chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site swelling and redness; increased warmth at injected site; Injection site swelling and redness; increased warmth at injected site; Injection site swelling and redness; increased warmth at injected site; This is a spontaneous report from a contactable consumer (patient husband). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated he know it's one of the possible mild side effect is injection site swelling and redness and what about increased warmth at injected site. He asked if it is normal to have. He know it says injection site swelling and also Injection site redness but what about like warmth like increase warmth, heat at injection site. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  Pfizer is a marketing authorization holder of [BNT162B2] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [BNT162B2] has submitted the same report to the regulatory authorities.    Lot/batch number has been requested in follow-up.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Myalgia
Clinical narrative: Muscle pain in my back, legs; Hard for me to walk; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Consumer stated, "I am calling for the side effects of the Vaccine, I am calling to see about it." When probed to clarify if consumer wanted to know about the side effects of COVID Vaccine, consumer stated, "Yes, because I am having muscle pain in my back, legs and it's hard for me to walk." The outcome of the events was unknown.   Information on the lot/ batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Pain in extremity, Pruritus, Rash macular
Clinical narrative: Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hives/welts came up on right ear and behind neck/welts under buttocks and behind knees, welts were large and red; Slight chills; Tenderness in injection arm; was just a little cold; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PAA156571), via an unspecified route of administration in left deltoid on 28Dec2020 10:00 at 0.3 mL single for covid-19 immunization; sulfamethoxazole, trimethoprim (BACTRIM DS), at twice a day for 10 days for perineal cyst. The patient was on her last day of sulfamethoxazole, trimethoprim on the day she got the COVID-19 vaccine (28Dec2020). Medical history included perineal cyst, COVID-19 in Apr2020 with no problem, only had a cough. Husband had COVID-19 and had loss of taste and smell, had fever, but he was not serious. Both her and her husband got tested for antibodies and were positive. Family medical history was none. The patient had unspecified flu vaccine (Lot: UJ428AB) on 18Dec2020 injected in left deltoid in two weeks prior to COVID-19 Vaccine.  Checked with three different people who stated the Flu vaccine would not interfere with COVID-19 Vaccine. Checked with two pharmacists who stated Bactrim DS would not affect her taking the COVID-19 Vaccine. She received COVID-19 Vaccine through her work in a nursing home.  There were no additional vaccines administered on same date of Pfizer suspect. On 28Dec2020 about 7 to 8 hours after vaccination, patient had slight chills and tenderness in her arm: was just a little cold. Thirty-six hours after injection, midnight on 29Dec2020, her scalp itched like crazy, broke out in hives. On 30Dec2020, rash developed on both lateral sides of her breast, welts came up on right ear and behind neck. On 31Dec2020, welts under buttocks and behind knees, welts were large and red. Rash on lateral breasts: felt a bit of itching. The patient had blotchy rashes, rash up in her hair above her neck and back of ear, had intense itching; which subsided. It was a little pink on her chest, little itching on her head. Her ear was better.  Symptoms were most mild because she was still able to function. Clarified as not serious.  The patient was taking diphenhydramine (BENADRYL, Lot: SMF011, Exp: May2022) at 25mg every 3.5 to 4 hours, cortisone cream 10 Maximum Strength (Lot: 20K434, Exp: Sep2023) for rash and welts; and doing tepid soaks. It was tolerable and faded. Rash had subsided, but was a little red.  Her greatest concern was what to do in regards to the second dose in three weeks. The reporter considered events were related with COVID-19 Vaccine. The action taken in response to the events for sulfamethoxazole, trimethoprim was unknown. The outcome of events was unknown.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, SARS-CoV-2 antibody test, Urticaria
Clinical narrative: Rash on lateral breasts/felt a bit of itching.; blotchy rashes; Itchiness on Scalp; broke out in hives/welts came up on right ear and behind neck/welts under buttocks and behind knees, welts were large and red; Slight chills; Tenderness in injection arm; was just a little cold; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: PAA156571), via an unspecified route of administration in left deltoid on 28Dec2020 10:00 at 0.3 mL single for covid-19 immunization; sulfamethoxazole, trimethoprim (BACTRIM DS), at twice a day for 10 days for perineal cyst. The patient was on her last day of sulfamethoxazole, trimethoprim on the day she got the COVID-19 vaccine (28Dec2020). Medical history included perineal cyst, COVID-19 in Apr2020 with no problem, only had a cough. Husband had COVID-19 and had loss of taste and smell, had fever, but he was not serious. Both her and her husband got tested for antibodies and were positive. Family medical history was none. The patient had unspecified flu vaccine (Lot: UJ428AB) on 18Dec2020 injected in left deltoid in two weeks prior to COVID-19 Vaccine.  