chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Flushing, Headache, Myalgia
Clinical narrative: PATIENT VACCINATED AROUND 9AM.  SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS.  SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM:  FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING.  AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED.  SYMPTOMS REPORTED IMPROVED FOLLOWING EPI.  EMS ARRIVED 10:05AM.  PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL.  WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Retching, Wheezing
Clinical narrative: PATIENT VACCINATED AROUND 9AM.  SHE REPORTS SHE FELT WARM/FLUSHING, FAINT AND STOMACH SPASMS WITHIN ABOUT 4-5 MINS.  SHE FELT BETTER AND GOT UP TO WALK ABOUT 30 MINS LATER. SYMPTOMS WORSENED AFTER WALKING ~9:45AM:  FAINT AGAIN, SEVERE RETCHING, BP196/140 TO 199/164, TROUBLE SWALLOWING, SOB, WHEEZING.  AT 9:58AM, EPI PEN 0.3MG ADMINISTERED AND EMS ACTIVATED.  SYMPTOMS REPORTED IMPROVED FOLLOWING EPI.  EMS ARRIVED 10:05AM.  PATIENT REPORTED RECEIVING 2 BAGS OF PEPCID, STEROIDS, AND ZOFRAN AT HOSPITAL.  WAS RELEASED BETWEEN 11:30AM-12PM ON 1/4/21, BP 140/90 AND ACUTE SYMPTOMS RESOLVED. FOLLOW UP WITH PATIENT 1/5/21: NO PRIOR HX OF HTN, BP 120/60, NO SOB/ BREATHING DIFFICULTY. C/O SEVERE HEADACHE, LOW TEMP, FATIGUE, MUSCLE ACHES, SORE THROAT.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Fever (99.6); Arm soreness; Headache; Fatigue; This is a spontaneous report from a contactable physician (patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EH9899), intramuscularly in the left arm, on 21Dec2020 at 07:15 (at the age of 28-years-old) at a single dose for COVID-19 immunization. Medical history included migraines and allergies to mango. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included magnesium (MANUFACTURER UNKNOWN) taken as supplement. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced fever (99.6), arm soreness, headache, and fatigue on 21Dec2020 at 20:00. The events were reported as non-serious. The patient underwent lab tests and procedures, which included body temperature: 99.6 on 21Dec2020. No therapeutic measures were taken as a result of the events. The clinical outcome of fever (99.6), arm soreness, headache, and fatigue was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Droopy left cheek.; This is a spontaneous report from a contactable nurse. A 52-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EJ1685), intramuscularly in the left arm, on 17Dec2020 at 14:30 (at the age of 52-years-old) at a single dose for COVID-19 immunization. The patient had no medical history or concomitant medications. The patient had no other medications within two weeks of vaccination. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took sulfamethoxazole, trimethoprim (SEPTRA) and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced droopy left cheek on 21Dec2020. No therapeutic measures were taken as a result of the event. The clinical outcome of droopy left cheek was recovered in Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of droopy left cheek might not be excluded considering the plausible temporal relationship.  The patient had previous allergy reaction to antibiotic (sulfamethoxazole, trimethoprim) use.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Sat 12-19-20 red spot around injection site, Mon 12/21/20 it feels warm and itching the redness is larger PT states she has taken Benadryl for symptoms
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Pain
Clinical narrative: Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; This is a spontaneous report from a contactable Nurse. A 43-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284), intramuscularly on 23Dec2020 08:30 at single dose on Left arm for immunisation.  The most recent COVID-19 vaccine was administered at Hospital. Medical history was none.  No other vaccine in four weeks and two weeks. No covid prior vaccination. The patient's concomitant medications were not reported.  The patient experienced tiredness, chills, body aches, diarrhea, persistent fevers even with tylenol or motrin taken 99.5-101.5degf on 23Dec2020 16:00. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for tiredness, chills, body aches, diarrhea. The outcome was not recovered. Covid test post vaccination included Covid 19 with type of Nasal Swab on 27Dec2020 with unknown results.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; Tiredness, chills, body aches, diarrhea, persistent fevers even with Tylenol or Motrin taken 99.5-101.5degF.; This is a spontaneous report from a contactable Nurse. A 43-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL1284), intramuscularly on 23Dec2020 08:30 at single dose on Left arm for immunisation.  The most recent COVID-19 vaccine was administered at Hospital. Medical history was none.  No other vaccine in four weeks and two weeks. No covid prior vaccination. The patient's concomitant medications were not reported.  The patient experienced tiredness, chills, body aches, diarrhea, persistent fevers even with tylenol or motrin taken 99.5-101.5degf on 23Dec2020 16:00. AE resulted in Doctor or other healthcare professional office/clinic visit. No treatment for tiredness, chills, body aches, diarrhea. The outcome was not recovered. Covid test post vaccination included Covid 19 with type of Nasal Swab on 27Dec2020 with unknown results.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Diarrhoea, Erythema, Pruritus
