chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Sneezing
Clinical narrative: fever of 103; every muscle and joint in her body is hurting; every muscle and joint in her body is hurting; difficult to walk with the pain; coughing; sneezing; no appetite; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 04Aug2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Aug2021, the patient experienced fever of 103, every muscle and joint in her body is hurting, difficult to walk with the pain, coughing, sneezing and no appetite. Patient took vaccine yesterday 04Aug2021. Stated everything that she read basically said after the first dose you will get a headache and a sore arm. She was sitting there now with a fever of 103, it had been going up; every muscle and joint in her body is hurting; and it was difficult to walk with the pain; she was coughing and sneezing and has no appetite. She asked should she take the second does? that was three weeks from now and this was just the first dose, asking with these side effects. Call sound was broken but sounds like caller asked if these are side effects? Another voice was heard stating, he already reported and she should go to the emergency room. Patient then stated looks like she should go to the emergency room. The patient underwent lab tests and procedures which included body temperature: 103 on Aug2021. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash erythematous
Clinical narrative: Itching and it looks like little red rash coming out at different parts of my body; little red rash coming out at different parts of my body; little red "patches; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on 04Aug2021 at 13:15 as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received first Pfizer (Covid-19 vaccine) dose yesterday on 04Aug2021 at 1:15 in the afternoon and on 05Aug2021, in evening patient started itching and it looks like patient have (little red) rash coming out at different parts of body and patient was just wondering does that go away. Patient stated little red patches (further not clarified), patient just wondering does it goes away. The first 48 hours of the vaccine or do patient need to go to the hospital. The outcome of events was not recovered.  Follow-up activities closed. Batch/lot number not available for [vaccine/BNT162B2].
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Afterwards, I became ill; This is a spontaneous report from a contactable consumer (patient) received from a  sponsored program . A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on unspecified date in Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history included none and prior to the vaccine patient had no underlying health issues. Concomitant medications were not reported. The patient experienced afterwards patient became ill unspecified date in Jan2021. Patient wanted to share experience with getting the COVID vaccine. Patient work at the local hospital as an MLT. Got the first shot in Jan. Afterwards, patient became ill, but got better. Clinical outcome of event was recovering.  Information about lot/batch number will be obtained during follow-up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Gait disturbance, Myalgia, SARS-CoV-2 test
Clinical narrative: Extreme muscle pain and weakness throughout entire body. Extreme joint pain throughout entire body. I'm barely about to walk up/down steps, sit on toilet, or dress.; Extreme muscle pain and weakness throughout entire body. Extreme joint pain throughout entire body. I'm barely about to walk up/down steps, sit on toilet, or dress.; Extreme muscle pain and weakness throughout entire body. Extreme joint pain throughout entire body. I'm barely about to walk up/down steps, sit on toilet, or dress.; Extreme muscle pain and weakness throughout entire body. Extreme joint pain throughout entire body. I'm barely about to walk up/down steps, sit on toilet, or dress.; This is a spontaneous report from a contactable consumer (patient). A 42-years-old female non pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0183, (Aug2021, as reported)), dose 2 via an unspecified route of administration, administered in Arm Left on 05Aug2021 at 13:00 (at the age of 42-years-old) as dose 2, single for COVID-19 immunization. Medical history included narcolepsy from an unknown date and unknown if ongoing, cataplexy from an unknown date and unknown if ongoing, dermatomyositis from an unknown date and unknown if ongoing, fibromuscular dysplasia from an unknown date and unknown if ongoing, Lupus/SLE from an unknown date and unknown if ongoing, COVID-19 from an unknown date and unknown if ongoing, Known allergies: Penicillin, humira, latex, salmetrol all from an unknown date and unknown if ongoing. Other medications (taken in two weeks) included mycophenolate mofetil hydrochloride (CELLCEPT [MYCOPHENOLATE MOFETIL HYDROCHLORIDE]); hydroxychloroquine phosphate (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]); doxycycline; armodafinil (NUVIGIL); oxybate sodium (XYREM), all taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0183), dose 1 via an unspecified route of administration, administered in Arm Left on 09Jul2021 at 3:30 (at the age of 42-years-old) as dose 1, single for COVID-19 immunization. Facility type were the patient received vaccine was Doctor's office/urgent care. The patient had COVID prior vaccination, was not COVID tested post vaccination, did not take other vaccine in four weeks. On 05Aug2021 at 10:00 PM (22:00), the patient experienced Extreme muscle pain and weakness throughout entire body. Extreme joint pain throughout entire body, she was barely about to walk up/down steps, sit on toilet, or dress. It was unknown if treatment was taken for events. The patient underwent lab test and procedure which included COVID-19 virus test: Positive on an unspecified date. The outcome of events was not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue, Gait disturbance, Movement disorder, Pain in extremity
