chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Oral herpes
Clinical narrative: developed a small patch of painful blisters on my right hand, inner area of ring finger, went to the walk-in clinic and was diagnosed with shingles and given a prescription for generic Valtrex; i developed a cold sore on my lower lip on the left side; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8735) via an unspecified route of administration, administered in left arm on 23Apr2021 at 10:00 (at the age of 63-year-old) at a single dose for covid-19 immunization. The patient medical history included hypothyroidism and penicillin Allergy. The patient did not receive any other vaccine within 4 weeks prior to vaccination. Concomitant medication included levothyroxine, Estradiol, cefalexin (CEPHALEXINE) and ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Nine days after the vaccination on 02May2021, at 09:00 the patient developed a cold sore on her lower lip on the left side and fourteen days post vaccination on 07May2021 at 09:00 the patient experienced a small patch of painful blisters on her right hand, inner area of ring finger. On 09May2021, she went to the walk-in clinic/doctor or other healthcare professional office and was diagnosed with shingles and given a prescription for generic Valtrex. It was reported patient experienced adverse event on 23Apr2021 at 11:15 (pending for clarification). Patient COVID-19 booster is scheduled on 14May2021. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Hypersensitivity, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test positive; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 55-years -old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration as single dose on 08Apr2021 at 19:00 into left arm for COVID-19 immunisation. Medical history included pancreatitis. The concomitant medications were not reported. Patient had no other vaccinations the same day as his first dose of the COVID-19 vaccine or in the four weeks prior. On 8Apr2021, patient experienced arm soreness. On 19Apr2021, patient COVID-19 PCR test was positive. Patient stated that he was diagnosed 34 years ago, he has been battling it since then and has numerous surgeries and numerous things since. He had symptoms starting Friday. He says this Friday will have been 7 days, on the 23rd. He says on the following Friday, which is the 30th he was told he could get his second shot, but he was scheduled to get his second shot on the 29th, he wonders if that day made a difference. He says he was symptomatic, so he didn't know where he is at on a timeline to getting the second dose. He says he got the first dose shot the week prior and then that happened to his mom, so going into that weekend he had the allergy symptoms and obviously to play it safely they got tested and they were all negative. He says that following Friday he thought he had normal sinus congestion after cutting the grass, he is also always getting the sniffles from his neighbor's white pollen tree. He says to play it safe he got tested again Monday and that turned out to be positive. He says on the Wednesday the week prior it was negative after the shot they had on the 8th, then this test he had it. He says that his mom passed on the 13th, then on Tuesday which was the 14th they all were tested and all were negative. He says that he got tested again and it was positive after he felt his runny nose and cough that he had originally thought was normal over the course of the weekend was not feeling normal after all, and to play it safe he got tested. He says after his positive test after his first test was negative, because he was positive the second time everyone got tested, and his daughter was the only one who was negative the second test. Enquired ask how they could get information from the facility about when it would be ok to get the second dose, if it was when they had no more symptoms or if it was after a person tested positive or was asymptomatic 10-14 days that they can go get second dose. Enquired when is the best time to get the second dose after testing positive, whether they are symptomatic or asymptomatic.The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Feeling abnormal, Pain in extremity, Rhinorrhoea, SARS-CoV-2 test