Clinical narrative: itching immediately after injection; then burning; then redness traveling up arm into chest; immediate onset of diarrhea; This is a spontaneous report from a contactable nurse(patient). A 42-year-old female non-pregnant patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=el0140), intramuscular on 26Dec2020 09:30 at left arm at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Hospital. The patient had no known allergies and no other medical history. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient experienced itching immediately after injection, then burning, then redness traveling up arm into chest, and immediate onset of diarrhea. Adverse event start date was 26Dec2020 09:30 AM. The events result in emergency room/department or urgent care. Treatment of Pepcid, Benadryl and prednisone received. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered in Dec2020.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: patient tested positive for COVID; patient tested positive for COVID; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program Pfizer First Connect.  A 29-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 17Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  On 27Dec2020, the patient tested positive for COVID.  The clinical outcome of patient tested positive for COVID was unknown.    The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug BNT162B2 to the reported events Drug ineffective and COVID 19 cannot be ruled out.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Erythema, Skin reaction
Clinical narrative: large bruising and redness, localized - delayed reaction
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neuralgia
Clinical narrative: Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; Nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists.; This is a spontaneous report from a contactable nurse (patient).  A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EK5730), via an unspecified route of administration on the right arm on 18Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital.  Medical history included Gyn issues, migraine and headaches but otherwise healthy. The patient also had allergies with sulfa, leminine, and latex sensitivity but not anaphylactic. Concomitant medications included elagolix sodium (ORILISSA), and calcium carbonate, colecalciferol, phytomenadione (VIACTIV). It was mentioned that prior to vaccination, the patient was not diagnosed with COVID-19 and had not been tested for COVID-19 since vaccination.  On 19Dec2020 14:00, the patient experienced nerve pain in lower back shooting into buttocks, also on bilateral (bil) wrists. The patient did not receive any treatment for the events. Outcome of the events were not recovered.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: she was administered the first dose of Pfizer COVID-19 Vaccine and later got COVID-19; she was administered the first dose of Pfizer COVID-19 Vaccine and later got COVID-19; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable female physician (patient) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date in 2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2020, the patient got the first shot of COVID vaccine and got COVID, she was wondering if she should still get the dose scheduled for 04Jan2021. The patient clarified that she is both a medical doctor/physician as well as the patient. She clarified that she was administered the first dose of Pfizer COVID-19 Vaccine and later got COVID-19. She called to ask if she should still get the second dose of COVID-19 Vaccine which is scheduled for 04Jan2021. She clarified that she does not think anything went wrong with the COVID-19 Vaccine. She does not think her receiving the COVID-19 Vaccine and developing COVID-19 are related; there was no way she would have had time to develop any protection from the COVID-19 Vaccine at the time she was exposed to COVID-19 2 days later. She does not think she can provide any relevant medical information that would be helpful for this report and declined to continue report. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported "developing COVID-19" after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Mild itching - no signs of distress at discontinuation of monitoring - asked to f/u w/ PCP
