chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: minor swelling and soreness in his arm; minor swelling and soreness in his arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Dec2020 (Lot number: EH9899) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "perforated ulcer" (unspecified if ongoing); "Arthritis" (unspecified if ongoing), notes: which he takes Celebrex as needed; "Influenza A", start date: Mar2020 (unspecified if ongoing), notes: suffered for 2 months on and off; "short term disability nd not working" (unspecified if ongoing), notes: when he was diagnosed with influenza A. The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "minor swelling and soreness in his arm".  Additional Information: As part of the patient's medical history, the patient reported that in Mar2020, he got severely sick while working in the ICU so he went to the Emergency Room and requested a Covid test, but they did not have them. He was then treated with oseltamivir phosphate (TAMIFLU), high dose prednisone, and was tested for Influenza which resulted with a positive Influenza A. He went a couple times more to the Emergency Department for the Influenza A and he reported that he was wheezing and received azithromycin, tami-flu, prednisone, Levaquin or something. They thought it was pneumonia but did not know that, so was being over cautious. That was in Mar2020 and Apr2020. In May2020 he had a Covid negative test. He had an antibody test in Aug2020 negative result. In Sep2020 his blood work was negative.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Animal scratch
Clinical narrative: got starched by a squirrel; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANIMAL SCRATCH (non-serious), outcome "unknown", described as "got starched by a squirrel".  Additional Information: The patient was scheduled to receive the second dose on 09Apr2021. He got starched by a squirrel and was going to the emergency room tomorrow (date unspecified) to receive the rabies vaccine. He wanted to know if the two vaccines can be administered close to one another and what's the longest interval between two doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: arm throbbing in his left arm where he had the vaccine administered; slight headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 (Lot number: EN6199) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "arm throbbing in his left arm where he had the vaccine administered"; HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "slight headache". Therapeutic measures were not taken as a result of vaccination site pain, headache. Additional information: The first dose was given at around 09:30-10:30 AM. Clinical course of events: A week after the 1st dose of the vaccine, the patient experienced arm throbbing in his left arm where he had the vaccine administered and at around the same time had a slight headache. His headache was so light that he really did not pick up that it was going on and his head was hurting a little bit; stated from 1 to 10 he would rate his headache at a 2. Arm throbbing lasted about 2-3 days and the headache has resolved and lasted about 3-4 days. The patient was vaccinated with the second dose of BNT162B2 (Lot number EP6955) in the left arm on 01Apr2021 at around 10:15-10:45am for COVID-19 immunisation. The patient wanted to know how long does the Pfizer COVID Vaccine last or does he have to take another shot of it in a year or so. The patient had no additional vaccines administered on same date of the suspect drug, no prior vaccinations (within 4 weeks), no family medical history relevant to adverse effects and no relevant tests.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: pain; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 06Apr2021 (Batch/Lot number: unknown) as dose 2, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1), for Covid-19 immunisation. The following information was reported: PAIN (non-serious) with onset 06Apr2021 20:00, outcome "unknown", described as "pain". Additional Information: After receiving the 2nd dose of the Pfizer COVID Vaccine, patient exhibited symptoms last night before the call at 8pm. Patient is asking what medication he can take for the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinus disorder
Clinical narrative: Colds; sinus stuff going on; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Colds"; SINUS DISORDER (non-serious), outcome "not recovered", described as "sinus stuff going on".  Additional information: Caller and his wife both have colds, sinus stuff going on and his wife is also on an antibiotic and is wanting to reschedule their 2nd dose today. Read FAQ. Fax to PSCC for AE, since caller and his wife could be having side effects with dose 1 and also since they are cancelling their appointment for the 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Sinus disorder
Clinical narrative: Colds; sinus stuff going on; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "Colds"; SINUS DISORDER (non-serious), outcome "not recovered", described as "sinus stuff going on ". Therapeutic measures were taken as a result of nasopharyngitis, sinus disorder.  Additional information: The patient was on an antibiotic.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Malaise
