chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Caller's sister, 57 years old, had the first dose of Pfizer Covid 19 vaccine and experienced dizziness three days later that lasted for two days and went away.This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 57 year-old 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: DIZZINESS (non-serious), outcome "recovered" described as "Caller's sister, 57 years old, had the first dose of Pfizer Covid 19 vaccine and experienced dizziness three days later that lasted for two days and went away.".  Additional Information: Caller is a 62-year-old female who received the second dose of the Pfizer Covid 19 vaccine Sunday.  Her arm was a bit sore. On Tuesday she started to get dizziness that has continued through today. She wanted to know if this is common. How long can it last. She read online has been reported as a side effect. She received Pfizer Lot #EN6198 for first dose and Pfizer Lot #EN6206 for second dose. Caller son in law, 30-year-old, received the second dose of the Pfizer Covid 19 vaccine on Sunday as well and was sick for 4 days: he had a bad headache, running a fever, 101.5 for a couple of days, very extremely tired from Sunday until today. Caller daughter, 30-year-old, received the Pfizer Covid 19 vaccine second dose on Sunday and experienced late that night chills, shaking, and felt faint. She took Tylenol, went to sleep, and was fine the next morning.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Tremor
Clinical narrative: Felt faint; Experienced late that night chills; Shaking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 30 year-old female patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: Covid-19 vaccine (MANUFACTURER UNKNOWN), for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Felt faint"; CHILLS (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Experienced late that night chills"; TREMOR (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Shaking". Therapeutic measures were taken as a result of dizziness, chills, tremor included Tylenol.  Additional information: Reporter's daughter, 30 years old, received the Pfizer Covid 19 vaccine second dose on Sunday and experienced late that night chills, shaking, and felt faint. She took Tylenol, went to sleep, and was fine the next morning.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Vaccination site pain
Clinical narrative: Soreness in left arm; Fatigue/needed to sleep and rest; lethargic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 10:15 (Lot number: EP6955) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPRINTEC; B12-VITAMIN; CLARITIN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 19Mar2021, outcome "recovered", described as "Soreness in left arm"; FATIGUE (non-serious) with onset 19Mar2021, outcome "recovered", described as "Fatigue/needed to sleep and rest"; LETHARGY (non-serious) with onset 19Mar2021, outcome "recovered", described as "lethargic". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, lethargy. Additional information: There were no other vaccine in four weeks. There was no covid prior vaccination and patient was not tested for covid post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: light headed, dizzy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program . The reporter is the parent.  A 57 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) for 1 day at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergic reactions" (unspecified if ongoing), notes: she has allergic reactions to everything. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "light headed, dizzy". Additional information: The patient had one dose of the Pfizer covid vaccine and she was lightheaded and dizzy. She is reluctant to get the second one. She has allergic reactions to everything. Her doctor said to go ahead and take it but she said that she is not going to do it, she is scared about doing it. She carries an epi pen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 (Lot number: ER8727) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: CALCIUM; VIT D; MAGNESIUM. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Mar2021 18:00, outcome "recovering", described as "Mild pain at the injection site". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine (prior vaccination was none). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered reported as Pharmacy or Drug Store. No known allergies. Upon follow-up response received for query. Patient arm started to become sore a few hours after vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Had some diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 11Mar2021 (Batch/Lot number: unknown) at the age of 35 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "PTSD (Post-traumatic stress disorder)" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing); "Kidney issue" (unspecified if ongoing); "Asthma" (unspecified if ongoing); "Hypersensitivity" (unspecified if ongoing); "Non-Hodgkin's Lymphoma", start date: 2005, stop date: 2005. The patient's concomitant medications were not reported.  The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Had some diarrhea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Weight bearing difficulty, X-ray
Clinical narrative: Had a problem with left foot; couldn't put weight on it or walk properly; Had a problem with left foot; couldn't put weight on it or walk properly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Mar2021 (Lot number: EN6203) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing), notes: have hypertension which is being treated successfully for like 8 years; "Arthritis" (unspecified if ongoing); "Mitral valve prolapse" (unspecified if ongoing); "Irritable bowel syndrome" (unspecified if ongoing). Concomitant medication(s) included: BENICAR; HCTZ; VITAMIN D [ERGOCALCIFEROL]; LOMOTIL [ATROPINE SULFATE;DIPHENOXYLATE HYDROCHLORIDE] taken for irritable bowel syndrome. The following information was reported: WEIGHT BEARING DIFFICULTY (non-serious), GAIT DISTURBANCE (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Had a problem with left foot; couldn't put weight on it or walk properly". The event "had a problem with left foot; couldn't put weight on it or walk properly" and "had a problem with left foot; couldn't put weight on it or walk properly" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient was also reported to be taking an unspecified multivitamins as concomitant medication. It was further reported that several hours after the vaccine, maybe about 8 or 9 hours after, patient had a problem with her left foot. She couldn't put weight on it or walk properly. Patient even went to an urgent care for her foot because she was really getting concerned. She wanted to make sure she wasn't getting a blood clot or something in the foot and the heel. Patient stated some X-rays on the foot was ordered at urgent care and she didn't know what was really there. She didn't have a spur, She guess there was some arthritis there, but her concern was she had never had any problems until 8 hours after that vaccine shot."  