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: She tested positive for COVID-19; She tested positive for COVID-19; This is a spontaneous report from a contactable healthcare professional (patient) via Pfizer sales representative. A 55-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), 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. The patient, who is a frontline medical worker, informed that she tested positive for COVID-19 today (28Dec2020). The patient stated that she was informed by her employee health division at (place) that she was exposed to a patient with COVID-19 prior to her vaccination. She asked to be contacted regarding the timing of her second dose in light of her current status. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: There is not a reasonable possibility that reported "tested positive for COVID-19" is related to BNT162B2 vaccine.  The patient exposed to a patient with COVID-19 before vaccination.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear discomfort, Headache, Malaise, Myalgia
Clinical narrative: Not feeling well; chills; muscle aches; headache; ears bothering; stuffy/runny nose; stuffy/runny nose; This is a spontaneous report from a non-contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), intramuscularly in the right arm, on 18Dec2020 at 06:00 (at the age of 43-years-old) at a single dose for COVID-19 immunization. Medical history included hypothyroid, breast cancer, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included levothyroxine (MANUFACTURER UNKNOWN) and tamoxifen (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose on 25Dec2020 at 20:00. The events were reported as non-serious. No therapeutic measures were taken as a result of the events. The clinical outcome of not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: Not feeling well; chills; muscle aches; headache; ears bothering; stuffy/runny nose; stuffy/runny nose; This is a spontaneous report from a non-contactable nurse (patient). A 43-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), intramuscularly in the right arm, on 18Dec2020 at 06:00 (at the age of 43-years-old) at a single dose for COVID-19 immunization. Medical history included hypothyroid, breast cancer, and penicillin allergy. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications, taken within two weeks of vaccination, included levothyroxine (MANUFACTURER UNKNOWN) and tamoxifen (MANUFACTURER UNKNOWN). Other concomitant medications included unspecified multivitamin. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose on 25Dec2020 at 20:00. The events were reported as non-serious. No therapeutic measures were taken as a result of the events. The clinical outcome of not feeling well, chills, muscle aches, headache, ears bothering, and stuffy/runny nose was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Epistaxis, Pyrexia
Clinical narrative: About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; About 45 minutes after injection, got a bloody nose out of no where, then at night started having GI symptoms & low grade fever; This is a spontaneous report from a contactable other healthcare professional (patient).  A 42-years-old female patient started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscularly on 28Dec2020 13:15 (at the age of 42-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included the patient had allergies to medications, food, or other products, Bactrim and Sulfa based medications, & food sensitivities. Concomitant medication included birth control. The patient previously took sulfamethoxazole and trimethoprim (BACTRIM) and experienced allergies to medications: BACTRIM.  The most recent COVID-19 vaccine was administered in the hospital. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 28Dec2020 About 45 minutes after injection, patient got a bloody nose out of nowhere (14:00), then at night at 22:00 (10:00PM) started having gastrointestinal (GI) symptoms & low grade fever.  The events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect.  No treatment was received for the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever.  Outcome of the events bloody nose out of nowhere, then at night started having gastrointestinal (GI) symptoms & low grade fever were recovering. Since the vaccination, the patient has not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash on arms; This is a spontaneous report from a non-contactable other-HCP (patient). A 34-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899), via an unspecified route of administration in the left arm on 22Dec2020 10:30 at a single dose for COVID-19 immunization at the hospital. The patient has no medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced itchy rash on arms on 25Dec2020 12:00. Outcome of the event was recovering. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received antihistamine for the event. The event was assessed as non-serious. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site discomfort
Clinical narrative: Recipient reported pulsating around the injection site during the 15 minute observation period. HR- 77-82, O2- 100%
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Very sore arm; This is a spontaneous report from a contactable nurse (patient). A 53-year-old non-pregnant female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in the right arm on 28Dec2020 08:30 at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension (HTN) and diabetes mellitus (DM). The patient has no known allergies. The patient had received unspecified other medications the patient received within 2 weeks of vaccination. The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced very sore arm on 28Dec2020 12:00. Outcome of the event was not recovered. No treatment was given for the event. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination. The event was assessed as non-serious.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Pyrexia
