifying a tooth being pulled and an implant (an antibiotic (Amoxicillin)) was used and shingles (7 years ago). The patient's concomitant medications were not reported. It was reported that Pharmacist had some left over in the vial and gave the patient on 28Jan2021. Patient wanted to make sure it was ok. Patient stated "she got shingles on her face, 7 years ago, and had recent dental work done," specifying a tooth being pulled and an implant. She stated she received the first dose of the COVID-19 vaccine last Thursday evening (28Jan2021). On 29Jan2021 and 30Jan2021 (friday and saturday), she mentioned, her "arm was a little sore". On 30Jan2021 and 31Jan2021 (saturday evening and sunday morning) she said her "upper back started hurting" and thought "maybe [she] sat on the couch for too long". On 31Jan2021 (Sunday evening), she added her "back was very tender and sensitive around the spine area" therefore, she "took some tylenol and used a heating pad thinking [she] pulled a muscle". On 01Feb2021 (By Monday) she said her "the back and front were very sensitive" to the point where: when she "touched [her] skin it felt like [she] was touching some live nerves". She explained seeing a physician assistant who "couldn't figure out what was going on" and since it seemed to be getting worst, she thought she could possibly have Shingles. She continued saying she then "went to see an orthopedic doctor who took x-rays and said he doesn't see anything, and it may be the beginning phases of Shingles". She mentioned she has an appointment with her internist today at 4:20. She later mentioned her "brother, who is a doctor, thinks [she] has post traumatic neuralgia" related to her shingles on an unspecified date in Jan2021. She then added there is "still a part of her forehead that feels like a live nerve" to touch, since having Shingles, on 01Feb2021. The outcome of the events was unknown. The outcome of the events was unknown.  The information on the Batch/Lot number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pruritus, Pyrexia
Clinical narrative: Itching; fever; chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female nurse received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 25Jan2021 at 08:15 AM (at the age of 56 years old) as a single dose in the left arm for COVID-19 immunization at hospital facility. Relevant medical history included hypothyroid and had BNT162B2 vaccine dose 1 on unknown date, lot unknown, administered at 10:45 AM on right arm. The patient had known allergies: Ibuprofen. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine sodium  (SYNTHROID), sertraline hydrochloride (ZOLOFT), liothyronine sodium (CYTOMEL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received levothyroxine, sertraline hydrochloride, liothyronine sodium within 2 weeks of vaccination. On 25Jan2021, at 12:00 PM, the patient experienced Itching, Fever, Chills. No treatment was received for the events Itching, Fever, Chills. The outcome of the events Itching, Fever, Chills was not recovered. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Neck pain, Pain in extremity
Clinical narrative: Sore arm; Sore neck; Swollen lymphnode under my left arm; This is a spontaneous report from a contactable 44-year-old female consumer (patient). A 44-year-old female received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date unknown), via unknown route of administration, on 14Jan2021 at 10:00 AM (at the age of 44 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included allergy to codeine, was diagnosed with COVID-19 prior to vaccination and had BNT162B2 vaccine dose 1 on unknown date, lot unknown. The patient was not pregnant at time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications was not provided. The patient did not receive any other vaccines within 4 weeks or any medications within 2 weeks prior to the COVID vaccine. On 16Jan2021, at 08:00 AM, the patient experienced sore arm, sore neck and swollen lymph node under my left arm.  No treatment was received for the events sore arm, sore neck and swollen lymph node under my left arm. The outcome of the events sore arm, sore neck and swollen lymph node under my left arm was recovering. Since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: racing heart; This is a spontaneous report from a contactable consumer, the patient. This 75 year old female patient  received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose  1 , single dose via an unspecified route of administration in the left arm on 25Jan2021 at 15:00 (at the age of 75 years old) for COVID-19 vaccination.  There was no relevant medical history. There were no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 26Jan2021, the patient had a racing heart. The event was reported as non-serious. There was no treatment received for the event. The clinical outcome of racing heart was recovered on an unknown date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Oral disorder