Clinical narrative: Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test positive; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 55-years -old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration as single dose on 08Apr2021 at 19:00 into left arm for COVID-19 immunisation. Medical history included pancreatitis. The concomitant medications were not reported. Patient had no other vaccinations the same day as his first dose of the COVID-19 vaccine or in the four weeks prior. On 8Apr2021, patient experienced arm soreness. On 19Apr2021, patient COVID-19 PCR test was positive. Patient stated that he was diagnosed 34 years ago, he has been battling it since then and has numerous surgeries and numerous things since. He had symptoms starting Friday. He says this Friday will have been 7 days, on the 23rd. He says on the following Friday, which is the 30th he was told he could get his second shot, but he was scheduled to get his second shot on the 29th, he wonders if that day made a difference. He says he was symptomatic, so he didn't know where he is at on a timeline to getting the second dose. He says he got the first dose shot the week prior and then that happened to his mom, so going into that weekend he had the allergy symptoms and obviously to play it safely they got tested and they were all negative. He says that following Friday he thought he had normal sinus congestion after cutting the grass, he is also always getting the sniffles from his neighbor's white pollen tree. He says to play it safe he got tested again Monday and that turned out to be positive. He says on the Wednesday the week prior it was negative after the shot they had on the 8th, then this test he had it. He says that his mom passed on the 13th, then on Tuesday which was the 14th they all were tested and all were negative. He says that he got tested again and it was positive after he felt his runny nose and cough that he had originally thought was normal over the course of the weekend was not feeling normal after all, and to play it safe he got tested. He says after his positive test after his first test was negative, because he was positive the second time everyone got tested, and his daughter was the only one who was negative the second test. Enquired ask how they could get information from the facility about when it would be ok to get the second dose, if it was when they had no more symptoms or if it was after a person tested positive or was asymptomatic 10-14 days that they can go get second dose. Enquired when is the best time to get the second dose after testing positive, whether they are symptomatic or asymptomatic.The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: Sniffles/ runny nose; not feeling normal after all; Sinus congestion; cough; COVID-19 PCR test positive; arm soreness; This is a spontaneous report from a contactable consumer (patient). A 55-years -old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration as single dose on 08Apr2021 at 19:00 into left arm for COVID-19 immunisation. Medical history included pancreatitis. The concomitant medications were not reported. Patient had no other vaccinations the same day as his first dose of the COVID-19 vaccine or in the four weeks prior. On 8Apr2021, patient experienced arm soreness. On 19Apr2021, patient COVID-19 PCR test was positive. Patient stated that he was diagnosed 34 years ago, he has been battling it since then and has numerous surgeries and numerous things since. He had symptoms starting Friday. He says this Friday will have been 7 days, on the 23rd. He says on the following Friday, which is the 30th he was told he could get his second shot, but he was scheduled to get his second shot on the 29th, he wonders if that day made a difference. He says he was symptomatic, so he didn't know where he is at on a timeline to getting the second dose. He says he got the first dose shot the week prior and then that happened to his mom, so going into that weekend he had the allergy symptoms and obviously to play it safely they got tested and they were all negative. He says that following Friday he thought he had normal sinus congestion after cutting the grass, he is also always getting the sniffles from his neighbor's white pollen tree. He says to play it safe he got tested again Monday and that turned out to be positive. He says on the Wednesday the week prior it was negative after the shot they had on the 8th, then this test he had it. He says that his mom passed on the 13th, then on Tuesday which was the 14th they all were tested and all were negative. He says that he got tested again and it was positive after he felt his runny nose and cough that he had originally thought was normal over the course of the weekend was not feeling normal after all, and to play it safe he got tested. He says after his positive test after his first test was negative, because he was positive the second time everyone got tested, and his daughter was the only one who was negative the second test. Enquired ask how they could get information from the facility about when it would be ok to get the second dose, if it was when they had no more symptoms or if it was after a person tested positive or was asymptomatic 10-14 days that they can go get second dose. Enquired when is the best time to get the second dose after testing positive, whether they are symptomatic or asymptomatic.The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Biopsy blood vessel abnormal, Blood test, Vasculitis
Clinical narrative: He came into see me on May 4th, Form of vasculitis HSP, proven by biopsy. Treated with prednisone starting May 5th. He began having severe abdominal pain and went into Clinic where he was admitted for three days on IV fluids.