Clinical narrative: she feels terrible.; terrible headache; drained; not energetic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "she feels terrible."; HEADACHE (non-serious), outcome "unknown", described as "terrible headache"; FATIGUE (non-serious), outcome "unknown", described as "drained"; ASTHENIA (non-serious), outcome "unknown", described as "not energetic".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: hoarse; This is a spontaneous report received from contactable reporter(s) (Other Health Professional and Consumer) for a Pfizer sponsored program.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic obstructive pulmonary disease" (unspecified if ongoing); "pulmonary fibrosis" (unspecified if ongoing); "rheumatoid arthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2, dose 1 for covid-19 immunisation. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "hoarse". Additional information: Patient reported being hoarse, and noticing it end of Feb2021 or mid-Mar2021. No exact date provided. Patient reported having had her second dose of Pfizer vaccine in Feb2021 and not long after she started feeling hoarse. Patient reported some days are worse than other days. Patient was seen by ear, nose and throat md, and no cancer was seen. No exact date provided.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Insomnia, Nasal pruritus, Neck pain, Pain in extremity
Clinical narrative: could not sleep last night; my arm last night pained right up to my neck ; real hurting me; my arm last night pained right up to my neck ; real hurting me/hand pained so badly; itchy nose or some kind of allergy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 (Lot number: ER8732) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetic" (unspecified if ongoing), notes: diabetic and I take my medication. Concomitant medication(s) included: INSULIN; ASPIRIN (E.C.); METFORMIN; GABAPENTIN; FUROSEMIDE; LISINOPRIL. Vaccination history included: Covid-19 vaccine (Dose 1,manufacturer unknown), for Covid-19 immunisation. The following information was reported: INSOMNIA (non-serious), outcome "unknown", described as "could not sleep last night"; NECK PAIN (non-serious), outcome "unknown", described as "my arm last night pained right up to my neck ; real hurting me"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "my arm last night pained right up to my neck ; real hurting me/hand pained so badly"; NASAL PRURITUS (non-serious), outcome "unknown", described as "itchy nose or some kind of allergy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of neck pain, pain in extremity.  Additional information: Reported as, yesterday patient had second dosage and from the minute she got the injection her arm start to pain, real pain she could not sleep last night she had to put ice on it, it was real hurting and she was not able to sleep, and my arm last night pained right up to my neck right patient have to put ice on it but it is still paining right but not that much because she put put a ice(Treatment) on it. Patient was very disappointed. When probed for causality,consumer further stated, "Yes, because in the first dosage patient didn't have these kind of symptoms, a little itchy nose or some kind of allergy and it went away cause she talked to his doctor but this one yesterday it was so painful she couldn't sleep.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling abnormal
Clinical narrative: cloudy head experience made it hard for the patient to focus; cloudy head experience made it hard for the patient to focus; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1), for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious), DISTURBANCE IN ATTENTION (non-serious) all with onset 07Apr2021, outcome "unknown" and all described as "cloudy head experience made it hard for the patient to focus".  Additional information: The events were reported as non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: 3rd day that she's feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset Apr2021, outcome "recovering", described as "3rd day that she's feeling tired".  Additional information: She got her first dose of the vaccine on Tuesday (30Mar2021) and scheduled for the 2nd dose on 20Apr2021. She said she's experiencing side effects and it's now the 3rd day that she's feeling tired. Also she said that she's feeling better now. She wants to know what are the preparations that she needs to do for her second dose if she feel any side effects again because she heard that the 2nd dose is more intense.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: second shot things have gotten much worse; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Colon Cancer" (unspecified if ongoing); "HELLP syndrome" (unspecified if ongoing); "carrier for hemochromatosis" (unspecified if ongoing). Concomitant medication(s) included: VITAMINS A & D. Vaccination history included: Bnt162b2 (Dose:1, Lot No:EN6199, vaccine location=Left arm,), administration date: 31Mar2021, for COVID-19 Immunization, reaction(s): "swollen, red,hot itchy ears"; Bnt162b2, for COVID-19 Immunization, reaction(s): "swollen, red,hot itchy ears", "swollen, red,hot itchy ears", "swollen, red,hot itchy ears". The following information was reported: CONDITION AGGRAVATED (non-serious) with onset Mar2021, outcome "not recovered", described as "second shot things have gotten much worse". The event "second shot things have gotten much worse" was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of condition aggravated.  Additional information: Stated that the patient received treatment with Steroids and antibiotics. The patient was not diagnosed with covid-19, before or after vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Dizziness, Full blood count, Lymph node pain, Urine analysis