Clinical narrative: She has a bump in her mouth; Dental work done gums are inflamed; This is a spontaneous report from a contactable consumer. This is a spontaneous report from a contactable consumer, the patient. This female patient of an unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: unknown),  dose 1, single dose via an unspecified route of administration on 11Jan2021 for COVID-19 vaccination.  Medical history included dental work on an unknown date. Concomitant medications were not reported. In Jan2021, the patient had dental work done and gums are inflamed and has a bump in her mouth. The events were reported as non-serious. The clinical outcome of gums are inflamed and has a bump in her mouth was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had arm soreness in her left arm from the injection; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that: A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration in left arm on 22Jan2021 8:00 at single dose for COVID-19 immunization. The patient medical history included Transient ischaemic attack (TIA) which was not ongoing.  The patient's concomitant medications were not reported.  The patient previously took 2 baby aspirin (162 mg) every evening and has done this for the past 15-20 years for Transient ischaemic attack. Received call from consumer regarding the Pfizer COVID vaccine. The reporter who asks if taking her regular regimen of 2 baby aspirin daily will interfere with the vaccine effectiveness. She had first covid vaccine dose Friday on 22Jan2021 at 8 am. She had no reaction other than a little soreness in her arm from the injection after getting the vaccine in Jan2021 and it went away in a couple of days. She just massaged her arm and it was fine. She reported that due to a history of TIA she took 2 baby aspirin every evening and has done this for the past 15-20 years. After getting her vaccine she was told that taking aspirin may interfere with the antibody response and she called today to ask if that was true and if she should take an antibody test. She was reading on some links yesterday about blood thinners. It kind of freaked her out. She took 2 baby aspirin daily and together it was 162 mg, which she has been taking for years. She used to get trans ischemic attacks and has not had any since she has been taking them. She took them at 6 pm, which she did the evening before she had the vaccine. She called to check, to see if taking 2 baby aspirin every day for the past 15 to 20 years would affect the vaccination that she got. She asked because she had someone telling her after getting the vaccine, oh you shouldn't have done that and so she called to check and to see if that was okay. She would be taking second dose on 12Feb2021. She would like to know if that reduced the effectiveness for her. She had not heard that anywhere previous or she would have stopped taking the aspirin 5 days prior. She was feeling fine. The outcome of the event 'arm soreness in her left arm from the injection' was recovered in Jan2021.   Information about lot and batch number has been requested.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Body height decreased, Diarrhoea
Clinical narrative: Really bad case of diarrhea/worst case of diarrhea he has ever had; Shrunk to about 5'10''; This is a spontaneous report from a contactable consumer (patient). A 93-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 25Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 25Jan2021, after the first dose of vaccination, the patient had a really bad case of diarrhea, and mentioned that it was the worst case of diarrhea he has ever had. In Jan2021, the patient had shrunk to about 5'10". The outcome of the events, 'diarrhea' and 'shrunk to about 5'10"', was unknown.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Cough, Diarrhoea, Pyrexia, Swelling
Clinical narrative: Fever; cough; diarrhea; swelling; burning; This is a spontaneous report from a contactable consumer. A 48-year-old female patient receive first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK4176) via an unspecified route of administration in right arm on 22Jan2021 12:00 at single dose for COVID-19 immunisation. The patient received the vaccine in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient medical history was not reported. The patient received unspecified medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced fever, cough, diarrhea, swelling, burning on 22Jan2021 16:00. The patient didn't receive any treatment for events. The outcome of events was recovering.
