chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Shoulder was a little sore; Arm soreness; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; itchiness, a rash, and a big area of redness on her left arm which was the injection arm; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the first of two reports.  A 69-year-old female patient (wife) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number reported as "ELI283 or EL1283"), via an unspecified route of administration on 30Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure (abnormal) and cholesterol (abnormal). Concomitant medications included blood pressure medication and cholesterol. The consumer was reporting on behalf of his 69 year old wife. She received the first dose of the BNT162B2 vaccine on 30Jan2021. On 06Feb2021, she started to experience itchiness, a rash, and a big area of redness on her left arm which was the injection arm. He stated he heard that the second dose can cause more side effects and he stated they both experienced arm soreness after the first dose on an unspecified date. Consumer stated, first of all thank you guys for making this vaccine. He and his wife received the vaccine (unspecified vaccine) their first dose last Saturday, a week ago yesterday and had no reaction to it at all, their shoulder was a little sore but that's it. Yesterday night, last night his wife noticed that the arm where she had the vaccination it has like a rash and he knows this online that Moderna has something called COVID arm but it doesn't say anything about Pfizer. He meant it's not to bother it itches a little bit you put some anti-itch cream on it wasn't a big deal. He was kind of concerned about the next you know they got the next one coming on the 18th, so, does she should change arm, do it on the other arm. Consumer added that that would be fine, he knows you guys want to know if there was any reaction so that you can log it in and that was basically why he called. They were going for their next shot they were going to the hospital and there were professionals there so pretty much ask them what they should do. Should they change arm or nothing to worry about if they do it again that was not the problem he just wanted to let you guys know that there was some kind of reaction a rash. Consumer stated he just put Cortaid cream on it and itch went away. The patient underwent lab tests and procedures which included lab work on 27Jan2021: doctor did for cholesterol, blood pressure reasons and everything was fine. The outcome was recovered for the event itchiness; and unknown for the rest of the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021170691 same reporter and drug, similar events, different patient
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Subsequently a patient who received the vaccine reported temporary paralysis at the injection site/The caller also describes the event as muscle soreness, not paralysis; This is a spontaneous report from a contactable two consumers. A 53-years-old female patient received bnt162b2 (Solution for injection, Batch/lot number: EL9262) via an unspecified route of administration from an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller reporting on the COVID 19 vaccine and who explains they had 2 vials on Tuesday that had little black specks that were noticed in them after the diluent was injected. The nurse caught one of the vials and discarded it but the other vial, 1-2 doses were administered before the black specks were noticed. Subsequently a patient who received the vaccine reported temporary paralysis at the injection site. This patient might have been the recipient of the dose with the little black specks in the vial. They need to report this. The original caller is (name) with a phone number of (phone number). The call is then handed to the Reporter as he has the information on the even to provide. Reporter explains that they have not contacted the patient and would like to speak with the doctor before providing patient contact details. It is explained that think they are able to determine whether the patent received the dose from this vial but they need to do some research and that has not been done at this point. The do not want to provide any details for the patient at this time other than what is populated. The caller also describes the event as muscle soreness, not paralysis. The outcome of the event was unknown. .