Clinical narrative: light headed, dizzy; Pain underneath the arm pits, I guess in the lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Feb2021 (Lot number: EL9262) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sulfar allergy" (unspecified if ongoing); "penicillin allergy" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN; TYLENOL; SIMVASTATIN; VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]. The following information was reported: DIZZINESS (non-serious), outcome "not recovered", described as "light headed, dizzy"; LYMPH NODE PAIN (non-serious), outcome "not recovered", described as "Pain underneath the arm pits, I guess in the lymph nodes". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dizziness, lymph node pain. Additional information: 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 and since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Depression, Insomnia, Tinnitus
Clinical narrative: agitation; feeling of depression; insomnia; anxiety; ringing in the ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67-year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single.), for Covid-19 immunization. The following information was reported: AGITATION (non-serious), outcome "unknown", described as "agitation"; DEPRESSION (non-serious), outcome "unknown", described as "feeling of depression"; INSOMNIA (non-serious), outcome "unknown", described as "insomnia"; ANXIETY (non-serious), outcome "unknown", described as "anxiety"; TINNITUS (non-serious), outcome "unknown", described as "ringing in the ear".  Additional information; In general local side effects, the ones you get on the arm where you got the shot (such as injection site redness and injection site swelling) were mostly mild-to-moderate in severity and resolved within 1 to 2 days. Side effects that you may experience throughout the rest of your body (systemic side effects) including fever and chills were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter Swollen lymph nodes (lymphadenopathy) which generally resolved within 10 days is likely to have resulted from a robust vaccine-elicited immune response.2  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Hyperhidrosis, Malaise, Vaccination site erythema
Clinical narrative: onsite swelling and redness; hot and cold sweats; Malaise/not feeling well; Dizziness; onsite swelling and redness; cold sweat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ZW0150) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose:lot unknown/expiration date: unknown, No reaction with 1st shot.), administration date: 03Mar2021, when the patient was 86 years old, for covid-19 immunization, reaction(s): "no adverse event". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "onsite swelling and redness"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "hot and cold sweats"; MALAISE (non-serious), outcome "unknown", described as "Malaise/not feeling well"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; COLD SWEAT (non-serious), outcome "unknown", described as "cold sweat".  Additional information: Reporter wanted to know if the reported adverse reactions of the vaccine. Investigation Assessment: Not Provided.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: onsite swelling and redness; hot and cold sweats; Malaise/not feeling well; Dizziness; onsite swelling and redness; cold sweat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 86 year-old female patient received bnt162b2 (BNT162B2), administration date 30Mar2021 (Lot number: ZW0150) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Parkinson's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose:lot unknown/expiration date: unknown, No reaction with 1st shot.), administration date: 03Mar2021, when the patient was 86 years old, for covid-19 immunization, reaction(s): "no adverse event". The following information was reported: VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "onsite swelling and redness"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "hot and cold sweats"; MALAISE (non-serious), outcome "unknown", described as "Malaise/not feeling well"; DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; COLD SWEAT (non-serious), outcome "unknown", described as "cold sweat".  Additional information: Reporter wanted to know if the reported adverse reactions of the vaccine. Investigation Assessment: Not Provided.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Feeling abnormal, Loss of personal independence in daily activities, Malaise