Checked with three different people who stated the Flu vaccine would not interfere with COVID-19 Vaccine. Checked with two pharmacists who stated Bactrim DS would not affect her taking the COVID-19 Vaccine. She received COVID-19 Vaccine through her work in a nursing home.  There were no additional vaccines administered on same date of Pfizer suspect. On 28Dec2020 about 7 to 8 hours after vaccination, patient had slight chills and tenderness in her arm: was just a little cold. Thirty-six hours after injection, midnight on 29Dec2020, her scalp itched like crazy, broke out in hives. On 30Dec2020, rash developed on both lateral sides of her breast, welts came up on right ear and behind neck. On 31Dec2020, welts under buttocks and behind knees, welts were large and red. Rash on lateral breasts: felt a bit of itching. The patient had blotchy rashes, rash up in her hair above her neck and back of ear, had intense itching; which subsided. It was a little pink on her chest, little itching on her head. Her ear was better.  Symptoms were most mild because she was still able to function. Clarified as not serious.  The patient was taking diphenhydramine (BENADRYL, Lot: SMF011, Exp: May2022) at 25mg every 3.5 to 4 hours, cortisone cream 10 Maximum Strength (Lot: 20K434, Exp: Sep2023) for rash and welts; and doing tepid soaks. It was tolerable and faded. Rash had subsided, but was a little red.  Her greatest concern was what to do in regards to the second dose in three weeks. The reporter considered events were related with COVID-19 Vaccine. The action taken in response to the events for sulfamethoxazole, trimethoprim was unknown. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: whole family started to get sick and experiencing same things she experienced (chills, not feeling well); whole family started to get sick and experiencing same things she experienced (chills, not feeling well); This is a spontaneous report from a contactable consumer (patient's daughter). This consumer reported similar events for two patients. This is the second of two reports.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Caller reported her mom received COVID vaccine on the 23Dec2020. On the 29Dec2020, her whole family started to get sick and experiencing the same things she experienced (chills and not feeling well). The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Really bad dizziness; Headache; This is a spontaneous report from a contactable consumer(patient). A patient of an unspecified age and gender received first dose BNT162B2, via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The medical history and concomitant medications were not reported. The patient got the vaccine today, the first dose, and the patient just had really bad dizziness and headache ever since in Dec2020. The patient was reading the side effects and it said that it can be a severe reaction. The patient didn't have any of the other severe side effects. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dysuria, Micturition urgency, Pollakiuria, Urinary tract infection, Urine analysis
Clinical narrative: Developed UTI symptoms of burning in urination and frequency and urgency; Developed UTI symptoms of burning in urination and frequency and urgency; Developed UTI symptoms of burning in urination and frequency and urgency; Developed UTI symptoms of burning in urination and frequency and urgency; This is a spontaneous report from Pfizer-sponsored program. A contactable Other HCP reported for a nurse (patient). An adult female patient received bnt162b2 (batch/lot number and expiration date not provided), via an unspecified route of administration, first dose on an unspecified date, at single dose, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter has a patient and the patient is having the symptoms of UTI after the patient got the first dose of COVID-19 vaccine on Monday. The patient who is a 30 year old female (Age at the time of adverse event was not confirmed) who got her vaccine on Monday. She is a nurse and she developed urinary tract infection (UTI) symptoms of burning in urination and frequency and urgency and a urine sample was sent for evaluation, if it is positive the patient was wondering if the vaccine response would be altered by taking antibiotics for UTI. The outcome of the events was unknown  Information on the lot/batch number has been requested
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Was diagnosed with the COVID-19 virus after receiving the COVID-19 Vaccine on 18Dec2020; Was diagnosed with the COVID-19 virus after receiving the COVID-19 Vaccine on 18Dec2020; This is a spontaneous report from a contactable Other Health Professional (patient) from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A 38 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 18Dec2020 at single dose in Deltoid Right for COVID-19 immunization. Medical history and concomitant medications were none. After receiving the COVID-19 Vaccine, the patient was diagnosed with the COVID-19 virus on 28Dec2020. she saw Dr. at the clinic where she works to seek treatment. She stated she is supposed to receive the 2nd dose of the COVID-19 Vaccine on 08Jan2021. She asked now that she is COVID-19 positive, should she get the 2nd COVID-19 Vaccine dose. Reported she had a rapid nasal swab COVID-19 test performed. Reported she is taking Hydroxychloroquine and a bunch of vitamins for treating COVID-19. Caller stated she did not have the COVID-19 Vaccine card with her to provide the Lot Number. The patient underwent lab tests and procedures, which included COVID-19 rapid POC test with positive result. Outcome of event was unknown.   Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported COVID-19 based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Neck pain, Pain in extremity, Poor quality sleep