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm pain; This is a spontaneous report from a contactable pharmacist (patient himself). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EK5730) intramuscularly on 22Dec2020 04:30 PM at single dose in left arm for COVID-19 immunization at Hospital. Medical history included ulcerative colitis, ADHD (Attention deficit hyperactivity disorder), prediabetes and high cholesterol. Allergies to medications, food, or other products were none. 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. Concomitant medications included mesalazine (LIALDA), methylphenidate hydrochloride (CONCERTA), cetirizine hydrochloride (ZYRTEC), vitamin d, citalopram, atorvastatin. The patient experienced arm pain on unknown date. No treatment received for the adverse event. Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was recovered on unknown date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Vomiting
Clinical narrative: feeling unwell; chills; throwing up food a couple of times; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced feeling unwell, chills, throwing up food a couple of times in Feb2021. The outcome of the events was unknown.   Information about batch/lot number has been requested.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Somnolence, Tenderness
Clinical narrative: I felt quite tired and sleepy the day after being vaccination; I felt quite tired and sleepy the day after being vaccination; My arm didn't start getting sore/tender until the night, and soreness subsided within a day; My arm didn't start getting sore/tender until the night, and soreness subsided within a day; This is a spontaneous report from a contactable consumer. A 24 -year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 08Feb2021  11:30 on (Lot number: EM9810) via an unspecified route of administration in the left arm at SINGLE DOSE for COVID-19 Immunization in the hospital. The patient had no medical history and allergies to medications, food, or other products. The patients concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient didn't any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19. The patient stated he felt quite tired and sleepy the day after being vaccinated. His arm didn't start getting sore/tender until the night, and soreness subsided within a day. The events assessed as non-serious by the reporter. The patient didn't receive any treatment. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headache; This is a spontaneous report from a Pfizer-sponsored program.  A contactable consumer (Patient) reported that the female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Feb2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient got her vaccine this afternoon (on 06Feb2021) and after 30mins she experienced a severe headache and asking if she can take medicine like TYLENOL. The event outcome was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Insomnia, Myalgia, Nausea
Clinical narrative: felt dizzy; hip pain/extreme muscular and joint pain; nauseat; pale; Insomnia; extremely thirsty but not wanting water; extreme muscular and joint pain; This is a spontaneous report from a contactable nurse (patient) reported that a 32-year-old female patient (non-pregnant) received BNT162B2 (COVID 19, brand: Pfizer, lot unknown reason was Unable to locate or read the details) via an unspecified route of administration on 09Feb2021 at 13:15 on Right arm for Covid-19 immunization. Patient medical history was not reported. The patient received other unknown vaccines within 4 weeks prior to the COVID vaccine on 19Jan2021 on Left arm. Concomitant medications were not reported. Patient previously had allergies to medications, food, or other products: Tramadol. Covid test post vaccination (covid test type post vaccination was Nasal Swab). Covid test name post vaccination was Aeon, covid test date was 04Feb2021 and Covid test result was negative. The most recent COVID-19 vaccine was administered in Nursing Home/Senior Living Facility. It was reported that, on 09Feb2021 at 14:30, after injection 1 hour she felt dizzy and had hip pain, nauseat and pale. Insomnia, extreme muscular and joint pain. On a scale of 1-10, with 10 being the worst that evening after injection 2, that night while trying to sleep. Around 13.5 hours after injection the pain was about a 5 more uncomfortable then anything. 23 hours from injection pain at a 10. Mpap helpful with headache Advil effective for all pain to make it tolerable, cyclobenzaprine slightly effective. Have no eaten since last night, extremely thirsty but not wanting water on 09Feb2021 at 14:30. No seriousness criteria was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with Test Aeon. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pallor, SARS-CoV-2 test, Thirst
Clinical narrative: felt dizzy; hip pain/extreme muscular and joint pain; nauseat; pale; Insomnia; extremely thirsty but not wanting water; extreme muscular and joint pain; This is a spontaneous report from a contactable nurse (patient) reported that a 32-year-old female patient (non-pregnant) received BNT162B2 (COVID 19, brand: Pfizer, lot unknown reason was Unable to locate or read the details) via an unspecified route of administration on 09Feb2021 at 13:15 on Right arm for Covid-19 immunization. Patient medical history was not reported. The patient received other unknown vaccines within 4 weeks prior to the COVID vaccine on 19Jan2021 on Left arm. Concomitant medications were not reported. Patient previously had allergies to medications, food, or other products: Tramadol. Covid test post vaccination (covid test type post vaccination was Nasal Swab). Covid test name post vaccination was Aeon, covid test date was 04Feb2021 and Covid test result was negative. The most recent COVID-19 vaccine was administered in Nursing Home/Senior Living Facility. It was reported that, on 09Feb2021 at 14:30, after injection 1 hour she felt dizzy and had hip pain, nauseat and pale. Insomnia, extreme muscular and joint pain. On a scale of 1-10, with 10 being the worst that evening after injection 2, that night while trying to sleep. Around 13.5 hours after injection the pain was about a 5 more uncomfortable then anything. 23 hours from injection pain at a 10. Mpap helpful with headache Advil effective for all pain to make it tolerable, cyclobenzaprine slightly effective. Have no eaten since last night, extremely thirsty but not wanting water on 09Feb2021 at 14:30. No seriousness criteria was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 with Test Aeon. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Bladder pain, Blood test, Blood thyroid stimulating hormone
