chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Nausea, Pain in extremity, Psychomotor hyperactivity, Rhinorrhoea
Clinical narrative: Nauseous; upset stomach; little tired; little lightheaded; Runny nose; little hyper; my heart rate was raising; Not my arm even hurt that much; I feel like cold; got sick; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 73-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number EN6203), via an unspecified route of administration, administered in Arm Left on 03Mar2021 (at age of 73-years-old) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included blood pressure, blood cholesterol and thyroid disorder. Concomitant medication(s) included nadolol (NADOLOL) taken for blood pressure, pitavastatin calcium (LIVALO) taken for blood cholesterol, levothyroxine (LEVOTHYROXINE) taken for thyroid disorder and amlodipine (AMLODIPINE) taken for blood pressure. The patient experienced nauseous, upset stomach, little tired, little lightheaded, runny nose, got sick and little hyper on an unspecified date. The patient reported that "When I got the vaccine I just felt a little tired, a little lightheaded, that was all I experienced". After vaccination: The arm did not bother her much, she felt just a little tired and had a runny nose "could be allergies". "On Saturday I felt the same way". On Sunday night: "I felt a little nauseous and felt a little hyper and my heart rate was raising but all went away and my stomach has been bothering me it felt like a virus (infection) but I feel better today". The patient stated, "I got my Covid shot on Wednesday and I don't, I don't "tired" (not clarified) whatever but I did not feel a bit, not my arm even hurt that much but yesterday I have a runny nose, I feel like cold and I felt the cold coming on and then last night it was very nauseous and I had both so it was very nauseous last night this was I had it Wednesday, so that was last night was Sunday night I felt a little nauseous I was wondering if that's the effect of the vaccine or maybe I got the cold.". The patient also stated "I am not experiencing the problem anymore. I just wanted to call up to see if that was a side effect, I had it last night and it went away, I just was curious if that was a side effects that was the reason of phone call." The patient didn't receive any treatment medication for the events. The events outcome was reported as recovered on an unspecified date of 2021.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Tremor
Clinical narrative: Severe chills; shaking like a leaf; This is a spontaneous report from a contactable Consumer. This Consumer reported for 83-years-old female patient (mother) that: A 83-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, NDC/UPC number: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date as DOSE 2, SINGLE for covid-19 immunization. Medical history included allergy, dementia with lewy Dementia, difficulty in walking and weak-all were from an unknown date and unknown if ongoing. It was reported that she just have difficulty in walking and she is very weak and I have to put her on a wheel chair. She has got Lewy Dementia (not appropriately paraphrased and clarified). Diagnosis date of Dementia: Probably a year ago. Concomitant medications included sertraline hydrochloride (ZOLOFT) taken for cognitive reasons, start and stop date were not reported (Reporter stated, Very small amount for her cognitive reasons) and clarithromycin (CLARITIN [CLARITHROMYCIN]) taken for allergy, start and stop date were not reported (Reporter stated, it was a just regular over the counter). On an unspecified date, the patient experienced severe chills and shaking like a leaf. Reporter stated, was just calling to let you all know that my mother had her second shot and she was having a reaction like she had chills, she was shaking like a leaf. She is 83 years old. She was sleeping right now. So was there anything else that we have to worry about. Anything serious. Reporter further stated, I guess I will take her to the ER if it is serious. Reporter was informed about role of Pfizer Drug Safety department and was provided with the number of Pfizer Medical Information Department. Reporter stated, she had severe chills today and I woke her up and she was shaking and now she is asleep. We gave her a Tylenol 600 and she is in sleep right now. Prescribing Healthcare professional details: Reporter stated, No, it was a regular facility. The patient received Tylenol 600mg as treatment for the adverse events. The outcome of events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: severe headaches; This is a spontaneous report from a contactable consumer or other non hcp.  A 70-years-old non- pregnant female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL9261; Expiration Date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 04Mar2021 09:15 (at the age of 70 years)as dose 2, single for COVID-19 immunisation. The patient took the historical BNT162B2 vaccine on 11Feb2021 as dose 1, single (Lot number: Unknown; Expiration Date: Unknown) for COVID-19 immunisation. Medical history included embolism, anaemia. Concomitant medications included losartan; apixaban; simvastatin; tizanidine; meloxicam. The patient previously took lisinopril for product used for unknown indication and experienced drug hypersensitivity. 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. Since the vaccination, the patient has not been tested for COVID-19. On 05Mar2021, 07:00 the patient experienced severe headaches. The clinical course of the event includes Beginning on Friday, 05Mar2021, the day after my second vaccine, my severe headaches began, lasting 24 hours a day for a total of 15 days, ending on Friday, 19Mar21. Completely disappeared on Saturday, 20Mar21 and did not return. Therapeutic measures were taken as a result of severe headaches with Hydrocodone-acetaminophen 5-325MG for pain. The clinical outcome of the event was resolved on 20Mar2021.   