Clinical narrative: fever. Highest temperature was 101.1 F. I took tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total; back aches/achiness were better after sleeping for the night; headache; Fatigue; This is a spontaneous report from a contactable nurse reporting for herself. A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration at left arm on 24Dec2020 08:30 at single dose for covid-19 immunization. It was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included Baseline leukopenia. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 12 hours after the vaccine the patient developed back aches, headache, and a fever. Highest temperature was 101.1 F. The patient took Tylenol which only brought it down to 100.6 F an hour later. Fever lasted for 5 hours total. Fatigue and achiness were better after sleeping for the night. Events onset date was provided as 24Dec2020 11:30 PM. No treatment was received for the events of back aches, headache and fatigue. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of the event fever was recovered on 25Dec2020 04:30, the outcome of the other events back aches, headache and fatigue was recovered on an unknown date in Dec2020.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired work ability, Pain, Pyrexia, Tonsillar hypertrophy
Clinical narrative: 4 days the vaccine I got a high fever, body aches and tonsils were severly swollen and couldnt work
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo, Vomiting
Clinical narrative: episode of vertigo; vomiting; nausea; This is a spontaneous report from contactable physicians (one is the patient). A 41-year-old female patient received the first dose of bnt162b2 (BNT162B2, Solution for injection, lot number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 at 12:45 at a single dose for immunization. Medical history included benign paroxysmal positional vertigo, but the patient has not had a flare of this condition in 3.5 years. The patient has no allergies to medications, food, or other products. Concomitant medications were not reported. The patient who has a history of Benign Paroxysmal Positional Vertigo (BPPV) had not had a flare of this condition in 3.5 years. Previously, it has only been brought on by scuba diving, then she woke up the day after receiving the Pfizer COVID 19 vaccine, on 23Dec2020 at 06:30 with an episode of vertigo consistent with prior episodes of BPPV. She has associated nausea and vomiting, and her symptoms mostly resolve with doing home exercises, rest and time. On 29Dec2020, that is day 7 after the vaccine and she still have mild vertigo. She has no fevers, chills, or myalgias. She stated that perhaps it was a coincidence but thought it might be worth reporting, and she fully intend to get the second Pfizer vaccine when available. No treatment was received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19, and since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, and no other medications were received by the patient within 2 weeks of vaccination. The events nausea and vomiting resolved in 2020 while the rest of the events was resolving.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itchy rash; This is a spontaneous report from a contactable nurse (patient). A 38-years-old female patient received the first dose of bnt162b2 (Pfizer BioNTech, Solution for injection, lot number: EK5730), via an unspecified route of administration on the left arm on 22Dec2020 17:45 at a single dose for immunization. Medical history was reported as none. The patient has no known allergies. The patient's concomitant medications were not reported. On 28Dec2020 at 06:00, 6 days after the initial Covid vaccine dose, the patient developed an itchy rash all over her body. Started first thing in the morning with itchy ankles, and by the afternoon, it was covering her whole body in patches and was intensely itchy. No other associated symptoms. No new detergent, clothing, foods, meds to explain. The patient left for work, showered, and took Benadryl. The rash went away and at the time of the report, feels fine. The patient was not diagnosed with COVID prior vaccination and was not tested post vaccination. The patient has no other vaccine in four weeks. The events resolved on an unspecified date in Dec2020.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Sneezing
Clinical narrative: Red, raised, warm pear-shaped area 3x5" noted 1/4/2021 @ 8:00 PM.I had used Benadryl 25mg night before for sneezing d/t putting Christmas stuff into attic. On Jan 4th, I used a cold compress and used Benadryl 50mg.  I notified my Dr's office and pharmacy.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Hypoaesthesia, Injection site hypoaesthesia, Musculoskeletal discomfort, Paraesthesia
