chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Rash pruritic, Thirst, Tremor
Clinical narrative: 10 minutes post-administration, patient developed itchy rash on right cheek.; Symptoms include itching, burning, and tingling at rash site/ Itching worsened and spread throughout body; Symptoms include itching, burning, and tingling at rash site.; Symptoms include itching, burning, and tingling at rash site.; Patient was also thirsty (was given water).; feverish; dizzy; Itching started in mouth; began to feel shaky and still feeling dizzy; This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported for a 67-year-old (non-pregnant) female patient who received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL3247) intramuscularly into the left arm on 28Jan2021 (at the age of 67-year-old) as first dose single for COVID-19 immunization. The patient medical history included hypertension, hypothyroid and known allergies to Aspirin, Codeine, Tolyn, Compazine, Nubain, Reglan, Toradol, Vicodin, morphine and Dilaudid at an unspecified date. Concomitant medications included Lisinopril, gabapentin, Ambien, Synthroid on an unspecified date. On an unspecified date, the patient had COVID prior vaccination and not tested post vaccination. On 28Jan2021, ten minutes post-administration, the patient developed itchy rash on right cheek. Symptoms included itching, burning and tingling at rash site. Patient was also thirsty (was given water). Benadryl oral was given. Symptoms were not resolving and patient began to feel feverish and dizzy. Itching worsened and spread throughout body. Dexamethasone oral was given. Itching started in mouth. EpiPen was administered intramuscularly to left vastus lateralis. Hypertension was seen. Itching in mouth subsided 15 minutes post EpiPen, but patient began to feel shaky and still feeling dizzy. The patient underwent lab tests which included body temperature as feverish on 28Jan2021. Monitored for additional 20 minutes. After, patient was stable and walked out via wheelchair enroute home. No other vaccines in four weeks. Treatment was received with Benadryl, dexamethasone, EpiPen. The outcome of the events were recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, Swollen tongue, Throat tightness
Clinical narrative: I heard from a nurse practitioner that she had heard there were 2 patients(both at least 65 years old; at least one was female) who had an allergic reaction; tongue swelling; throat closing; This is a spontaneous report from a contactable consumer. This consumer reported similar events for two patients. This is second of 02 reports. An elderly patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on 22Jan2021 as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had allergies and had Epi-pen. On 22Jan2021, the patient had allergic reaction (tongue swelling and throat closing) after taking the vaccine. The patient had own Epi-pens and used them. The adverse reactions were reversed by single use of Epi-pens. The patient was taken to the emergency room to be safe. The events resulted in emergency room/department or urgent care. The patient received treatment with self administered epi-pen. The outcome of events was recovered on an unspecified date in Jan2021.  Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021087746 same reporter/ drug, different patient/ similar AE
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: face broke out at about 4 pm on Thursday, has cleared up by Friday; This is a spontaneous report from a contactable Consumer (reporting herself). A 36-Year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration in left arm on 28Jan2021 at 10:00 as a single dose for COVID-19 immunization. The patient did not receive other vaccination in four weeks. The patient was on birth control. The patient's concomitant medication included Prozac and trazadone. The patient was not diagnosed with COVID prior vaccination. The patient did not underwent COVID test post vaccination. On an unknown date, the patient's face broke out at about 4 pm on Thursday and had cleared up by Friday. The patient did not receive any treatment medication for the event. The outcome of the event was recovered.  Information on Lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Nausea, Pain
Clinical narrative: Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; Delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EL9262, Expiration date unknown), via an unspecified route of administration in left arm on 21Jan2021 16:00 (at the age 69-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. The patient was not COVID positive prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medications included Simvastatin (SIMVASTATIN) 20MG, fish oil (FISH OIL), acetylsalicylic acid (BABY ASPIRIN); all for unspecified indication from an unspecified date and unknown if ongoing. The patient did not receive any other vaccine in 4 weeks prior to vaccination. The patient experienced delayed onset 4 days after inoculation: Nausea; stomach, body and joint aches, general weakness on 25Jan2021 17:00. The patient did not receive any treatment for the events. The outcome of the event was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the arm the next day; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified aged received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot No: Unknown), via an unspecified route of administration on 27Jan2021 as unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Jan2021, the patient experienced pain in the arm the next day. She is wondering if she can continue to do her routine exercise. The outcome of the event was unknown.  