chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: a little sore on the injection site; This is a spontaneous report from a Pfizer Sponsored Program COVAX US Support, received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had a little sore on the injection site. It was also reported that had her 1st dose today 26Feb2021, but they mistakenly put the wrong date which is on 24Feb2021. It's also showing on the vaccination card that her 2nd dose schedule is 18Mar2021 which is less than 21 days. The outcome of the evet was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraine; This is a spontaneous report from a Pfizer Sponsored Program, received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient had vaccine first dose this afternoon (26Feb2021) and wanted to know if she can take migraine medication The outcome of the event was unknown.   No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: awesome, like an energy boost; This is a spontaneous report from a non-contactable consumer. This consumer reported similar event for two patients. This is the first of two reports (reporter's sister). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. On an unspecified date after the second BNT162B2 vaccine, the patient felt "awesome, like an energy boost". The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240906 Same reporter and suspect drug, similar event; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: awesome, like an energy boost; This is a spontaneous report from a non-contactable consumer. This consumer reported similar event for two patients. This is the second of two reports (friend of reporter's sister). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date after the BNT162B2 vaccine, the patient felt "awesome, like an energy boost". The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021240905 Same reporter and suspect drug, similar event; different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: whole body started hurting; This is a spontaneous report from a Pfizer-sponsored program Support. A contactable consumer (patient) reported that female patient of unspecified age received first dose of BNT162B2 (Covid 19 Vaccine), via an unspecified route of administration on 22Feb2021 as single dose for COVID-19 immunisation. Medical history included diabetic and nail infection. Concomitant medications were not reported. The patient received the 1st dose on Monday (22Feb2021). Her whole body started hurting after receiving the 1st dose (Feb2021). She was diabetic and had nail infections which already existed before getting the 1st dose. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 27Feb2021 at 11:30 (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Feb2021, the patient got up to walk and felt dizzy. The patient has been dizzy all day and was dizzier when getting up to stand. The patient asked if someone could still get dizzy after 15-30 minutes period from the vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chill; This is a spontaneous report from a contactable consumer (patient). A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Feb2021 10:30 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient age at vaccination was 24-year-old. The patient medical history was not reported. The patient's concomitant medication included ongoing cetirizine hydrochloride (ZYRTEC [CETIRIZINEHYDROCHLORIDE]). The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3247) on 19Jan2021 and age was 24-year-old for COVID-19 immunisation and experienced Fatigue, Dizziness, and Increased Hunger. On 09Feb2021, the patient experienced Chill.  The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from Pfizer Sponsored Program from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date with outcome of unknown. Patient took Tylenol for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Throwing up; This is a spontaneous report from a contactable consumer (patient's parent). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Feb2021 (Batch/Lot Number: EL9266) (at the age of 47 years) as dose number unknown, single for COVID-19 immunisation. The patient medical history was none. There were unspecified concomitant medications. The patient started throwing up on 27Feb2021 with outcome of not recovered. Treatment included Tylenol.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer (reporter's mother) case number: 01873713. A 68-year-old female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# not reported), via an unspecified route of administration, on Feb 20, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient was sore, fatigued and very tired on unknown date. The outcome of the events: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: sick; This is a spontaneous report from a Pfizer-sponsored program, Support. A contactable consumer (patient) reported that a female patient of unspecified age received unknown dose number of BNT162B2 (Covid-19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient has been sick for the last few days on unspecified date. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The arm is a little bit sore; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program Support.   A male patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on 27Feb2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  First shot on Saturday. The arm is a little bit sore. Took half a dose of Ibuprofen. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: Nausea; feels tired; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had the first shot on Saturday, mid-day about 11:00. The past few days the patient had nausea in the morning and wanted to know if they were connected or not. The nausea comes for 10 to 15 minutes at a time and goes away. The patient also feels tired throughout the day. The patient wanted to know of these were possible symptoms or side effects. The patient recovered from nausea on an unspecified date while the outcome of the event feels tired was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension
Clinical narrative: high blood pressure; This is a spontaneous report from a Pfizer-sponsored program, Support. A contactable consumer (patient) reported that a female patient of unspecified age received first dose of BNT162B2 (Pfizer Covid 19 Vaccine), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history included diabetic. Concomitant medications were not reported. The patient lost her vaccination card however, after her first dose, she experienced high blood pressure on an unspecified date because she was diabetic as well. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in her ears; This is a spontaneous report from a contactable physician. An 8-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ringing in her ears on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: The under arm pit swelling and pain; The under arm pit swelling and pain; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot Number: EN6205) (at the age of 46 years) as dose number unknown, single for covid-19 immunisation. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications included unspecified vitamins. The patient experienced under arm pit swelling and pain on an unspecified date with outcome of unknown. Patient just got the shot on Sunday (unspecified date in 2021) and read that it was common. Patient called the doctor she said wait for a week because she has rheumatoid arthritis, so she said wait because some people with rheumatoid arthritis end up with the swollen armpit gland. So, she said just waited a little bit, just took Tylenol. The outcome of events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: got really sick; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, on 08Feb2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient wasn't able to get the second dose last 01Mar2021 because the she got really sick on an unspecified date in Feb2021, after the first BNT162B2 dose. The patient wanted to know how she can reschedule the second dose. The outcome of event got really sick was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). An 83-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6203), at the age of 83, via an unspecified route of administration, on Mar 2, 2021, single dose, for COVID-19 immunisation. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. There were unspecified concomitant medications. Historical vaccine included COVID-19 vaccine, dose 1 (manufacturer unknown), on an unknown date, for COVID-19 immunisation. Patient had the second vaccination yesterday and woke up this morning (Mar 3, 2021) with chills. His arm really hurts too. He took his temperature, he does not have a fever. He wondered if he should take some Tylenol or something for his chills. The outcome of events: unknown. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Vaccination site pain
Clinical narrative: got the Pfizer vaccination it hurts real bad; hair would come out; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable consumer (patient) reported that a patient of unspecified age and gender received unknown dose number of BNT162B2 (Pfizer Covid Vaccine), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient just got the Pfizer vaccination, it hurt real bad. One thing they did not tell the patient about was that his/her hair would come out. The patient stated he/she can't walk around looking like this. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swelling; This is a spontaneous report from a contactable consumer (patient) via the Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via an unspecified route of administration on an unspecified date (lot number was not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she was afraid to take the 2nd dose due her lymph node swelling on an unspecified date. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received COVID-19 vaccine (Manufacturer Unknown), on an unspecified date, as dose 1, single for COVID-19 immunisation. The patient experienced fatigue (mainly in the afternoon) on an unspecified date after the second BNT162B2 dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tenderness
Clinical narrative: tenderness and swelling in the areas where the filler was injected; tenderness and swelling in the areas where the filler was injected; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW 0150) via an unspecified route of administration in the arm left on 06Apr2021 at 08:15 (at the age of 33-year-old) as a dose 2, single for COVID-19 immunization. Medical history included dermal filler injection (had hyaluronic acid dermal fillers in my chin and along my jaw line approx. 1.5 years ago) and allergy to kiwi (fruit allergy). Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6206) via an unspecified route of administration in the arm left on 16Mar2021 at 18:30 (at the age of 33-year-old) as a dose 1, single for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 15:00, the patient experienced tenderness and swelling in the areas where the filler was injected. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event tenderness and swelling in the areas where the filler was injected was not recovered.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: 1. Country of Incidence and Event Occurred Country and Obtain Drug Country updated to US since not mentioned UNITED ARAB EMIRATES 2. Postal Code added in slide#1 reporter and patient tab.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Lymphadenopathy, Nausea
