chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Photophobia
Clinical narrative: left eye was irritated; left eye was sensitive to light; left eye was painful weeping and red.; left eye was red; left eye weepy; entire left side was sore, achy, including her jaw and stuff; entire left side was sore, achy, including her jaw and stuff; This is a spontaneous report from a contactable consumer. A female patient of unspecified age (reported as 59 with no unit) received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine), via an unspecified route of administration on right arm on 16Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was painless on 16Dec2020. On 17Dec2020, her entire left side was sore, achy, including her jaw and stuff, 18Dec2020 evening, her left eye was irritated, sensitive to light, painful weeping and red (left eye was painful, red, and weepy). She called her doctor on 19Dec2020 and he gave her some eye drops. On 20Dec2020, the eye drops seemed to irritate her eye more. She woke up in the morning and it was seeming to get better as she had been taking Excedrin. She was supposed to wait 6 hours between drops, then her eye again was sensitive to light and painful, so she took another Excedrin, which helped again. She was trying to see an eye specialist the day after the time of the report. She had asked around at work and nobody else had any issues. She was wondering if this was vaccine related. She wanted to get tested for COVID, not that she thought she had it now, but might be she had it before she got the vaccine. She had not even talked to her workplace about this or anything. They asked everyone the first day after, if there were any issues and to report them to HR/Employee Health. She had not done so yet, so she wanted to do that first. Outcome of the events left eye was irritated, sensitive to light, painful weeping and red, and left eye weepy was resolving, and of other events was unknown.  Lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nausea; headache; fatigue; This is a spontaneous report from a contactable healthcare professional. A 31-year-old male patient received BNT162B2 (Lot number: EJ1685), intramuscularly on right arm on 20Dec2020 07:00 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications in two weeks included emtricitabine/tenofovir disoproxil fumarate (TRUVADA), bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), and valaciclovir (VALACYCLOVIR). Patient experienced nausea, headache, and fatigue on 21Dec2020 07:00. No treatment received for these events. Outcome of the events was not resolved.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Headache
Clinical narrative: headache; take BP. My usual normal is 125/80. 164/93 just mow; This is a spontaneous report from two contactable pharmacists. A 53-year-old female patient received BNT162B2 (lot number: EJ1685), via an unspecified route of administration on left arm on 21Dec2020 07:00 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient began getting a headache (H) on 21Dec2020 09:00 (around 9:30), felt like a different kind of headache that progressed. At 2:30, patient went back to monitoring area and asked them to take blood pressure (BP). Her usual normal was 125/80, but 164/93 just now (21Dec2020 09:00). COVID-19 vaccine was administered in the hospital. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Outcome of the events was resolving.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the first of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020.  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505821 different patient/same drug/event;US-PFIZER INC-2020505822 different patient/same drug/event;US-PFIZER INC-2020505823 different patient/same drug/event;US-PFIZER INC-2020505824 different patient/same drug/event;US-PFIZER INC-2020505825 different patient/same drug/event
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the second of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020.  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the third of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020.  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the fourth of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020.  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the fifth of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020. Therapeutic measures were taken as a result of the event and included administration of epinephrine (MANUFACTURER UNKNOWN).  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is the sixth of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: AK 5730, EG 1685), via an unspecified route of administration in Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced anaphylaxis in Dec2020. Therapeutic measures were taken as a result of the event and included administration of epinephrine (MANUFACTURER UNKNOWN).  The clinical outcome of anaphylaxis was unknown.    No follow-up attempts are possible.  No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020505820 different patient/same drug/event
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on throat, chest, back and legs; This is a spontaneous report from a contactable healthcare professional.  A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 19Dec2020 07:45 at single dose for COVID-19 immunisation.  Medical history included known allergies: penicillin.  The patient's concomitant medications were not reported.  The patient experienced rash on throat, chest, back and legs on 19Dec2020 11:30. Patient does not receive any treatment. The outcome of the events was recovering.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Flushing, Gastrointestinal pain, Headache, Muscle spasms
