chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: arm is sore; pain in her chest as she had before/pain in chest to her left upper sternal border area (under collar bone); fatigued; chills; fever; body aches, it was more like body cramping; body aches, it was more like body cramping; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231 and expiry date: unknown), intramuscular on the left deltoid, on 14Jan2021 07:15 at a single dose for COVID-19 immunization. The first dose was received on 28Dec2020 (lot number: EK9231), intramuscular on the left deltoid and patient experienced sore arm, and left upper (under collar bone) pain in her chest. The patient medical history was not reported. There were no concomitant medications. She received the vaccine around 7:15 in the morning and by midnight on 15Jan2021 (she works nights), she started to feel the pain. By that point, she was like "ooh, my arm is sore". She also started to have the same pain in her chest as she had before (pain in chest to her left upper sternal border area (under collar bone). Her doctor ordered a chest x-ray on 25Jan2021. Patient stated it was not cardiac. It's just there. The pain was annoying and she can feel it when she moves or when she goes to get up, it's an ache. Its a pain in the neck. On Friday, 15Jan2021, she was real fatigued, had chills, a little bit of a fever, and body aches. She clarified it was more like body cramping and her body hurt so bad. She over that by Sunday.All of her symptoms resolved by Sunday 17Jan2021, except for the pain she was experiencing in her chest which was still ongoing and persisting. She had taken Tylenol, Aleve, and Ibuprofen, but it doesn't resolve the pain at all. Outcome of the event of sore arm was unknown, for pain in chest was not recovered while for the remaining events was recovered on 17Jan2021.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monday-second day after=started to feel more sick, scratchy/sore throat/scratchy throat; Chest heaviness/tightness-slightly short of breath/chest tightness; Chest heaviness/tightness-slightly short of breath; Muscle aches; Minor chills; Headache; Sunday-first day after=just felt lousy, fatigue/fatigue; General malaise/ just felt lousy; Saturday night= extremely sore arm (lasted for first 24-48 hrs after); This is a spontaneous report from a contactable nurse. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), intramuscular on the left arm at the age of 32 years, on 23Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included eczema and allergy to metals from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient received the first dose on 02Jan2021. On Saturday night (23Jan2021), the patient's had extremely sore arm (lasted for first 24-48 hrs. Then on Sunday( 24Jan2021), patient just felt lousy and fatigue. On Monday (25Jan2021), patient started to feel more sick, scratchy/sore throat, fatigue, chest heaviness/tightness lightly short of breath, muscle aches, minor chills, headache. On Tuesday, third day after, muscle aches, headache, fatigue, general malaise, scratchy throat, chest tightness. No treatment was received for the events. The outcome of the events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monday-second day after=started to feel more sick, scratchy/sore throat/scratchy throat; Chest heaviness/tightness-slightly short of breath/chest tightness; Chest heaviness/tightness-slightly short of breath; Muscle aches; Minor chills; Headache; Sunday-first day after=just felt lousy, fatigue/fatigue; General malaise/ just felt lousy; Saturday night= extremely sore arm (lasted for first 24-48 hrs after); This is a spontaneous report from a contactable nurse. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), intramuscular on the left arm at the age of 32 years, on 23Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included eczema and allergy to metals from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient received the first dose on 02Jan2021. On Saturday night (23Jan2021), the patient's had extremely sore arm (lasted for first 24-48 hrs. Then on Sunday( 24Jan2021), patient just felt lousy and fatigue. On Monday (25Jan2021), patient started to feel more sick, scratchy/sore throat, fatigue, chest heaviness/tightness lightly short of breath, muscle aches, minor chills, headache. On Tuesday, third day after, muscle aches, headache, fatigue, general malaise, scratchy throat, chest tightness. No treatment was received for the events. The outcome of the events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Monday-second day after=started to feel more sick, scratchy/sore throat; scratchy/sore throat; Monday-second day after=started to feel more sick, scratchy/sore throat/scratchy throat; Chest heaviness/tightness-slightly short of breath/chest tightness; Chest heaviness/tightness-slightly short of breath; Muscle aches; Minor chills; Headache; Sunday-first day after=just felt lousy, fatigue/fatigue; General malaise/ just felt lousy; Saturday night= extremely sore arm (lasted for first 24-48 hrs after); This is a spontaneous report from a contactable nurse. A 