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Biopsy blood vessel abnormal, Henoch-Schonlein purpura
Clinical narrative: He came into see me on May 4th, Form of vasculitis HSP, proven by biopsy. Treated with prednisone starting May 5th. He began having severe abdominal pain and went into Clinic where he was admitted for three days on IV fluids.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Blood test, Computerised tomogram, Renal artery thrombosis
Clinical narrative: extreme pain in the abdomen/abdominal discomfort progressively getting worse/Renal Artery Thrombosis; This is a spontaneous report from a contactable consumer(patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06Apr2021 12:00 (Lot Number: EW0158/EN6207, pending clarify) at 37-year-old male as 2nd dose, single dose for covid-19 immunization. No other vaccine in four weeks. No known allergies. Other medical history was none. Concomitant medications included OMEGA-3 supplement, vitamin B Complex, vitamin C. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Mar2021 12:00 PM (lot number=EN6207, also reported as EW0158) at Right arm for covid-19 immunization. Four days after the second shot the patient began to feel abdominal discomfort progressively getting worse. Four weeks and six days later the patient felt sudden extreme pain in the abdomen and was admitted to hospital. CT Scans identified Renal Artery Thrombosis (on 10May2021), an extremely rare condition for a perfectly healthy 37 year old who exercises often, normal weight, good blood flow, all other signs OK. The patient spent five days in the hospital with extreme pain. Now released on heavy dose of blood thinners. Doctors say hundreds of tiny blood clots could be active all over body. Pfizer shot was identified as major contributing factor although they cannot say if any other contributing factors exist. No prior conditions, no prior medical history, no trace of genetic blood clotting or family history. Adverse event start date was 10Apr2021 12:00 AM. The event resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 5 days, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment received included Heparin, Eliquis. Covid test via Nasal Swab post vaccination on 10May2021 with Negative result. Outcome of the event was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal discomfort, Anticoagulant therapy, Chest X-ray normal, Colonoscopy normal, Computerised tomogram head normal
Clinical narrative: extreme pain in the abdomen/abdominal discomfort progressively getting worse/Renal Artery Thrombosis; This is a spontaneous report from a contactable consumer(patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06Apr2021 12:00 (Lot Number: EW0158/EN6207, pending clarify) at 37-year-old male as 2nd dose, single dose for covid-19 immunization. No other vaccine in four weeks. No known allergies. Other medical history was none. Concomitant medications included OMEGA-3 supplement, vitamin B Complex, vitamin C. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Mar2021 12:00 PM (lot number=EN6207, also reported as EW0158) at Right arm for covid-19 immunization. Four days after the second shot the patient began to feel abdominal discomfort progressively getting worse. Four weeks and six days later the patient felt sudden extreme pain in the abdomen and was admitted to hospital. CT Scans identified Renal Artery Thrombosis (on 10May2021), an extremely rare condition for a perfectly healthy 37 year old who exercises often, normal weight, good blood flow, all other signs OK. The patient spent five days in the hospital with extreme pain. Now released on heavy dose of blood thinners. Doctors say hundreds of tiny blood clots could be active all over body. Pfizer shot was identified as major contributing factor although they cannot say if any other contributing factors exist. No prior conditions, no prior medical history, no trace of genetic blood clotting or family history. Adverse event start date was 10Apr2021 12:00 AM. The event resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 5 days, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment received included Heparin, Eliquis. Covid test via Nasal Swab post vaccination on 10May2021 with Negative result. Outcome of the event was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram normal, Endoscopy normal, Renal vascular thrombosis, Ultrasound abdomen abnormal