No follow-up attempts are possible, no information is required.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: severe vomiting; nausea; This is a spontaneous report from a non-contactable consumer (patient). A 17-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EW0153; Expiration date was not reported), first dose via an unspecified route of administration, administered in arm left on 10Apr2021 16:15 (at the age of 17-years) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy or Drug Store. Medical history included none. Had no known allergies. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. Other vaccines within 4 weeks prior to the COVID vaccine included none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced severe vomiting, nausea on 10Apr2021 22:00. The events were not serious. Therapeutic measures were taken as a result of the reported events. AE resulted in Emergency room/department or urgent care. AE treatment included IV fluids, nausea medication via IV. Clinical outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Pruritus, Pyrexia
Clinical narrative: Feverish; Sore shoulder; I was just feeling dizzy like sleepy the whole time after getting the vaccinated; Little itchy; Shivering; This is a spontaneous report from a contactable consumer (Patient). A 17-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW017), via an unspecified route of administration, administered in Arm Left on 21Apr2021(at the age of 17-years) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Consumer stated, "So we, my family took vaccination Pfizer vaccine on like 2-3 days ago at (pharmacy name withheld), me, my father, my mom and my brother, we took it, we three were able to get the side effects immediately after getting the vaccine like 2-3 hours we started getting like feverish and all that was normal, my brother he was started numb his hands were numb and his one leg is numb, and yesterday night he was even feeling pain in his arm but he just took a sleep because we couldn't contact anyone it was closed so he slept and today morning the pain is gone but the numbness is still there, so it was kind of change because none of us had this reaction, so we were little scared to like you know hence contacting Pfizer to the website that we had the number so we were hoping that we can get any solution is it normal if it's not what can we do?" On 21Apr2021 the patient experienced feverish with outcome of unknown, sore shoulder, I was just feeling dizzy like sleepy the whole time after getting the vaccinated, little itchy and shivering. Therapeutic measures were taken as a result of sore shoulder. Patient recovered from feverish. Patient was recovering from events I was just feeling dizzy like sleepy the whole time after getting the vaccinated and little itchy. The outcome of the event shivering was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Severe headache; This is a spontaneous report from a contactable other hcp. A 31-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6203) intramuscular, administered in Arm Left on 05Mar2021 15:15 as DOSE 1, SINGLE (at the age of 31-year-old) for covid-19 immunisation. Patient received bnt162b2, Batch/Lot number: ER8734, intramuscularly on 19Apr2021 06:30 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history included hypothyroidism, PCOS, polycystic ovaries, drug hypersensitivity (known allergies: Sulfa antibiotics). Concomitant medication(s) included levothyroxine (LEVOTHYROXINE); amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); metformin (METFORMIN). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that, on 05Mar2021 at 15:45 30 minutes after initial injection patient experienced severe headache that lasted about 12 hours. Therapeutic measures were taken as a result of severe headache. AE resulted in doctor or other healthcare professional office/clinic visit. AE treatment informed to take NSAIDs to help with total body discomfort. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fatigue; Fever; Chills; This is a spontaneous report from a contactable consumer (Patient). A 35-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection) via an unspecified route of administration, administered in right arm on 31Mar2021 (Lot Number: EN6206 and Expiration Date: Unknown, at the age of 35-year-old) as dose 2, single for COVID-19 immunization. Medical history included hypothyroidism, drug hypersensitivity, known allergies, Sulfa based medications, mollusks, allergy to animal known allergies, Sulfa based medications, hypertension. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously received dose 1 BNT162B2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6205) administered in right arm on 12Mar2021 12:45 PM and experienced raised rash about 2 in diameter, red, itchy. On 31Mar2021, the patient experienced fatigue, fever, chills. Patient did not receive any treatment. Outcome of all events was recovered on 04Apr2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Peripheral swelling