32-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1284), intramuscular on the left arm at the age of 32 years, on 23Jan2021 11:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included eczema and allergy to metals from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (ZOLOFT). The patient received the first dose on 02Jan2021. On Saturday night (23Jan2021), the patient's had extremely sore arm (lasted for first 24-48 hrs. Then on Sunday( 24Jan2021), patient just felt lousy and fatigue. On Monday (25Jan2021), patient started to feel more sick, scratchy/sore throat, fatigue, chest heaviness/tightness lightly short of breath, muscle aches, minor chills, headache. On Tuesday, third day after, muscle aches, headache, fatigue, general malaise, scratchy throat, chest tightness. No treatment was received for the events. The outcome of the events was recovering.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever of 102.8; Chills; fatigue; head and body aches; body aches; This is a spontaneous report from a contactable consumer (patient). A 29- year-old male patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3248) via unknown route of administration on left arm, at 05:45 on 01Feb2021, at single dose for COVID-19 immunization. The patient medical history included Coeliac disease and gluten allergy. The concomitant medication included finesteride, iron, biotin, niacin and zinc. The patient experienced fever 102.8 centigrade, chills, fatigue, head and body aches at 18.30 on 01Feb2021. The patient didn't receive any treatment. The patient was not diagnosed with COVID-19 prior to vaccination and after vaccination. The patient received COVID-19 vaccine at workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever of 102.8; Chills; fatigue; head and body aches; body aches; This is a spontaneous report from a contactable consumer (patient). A 29- year-old male patient received first dose of bnt162b2 (Brand: Pfizer, Formulation: solution for injection, Lot number: EL3248) via unknown route of administration on left arm, at 05:45 on 01Feb2021, at single dose for COVID-19 immunization. The patient medical history included Coeliac disease and gluten allergy. The concomitant medication included finesteride, iron, biotin, niacin and zinc. The patient experienced fever 102.8 centigrade, chills, fatigue, head and body aches at 18.30 on 01Feb2021. The patient didn't receive any treatment. The patient was not diagnosed with COVID-19 prior to vaccination and after vaccination. The patient received COVID-19 vaccine at workplace clinic. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The events was reported as non-serious by the reporter. The outcome of the events was reported as recovered on an unknown date in Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pain, Vaccination site pain
Clinical narrative: soreness at injection site; Splitting headache for 48 hours after injection; nausea; body aches; fatigue; This is a spontaneous report from non-contactable consumer (patient). An adult male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date unknown), via an unspecified route of administration on 30Jan2021 at a single dose for COVID-19 immunisation. Medical history included asthma. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot unknown and expiration date unknown) on 09Jan2021 for COVID-19 immunisation. The patient's concomitant medications were not reported. It was not known if the patient received other vaccines within 4 weeks prior to the COVID vaccine. It was not known if the patient was diagnosed with COVID-19 prior to vaccination. The patient experienced splitting headache for 48 hours after injection, nausea, body aches, fatigue and soreness at injection site all on 30Jan2021. The patient recovered from splitting headache on 01Feb2021 while the patient recovered from the other events on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: breakout rash on her chest, neck, and under her chin; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9262, expiry date: May2021), via intramuscular route of administration on 23Jan2021 at 16:25 at 0.3 mL, single  for COVID-19 immunization. Medical history included allergy, penicillin allergy, allergic to bee stings, and allergic to baby powder. The patient's concomitant medications were not reported. On 23Jan2021 at 23:30, the patient had breakout rash on her chest, neck, and under her chin. She says she took Benadryl, which puts her right to sleep, and she slept 12 hours. The outcome of the event was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pyrexia, Vertigo
