chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: severe arm pain, swollen lump in arm, feverish with no fever, chills, headache
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; Swelling and redness an inch below injection site. Tenderness and site is warm to touch.; This is a spontaneous report from a contactable Nurse reporting for herself. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot number EJ1685, via an unspecified route of administration on 22Dec2020 08:00 as a single dose in the left arm  (Dose number: 1) for COVID-19 vaccination.  The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There were no other vaccines received by the patient within 4 weeks prior to the COVID-19 vaccine. Medical history included diagnosed with COVID-19 on an unknown date prior to vaccination. There were no allergies to medications, food, or other products. Concomitant medication included atorvastatin (ATORVASTATIN), ethinylestradiol, norgestimate (TRI LO MILI), and vitamin D2 (VITAMIN D2).  On 24Dec2020 at 16:00, the patient experienced swelling and redness an inch belowinjection site, tenderness, site was warm to touch, and commented "it's 4 days already after vaccination date" (as of reporting on 26Dec2020). There was no treatment received for the events. The clinical outcome of the events swelling and redness an inch below injection site, tenderness, and site was warm to touch was not recovered. The patient was not COVID tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pain, Pruritus
Clinical narrative: severe body ache; a burning itching sensation in his back; a burning itching sensation in his back; This is a spontaneous report from a non-contactable nurse (patient's spouse). A male patient of an unspecified age received bnt162b2, via an unspecified route of administration on 22Dec2020 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient started to experience side effects on 23Dec2020 including severe body aches and a burning itching sensation in his back. He has had no fever. She was wondering how long symptoms usually last. And if he should be tested for Covid because she was exposed. The outcome of the events was unknown.   No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Developed mild itching that turned into wide spread, severe itching and pain. Given benedryl and tylenol per peer RN recommendations. Improved, but ongoing
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Painful and swollen axillary lymph nodes on the same side as the vaccine; This is a spontaneous report from a contactable other hcp (patient). A 29-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the right arm on 17Dec2020 15:00 at a single dose for COVID-19 immunization at the hospital. The patient's medical history was not reported. The patient has no known allergies. Concomitant medication included ethinylestradiol, ferrous bisglycinate, levonorgestrel (BALCOLTRA) and ibuprofen. The patient did not receive other vaccine within four weeks prior to COVID vaccine.The patient experienced painful and swollen axillary lymph nodes on the same side as the vaccine on 25Dec2020 10:00. The event led a clinic visit to the doctor or other healthcare professional office. It was unknown if treatment was given. Outcome of the event was not recovered. The event was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient has not been tested for COVID-19.  Information on the Lot/Batch Number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Full body joint pain, muscle pains, low grade fever, headache, pain, redness and swelling at injection site.  Two days after injection, injection site became itchy as I complete this form injection site still itchy.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Full body joint pain, muscle pains, low grade fever, headache, pain, redness and swelling at injection site.  Two days after injection, injection site became itchy as I complete this form injection site still itchy.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever, chills, nausea, headache, body aches
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: Right arm soreness Dec 24 , Fatique on Dec 25 , Severe Chills DEC 26 and fever of 101.5
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Fatigue, Headache, Nausea, Pain
Clinical narrative: Body aches, severe fatigue, Temp 101.2F, persistent head ache, slight nausea. Symptoms resolved by post-vaccine day 3.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Body aches, severe fatigue, Temp 101.2F, persistent head ache, slight nausea. Symptoms resolved by post-vaccine day 3.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Nausea, Vision blurred
Clinical narrative: dizzinessand lightheaded; Vision slightly blurred; BP elevated to 144/96; Slight nausea for remainder of day; This is a spontaneous report from a contactable nurse reporting for herself.  A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 23Dec2020 14:00 at a single dose for COVID 19 vaccination. The facility where the most recent COVID-19 vaccine was administered was a hospital. The patient was not pregnant at the time of vaccination. There was no other vaccination administered in the 4 weeks prior to COVID-19 vaccination. Medical history included multiple sclerosis from an unknown date and unknown if ongoing. There were no allergies to medications, food, or other products.  The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported; the patient did receive other medications within 2 weeks prior to COVID-19 vaccination.The patient experienced dizziness and lightheaded, noticed about 30 minutes after vaccine. Vision slightly blurred. BP elevated to 144/96. Slight nausea for remainder of day. The events occurred on 23Dec2020 at 14:45 pm. No treatment was received for the events. The patient recovered from the events dizziness, lightheaded, vision slightly blurred, BP elevated to 144/96, and slight nausea on an unknown date in Dec2020. The patient was not COVID-tested post vaccination.