Clinical narrative: feeling bad; Her temperature is 99.3 and 98.7.; body aches; doesn't feel good; Usually she can go to the gym and work out and stuff, but she cannot right now.; She cannot put a finger on it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6207, Expiration Date: Jun2021) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling bad"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Her temperature is 99.3 and 98.7."; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "doesn't feel good"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Usually she can go to the gym and work out and stuff, but she cannot right now."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "She cannot put a finger on it.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After getting first dose she got her second dose one this Friday. Probably two or 3 days after the vaccine, she first started feeling bad on and off. Some days were worst. They were on and off not improving persisting or worsening. Like Sunday she was feeling fine, and then that night, she started feeling bad. She never ran a fever. Today she came home from work. She started feeling bad again yesterday. Her temperature was 99.3 and 98.7. She did not feel like she has a fever, but she has body aches. She did not feel good. She did not have side effects other than feeling bad on and off after the vaccine. She has tried to take Claritin (lot: OKE2401A; expiration: May 2022) because she thought maybe it was the pollen, but the Claritin did not do anything. It was extra strength, antihistamine, pharmacy brand. She has not been taking it every day and not feeling well at all. Usually, she can go to the gym and work out and stuff, but she cannot right now. She did not feel good and cannot put a finger on it. The Tylenol seems to help and take the edge off.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: feeling bad; Her temperature is 99.3 and 98.7.; body aches; doesn't feel good; Usually she can go to the gym and work out and stuff, but she cannot right now.; She cannot put a finger on it.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EN6207, Expiration Date: Jun2021) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling bad"; BODY TEMPERATURE ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Her temperature is 99.3 and 98.7."; PAIN (non-serious) with onset 2021, outcome "unknown", described as "body aches"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "doesn't feel good"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "Usually she can go to the gym and work out and stuff, but she cannot right now."; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "She cannot put a finger on it.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: After getting first dose she got her second dose one this Friday. Probably two or 3 days after the vaccine, she first started feeling bad on and off. Some days were worst. They were on and off not improving persisting or worsening. Like Sunday she was feeling fine, and then that night, she started feeling bad. She never ran a fever. Today she came home from work. She started feeling bad again yesterday. Her temperature was 99.3 and 98.7. She did not feel like she has a fever, but she has body aches. She did not feel good. She did not have side effects other than feeling bad on and off after the vaccine. She has tried to take Claritin (lot: OKE2401A; expiration: May 2022) because she thought maybe it was the pollen, but the Claritin did not do anything. It was extra strength, antihistamine, pharmacy brand. She has not been taking it every day and not feeling well at all. Usually, she can go to the gym and work out and stuff, but she cannot right now. She did not feel good and cannot put a finger on it. The Tylenol seems to help and take the edge off.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Tingling on the left side of my face and my hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 01Apr2021 08:30 (Lot number: EP6955) at the age of 60 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Hypertension" (ongoing); "Low potassium" (ongoing); "High cholesterol" (ongoing); "Anxiety" (ongoing). Concomitant medication(s) included: METOPROLOL taken for hypertension (ongoing); AMLODIPINE taken for hypertension (ongoing); KLOR-CON taken for blood potassium decreased (ongoing); ROSUVASTATIN taken for hypertension (ongoing); BUPROPION taken for anxiety (ongoing). The following information was reported: PARAESTHESIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "Tingling on the left side of my face and my hand".  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain in extremity
