chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid tumour, Ocular hyperaemia
Clinical narrative: swollen; little tumor on the eyelid; pain in her eye; eye was irritated; left eye tumor red and itching; left eye tumor red and itching; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route on 11Mar2021 at 09:30 (at the age of 80-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included anxiety diagnosed a long time ago, diabetes from 1958 to ongoing, blood pressure high diagnosed 10 or 13 years ago, high cholesterol diagnosed since the caller was in her 40's and got the shingles vaccine before, family history her mother had glaucoma. The patient concomitant medications were not reported. The patient historical vaccine included BNT162b2 Covid 19 shot (Batch/lot number: EN9267) and experienced eye was very red and itchy and swollen, very dry tongue and mouth and used refresh eye drops for her eyes but she stopped using them and got a Flu shot last Sep. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced left eye tumour red and itching. Patient received the first shot and she got strong side effects in her right eye, she doesn't know if it's the shot. The patient eye was very red and itchy and swollen. The patient also had a very dry tongue and mouth. The patient was planning on going to the pharmacy in a little while to ask for something for her eye. The patient first shot was 17Feb2021 and then on the right eye it looked like a small tumour, that is severe. Today 11Mar2021 the patient went for her second shot and on the other eye, her left eye, it's like a little tumour on the eyelid, red and very itchy and has to keep from scratching it all the time. The patient was going to the pharmacy right now to get something for her eye. The patient other eye, the right eye, was clear already, she's hoping her left eye will clear up like this. After the second dose the side effect is her left eye, sometimes she feels pain in her eye and sometimes she doesn't, if she closes it or applies pressure she feels pain. The itch is worse, than when the patient got the shot she didn't have the itch and now it started itching when she got home. The patient eye was irritated. The patient got blood test about 2.5 months ago but that was before she received the vaccines. Patient did not visit to Emergency room or Physician's office. Lately the patient had been suffering from her eyes, she had some condition where she thought her eyes were closed but they weren't but this was from a medication which she stopped taking and it hadn't happened since, she was given the wrong medication for her illness. The outcome of the events left eye tumour red and itching was not recovered and other events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Pain in extremity
Clinical narrative: Patient was given the first Moderna COVID-19 vaccine on 25/JAN/2021 and 0n 22/FEB/2021, the patient got her second COVID-19 vaccine.; Patient was given the first Moderna COVID-19 vaccine on 25/JAN/2021 and 0n 22/FEB/2021, the patient got her second COVID-19 vaccine.; had no reaction to the COVID-19 vaccine injections except for a little soreness in the arm; This is a spontaneous report based on information received from a non-Pfizer sponsored program (marketing program name not available) by Pfizer (manufacturer control number: US-AMGEN-USASL2019000533), license party for etanercept (ENBREL). A contactable consumer reported a 76-years-old female patient received bnt162b2 (PFIZE-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on 22Feb2021 as dose 2 (initial Pfizer dose), single for covid-19 immunisation. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. The patient previously took gold and prednisone for unknown indication and also took moderna covid-19 vaccine on 25Jan2021 for covid-19 immunisation and experienced a little bruise and soreness. The patient was given the first Moderna COVID-19 vaccine on 25Jan2021 and on 22Feb2021, she got her second COVID-19 vaccine. She had completed two COVID-19 vaccine injections. On unknown date in feb2021, she had no reaction to the COVID-19 vaccine injections except for a little soreness in the arm. Patient had no fever and no headache with the COVID-19 vaccine either. Subsequently, the patient took Tylenol (paracetamol) as a treatment right after she got the COVID-19 vaccine, and she did. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Insomnia, Vaccination site pain
Clinical narrative: wife was injected by the needle in the right arm, but "screamed out" because the needle was put in a bad spot; keeps her awake at night; Right arm is still hurting her and is getting Worse; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9263), via an unspecified route on 29Jan2021 (at the age of 76-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 29Jan2021, the patient experienced was injected by the needle in the right arm, but "screamed out" because the needle was put in a bad spot. The vaccine provider then administered dose in left arm. Reporter says his wife is still having right arm pain. Reporter was unsure if wife had vaccine dose injected into right arm or just needle insertion. Reporter says 2nd dose was given in left arm because right arm was still hurting at the time of 2nd dose. She had 2 of them, the first was on 29Jan2021 and the second was on 26Feb2021. Reporter asking what he and his wife should do about the