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; developed a cough once the numbness and tingling reached my throat; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 15:30 at a single dose for COVID-19 immunization. Medical history included thyroidectomy for thyroid cancer, anaphylaxis to mangoes and allergic to multiple medications. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine and liothyronine. The patient received the vaccine at 3:30pm, ten minutes later her lips, tongue and throat became numb and tingly. She developed a cough once the numbness and tingling reached my throat. She was given Benadryl at the time, 15 minutes after injection. She was still having numbness and tingling to the back of her tongue currently (8 days after injection). The patient was not hospitalized for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip oedema, Oedema mouth
Clinical narrative: lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; lips, tongue and throat became numb and tingly; developed a cough once the numbness and tingling reached my throat; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at the left arm on 18Dec2020 15:30 at a single dose for COVID-19 immunization. Medical history included thyroidectomy for thyroid cancer, anaphylaxis to mangoes and allergic to multiple medications. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine and liothyronine. The patient received the vaccine at 3:30pm, ten minutes later her lips, tongue and throat became numb and tingly. She developed a cough once the numbness and tingling reached my throat. She was given Benadryl at the time, 15 minutes after injection. She was still having numbness and tingling to the back of her tongue currently (8 days after injection). The patient was not hospitalized for the events. The events were reported as non-serious. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Dec2020 with sequel.
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Hypoaesthesia oral, Paraesthesia oral, Pharyngeal hypoaesthesia, Pharyngeal paraesthesia
Clinical narrative: Lip/Mouth Edema
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip oedema, Oedema mouth
Clinical narrative: Lip/Mouth Edema
Age: 60.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Face oedema, Peripheral swelling, Pruritus, Swelling of eyelid
Clinical narrative: Pt stated "I just wanted to report that for 3 days following my Hep B i was having facial edema and hand swelling, along with itching. (no hives just arm and head itching.) It was relieved with Benedryl. I did not have a temp, no cough, no tiredness, no respiratory distress. After 3 days it went away. Just puffy face, lower eyelids and both my hands were swollen."
Age: 60.0
Sex: F
Vaccine: HEP, HEP
Symptoms: Face oedema, Peripheral swelling, Pruritus, Swelling face, Swelling of eyelid
Clinical narrative: Pt stated "I just wanted to report that for 3 days following my Hep B i was having facial edema and hand swelling, along with itching. (no hives just arm and head itching.) It was relieved with Benedryl. I did not have a temp, no cough, no tiredness, no respiratory distress. After 3 days it went away. Just puffy face, lower eyelids and both my hands were swollen."
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: rash; shingles; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable nurse reported that a 43-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced developed a rash and shingles in Dec2020. The action taken in response to the events for bnt162b2 was not applicable. The outcome of events was unknown.  Information about batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: stuffy nose; cough; This is a spontaneous report from Pfizer-sponsored program Pfizer First Connect. A contactable physician reported for himself that a 66-year-male received first dose (BNT162B2) , intramuscular at arm in Dec2020 at single dose for COVID-19 immunization.  The medical history included High Blood Pressure, Cholesterol and chills. The patient was a physician who reported being exposed to Covid 19 via his daughter. He completed a PCR test which was negative and received his vaccine at work  a few days later.  After receiving the vaccine he had a stuffy nose and cough and completed an antigen test which was positive in Dec2020.  He was given monoclonal antibodies the same day as his positive test.  He is supposed to take the second dose of the vaccine 11Jan2021. The background was on Thursday he had a PCR 5 days after possible exposure, so he stepped forward for vaccine on Monday, so he got the vaccine on Monday and usual chills and all that stuff that went away. He went to work on Tuesday and was little stuffy so he went downstairs to get the rapid test, he had cough too and they have been developing for several days. He went downstairs to go rapid test and it was positive and he didn't conform with the PCR. (word incomprehensible) around 9 percent so used to get 20 percent false positive so he got the infusion. The patient underwent lab tests and procedures, which included antigen test positive in Dec2020, PCR test negative in Dec2020. The outcome of the events was unknown.   The information on the batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Normal redness swelling soreness of arm which resolved after couple days along with other normal normal reactions, myalgia, low grade fever etc.  However about one week to the day, 12/31/20 same ~6 cm circ red itchy sore are reappeared on arm and is still here 1/5/20.  It may be starting to fade some.     Just wanted to let you know.  