Clinical narrative: Extreme fatigue; Slight metal taste in mouth; could not complete normal evening walk without a struggle; Soreness in left arm; Inability to totally raise arm; This is a spontaneous report from a contactable consumer. A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0198), dose 1 via an unspecified route of administration, administered in Arm Left on 04Aug2021 at 12:00 (at the age of 68 year) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included COVID-19. Patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. There were no concomitant medications. On 04Aug2021, first day patient experienced only soreness in left arm and inability to totally raise arm. On 05Aug2021, second day arm fine, but could not complete normal evening walk without a struggle. On 06Aug2021, today (three days later) extreme fatigue and slight metal taste in mouth. AE did not result in emergency room and physician office. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on his leg; This is a spontaneous report from a contactable consumer or other non hcp (patient). A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date at dose number unknown, single for covid-19 immunisation. Medical history included colitis ulcerative (He said he also takes entyvio for ulcerative colitis). Concomitant medication included vedolizumab (ENTYVIO) taken for colitis ulcerative, start and stop date were not reported. On an unspecified date the patient experienced rash on his leg. He is calling about the covid 19 vaccine. He had already reported and has a manufacturers report. He had called about a reaction, it was nothing major. It is about when it was taken. It says are there any other side effects other than the rash on his leg that he had before. He said he also takes entyvio for ulcerative colitis. He can't remember the actual side effect. There is a questionnaire. He was trying to think, he thinks it was in march. Someone else he knew had a horrible headache but it wasn't that for him. Reporter doesn't remember who it was he thinks it was a friend of a friend who had taken Moderna. No further details provided. He was calling to see if it would show what side effect he had reported. Outcome of the event was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Pain
Clinical narrative: She came down with shingles the other day; blisters all over her neck are nasty; Very painful; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 27May2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously 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 06May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient reported on unspecified date on 2021, she came down with shingles the other day and her daughter in law, who was a nurse, said there had been studies of people getting shingles after getting the vaccine. She didn't think of any relation of that to the vaccine. Patient reports on unspecified date on 2021, that the blisters all over her neck were nasty. Very painful. Patient stated that people should get their shingles shot, that they should get the Covid vaccine, definitely, but also get that if you're older. She reported she went to a dermatologist initially and was mis-diagnosed it before, but today got a definitive diagnosis and started the medication, which was not as effective as it would have been if she would have started it in the first few days. The reporter was not related to a study or programme. The patient received treatment for the events. The outcome of the event was unknown.   Follow up attempts are needed. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Exhausted, very tired; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for self. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced exhausted, very tired on an unspecified date. Outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy, Pruritus, Rash
Clinical narrative: severe itching; has a severe rash under her armpits and went on for a day or so; swollen lymph nodes; had the, one injection on March the 12th/they can give me you kow, some further information and with I can get the second shot; This is a spontaneous report from contactable consumer (patient). A 77-year-old female patient received BNT162B2 (Pfizer-BionTech Covid-19 Vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 12Mar2021 as dose 1, single and supposedly received her second dose of BNT162B2 (Pfizer-BionTech Covid-19 Vaccine, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on April2021 for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced on an unspecified date in 2021, severe itching, she mentioned that they may be related to lymph nodes. She never saw the swollen lymph nodes. The night of the injection at 2:30 in the afternoon and about 1:30 at night she had a severe rash under her armpits and went on for a day or so. She wanted to know how long these symptoms would last? Is it okay to take the second shot? She also wanted to know if she could have the second dose longer than 3 weeks & 6 weeks after the first dose? She wanted to know if the antibody testing would determine if she had developed antibodies from the vaccine. If the antibodies that she has would be enough not to get the second dose of the vaccine. How long would she get antibodies after getting the dose? The outcome of the events 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