Information about lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: they administered the shot it felt like a quick pin prick; This is a spontaneous report from a Pfizer-sponsored program. A contactable female Other HCP reported that:  A female patent of unspecified age  is a Physical therapist received second dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number and expiration date were not reported) via an unspecified route of administration, on 28Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Jan2021 (same day of vaccination), when they administered the shot it felt like a quick pin prick but did not feel the injection. The outcome of event was unknown.  Caller asks, "is there a test to verify that I got the injection or should I just assume I got it, because my arm isn't hurting". Caller reports concern that her arm did not become sore after receiving the vaccine and now questions if she actually received the vaccine and if so, will it be effective.   E-transmitting for AE. Caller reports concern that the vaccination did not cause arm soreness. Offered caller warm transfer, offer declined.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Groin pain
Clinical narrative: right hip pain; right groin pain; This is a spontaneous report from a contactable nurse (patient). A 56 years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA: Lot number: not reported) via intramuscular route of administration in right arm on 31Dec2021 at 02:00 PM as a single dose for covid-19 immunisation (age at vaccination was 56 years). Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient's medical history includes hypothyroidism. Patient's concomitant medication includes synthroid, clonazempam, trintelliz, vitamin D, amytriptaline for unknown indications on unspecified dates. On 08Jan2021 the patient experienced right groin pain, right hip pain. Right hip pain increased on 11Jan2021. Patient did not receive any other treatment for the events. The outcome of all events was not resolved.  Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Body temperature, Nasal congestion
Clinical narrative: Congestion; Lost of smell and taste; Lost of smell and taste; This is a spontaneous report from a contactable Other-HCP. This male Other-HCP reported for himself that: A Male patient of unspecified age received first dose of BNT162B2 (COMIRNAT, solution for Injection, lot number and Expiration date was not reported) via an unspecified route of administration on 09Jan2021 as first dose, single for COVID-19 Immunization. Medical history and concomitant medications were not reported. On 09Jan2021 the patient received first dose of the vaccine and Today he is scheduled to get the second dose, but he had a congestion and loss of smell and taste but no fever (98.5 degree F) though. He wanted to know if he should go to get the vaccine or maybe some other day. The outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot
Clinical narrative: her face and ears got really hot; This is a spontaneous report from a contactable consumer or other non-Health care Professional. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Callback to consumer who has already reported her experience(unable to confirm spelling of patient's name as she was quick to get off the phone). She reports that after her first dose of the Pfizer-Biontech COVID 19 vaccine patient experienced her face and ears got really hot. She wants to know if she can treat with aspirin or Tylenol better. Patient asked that she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. COVID 19 first shot-I had a reaction and I spoke to the girl before and told her what it was-face and my ears really hot. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fibromyalgia, Pain in extremity
Clinical narrative: sore arm; it felt like a fibromyalgia flare; This is a spontaneous report from a contactable consumer, the patient. A 29-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 28Jan2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she took 400 mg of Advil 1.5 hours after the dose because of a sore arm and added "it still hurts a lot. It was ok the first 15 mins after the shot, then within 45 mins it felt like a fibromyalgia flare." Caller is asking if it was ok to take the Advil after the vaccine. She used a nasal spray and she wants to know if using the nasal spray will interact with the vaccine. The outcome of the event- it felt like a fibromyalgia flare was unknown, while that of the sore arm was not recovered at the time of report.  Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Lip swelling