Clinical narrative: extreme pain in the abdomen/abdominal discomfort progressively getting worse/Renal Artery Thrombosis; This is a spontaneous report from a contactable consumer(patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06Apr2021 12:00 (Lot Number: EW0158/EN6207, pending clarify) at 37-year-old male as 2nd dose, single dose for covid-19 immunization. No other vaccine in four weeks. No known allergies. Other medical history was none. Concomitant medications included OMEGA-3 supplement, vitamin B Complex, vitamin C. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Mar2021 12:00 PM (lot number=EN6207, also reported as EW0158) at Right arm for covid-19 immunization. Four days after the second shot the patient began to feel abdominal discomfort progressively getting worse. Four weeks and six days later the patient felt sudden extreme pain in the abdomen and was admitted to hospital. CT Scans identified Renal Artery Thrombosis (on 10May2021), an extremely rare condition for a perfectly healthy 37 year old who exercises often, normal weight, good blood flow, all other signs OK. The patient spent five days in the hospital with extreme pain. Now released on heavy dose of blood thinners. Doctors say hundreds of tiny blood clots could be active all over body. Pfizer shot was identified as major contributing factor although they cannot say if any other contributing factors exist. No prior conditions, no prior medical history, no trace of genetic blood clotting or family history. Adverse event start date was 10Apr2021 12:00 AM. The event resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 5 days, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment received included Heparin, Eliquis. Covid test via Nasal Swab post vaccination on 10May2021 with Negative result. Outcome of the event was not recovered.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Renal artery thrombosis, SARS-CoV-2 test, Weight
Clinical narrative: extreme pain in the abdomen/abdominal discomfort progressively getting worse/Renal Artery Thrombosis; This is a spontaneous report from a contactable consumer(patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 06Apr2021 12:00 (Lot Number: EW0158/EN6207, pending clarify) at 37-year-old male as 2nd dose, single dose for covid-19 immunization. No other vaccine in four weeks. No known allergies. Other medical history was none. Concomitant medications included OMEGA-3 supplement, vitamin B Complex, vitamin C. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Mar2021 12:00 PM (lot number=EN6207, also reported as EW0158) at Right arm for covid-19 immunization. Four days after the second shot the patient began to feel abdominal discomfort progressively getting worse. Four weeks and six days later the patient felt sudden extreme pain in the abdomen and was admitted to hospital. CT Scans identified Renal Artery Thrombosis (on 10May2021), an extremely rare condition for a perfectly healthy 37 year old who exercises often, normal weight, good blood flow, all other signs OK. The patient spent five days in the hospital with extreme pain. Now released on heavy dose of blood thinners. Doctors say hundreds of tiny blood clots could be active all over body. Pfizer shot was identified as major contributing factor although they cannot say if any other contributing factors exist. No prior conditions, no prior medical history, no trace of genetic blood clotting or family history. Adverse event start date was 10Apr2021 12:00 AM. The event resulted in [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization for 5 days, Life threatening illness (immediate risk of death from the event), Disability or permanent damage]. Treatment received included Heparin, Eliquis. Covid test via Nasal Swab post vaccination on 10May2021 with Negative result. Outcome of the event was not recovered.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Unexpected death within 24 hours of vaccine administration.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Autopsy, Cardiac disorder, Death, Laboratory test, Lung disorder
Clinical narrative: Unexpected death within 24 hours of vaccine administration.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Unexpected death within 24 hours of vaccine administration.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Ear pain, Fatigue, Headache, Hypoaesthesia
Clinical narrative: June 5 - Trigeminal Neuralgia like pain in left lower jaw June 10 - Sores developed on lower left gum - started regimen for Shingles
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head normal, Ultrasound scan normal
Clinical narrative: June 5 - Trigeminal Neuralgia like pain in left lower jaw June 10 - Sores developed on lower left gum - started regimen for Shingles
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Neuralgia, Noninfective gingivitis, Pain in jaw
Clinical narrative: June 5 - Trigeminal Neuralgia like pain in left lower jaw June 10 - Sores developed on lower left gum - started regimen for Shingles
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Feeling cold, Feeling hot, Injection site pain