Clinical narrative: Nausea; tiredness; swollen lymph node in armpit; aching joints; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 16:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and insulin resistance. The patient received unspecified blood pressure medicine and allergy medicine within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Mar2021 at 16:45 (at the age of 55-years-old) as a single dose for COVID-19 immunisation and also had unspecified allergies to 17 different things (unspecified). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Mar2021, the patient experienced nausea, tiredness, swollen lymph node in armpit and aching joints. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/ department or urgent care. The clinical outcomes of the events nausea and tiredness were recovered on 01Apr2021 after the duration of 1 day; while that of swollen lymph node in armpit and aching joints were recovered on unknown date in Apr2021 (reported as for about a week after).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: updated relevant medical history.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Rash pruritic
Clinical narrative: Left ankle delayed itchy rash.; Then became a very dark red and looks like a bruise one week later.; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 29Mar2021 at 10:00, as a dose 1 single for COVID-19 immunization. Medical history and concomitant medications were 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced itchy rash and bruise. No therapeutic measures were taken as a result of the events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events itchy rash and bruise was recovering.  No further information is expected; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Reporter name updated, patient race information added and facility information added
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Premature delivery, Urine analysis
Clinical narrative: I am pregnant for 8 weeks; Premature live birth; This is a spontaneous report from a contactable consumer (patient). This consumer or other non hcp reported information for both mother and fetus/baby. This is a mother report.  A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8734) via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 16:00 (at the age of 29-year-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6204) via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 16:30 (at the age of 29-year-old) as dose 1, single for COVID-19 immunisation. It was reported that patient did not smoke and drink alcohol during pregnancy. It was reported that patient did not use illicit drugs during pregnancy. It was reported that patient had no previous Pregnancy. It was reported that patient had no problems before delivery, during delivery and after delivery. Gestational age at birth in weeks reported as 34 weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient's husband did not smoke and drink alcohol during pregnancy. It was reported that the patient's husband did use illicit drugs during pregnancy. The patient reported she was pregnant for 8 weeks (maternal exposure during pregnancy) and she has not had any symptoms so far, she was feeling well. She sent this message making myself available for any follow-up or research that you want to do with pregnant women, she will be happy if she can help or contribute with something in some study. Thank you very much and congratulations on your work. On 01Nov2021 it was reported that premature live birth on unknown date in 2021. The mother reported she became pregnant while taking bnt162b2. The mother was 9 Weeks pregnant at the onset of the event. The mother was due to deliver on 06Nov2021. The patient underwent lab tests and procedures which included urine analysis: positive on 03Mar2021 Pregnancy. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow up (01Nov2021): This is a follow-up spontaneous report received from a contactable consumer. This consumer reported in response to EDP letter which included that: dose 1 and dose 2 information, patient age, height, weight and clinical course information.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pallor, Vaccination site swelling, Vaccination site warmth
Clinical narrative: lightheaded; pale; very fatigued; At the sit of injection, it was the size of a baseball and hot to the touch; At the sit of injection, it was the size of a baseball and hot to the touch; This is a spontaneous report from a contactable Nurse.  A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. Patient previously received historical vaccine bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, the patient experienced lightheaded; pale; very fatigued; at the sit of injection, it was the size of a baseball and hot to the touch. It was stated that the event took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Hypersensitivity, Muscular weakness, Palpitations