Sex: F
Vaccine: UNK
Symptoms: Blood glucose increased, Rash
Clinical narrative: She got her blood levels checked for taking warfarin in which they were 500/they have never been this high/Could the vaccine be effecting her blood thinner; could the vaccine be effecting her blood thinner; Experiencing a rash and itching on arms and across the top of her back and hands; Experiencing a rash and itching on arms and across the top of her back and hands; This is a spontaneous report from a contactable consumer (patient's husband) and a contactable consumer (patient). An 80-year-old female patient received first dose of BNT162B2, via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization and warfarin via an unspecified route of administration from an unspecified date at an unknown dosage for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient experienced a rash and itching on arms and across the top of her back and hands on 19Jan2021. The patient stated that she got her blood levels checked for taking warfarin in which they were 500. She stated that they have never been this high and nothing different had happened other than receiving the vaccine. She asked if these levels could be because of the Covid vaccine. The patient's husband stated that his wife was having some side effects, statesd she had the Pfizer Covid shot, she was having a rash problem with it, also she took Warfarin and it seemed to be effecting the blood thinner. Could the vaccine be effecting her blood thinner. The action taken in response to the events for warfarin was unknown. The outcome of the events was unknown.  Information about Lot/batch no has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hypoaesthesia, Malaise
Clinical narrative: Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb/Arm still has this sensation (like sleep, cold, numb feeling); Arm still has this sensation (like sleep, cold, numb feeling); Fever 102 degrees Fahrenheight; Feeling sick; Chills; Shakes; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date: Mar2021), intramuscularly on the left arm on 07Jan2021 (09:00) at a single dose for COVID-19 immunization at the school/student health clinic (not a military facility). Medical history included ongoing rheumatoid arthritis diagnosed about 5 years ago; ongoing high blood pressure diagnosed a couple of years ago, and ongoing Grave's disease diagnosed about 30-32 years ago. Concomitant medications included ongoing hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis; and levothyroxine sodium (SYNTHROID) for Grave's disease. On 07Jan2021, the patient had cold sensation in the arm, tingly sensation down in her arm like her arm was cold/numb; arm still had the sensation (like sleep, cold and numb feeling); had fever with body temperature of 102 degrees Fahrenheit; was feeling sick; had chills; shakes; and fatigue. The outcome of the events was not recovered for 'cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb' and 'arm still had the sensation (like sleep, cold and numb feeling)'; was recovered on 09Jan2021 for 'fever with body temperature of 102 degrees Fahrenheit', 'chills', 'shakes' and 'fatigue'; and was recovered in Jan2021 for 'feeling sick'. The patient was asking if these same symptoms should be expected after the second dose, and if it would be okay to get the second dose of vaccination.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Peripheral coldness, Pyrexia, Tremor
Clinical narrative: Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb; Cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb/Arm still has this sensation (like sleep, cold, numb feeling); Arm still has this sensation (like sleep, cold, numb feeling); Fever 102 degrees Fahrenheight; Feeling sick; Chills; Shakes; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date: Mar2021), intramuscularly on the left arm on 07Jan2021 (09:00) at a single dose for COVID-19 immunization at the school/student health clinic (not a military facility). Medical history included ongoing rheumatoid arthritis diagnosed about 5 years ago; ongoing high blood pressure diagnosed a couple of years ago, and ongoing Grave's disease diagnosed about 30-32 years ago. Concomitant medications included ongoing hydroxychloroquine phosphate (PLAQUENIL) for rheumatoid arthritis; and levothyroxine sodium (SYNTHROID) for Grave's disease. On 07Jan2021, the patient had cold sensation in the arm, tingly sensation down in her arm like her arm was cold/numb; arm still had the sensation (like sleep, cold and numb feeling); had fever with body temperature of 102 degrees Fahrenheit; was feeling sick; had chills; shakes; and fatigue. The outcome of the events was not recovered for 'cold sensation in the arm/tingly sensation down her arm like her arm is cold/numb' and 'arm still had the sensation (like sleep, cold and numb feeling)'; was recovered on 09Jan2021 for 'fever with body temperature of 102 degrees Fahrenheit', 'chills', 'shakes' and 'fatigue'; and was recovered in Jan2021 for 'feeling sick'. The patient was asking if these same symptoms should be expected after the second dose, and if it would be okay to get the second dose of vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Pruritus, Vertigo