Clinical narrative: had a little side step/unbalance moment; left hand started tingling/tingling in left foot and left side of face; neck on left side felt like someone had hit it; injection site and whole deltoid was numb.; Left side of face, left foot and left ear all felt numb but with tingles; This is a spontaneous report from a contactable other HCP (patient). A 48-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL0140), via an unspecified route of administration in Left arm on 28Dec2020 16:30 at single dose for covid-19 immunisation. The COVID-19 vaccine was administered at workplace clinic. Medical history included known allergies to food - vegetables, berries, shellfish, environmental. Concomitant medication in two weeks included desogestrel, ethinylestradiol (MIRCETTE), fluticasone propionate (FLONASE), iron, multi vitamin, elderberry w/z. The patient previously took benzoyl peroxide and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient waited 20min, went up to leave and while walking out had a little side step/unbalance moment. The patient thought nothing of it and went to car and was waiting in car for an extra 10 min. Her left hand started tingling, same tingling like if it was asleep and was waking up. Then she started to drive home, on the way home, noticed tingling in left foot and left side of face, neck on left side felt like someone had hit it. About 50 min after receiving injection, was at home, injection site and whole deltoid was numb. Left side of face, left foot and left ear all felt numb but with tingles. She had stopped timer after 2 hours. Tingling and numbness subsided sometime after 2 hours of receiving vaccine. Today (29Dec2020), everything felt fine. Injection site just felt like I got a shot, can barely notice it. Adverse event start date provided as 28Dec2020 05:15 PM. No treatment received for the events. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 29Dec2020.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Dizziness, Fatigue, Headache
Clinical narrative: fatigue; Swollen left elbow (tender to touch); dizziness; headaches; high temperature; Swollen left elbow (tender to touch); This is a spontaneous report from a contactable other health professional (HCP, reported for herself). A 44-year-old female patient (not pregnant at the time of vaccination) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1830), intramuscular on 22Dec2020 12:45 at single dose at left arm for COVID-19 immunization. Medical history and concomitant medications were none. 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. The patient did not receive any other medications within 2 weeks of vaccination. On 22Dec2020 16:45 (04:45 PM), the patient experienced swollen left elbow (tender to touch), dizziness/headaches, high temperature, fatigue. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Pyrexia
Clinical narrative: fatigue; Swollen left elbow (tender to touch); dizziness; headaches; high temperature; Swollen left elbow (tender to touch); This is a spontaneous report from a contactable other health professional (HCP, reported for herself). A 44-year-old female patient (not pregnant at the time of vaccination) received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 1830), intramuscular on 22Dec2020 12:45 at single dose at left arm for COVID-19 immunization. Medical history and concomitant medications were none. 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. The patient did not receive any other medications within 2 weeks of vaccination. On 22Dec2020 16:45 (04:45 PM), the patient experienced swollen left elbow (tender to touch), dizziness/headaches, high temperature, fatigue. The adverse events resulted in doctor or other healthcare professional office/clinic visit. No treatment received for the adverse events. The events were non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Eye disorder, Eye irritation, Hypertension, Ocular hyperaemia
Clinical narrative: eye irritation; eyes turn red; blurry vision; difficulty keeping eyes open; BP 160/85; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old male patient received bnt162b2 (lot number: EL0140), intramuscularly at arm left, first dose on 28Dec2020, at single dose, for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the within 2 weeks of vaccination. The patient experienced eye irritation, eyes turn red, blurry vision, difficulty keeping eyes open, BP 160/85 on 28Dec2020. No treatment received for the adverse event. The event was reported as non-serious. The outcome of the events was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: eye irritation; eyes turn red; blurry vision; difficulty keeping eyes open; BP 160/85; This is a spontaneous report from a contactable other hcp (patient). A 50-year-old male patient received bnt162b2 (lot number: EL0140), intramuscularly at arm left, first dose on 28Dec2020, at single dose, for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications the within 2 weeks of vaccination. The patient experienced eye irritation, eyes turn red, blurry vision, difficulty keeping eyes open, BP 160/85 on 28Dec2020. No treatment received for the adverse event. The event was reported as non-serious. The outcome of the events was recovering.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pruritus, Tachycardia, Urticaria