No action desired.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Normal redness swelling soreness of arm which resolved after couple days along with other normal normal reactions, myalgia, low grade fever etc.  However about one week to the day, 12/31/20 same ~6 cm circ red itchy sore are reappeared on arm and is still here 1/5/20.  It may be starting to fade some.     Just wanted to let you know.  No action desired.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: received the vaccine on Friday and tested positive; received the vaccine on Friday and tested positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable other healthcare professional. A 27-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration in Dec2020 (reported as on Friday) at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine on Friday and tested positive today 26Dec2020. The outcome of event was unknown.  Information about batch/lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event COVID-19 virus test positive based on the known safety profile.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Shot was given around 12:40 pm on 1/4/2021. I woke up with shivers and low grade fever (99.6) at about 11:30pm. Took a Tylenol at that time. Low grade fever still persists (and rose to 100 degrees at the highest), mild body aches at 6am and headache.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Rhinorrhoea, Sinusitis
Clinical narrative: Sinus Infection (sneezing & runny nose); Sinus Infection (sneezing & runny nose); headache; fatigue; Sinus Infection (sneezing & runny nose); Sinus infection was reported as worsened; This is a spontaneous report from a contactable other health professional reporting for himself. A 31-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# Lot EH9899), intramuscular in left arm, on 23Dec2020 at 12:00 PM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced sinus infection (sneezing & runny nose) on 25Dec2020 at 12:00 PM with outcome of not recovered, headache on 25Dec2020 12:00 PM with outcome of not recovered, fatigue on 25Dec2020 at 12:00 PM with outcome of not recovered. The event sinus infection was reported as worsened in Dec2020 with outcome of unknown. No therapeutic measures were taken as a result of the events. The events were considered as non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sneezing
Clinical narrative: Sinus Infection (sneezing & runny nose); Sinus Infection (sneezing & runny nose); headache; fatigue; Sinus Infection (sneezing & runny nose); Sinus infection was reported as worsened; This is a spontaneous report from a contactable other health professional reporting for himself. A 31-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# Lot EH9899), intramuscular in left arm, on 23Dec2020 at 12:00 PM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced sinus infection (sneezing & runny nose) on 25Dec2020 at 12:00 PM with outcome of not recovered, headache on 25Dec2020 12:00 PM with outcome of not recovered, fatigue on 25Dec2020 at 12:00 PM with outcome of not recovered. The event sinus infection was reported as worsened in Dec2020 with outcome of unknown. No therapeutic measures were taken as a result of the events. The events were considered as non-serious.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Rhinorrhoea, Sinusitis, Sneezing
Clinical narrative: Sinus Infection (sneezing & runny nose); Sinus Infection (sneezing & runny nose); headache; fatigue; Sinus Infection (sneezing & runny nose); Sinus infection was reported as worsened; This is a spontaneous report from a contactable other health professional reporting for himself. A 31-year-old male patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, Lot# Lot EH9899), intramuscular in left arm, on 23Dec2020 at 12:00 PM, at single dose, for COVID-19 immunisation. Medical history and concomitant medications were none. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced sinus infection (sneezing & runny nose) on 25Dec2020 at 12:00 PM with outcome of not recovered, headache on 25Dec2020 12:00 PM with outcome of not recovered, fatigue on 25Dec2020 at 12:00 PM with outcome of not recovered. The event sinus infection was reported as worsened in Dec2020 with outcome of unknown. No therapeutic measures were taken as a result of the events. The events were considered as non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Fatigue, Headache, Rhinorrhoea, Sinusitis
Clinical narrative: fatigue; sneezing; runny nose; Headache; Sinus infection; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported to had taken the vaccine 3 days before (23Dec2020) and showed symptoms of fatigue, sneezing, and runny nose roughly after 48 hours (on 25Dec2020) and had been getting worse. He was asking for any recommendations such as testing and what to do next. Consumer stated that he was just calling because he got the vaccine 3 days before (23Dec2020) and he was having few side effects. He didn't know if they were related or not but he was wondering if he need to get tested or not. He was having sinus infection (in Dec2020), he have pretty heaving runny nose, sneezing, headache and fatigue in Dec2020. The outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Sneezing
Clinical narrative: fatigue; sneezing; runny nose; Headache; Sinus infection; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported to had taken the vaccine 3 days before (23Dec2020) and showed symptoms of fatigue, sneezing, and runny nose roughly after 48 hours (on 25Dec2020) and had been getting worse. He was asking for any recommendations such as testing and what to do next. Consumer stated that he was just calling because he got the vaccine 3 days before (23Dec2020) and he was having few side effects. He didn't know if they were related or not but he was wondering if he need to get tested or not. He was having sinus infection (in Dec2020), he have pretty heaving runny nose, sneezing, headache and fatigue in Dec2020. The outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Rhinorrhoea, Sinusitis, Sneezing