Clinical narrative: It is warm; Even up to the back of the shoulder to the neck is painful; Even up to the back of the shoulder to the neck is painful; Her whole arm is sore up to her neck and down the arm/It is very painful/it throbs; Last night she was up all night, every 3 hours; This is a spontaneous report from a contactable consumer (patient).  A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL1284, expiration date Apr2021), via an unspecified route of administration at left arm on 30Dec2020 09:30 at single dose for COVID-19 immunization, at a hospital. The vaccine was not administered at military facility. The patient's medical history included ongoing asthma from 2005 (diagnosed 15 years ago) and allergies. For asthma She has ProAir rescue inhaler to use as needed. Breo inhaler she uses at night. She has been on it for 2 years. She has been on different inhalers. Family medical history relevant to events was reported as none. Concomitant medication included montelukast sodium (SINGULAIR) from 2005 (had been on it probably 15 years) and ongoing at 10 mg, daily for allergies; fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA) inhaler via resp Inhalation from 2018 (has been on it for 2 years), uses it at night, for asthma; and salbutamol sulfate (PROAIR HFA) rescue inhaler via resp Inhalation, to use as needed for asthma. The patient had no history of previous immunization with the Pfizer vaccine. For historical vaccine, the patient received Tetanus for immunization and had allergic to Tetanus, her arm swelled and she couldn't move it (which was kind of like this, but not as severe).  She didn't know the brand name for the tetanus vaccine she had reaction to. She didn't have NDC, lot, or expiry. It was 40 years ago. She had the reaction when she was 18 years old. There was no vaccine administered on same date of the Pfizer suspect, and tno vaccinations within 4 weeks prior to the Pfizer suspect. It was reported that last night (30Dec2020) she was up all night, every 3 hours. She was taking Advil. Her whole arm was sore up to her neck and down the arm. She had a nurse look at it this morning (31Dec2020) and it was not red. It was warm and it throbs. No rash. It was very painful. Even up to the back of the shoulder to the neck was painful. Her arm being sore and painful was ongoing at the time of report. She had been taking Advil. The pain had stayed the same even with the Advil. The events started probably between 14:00 and 14:30, it started off sore then became more painful. At the time of reporting, she was not at home and didn't have the bottle to provide NDC, lot, and expiry for Advil. She was taking some at the office, but that was in a travel bottle and didn't have the lot, expiry, and NDC. No emergency room or physician office visit. Relevant tests was none. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate increased, Swelling
Clinical narrative: Short of breath; Heartbeat is fast; Feels like she has some swelling; This is a spontaneous report from a non-contactable consumer. This consumer reported for a 30-year-old female patient (daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch unknown) via an unspecified route of administration on 31Dec2020 11:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the vaccine today at her place of work and at the moment she did not have any side effects. But now during the night she was feeling short of breath and her heartbeat was fast and she felt like she has some swelling and some other more severe side effects that were put on the paperwork and reporter was wondering she was not acutely ill in spite of being short of breath. But she was worried about if she could get worse. So, would it be wise for reporter to give her Benadryl if this is an allergic reaction. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was unknown), via an unspecified route of administration on 28Dec2020 09:00 at single dose for covid-19 immunization. The patient had no medical history. The patient's concomitant medications were not reported. The patient calling concerning the vaccination, the patient received vaccination on this past Tuesday which was 28Dec2020 and the patient had recently just recovered from Covid and the patient asked the person giving her/him the vaccination it was okay since the patient just recovered from Covid to have it. She said yes. The patient could have it. Since last Tuesday (28Dec2020) the patient got the vaccination at 9 AM in the morning. The patient did fine all during the day. That night the patient started to run fever (in Dec2020) and the patient kept on fever all of that night, yesterday (30Dec2020) and today (31Dec2020) and the patient was just curious if this was normal. Yesterday (30Dec2020) because the patient thought may be she/he should go have the test again for Covid, the patient's normal nurse practitioner, doctor said no, but the patient probably shouldn't take the second vaccine, so that's what the patient's question is and the patient what to know if there are going to have an adverse reaction. The patient underwent laboratory test included only the Covid test on an unspecified date. The outcome of the event was unknown. Information on lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Headache; Sore throat; This is a spontaneous report from a contactable nurse (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had a vaccine received this afternoon on 30Dec2020, 4 to 5 hours after, she was having a headache and had sore throat as well. The patient wanted to know if it was okay to take Tylenol. The outcome of events was unknown.  