Clinical narrative: upper lip is swollen was reported as worsened; upper lip started to swell, is having difficulty talking/upper lip is swollen; This is a spontaneous report from a contactable consumer. A 54-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in right arm on 26Jan2021 14:30 (at the age of 54-years-old) as a single dose for covid-19 immunization. Family Medical History included high blood pressure. Medical history included blood pressure abnormal, fibromyalgia, cardiac disorder, anxiety, hypertension. Concomitant medication(s) included amlodipine besylate (10mg take once daily by mouth, taking for 4 years) taken for blood pressure abnormal; aspirin [acetylsalicylic acid] (81mg take once daily by mouth, taking for 4 years) taken for blood pressure abnormal, cardiac disorder; chlorthalidone (50mg take once daily by mouth) taken for blood pressure abnormal, taking for 4 years; duloxetine hydrochloride (20mg take once daily by mouth, taking for a year) taken for fibromyalgia, anxiety; lisinopril (40mg take once daily by mouth, taking for 4 years) taken for blood pressure abnormal. The patient had no other vaccine within four weeks. The patient had a bad reaction to the shot. He had it a couple of days ago and on 28Jan2021, his upper lip was swollen. Adds he was unable to take medication, clarified he was asking is there something he isn't supposed to take of his unusual medications. and what should he do. He was having a hard time talking. The event upper lip is swollen was reported as worsened. He is taking several blood pressure medications and is wondering if they are interacting with the vaccine or if they should be discontinued. He is scheduled for the second dose of the vaccine on 16Feb2021. The outcome of the upper lip is swollen was reported as worsened was unknown, while that of the upper lip started to swell, is having difficulty talking/upper lip is swollen was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Chest X-ray, Dyspnoea, Fatigue
Clinical narrative: shortness of breath; worsened on Sunday; She had a fever Tuesday night; Her HR was 130; She feels tired and weak; She feels tired and weak; This is a spontaneous report from a contactable consumer, the patient via Pfizer. A 2-decade-old (in her late 20's) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Jan2021 as single for COVID-19 immunization. Medical history included allergy induced asthma. She had multiple bouts of pneumonia as a child and was also prone to bronchitis. The patient's concomitant medications were not reported. Patient received her 2nd dose of vaccine on Friday. On Saturday, patient noticed some shortness of breath which worsened on Sunday. Patient saw her doctor on Monday. Patient had a D-dimer that was normal. She was started on steroids. She had a fever Tuesday night. She had a negative COVID test and chest X-ray on Wednesday. After lunch, shortness of breath pronounced. Her HR was 130. She felt tired and weak. It was reported that the events took place after the use of product. Outcome of the events shortness of breath and worsened on Sunday was not recovered while of HR was 130, fever, tired and weak was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pyrexia, SARS-CoV-2 test
Clinical narrative: shortness of breath; worsened on Sunday; She had a fever Tuesday night; Her HR was 130; She feels tired and weak; She feels tired and weak; This is a spontaneous report from a contactable consumer, the patient via Pfizer. A 2-decade-old (in her late 20's) female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Jan2021 as single for COVID-19 immunization. Medical history included allergy induced asthma. She had multiple bouts of pneumonia as a child and was also prone to bronchitis. The patient's concomitant medications were not reported. Patient received her 2nd dose of vaccine on Friday. On Saturday, patient noticed some shortness of breath which worsened on Sunday. Patient saw her doctor on Monday. Patient had a D-dimer that was normal. She was started on steroids. She had a fever Tuesday night. She had a negative COVID test and chest X-ray on Wednesday. After lunch, shortness of breath pronounced. Her HR was 130. She felt tired and weak. It was reported that the events took place after the use of product. Outcome of the events shortness of breath and worsened on Sunday was not recovered while of HR was 130, fever, tired and weak was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, SARS-CoV-2 test
Clinical narrative: Significant and long lasting hot flashes; This is a spontaneous report from a contactable other hcp. A 37-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot Number: EL1284 ), dose 2 via an unspecified route of administration, administered in Arm Left on 18Jan2021 as 2nd dose, single for covid-19 immunisation(Age at vaccination: 37 Years). Medical history included hepatitis c. Concomitant medications included buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE) , bupropion hydrochloride (WELLBUTRIN), meloxicam, lamotrigine (LAMICTAL). The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection, Lot Number: EK5730), administered in Arm Left on 28Dec2020 for covid-19 immunisation and experienced Soreness in arm extending beyond injection site, fatigue for 2 days after the first dose. The patient experienced significant and long lasting hot flashes after getting the second dose in Jan2021, experienced them almost two weeks. The patient underwent lab tests and procedures which included covid test post vaccination on 28Dec2020, 30Dec2020, 04Jan2021, 08Jan2021, 11Jan2021, 14Jan2021, 19Jan2021, 25Jan2021 and result of all was negative. patient was not diagnosed with COVID-19 post vaccination.She is not pregnant at the time of vaccination. She did not receive treatment for the adverse event. Patient has no allergies to medications, food, or other products. The Outcome of the event was not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Limb discomfort, Movement disorder