Clinical narrative: 1-2 days after the second vaccine, all joints became extremely painful/hips, shoulders, elbows and wrists extremely painful. Pain did not subside.; Hands became swollen; This is a spontaneous report from a contactable consumer or other non hcp.  A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6203), dose 2 via an unspecified route of administration, administered in Arm Right on 22Mar2021 (Age at vaccination: 60 years) as DOSE 2, SINGLE for covid-19 immunisation at hospital . The patient medical history was not reported. Concomitant medication(s) included aspirin [acetylsalicylic acid] 81 mg/day, taken for an unspecified indication, start and stop date were not reported: Rosuvastatin 5 mg/day. Historical vaccine included bnt162b2 (COMIRNATY) as dose 1 for covid-19 immunisation on 12Feb2021 with lot number EM9809 taken in right arm.  Patient did not receive any other vaccines in 4 weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. The patient experienced 1-2 days after the second vaccine, all joints became extremely painful/hips, shoulders, elbows and wrists extremely painful. pain did not subside, and hands became swollen on 23Mar2021. Therapeutic measures were taken as a result of 1-2 days after the second vaccine, all joints became extremely painful/hips, shoulders, elbows and wrists extremely painful. pain did not subside. (arthralgia), hands became swollen (peripheral swelling). Adverse event resulted  in doctors' office visit. Subsequently prescribed steroid for relief Methylprednisone (50 mg/day). Realized some relief, condition persists. The outcome of the events was recovering.   No follow-up attempts are required. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Malaise
Clinical narrative: Throwing up; Cold; chilled; feeling horrible; achy body; headache; no energy; extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 13:15 as dose 2, single for COVID-19 immunization. No other vaccine was received in four weeks. Other medication in two weeks. No COVID prior vaccination and not tested post vaccination. There are no known allergies. Medical history included osteoarthritis from an unknown start and stop date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:30 as dose 1, single for COVID-19 immunization and experienced ocular migraine. The patient experienced throwing up, cold, chilled, feeling horrible, achy body, headache, no energy and extreme fatigue on 22Apr2021 22:15. The patient underwent lab tests and procedures which included ophthalmological examination: unknown on an unspecified date. The adverse events were considered as non-serious. AE was resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of throwing up, cold, chilled, feeling horrible, achy body, headache, no energy and extreme fatigue included eye exam. The outcome of the events throwing up, cold, chilled, feeling horrible, achy body, headache, no energy and extreme fatigue recovered on 23Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Ophthalmological examination, Pain, Vomiting
Clinical narrative: Throwing up; Cold; chilled; feeling horrible; achy body; headache; no energy; extreme fatigue; This is a spontaneous report from a contactable consumer or other non hcp. A adult non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 22Apr2021 13:15 as dose 2, single for COVID-19 immunization. No other vaccine was received in four weeks. Other medication in two weeks. No COVID prior vaccination and not tested post vaccination. There are no known allergies. Medical history included osteoarthritis from an unknown start and stop date and unknown if ongoing. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 02Apr2021 12:30 as dose 1, single for COVID-19 immunization and experienced ocular migraine. The patient experienced throwing up, cold, chilled, feeling horrible, achy body, headache, no energy and extreme fatigue on 22Apr2021 22:15. The patient underwent lab tests and procedures which included ophthalmological examination: unknown on an unspecified date. The adverse events were considered as non-serious. AE was resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of throwing up, cold, chilled, feeling horrible, achy body, headache, no energy and extreme fatigue included eye exam. The outcome of the events throwing up, cold, chilled, feeling horrible, achy body, headache, no energy and extreme fatigue recovered on 23Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Contusion
Clinical narrative: there was pain in my joints (knees and hip); hematoma-like bruising on my palm after using a hammer (it disappeared after a couple days and left no residual markings).; This is a spontaneous report from a contactable nurse (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EL9267) dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 13:00 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus and allergy to Sulfa and Keflex. Concomitant medications included Canagliflozin (INVOKANA [CANAGLIFLOZIN]), Metformin (METFORMIN). It was reported that the patient received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 AM as DOSE 2, SINGLE for covid-19 immunisation and had hair on head is falling out/thinning, gums bled more than usual during dental cleaning, slight incontinence that seems to be worsening (not associated with toileting). On 01mar2021, the patient experienced there was pain in my joints and hematoma-like bruising on my palm after using a hammer (it disappeared after a couple days and left no residual markings).  The patient did not received treatment for the adverse events. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: headache; body aches; left arm pain at injection site; Fever of 99; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: ER8736), via an unspecified route of administration, administered in Arm Left on 06May2021 11:45 (at the age of 74-year-old) as dose 2, single for COVID-19 immunisation. Medical history included supraventricular tachycardia PSVT, Osteoporosis, PreDiabetes, osteoporosis, glucose tolerance impaired, known allergies-Shellfish, contrast dye, Paramenobenzoic acid (PAPA). Patient was not pregnant at time of vaccination. Historical vaccine received was first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EW0151), via an unspecified route of administration, administered in Arm Left on 13Apr2021 12:30 PM as dose 1, single for COVID-19 immunisation. Concomitant medications included verapamil (VERAPAMIL) taken for an unspecified indication. Patient did not receive other vaccine in four weeks of vaccination. Patient received other medications as Verapamil, vitamins in two weeks of vaccination. The patient experienced fever of 99 on 07May2021 18:30, on an unspecified date headache, body aches, left arm pain at injection site. Patient was not diagnosed with COVID, prior vaccination. Events were reported as non- serious. Lab test included body temperature: 99. No treatment received for the events. The patient recovered from fever of 99. The outcome for the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Pyrexia