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia
Clinical narrative: insomnia; headaches; 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 57 year-old male patient received bnt162b2 (BNT162B2), administration date 14Mar2021 (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: INSOMNIA (non-serious), outcome "unknown", described as "insomnia"; HEADACHE (non-serious), outcome "unknown", described as "headaches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle pain in his arm; 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 29 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 20Mar2021 (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: MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "muscle pain in his arm".  Additional information: The patient received his first dose of the Pfizer BioNTech COVID-19 vaccine on Saturday. He reported no side effects except muscle pain in his arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 93.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test
Clinical narrative: Second vaccine I am now 3 weeks of uninterrupted illness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 93-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm, administration date 26Feb2021 (Lot number: ENG203) at the age of 93 years as dose 2, single for COVID-19 immunisation. Relevant medical history included: "fibromyalgia" (unspecified if ongoing); "HTN" (unspecified if ongoing); "COPD" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing); "dairy allergy" (unspecified if ongoing). Concomitant medication(s) included: THYROID; CARVEDILOL; AMLODIPINE; TORSEMIDE; PRAVA [PRAVASTATIN SODIUM]. Vaccination history included: Bnt162b2 (Dose Number: 01, Lot Number: EL9264, Administration time; 11:00AM, Vaccine location; Left arm), administration date: 05Feb2021, when the patient was 93 years old, for Covid-19 Immunization, reaction(s): "fever", "chills", "fatigue", "lack of appetite". The following information was reported: ILLNESS (non-serious) with onset 2021, outcome "not recovered", described as "Second vaccine I am now 3 weeks of uninterrupted illness". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and was not diagnosed with COVID-19 prior to vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: patient hasn't really done very well after the first dose; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "some allergic reactions to other medications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "not recovered", described as "patient hasn't really done very well after the first 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: Illness
Clinical narrative: will get her second dose on 18Mar2021 but she has been sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Feb2021 (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: ILLNESS (non-serious), outcome "unknown", described as "will get her second dose on 18Mar2021 but she has been sick". Therapeutic measures were taken as a result of illness.  Additional information: The patient was on some antibiotic and was asking if she can take the second dose of vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Malaise, Nausea
Clinical narrative: sick; nausea; diarrhea; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "sick"; NAUSEA (non-serious), outcome "unknown", described as "nausea"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea".  Additional information: Reporter and his wife want to reschedule their 2nd dose which is due tomorrow the 18Mar2021 because his wife is sick. His wife had arthroscopic surgery and is experiencing nausea and diarrhea. The date of their 1st dose was not verified.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea
Clinical narrative: sore throat; sniffles; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 31 year-old 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: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; RHINORRHOEA (non-serious), outcome "unknown", described as "sniffles".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: mild discomfort in his arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. 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: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "mild discomfort in his arm".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Pain in extremity