arm pain. Reporter stated that his wife had severe pain in the right arm from the first shot and it keeps her awake at night. What his wife said was at the site, for the first dose they initially put the shot in the right arm and then the person administering the shot said they had a problem, and so then they put the shot on the left arm. Reporter stated that he thinks the needle broke in the arm. He again confirms that they made an attempt to administer the vaccine on the right arm, but because they had a problem administered the vaccine in the left arm. After his wife was done he saw that the patch was placed on her left arm. Her Right arm is still hurting her at the moment. He asks is this normal and how to deal with it. He confirms it was her right arm still hurting her and getting Worse. The outcome of the event keeps her awake at night was unknown and other events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-Health Care Professional.   A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6206 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021   at the age of 69-years-old as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. Concomitant medication included lisinopril taken for hypertension from an unspecified start date and ongoing; vitamin c [ascorbic acid] taken for supplementation therapy from an unspecified start date and ongoing; multivitamins (MULTIVITAMINS [VITAMINS NOS]) taken for supplementation therapy, start and stop date were not reported; atenolol taken for an unspecified indication from an unspecified start date and ongoing. On 11Mar2021 the patient experienced took her temperature an hour or 2 later, it dropped to 93*f and that she never had a temperature that low as her normal temperature was 97-98*f/temperature was 93, 94, 95, 96, fluctuating , she was extremely tired, there was soreness in her arm. The patient underwent lab tests and procedures which included body temperature: 98.5 fahrenheit on 11Mar2021 her temperature went back to 98.5*F at 8pm , body temperature: 93 fahrenheit on 11Mar2021 Took her temperature an hour or 2 later, it dropped to 93*F and that she never had a temperature that low , body temperature: 97-98 fahrenheit on   normal temperature was 97-98*F , body temperature: 94 fahrenheit on 11Mar2021, body temperature: 96 fahrenheit on 11Mar2021. On 11MAR2021 the outcome of event took her temperature an hour or 2 later was recovered. On MAR2021 the outcome of event she was extremely tired  was recovered. On an unspecified date the patient experienced she was extremely tired was recovering. Information on the lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Tachyphrenia
Clinical narrative: Insomnia/Sleeplessness; his brain won't shut off it keeps racing; This is a spontaneous report received from a 60-year-old male contactable consumer (patient). The patient reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6202) via an unspecified route of administration on 05Mar2021 (at-60-year-old), as dose 1, single for COVID-19 immunization. The medical history was reported as none. The patient's concomitant medications were not reported. On 07Mar2021 the patient experienced Insomnia /Sleeplessness and his brain would not shut off it keeps racing. The patient wanted to know if it was normal to happen with the vaccine. He clarified it was the Pfizer COVID 19 vaccine. He went to the doctor regarding it yesterday, he could not sleep, his brain would not shut off it keeps racing. It was ongoing, it was getting better but it was lingering and sleep deprivation was never good. He says he was not going to say it is improved he would say it has persisted about the same. The patient had not recovered. Communication: The caller was provided the contact number and hours of operation of Monday through Sunday 8AM-8PM for COVID vaccine calls prior to attempted warm transfer to Medical Information. Due to high call volume caller elects to be placed in the hold queue to continue holding for an agent.  Follow-up attempts were completed. No further information was expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Dry eye, Visual impairment
Clinical narrative: having trouble with her close vision; dry eyes; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9267, and Expiration date: May2021), via an unspecified route of administration on 21Feb2021 (at the age of 74-year-old) as dose 2, single for COVID-19 immunization. The patient medical history included cataract surgery (surgery a year and a half ago) and rubella (when she was a child, she has caught rubella three times when you are only supposed to get the infection once, which was before rubella shots and was back in 1950s). The historical vaccines included Hepatitis B vaccine (she had an immunity of 14 while the cut of was 10, she was barely above immunity which they checked again and she had to start another series of the 4 vaccinations and she had 98, then they never tested it again) and 2 shots of unspecified flu A and flu B vaccine (She said the recommended dosage of vaccines did not work on her, she always tried get this vaccine at the end of September, she knew one date she got it again was February, and then she came down with it again and then they just started giving her two Flu shots a year, one at the end of September, and one at the beginning of January). The concomitant medications for patient