Clinical narrative: the room was spinning/whole room was spinning; dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side; her scalp was itching and her back and stomach was itching; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm, on 21Jan2021 15:00, at single dose, for COVID-19 immunization. There were no medical history and concomitant medications. On 21Jan2021 at 15:00 (last Thursday), the patient received the first dose. On 22Jan2021 (the day after the vaccine) at 07:00, her scalp was itching and her back and stomach was itching and that went away the same day. In the morning of 23Jan2021 (also reported as "either 22Jan2021 or 23Jan202"), the patient had dizzy spells, more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side. She stated that it usually happens when bending over, reaching up high, in a recline position or when switching sides on the pillow. She reported that she is still experiencing this symptom with no improvement and reported that dizziness worsened. In the morning of 26Jan2021, the patient reported that it was worst, the whole room was spinning but that spell went away after a few seconds. The patient reported her second dose was scheduled on 11Feb2021 and asked if the side effects after the second dose will be worse. The patient did not visit the emergency room and physician office. The outcome of the event "dizzy spells/more of when she is in a certain position like when she is reaching up to get something or bending down, or at night when she reclines or is switching from side to side" was not recovered; "the room was spinning/whole room was spinning" was recovered on 26Jan2021 (reported as "went away after a few seconds"); and "her scalp was itching and her back and stomach was itching" was recovered on 22Jan2021 (also reported as recovered on 23Jan2021).  Information on lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis
Clinical narrative: stuffy nose; like a cold but it doesn't feel the same as a cold; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3246), intramuscular at Arm Left on 17Jan2021 07:30 at the 70 years old at single dose for COVID-19 vaccination.  The medical history included asthmatic.  The concomitant medications were none. The patient had the first dose of the vaccine on the morning of 17Jan2021 and that afternoon on 17Jan2021 she started having a stuffy nose like a cold but it doesn't feel the same as a cold. This has been occurring for 9 days now. She called to ask if this was one of the more obscure side effects of the vaccine. The patient received the vaccination on the 17Jan2021, and in the afternoon of that day, she got a stuffy nose. She said that she did not see it as a side effect, but 9 days later she still has a stuffy nose. She said that she does not have a temperature, headache, or anything else going on. She said that she knows a stuffy nose is a side effect of Covid-19 though. The caller said that she has been reporting this on the (App Name) everyday. The patient said that the stuffy nose was the same as it had been. The patient said that she was not feeling sick, sick, just stuffed up. She did not have shortness of breath or anything like that. There was no History of all previous immunization with the Pfizer vaccine considered as suspect. The events did not require a visit to Emergency Room and Physician Office. There was no family Medical History Relevant to events.  There was none Prior Vaccinations within 4 weeks. There were none relevant tests. The outcome of the events was not recovered.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Discomfort, Flushing, Head discomfort, Heart rate
Clinical narrative: pressure all in her head and all over her body; pressure all in her head and all over her body; Feeling flushed; Nausea; feel her heart beating; legs feet and hands would feel tingly; She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total.; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: Unknown, Batch/lot number: EL9261, Expiry Date: 31May2021), via an unspecified route of administration in the left arm on 22Jan2021 at 0.3 mL, single for she did not got COVID. Medical history included continuing A-fib, takes medication for this everyday. Diagnosed at least 10 years ago. The patient's concomitant medications were not reported. Last night (25Jan2021) her symptoms started. She was unsure if it was from the vaccine or not but she was thinking it was, she had not had it before. Around 11 pm last night (25Jan2021) she got a pressure all in her head and all over her body. She felt flushed. She had nausea. She could feel her heart beating. She could really feel it. It was not abnormal. She did have A-fib, but this was normal, not like A-fib. Her took her blood pressure which was normal. She took her pulse which was normal. She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total. Sometimes her legs feet and hands would feel tingly. And the flushing continue- it feels like her body was hot, but it was not hot to the touch. She had felt better this morning when she got up, but she did have one bout when she was just sitting here. She had improved overall. Caller stated she already spoke to the safety department but did not have any reference number to provide. The outcome of event 'Feeling flushed' and 'Sometimes her legs feet and hands would feel tingly' was recovered on 26Jan2021, of the other events was recovering.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Nausea, Paraesthesia