Clinical narrative: pain on her arm; hardly lifts her arm; 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 11Mar2021 (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 (First dose), administration date: 18Feb2021, for COVID-19 IMMUNISATION. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain on her arm"; HYPOKINESIA (non-serious), outcome "unknown", described as "hardly lifts her arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: started feeling a really strong pain on my left thigh; 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 40 year-old male patient received bnt162b2 (BNT162B2), administration date 22Mar2021 (Batch/Lot number: unknown) at the age of 40 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: PAIN IN EXTREMITY (non-serious) with onset 22Mar2021, outcome "unknown", described as "started feeling a really strong pain on my left thigh". Additional information: The patient was walking around and started to feel a really strong pain on left thigh. The patient reported that his arm does not hurt but it feels like the injection was on the thigh.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 20Mar2021, outcome "unknown", described as "Dizzy". Therapeutic measures were not taken as a result of dizziness.  Additional information: Reason for no lot number: of COVID Vaccine: Other: patient stated, "No, patient do not have. Additional Context: patient stated, he took the shot on Thursday and yesterday and today, he had been feeling very dizzy. Start date: patient stated, "Wednesday." (not clarified further) patient further stated, he need some advice, do he need to go to the doctor or hospital as he was feeling dizzy or not. Patient was informed about Pfizer Medical Information department and provided with the number.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: Had a flare; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (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: CONDITION AGGRAVATED (non-serious), outcome "unknown", described as "Had a flare".  Additional information: The patient had received her first Covid shot and had a flare. The patient was due for her second Covid shot on 26Mar2021. The patient was supposed to have Humira shot the night of the 25th but is considering holding off because she is concerned how it will interact with the vaccine. Her rheumatologist told her she can go ahead and use Humira like normal, regardless of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Illness, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).A male patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (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: CHILLS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 25Feb2021, outcome "unknown", described as "body aches"; ILLNESS (non-serious) with onset 25Feb2021, outcome "unknown", described as "Sick twice"; DECREASED APPETITE (non-serious) with onset 25Feb2021, outcome "unknown", described as "doesn't want to eat".Additional Information: No patient identifiers were provided but the reporter has firsthand knowledge of the patient and was reporting on a specific patient. The reporter was asking if the patient should get the second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue
Clinical narrative: diarrhea; fatigue and tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 21Feb2021 09:30 (Lot number: EN6201, Expiration Date: Jun2021) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (ongoing); "Allergies" (ongoing); "High cholesterol" (ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure increased, start date: 2016 (ongoing); SINGULAIR taken for hypersensitivity, start date: 2011 (ongoing); ROSUVASTATIN CALCIUM taken for blood cholesterol increased, start date: 2011 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Time: 10:30 AM, Anatomical Site of Injection: Left arm, Route of administration: Intramuscular, Batch/Lot number: EL9263, Expiration Date: May2021), administration date: 31Jan2021, when the patient was 69 years old, for COVID-19 immunisation, reaction(s): "sore arm", "Terrible burning sensation immediately after injection/very sore and burning pain at the time of injection", "Weird taste in mouth", "Fatigue", "Very thirsty", "Mouth was dry", "A little weak", "anxiety", "diarrhea on and off for two weeks". The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; FATIGUE (non-serious), outcome "unknown", described as "fatigue and tiredness".  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the second dose, patient did not experience any pain of injection or afterwards. Patient did continue to experience on and off diarrhea. He also experienced more fatigue and tiredness for several days.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 71 years 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: CHILLS (non-serious) with onset 16Mar2021, outcome "recovering", described as "chills".  Additional information: The patient called to check on the status of the order for Chantix. While on the call, the patient stated that they were out today and was all good. Patient got the chills and was feeling a little better today (as reported) and they were sure it's going to all clear up. The patient was experiencing exactly the side effects that they said they would get.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 21Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset 21Mar2021, outcome "not recovered", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: she was really cold/right calf is cold to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 08:30 (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: FEELING COLD (non-serious) with onset Mar2021, outcome "not recovered", described as "she was really cold/right calf is cold to touch". Additional information: The patient had her vaccine at 8:30 on morning of day of reporting. The patient did not really have any reaction when she was there. When she got back to work, she was really cold. That went away except on her right calf. Her right calf was cold to touch. There was no rash.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain
Clinical narrative: Caller experiencing Pain in right breast and under arm after receiving vaccine; Caller experiencing Pain in right breast and under arm after receiving vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female 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: BREAST PAIN (non-serious), AXILLARY PAIN (non-serious), outcome "unknown" and all described as "Caller experiencing Pain in right breast and under arm after receiving vaccine".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: body aches overnight; headache; mild nausea; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 54 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Mar2021 13:50 (Lot number: EN6203) at the age of 54 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FAMOTIDINE taken for reflux gastritis (ongoing). Vaccination history included: Bnt162b2 (1st dose, Time: 13:50, Anatomical location: Left arm, Route of administration: Intramuscular, Lot No. : EL3247), administration date: 24Feb2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "muscle soreness at injection site". The following information was reported: PAIN (non-serious) with onset 17Mar2021 23:00, outcome "recovered" (Mar2021), described as "body aches overnight"; HEADACHE (non-serious) with onset 17Mar2021, outcome "recovered" (Mar2021), described as "headache"; NAUSEA (non-serious) with onset 17Mar2021, outcome "recovered" (Mar2021), described as "mild nausea". Therapeutic measures were taken as a result of pain, headache.  