No follow-up attempts are possible; Information on Lot/Batch Number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a contactable consumer (patient). An adult male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. The patient experienced soreness at injection site in Dec2020. Since the vaccination, it was unknown had patient been tested for COVID-19. The outcome of the event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I think it helps in my pain that I used to have; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0140), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunization. Medical history included pain from an unknown date. The patient's concomitant medications were not reported. The patient got the vaccine on 29 and just at the site where patient got the needle, that is it and right now, it actually be going away, patient put hand up on it and didn't even feel it, patient was not throwing up, have no headache, no body ache. Patient was doing fine so far it is just 2 day, patient was not in any pain. Actually, patient think it help in pain that patient used to have. The occurrence date was Dec2020. The action taken in response to the event for bnt162b2 was not applicable. 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: Back pain, Bone pain, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Stiff neck; soreness in my arm; severe pain in neck; squeezing on a nerve; pain came from up head, under my clavicle and down my back.; pain came from up head, under my clavicle and down my back.; pain came from up head, under my clavicle and down my back.; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  When the patient tried to turn around to speak to nurse (reporter), she complained of a stiff neck. The patient had the same symptoms as nurse (reporter). The nurse stated "I got the Covid vaccine on 18Dec2020 and had soreness in my arm that was gone by the next day. On 23Dec2020, while driving home driving home, I felt severe pain in neck. I almost felt like something went up in my neck and started squeezing on a nerve. It proceeded to get bad so I took muscle relaxants. Christmas day was horrible, I couldn't lift my head off my pillow. The pain came from up head, under my clavicle and down my back. " The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nerve compression, Pain in extremity
Clinical narrative: Stiff neck; soreness in my arm; severe pain in neck; squeezing on a nerve; pain came from up head, under my clavicle and down my back.; pain came from up head, under my clavicle and down my back.; pain came from up head, under my clavicle and down my back.; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  When the patient tried to turn around to speak to nurse (reporter), she complained of a stiff neck. The patient had the same symptoms as nurse (reporter). The nurse stated "I got the Covid vaccine on 18Dec2020 and had soreness in my arm that was gone by the next day. On 23Dec2020, while driving home driving home, I felt severe pain in neck. I almost felt like something went up in my neck and started squeezing on a nerve. It proceeded to get bad so I took muscle relaxants. Christmas day was horrible, I couldn't lift my head off my pillow. The pain came from up head, under my clavicle and down my back. " The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Headache, Neck pain, Nerve compression
Clinical narrative: severe pain in neck; squeezing on a nerve; soreness in my arm; pain came from up head, under my clavicle and down my back; pain came from up head, under my clavicle and down my back; pain came from up head, under my clavicle and down my back; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the same symptoms as nurse (reporter). The nurse stated "I got the Covid vaccine on 18Dec2020 and had soreness in my arm that was gone by the next day. On 23Dec2020, while driving home driving home, I felt severe pain in neck. I almost felt like something went up in my neck and started squeezing on a nerve. It proceeded to get bad so I took muscle relaxants. Christmas day was horrible, I couldn't lift my head off my pillow. The pain came from up head, under my clavicle and down my back. " The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: severe pain in neck; squeezing on a nerve; soreness in my arm; pain came from up head, under my clavicle and down my back; pain came from up head, under my clavicle and down my back; pain came from up head, under my clavicle and down my back; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had the same symptoms as nurse (reporter). The nurse stated "I got the Covid vaccine on 18Dec2020 and had soreness in my arm that was gone by the next day. On 23Dec2020, while driving home driving home, I felt severe pain in neck. I almost felt like something went up in my neck and started squeezing on a nerve. It proceeded to get bad so I took muscle relaxants. Christmas day was horrible, I couldn't lift my head off my pillow. The pain came from up head, under my clavicle and down my back. " The outcome of events was unknown.  Information on Lot/Batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Nausea, Pyrexia