Clinical narrative: slight fever (99.9°F); joint pain; felt cold; nasal congestion; injection site soreness / injection site pain; muscle soreness / muscle pain; tiredness; felt warm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0161, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 26Apr2021 09:30 (at the age of 24-years-old), as second dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included iron; colecalciferol (VITAMIN D [COLECALCIFEROL]) both taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0150, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 05Apr2021 09:30 (at the age of 24-years-old), as first dose, single dose for COVID-19 immunisation. After 1st dose administration, patient experienced injection site soreness, muscle soreness, and tiredness on 05Apr2021. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Apr2021 10:00 to 12:00, the patient experienced injection site soreness, muscle soreness, tiredness, and felt warm. On 27Apr2021 and 28Apr 00:00 to 06:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt cold, and nasal congestion. On 27Apr2021 06:00 to 12:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, nasal congestion, and slight fever (99.9°F). On 27Apr2021 12:00 to 18:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, and slight fever (99.9°F). On 27Apr2021 18:00 to 28Apr2021 00:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, and slight fever (99.9°F). The patient underwent lab tests and procedures which included body temperature: 99.9 fahrenheit (slight fever) on 27Apr2021. Patient rested, slept, took 2 acetaminophen (TYLENOL extra strength) caplets, and used camphor, eucalyptus oil, menthol (VICK'S VAPOR RUB) topical ointment as a result of the events. The outcome of slight fever and felt warm was recovered on 28Apr2021 00:00 and the rest of the events recovered on 28Apr2021 06:00.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, Sluggishness
Clinical narrative: slight fever (99.9°F); joint pain; felt cold; nasal congestion; injection site soreness / injection site pain; muscle soreness / muscle pain; tiredness; felt warm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0161, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 26Apr2021 09:30 (at the age of 24-years-old), as second dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included iron; colecalciferol (VITAMIN D [COLECALCIFEROL]) both taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0150, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 05Apr2021 09:30 (at the age of 24-years-old), as first dose, single dose for COVID-19 immunisation. After 1st dose administration, patient experienced injection site soreness, muscle soreness, and tiredness on 05Apr2021. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Apr2021 10:00 to 12:00, the patient experienced injection site soreness, muscle soreness, tiredness, and felt warm. On 27Apr2021 and 28Apr 00:00 to 06:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt cold, and nasal congestion. On 27Apr2021 06:00 to 12:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, nasal congestion, and slight fever (99.9°F). On 27Apr2021 12:00 to 18:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, and slight fever (99.9°F). On 27Apr2021 18:00 to 28Apr2021 00:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, and slight fever (99.9°F). The patient underwent lab tests and procedures which included body temperature: 99.9 fahrenheit (slight fever) on 27Apr2021. Patient rested, slept, took 2 acetaminophen (TYLENOL extra strength) caplets, and used camphor, eucalyptus oil, menthol (VICK'S VAPOR RUB) topical ointment as a result of the events. The outcome of slight fever and felt warm was recovered on 28Apr2021 00:00 and the rest of the events recovered on 28Apr2021 06:00.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Feeling cold, Feeling hot
Clinical narrative: slight fever (99.9°F); joint pain; felt cold; nasal congestion; injection site soreness / injection site pain; muscle soreness / muscle pain; tiredness; felt warm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0161, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 26Apr2021 09:30 (at the age of 24-years-old), as second dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included iron; colecalciferol (VITAMIN D [COLECALCIFEROL]) both taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0150, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 05Apr2021 09:30 (at the age of 24-years-old), as first dose, single dose for COVID-19 immunisation. After 1st dose administration, patient experienced injection site soreness, muscle soreness, and tiredness on 05Apr2021. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Apr2021 10:00 to 12:00, the patient experienced injection site soreness, muscle soreness, tiredness, and felt warm. On 27Apr2021 and 28Apr 00:00 to 06:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt cold, and nasal congestion. On 27Apr2021 06:00 to 12:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, nasal congestion, and slight fever (99.9°F). On 27Apr2021 12:00 to 18:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, and slight fever (99.9°F). On 27Apr2021 18:00 to 28Apr2021 00:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, and slight fever (99.9°F). The patient underwent lab tests and procedures which included body temperature: 99.9 fahrenheit (slight fever) on 27Apr2021. Patient rested, slept, took 2 acetaminophen (TYLENOL extra strength) caplets, and used camphor, eucalyptus oil, menthol (VICK'S VAPOR RUB) topical ointment as a result of the events. The outcome of slight fever and felt warm was recovered on 28Apr2021 00:00 and the rest of the events recovered on 28Apr2021 06:00.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Nasal congestion, Pyrexia, Vaccination site pain