Clinical narrative: fever; body aches; mild vertigo; The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021; This is a spontaneous report from a contactable Other Health Professional reporting for herself. A 52-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown), via an unspecified route of administration (left arm) from 16Jan2021 17:30 (05:30 PM) at SINGLE DOSE for covid-19 immunisation. Medical history included known allergies: Keflex and sulfa from unspecified date. Patient is not pregnant. No other vaccine was given in four weeks. Patient did not have COVID prior vaccination. Patient was not tested for COVID post vaccination. Concomitant medication included botulinum toxin type a (BOTOX), and ibuprofen (MOTRIN) from an unspecified date for an unspecified indication (medications in two weeks). The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number unknown) on 02Dec2020 07:45 AM, Left arm. The first dose was received on 02Dec2020 and the second dose was received on 16Jan2021. The patient experienced fever, body aches, mild vertigo on 17Jan2021 12:00. Treatment was not given. Outcome of the events was recovered in 2021.  Information about lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Throat irritation, Throat tightness
Clinical narrative: metallic taste in mouth; itchy throat that felt constricted; itchy throat that felt constricted; This is a spontaneous report from a contactable other healthcare professional (patient). A 39-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL0142) intramuscular on the left arm on 30Dec2020 10:30 at a single dose for COVID-19 immunization. Medical history included pre-diabetes and known allergies: Penicillin. Concomitant medication included escitalopram oxalate (LEXAPRO). Immediately after the 1st dose on 30Dec2020, the patient experienced metallic taste in mouth followed by itchy throat that felt constricted. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Dysgeusia, Hypoaesthesia oral, Pruritus
Clinical narrative: tongue numbness; weird taste; persistent allergies; itchy face; This is a spontaneous report from a contactable health care professional (patient).  A 39-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL8982, expiry date unknown), via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. Medical history included pre-diabetes and allergies to penicillin both from an unknown date and unknown if ongoing. The patient concomitantly received cetirizine hydrochloride (ZYRTEC) as pre-medication and Lexi pro (as reported). The patient received the first dose of BNT162B2 (lot number: EL0142, expiry date unknown), intramuscular on 30Dec2020 at 10:30 AM on the left arm for COVID-19 immunization where the patient immediately after experienced metallic taste in mouth followed by itchy throat that felt constricted. Prior to vaccination, the patient has not had COVID-19. The patient has not been tested for COVID-19 post vaccination. The patient was premedicated with Zyrtec and 15 minutes after second dose had tongue numbness and weird tast on 20Jan2021 at 16:15 and itchy face started hours later and then continued with persistent allergies every day since the second dose until present was placed on oral steroid. The events resulted in a doctor or other healthcare professional office/clinic visit. The patient received oral steroid and Benadryl as treatment for the events. The outcome of the events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Irritability, Migraine, Vaccination site pain, Vaccination site swelling
Clinical narrative: Site swelling and high pain for 3 days; Site swelling and high pain for 3 days; Global Migraines; Irritated; This is a spontaneous report from a non-contactable nurse (patient). A 29-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9262) via an unspecified route of administration on the left arm on 21Jan2021 22:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 31Dec2020 for COVID-19 immunization. On 22Jan2021 03:00 AM, the patient experienced site swelling and high pain for 3 days. Global Migraines that I have never hard before 2 days after vaccination and irritated. Events treatment included paracetamol (TYLENOL), cetirizine (ZYRTEC) and diphenhydramine (BENADRYL). Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovered on an unspecified date.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Cough, Oropharyngeal pain, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site; sore throat; cough; fever for two nights (101 [unit unspecified]/100 [unit unspecified]); This is a spontaneous report from a contactable consumer (patient). An elderly non-pregnant female patient (reported as 65 [unit unspecified]) received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9263; expiration date: unknown) unknown age of vaccination via an unspecified route of administration left arm on 23Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included had covid-19 prior vaccination (if covid prior vaccination: yes). Concomitant medication includes unspecified medications. The patient did not received vaccination in four weeks. The patient received the vaccine in a hospital. On 24Jan2021 09:00 AM, the patient had soreness at injection site, sore throat, fever for two nights (101 [unit unspecified] on 24Jan2021 and 100 [unit unspecified] on 25Jan2021) and cough. The patient did not received treatment for the adverse events. The patient has not been covid tested post vaccination. The outcome of the event was recovering.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dysphagia, Fatigue, Glossodynia, Lymphadenopathy