Clinical narrative: fatigue; sneezing; runny nose; Headache; Sinus infection; This is a spontaneous report from a contactable other HCP (patient). A male patient of an unspecified age started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Caller reported to had taken the vaccine 3 days before (23Dec2020) and showed symptoms of fatigue, sneezing, and runny nose roughly after 48 hours (on 25Dec2020) and had been getting worse. He was asking for any recommendations such as testing and what to do next. Consumer stated that he was just calling because he got the vaccine 3 days before (23Dec2020) and he was having few side effects. He didn't know if they were related or not but he was wondering if he need to get tested or not. He was having sinus infection (in Dec2020), he have pretty heaving runny nose, sneezing, headache and fatigue in Dec2020. The outcome of the events was unknown.  Information on the Lot/Batch Number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cough, Malaise, Myalgia
Clinical narrative: Slight fever (99.3); muscle/joint aches; muscle/joint aches; congested cough; tachypnea; nausea; malaise for about 12 hours 60 hours; This is a spontaneous report from a non-contactable nurse. An adult female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), intramuscular on 22Dec2020 11:00 at single dose at left arm for COVID-19 immunization. Medical history was none, no known allergies. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Dec2020 23:00 (11:00 PM), the patient experienced slight fever (99.3), muscle/joint aches, congested cough, tachypnea, nausea, malaise for about 12 hours 60 hours after injection. The events were non-serious per the reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Dec2020.  No follow-up attempts are possible. Information about lot/batch number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Tachypnoea
Clinical narrative: Slight fever (99.3); muscle/joint aches; muscle/joint aches; congested cough; tachypnea; nausea; malaise for about 12 hours 60 hours; This is a spontaneous report from a non-contactable nurse. An adult female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), intramuscular on 22Dec2020 11:00 at single dose at left arm for COVID-19 immunization. Medical history was none, no known allergies. The patient's concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Dec2020 23:00 (11:00 PM), the patient experienced slight fever (99.3), muscle/joint aches, congested cough, tachypnea, nausea, malaise for about 12 hours 60 hours after injection. The events were non-serious per the reporter. No treatment received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Dec2020.  No follow-up attempts are possible. Information about lot/batch number could not be requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash erythematous
Clinical narrative: Swollen arm.  Redness of arm.  Erythematous patch
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pruritus, Rhinorrhoea
Clinical narrative: sinus like symptoms/ bad runny nose; sinus like symptoms/ congestion/ sinus congestion; Itchiness; chills; body ache; head ache; This is a spontaneous report from a contactable other health professional (patient). A 28-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), intramuscularly on 23Dec2020 at single dose for COVID-19 immunization because he work in a hospital. Medical history was reported as none. There were no concomitant medications. The patient reported to have been vaccinated last Wednesday and developed symptoms on Thursday (24Dec2020) with a pretty bad chills, body ache, headache, itchiness, then got sort of better and that was on Thursday. He felt better on Friday (25Dec2020) but reported a really bad runny nose and congestion, he started to develop sinus like symptoms like runny nose, like sinus congestion and that's so something that he was experiencing like 26Dec2020 to Saturday. The patient was asking if these were the typical symptoms/ normal reaction to the vaccine and if he had that reaction were normal and how long would they usually last. The outcome of chills, headache, itchiness was recovering, of the other events was unknown.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus congestion
Clinical narrative: sinus like symptoms/ bad runny nose; sinus like symptoms/ congestion/ sinus congestion; Itchiness; chills; body ache; head ache; This is a spontaneous report from a contactable other health professional (patient). A 28-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), intramuscularly on 23Dec2020 at single dose for COVID-19 immunization because he work in a hospital. Medical history was reported as none. There were no concomitant medications. The patient reported to have been vaccinated last Wednesday and developed symptoms on Thursday (24Dec2020) with a pretty bad chills, body ache, headache, itchiness, then got sort of better and that was on Thursday. He felt better on Friday (25Dec2020) but reported a really bad runny nose and congestion, he started to develop sinus like symptoms like runny nose, like sinus congestion and that's so something that he was experiencing like 26Dec2020 to Saturday. The patient was asking if these were the typical symptoms/ normal reaction to the vaccine and if he had that reaction were normal and how long would they usually last. The outcome of chills, headache, itchiness was recovering, of the other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruise on antecubital area, kind of spreading a little bit to plexus like the extensor muscle on forearm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2, lot number: EL1284, via an unspecified route of administration on 24Dec2020 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient got the COVID Vaccine yesterday as a 'healthcare worker' and noticed three hours ago (Dec2020), that he/she had bruise on the antecubital area and then it was kind of spreading a little bit to the plexus like the extensor muscles on the forearm. Patient was just wondering if this was part of the side effect. The patient has not yet recovered from the event.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Extreme fatigue, injection site soreness, body ache