were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9265, and Expiration date: May2021), via an unspecified route of administration on 28Jan2021 (at the age of 74-year-old) as dose 1, single for COVID-19 immunization. It was reported that, on an unspecified date in 2021, the patient was "having trouble with her close vision" which she clarified was due to having cataract surgery a year and a half ago. On an unspecified date in 2021, she had "dry eyes" and had not gotten drops yet that she was not allergic to, as well as she had problems with the glasses she got after cataract surgery, they were not right on her close vision, so she was having trouble with it. No further details provided about her dry eye drops. The patient considered herself not getting immunity with the Pfizer COVID-19 vaccine since she had history of not being immune to infections and vaccines before. The patient reported that, her doctor recommended her to get the COVID-19 vaccine and she was wondering if there was a way, she could run a titer to see if she was immune or not to COVID-19. She wanted to know if there a test currently available. The investigation assessment was not provided. The outcome of events was reported as unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Infection, Pain in extremity
Clinical narrative: soreness of arm; headache; steroid pills for 7 days due to infection; This is a spontaneous report received from a female consumer (patient), reported for herself.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. on an unspecified date Patient called to request for cancellation of the 2nd dose of PFIZER-BIONTECH COVID-19 VACCINE schedule on 03/18/21 She received the 1st dose last 02/28/21 and had minor side effects like soreness of arm and headache. She was not sure if she has reported this to DSU but she was able to speak with 2 different people with Pfizer Due to long wait, she requested for callback from us and called the pharmacy to cancel the appointment She was advised by the pharmacist to cancel the 2nd dose appointment as she will have steroid pills for 7 days due to infection and wait until the steroid medication is done 2nd dose will be scheduled within 42 days after the 1st dose. Therapeutic measures were taken as a result of steroid pills for 7 days due to infection (infection). Outcome of event infection was unknown, for the events   pain in extremity, headache was recovered on unspecified date.   Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: lump, warmth and itching at the injection site; lump, warmth, and itching at the injection site/the place where she had the shot (injection site) started to get itchy and warm; lump, warmth, and itching at the injection site/the place where she had the shot (injection site) started to get itchy and warm; This is a spontaneous report received from a contactable consumer (patient). A 83-year-old female patient received PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) in right arm on 06Mar2021 (at the age of 83-year-old) as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in Mar2021, few days after receiving vaccination patient noticed a lump, warmth, and itching at the injection site. Patient asked if she could get the second shot in the same arm if the lump was still there, she was left-handed and sleep on her left side. She would like to get it in right arm which was the same as her first shot. Patient asked if it was normal to occur this many days after. She was reading the side effects and explained after 2-3 days of getting the shot, she was fine. After a few days, she noticed the place where she had the shot (injection site) started to get itchy and warm. Outcome of the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain in extremity, SARS-CoV-2 test
Clinical narrative: fatigue; her arm was sore; bad brain fog/head fog; This is a spontaneous report from a contactable other hcp (Nurse) (patient). A 74-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 (at the age of 74-year-old) at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 01Mar2021 the patient experienced fatigue, her arm was sore, bad brain fog/head fog. Reporter would like to know if she may only require one dose of the Pfizer Covid vaccine since she has a history of the Covid infection. Reporter does not wish to hold but agrees to call back from DSU, if required. Caller had Covid infection in Nov2020. She quarantined after a positive test and recalls symptoms of fatigue. She knows she has antibodies because she donated plasma in the following months up to Feb2021. She received her 1st dose of the Pfizer Covid vaccine 1Mar2021. She experienced fatigue, her arm was sore and she had really bad brain fog the next day. She couldn't remember that she needed to put her email in at work and was asleep the day before on the computer. Reporter would like to know if brain fog has been reported as a side effect of the Pfizer Covid vaccine. Reporter would like to know whether her side effect of brain fog would get worse after receiving the 2nd dose of the Pfizer Covid vaccine. Verbatim and Event Description: Inquiring if she can take the second Covid dose. She is getting head fog. The patient underwent lab tests and procedures which included covid: positive test on an unspecified date in Nov2020. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin reaction