Clinical narrative: a lot of pain; Abdominal pain/The pain that radiated down her right leg; a lot of cramp in her stomach, like the bladder area, more like period cramps; a lot of cramp in her stomach, like the bladder area, more like period cramps; tingling; she missed her regular menstruation period.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 24 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot number EJ1686, at the age of 23 years) via an unspecified route of administration on 06Jan2021 and second dose (lot number unknown, at the age of 24 years) on 27Jan2021 both at single dose for COVID-19 immunisation. The patient previously received a depo-provera shot in 2020 and her experience was similar to that no period and cramping. The patient's concomitant medications were reported as none. The patient missed her regular menstruation period. She said she was 16 days late but she was not sexually active, she never had this problem ever in her life. She was supposed to have her menses on 18Jan2021 that was when every month on the 18th, but never did get a period in Jan. she also mentioned she got some negative results for pregnancy tests. She did talk to her primary care doctor and 'OB' (not clarified) doctor on Thursday and they did do the blood work to see her hormone level and then they did do the urine exam. So, it was okay. She talked to infection disease doctor that worked at the hospital. She was scheduled for an ultrasound 11Feb2021. Since she got the vaccine, she was having a lot of pain, abdominal pain. She had a lot of cramp in her stomach, like the bladder area, more like period cramps; It came in and goes and then she thought it was normal and it had been progressive every day. Tingling and pain. She had been taking ibuprofen for her pain but she had stopped taking it now, didn't want to dull the pain, because she wanted to know when it resolves. She was just putting like ice on and then kind of lay down with it when it started. The pain that radiated down her right leg. The outcome of events a lot of pain and lot of cramp in her stomach, and especially down to the, like the bladder area was not recovered; events missed her periods, abdominal pain and tingling was unknown.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pain, Paraesthesia, Pregnancy test, Urine analysis
Clinical narrative: a lot of pain; Abdominal pain/The pain that radiated down her right leg; a lot of cramp in her stomach, like the bladder area, more like period cramps; a lot of cramp in her stomach, like the bladder area, more like period cramps; tingling; she missed her regular menstruation period.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 24 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose (lot number EJ1686, at the age of 23 years) via an unspecified route of administration on 06Jan2021 and second dose (lot number unknown, at the age of 24 years) on 27Jan2021 both at single dose for COVID-19 immunisation. The patient previously received a depo-provera shot in 2020 and her experience was similar to that no period and cramping. The patient's concomitant medications were reported as none. The patient missed her regular menstruation period. She said she was 16 days late but she was not sexually active, she never had this problem ever in her life. She was supposed to have her menses on 18Jan2021 that was when every month on the 18th, but never did get a period in Jan. she also mentioned she got some negative results for pregnancy tests. She did talk to her primary care doctor and 'OB' (not clarified) doctor on Thursday and they did do the blood work to see her hormone level and then they did do the urine exam. So, it was okay. She talked to infection disease doctor that worked at the hospital. She was scheduled for an ultrasound 11Feb2021. Since she got the vaccine, she was having a lot of pain, abdominal pain. She had a lot of cramp in her stomach, like the bladder area, more like period cramps; It came in and goes and then she thought it was normal and it had been progressive every day. Tingling and pain. She had been taking ibuprofen for her pain but she had stopped taking it now, didn't want to dull the pain, because she wanted to know when it resolves. She was just putting like ice on and then kind of lay down with it when it started. The pain that radiated down her right leg. The outcome of events a lot of pain and lot of cramp in her stomach, and especially down to the, like the bladder area was not recovered; events missed her periods, abdominal pain and tingling was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a non-contactable consumer (patient) from a sponsored program. A female patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration in Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea on an unspecified date. Reported as: Caller got the vaccines on Jan, wanted to cancel appointment because they have Diarrhea. The outcome of the event was unknown.  No follow-up attempts are possible, information on batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Tested positive before 2nd dose; Tested positive before 2nd dose; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported a female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unknown date, the patient tested positive for COVID-19 before the second dose of BNT162B2. The outcome of tested positive before 2nd dose was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscular pain; This is a spontaneous report from a Sponsored Program from a contactable consumer reported for her relative. A female patient of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got the first dose and after 4 hours took Percocet due to muscular pain. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report from a Pfizer-sponsored program . A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was taking the high blood pressure medication every morning ever since she took the vaccine. She was asking if it was possible to take her high blood pressure medication (hydrochlorothiazide) before she would take the second dose. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Suffering from a migraine; Slight headache; This is a spontaneous report from a sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 06Feb2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included acetylsalicylic acid, caffeine, paracetamol (EXCEDRIN). In Feb2021, the patient was suffering from a migraine; and had a slight headache. The outcome of the events, 'migraine' and 'slight headache', was unknown.  Information on lot/batch number has been requested.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Ear pain, Headache, Neck pain, Pain in extremity