Clinical narrative: With the 1st shot arms got heavy; Couldn't move arms for about 4 min; The next 2 days I felt like an oven door was opened inside me. Very hot inside but outside body was cool; This is a spontaneous report from a contactable 60-year-old female (Nurse). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot no: EL1283) via intramuscular administration, administrated in right arm on 12Jan2021 11:15 AM, as single dose and second dose (Batch/Lot no: EL3302) via other route administrated in right arm on 02Feb2021 12:15 PM as single dose for COVID-19 immunization. The patient medical history included depression Depression, Hypothyroidism, High Cholesterol, Osteopenia, Occasional vertigo. The patient concomitant medications included Simvastatin 40mg, Duloxetine 30-60mg, Raloxifene 60mg, Chlorthalidone 25mg, Levothyroxine 0.88mcg, Calcium 600mg with 500IU Vitamin D, Folic Acid 400mcg, Fish Oil 1400mcg, B12 5000mcg, Vitamin D 2000IU and Tumeric 1000mg. The patient had second dose on 02Feb2021. After the first dose patient experienced patient arms got heavy and then pateint couldn't move them for about 4 min. The next 2 days patient felt like an oven door was opened inside. Very hot inside but outside body was cool, no redness or sweating.  patient 2nd shot on arms didn't get heavy, just felt a weakness going from shoulders down to hands. Couldn't move or feel them for 15 min. Slowly patient could move fingers then hands then lift arms. The next day patient brain felt kind of fuzzy. Still a little "off kilter" on 2nd day. Patient did not have any anxiety about either shot, even with what happened with the first one. (patient the one reporting - it says patient from a healthcare professional reporting for a patient and patient couldn't change it). Prior to vaccination, was the patient did not diagnose with COVID-19. Since the vaccination, the patient had been not tested for COVID-19. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021136873 Same patient, same drug, different vaccine date
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: soreness; bad headache; chills; This is a spontaneous report from a contactable Other Health care Professional reported for herself. A 40-year-old non-pregnant female patient received (PFIZER-BIONTECH, COVID-19 Vaccine, Solution for injection, Lot number: EL9265, Expiration date: Not reported) 1ST dose via an unspecified route of administration, administered in Arm Left on 02Feb2021 17:00 as SINGLE DOSE for covid-19 immunization. There is no specific Medical history reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. On 03Feb2021 at 06:00 AM she started experiencing soreness, bad headache, and chills. The outcome of events are of recovering.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Pyrexia, Rhinorrhoea
Clinical narrative: Nausea; headache; soreness at injection point; fever; runny nose; This is a spontaneous report from a contactable Consumer (patient). A 16-year-old female non-pregnant patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN5318, Expiration date not reported), via an unspecified route of administration in arm left on 27Jan2021 (at the age 16-year-old), as a single dose for COVID-19 immunization. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included escitalopram oxalate (LEXAPRO). The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3249, Expiration date not reported), via an unspecified route of administration in arm right on 06Jan2021, as a single dose for COVID-19 immunization. The patient did not receive any other vaccine in four weeks before vaccination. The patient experienced nausea, headache, soreness at injection point, fever and runny nose on 27Jan2021. The patient did not receive any treatment for the events. The outcome of the events was reported as recovering  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria, Vaccination site rash, Vaccination site urticaria
Clinical narrative: Rash/Hives at injection site and left side of chest, neck and arm; Rash/Hives at injection site and left side of chest, neck and arm; Rash/Hives at injection site and left side of chest, neck and arm; Rash/Hives at injection site and left side of chest, neck and arm; This is a spontaneous report from a non-contactable Nurse reported for a female patient. A 32-years-old female patient (non-pregnant) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: el1283), via intramuscular route of administration in left arm on 10Jan2021 at 12:30 (at the age of 32-years-old) as single dose for COVID-19 immunisation. Medical history included allergic to latex and morphine. 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 has allergic to latex and morphine. The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jan2021 at 12:45, the patient experienced rash, hives at injection site and left side of chest, neck, and arm. The patient did not receive any treatment for the events. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: She is experiencing chills and she got a 102.7 temperature; She is experiencing chills and she got a 102.7 temperature; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on 27JAN2021 as unknown single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On JAN2020 on unspecified date the patient was experienced chills and she got a 102.7 temperature. The patient underwent lab tests and procedures which included body temperature: 102.7 on an unspecified date. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Gastrointestinal disorder, Insomnia, Nausea, Nervous system disorder