Clinical narrative: She specified "not at the injection site", but "a general outbreak", "like acne" and "outside the skin"; This is a spontaneous case received from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: not provided; Expiration date: not provided) via an unspecified route of administration on an unspecified date as dose 1, single for Covid-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date patient specified not at the injection site, but a general outbreak, like acne and outside the skin. Patient explained she may have experienced it after the first dose and was not sure. She also mentioned she does not know if it was related to the vaccine and she will consult her Health care professional. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: her mom experiencing ear buzzing; This is a spontaneous report from contactable consumer was reported for the patient (mother) from a Regulatory Authority.  A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 03Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced ear buzzing and had been hearing some kind of noises. Reporter stated that on behalf of her mom to ask for assistance on rescheduling her mom's 2nd dose schedule. Her mom got the 1st shot on 03Mar2021 and her mom is scheduled to return on 21Mar2021 and wants to reschedule the vaccine shot on March 25, 2021 because this is also the day her mom will attend a Physician for general physical exam. The outcome of event was unknown.  Information about batch/lot number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness in left arm at injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced soreness in left arm at injection site of COVID-19 vaccine lasting 2 days. The clinical outcome of the event was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Viral infection
Clinical narrative: viral infection; This is a spontaneous report from program. A contactable Female Consumer reported for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration on 11Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, the patient had viral infection after the first dose dated 11Feb2021. The patient took antibiotics (unspecified) as a result of viral infection. The patient was asking was it ok to take the second dose. The outcome of the event was unknown. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: Caller can no longer remember when he takes the 1st shot  / He wants to know if he did attend his 2nd dose schedule because he can no longer remember it.; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A male 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 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. As reported "caller (Patient) can no longer remember when he took the 1st shot but he had a paper work that he should be returning on 26Feb2021 for his 2nd dose / he wanted to know if he did attend his 2nd dose schedule because he can no longer remember it." The clinical outcome of the event was unknown.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: felt dizzy; Vertigo; This is a spontaneous report received from a contactable consumer (patient) via Pfizer Sponsored Program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 28Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 07Feb2021 for COVID-19 immunization. On an unspecified date in 2021, patient experienced felt dizzy, vertigo. Therapeutic measures (aspirin, tylenol and pills) were taken as a result of felt dizzy, vertigo. The clinical outcome of events was unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in arm of injection site; This is a spontaneous report from a Pfizer Sponsored Program. A non-contactable consumer reported on behalf of the female patient. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On 12Mar2021 the patient experienced soreness in arm of injection site. Adverse event details: Reporter wanted to report side effect, soreness in arm of injection site. Outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nausea, Pain
Clinical narrative: I felt so fatigue and nauseated; My body was sore, my joints was sore; I felt so fatigue and nauseated; Got this pain in my back on my right shoulders; it hurts when I breathe, I felt like it is down in my muscles; I am in pain I mean my shoulder blade it's hurting and it hurts when I take deep breath; This is a spontaneous report from a contactable consumer. This 67-year-old female consumer (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6199) via an unspecified route of administration on 12Mar2021 (at 67-year-old), as dose 2, single for COVID-19 immunization. The patient's medical history included high blood pressure and asthma. Patient was taking blood pressure medication and she does not remember it. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date (at 67-year-old), as dose 1, single for COVID-19 immunization. No investigation assessment was performed. On 13Mar2021 she felt so fatigue and nauseated, her body was sore, my joints were sore and everything and she took Tylenol and stuff yesterday and then today she still felt little fatigue and on an unknown date in Mar2021 she got this pain in her back on her right shoulders, her back on the right side, upper back. She thought it was her asthma (Clarified as other medical condition) but it was not because I took out my asthma medicine and stuff and it hurt when she breathes, she felt like it was down in her muscles. She had none of this before I had that vaccine, this was the second one. The patient had not recovered.  Consumer was provided with the number of Pfizer Medical Information Department.  No follow-up attempts were possible. No further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Muscle spasms, Tremor