Clinical narrative: I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; torn rotator cuff; I have a slight headache in the back of my head too; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9262), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included High blood pressure. Concomitant medication included olmesartan medoxomil for high blood pressure and pravastatin sodium. The patient stated she was 91 years old and that was why she got the first shot of the Covid19 vaccine Pfizer about 10 days ago (27Jan2021). Last night (05Feb2021) she had such pain all night and she still had it. It was all around her neck and up to the top of the ears and then her right shoulder down the front and to the back, she had a torn rotator cuff there and all the way down to her fingertips she had pain. Event onset last night, during the night. Like 9 days well, coming into the 10th day. She did not know why she have it. It was fine until last night and now it was terrible. She had a slight headache in the back of her head too on an unspecified date in 2021. She had been taking Tylenol and put some Icy Hot, you rub it on when you have pain but it did not do anything. She wanted to know will she get the same type of reaction when she get the second shot. There was no expiration date on it. There was nothing else. The outcome of the event slight headache in the back of head was unknown and the outcome of the other events was not recovered.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Rotator cuff syndrome
Clinical narrative: I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; I had such pain all night and I still have it. It is all around my neck and up to the top of the ears and then my right shoulder down the front and to the back and all the way down to my fingertips; torn rotator cuff; I have a slight headache in the back of my head too; This is a spontaneous report from a contactable consumer (patient). A 91-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL9262), via an unspecified route of administration on 27Jan2021 at single dose for COVID-19 immunization. Medical history included High blood pressure. Concomitant medication included olmesartan medoxomil for high blood pressure and pravastatin sodium. The patient stated she was 91 years old and that was why she got the first shot of the Covid19 vaccine Pfizer about 10 days ago (27Jan2021). Last night (05Feb2021) she had such pain all night and she still had it. It was all around her neck and up to the top of the ears and then her right shoulder down the front and to the back, she had a torn rotator cuff there and all the way down to her fingertips she had pain. Event onset last night, during the night. Like 9 days well, coming into the 10th day. She did not know why she have it. It was fine until last night and now it was terrible. She had a slight headache in the back of her head too on an unspecified date in 2021. She had been taking Tylenol and put some Icy Hot, you rub it on when you have pain but it did not do anything. She wanted to know will she get the same type of reaction when she get the second shot. There was no expiration date on it. There was nothing else. The outcome of the event slight headache in the back of head was unknown and the outcome of the other events was not recovered.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Chest pain
Clinical narrative: Starting about middle of my chest up to my neck it started to get little bit bubbles on it and now it's just burning like crazy and it's starting around my ankles; It's like my chest is burned; This is a spontaneous report from a contactable consumer (patient). A 79-year-old Female patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9261), via an unspecified route of administration on 29Jan2021 at SINGLE DOSE for COVID-19 immunization. Medical history included Atrial fibrillation (AFib) and back surgery (reported as: I am recovering from very serious back surgery) both from an unknown date and unknown if ongoing. Concomitant medication included methotrexate (reported as , it's a little cancer pill (Further clarification was unknown if consumer have cancer, hence cancer was not captured in medical condition), once a week), tocilizumab (ACTEMRA) (reported as I am on IV Infusions every 4 weeks and the name of it is Actemra), apixaban (ELIQUIS) (reported as I am on Eliquis because I am AFib, heart), and then another heart medicine plus all the patient's 'vitamins' (unspecified). The patient previously took oxycodone and experienced allergy (reported as I can't take any of those drugs, I am allergic to all that stuff. Yeah I can't take any of that pain medicine (Unspecified Medications)). The patient stated that: "I was calling about the, I had my first shot for the virus and on my chest, starting about middle of my chest up to my neck it started to get little bit bubbles on it and now it's just burning like crazy and it's starting around my ankles. Does that have anything to do with that shot?" The reporter confirmed that the next shot is due on 22Feb2021. The patient added that, "Actually last week they were really light, and they just keep getting worst. I was actually going to call my doctor tomorrow because I was concerned about getting this injection anyways because of my history on having reactions to medicine. I can't take any like Oxycodone or like any of those (also reported as "I can't take any of those drugs, I am allergic to all that stuff. Yeah I can't take any of that pain medicine (Unspecified Medications). No, I don't have anything like that."). I can't take any of those drugs (Unspecified Medications). And she said she thought it would be alright but I am recovering from very serious back surgery and so I have had a hard time with that. So, I thought I should call and see if I should get my second injection or if I should just let it go." It was also reported that:  "Yes, it's like my chest is burned." Consumer stated for the treatment, "The only thing I put on was Benadryl cream. To keep it from 'itching'." The patient asked "Should I get the second injection?" The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity, Skin irritation