Clinical narrative: slight fever (99.9°F); joint pain; felt cold; nasal congestion; injection site soreness / injection site pain; muscle soreness / muscle pain; tiredness; felt warm; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0161, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 26Apr2021 09:30 (at the age of 24-years-old), as second dose, single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included iron; colecalciferol (VITAMIN D [COLECALCIFEROL]) both taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EW0150, expiration date were not reported), via an unspecified route of administration, administered in the left arm on 05Apr2021 09:30 (at the age of 24-years-old), as first dose, single dose for COVID-19 immunisation. After 1st dose administration, patient experienced injection site soreness, muscle soreness, and tiredness on 05Apr2021. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Apr2021 10:00 to 12:00, the patient experienced injection site soreness, muscle soreness, tiredness, and felt warm. On 27Apr2021 and 28Apr 00:00 to 06:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt cold, and nasal congestion. On 27Apr2021 06:00 to 12:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, nasal congestion, and slight fever (99.9°F). On 27Apr2021 12:00 to 18:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, and slight fever (99.9°F). On 27Apr2021 18:00 to 28Apr2021 00:00, the patient experienced injection site pain, muscle pain, joint pain, tiredness, felt warm, and slight fever (99.9°F). The patient underwent lab tests and procedures which included body temperature: 99.9 fahrenheit (slight fever) on 27Apr2021. Patient rested, slept, took 2 acetaminophen (TYLENOL extra strength) caplets, and used camphor, eucalyptus oil, menthol (VICK'S VAPOR RUB) topical ointment as a result of the events. The outcome of slight fever and felt warm was recovered on 28Apr2021 00:00 and the rest of the events recovered on 28Apr2021 06:00.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Medication error, Product storage error
Clinical narrative: Vaccine administered outside recommended timeframe since first vial puncture
Age: 49.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered outside recommended timeframe since first vial puncture
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine administered outside recommended time frame since vial was first punctured
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered outside recommended time frame since vial was first punctured
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vaccine given outside recommended timeframe since first puncture
Age: 22.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine given outside recommended timeframe since first puncture
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Blood glucose increased, Throat tightness
Clinical narrative: Developed sever allergic reaction; Throat closure; Nausea; This is a spontaneous report from a contactable physician. A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13May2021 17:15 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing type 1 diabetes mellitus, and ongoing allergy to shellfish. Patient had no relevant family history. There were no concomitant medications. No vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 13May2021 17:25, about 10 minutes after being administered that dose the patient had severe allergic reaction described as feeling as though he was having throat closure. EMS was called, that is when the patient was administered Epi-Pen and Benadryl: 1mg IM Epinephrine and 50 of Benadryl. Emergency room notes show the patient reports associated nausea, denies shortness of breath. He was administered Epi-pen twice, transported to the hospital emergency room where he was not admitted overnight, was kept for monitoring for about 3 hours then discharged from hospital emergency room on 13May2021. On 27May2021, the patient had another severe reaction. The patient was again administered Epipen and EMS transported patient to the hospital. The patient was at hospital emergency room for a couple of hours and then discharged on 27May2021. The patient has had several visits to the physician's office relative to severe reaction; he is scheduled in today for follow-up. After first emergency room visit he came into the physician's office and was seen on 18May2021; talked to patient on 21May2021 and 22May2021, then he was again seen on 25May2021. It was clarified that the patient not hospitalized, only kept for monitoring in emergency room, not overnight. The pediatric doctor wanted to know if a patient having multiple severe reactions after the Covid Vaccine had been heard off. Outcome of the events was unknown.   Follow-up attempts are needed. Further information has been requested.; Sender's Comments: The events are possibly related to the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Age: 14.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Nausea, Throat tightness