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: one woman had diarrhea for 3 days; This is a spontaneous report received from a contactable consumer reported for female (patient). A female patient of unspecified age received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Reporter states that she lives in a retirement community and that COVID 19 had affected people who live there who have been fully vaccinated. She relayed that one woman had diarrhea for 3 days which she states can be very dangerous because it can lead to dehydration. Reporter wanted to know when would the booster dose be available and is it the same as the first two doses or different? She thinks you all do a great job. Thank you you're so articulate and knowledgeable, she appreciates it. She was very grateful recipient of the Pfizer COVID 19 vaccine and really feel like she owes her life to Pfizer for this vaccine. She asked is the vaccine effective against the delta and delta plus variant? Do you have any information on the Lambda variant? The clinical outcome of diarrhoea was recovered in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Sinus congestion
Clinical narrative: fever; headache; nausea; sinus congestion; This is a spontaneous report received from a contactable Pharmacist. This Pharmacist reported for female (patient).  A 7-decade-old female patient received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history includes Anaemia and Dementia both from an unknown onset and ongoing and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient experienced fever, headache, nausea and sinus congestion. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (13Sep2021): 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.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Dyspnoea, Heart rate, Heart rate increased
Clinical narrative: topical irritation; fast beating heart; shortness of breath; Experience brief chest pain like my heart ache, little bit in my upper back and it is not consistent like I am going to watch every minute; Experience brief chest pain like my heart ache, little bit in my upper back and it is not consistent like I am going to watch every minute; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced topical irritation, fast beating heart, shortness of breath, "experience brief chest pain like my heart ache, little bit in my upper back and it is not consistent like i am going to watch every minute" on Aug2021. Reported as, patient received the vaccine counting today 3 days ago on 04Aug Wednesday and don't know patient have like topical irritation or fast beating heart or shortness of breath anything but have experience like brief chest pain like his heart ache and little bit in his upper back and again it was not like consistent, like patient was going to watch every minute and it's more sort of, it will go in and out. The patient underwent lab tests and procedures which included heart rate: fast on Aug2021. Outcome of all the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Skin irritation
Clinical narrative: topical irritation; fast beating heart; shortness of breath; Experience brief chest pain like my heart ache, little bit in my upper back and it is not consistent like I am going to watch every minute; Experience brief chest pain like my heart ache, little bit in my upper back and it is not consistent like I am going to watch every minute; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Aug2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced topical irritation, fast beating heart, shortness of breath, "experience brief chest pain like my heart ache, little bit in my upper back and it is not consistent like i am going to watch every minute" on Aug2021. Reported as, patient received the vaccine counting today 3 days ago on 04Aug Wednesday and don't know patient have like topical irritation or fast beating heart or shortness of breath anything but have experience like brief chest pain like his heart ache and little bit in his upper back and again it was not like consistent, like patient was going to watch every minute and it's more sort of, it will go in and out. The patient underwent lab tests and procedures which included heart rate: fast on Aug2021. Outcome of all the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthma, Pyrexia, Swelling