Clinical narrative: Burning sensation of my inner foot and palm; Body ache; Fever; This is a spontaneous report from a contactable consumer (Patient itself). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, formulation: solution for injection, lot number: EW0182 and expiration date: not reported), via an unspecified route of administration on 05May2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was experiencing side effects of COVID Vaccine. The patient had fever and body ache on 06May2021. The patient had vaccine on last Wednesday and had 'fever' on Thursday, was okay on Friday and Saturday and on Sunday had fever and along with that also had burning sensation of inner foot and palm on 09May2021. The patient took Tylenol 500mg (dose) for fever and pain. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Insomnia, Nausea
Clinical narrative: Chills; aching joints; back pain; soreness at injection site; nausea; insomnia; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp received via a sales representative. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced chills, aching joints, back pain, soreness at injection site, nausea and insomnia. Event took place after use of product. At the time of this report the outcome of the events were unknown.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Chills; aching joints; back pain; soreness at injection site; nausea; insomnia; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp received via a sales representative. A patient of unspecified age and gender received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: ER8732) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, formulation: solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced chills, aching joints, back pain, soreness at injection site, nausea and insomnia. Event took place after use of product. At the time of this report the outcome of the events were unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Second day after the first dose she had a small amount of itching on her lower back; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient reported for herself). This case is for Dose 1. A 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 10Feb2021 as dose 1, single for covid-19 immunization. The patient medical history included lupus (Patient also had lupus and so also some skin problems anyway). Concomitant medications were not reported. Patient previously took two cortisone shots in her ankle one on 12Jan2021 and the second was on 08Feb2021 which was two days before she had her first covid shot. Patient reported that she had her first Pfizer covid 19 vaccines on 10Feb2021. she stated that patient did not have any immediate reactions, sat at the clinic for 20 minutes and then went home. She stated that she was fine until the second day after the first dose and had a small amount of itching on her lower back (12Feb2021) when she went to shower, but it went away. Reporter considered the event as non-serious. Outcome of the event was recovered on an unspecified date in Feb2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Stomatitis, Tongue eruption
Clinical narrative: pimples on end on end of tongue; big  pimples on right side of cheeks/pimples on end on end of tongue; lump  on side of throat; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on 18May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Patient reported that she received second dose on 18May, 24May she flew out of county for work travel and began to have the following symptoms: big pimples on right side of cheeks, lump on side of throat, pimples on end on end of tongue. The clinical outcome for the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: skin inflammation near the armpit, near the chest; This is a spontaneous report from a contactable pharmacist. A 40-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Reporter mentioned that patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine and experienced a skin inflammation near the armpit, near the chest when he got vaccinated and was told to wait until 4 weeks. It was unknown what kind of skin inflammation, only that the inflammation can be visually seen and this did not go away after a month. Patient went to the Doctor's office, went to order an ultrasound but said it would interfere with the vaccine. Upon checking, doctor said that it was nothing internal, only outside inflammation. Reporter stated that over the weekend, the inflammation got worse. Patient went to urgent care and was told that this was a common reaction. Patient was advised to wait 3-6 months. Reporter asked how long the skin inflammation would last, since they have been advised to wait for months for it to go away. The outcome of the event was not recovered.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Joint injury, Limb injury