Clinical narrative: Trouble Breathing; Heart racing; Legs weak upon standing; she was feeling so bad after her vaccine; allergic reaction to the first dose of the Covid Vaccine; This is a spontaneous report from a contactable consumer. A 72-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EN6206 and expiration date: not reported) via an unspecified route of administration into arm on 12Mar2021 as DOSE 1, SINGLE (at an age of 72-year-old) for covid-19 immunization. The patient medical history had included thyroid condition Ongoing, Hashimoto's Ongoing and stated that she was diagnosed about 15 years ago, Sjogren's Ongoing and stated that she was diagnosed about 15 years ago, Allergies to dust and mold Ongoing and Stated that had been a lifelong condition, Allergies to bees, hornets, and wasps Ongoing States has had this for about a year and said she has had anaphylaxis with this allergy. The patient concomitant medication had included Levothyroxine sodium (Synthroid,75 ug, 1x/day) from 2006 ongoing for the indication of thyroid condition. On 12 Mar2021 the patient had experienced that her heart was racing, her legs were weak upon standing, she was feeling so bad after her vaccine and she had trouble breathing. Patient was also reported that she was told by her doctor not to get the second dose of the Covid Vaccine due to an allergic reaction to the first dose of the Covid Vaccine. The clinical outcome of the events were recovered and outcome of the event she was feeling so bad after her vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: fever of 101 degrees; Chills; Body aches; Headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 03May2021 at 13:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 12Apr2021 at 16:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 22:00, the patient experienced fever of 101 degrees, chills, body aches, headache, and fatigue. The following morning, the fever went away and continue to have minor chills, body aches, headache, and fatigue. On 03May2021 at 22:00, the patent underwent lab test for body temperature and the result was 101 degrees Fahrenheit. Therapeutic measures were taken as a result of the event body aches which included MOTRIN. The clinical outcome of the events fever was recovered on 04May2021, chills, body aches and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Type added, Concomitant Therapy selected None, fever of 101 degrees updated as event verbatim and Event fatigue added.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever of 101 degrees; Chills; Body aches; Headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 03May2021 at 13:15 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were none. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the arm left on 12Apr2021 at 16:45 (at the age of 39-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 22:00, the patient experienced fever of 101 degrees, chills, body aches, headache, and fatigue. The following morning, the fever went away and continue to have minor chills, body aches, headache, and fatigue. On 03May2021 at 22:00, the patent underwent lab test for body temperature and the result was 101 degrees Fahrenheit. Therapeutic measures were taken as a result of the event body aches which included MOTRIN. The clinical outcome of the events fever was recovered on 04May2021, chills, body aches and headache was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Type added, Concomitant Therapy selected None, fever of 101 degrees updated as event verbatim and Event fatigue added.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Paraesthesia
Clinical narrative: Dizziness; Pain in right wrist, Pins and needles right arm/hand, then left arm hand.  Now, pins and needles in feet and face.  Dizziness; Pins and needles right arm/hand, then left arm hand.  Now, pins and needles in feet and face.; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the left arm on an unknown date in Feb2021 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Concomitant medications included ibuprofen (ADVIL) from an unknown date for an unspecified indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Mar2021 the patient experienced pain in right wrist, pins and needles right arm/hand, then left arm hand. Now, pins and needles in feet and face. Dizziness. Patient received treatment for the events which included antibiotic. The events resulted in doctor or other healthcare professional office/clinic visit. Clinical outcome of dizziness, wrist pain, pins and needles were not recovered. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 16:15 (at the age of 42-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated narrative.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous, Rash papular
Clinical narrative: Red rash developed on left shoulder; Rashes appeared at waist line, and hip with itching/ Rash itches; Rash has bumps; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 23Mar2021 at 12:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included shingles as teenager one time and remained dominant and asthma and Penicillin allergies. Concomitant medications included fluoxetine (MANUFACTURER UNKNOWN), simvastatin (MANUFACTURER UNKNOWN) and nature plus gold vitamin all are received for unknown indication and since unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 13:00, 1 week after shot the patient experienced red rash developed on left shoulder. On an unknown date in 2021, 1.5 to 2 weeks later the patient experienced rashes appeared at waist line and hip with itching. Rash has bumps, rash itches at night. Therapeutic measures were taken as a result of adverse events and included treatment with over-the-counter creams and meds did not help or do antihistamines. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event red rash, itching and raised rash was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Age at Vaccination was updated to 62 years, Penicillin allergy was updated to relevant medical history, not past drug event and updated narrative "1 week after shot" was added and "meds did not help but do antihistamines" was updated to "meds did not help or do antihistamines".