Clinical narrative: She started feeling cold; Uncontrollably shaking that lasted for like 4 hours; Muscle cramps above her stomach; Hard cramps in her 2 legs all night; This is a spontaneous report from a contactable consumer or other non-Health Care Professional and via from a Pfizer sponsored program.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 1 via an unspecified route of administration on 06Mar2021 as SINGLE DOSE for Covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported.On 06Mar2021 the patient experienced muscle cramps above her stomach , hard cramps in her 2 legs all night. On 08Mar2021 the patient experienced she started feeling cold, uncontrollably shaking that lasted for like 4 hours. The outcome of events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report received from a Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on 12Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included oesophageal carcinoma (Esophageal cancer and undergoing radiation therapy (5 times a week), chemotherapy (once a week)). The patient's concomitant medications were not reported. The patient experienced pain on the injection site of the vaccine on unspecified date in Mar2021. Therapeutic measures were taken as a result of event. The outcome of the event was unknown. Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: I noticed a rash around my eye on left side and a slight little lesion on the right under but more everything was on the left; Shingles; This is a spontaneous report from a contactable consumer. This 80-year-old female consumer (patient) reported for self.  An 80-year-old female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9263, Expiration date: unknown), via unspecified route, administered on 22Feb2021 (at the age of 80-year-old) as dose 1, single for COVID-19 immunization. The patient medical history high blood pressure from unknown onset and unknown ongoing and concomitant medications includes Metoprolol 50mg and Rosuvastatin 10mg both from an unknown onset and unknown ongoing. On 28Feb2021, after the vaccination, the patient noticed a rash around her eye on left side and a slight little lesion on the right under but more everything was on the left. So, she called her doctor and he gave her a medicine that starts with a V for shingles, he thought it was definitely shingles, that was on 28Feb almost 6 days later after the shot that she had this which doctor thinks is shingles, doctor is pretty sure but she took the medicine and it looks like it went away, few days later doctor came over to visit because he was concerned and still was questioning because of the one spot on  the right side, he said shingles stays on the left side and he knew that I had taken the Pfizer, he said that there is idea that maybe the Pfizer vaccine brought it on or and she wants her to go to dermatologist. she had schedule for other shot on Monday, second shot which doctor told her to cancel because she still has a rash around her eyes, and it looks like its shingles. Her second shot was rescheduled to 29Mar2021. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Feeling hot, Feeling jittery, Flushing
Clinical narrative: face was feeling hot and flushed; blood pressure was high 140-150, usually it is no more than 125; face was feeling hot and flushed; fever; felt jittery; This is a spontaneous report from a contactable consumer (patient herself). An 85-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6198, expiry date: unknown) via unspecified route of administration on 02Mar2021 (age at vaccination: 85-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2, via unspecified route of administration, left shoulder as reported on 06Feb2021 (age at vaccination: 85-years) as dose 1, single for covid-19 immunisation and experienced sore arm, face was flushed, Blood pressure high, face was feeling hot and flushed, 98.5F fever and felt jittery. vaccination facility type was building adjacent to the main hospital. Patients medical history included high blood pressure, from an unspecified date and unknown if ongoing (Diagnosed around 2010. Under control with medication). Past drug included sulfameth TMP and Adenosine and experienced allergies. There was no other additional Vaccines administered on same date of the Pfizer suspect. Patient had always been in good health. She did not have any side effects except a sore arm the next day. The next day her face was flushed and then she developed a 98.5F fever, felt jittery then it went away. This was with the first shot. This Saturday the caller began to feel the same thing, her pressure went up pretty high, she took blood pressure medicine every day. On Saturday and Sunday patients blood pres-sure was high 140-150, usually it was no more than 125. She noticed that the same symptoms as the first shot were occurring to her. The patient had a sore arm but went away after 2 days, she put a heating pad on it. Her face was feeling hot and flushed. She did not take her temperature the first day she got the shot. For about a day or 2 days for her blood pressure was high. The second shot she didn't have a sore arm. The patient was concerned that why was it after a couple of weeks or a month she was having the same symptoms. The patient underwent lab test which included, blood pressure measurement, results: 140-150, high, and no more than 125 and fever, result: 98.5 Fahrenheit on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Pyrexia