Clinical narrative: Urticaria, diffuse flushing head to toe, significant pruritus, tachycardia
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea, Upper respiratory tract congestion, Vertigo
Clinical narrative: Vertigo/it is now full blown vertigo; Stuffy head; She does not feel safe walking in her home; Nausea/ Acute nausea; Dizziness; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK3730, expiration date: 20Mar2021), via an unspecified route of administration on 17Dec2020 at left deltoid, at single dose for covid-19 immunization. Medical history included patent foramen ovale in patient's heart from 2013 and ongoing, and the patient used to be 5'4" and noticed the shrinkage before the Covid 19 vaccine and baby aspirin. Concomitant medication included acetylsalicylic acid (BABY ASPIRIN) from 2013 and ongoing for patent foramen ovale. The patient got the Pfizer vaccine on 17Dec2020 and on 25Dec2020 had experienced acute nausea and dizziness that persisted during weekend. Stated that it is now full blown vertigo. Stated that her doctor and pharmacist stated that people reported symptoms but did not know if these were symptoms of the vaccine because it is not listed. The patient experienced stuff head on 28Dec2020. Stated that the nausea comes and goes. Stated that she got physical therapy treatment Epley for vertigo on 28Dec2020 and it did some good but she woke it with it again this morning on 29Dec2020. Stated that the therapy lessened her nausea as well. Stated vertigo was manageable 25-26 and then did not feel safe walking in her home on 26Dec2020. Stated that she had no symptoms after she received it up until 25Dec2020. Stated that she will get the second dose 07Jan2021. The outcome of the events was not recovered.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pyrexia
Clinical narrative: FEVER, CHILLS, BODY ACHES, MALAISE
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vaccination site pain
Clinical narrative: headache; arm soreness under injection; This is a spontaneous report from a contactable nurse (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ej1685), intramuscular on 28Dec2020 12:00 in left arm at single dose for COVID-19 immunization. Medical history included depression, osa (obstructive sleep apnea syndrome) and obesity from an unknown date and unknown if ongoing. Concomitant medication included escitalopram oxalate (LEXAPRO), lansoprazole (PREVACID), clarithromycin (CLARITIN [CLARITHROMYCIN]) and losartan potassium (COZAAR). The patient had arm soreness under injection and slight headache on 28Dec2020 21:00 and took Tylenol and aleave as treatment. The facility where the most recent COVID-19 vaccine was administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The events was considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect. The outcome of the events was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable nurse (patient).  A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient is a nurse anesthetist that got Covid vaccine on 17Dec2020 and tested positive for COVID-19 after the vaccine on 26Dec2020. The patient was wondering if have seen this. Stated that she was signed up for the booster scheduled for 05Jan2021 and wanted to know if they had any information about taking this. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect drug bnt162b2 to the reported events drug ineffective and COVID-19 cannot be ruled out.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Fluid retention, Headache, Peripheral swelling
Clinical narrative: NOT SURE THIS IS EVEN AN OUTCOME OF THE VACCINE, BECAUSE I HAVE HAD THE HEAD COLD AT THE EXACT SAME TIME AS GETTING THE VACCINE ON JAN 31, 2020, BUT THOUGHT I SHOULD REPORT.    1.  HAD A VERY MINOR HEADACHE THE TWO DAYS FOLLOWING THE VACCINE, JUST MILD DISCOMFORT.  FULLY RESOLVED ON ITS OWN AFTER TWO DAYS.  2.  MONDAY, JANUARY 4 WHEN I WOKE UP I FELT "PUFFY" - FEET AND HANDS WERE MILDLY SWOLLEN.  NOTICED MY SHOES FELT TIGHTER THAN USUAL AND HANDS FELT A BIT DIFFICULT TO FULLY CLOSE.  THIS IS FLUID RETENTION, AS IF YOU HAD TOO MUCH SALTY FOOD THE DAY BEFORE, AND I THOUGHT PERHAPS I HAD INGESTED MORE SALT THAN I REALIZED ON SUNDAY.  BUT IT HAS BEEN YEARS SINCE THAT OCCURRED FOR ME AND MY DIET DOES NOT INCLUDE MUCH SALT OR PROCESSED FOODS.  THEN TODAY MY FEET AND HANDS STILL FEEL PUFFY, SHOES STILL A BIT TIGHT AND HANDS A BIT HARD TO CLOSE SO THERE IS STILL SOME FLUID RETENTION GOING ON.  THIS IS QUITE UNUSUAL FOR ME, I AM QUITE HEALTHY AND HAVE A GOOD DIET AND DON'T RECALL THIS HAPPENING BEFORE.    AGAIN, NOT AT ALL SURE THIS IS RELATED TO THE VACCINE, IT MAY HAVE SOMETHING TO DO WITH THE HEAD COLD, BUT AS I AM NOT SURE AND THIS IS UNUSUAL AND HAS OCCURRED AFTER RECEIVING THE VACCINE, I FELT I SHOULD REPORT IT.  THIS EFFECT IS VERY MILD AND I AM NOT CONCERNED ABOUT IT AND IT.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia, Peripheral coldness, Vaccination site pain