Clinical narrative: My nervous system is a wreck; Have not slept in two days; My digestive system is unfix, I have gone to bathroom like 3 times yesterday; I feel like I wanted to throw up; discomfort; This is the spontaneous report from a contactable consumer (patient). An 86-year-old male patient received BNT162B2 (Pfizer vaccine; Lot number: unknown; Expiry date: Unknown), via an unspecified route of administration on 25Jan2021 as a single dose for COVID-19 immunization. Medical history included unspecified Diabetes. Concomitant medications included Losartan (unspecified dose) and Xarelto 20 mg. On 26Jan2021, patient experienced my nervous system is a wreck (nervous system disorder), I have not slept in two days (insomnia), my digestive system is unfix , I have gone to bathroom like 3 times yesterday(gastrointestinal disorder), I feel like I wanted to throw up (nausea), discomfort (discomfort) and I can't you know (incomplete sentence) and the patient was just trying to find out, how long this side effect would last approximately or what to do, to ease my discomfort. Therapeutic measures taken as a result of the events; Tylenol and patient regular medications were taken. The outcome of the events were not recovered.  No follow up attempts are possible. No further information is expected.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: swelling of lower lip and other parts of face; swelling of lower lip and other parts of face; This is a spontaneous report received from a contactable consumer or other non hcp. A 81-years-old  non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration in Arm Left on 19Jan2021 10:00 (Batch/Lot Number: ELI283) as single dose for covid-19 immunisation. The patient medical history included hypertension, arthritis, vertigo from an unknown date and unknown if ongoing. The patient had allergies to medications, food, or other products with Codeine, Z-pak, some Sulfa drugs. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took codeine and, zithromax z-pack and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced swelling of lower lip and, swelling of face on 20Jan2021 03:00 primarily noticeable to me and others who know me. Otherwise, not particularly noticeable .The patient visited  Emergency room/department or urgent care for the event.Outcome of the event unknown.   Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Headache; Sore injection site; Nausea; Fever over 101 F.; This is a spontaneous report from a non-contactable consumer (patient). A 50-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in arm left on 04Feb2021 at 11:00 (Batch/Lot Number: EM9810) (at the age of 50-years-old) as 1st dose, single for COVID-19 immunization. The patient medical history was not reported. The patient did not had allergies to medications, food or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 04Feb2021 at 17:00, the patient experienced headache, sore injection site, nausea and fever over 101 F. The patient underwent lab tests and procedures which included body temperature: over 101 Fahrenheit on 04Feb2021 (fever over 101 F). The patient did not receive treatment for the events. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arms; This is a spontaneous report from a contactable pharmacist (husband) via Medical Information Team. This consumer reported similar events for himself and 1 patient. This is a 2nd of 2 reports. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration on 27Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, patient experienced a sore arm. The outcome of the event sore arm was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021086111 Same reporter/drug/AE and different patients.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Headache, Illness, Loss of personal independence in daily activities
Clinical narrative: Dizzy; Headache/ sick headache; I have been in bed ever since/I can't turn my head or anything; it got worse today; Sick; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 27Jan2021 (age at vaccination was 63 years) as 2ND DOSE, SINGLE for COVID-19 immunization. Medical history included anxiety. Concomitant medication included escitalopram oxalate (LEXAPRO) taken for anxiety. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: unknown, Expiration Date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unknown date (age at vaccination was unknown) as 1ST DOSE, SINGLE for COVID-19 immunization. The consumer stated that she had been sick since yesterday. She was at work and got dizzy and had a headache. She took like for the headache, she had like a sick headache at night and she took Tylenol (Lot no: E2392V, Expiration date: 20/22) but it seemed like it got worse today. She had a second shot of the virus shot and she had been in bed ever since. She felt very dizzy. She couldn't turn her head or anything, so she went to urgent care and they told her to call them right away that they thought that might be it was an allergic reaction. (As consumer was sure, hence allergic reaction not captured as event). The consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the website link as (Website provided). The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: in the last hour that she has had a headache and diarrhea twice; in the last hour that she has had a headache and diarrhea twice; This is a spontaneous report from a contactable consumer (patient) reporting about herself.  A 77-year-old female patient (77 years age at vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported, Expiration Date: 2021), via an unspecified route of administration, in left arm on 28Jan2021 at 13:40 as (0.3 ML) single dose for COVID-19 immunisation. The patient's medical history stated that she dropped weight before the vaccine. She usually had diarrhoea that it depended on what she ate. In the last hour following vaccination (28Jan2021, afternoon), the patient experienced a dull headache and diarrhoea twice. She stated that sometimes it was normal to have diarrhoea for her, but she did not know the reason as it started so bad that afternoon.  The patient said that she took Pepto-Bismol (unspecified formulation) for her diarrhoea that she normally used to take, as treatment medication. The outcome of the event headache was reported as recovering while the outcome of the event diarrhoea was reported as unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Chest pain, Oxygen saturation, Oxygen saturation abnormal
Clinical narrative: temperature 98.8; oxygen is at 94; Chest pain/The pain is when he breathes and they are in the center of chest, they are very strong pains; have been same for past 8 hours; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Husband). A male patient of unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown) via unspecified route of administration on 27Jan2021 as UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient had taken the Pfizer Covid-19 vaccine yesterday at 6pm. By 12 that night he had chest pains. The pain was when he breathes and they were in the center of his chest, they were very strong pains. It had not got worsened but continued to be the same for about the past 8 hours. His oxygen was at 94, temperature 98.8 and he had no other symptoms. The outcomes of the event chest pain were not recovered and other events was unknown. Declines to provide an address or email. Declines report. Just wants to speak to someone. Also recommended if husband does get worse to seek emergency care/provider care.   Information about lot/batch number requested  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: her arm was sore; her arm started to itch and get red and swollen; her arm started to itch and get red and swollen; her arm started to itch and get red and swollen; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 25Jan2021 as unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her arm was sore and her arm started to itch and get red and swollen on 26Jan2021. Clinical course of the events was as follow: the patient said she got her COVID vaccine on Monday 25Jan2021 at the institute. She said what happened was at first, she had nothing then on Tuesday she woke up and her arm was sore and later in the day it started to itch and get red and swollen and today, Thursday it was a tiny bit less swollen she thought but still red probably about 4-5 inches toward going under her arm and it had itched a little less than it did. She called to see if this was anything to be concerned about. She said she could really quickly answer questions but she just got home from the hospital visiting and the nurse was going to be stopping by her house soon. She would rather bet transferred to where she needed to go now because the nurse was going to be walking through the door any minute. The outcome of the events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes on right side of face; This is a spontaneous report from a contactable consumer (patient). A 43-Year-old female patient received BNT162B2 (COMIRNAT, Solution for injection, Lot number: EL3247 Expiration date: 31May2021), via unspecified route of administration in left arm on 16Jan2021 as 1ST DOSE, SINGLE for COVID-19 immunization. Medical History was not reported. The Patient Concomitant medications were not reported. The patient stated that she was having a reaction to her first dose that was given on 16Jan. She Stated that she tried to use Vsafe but was not getting a verification code, was Pfizer Covid vaccine. On 26Jan2021 the patient experience swollen lymph nodes on the right side of her face. The patient also stated that they would decrease and when she chews on something will increase, harden and make it painful. The patient stated that she has swollen lymph nodes on the right side of her face. Wanted to know what to do about the swollen lymph nodes. No treatment was given to the condition. The event of the outcome was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; Has a temp of 100; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife).  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3247), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date, after vaccination the patient experienced diarrhea and he had a temp of 100. The caller stated, her husband had his Pfizer first vaccine on Tuesday and this morning he woke up with pretty extreme diarrhea and she just checked him he had a temp of 100 so. The caller also stated, she just needs to know about her husband's symptoms and who needs to know those and what she should do about it. Outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chills, Headache, Injection site pain