Clinical narrative: felt kind of achy in her arms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), administration date 08Mar2021 (Lot number: ER8733) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus (ongoing); JANUVIA [SITAGLIPTIN PHOSPHATE] taken for diabetes mellitus (ongoing); INDAPAMIDE taken for hypertension (ongoing); LISINOPRIL taken for hypertension (ongoing). The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "felt kind of achy in her arms". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: chills; tiredness and, only extreme fatigue on the next day; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.  A 25 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 22Mar2021 (Lot number: Ep7534) at the age of 25 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Colitis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, single; Arm left; Lot number: En6198; Administration time: 17: 30), administration date: 26Feb2021, when the patient was 24 years old, for COVID-19 immunisation, reactions: "Headaches within 10 minutes of shot/headaches for 3 weeks after 1st dose", "Anxiety within 10 minutes of shot", "arm sore", "Nausea", "Fever". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "tiredness and, only extreme fatigue on the next day". Therapeutic measures were not taken as a result of chills, fatigue. Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: got diarrhea after getting his 1st dose of the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Mar2021 (Lot number: EN6206) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious) with onset 13Mar2021, outcome "not recovered", described as "got diarrhea after getting his 1st dose of the vaccine". Therapeutic measures were not taken as a result of diarrhoea.  Additional information: Patient states he is calling about the Pfizer COVID19 Vaccine and states he just wondered if diarrhea is a side effect and he got diarrhea after getting his 1st dose of the vaccine; states the diarrhea is occurring on and off. Patient states he is going to call the HCP to make an appointment to see her but wanted to call Pfizer first to see if there is anything regarding his question first. States the diarrhea began on the way home from his 1st dose of the Pfizer COVID19 vaccine and is off and on and he has not yet required treatment or a visit to his HCP or to the emergency room. History of all previous immunization with the Pfizer vaccine considered as suspect: 1st dose administered on 13Mar2021. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks): Yes, states he had a shingles vaccine administered in HCP office but has no lot number or name of the shingles vaccine and no further information to provide and stated he did not experience an AE after receiving the shingles vaccine. Family Medical History Relevant to AE(s): None. Relevant Tests: None.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Influenza like illness, Nausea, Vaccination site erythema
Clinical narrative: Flu-like aches; Fatigue; Nausea; Flu-like chills; Injection site still red 3 weeks later; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 19:30 (Lot number: En6206) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "cats" (unspecified if ongoing), notes: Cats; "Seasonal allergy" (unspecified if ongoing); "Latex allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing); "polycystic ovarian syndrome (PCOS)" (unspecified if ongoing), notes: PCOS; "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 13Mar2021 07:00, outcome "recovered" (15Mar2021), described as "Flu-like aches"; FATIGUE (non-serious) with onset 13Mar2021 07:00, outcome "recovered" (15Mar2021), described as "Fatigue"; NAUSEA (non-serious) with onset 13Mar2021 07:00, outcome "recovered" (15Mar2021), described as "Nausea"; CHILLS (non-serious) with onset 13Mar2021 07:00, outcome "recovered" (15Mar2021), described as "Flu-like chills"; VACCINATION SITE ERYTHEMA (non-serious) with onset 13Mar2021 07:00, outcome "recovered with sequelae" (2021), described as "Injection site still red 3 weeks later". Therapeutic measures were not taken as a result of influenza like illness, fatigue, nausea, chills, vaccination site erythema.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus from old injury doubled in intensity/ tinnitus, it was ringing in the ears; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 05Feb2021 17:15 (Lot number: EL9261) at the age of 68 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "tinnitus" (unspecified if ongoing), notes: from old injury. Concomitant medication included: OLMESARTAN MEDOXOMIL. Vaccination history included: BNT162B2 (dose 1, administered in the right arm, Batch/Lot number: EL0140), administration date: 15Jan2021 17:30, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 05Feb2021 17:15, outcome "not recovered", described as "tinnitus from old injury doubled in intensity/ tinnitus, it was ringing in the ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient reported the Lot number for dose 2 as "EL8261 or that might be EL9261."   No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: tinnitus from old injury doubled in intensity/ tinnitus, it was ringing in the ears; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right arm, administration date 05Feb2021 17:15 (Lot number: EL9261) at the age of 68 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing); "tinnitus" (unspecified if ongoing), notes: from old injury. Concomitant medication included: OLMESARTAN MEDOXOMIL. Vaccination history included: BNT162B2 (dose 1, administered in the right arm, Batch/Lot number: EL0140), administration date: 15Jan2021 17:30, when the patient was 68 years old, for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 05Feb2021 17:15, outcome "not recovered", described as "tinnitus from old injury doubled in intensity/ tinnitus, it was ringing in the ears". Therapeutic measures were not taken as a result of tinnitus.  Additional information: The patient reported the Lot number for dose 2 as "EL8261 or that might be EL9261."   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling in both hands and feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient in her 50's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in both hands and feet". Additional information: A previous Pfizer colleague, female, in her 50s, shared that after receiving both doses of the COVID-19 vaccine, she experienced tingling in both hands and feet, more significantly after second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysphonia, Headache, Irritability, Malaise