Additional information: Patient's medical history, family medical history and relevant test was reported as none. No other prior vaccinations. Body aches were still present the next day (on 18Mar2021). Headache and body aches responded to acetaminophen (TYLENOL) given as needed.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: Arm soreness; Lower back pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Feb2021 (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: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Arm soreness"; BACK PAIN (non-serious) with onset Feb2021, outcome "recovered" (Feb2021), described as "Lower back pain".  Additional information: Reported by: Other HCP. Reporter Contact Information: Reported by Pfizer Colleague whose family member contacted me to notify me of the reaction. Description of Event: Dose 1 on 19Feb2021 experienced arm soreness 24 hours later that resolved in a day and then experienced lower back pain starting 48 hours later lasting one week. Name of Product: BNT162b2. Awareness Date: 31Mar2021. Country of Occurrence: United States. Event took place after use of product. [Query]: Please kindly help to confirm who is the reporter reported these events to you (Name) and pls help to provide his/her contact information if available. Besides, help confirm your awareness date of these events, I captured 21Mar2021 as PRD conservatively in case (withheld); (withheld); (withheld). [Response]: Yes, I am the reporter and reported immediately upon awareness. Asked if it was DSU reporting convention to have 3 AERs for a single report. [Query]: Could you please help to confirm the relationship between the patient (Initials) and yourself? Besides, is the patient your family member, who reported those adverse events to you, I created 3 cases for AER (withheld) (BNT162B2, 1st dose), AER (withheld) (BNT162B2, 2ND dose), AER (withheld) (Advil). [Response]: Yes, VA is an extended family member.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021314729 Same patient/ product, different dose/ event
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swollen hand; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 18Mar2021, outcome "not recovered", described as "swollen hand".  Additional Information: Event: The caller and the patient just wanted to make sure her arm didn't fall off, it was 83 times the size it should be. This event happened on the patient's left arm. The patient mentions that she was about to take a Benadryl. The caller mentioned that she has been on the line for over 50 minutes to speak to someone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hip arthroplasty
Clinical narrative: hip replacement; can hardly walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 was not reported. Concomitant medication(s) included: TYLENOL. The following information was reported: HIP ARTHROPLASTY (medically significant), outcome "unknown", described as "hip replacement"; GAIT DISTURBANCE (medically significant), outcome "unknown", described as "can hardly walk". Additional information: Patient asked if she can take TYLENOL prior to getting the Pfizer Covid vaccine. She needed a hip replacement and can hardly walk. This will be her second shot. She was told last time when she went to get the shot that she was not able to get the first dose because she took TYLENOL and then went somewhere else so she could get the shot.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Middle insomnia, Night sweats
Clinical narrative: Woke up with sweats in upper body/woke up in the middle of the night with sweats in his upper body; woke up in the middle of the night with sweats in his upper body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old male patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) at the age of 77 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: NIGHT SWEATS (non-serious), outcome "unknown", described as "Woke up with sweats in upper body/woke up in the middle of the night with sweats in his upper body"; MIDDLE INSOMNIA (non-serious), outcome "unknown", described as "woke up in the middle of the night with sweats in his upper body".  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: fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a sponsored program (143231). The reporter is the patient.  A 62 year-old female 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: FATIGUE (non-serious), outcome "unknown", described as "fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Said after both doses, no longer needs glasses for being near sighted; 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) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "near sighted" (unspecified if ongoing), notes: wears glasses. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "Said after both doses, no longer needs glasses for being near sighted".  Additional information: The patient wanted to know if anyone else has called regarding their vision. The patient reported that after both doses, she no longer needs her glasses for being near sighted.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Yellow skin