Clinical narrative: pressure all in her head and all over her body; pressure all in her head and all over her body; Feeling flushed; Nausea; feel her heart beating; legs feet and hands would feel tingly; She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total.; This is a spontaneous report from a contactable consumer (patient). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC number: Unknown, Batch/lot number: EL9261, Expiry Date: 31May2021), via an unspecified route of administration in the left arm on 22Jan2021 at 0.3 mL, single for she did not got COVID. Medical history included continuing A-fib, takes medication for this everyday. Diagnosed at least 10 years ago. The patient's concomitant medications were not reported. Last night (25Jan2021) her symptoms started. She was unsure if it was from the vaccine or not but she was thinking it was, she had not had it before. Around 11 pm last night (25Jan2021) she got a pressure all in her head and all over her body. She felt flushed. She had nausea. She could feel her heart beating. She could really feel it. It was not abnormal. She did have A-fib, but this was normal, not like A-fib. Her took her blood pressure which was normal. She took her pulse which was normal. She went to bed around 1am. This went on all night off and on. She slept maybe about 3 hours total. Sometimes her legs feet and hands would feel tingly. And the flushing continue- it feels like her body was hot, but it was not hot to the touch. She had felt better this morning when she got up, but she did have one bout when she was just sitting here. She had improved overall. Caller stated she already spoke to the safety department but did not have any reference number to provide. The outcome of event 'Feeling flushed' and 'Sometimes her legs feet and hands would feel tingly' was recovered on 26Jan2021, of the other events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vomiting
Clinical narrative: continues vomiting; developed Migraine headache and is gotten worse ever since; This is a spontaneous report received from a contactable consumer (patient's husband). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 25Jan2021, at single dose, for COVID-19 immunization. The patient medical history concomitant medications were not reported. It was reported that the patient got the COVID-19 shot in the morning of 25Jan2021 (yesterday) which developed into a migraine headache that has done nothing but gotten worse and on 26Jn2021, she had continued vomiting. The reporter asked if these were normal and how long will these last. The outcome of the events was not recovered.   Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Dizziness, Flushing, Hyperhidrosis
Clinical narrative: her blood pressure also dropped; broke out in sweat; real hot flush again; the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out; the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out; she was pale and white; This is a spontaneous report from a contactable nurse (patient's mother). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on an unspecified date "3 weeks ago" as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Fifteen minutes after the vaccination, the patient "broke out in sweat," sat down on a table where she laid her head, and felt better after drinking "coke." Two and a half hours later, the patient felt a real hot flush again, the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out. The patient's blood pressure also dropped. The patient was placed in a ventilated room on an inclined chair for an hour. The patient's mother wanted to know if the patient could receive the second dose of the vaccine given her reaction to the first dose. The outcomes of broke out in sweat, hot flush, the room turned a certain color, she was pale and white, she could tell that she was going to pass out, and blood pressure also dropped were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pallor, Visual impairment
Clinical narrative: her blood pressure also dropped; broke out in sweat; real hot flush again; the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out; the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out; she was pale and white; This is a spontaneous report from a contactable nurse (patient's mother). A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on an unspecified date "3 weeks ago" as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Fifteen minutes after the vaccination, the patient "broke out in sweat," sat down on a table where she laid her head, and felt better after drinking "coke." Two and a half hours later, the patient felt a real hot flush again, the room turned a certain color, yellow, she was pale and white, and she could tell that she was going to pass out. The patient's blood pressure also dropped. The patient was placed in a ventilated room on an inclined chair for an hour. The patient's mother wanted to know if the patient could receive the second dose of the vaccine given her reaction to the first dose. The outcomes of broke out in sweat, hot flush, the room turned a certain color, she was pale and white, she could tell that she was going to pass out, and blood pressure also dropped were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: woke up with huge itchy all down from his rear end to his ankle and the back side of his leg; This is a spontaneous report from a contactable consumer reported for husband. A male patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 20Jan2021 16:30 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. No issues for a couple of days, but then in the middle of the night at 3 a.m. husband woke up with huge itchy all down from his rear end to his ankle and the back side of his leg, itch came to the front a little bit, took some Benadryl 50 mg and itch cream, it pretty much subsided. The event outcome was recovering.