Clinical narrative: Dizzy; Grumpy/Cranky; His voice is totally different; stress; Headache; does not feel good; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes, He is on Metformin.; "Depression (Mental Illness)" (unspecified if ongoing), notes: Verbatim: Depression (Mental Illness); "He also a smoker, alcohol" (unspecified if ongoing); "He also a smoker, alcohol" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (1st dose., Anatomical location: right arm), for COVID-19 immunization, reaction(s): "cranky and irritable". The following information was reported: DIZZINESS (non-serious) with onset 01Apr2021, outcome "unknown", described as "Dizzy"; IRRITABILITY (non-serious) with onset 01Apr2021, outcome "unknown", described as "Grumpy/Cranky"; DYSPHONIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "His voice is totally different"; STRESS (non-serious) with onset 01Apr2021, outcome "unknown", described as "stress"; HEADACHE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset 01Apr2021, outcome "unknown", described as "does not feel good".   Additional information: He has mild limited health issues but last time we went we did not stay after the shot. He got dizzy real dizzy, dizzy in the sense reporter almost took him to the hospital and we had probably been a block or 2 of it, and he said now really fine but today he stayed 30 minutes. He did he got dizziness again but he also got bad headache, he got really what he would consider grumpy from an outside source and headache. It used to be that he would eat chips. He would just have the mood change made him toxic to being here. He was almost that bad with headache, and his voice was totally different, he does not feel good, have headache. This is just a one time, maybe its headache, maybe it is just phone making irritable, maybe it was stress going Covid shot, in fact this was that is the Covid shot, he was very adamant he was not going to get the second shot and then something changed in his mind we decide to get the shot. Another problem to know about that, he was cranky and irritable after the first shot but most of this time.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Dizzy; Grumpy/Cranky; His voice is totally different; stress; Headache; does not feel good; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm right (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing), notes: Verbatim: Diabetes, He is on Metformin.; "Depression (Mental Illness)" (unspecified if ongoing), notes: Verbatim: Depression (Mental Illness); "He also a smoker, alcohol" (unspecified if ongoing); "He also a smoker, alcohol" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (1st dose., Anatomical location: right arm), for COVID-19 immunization, reaction(s): "cranky and irritable". The following information was reported: DIZZINESS (non-serious) with onset 01Apr2021, outcome "unknown", described as "Dizzy"; IRRITABILITY (non-serious) with onset 01Apr2021, outcome "unknown", described as "Grumpy/Cranky"; DYSPHONIA (non-serious) with onset 01Apr2021, outcome "unknown", described as "His voice is totally different"; STRESS (non-serious) with onset 01Apr2021, outcome "unknown", described as "stress"; HEADACHE (non-serious) with onset 01Apr2021, outcome "unknown", described as "Headache"; MALAISE (non-serious) with onset 01Apr2021, outcome "unknown", described as "does not feel good".   Additional information: He has mild limited health issues but last time we went we did not stay after the shot. He got dizzy real dizzy, dizzy in the sense reporter almost took him to the hospital and we had probably been a block or 2 of it, and he said now really fine but today he stayed 30 minutes. He did he got dizziness again but he also got bad headache, he got really what he would consider grumpy from an outside source and headache. It used to be that he would eat chips. He would just have the mood change made him toxic to being here. He was almost that bad with headache, and his voice was totally different, he does not feel good, have headache. This is just a one time, maybe its headache, maybe it is just phone making irritable, maybe it was stress going Covid shot, in fact this was that is the Covid shot, he was very adamant he was not going to get the second shot and then something changed in his mind we decide to get the shot. Another problem to know about that, he was cranky and irritable after the first shot but most of this time.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.