Clinical narrative: intermittent fever; diarrhea; chills; nausea; This is spontaneous report from a non-contactable other health professional. An adult female patient (occupation: Nurse, not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), intramuscularly at the age of 36-year-old (age at the time of vaccination) on 28Dec2020 at single dose at left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that 2 days later (30Dec2020): diarrhea, chills, nausea, intermittent fever. The events were non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was unknown.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: slight shortness of breath all lasting over 1 week; Extreme chills; extreme fatigue and tiredness; whole body muscle aches; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received bnt162b2 (batch/lot number and expiration date not provided, not available/provided to reporter at the time of report completion), via an unspecified route of administration, at arm left, first dose on 23Dec2020 09:15, at single dose, for COVID-19 immunization. No relevant medical history. No known allergies to medications, food, or other products. There were no concomitant medications. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced extreme chills, extreme fatigue and tiredness, whole body muscle aches, slight shortness of breath all lasting over 1 week, all from 23Dec2020 16:15. The adverse event result in doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse event. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (test type: Nasal Swab, test name: rapid test): negative, on both 27Dec2020 and 30Dec2020. The outcome of the events was not recovered.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm soreness around injection site of vaccination; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on an unspecified date at single dose in the arm for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient's arm soreness around injection site of vaccination. Event took place after use of product. Outcome of event was unknown.    Information on the lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Bone pain, Cough, Feeling abnormal
Clinical narrative: Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; Pale; I felt weak; Bones ache; Have not been feeling good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 28Dec2020 at single dose on arm for suppress the COVID-19 (COVID-19 immunization). The patient's medical history included blood pressure, stomach ulcer and psoriatic arthritis. The concomitant drug was reported as colecalciferol (VITAMIN D), potassium citrate, multivitamin, etanercept (ENBREL) at once a week, pen shot in stomach, omeprazole (PROTONIX) at once a day for stomach ulcer and blood pressure medications. The patient was a correction officer, patient work at the prisons in (state name) and were given vaccination of Pfizer on Monday and he did that on Monday and have been getting sick and it's getting worse everyday, so yesterday at work everything was fine and he went home at 8 'O' clock at night because he was getting pale, felt weak, bones ache and have not been feeling good and today he called it in because he woke up with the cough, flu like symptoms. And it's worse today than it was yesterday. Consumer stated today, bones ache was worsening of like weaker, it hurts to walk and bone ache was really, today was worse than yesterday for the bone. Today flu like symptoms was worse, today patient have more heavier cough, was coughing more today and have a stuffed up nose, I did not have it yesterday. Wanted to know if this was a side effect or is that normal with that vaccine. Start date of events was on 28Dec2020. When patient started feeling some symptoms that started getting progressively worse on 29Dec2020. Treatment included Tylenol for bone pain and hurts to walk. Lab test blood work done in Dec2020, once a month through psoriatic arthritis doctor. The outcome of events, weak, Bone pain, Cough, Flu like symptoms, was not recovered. The outcome of other events was unknown.  Information on Lot/batch number has been requested.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Nasal congestion, Pain, Pallor
Clinical narrative: Cough; Flu like symptoms; It hurts to walk; I have a stuffed up nose, I did not have it yesterday; Pale; I felt weak; Bones ache; Have not been feeling good; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 28Dec2020 at single dose on arm for suppress the COVID-19 (COVID-19 immunization). The patient's medical history included blood pressure, stomach ulcer and psoriatic arthritis. The concomitant drug was reported as colecalciferol (VITAMIN D), potassium citrate, multivitamin, etanercept (ENBREL) at once a week, pen shot in stomach, omeprazole (PROTONIX) at once a day for stomach ulcer and blood pressure medications. The patient was a correction officer, patient work at the prisons in (state name) and were given vaccination of Pfizer on Monday and he did that on Monday and have been getting sick and it's getting worse everyday, so yesterday at work