Clinical narrative: Developed sever allergic reaction; Throat closure; Nausea; This is a spontaneous report from a contactable physician. A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13May2021 17:15 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing type 1 diabetes mellitus, and ongoing allergy to shellfish. Patient had no relevant family history. There were no concomitant medications. No vaccines administered on same date of the Pfizer suspect. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. On 13May2021 17:25, about 10 minutes after being administered that dose the patient had severe allergic reaction described as feeling as though he was having throat closure. EMS was called, that is when the patient was administered Epi-Pen and Benadryl: 1mg IM Epinephrine and 50 of Benadryl. Emergency room notes show the patient reports associated nausea, denies shortness of breath. He was administered Epi-pen twice, transported to the hospital emergency room where he was not admitted overnight, was kept for monitoring for about 3 hours then discharged from hospital emergency room on 13May2021. On 27May2021, the patient had another severe reaction. The patient was again administered Epipen and EMS transported patient to the hospital. The patient was at hospital emergency room for a couple of hours and then discharged on 27May2021. The patient has had several visits to the physician's office relative to severe reaction; he is scheduled in today for follow-up. After first emergency room visit he came into the physician's office and was seen on 18May2021; talked to patient on 21May2021 and 22May2021, then he was again seen on 25May2021. It was clarified that the patient not hospitalized, only kept for monitoring in emergency room, not overnight. The pediatric doctor wanted to know if a patient having multiple severe reactions after the Covid Vaccine had been heard off. Outcome of the events was unknown.   Follow-up attempts are needed. Further information has been requested.; Sender's Comments: The events are possibly related to the suspect product BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE).
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered outside recommended time frame since first puncture of vial
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Vaccine administered outside recommended time frame since first puncture of vial
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ophthalmological examination, Photophobia
Clinical narrative: At 4pm on 03/12 the day of the shot I was out walking and I got a stabbing pain in both eyes. I had to cover my eyes walking home and after that I had severe light sensitivity and eye pain. Its just now getting better three months later. So I went to the doctor who is an ophthalmologist. My vision was not effected as far as what I could see and couldn't see. He prescribed prednisolone drops for three weeks with no response. Then I had 3 more weeks and then for the last week or so I've been getting better. I didn't go see him for about a month because I thought it would go away. I saw him on April 9th and May 20th. I still have to wear sunglasses indoors if there is any bright light. My eyes before felt swollen inside and it was very painful especially with light. I use regular over the count eye drops for dryness. Its new and I've never had this happen before. I use them about 6 to 8 times a day. On 03/14/2021 in the morning I got slammed with incredible fatigue. Mine lasted for months after three  months I'm less fatigued probably by 50%. The fatigue was nauseating. In March  I was agitated with the fatigue. I had difficulty sleeping and I two weeks of profound depression. After two weeks it was gone.  The fatigue has lasted until now, I have to sleep for 9 hours plus naps. I'm a very energetic person until this shot. So this is a big change for me.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Depression, Eye pain, Fatigue, Full blood count, Insomnia