Clinical narrative: Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Felt pains; Lymph nodes, they swelled; Pain on tongue; Extreme dehydration; Fatigue; Difficulty swallowing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 26Jan2021 (09:15) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the pharmacy/drug store. Medical history included anemia and allergies. Concomitant medications included an unspecified allergy shot. The patient was not pregnant at the time of vaccination. On 26Jan2021 (12:15), the patient had felt pains; lymph nodes had swelled; had pain on tongue; extreme dehydration; fatigue; and difficulty swallowing. The patient had received diphenhydramine (BENADRYL) as treatment for the events, and drank lots of water. The outcome of the events, 'felt pains', 'lymph nodes swelled', 'pain on tongue', 'extreme dehydration', 'fatigue' and 'difficulty swallowing', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Blister, Peripheral swelling, Rash
Clinical narrative: Rash and swelling in hands; Rash and swelling in hands; Blisters; This is a spontaneous report from a contactable healthcare professional (patient). An adult male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 13Jan2021 (12:00) at a single dose, with route of administration unspecified, for COVID-19 immunization at the hospital. The patient did not have relevant medical history and concomitant medications. On 15Jan2021, the patient had rash and swelling in hands; and blisters. The events resulted in doctor or other healthcare professional office/clinic visit. The patient had received valacyclovir as treatment for the reported events. The outcome of the events, 'rash and swelling in hands' and 'blisters', was recovering. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested post-vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Peripheral swelling, Pyrexia
Clinical narrative: swollen neck lymph nodes five days after shot; My left arm was swollen; low grade fever; This is a spontaneous report from a contactable consumer reporting for herself. A 74-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EL1283), via an unspecified route of administration (left arm) on 21Jan2021 15:00 at SINGLE DOSE for covid-19 immunisation. Medical history included cholesterol (abnormal) from an unknown date. Patient is not pregnant. No other vaccines were given in four weeks. Patient did not have COVID prior vaccination and patient was not tested for COVID post vaccination. Concomitant medications (medications in two weeks) included pravastatin from unspecified date for cholesterol (abnormal); estrogens conjugated (PREMARIN), allopurinol (ELAVIL), ascorbic acid, betacarotene, cupric oxide, manganese sulfate, selenium, tocopheryl acetate, ubidecarenone, zinc oxide (COQ10), aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX) from an unspecified date for an unspecified indication. The patient experienced low grade fever on 25Jan2021 that went away but the following morning on 26Jan2021, the patient also experienced swollen neck lymph nodes five days (five days as reported) after shot. Patient stated she does not know if it was going away. Patient's left arm was also swollen on 26Jan2021. Left arm was described as swollen just little bit, not much but that's gone down. The patient stated there was no fever as of reporting, but the swollen lymph node was being reported and since she has been up, it's gone down considerably but she can just feel them a little bit on her neck. Treatment was not given. She mentioned she has a person coming to do a work at the house and wanted to know if it is okay if she still comes. She asked if she should be alarmed about the side effect. She mentioned she was just concerned about if she needs to be concerned about this or if she can be around people. She mentioned she wear masks anyways but just need to know if it is okay if people come into her home. Outcome of the events low grade fever and left arm was swollen was recovered on Jan2021, while unknown for swollen neck lymph nodes five days after shot.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, SARS-CoV-2 test
Clinical narrative: joint pain; muscle ache; fatigue; This is a spontaneous report received from a contactable consumer. A 51-year-old female patient receive the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 04Jan2021 (lot number and expiry date unknown), at single dose; then received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19), via an unspecified route of administration, on 25Jan2021 (lot number and expiry date unknown), at single dose, for COVID-19 immunization. Medical history included type 2 diabetes mellitus (reported as "t2dm"). The patient did not have COVID-19 prior to vaccination. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive other vaccines in four weeks. The patient experienced joint pain, muscle ache and fatigue in Jan2021. Treatment for the events included APAP. The patient was tested for COVID-19 post vaccination in Jan2021 thru nasal swab with unknown results. The patient was recovering from the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Palpitations