everything was fine and he went home at 8 'O' clock at night because he was getting pale, felt weak, bones ache and have not been feeling good and today he called it in because he woke up with the cough, flu like symptoms. And it's worse today than it was yesterday. Consumer stated today, bones ache was worsening of like weaker, it hurts to walk and bone ache was really, today was worse than yesterday for the bone. Today flu like symptoms was worse, today patient have more heavier cough, was coughing more today and have a stuffed up nose, I did not have it yesterday. Wanted to know if this was a side effect or is that normal with that vaccine. Start date of events was on 28Dec2020. When patient started feeling some symptoms that started getting progressively worse on 29Dec2020. Treatment included Tylenol for bone pain and hurts to walk. Lab test blood work done in Dec2020, once a month through psoriatic arthritis doctor. The outcome of events, weak, Bone pain, Cough, Flu like symptoms, was not recovered. The outcome of other events was unknown.  Information on Lot/batch number has been requested.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Pain, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Lost sense of taste; Lost sense of smell; Whole body is sore; Rapid test came back positive for COVID; Rapid test came back positive for COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) via a contactable consumer (patient). A 21-year-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730, expiration date: 31Mar2021), via intramuscular on 29Dec2020 07:40 at 0.3 mL, single dose on his left deltoid for covid-19 immunization. Medical history included allergic to wasp stings. There were no concomitant medications. The patient had no additional vaccines administrated on the same date and no prior vaccinations were received within 4 weeks. Caller on the line calling about the COVID Vaccine he received on 29Dec2020. The day after receiving it he woke up and had a loss of sense of smell on 30Dec2020 12:00. That afternoon he went to get tested and the rapid test came back positive for COIVD on 30Dec2020. He was now waiting on the other one, clarified to be the PCR test, the lab test. The next day he also lost his sense of taste on 31Dec2020 11:00 and his whole body feels sore on 30Dec2020 around noon. Transfer agent stated the caller needs to be transferred to Medical Information as he was scheduled to get the next shot on 19Jan2021 and he was calling to ask if he should proceed with that. It was reported that the patient works in a hospital (not an HCP). No emergency room was visited and no physician office was visited. The outcome of the event "rapid test came back positive for covid" was unknown, the outcome of the other events "lost sense of smell", "lost sense of taste", "whole body is sore" were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Report she had nausea 2 days after the shot; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had nausea 2 days after the shot on unknown date. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain
Clinical narrative: aches; chills; This is a spontaneous report from contactable nurse (patient) via a sales representative. A patient of unspecified age and gender started to receive BNT162B2 (also reported as "Pfizer COVID Vaccine"), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was given 2nd dose of the COVID vaccine and 24 hours later, the patient had aches and chills. The outcome of the events was unknown.    No follow-up attempts are possible. Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Palatal swelling, Product use issue, Swollen tongue
Clinical narrative: 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; 10 minutes after administration, back of tongue and soft palate started feeling strange sensation with some swelling; Other vaccine was received on same date vaccine date 30Dec2020; This is a spontaneous report from a contactable other healthcare professional (patient). A 52-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EJ1685), intramuscularly on 30Dec2020 at 12:30 PM on Right arm at single dose for COVID-19 immunization in hospital. Other vaccine was received on same date vaccine date 30Dec2020. The patient medical history included known allergies: Shellfish. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, or any other medications within two weeks of vaccination. The patient experienced 10 minutes after administration on 30Dec2020 at 12:40 PM, back of tongue and soft palate started feeling strange sensation with some swelling. After 30 minutes, the sensation eased up but the swelling stayed the same, not getting any worse. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of the events included diphenhydramine hydrochloride (BENADRYL). The outcome of the event 'feeling strange sensation' was recovering, outcome of events 'back of tongue and soft palate swelling' was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headaches; This is a spontaneous report from a contactable consumer from a Pfizer Sponsored Program. A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Dec2020 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced severe headaches on an unspecified date. The event outcome was unknown.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Fever, dizziness / light headedness, servere muscle aches,  vomiting,  diarrhea,  sore throat, like I got a servere flu