Clinical narrative: Fever; I flare-up usually when I have asthma flare-up; I feel like swollen; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received first dose bnt162b2 (BNT162B2, Batch/Lot number was not reported) via an unspecified route of administration on 05Aug2021 as DOSE 1, SINGLE for covid-19 immunisation. On 08Aug2021 the patient medical history and concomitant medications were not reported. The patient experienced fever, I flare-up usually when I have asthma flare-up, I feel like swollen. The outcome of the events pyrexia, asthma was not recovered, the outcome of the event swelling was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Pruritus
Clinical narrative: Itching; Weakness; This is a spontaneous report from a contactable consumer or other non-hcp (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date in 2021 (Lot Number: FA7485, Expiry date: Unknown) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced itching and weakness. The outcome of the event was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: Period delayed. My period is regular (average cycle length is 28-30 days). However, my period was delayed 10 days after I had 1st dose of Pfizer (16Jun2021).; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 44-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration, administered in Arm Left on 16Jun2021 16:00 (at the age of 44-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. Patient received vaccine facility vaccine in pharmacy or drug store. Patient stated, Period delayed. My period is regular (average cycle length is 28-30 days). However, my period was delayed 10 days after I had 1st dose of Pfizer (16Jun2021) on unknown date. After 2nd dose of Pfizer (09Jul2021), my period was delayed 14 days. I had a little dark brown spotting right after the 2nd dose for 4 days. No treatment was received for the event. The outcome of the event was reported as unknown.  Information about lot/batch number has been requested.  Follow-up (25Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Swelling, Vaccination site pain
Clinical narrative: injection site pain; swelling; chills; This is a spontaneous report from a Sponsored Program . A contactable female consumer (patient) reported for herself. A 16-year-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on 21Jul2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, it was reported that the caller asked what side effects were experienced by vaccine participants 16 years of age and older and for how long. Caller advised they experienced injection site pain, swelling as well as chills after the first dose of vaccine. The clinical outcome of the event was unknown.    Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding, Menstruation delayed
Clinical narrative: After 2nd dose of Pfizer (09Jul2021) my period was delayed 14 days; I had a little dark brown spotting right after the 2nd dose for 4 days; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 44-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration (at the age of 44-years), on 09Jul2021 as dose 2, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EW0180), via an unspecified route of administration, administered in left arm on 16Jun2021 at 16:00 as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine in four weeks. Patient does not have covid prior vaccination and has not been tested for covid post vaccination. On 09Jul2021, the patient experienced after 2nd dose of Pfizer (09Jul2021) my period was delayed 14 days and i had a little dark brown spotting right after the 2nd dose for 4 days. The treatment was received for the adverse events. The clinical outcome for all the events was reported as unknown.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Pityriasis rosea
Clinical narrative: rash all over the body except her neck and head/Pityriasis Rosea/circular patches on back, buttock, legs, arms, and stomach/still getting little spots that are the same thing; This is a spontaneous report received from a contactable consumer. This consumer (patient's mother) reported for a female patient (reporter's daughter) A 22-year-old female patient had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: unknown) via an unspecified route of administration in arm on 23Jul2021 (at the age of 22-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications had included oral contraceptive birth control since either Sep or Dec2020. On 25Jul2021 the patient had experienced rash all over the body except her neck and head/Pityriasis Rosea/circular patches on back, buttock, legs, arms, and stomach/still getting little spots that are the same thing. It was reported patient is due to receive the second dose on Friday and wanted to know if she can receive the second dose of the vaccine. Reporter got response that if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision and advised caller rash is a side effect related to the vaccine but is considered a non-severe allergic reaction. Reporter reported that her daughter broke out in rash all over the body but was diagnosed with Pityriasis Rosea.  it was reported that patient got the Pfizer vaccine about two and a half weeks ago. She started breaking out in a rash and reported that It looks like ring worm. They thought it was ring worm at first. It is circular patches on back, buttock, legs, arms, and stomach. On 25Jul2021, the patient underwent lab test and procedures which included Biopsy/Pathology test and was diagnosed as Pityriasis Rosea. It is all over. She is still getting little spots that are the same thing. They were not as big and troublesome. The caller was enquiring about what are the chances it would get worse, should she do the second shot or just skip it all together or not. Hopefully she has some immunity. The patient had visited physician office. The clinical outcome of the event was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Dyspnoea, Palpitations, Vomiting