Clinical narrative: face was feeling hot and flushed; blood pressure was high 140-150, usually it is no more than 125; face was feeling hot and flushed; fever; felt jittery; This is a spontaneous report from a contactable consumer (patient herself). An 85-years-old female patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6198, expiry date: unknown) via unspecified route of administration on 02Mar2021 (age at vaccination: 85-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose of BNT162B2, via unspecified route of administration, left shoulder as reported on 06Feb2021 (age at vaccination: 85-years) as dose 1, single for covid-19 immunisation and experienced sore arm, face was flushed, Blood pressure high, face was feeling hot and flushed, 98.5F fever and felt jittery. vaccination facility type was building adjacent to the main hospital. Patients medical history included high blood pressure, from an unspecified date and unknown if ongoing (Diagnosed around 2010. Under control with medication). Past drug included sulfameth TMP and Adenosine and experienced allergies. There was no other additional Vaccines administered on same date of the Pfizer suspect. Patient had always been in good health. She did not have any side effects except a sore arm the next day. The next day her face was flushed and then she developed a 98.5F fever, felt jittery then it went away. This was with the first shot. This Saturday the caller began to feel the same thing, her pressure went up pretty high, she took blood pressure medicine every day. On Saturday and Sunday patients blood pres-sure was high 140-150, usually it was no more than 125. She noticed that the same symptoms as the first shot were occurring to her. The patient had a sore arm but went away after 2 days, she put a heating pad on it. Her face was feeling hot and flushed. She did not take her temperature the first day she got the shot. For about a day or 2 days for her blood pressure was high. The second shot she didn't have a sore arm. The patient was concerned that why was it after a couple of weeks or a month she was having the same symptoms. The patient underwent lab test which included, blood pressure measurement, results: 140-150, high, and no more than 125 and fever, result: 98.5 Fahrenheit on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blister, Herpes zoster, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Full blown shingles; left arm was a little bit sore; blisters; Pain in shoulders and upper rib area; Pain in shoulders and upper rib area; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration, administered in Arm Left (Left Arm Close to the shoulder in the muscle) on 05Mar2021 11:00 (at the age of 77 years old) as dose 1, single for COVID-19 immunisation. Medical history included ongoing arthritis, ongoing Little bit of heart disease. There were no concomitant medications. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations within 4 weeks was none. The patient experienced pain in shoulders and upper rib area, left arm was a little bit sore, blisters on Mar2021, full blown shingles on 12Mar2021. Reported as, he had the first shot on 05Mar2021 and everything went fine except for a couple or three days later he experienced a lot of pain in the shoulders and upper rib area. on 12Mar2021 he got full blown shingles. His left arm was a little bit sore right after the shot but no problem there. The pain started a couple days after the shot. It was painful with touches of pain, after that is got worse. It was after that the blister showed up. He went to his doctor and was told he had full blown shingles. 4 days after vaccine was when he noticed blisters and that skin was painful to touch. Adverse event resulted in physician office visit for Pain in shoulders and upper rib area, full blown shingles. Outcome of the event full blown shingles was not recovered and unknown for other events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Condition aggravated, Diarrhoea, Dizziness, Erythema
Clinical narrative: Extremely fatigued and sick to my stomach I had diarrhea for few days but the problem is that I keep feeling worse instead of better and its already been 6 days; Its getting worse; Almost immediately after I had the vaccine my whole body turned red and very hot; Almost immediately after I had the vaccine my whole body turned red and very hot/I did not have the fever but I thought feel like very internally hot; I broke out in rash on my chest; I felt very light headed like I was going to pass out; Nauseous; I have been experiencing extreme fatigue; Feeling very sick to my stomach; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 45-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for hyperthyroidism, start and stop date were not reported, diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Consumer stated, On 09Mar2021 Almost immediately after I had the vaccine my whole body turned red and very hot, I did not have the fever but I thought feel like very internally hot, I broke out in rash on my chest and I felt very light headed like I was going to pass