Clinical narrative: Arm hurt; Diarrhea; Knees hurt; Cold; Had a temperature; Lightheaded; Tired; Memory was worsened; This is a spontaneous report from a non contactable consumer (Patient) or other non-HCP.  A patient of an unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Arm hurt, Diarrhea, Knees hurt, Cold, Had a temperature, Lightheaded, Tired and Memory was worsened. Additional Information: Consumer reported that she was connected to something last time that was to tell of certain symptom were ongoing out of one time happening and was somewhat disappointed and what she got for an answer. Her symptoms, had initial symptoms one day and after that had other things. She confirmed Pfizer Covid-19 vaccine. She stated that Well, she supposed to early to know how long this symptoms last and if more will appear because was put in some department last time and was not real happy with it. She was informed about the role of Pfizer drug safety. When she was probed for the experiences she had after the second shot, she stated that the first one was the day after the second shot and thought that all that was fairly normal. She was an arm hurt, diarrhea, my knees hurt, was cold and had a temperature. That was just the day after and then it was gone but the thing that have been continuing are, lightheaded it was there a day and then gone. May be a day or two very tired and then alright for little while and memory was worsened than that it was before. She stated that what she would like to know is the thing that she had in this product, has not been on the market long enough to know anything and was wandering if other people were having some of these same things. She had met two people that had the same thing that I have. When she was asked for further question stated, No and was given something else last time and they were to tell me some of the side effects. And she did not knew that the one they give her were an ongoing effect or just the first day affect and she was little bit disappointed in that because, she want to know if it was long term and we did not knew enough about this stuff to know, what was going to be happening or when it will disappear. She was informed about the medical information department and telephone number was shared. Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed as she was unwilling to share further information. Hence, further probing could not be done. Limited information available over the call. The clinical outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021688857 Same reporter/drug/events, different patients
Sex: U
Vaccine: COVID19
Symptoms: Memory impairment, Nasopharyngitis, Pyrexia
Clinical narrative: Arm hurt; Diarrhea; Knees hurt; Cold; Had a temperature; Lightheaded; Tired; Memory was worsened; This is a spontaneous report from a non contactable consumer (Patient) or other non-HCP.  A patient of an unspecified age and gender received dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced Arm hurt, Diarrhea, Knees hurt, Cold, Had a temperature, Lightheaded, Tired and Memory was worsened. Additional Information: Consumer reported that she was connected to something last time that was to tell of certain symptom were ongoing out of one time happening and was somewhat disappointed and what she got for an answer. Her symptoms, had initial symptoms one day and after that had other things. She confirmed Pfizer Covid-19 vaccine. She stated that Well, she supposed to early to know how long this symptoms last and if more will appear because was put in some department last time and was not real happy with it. She was informed about the role of Pfizer drug safety. When she was probed for the experiences she had after the second shot, she stated that the first one was the day after the second shot and thought that all that was fairly normal. She was an arm hurt, diarrhea, my knees hurt, was cold and had a temperature. That was just the day after and then it was gone but the thing that have been continuing are, lightheaded it was there a day and then gone. May be a day or two very tired and then alright for little while and memory was worsened than that it was before. She stated that what she would like to know is the thing that she had in this product, has not been on the market long enough to know anything and was wandering if other people were having some of these same things. She had met two people that had the same thing that I have. When she was asked for further question stated, No and was given something else last time and they were to tell me some of the side effects. And she did not knew that the one they give her were an ongoing effect or just the first day affect and she was little bit disappointed in that because, she want to know if it was long term and we did not knew enough about this stuff to know, what was going to be happening or when it will disappear. She was informed about the medical information department and telephone number was shared. Product details (NDC# UPC# and Treatment) and Pharmacy details could not be probed as she was unwilling to share further information. Hence, further probing could not be done. Limited information available over the call. The clinical outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021688857 Same reporter/drug/events, different patients
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, SARS-CoV-2 test
Clinical narrative: After he got the second shot, he had shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204, Expiry date: Unknown), via an unspecified route of administration, administered in right arm on 11Mar2021 (at the age of 78 years) as dose 2, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 30Jan2021 (at the age of 78 years) and experienced tested positive for COVID-19 on an unknown date in Feb2021. The patient experienced shortness of breath on an unknown date in Mar2021. As reported clinical course as, after he got the second shot, he had shortness of breath, but he had a history of COPD, so he was not so worried about that. He got the vaccine because he tested positive for COVID. He tested negative a couple of times, but then he went and got checked and it said positive. He was testing negative for COVID before getting the first dose of the vaccine, but he went to rehab and was tested, and tested positive for COVID in Feb2021. He left rehab on 11Mar2021, and he went that same day to go get his second dose of the product. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Feb2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Dizziness, Dyspnoea, SARS-CoV-2 test, Vertigo