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Moderna COVID-19 Vaccine EUA Injection site redness, swelling, itching, discomfort the size of a fist 7 days after injection.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Influenza like illness, Malaise, Nasal congestion
Clinical narrative: tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included polycystic ovarian diseases from an unknown date. Concomitant medication included metformin, omeprazole, apremilast (OTEZLA). Patient stated she got the vaccine on the 18th. She took the vaccine on 20Dec2020. Yesterday (25Dec2020) she started to feeling sick and today (26Dec2020) patient got tested and she have Covid. She reported to have tested positive for COVID today (26Dec2020) with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms yesterday at around 4:00pm. This was the first time she has taken the Covid test. The physician stated she didn't know the causality between the event and vaccine. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive test for COVID based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; tested positive for COVID with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms; This is a spontaneous report from a contactable physician (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for covid-19 immunization. Vaccine location was left deltoid. The facility type vaccine was hospital. Medical history included polycystic ovarian diseases from an unknown date. Concomitant medication included metformin, omeprazole, apremilast (OTEZLA). Patient stated she got the vaccine on the 18th. She took the vaccine on 20Dec2020. Yesterday (25Dec2020) she started to feeling sick and today (26Dec2020) patient got tested and she have Covid. She reported to have tested positive for COVID today (26Dec2020) with symptoms such as nasal congestion, sore throat, weakness, and flu-like symptoms yesterday at around 4:00pm. This was the first time she has taken the Covid test. The physician stated she didn't know the causality between the event and vaccine. The action taken in response to the events for BNT162B2 was not applicable. The outcome of events was unknown.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event positive test for COVID based on the known safety profile. However the short duration of 5 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pain
Clinical narrative: Got the vaccine around 9:20-9:30 am, experienced a sore arm and headache a few hours later and some body aches. Woke up in the middle of the night with chills- fever Of 101, nausea, dizziness, headache, sore arm, and body aches
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Got the vaccine around 9:20-9:30 am, experienced a sore arm and headache a few hours later and some body aches. Woke up in the middle of the night with chills- fever Of 101, nausea, dizziness, headache, sore arm, and body aches
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Pain on the right side of my head; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient started to receive BNT162B2 (lot number: EH9899), via an unspecified route of administration on 21Dec2020 at SINGLE DOSE for exposure to COVID. There were no medical history. Concomitant medication included ibuprofen (ADVIL) and unspecified birth control. The patient experienced pain on the right side of her head on an unspecified date. No treatment received for the event. The outcome of the event was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Electrocardiogram, Hypertension, Nausea, Palpitations
Clinical narrative: PALPITATIONS, HIGH BLOOD PRESSURE, NAUSEA AND DIZZINESS
Sex: F
Vaccine: COVID19
Symptoms: Cough, Throat irritation
Clinical narrative: he felt the same as when she had COVID (scratchy throat and cough); he felt the same as when she had COVID (scratchy throat and cough); This is a spontaneous report from a contactable nurse. This nurse is reporting similar events for two patients. This is the second of two reports.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation.  The patient medical history included COVID. Concomitant medications were not reported.  It was reported that the patient got the vaccine (COVID 19 Vaccine) same day and was saying that she felt the same as when she had COVID (scratchy throat and cough) on Sunday (20Dec2020).. The outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020514115 same reporter, same drug, same event, different patient.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got vaccinated and contracted COVID the following week; Got vaccinated and contracted COVID the following week; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown as the reporter did not have any of that information at the moment of reporting), via an unspecified route of administration on 15Dec2020 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported.  It was reported that the patient got vaccinated on December 15th and contracted COVID the following week (Dec2020). Treatment included regeneron infusion last night (24Dec2020). Patient was wondering if zinc supplements should be taken or how to handle own's immune system because the patient had the first immunization. The outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Experienced nausea, fever, chills, and body aches