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Fever, dizziness / light headedness, servere muscle aches,  vomiting,  diarrhea,  sore throat, like I got a servere flu
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; Golf ball size swelling below the injection site. Arm is red and itchy; This is a spontaneous report from a contactable other-HCP (patient). This 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly on 28Dec2020 14:30 at single dose on the left arm for COVID-19 immunization. Medical history included pulmonary embolism and known allergies: penicillin. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), vitamin b complex (VITAMIN B), ascorbic acid (VITAMIN C), colecalciferol (VITAMIN D), tocopherol (VITAMIN E), received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine administered was in Pharmacy or Drug Store. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Dec2020 14:45, the patient experienced golf ball size swelling below the injection site. Arm was red and itchy. No treatment received for the adverse event. Outcome of the events was recovering. This report was assessed as non-serious.   Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain, Pain in extremity, Swelling
Clinical narrative: Feels sore and little swollen; Arm soreness and feeling crummy like does not feel good; Arm soreness and feeling crummy like does not feel good; Feels sore and little swollen; This is a spontaneous report from a Pfizer-sponsored program from a contactable Nurse (patient).  A 34-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot #: EK9231), on an unspecified date at single dose on arm for COVID-19 immunisation.  Medical history included asthma. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR), took one puff twice a day and it's 100 over 50. The patient took the Covid vaccine. Her arm was feeling sore and she feels a little crummy after the vaccine like she feel crummy like she does not feel good. She wanted to know if she could take Tylenol because of her arm soreness and feeling crummy. It feels really sore and little swollen yeah. The outcome was unknown.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Cervical lymphadenopathy, developing over 2 weeks; This is a spontaneous report from a contactable physician reported for herself. This 27-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on an 17Dec2020 12:45 PM on left arm at single dose (Lot # EX5730) for covid-19 immunisation. No other vaccine in four weeks. The patient experienced cervical lymphadenopathy on 23Dec2020, developing over 2 weeks. No treatments were received. Outcome of the event was recovering.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Itching; Redness; Swelling; it felt hot; This is a spontaneous report from a contactable other Nurse(patient).  The 43-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration by injection in the right deltoid on 21Dec2020 at single dose to protect herself from getting COVID.  Medical history included ongoing chronic sinusitis , ongoing seasonal allergy.  Concomitant medication included ongoing cephalosporin for Chronic sinusitis from 29Dec2020 which was the only thing new that she has been taking, but she had taken it in the past many times, ongoing cetirizine hydrochloride(ZYRTEC) for seasonal allergies, ongoing fluticasone propionate (FLONASE) for seasonal allergies which had been taking this for years.  She got her first dose of the COVID vaccine last Monday, the Monday before Christmas on 21Dec2020. Yesterday(30Dec2020), in the exact spot that she received it, she was getting itching, redness, and swelling. She read and was told that that could happen, she just thought it would be sooner rather than 9 days later. She was calling to get this reported. Otherwise, she is fine. She had been using antihistamines and cortisone cream as treatments. She had been taking cetirizine hydrochloride for years. She normally took at night, but because of her arm she took it this morning.Last night(30Dec2020) she also put ice to the are as it felt hot.  Outcome of events was not recovered. Events(itching, redness, and swelling) were assessed as non-serious.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Headache, Musculoskeletal stiffness
Clinical narrative: "Tightness in lungs/chest", stiff neck, headache
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Eye pain, Fatigue, Headache
Clinical narrative: muscle aches; eyes watering and won't stop; Neck pain; feeling tired; eyes hurt; feels very weak; headache; Nausea; left arm numbness; left arm tingling; left hand numbness/left side of face and head numb; left hand tingling; Dizziness; This is a spontaneous report from a contactable consumer (patient).  A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL1284), intramuscular on 30Dec2020 04:45 at single dose at left deltoid as Covid vaccine for coronavirus.  Medical history was none. There were no concomitant medications. The patient stated that she had Covid vaccine. She had dizziness, headache, nausea, left arm hand numbness and tingling, feels very weak, left side of face and head numb, all on 30Dec2020, neck pain and feeling tired, muscle aches, eyes watering and won't stop, eyes hurt in the morning, all on 31Dec2020. Treatment was None. Headache, eyes watering and won't stop, feels very weak and tired, eyes hurt was reported as worsened. Outcome of Nausea, left arm numbness was recovering, of other events were not recovered.