Clinical narrative: After he got the second shot, he had shortness of breath; This is a spontaneous report from a contactable consumer (patient). A 78-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6204, Expiry date: Unknown), via an unspecified route of administration, administered in right arm on 11Mar2021 (at the age of 78 years) as dose 2, single for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9264, Expiry date: Unknown) via an unspecified route of administration, administered in right arm on 30Jan2021 (at the age of 78 years) and experienced tested positive for COVID-19 on an unknown date in Feb2021. The patient experienced shortness of breath on an unknown date in Mar2021. As reported clinical course as, after he got the second shot, he had shortness of breath, but he had a history of COPD, so he was not so worried about that. He got the vaccine because he tested positive for COVID. He tested negative a couple of times, but then he went and got checked and it said positive. He was testing negative for COVID before getting the first dose of the vaccine, but he went to rehab and was tested, and tested positive for COVID in Feb2021. He left rehab on 11Mar2021, and he went that same day to go get his second dose of the product. The patient underwent lab tests and procedures which included sars-cov-2 test: positive in Feb2021. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling of the lymph nodes on her neck and stuff; This is a spontaneous report from a contactable other Health Professional (parent).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Medical history included nodules in both breasts and got markers put in. There were no concomitant medications. On an unspecified date, the patient experienced swelling of the lymph nodes on her neck and stuff, the reporter stated that it was not a big thing not really turn into any things. The outcome of event was unknown.    Follow-up (04Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Vaccination site pain
Clinical narrative: Sore, for 5 months, at the site where he got his vaccine, after second dose.; Muscle pain, after second dose.; thought the pain would be gone; This is a spontaneous report from a contactable consumer(patient). A 93-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on 12Feb2021 (at the age of 92-years-old) at single dose for covid-19 immunisation in drug store. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (MANUFACTURER UNKNOWN, Batch/Lot Number and expiration date were not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation, the patient stated his first vaccination was perfect. The patient experienced sore, for 5 months, at the site where he got his vaccine and Muscle pain and pain after second dose. He thought the pain would be gone in a couple of days. The patient stated he had been to his doctor, and the doctor told him that she cannot do anything about his symptoms. The patient stated the doctor didn't do anything and told him to wait, maybe 6 months, he called the drug store, where he received the vaccine, and they told him they just give the vaccines, they don't make recommendations. The outcome of the events was unknown.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: feeling very fatigue; I also have a stuffy nose; I can only breathe through my mouth; I was feeling so cold; My chest started to hurt; I feel very dizzy/lightheaded; headache; I was sweating a lot; I have a fever; when I get up I feel like I'm going to pass out; I still feel very warm; felt like she was going to pass out; I feel very sick right now; My arm is sore; This is a spontaneous report from a contactable consumer(patient). An 18-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE Batch/Lot Number EW0186, expiration date was not reported) via an unspecified route of administration in the arm left on 14Jul2021 15:45(at the age of 18-years-old) at single dose for covid-19 immunisation at workplace clinic. The patient was not pregnant. The patient was not pregnant at time of vaccination. Medical history included asthma and known allergies for soda (get hives on body when consume it ) from an unknown date.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no list of any other medications received within 2 weeks of vaccination. The patient concomitant medication was reported as none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient got the Pfizer vaccine 2 days ago. the side effects started at 4:00 Am on 15Jul2021, about 12 hours after I received the vaccine. she was feeling so cold but body was very warm, chest started to hurt up until 3:00pm on 15Jul2021. she got up, she felt very dizzy, lightheaded and that had been going on since 12pm 15Jul2021, it is currently 1:39am 16Jul2021. She took a Tylenol around 3:45-4:00 15Jul2021 to relieve headache. She was feeling very fatigue at 8pm on 15Jul2021 so she fell asleep, woke up at 10:12- 15pm because she was sweating a lot and had a fever, the AC in my apartment is on blast and it's always cold I still felt very warm and had a headache especially when she got up she felt like she was going to pass out. She was drinking lots of liquids to relieve her symptoms, such as gatorade and water. She also had a stuffy nose, she can only breathe through mouth! This started around 5pm 15Jul2021. Something to note is that she hadn't been sick since March of 2020, and she felt very sick right now. Her arm was sore. The events didn't result in Emergency Room Visit nor Physician Office Visit. Treatment was received for event headache, I was sweating a lot, fever, still feel very warm, felt like she was going to pass out. No treatment was received for the other events. The outcome of event chest started to hurt was recovered on 15Jul2021 3:00pm. The outcome of the other events was not recovered  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.