Clinical narrative: Heart palpitations for three days after injection; Cold symptoms for three days after injection; This is a spontaneous report from a non-contactable consumer. A 26-year-old patient of an unspecified gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on the left arm on 08Jan2021 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced heart palpitations and cold symptoms for three days after injection on 08Jan2021. No treatment was received for the events. The outcome of the event was recovered on an unspecified date.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Dizziness, Fatigue, Pain
Clinical narrative: Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched and burned on my head; Rash to my face; Body aches; weakness; fatigue and woozy feeling xs 4 days; fatigue and woozy feeling xs 4 days; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 20Jan2021 23:15 at a single dose for COVID-19 immunization. Medical history included Raynaud's, hypotension, known allergies: barley, oatmeal, pork, tomatoes. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took doxycycline and experienced allergies. Benadryl prior to administration. On 20Jan2021 03:00 PM, the patient experienced hives that itched and burned on her head - still remain after 6 days but improved. Rash to her face, body aches, weakness, fatigue and woozy feeling for 4 days. Events treatment included diphenhydramine (BENADRYL). The facility where the vaccine was administered was in a nursing home/senior living facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID test post vaccination included Nasal Swab (Rapid and PCR) on 21Jan2021: negative. Outcome of the events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives that itched and burned on my head; Hives that itched and burned on my head; Hives that itched and burned on my head; Rash to my face; Body aches; weakness; fatigue and woozy feeling xs 4 days; fatigue and woozy feeling xs 4 days; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 20Jan2021 23:15 at a single dose for COVID-19 immunization. Medical history included Raynaud's, hypotension, known allergies: barley, oatmeal, pork, tomatoes. Concomitant medication included diphenhydramine hydrochloride (BENADRYL). The patient previously took doxycycline and experienced allergies. Benadryl prior to administration. On 20Jan2021 03:00 PM, the patient experienced hives that itched and burned on her head - still remain after 6 days but improved. Rash to her face, body aches, weakness, fatigue and woozy feeling for 4 days. Events treatment included diphenhydramine (BENADRYL). The facility where the vaccine was administered was in a nursing home/senior living facility. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. COVID test post vaccination included Nasal Swab (Rapid and PCR) on 21Jan2021: negative. Outcome of the events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Myalgia
Clinical narrative: Muscle aches; overnight chills; This is a spontaneous report from a non-contactable pharmacist. A 41-year-old male patient received his second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient describes muscle aches and overnight chills after receiving the 2nd COVID19 vaccine injection on 25Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Head discomfort, Headache, Urticaria, Vaccination site pain
Clinical narrative: Very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today; pain and pressure in head through today; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 20Jan2021 07:45 AM at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines weeks prior to receiving bnt162b2. The patient was not pregnant. Prior vaccination, the patient was not diagnosed with covid. Medical history included prone to headaches. She had no known allergies. Concomitant medications included clarithromycin (CLARITIN), dextroamphetamine [dexamfetamine], fish oil, and "Olly multivit". On 20Jan2021 02:00 PM, the patient experienced very painful arm 6-14 hours after injection; one hive on left forearm; pain and pressure in head through today, Day 6 after vaccine, and counting. No corrective treatment was received. Outcome of the events was not recovered. The patient was not tested for covid post vaccination.   Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: red rash over her torso including her back and lower stomach and a slight rash on her arms and legs; This is a spontaneous report from a contactable consumer (patient).  A 48-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EN5318) in a Public Health Clinic, via an unspecified route of administration on 21Jan2021 at 16:00 at a single dose on the left arm for COVID-19 immunization.  Medical history included diabetes and high blood pressure both from an unknown date and unknown if ongoing. The patient had COVID-19 prior to vaccination on an unspecified date. The patient had no known allergies. The patient has not been tested for COVID-19 post vaccination. Concomitant medication included metformin hydrochloride, pioglitazone hydrochloride (ACTOPLUS MET), olmesartan medoxomil (BENICAR), loratadine (CLARITIN) and montelukast sodium (SINGULAIR). The patient had red rash over her torso including her back and lower stomach and a slight rash on her arms and legs on 24Jan2021 at 12:00. The event resulted in a doctor or other healthcare professional office/clinic visit. The patient was administered a steroid shot by her primary physician as treatment for the event. The outcome of the event was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Chills, Headache, Nausea, Oropharyngeal pain