Clinical narrative: Skin is turning yellow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, administration date 17Mar2021 (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: YELLOW SKIN (non-serious) with onset 18Mar2021, outcome "unknown", described as "Skin is turning yellow".  Additional information: Patient wants to know if skin turning yellow after vaccination was normal and was provided with the number of Pfizer Medical information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm (Lot number: EN6205) at the age of 74 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: takes a regular medication, one little pill; "Diabetes" (unspecified if ongoing), notes: takes medication, she was in her late 40s that she got diabetes; "COVID-19", start date: Jan2021 (not ongoing), notes: recovered before she got the vaccine. The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain". Additional information: The patient had pain at the injection site on the arm muscle. The patient will get the second dose on 30Mar2021 and she is afraid of the side effects of the vaccine and afraid of getting COVID again. She is worried about possible side effects from second dose of the vaccine. Patient takes unspecified medications for diabetes and blood pressure.  No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness
Clinical narrative: yesterday afternoon around 1700 she started having diarrhea, she went 21 times until 4am this morning; lightheaded; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 81-year-old female patient received bnt162b2 (BNT162B2), intramuscular administered in arm left, administration date 17Mar2021 13:15 (Lot number: EN6203, Expiration Date: 30Jun2021) at the age of 81 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic fibromyalgia" (unspecified if ongoing), notes: goes into flares and sometimes during flares she has diarrhea problems; "diarrhea problems" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DIARRHOEA (medically significant) with onset 18Mar2021 17:00, outcome "recovering", described as "yesterday afternoon around 1700 she started having diarrhea, she went 21 times until 4am this morning"; DIZZINESS (non-serious) with onset 18Mar2021, outcome "recovering", described as "lightheaded". Therapeutic measures were taken as a result of diarrhoea, dizziness. Additional information: The patient reported that she has a chronic fibromyalgia and goes into flares. Sometimes, during flares, the patient has diarrhea problems but nothing like what she was experiencing after the vaccine. In the afternoon of the day the patient received the vaccine, she had no problems. But on 18Mar2021, around 17:00, the patient started to have diarrhea. She went 21 times until 4:00 in the morning of 19Mar2021. The patient took antidiarrheal medication, but it kept breaking through. The patient also drank Gatorade since she got so lightheaded and figured that she needed electrolytes. The patient stated that the diarrhea calmed down finally and stated that she feels a lot better. The patient also reported that what occurred to her was shocking. The patient will get the second dose scheduled in Apr2021. The events did not require visit to emergency room and physician office. The patient has no prior vaccinations within 4 weeks, has no family medical history relevant to the adverse event, and has no relevant tests.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Mild nausea; Right arm pain at site of injection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 18Mar2021 (Lot number: EN6203) at the age of 50 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 (1st dose.), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Right arm pain at site of injection"; NAUSEA (non-serious) with onset 19Mar2021, outcome "recovered", described as "Mild nausea".  Additional information: Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Neck pain
Clinical narrative: Sore/painful neck; Sore/painful neck from enlarged neck lymph nodes on same side of body as vaccine was given.; Sore/painful neck from enlarged neck lymph nodes on same side of body as vaccine was given.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 12Mar2021 (Batch/Lot number: unknown) as dose number unknown for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NECK PAIN (non-serious) with onset 12Mar2021, outcome "not recovered", described as "Sore/painful neck"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 12Mar2021, outcome "not recovered" and all described as "Sore/painful neck from enlarged neck lymph nodes on same side of body as vaccine was given.". It was unknown if therapeutic measures were taken as a result of neck pain, lymphadenopathy, lymph node pain.  No follow-up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity, Vomiting
Clinical narrative: I threw up all night; Headache; Sore arm; Chills; Nausea; 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 male patient received bnt162b2 (BNT162B2), administered in arm left (Lot number: EN6199, Expiration Date: 30Jun2021) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetic" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for type 2 diabetes mellitus. Vaccination history included: Bnt162b2 (Dose 1, Lot: EL9266; Expiration date: 31May2021), for Covid-19 immunization. The following information was reported: VOMITING (non-serious), outcome "not recovered", described as "I threw up all night"; HEADACHE (non-serious), outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; CHILLS (non-serious), outcome "unknown", described as "Chills"; NAUSEA (non-serious), outcome "not recovered", described as "Nausea". Therapeutic measures were taken as a result of vomiting, headache, pain in extremity, chills, nausea.  Additional information: He had his second shot of Pfizer on the 9th very next day, he had really sore arm, chills and then on this last Saturday he couldn't go to work as he threw up all night. Since that point of time, he had headache and nothing takes that, he had nothing but the headaches and nothing take this headache and nausea away. He had got chills and headache and he had never got headache before; he could not take this headache. The patient stated the very next day from the shot, he had soreness in his arm, which he didn't in the first time. He started getting chills, whole day almost 24 hours. Then everything was fine and then actually Friday night, he started getting nauseated, he threw up all night. The patient took only self-treatment and took Ibuprofen or Tylenol or Advil something to make it better, but nothing took it away. Just the recommended dose 2 pills may be every 6 hours something like that.  No follow-up attempts are possible. No further information is expected.