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This is a spontaneous report from a non-contactable consumer (patient). This female patient of unspecified age received the 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the right arm on 22Dec2020 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient stated: "I am having muscle... I guess is joint pain?" The patient stated that she received her first dose of the Pfizer-BioNTech COVID-19 Vaccine on 22Dec2020 and also stated it was strange that she's experiencing those side effects on the left arm because she received the injection in the right arm. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Headache, Hyperhidrosis
Clinical narrative: tightness of the total upper torso; muscle pain; chills; sweating; nausea; dizziness; weakness; headache; This is a spontaneous report from a contactable consumer reported for self. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan 2021 15:00 Left arm at single dose (Lot # FL7262) for covid-19 immunisation. Medical history included high blood pressure, diabetes, high cholesterol, covid prior vaccination, known allergies: Penicillin, codeine. No other vaccine in four weeks. Other medications in two weeks. He experienced tightness of the total upper torso, muscle pain, chills, sweating, nausea, dizziness and weakness, headache on 25Jan2021 03:00 AM. No covid tested post vaccination. No treatments were received. Outcome of the events was recovered in Jan2021.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle tightness, Myalgia, Nausea
Clinical narrative: tightness of the total upper torso; muscle pain; chills; sweating; nausea; dizziness; weakness; headache; This is a spontaneous report from a contactable consumer reported for self. This 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Jan 2021 15:00 Left arm at single dose (Lot # FL7262) for covid-19 immunisation. Medical history included high blood pressure, diabetes, high cholesterol, covid prior vaccination, known allergies: Penicillin, codeine. No other vaccine in four weeks. Other medications in two weeks. He experienced tightness of the total upper torso, muscle pain, chills, sweating, nausea, dizziness and weakness, headache on 25Jan2021 03:00 AM. No covid tested post vaccination. No treatments were received. Outcome of the events was recovered in Jan2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer reported for herself. This 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 26Jan2021 09:15 AM Left arm at single dose (Lot # EL4237) for covid-19 immunisation. No Pregnant at the time of vaccination. Medical history was none. No Allergies to medications, food, or other products. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. None other medications the patient received within 2 weeks of vaccination. Headache occurred about 1 hr after receive vaccine 26Jan2021 10:15 which was non serious, went away within 2 hours. Since the vaccination, the patient has not been tested for COVID-19. No treatments were received. Outcome of the event was recovered on 26Jan2021.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Burning sensation, Chills, Decreased appetite, Dysgeusia
Clinical narrative: anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on  20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: anxious; chills; No appetite; metallic taste in her mouth/ had a burnt taste in her mouth; burning sensation in her whole torso; fast heart rate; This is a spontaneous report from a contactable consumer reported for self and a contactable consumer (husband). This 63-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 09:00 on Arm left via Intramuscular at single dose (Lot # EL3247) for covid-19 immunisation. Medical history included allergic to penicillin when she was a kid. She said that her lips swelled up. No other products. Since receiving the vaccine, she's had a burnt taste in her mouth on 20Jan2021 and also reported that she had a burning sensation in her whole torso that lasted 2-3 mins after she received vaccine on  20Jan2021 and her heart rate was racing but resolved after a few minutes. She had a metallic taste in her mouth. It made her very anxious and she was having a fast heart rate on 20Jan2021. She got panicky because of the metallic taste. She clarified that the burning sensation she felt was a burning in her whole torso on 20Jan2021 and it was extremely hot like a chemical went into her body that was burning her guts. She said that the burning sensation only lasted 2-3 minutes and was