Clinical narrative: tired and laid down; soreness to the injection site; paresthesia - tingling in hands and feet; hands and feet are cold/She felt cold; This is a spontaneous report from a contactable nurse (patient). A 51 years old female patient received the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via Intramuscular on 28Dec2020 10:00 at single dose in the arm left for covid-19 immunisation. Medical history included change in taste, altered taste. Concomitant medications were none. Caller reported she was having side effects with the COVID vaccine she received yesterday (28Dec2020) morning at 10am. The patient experienced paresthesia, tingling in hands and feet and they are cold, said she "felt cold" and has soreness in the injection site on 28Dec2020 17:00. Caller confirmed the above details. Her hands got really cold and tingling to them and she was wondering what this is and went to her other half and asked him to take a look. It passed and lasted about 10-15 minutes and just thought it was unusual. Did a 5:00pm check-in and she was doing okay and everything was fine so she didn't mention it. At 7:00pm she got tired and laid down and started feeling the tingling in the fingers and her hands. Upon waking this morning when her feet met the ground it was intensified, the tingling, and she went to walk it out it got better, but she is still having the tingling in both fingers/hands and feet. Stated unsure of seriousness criteria for the tingling in hands and feet and coldness. Wondered if it is something she needs to worry about that is why she called. Is it something that could go away or worse like with Guillain-barre syndrome. It's not disabling, but it is concerning. Unable to provide the NDC or expiry for COVID vaccine given. Stated she can't understand the writing on the card provided for her with product details. Does see on card Pfizer, X40113 and stated the lot number looks to be either "ES1685 or EJ1685 or E51685". Unable to provide the dose/strength. Received this vaccine at her workplace. Mentioned in past she had flu vaccine with the additive of mercury and experienced changes in taste, altered taste. It was reported to her primary care provider. This was between 6-8 years ago, unable to provide name of vaccine, NDC, Lot, or expiry. Since then she only receives single dose vials instead of multidose vials. They were looking for a list of side effects and wanted to know if she should seek care for her symptoms, it's unusual. Wanted to know if the side effects she is having is something Pfizer has been seeing and will it go away and when. Previous transfer agent sent her to safety. It is difficult to navigate the website. Outcome of event fatigue was unknown, while outcome of other events was not recovered. Causal relationship between vaccine and events "paresthesia, tingling in hands and feet" "hands and feet are cold" "soreness in injection site" were related by agency and Primary Source Reporter.   Information about Lot/Batch number has been requested.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Pruritos Hives on chest, back, stomach and upper arms; This is a spontaneous report from a contactable physician reporting for himself. This 33-year-old male patient received on 18Dec2020 11:00 first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot FJ1685) at single dose in the left arm for COVID-19 immunization. Medical history included seasonal allergies. Prior to vaccination, the patient was not diagnosed with COVID 19. Post vaccination, the patient had not been tested for Covid-19. Concomitant medications were not reported. On 24Dec2020, the patient had pruritus hives on chest, back, stomach and upper arms. No fevers/chills, difficulty breathing, throat swelling or other symptoms. Outcome was not recovered.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose normal, Feeling hot, Loss of consciousness, Muscular weakness
Clinical narrative: After receiving the vaccine, I was instructed to wait i for 15 minutes to ensure there were no reactions. I sat down in the provided chair, put my headphones in my ears, and started my timer on my watch for 15 minutes. after about 5 minutes I began to feel like my injection arm was a little weak, as if perhaps my arm was stiffening from the injection sore. I remember feeling slightly warm and started to read over the COVID-19 Vaccine symptoms sheet and then I blacked out (Fainted). The nurse in the hallway woke me up and was asking me if i was alright and then rushed me in the back room where they tested me and ensured I was ok. I had not eaten anything the morning of the vaccination shot and barely anything the night before. I have been experiencing higher levels of anxiety recently due to pressures of day to day life; school, work, etc. The nurses are thinking it is likely I had more of a reaction to the anxiety and low food or blood sugar (I am not diabetic), than a reaction to the vaccine itself. They did refer to my experience as sounding like Vasovagal syncope. I have never had this experience with any flu vaccine or shots before; I do not have a fear of needles or shots.