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: Fever (99.3F); Body aches; Inability to lift up the arm where the injection was done; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170), via an unspecified route of administration in the left arm on 04May2021 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Medical history included graves' disease and the patient had a history of peanut allergy. Concomitant medications taken within two weeks prior to the vaccination included thiamazole (METHIMAZOLE), rosuvastatin (MANUFACTURER UNKNOWN), latanoprost (MANUFACTURER UNKNOWN) and brimonidine tartrate (ALPHAGAN), all from an unknown date for an unknown indication. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0153), via an unspecified route of administration in the left arm on 12Apr2021 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021 at 16:00, the patient experienced fever (99.3-degree Fahrenheit), body aches and an inability to lift up the arm where the injection was done. On 04May2021, the patient underwent lab tests and procedures which included body temperature test and the result was reported as 99.3-degree Fahrenheit. The clinical outcome of the events fever (99.3-degree Fahrenheit), body aches and an inability to lift up the arm where the injection was done was resolving at the time of this report.   No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Lab data unit updated and Treatment Received selected as No.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Fever of 100 degrees; Muscle aches; Fatigue; Headache; General malaise; Pain at injection site (radiated down to elbow, pain on movement); Pain at injection site (radiated down to elbow, pain on movement); This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 03May2021 at 15:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 12Apr2021 at 15:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation and ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 02:45, the day after second dose of vaccination, the patient experienced a fever of 100 degrees, muscle aches, fatigue, headache, general malaise, and pain at injection site that radiated down to her elbow, pain on movement. On 04May2021 at 02:45, the patient's body temperature was found to be 100 degrees. Day two after second dose of vaccination, the patient felt much better but still did not feel good. The clinical outcome of the events fever of 100 degrees, muscle aches, fatigue, headache, general malaise, and pain at injection site that radiated down to her elbow was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated Lab data, Best Doctor/Health Care Professional Information, Treatment Received as No was updated.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: Fever of 100 degrees; Muscle aches; Fatigue; Headache; General malaise; Pain at injection site (radiated down to elbow, pain on movement); Pain at injection site (radiated down to elbow, pain on movement); This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 03May2021 at 15:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 12Apr2021 at 15:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation and ibuprofen (MANUFACTURER UNKNOWN) for unknown indication from an unknown date and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 02:45, the day after second dose of vaccination, the patient experienced a fever of 100 degrees, muscle aches, fatigue, headache, general malaise, and pain at injection site that radiated down to her elbow, pain on movement. On 04May2021 at 02:45, the patient's body temperature was found to be 100 degrees. Day two after second dose of vaccination, the patient felt much better but still did not feel good. The clinical outcome of the events fever of 100 degrees, muscle aches, fatigue, headache, general malaise, and pain at injection site that radiated down to her elbow was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: updated Lab data, Best Doctor/Health Care Professional Information, Treatment Received as No was updated.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Fatigue, Nasopharyngitis
Clinical narrative: Sever cold; Severe cough; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0171), via an unspecified route of administration on 28Apr2021 at 09:15 (at the age of 46-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were 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. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 01May2021 at 17:00, the patient experienced severe cold and cough. On an unknown date in May2021 (one week after the vaccination), the patient still had fatigue. The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received. The clinical outcome of the events severe cold, cough and fatigue was not recovered.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: patient information, Treatment Received updated to NO for all events, "The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received" added in narrative.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain, Pain in extremity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Body ache; sore left arm; felt drained of energy.; a constant feverish feeling; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 04May2021 at 14:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient had no known allergies. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 10Apr2021 at 10:30 as single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 05May2021, the patient underwent lab test for nasal swab COVID-19 PCR test and the result was negative. On 04May2021 at 23:45 the patient experienced body ache that started the night of the dose and continued through the next morning, sore left arm, and a constant feverish feeling and felt drained of energy. The clinical outcome for the events general body pain, pain in arm, feverish and loss of energy were recovered with sequel in May2021.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Treatment Received should be No; known allergies: No captured in narrative; Stop Date/Time captured as May2021.