Clinical narrative: chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the right arm, on 05Jan2021 10:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications included omeprazole; metoprolol; methocarbamol; vitamin d3; pregabalin; and levothyroxine. The patient did not have Covid prior vaccination. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first shot the patient experienced chills, headache, sore throat, nausea and, loss of smell - all on 08Jan2021. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for these adverse events. At the time of the report, the patient was recovering from the events. The patient had a nasal swab for Covid on 11Jan2021 with results of negative.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: chills; headache; sore throat; nausea; Loss of smell; This is a spontaneous report from a contactable other healthcare professional (patient). A 48-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730), intramuscularly on the right arm, on 05Jan2021 10:00, at single dose, for covid-19 immunization. The patient's medical history was not reported. The patient had no known allergies. Concomitant medications included omeprazole; metoprolol; methocarbamol; vitamin d3; pregabalin; and levothyroxine. The patient did not have Covid prior vaccination. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. With the first shot the patient experienced chills, headache, sore throat, nausea and, loss of smell - all on 08Jan2021. These adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for these adverse events. At the time of the report, the patient was recovering from the events. The patient had a nasal swab for Covid on 11Jan2021 with results of negative.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Synovitis
Clinical narrative: synovitis bilateral hands; This is a spontaneous report from a contactable other health professional. A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 09Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient had unspecified concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 11Jan2021, the patient had synovitis bilateral hands. The patient received an unspecified steroids as treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event was not recovered.  No follow-up attempts are possible; Information about lot/batch could not be obtained.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Low grade fever (100 degrees); Chills; aches; fatigue; This is a spontaneous report from a contactable consumer reported for himself. A 36-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot No: EL3248), on right arm via an unspecified route of administration on 01Feb2021 13:15 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, (Lot no: EL3248) on 13Jan2021 01:15 pm for covid-19 immunisation. On 02Feb2021 12:00 AM patient experienced low grade fever (100 degrees), chills, aches and fatigue. Outcome of the events was recovered on unspecified date in 2021.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: A slight fever on the day after injection.; Pain in left arm at injection site as well as soreness in left arm as a whole; Pain in left arm at injection site as well as soreness in left arm as a whole.; A Migraine on day of injection as well as the following day; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date unknown), via an unspecified route of administration on left arm on 01Feb2021, at 09:15 AM at the age of 24 years old at a single dose for Covid-19 immunization in the hospital. Patient was not pregnant at the time of vaccination. The patient's medical history included complex aphthosis. Concomitant medications included probiotics. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received probiotics within 2 weeks of vaccination. On 01Feb2021 at 11:00, the patient experienced pain in left arm at injection site as well as soreness in left arm as a whole. A Migraine on day of injection (01Feb201 at 11:00) as well as the following day. On 02Feb2021, on the day after injection a slight fever. The patient assessed the events as non-serious. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient recovered from the events on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness
Clinical narrative: 24 hours of flu like body aches; extreme tiredness; Sore shoulder; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown), via an unspecified route of administration on left arm at the age of 56 years old on 02Feb2021 at 14:30 at a single dose for COVID-19 immunisation at workplace clinic. The patient's medical history was not reported. Allergies to medications, food, or other products was none. Concomitant medications included atorvastatin calcium (LIPITOR), hydrochlorothiazide, irbesartan (AVALIDE), famotidine and amlodipine besilate (NORVASC). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown, expiration date unknown) on left arm on 12Jan2021 at 07:00 AM for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient experienced sore shoulder, 24 hours of flu like body aches and extreme tiredness all on 02Feb2021 at 04:30 AM. The patient assessed the events as non-serious. No treatment was received in response to the events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. The patient has recovered from flu like body aches on 03Feb2021 while the patient recovered from the sore shoulder and extreme tiredness on an unspecified date in Feb2021.  The information on the Batch/Lot number has been requested.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: Soreness at injection site; Following morning experienced headache and fatigue throughout day; Following morning experienced headache and fatigue throughout day; queasiness; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3248, Expiry date: unknown) at 28 years of age via an unspecified route of administration on the right arm on 01Feb2021 at 09:15 am at a single dose for COVID-19 immunisation. Medical history and some surgeries were none. The patient has no allergies to medications, food, or other products. Concomitant medications included fluticasone propionate (50mcg) nasal spray and ascorbic acid, calcium pantothenate, colecalciferol, cyanocobalamin, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine hydrochloride, tocopherol (VITAM). The patient previously took the first dose of BNT162B2 (lot number: EL3248, expiry date: unknown) on 12Jan2021 at 08:30 am on left arm for COVID-19 immunisation. The patient experienced soreness at injection site. Following morning experienced headache and fatigue throughout day. Some queasiness possibly related to vaccine. Following day, it was reported that the only remaining symptom is a slight headache. The events were assessed as non-serious by the reporter. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events. The patient was recovering from the events.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity, Peripheral swelling, Vertigo
Clinical narrative: she woke up and noticed everything was spinning; Dizzy; sore arm after the shot.; Swollen arm; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on his right arm, via an unspecified route of administration on 22Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included blood pressure high and surgery. There were no concomitant medications. Historical vaccine included a flu shot for flu immunization and experienced arm is sore and pain. The patient reported she got the COVID shot last Friday at 3pm. That night she woke up at 2am and everything was spinning. She is better now but not completely. If she lies down and gets up or turns her head a certain way, she gets dizzy. She had a swollen arm and sore arm after the shot. No treatment was received for the events. The outcome of the events swollen arm and sore arm was unknown while recovering for the other events.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nasopharyngitis
Clinical narrative: she just does not feel good; Feeling like she is getting a cold; This is a spontaneous report from a contactable nurse (patient). A 72-year-old female received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: 30Apr2021), via an unspecified route of administration on the right arm, on 22Jan2021 at 0.3 mL, single for COVID-19 immunization. There were no medical history and concomitant medications. Patient stated she was feeling like she was getting a cold. She clarified that she started feeling this way starting last night on 25Jan2021, and today on 26Jan2021, she just does not feel good. Outcome of the events was not recovered. The reporter considered the events non-serious.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dyspnoea, Folliculitis, Investigation, Rash
Clinical narrative: dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); This is a spontaneous report from a contactable other health professional (patient).  A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek5760, via an unspecified route of administration in the right arm, on 19Dec2020 17:00 at SINGLE DOSE for covid-19 immunization. The patient's medical history included urticaria and folliculitis: patient was under successful treatment for urticaria and folliculitis with near resolution. Concomitant medication included cefalexin (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC) and triamcinolone. The patient received BNT162B2 on 19Dec2020. Then on 29Dec2020, 12:00, severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); experienced rash and dyspnea requiring steroids and epipen. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. The patient was recovering from all events. Treatment for the events included Prednisone course, epipen, and H2 blockers.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between rash, dyspnea and suspect product cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.