Clinical narrative: some arm irritation/ pain; some arm irritation/ pain; felt dazed; This is a spontaneous report from a non-contactable consumer (patient) . A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 06Feb2021 at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the vaccine yesterday (06Feb2021) and that it went well - only had some arm irritation/ pain and felt dazed on an unspecified date in Feb2021. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: diagnosed positive for COVID/ tested positive for COVID virus; This is a spontaneous report received from two contactable consumers (patient and patient's husband) via the sponsored program medical Information Team. The consumers reported similar events for 2 patients. This is the 1st of 2 reports.   A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's first dose was a week before his (husband), so a week before 21Jan2021, she received her vaccine at work. She did not know the exact date of her first dose. She was diagnosed positive for COVID/ tested positive for COVID virus 2 days before he was diagnosed. She was diagnosed positive on either 21Jan2021 or 22Jan2021, she also did a test in which it gave her the test results the same day. She probably had the same type of test. Her antibody infusion was a couple days before him. The case was assessed as non-serious. The outcome of event was reported as unknown.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s): 2021144363 same reporter/drug/AE, different patient.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Movement disorder, Pain, Pyrexia, Urticaria
Clinical narrative: Feeling sick/doesn't feel very well; hives (on neck and shoulder); Feverish; Achy; cannot move; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history included "coronavirus" and allergies. The patient's concomitant medications were not reported. On an unspecified date, the patient was feeling sick and developed hives (on neck and shoulder). She wanted to know if she needs to get the second dose since she is afraid to have the side effects again. Patient was feeling feverish and achy, cannot move and doesn't feel very well on an unspecified date. She stated that the place where she received the vaccine had several sites set up. She got the first at one site. She is scheduled for her second dose at another site, but she read or heard it should be done at the same site. She wanted to know if it is safe to have the second shot. The outcome of the events was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, COVID-19, Cough, Drug ineffective
Clinical narrative: went for the rapid test/positive/have COVID; went for the rapid test positive/have COVID; No sense of taste or smell; No sense of taste or smell; Coughing; Fatigue extreme; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports, reporting for the husband. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 to 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing chronic fatigue syndrome. The patient's concomitant medications were not reported. The patient exhibited a lot of symptoms. And he by the way he complicated things. He got his shot, his first Pfizer shot on 20Jan2021, and then on the 24Jan2021 he left to go to (Name). He came home on the end of the week, he came on Friday. He was coughing and exhibiting extreme fatigue in Jan2021, but he also suffered from chronic fatigue syndrome and other underline situations, so he attributed to that. So he went ahead and they cohabitated and on Sunday the consumer started to get these symptoms. This past Wednesday (03Feb2021) he came to consumer and said he had no sense of taste or smell, and they knew what that meant. So, he immediately went to get a COVID test, but he had to wait. And then in the interim the consumer's situation pretty much stayed rather static, it didn't much change. Then on Thursday (04Feb2021) he said he was going for a rapid test, and consumer said wanted to go too. So, they went ahead and they went to an urgent care and they went for the rapid test and they were both been positive. They both had COVID. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145196 same reporter/product, different patient, similar event
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, SARS-CoV-2 test
Clinical narrative: went for the rapid test/positive/have COVID; went for the rapid test positive/have COVID; No sense of taste or smell; No sense of taste or smell; Coughing; Fatigue extreme; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is the second of two reports, reporting for the husband. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 to 20Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing chronic fatigue syndrome. The patient's concomitant medications were not reported. The patient exhibited a lot of symptoms. And he by the way he complicated things. He got his shot, his first Pfizer shot on 20Jan2021, and then on the 24Jan2021 he left to go to (Name). He came home on the end of the week, he came on Friday. He was coughing and exhibiting extreme fatigue in Jan2021, but he also suffered from chronic fatigue syndrome and other underline situations, so he attributed to that. So he went ahead and they cohabitated and on Sunday the consumer started to get these symptoms. This past Wednesday (03Feb2021) he came to consumer and said he had no sense of taste or smell, and they knew what that meant. So, he immediately went to get a COVID test, but he had to wait. And then in the interim the consumer's situation pretty much stayed rather static, it didn't much change. Then on Thursday (04Feb2021) he said he was going for a rapid test, and consumer said wanted to go too. So, they went ahead and they went to an urgent care and they went for the rapid test and they were both been positive. They both had COVID. The event outcome was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021145196 same reporter/product, different patient, similar event
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rhinorrhoea