Clinical narrative: Injection site pain; Lethargy; Headache; Sore throat; Muscle pain; Chills; Joint pain; Injection site swelling; it was hard but it was not red; Swollen lymph nodes; Severe abdominal pain; This is a spontaneous report from a contactable (Patient).   A 46-years-old female patient received second dose bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3302, expiry date was not reported), via an unspecified route of administration on 14Jan2021 as, SINGLE for covid-19 immunisation.The patient medical history was not reported. Concomitant medication(s) included Latuda, Synthroid taken for an unspecified indication. Patient previously took First dose of bnt162b2 (BNT162B2, solution for injection, Lot number EH9899 and expiry date was not reported), via an unspecified route of administration on 22Dec2020 as 1st dose single for covid-19 immunisation. The patient experienced injection site pain, lethargy, headache, sore throat, myalgia, chills, arthralgia, injection site swelling, lymphadenopathy, abdominal pain on 14Jan2021. Consumer who was a nurse Practitioner stated, "I wanted to report side effects for Pfizer-BioNTech COVID-19 Vaccine (later confirmed). I have injection site pain, lethargy, headache, sore throat, muscle pain, chill, joint pain, injection site swelling and it is so hard but it was not red and swollen lymph nodes and I felt feverish and then about 4 days later, I had severe abdominal pain but I do not know if that was related as she still had on and off abdominal pain, while everything else went away after about three days and when asked about expiration date of 1st dose consumer stated, "It does not say an expiration date here." Patient also informed that all the adverse events occurred after the second vaccination. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lethargy, Lymphadenopathy, Myalgia, Oropharyngeal pain
Clinical narrative: Injection site pain; Lethargy; Headache; Sore throat; Muscle pain; Chills; Joint pain; Injection site swelling; it was hard but it was not red; Swollen lymph nodes; Severe abdominal pain; This is a spontaneous report from a contactable (Patient).   A 46-years-old female patient received second dose bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3302, expiry date was not reported), via an unspecified route of administration on 14Jan2021 as, SINGLE for covid-19 immunisation.The patient medical history was not reported. Concomitant medication(s) included Latuda, Synthroid taken for an unspecified indication. Patient previously took First dose of bnt162b2 (BNT162B2, solution for injection, Lot number EH9899 and expiry date was not reported), via an unspecified route of administration on 22Dec2020 as 1st dose single for covid-19 immunisation. The patient experienced injection site pain, lethargy, headache, sore throat, myalgia, chills, arthralgia, injection site swelling, lymphadenopathy, abdominal pain on 14Jan2021. Consumer who was a nurse Practitioner stated, "I wanted to report side effects for Pfizer-BioNTech COVID-19 Vaccine (later confirmed). I have injection site pain, lethargy, headache, sore throat, muscle pain, chill, joint pain, injection site swelling and it is so hard but it was not red and swollen lymph nodes and I felt feverish and then about 4 days later, I had severe abdominal pain but I do not know if that was related as she still had on and off abdominal pain, while everything else went away after about three days and when asked about expiration date of 1st dose consumer stated, "It does not say an expiration date here." Patient also informed that all the adverse events occurred after the second vaccination. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dizziness, Dyspnoea, Fatigue
Clinical narrative: dizziness; weakness; fatigue; loss of appetite; shortness of breath; This is a spontaneous report from a contactable Nurse. An 80-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1284, Expiration date was not reported), via intramuscular, administered in left arm on 14Jan2021 15:00 as first dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation (A-Fib), coronary artery disease (CAD), hypercholesterolemia, GERD, benign prostatic hyperplasia (BPH) and peripheral vascular disorder (PVD). The patient concomitant medication was not reported. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Resident within 15 minutes of vaccination complained of dizziness, he then subsequently had other symptoms of weakness, fatigue, no fever, loss of appetite, shortness of breath on 14Jan2021 03:15 AM. Patient received treatment of prednisone. The patient underwent lab tests and procedures which included nasal swab test: negative on 03Feb2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.