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Oral herpes, Periorbital oedema
Clinical narrative: Periorbital edema more on the right than the left; Herpes labials; This is a spontaneous report from a contactable Physician (patient). A 59-years-old male patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot EH9899) via an unspecified route of administration on 17Dec2020 18:45 at single dose in left arm for COVID-19 immunisation. Medical history included Hypertension, Hyperlipidemia, nocturnal seizures and known allergies: Quinolones. Concomitant medications included Atorvastatin, Gabapentin, magnesium chloride (MAG), Telmisartan and riboflavin (VIT B2). The patient experienced Periorbital edema more on the right than the left at 25Dec2020 08:00, herpes labials on 21Dec2020. The patient did not receive any treatment. Outcome of events was not recovered.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the left arm on 24Dec2020 at 07:30 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included penicillin allergy from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing and a thyroid disorder from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took iodine for an unknown indication and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Dec2020 at 15:30, the patient experienced headache, nausea, vomiting, chills, rigor, fever and fatigue. No therapeutic measures were taken as a result of the events. The clinical outcome of the headache, nausea, vomiting, chills, rigor, fever and fatigue was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: headache; nausea; vomiting; chills, rigor; fever; fatigue; This is a spontaneous report from a contactable other hcp. A 68-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), intramuscularly in the left arm on 24Dec2020 at 07:30 (at the age of 68-years-old) as a single dose for COVID-19 vaccination. Medical history included penicillin allergy from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing and a thyroid disorder from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID). The patient previously took iodine for an unknown indication and experienced drug hypersensitivity. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Dec2020 at 15:30, the patient experienced headache, nausea, vomiting, chills, rigor, fever and fatigue. No therapeutic measures were taken as a result of the events. The clinical outcome of the headache, nausea, vomiting, chills, rigor, fever and fatigue was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Moderna COVID-19 Vaccine EUA Fatigue, Muscle Pain, Chills, Joint Pain, Nausea x 24hrs. Headache x 3 days Pain at injection site x 4 days
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea
Clinical narrative: Moderna COVID-19 Vaccine EUA Fatigue, Muscle Pain, Chills, Joint Pain, Nausea x 24hrs. Headache x 3 days Pain at injection site x 4 days
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Erythema, Headache, Muscle twitching
Clinical narrative: metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to 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 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: metallic taste; developed mild headache; about 30 minutes developed itching and redness of both legs; about 30 minutes developed itching and redness of both legs; Started immediately having dizziness; Right upper facial muscles started twitching around eye area; This is a spontaneous report from a contactable physician (patient). A 57-year-old female patient the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), intramuscularly on 16Dec2020 14:00 at left arm, at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. After vaccination injection, the patient started immediately having dizziness from 16Dec2020 14:00 and then about 30 minutes developed itching and redness of both legs on 16Dec2020 14:30. About 2 hours after vaccine on 16Dec2020 16:00 went home still itching with redness, dizziness, developed mild headache and metallic taste. Right upper facial muscles started twitching around eye area. Took Benadryl and Tylenol went to sleep. Woke up 5 hours later, all symptoms gone accept still a little dizzy. By the next morning felt weird then by 24 hours everything resolved. The outcome of the events was recovered in Dec2020. Prior to 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 4 weeks prior to the COVID vaccine. No seriousness criteria: no Results in death, no Life threatening, no Caused/prolonged hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Culture throat positive, Dyspnoea
Clinical narrative: had a testing, came up positive; had a testing, came up positive/sporadic coughing and a little short of breath. Maybe a little sore throat; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), via an unspecified route of administration on 20Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received Pfizer COVID Vaccine (further clarified) on 20Dec2020. And maybe two days after that, the patient kind of developed a little like very sporadic coughing, it was very mild and a little short of breath. Maybe a little sore throat so that's why the patient was concerned. The patient had a testing in Dec2020, they did swab the patient's throat, it came up positive. The outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: very sick for two days; This is a spontaneous report from a non-contactable consumer communicated to a Pfizer colleague. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the COVID vaccine and was very sick for two days. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.