Clinical narrative: My heart began to pound rapidly; I felt breathless and lightheaded; I felt breathless and lightheaded; and also felt as though I might either vomit or lose control of my bowels; and also felt as though I might either vomit or lose control of my bowels; This is a spontaneous report from a contactable consumer (patient herself).   A 50 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Left Arm on Aug2021 at 13:00 as a Dose number unknown, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included other medication sensitivities (nonallergic). The patient's concomitant medications within two weeks of vaccination was reported as none. The patient previously taken Reglan which caused her anaphylaxis. The patient had not received any other vaccine within four weeks prior to vaccination. The patient was not diagnosed for Covid prior vaccination. The patient was not tested for covid post vaccination. On 04Aug2021 at 13:00, the reporter stated that she received the shot and was directed to sit in another chair and wait 15 minutes. She got up and walked to the chair, sat down and within 60 seconds of sitting down her heart began to pound rapidly, she felt breathless and lightheaded and also felt as though she might either vomit or lose control of her bowels. From the time the symptoms began, they subsided within a minute or so. No treatment received for the resulted events. The outcome of the events was recovered on 04Aug2021.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia
Clinical narrative: Very tired all day; slight fever (99.3) for a few hours; This is a spontaneous report from a contactable consumer (Patient). A (Age 83; unit Unspecified) non-pregnant female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: FA6780) via an unspecified route of administration, administered in Arm Left on 04Aug2021 11:15 as dose number unknown, single for covid-19 immunisation. Medical history included hypertension from an unknown date. Concomitant medication(s) included atenolol (MANUFACTURER UNKNOWN), chlorthalidone (MANUFACTURER UNKNOWN) taken for an unspecified indication. Other medications in two weeks included multivitamins. No other vaccine was given in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. No known allergies were reported. On 05Aug2021, the patient experienced very tired all day and slight fever (99.3) for a few hours. The patient did not receive any treatment for the events. On 05Aug2021, the patient underwent lab tests and procedures which included body temperature: 99.3. The outcome of the event was recovered on an unspecified date in 2021.  Follow-Up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Rash
Clinical narrative: Covid arm, bump on arm, after first vaccine; Covid arm, rash on arm, after first vaccine; 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, administered in Arm on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced covid arm, bump on arm, after first vaccine, covid arm, rash on arm, after first vaccine. The outcome of the events limb discomfort, rash was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Information about lot/batch number [BNT162B2] cannot be obtained. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: DNA test for fragile X, Musculoskeletal stiffness, Serum ferritin
Clinical narrative: The first Pfizer shot I had a very stiff neck on the side of the shot; This is a spontaneous report from a contactable other health care professional (Patient). A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8732 and Expiry date was not reported), via an unspecified route of administration on 27Apr2021 09:00 (at the age of 54-years-old) in Arm Right as dose 1, single for COVID-19 immunization. The patient Medical history included haemochromatosis, ehlers-danlos syndrome. Concomitant medications included cyclobenzaprine hydrochloride (FLEXERIL); levothyroxine sodium (SYNTHROID); hydrocodone bitartrate, paracetamol (NORCO). The patient previously took methotrexate, naproxen, azithromycin and experienced known drug allergies. The patient had not received any other vaccines within 4 weeks prior to COVID-19. The Patient had not diagnosed with COVID-19 prior to vaccination and the patient had not tested for COVID-19 post vaccination. On 30Apr2021 06:00, the patient experienced first Pfizer shot she had a very stiff neck on the side of the shot, Right side, second shot she did fine. The patient visited physician office and patient did not received treatment. The problem is she have Hemochromatosis classic she had a DNA test in 2018 to confirm, same 2 C282Y genes in Iron overload for 13years. After bleeds for 2 years her Ferritin went from 1500 to 53. she was at 53 at the time of Pfizer vaccines, and it made my Ferritin Jump from 53 to 324 so she was Iron overload again. Advised to wait 8 more weeks to see if it goes down, If not she will have to have another unit taken out to get Ferritin down again. The outcome for the events was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: Arm is extremely red; Looks like a birth mark/I looks like a 'bruise', like birth mark on it.; This is a spontaneous report from contactable consumer. This consumer reported for 20-years-old patient that:  A 20-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FA6780, Expiry date: Unknown) via an unspecified route of administration in arm right on 01Aug2021 (at the age 20-year-old) at 4 or 5 pm as dose 1, single for COVID-19 immunization. Medical history included patient had Pfizer shot and 2 weeks ago her arm extremely "swelled" up and red (looks like yesterday took shot). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Second shot due ate around 22 or something. Investigation assessment was not reported. On 01Aug2021 patient experienced arm is extremely red; Looks like a birth mark/I looks like a 'bruise', like birth mark on it. The patient didn't received treatment for events. The clinical outcome of the event was not recovered.  No follow-up attempts possible. No further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A little bit sore in the arm; This is a spontaneous report from a contactable other health care professional, the patient. A 58-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: FA6780), intramuscular in the arm left on 14Jul2021 as dose 1, single (at the age of 58-years-old) for covid-19 immunization. Medical history included red circle and it was inflamed and painful and just around the injection site. The patient concomitant medications were not reported. The patient previously took flu shot. On an unknown date in 2021, the patient experienced a little bit sore in the arm. The outcome of the event was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Feeling hot, Pruritus, Sunburn
Clinical narrative: I had a few spots itching, particularly one that was close to the shot; It felt blistery like kind of little warm, almost sunburn feeling; I had a few spots itching, particularly one that was close to the shot; It felt blistery like kind of little warm, almost sunburn feeling; I had a few spots itching, particularly one that was close to the shot; It felt blistery like kind of little warm, almost sunburn feeling; I had a few spots itching, particularly one that was close to the shot; It felt blistery like kind of little warm, almost sunburn feeling; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 49-years-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0171) via intramuscularly (reported as it was in the muscle) administered in left arm on 09Aug2021 09:00 as dose 1, single (at the age of 49 years-old) for COVID-19 immunization. Patient medical history included High Blood Pressure, psoriasis and infection from an unknown date and unknown if ongoing. The concomitant medications included amlodipine taken at a dose of 2.5 mg daily for hypertension, start and stop date were not reported. The patient previously took doxycycline hyclate 100 mg capsules for it but that ended like two days ago. The patient reported that patient had a few spots itching, particularly one that was close to the shot, it felt blistery like kind of little warm, almost sunburn feeling on 09Aug2021 20:00. Vaccination facility type was reported as Public Health Department (It was a health department). Patient did not receive any other vaccine in four weeks. Patient stated that patient had a breast monogram like a typical screening today, patient did that yesterday right few hours after I took the shot. The treatment of the event was reported as No, nothing out of the way for that. The outcome of events was unknown.  Follow-up (18Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Unexpected vaginal bleeding. EBL less than 200mls. Sustained for 1 hour or less; This is a spontaneous report from a contactable nurse (patient). A 30-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: Evrc180), via an unspecified route of administration, administered in arm left on 10Aug2021 at 15:00 (03:00 PM) (at the age of 30-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no known allergies. The patient did not receive any other vaccine in four weeks. The patient did not receive any other medications in two weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 10Aug2021 at 21:30 (09:30 PM), the patient experienced unexpected vaginal bleeding. EBL less than 200mls. Sustained for 1 hour or less. The patient did not receive treatment for the event. Outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pain in extremity, Peripheral swelling
Clinical narrative: left hand index finger, red swollen, inflamed and painful, unable to curl finger down due to inflammation; left hand index finger, red swollen, inflamed and painful, unable to curl finger down due to inflammation; unable to curl finger down due to inflammation; left hand index finger, red swollen, inflamed and painful, unable to curl finger down due to inflammation; This is a spontaneous report from a contactable consumer. This consumer reported for 58-year-old male patient (Husband) that: A 58-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via unspecified route administration on 10Aug2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced left hand index finger, red swollen, inflamed and painful and unable to curl finger down due to inflammation. It was reported that reporter was a Pfizer employee calling on behalf or her 58 years old husband who received the first dose of the Pfizer Covid vaccine on 10Aug2021. He was reporting left hand index finger, red swollen, inflamed and painful, unable to curl finger down due to inflammation. Although swelling was reported as side effect of the Pfizer Covid vaccine. Specifics of where you are reporting the swelling is not listed. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. The outcome of events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 73.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: I'm not as well on this as before. the effects it has on the human body.; This is a spontaneous report from a contactable consumer (patient).   A 73-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number, Expiration date were not provided), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation and palbociclib (IBRANCE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 100 mg for an unspecified indication. The patient's medical history and Concomitant medication were not reported. The patient stated "I'm not as well on this as before. I'm not sure if it's the COVID shot and the effects it has on the human body." The outcome of the event was Unknown.   The lot number for the vaccine was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101034137
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Heart rate increased, Increased appetite, Nervousness, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 70-year-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EW0191; Expiration Date: Sep2021), via an unspecified route of administration in arm right on 09Aug2021 at 18:50 (at the age of 70-years-old) as dose 1, single for COVID-19 immunisation. The medical history of the patient was reported as none. The concomitant medications of the patient were not reported. The Additional Vaccines Administered on Same Date of the Pfizer Suspect were reported as none. The AE(s) following prior vaccinations and Family Medical History Relevant to AE(s) were reported as none. On 09Aug2021, the patient experienced sore arm, increased appetite, fast heart rate and nervous about getting the shot. The patient asked if he should have been tested for Covid prior to getting vaccine. Stated he was thinking what if he had it, although he does not have any symptoms and checks his temperature every day anyway. Thought maybe they should test before, maybe should tell the higher ups and maybe it would help. Asked how do you know if they had it or not?, that it would only take a few seconds to check for a fever, and if they are running a temperature, maybe they have it and should recover. Stated that was just his opinion, to at least test to see. He said he had a sore arm and his heart rate increased for about 30 seconds and then it went away. Told it may had been because he was nervous. An hour or so later, his appetite kicked up and had an appetite like a horse. Said, that may be because he was relaxed once it was over, that it could had been mental. Stated that when he gets the second shot in 3 weeks, if he has a reaction and his heart rate increases, he will tell the girl, and that the first time, if it would have been worse or did not go away, he would had, but since it went away, figured it was gone and still here. The patient underwent lab tests and procedures which included body temperature: unknown on an unspecified date. The patient recovered from the fast heart rate on 09Aug2021, recovered from increased appetite on 10Aug2021, the outcome of the event sore arm was recovering and the outcome of the event nervous about getting the shot was reported as unknown. Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Muscular weakness, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: This is a spontaneous report from a contactable other hcp (nurse). A 14-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FC3181, Expiry: unknown), via an unspecified route of administration, administered in Arm Right on 10Aug2021 17:00 (at the age of 14-year-old) as dose 2, 0.3 ml, single for covid-19 immunisation. Medical history included cellulitis staphylococcal from an unknown date and unknown if ongoing No adversity, cardiac disorder from an unknown date and unknown if ongoing taking precautions,patient grandmother, neoplasm malignant from an unknown date and unknown if ongoing Four times,taking precautions,patient grandmother, asthma from an unknown date and unknown if ongoing taking precautions,patient grandmother. No concomitant medications. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: FA7484, Expiry: unknown), via an unspecified route of administration, administered in Arm Right on 20Jul2021 (at the age of 14-year-old) as dose 1, single for covid-19 immunisation. On 11Aug2021, the patient experienced swelling and stiffness in arm, legs feeling weak and wobbly. The reporter stated that This morning when he woke up he started hollering that he felt like he was burning up inside he told her that his legs felt weak and wobbly. She checked his temperature and he had no temperature. She told him to crawl back in bed. The events did not result in emergency room or physician office visit. The reporter seriousness for swelling and stiffness in arm was non serious. No relevant tests were done. The outcome of the events was unknown.