out and also nauseous so they gave me Benadryl and steroids and Pepcid and I stayed for a while and I felt a little better went home and then I got up to next day and all reaction they came and since then I have been experiencing extreme fatigue and feeling very sick to my stomach,I have been getting very hot again not a fever it is very hot internally and it has been going on for 6 days. Consumer also stated, Extremely fatigued and sick to my stomach I had diarrhea for few days but the problem was that I keep feeling worse instead of better and its already been 6 days. consumer stated, its getting worse. Patient received treatment for the events as Benadryl every 6 hours and steroids and Pepcid. Consumer stated well I went to emergency room yesterday. The patient underwent lab tests and procedures which included blood test: unknown result on unknown date. The outcome of the events diarrhoea, condition aggravated was reported as unknown and while other events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Malaise, Nausea, Rash
Clinical narrative: Extremely fatigued and sick to my stomach I had diarrhea for few days but the problem is that I keep feeling worse instead of better and its already been 6 days; Its getting worse; Almost immediately after I had the vaccine my whole body turned red and very hot; Almost immediately after I had the vaccine my whole body turned red and very hot/I did not have the fever but I thought feel like very internally hot; I broke out in rash on my chest; I felt very light headed like I was going to pass out; Nauseous; I have been experiencing extreme fatigue; Feeling very sick to my stomach; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 45-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. Medical history included hyperthyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine (LEVOTHYROXINE) taken for hyperthyroidism, start and stop date were not reported, diphenhydramine hydrochloride (BENADRYL) taken for an unspecified indication, start and stop date were not reported. Consumer stated, On 09Mar2021 Almost immediately after I had the vaccine my whole body turned red and very hot, I did not have the fever but I thought feel like very internally hot, I broke out in rash on my chest and I felt very light headed like I was going to pass out and also nauseous so they gave me Benadryl and steroids and Pepcid and I stayed for a while and I felt a little better went home and then I got up to next day and all reaction they came and since then I have been experiencing extreme fatigue and feeling very sick to my stomach,I have been getting very hot again not a fever it is very hot internally and it has been going on for 6 days. Consumer also stated, Extremely fatigued and sick to my stomach I had diarrhea for few days but the problem was that I keep feeling worse instead of better and its already been 6 days. consumer stated, its getting worse. Patient received treatment for the events as Benadryl every 6 hours and steroids and Pepcid. Consumer stated well I went to emergency room yesterday. The patient underwent lab tests and procedures which included blood test: unknown result on unknown date. The outcome of the events diarrhoea, condition aggravated was reported as unknown and while other events was not recovered.  No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Caller got both Covid doses and after her 2nd dose she experienced a very dry mouth; her lips were numb and so were her cheeks; her lips were numb and so were her cheeks; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received first dose bnt162b2 (BNT162B2, Solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced caller got both covid doses and after her 2nd dose she experienced a very dry mouth, her lips were numb and so were her cheeks, her lips were numb and so were her cheeks. The outcome of the events dry mouth, hypoaesthesia, hypoaesthesia oral was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick for a week; This is a spontaneous report from non-contactable consumer (patient mother). A 41-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at the age of 41-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sick for a week. It was stated that caller's son, 41 y/o was sick for a week after his pfizer vaccine dose. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Felt "crummy" after the second shot; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Historical Vaccine BNT162B2 Dose number 1 COVID-19 immunisation. On an unspecified date the patient experienced felt "crummy" after the second shot. Outcome of the event was recovered on unspecified date.   No follow-up attempts needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: This is a spontaneous report from a non-contactable consumer or other non hcp from Pfizer sponsored program COVAX US Support.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing, was suicidal from an unknown date and unknown if ongoing, Hospitalization. Patient had been hospitalized, was suicidal, was treatment and was on medication. The patient's concomitant medications were not mentioned. On an unspecified date in Mar2021, the patient experienced, seems vaccine has cured his anxiety and depression. It was reported that since getting vaccine things have changed drastically. Said was on top of the world. He feels amazing. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.