Clinical narrative: chills; fever; runny nose; This is a spontaneous report from a contactable consumer from the Pfizer-sponsored program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date unknown), via an unspecified route of administration on 03Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose last 03Feb2021, then the next day 04Feb2021, she experienced chills, fever and runny nose. They gave her decongestant because of the runny nose. The reporter was asking if it's the side effect of the first dose. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested COVID-19 positive; This is a spontaneous report from a contactable consumer (patient).  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 01Feb2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that received her first vaccine shot on 01Feb2021 and she tested COVID-19 positive on 03Feb2021. Her second dose schedule is on 22Feb2021. The patient asked if she should still take the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain
Clinical narrative: sore throat; colds; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received second single dose BNT162B2 (Pfizer Covid-19 Vaccine, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on 01Feb2021 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took first single dose of BNT162B2 (Pfizer Covid-19 vaccine) on an unspecified date for COVID-19 immunization.The patient received 2nd dose on a Monday and tolerated the dose she received without adverse reaction. On an unspecified date in Feb2021 (last Friday) she had a sore throat and colds and was wondering if this was due to the weather. Patient wanted to know if she should be tested for Covid-19. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red rash all over her body; This is spontaneous report from a contactable consumer, the patient, via the Pfizer Sponsored Program.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient had a red rash all over her body. The clinical outcome of red rash all over her body was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had hives after taking the first dose of the covid-19 vaccine. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: mild fever after the first dose; This is spontaneous report from a contactable consumer (the patient) from a Pfizer-sponsored program. A female patient of an unspecified age received the first and second doses of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified dates (lot numbers not provided), both via an unspecified route of administration on unspecified dates (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she had a mild fever after the first dose. After her second vaccine yesterday (unspecified date), she had a very low-grade fever 99. She asked would she need to worry about contagious to anybody or was it normal? The clinical outcome of fever was unknown.  Information about lot number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight sore right arm in shot location; This is a spontaneous report from a contactable consumer, the patient. A 79-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; EL9267), via an unspecified route of administration in the right arm on 10Feb2021 at 00:30 (at the age of 79-years-old) as a single dose for COVID-19 immunization. Medical history included allergy to latex and penicillin, Afib, asthma and diabetes (under control with diet). Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On an unspecified date in Feb2021, the patient experienced a slight sore right arm in the shot location. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of slight sore right arm in shot location was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: pain on his lower back; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of unspecified age received first dose of BNT162B2, via an unspecified route of administration on 05Feb2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient took the 1st dose on 05Feb2021. After taking the 1st dose, he experienced pain on his lower back on Feb2021 and would like to know if he can take ibuprofen. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test; This is a spontaneous report received from a contactable pharmacist through a Pfizer-sponsored program. This pharmacist reported similar events for three patients. This is the first of the three reports.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 17Jan2021 at a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and patient's concomitant medications were not reported. On an unspecified date in 2021, the patient had COVID-19 confirmed by positive COVID-19 test, and was put on isolation. The outcome of the event, 'COVID-19 confirmed by positive COVID-19 test', was unknown. The reporting pharmacist was wondering the there was a need to hold off the second dose of vaccination.  Information on the lot/batch number has been requested.; Sender's Comments: The contributory role of the suspect product to the reported drug ineffective cannot be excluded as the efficacy of a drug varies individually and may be affected by different factors including drug potency.,Linked Report(s) : US-PFIZER INC-2021148567 same reporter/product/events, different patient;US-PFIZER INC-2021148568 same reporter/product/events, different patient;US-PFIZER INC-2021148567 same drug and event, different patient;US-PFIZER INC-2021148568 same drug and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Laryngitis
Clinical narrative: laryngitis; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration, on 21Jan2021, at single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In 2021, the patient experienced laryngitis. She was prescribed with prednisone for it, but she has not taken it yet. She was wondering if it will change the efficacy of the vaccine. The outcome of the event was unknown.  Information about the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Still have arm pain on the injection site; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration in the arm on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first shot on 20Jan2021 and still had arm pain on the injection site on an unspecified date in 2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nauseous; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced nauseous on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.