Clinical narrative: At 4pm on 03/12 the day of the shot I was out walking and I got a stabbing pain in both eyes. I had to cover my eyes walking home and after that I had severe light sensitivity and eye pain. Its just now getting better three months later. So I went to the doctor who is an ophthalmologist. My vision was not effected as far as what I could see and couldn't see. He prescribed prednisolone drops for three weeks with no response. Then I had 3 more weeks and then for the last week or so I've been getting better. I didn't go see him for about a month because I thought it would go away. I saw him on April 9th and May 20th. I still have to wear sunglasses indoors if there is any bright light. My eyes before felt swollen inside and it was very painful especially with light. I use regular over the count eye drops for dryness. Its new and I've never had this happen before. I use them about 6 to 8 times a day. On 03/14/2021 in the morning I got slammed with incredible fatigue. Mine lasted for months after three  months I'm less fatigued probably by 50%. The fatigue was nauseating. In March  I was agitated with the fatigue. I had difficulty sleeping and I two weeks of profound depression. After two weeks it was gone.  The fatigue has lasted until now, I have to sleep for 9 hours plus naps. I'm a very energetic person until this shot. So this is a big change for me.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Laboratory test, Nausea, Ocular discomfort, Pain, Photophobia
Clinical narrative: At 4pm on 03/12 the day of the shot I was out walking and I got a stabbing pain in both eyes. I had to cover my eyes walking home and after that I had severe light sensitivity and eye pain. Its just now getting better three months later. So I went to the doctor who is an ophthalmologist. My vision was not effected as far as what I could see and couldn't see. He prescribed prednisolone drops for three weeks with no response. Then I had 3 more weeks and then for the last week or so I've been getting better. I didn't go see him for about a month because I thought it would go away. I saw him on April 9th and May 20th. I still have to wear sunglasses indoors if there is any bright light. My eyes before felt swollen inside and it was very painful especially with light. I use regular over the count eye drops for dryness. Its new and I've never had this happen before. I use them about 6 to 8 times a day. On 03/14/2021 in the morning I got slammed with incredible fatigue. Mine lasted for months after three  months I'm less fatigued probably by 50%. The fatigue was nauseating. In March  I was agitated with the fatigue. I had difficulty sleeping and I two weeks of profound depression. After two weeks it was gone.  The fatigue has lasted until now, I have to sleep for 9 hours plus naps. I'm a very energetic person until this shot. So this is a big change for me.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thyroid function test
Clinical narrative: At 4pm on 03/12 the day of the shot I was out walking and I got a stabbing pain in both eyes. I had to cover my eyes walking home and after that I had severe light sensitivity and eye pain. Its just now getting better three months later. So I went to the doctor who is an ophthalmologist. My vision was not effected as far as what I could see and couldn't see. He prescribed prednisolone drops for three weeks with no response. Then I had 3 more weeks and then for the last week or so I've been getting better. I didn't go see him for about a month because I thought it would go away. I saw him on April 9th and May 20th. I still have to wear sunglasses indoors if there is any bright light. My eyes before felt swollen inside and it was very painful especially with light. I use regular over the count eye drops for dryness. Its new and I've never had this happen before. I use them about 6 to 8 times a day. On 03/14/2021 in the morning I got slammed with incredible fatigue. Mine lasted for months after three  months I'm less fatigued probably by 50%. The fatigue was nauseating. In March  I was agitated with the fatigue. I had difficulty sleeping and I two weeks of profound depression. After two weeks it was gone.  The fatigue has lasted until now, I have to sleep for 9 hours plus naps. I'm a very energetic person until this shot. So this is a big change for me.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Pain in extremity, Paraesthesia, Pruritus, Sensory loss
Clinical narrative: Shingles diagnosis 1.5 weeks after vaccine.; This is a spontaneous report from a contactable consumer (patient). A 35-years-old (non-pregnant) female patient received bnt162b2 (BNT162B2), Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 25Apr2021 at 16:00 as UNKNOWN, single dose for COVID-19 immunization. The patient was 35-years-old and was not-pregnant at the time of vaccination. Facility where the most recent COVID-19 vaccine was administered was public Health Clinic Administration facility. No other vaccines received by patient within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination. The patient has not been tested for COVID since the vaccination. The patient received other medications within 2 weeks of vaccination was valacyclovir. The patient medical history and concomitant medications were not reported. It was reported that on 03May2021, the patient experienced shingles diagnosis 1.5 weeks after vaccine. The adverse event result in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of shingles diagnosis 1.5 weeks after vaccine. Valacyclovir treatment received for the adverse event. The clinical outcome of event was recovering.  Information on the lot/batch number has been requested.