gone. She said that she got scared and her heart was racing a little bit on 20Jan2021. Her heart racing resolved that same day after a little bit. She clarified that she has like a burnt taste in her mouth. She said that it is the roof of her mouth and her tongue that taste like this. The burnt taste is still ongoing. She said that she tried to call the physician, but has not heard back yet. She said that she had chills and no appetite that day on 20Jan2021, but it was gone by the next day 21Jan2021. Outcome of the event metallic taste in her mouth/ had a burnt taste in her mouth was not recovered. Outcome of the event burning sensation, fast heart rate was recovered on 20Jan2021. Outcome of the events chills and no appetite was recovered on 21Jan2021. Outcome of other event was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slight soreness in my right arm; This is a spontaneous report from a contactable consumer report for self. A 25-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) via an unspecified route of administration at right arm on 25Jan2021 15:30 at single dose for covid-19 immunization. The patient's medical history included allergies to Amoxil, but not severely. Patient was not pregnant at the time of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medication within 4 weeks prior to the COVID vaccine included influenza vaccine, ethinylestradiol, levonorgestrel (KURVELO), fluoxetine hydrochloride (PROZAC). On 25Jan2021 05:00 PM, patient developed just slight soreness in right arm, but that usually happens to her when got any vaccine. No treatment received for the adverse event. Event outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysgeusia, Vaccination site pain
Clinical narrative: sore arm; diarrhea; bad taste in her mouth/can taste vaccine in her mouth and throat; This is a spontaneous report from a contactable consumer (patient). This 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot#: EL1283), via an unspecified route of administration on 26Jan2021 09:55 at single dose in the left arm for COVID-19 vaccination. Medical history and concomitant medications were none. Patient got her first injection of the COVID-19 vaccine on 26Jan2021 at 09:55AM in her left arm. Patient said that the diarrhea just started on 26Jan2021, she had tried calling earlier and had to hang up because of it, maybe because she was nervous. Patient said that she tasted the vaccine constantly, she has been experiencing a bad taste in her mouth, she couldn't stand the taste. Patient couldn't get rid of the taste. She said beforehand she was scared of anaphylactic shock, but she was having the taste in her mouth and diarrhea. She said she had the taste of the vaccine in her mouth and throat on 26Jan2021. She said that everything that she eats she is trying to get taste out of her throat. Patient has done no treatment yet for the diarrhea or the taste in her mouth. She said that her arm didn't hurt afterwards and she didn't feel the shot, and now she can't touch her arm without it hurting though she has been moving her arm a lot. She said she knew that from the flu shot, but that never hurt her, this thing was sore (sore arm) on 26Jan2021. She said she wasn't worried about that though, she just wanted to know if the taste would go away, and if it was normal. She said that there was nothing that said anything about diarrhea either, and she was not sick, she didn't feel sick, there was just the taste. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a contactable consumer (patient's husband). A 66-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date at single dose for covid-19 immunisation. Medical history and concomitant medications were not provided. In the morning of 26Jan2021, four and a half hour ago (unspecified time), the patient experienced diarrhea, she used the bathroom twice thus far. The reporting consumer asked if diarrhea was also reported as a side effect of the vaccine, if they recommend for her to consult a healthcare professional (HCP) at this stage. Outcome of the event was unknown.  Information on the batch/lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Investigation, Nausea, Vaccination site pain
Clinical narrative: a little tenderness on the injection site; diarrhea; nausea; This is a spontaneous report from a contactable consumer. This 68-year-old female consumer reported for herself that she received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EL9261) at single dose on 24Jan2021 at 13:00 for COVID-19 immunisation. Relevant history included thyroid removal on 11Sep2019, and tumor removed from her appendix on May2020. Relevant family medical history was none.  Concomitant Products included: Levothyroxinesince Sep2019 and Ongoing.  FIBO tests in 2020 that were positive for Hydrogen FIBO. The patient experienced no symptoms by then except for a little tenderness on the injection site. On 26Jan2021, she experienced a sudden onset of diarrhea and nausea at 15:00.  Treatment included Zofran.  The patient stated that she did get the Vsafe contact but not today (26Jan2021). Outcome of event nausea was not resolved, outcome of other events was unknown. No emergency room required, no physician office visit. No any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.