Clinical narrative: gut pain; headache; cramping; diarrhea/7 bouts of diarrhea over 3 hours; facial flushing; This is a spontaneous report from contactable nurse.  A 58-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 19Dec2020 10:30 at a single dose for COVID-19 immunization at a hospital.  Medical history included hypertension and obesity. The patient has no known allergies. The patient was not tested for it since the vaccination. The patient's concomitant medications were not reported.  Adverse event: On 21Dec2020, 12:00, patient experienced gut pain, headache, cramping, 7 bouts of diarrhea over 3 hours, and 3/7 also coincided with facial flushing with no treatment. The patient did not recover from the events.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itching on back; hives in a small area; This is a spontaneous report from two contactable consumers (patient and patient's mother). A 22-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, lot number: EH9899, expiry date: 31Mar2021), intramuscular in left arm on 21Dec2020 (about 9:45 -09:50 a.m. this morning) at a single dose for COVID-19 immunization. The patient has no other patient history, no concomitant medications, and no investigation assessment provided. The patient has no previous immunizations. The patient received the COVID vaccine about 9:45 -09:50 a.m. this morning (21Dec2020). She noticed just recently that she was starting to itch on her back and has hives and did not know if it was a side effect. Time of onset of itching on back was around 15:00-15:30 (estimated at within past 30 minutes), while the hives started around 5 minutes later than the itching. No ER or physician's office required. She is a nursing student, so it was recommended she receive the vaccine by the college of nursing. She received it at the hospital. They put Neosporin on her back, and it helped. She does not feel the itching. When asked to provide outcome of the hives, she stated it looks like the hives are getting smaller, but they are still there. The outcome of the events was recovering.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Nasal discomfort, Oropharyngeal pain, SARS-CoV-2 test, Throat irritation
Clinical narrative: Nasal swab for COVID 19 test; Sore throat. First noticed Saturday morning and not to the point where it's painful to swallow.; Burning from the back of left nostril and down throat; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date was not provided) solution for injection, via an unspecified route of administration (on left arm) on 17Dec2020 17:00 at a single dose for Covid-19 immunisation. Medical history was reported as none. Patient had no known allergies. Concomitant medication included ibuprofen. The patient experienced sore throat, he first noticed it Saturday morning (19Dec2020 04:45) and not to the point where it's painful to swallow. Patient reported there was burning from the back of left nostril and down the throat (19Dec2020 04:45). No treatment was administered. The patient underwent nasal swab for Covid 19 test on 21Dec2020 with pending result. Outcome of the event Suspected COVID-19 was unknown while for the other events was recovering.; Sender's Comments: 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: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Discomfort, Dizziness, Feeling abnormal, Heart rate increased
Clinical narrative: I felt slight dizziness immediately after injection/dizziness increased; feel my heart beating quickly; achiness in my joints; soreness at the injection site; feeling strange; remain uncomfortable; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EH9899), via an unspecified route of administration in the left arm on 21Dec2020 14:45 at single dose, for immunisation. Medical history included rheumatoid arthritis, osteoarthritis, anaemia, bipolar disorder II, hypertension, and GERD. She had no Covid/ Covid test prior to vaccination. She had other medications in two weeks. The patient previously took hydrocodone and experienced drug allergy. The patient felt slight dizziness immediately after injection. When she walked to the 15 min. waiting area, the dizziness increased and she began to feel her heart beating quickly. She drank 8 oz. of water and told the attendant she was feeling strange. She took a pulse and oximetry reading - 110 and 95%. A nurse came over to check on her. The patient wanted to sit where the patient was for a few minutes longer. After about 20 mins. the dizziness immediately subsided and patient felt her pulse decreased. She got her things and left. After a few minutes, the patient began to feel achiness in her joints and felt soreness at the injection site. She had taken two Acetaminophen and remain uncomfortable. She planned to go home and rest. The events were reported as non-serious. No treatment was reported for dizziness and increased heart rate. The outcome of events Dizziness, Heart rate increased was recovered on 21Dec2020; for other events was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: I felt slight dizziness immediately after injection/dizziness increased; feel my heart beating quickly; achiness in my joints; soreness at the injection site; feeling strange; remain uncomfortable; This is a spontaneous report from a nurse (patient herself). A 57-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EH9899), via an unspecified route of administration in the left arm on 21Dec2020 14:45 at single dose, for immunisation. Medical history included rheumatoid arthritis, osteoarthritis, anaemia, bipolar disorder II, hypertension, and GERD. She had no Covid/ Covid test prior to vaccination. She had other medications in two weeks. The patient previously took hydrocodone and experienced drug allergy. The patient felt slight dizziness immediately after injection. When she walked to the 15 min. waiting area, the dizziness increased and she began to feel her heart beating quickly. She drank 8 oz. of water and told the attendant she was feeling strange. She took a pulse and oximetry reading - 110 and 95%. A nurse came over to check on her. The patient wanted to sit where the patient was for a few minutes longer. After about 20 mins. the dizziness immediately subsided and patient felt her pulse decreased. She got her things and left. After a few minutes, the patient began to feel achiness in her joints and felt soreness at the injection site. She had taken two Acetaminophen and remain uncomfortable. She planned to go home and rest. The events were reported as non-serious. No treatment was reported for dizziness and increased heart rate. The outcome of events Dizziness, Heart rate increased was recovered on 21Dec2020; for other events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Dysgeusia
Clinical narrative: a funny metallic taste in her mouth; she felt like she had cotton mouth; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received the first dose of bnt162b2 (COVID 19 vaccine) lot no: EH9899, via an unspecified route of administration in left arm on 21Dec2020 08:00 at a single dose for COVID-19 immunization.  Medical history included diabetic type 2 and allergic to metal, both from an unknown date and unknown if ongoing. Concomitant medication included ongoing metformin hydrochloride (METFORMIN ER) for diabetes, taking for a couple of years. The patient received the vaccine on 21Dec2020 8am at her hospital, and by 10:30AM or 11:00AM she noticed "a funny metallic taste in her mouth." She stated it was like a metal cup a tin taste like that and she wanted ice water. The patient is a phlebotomist, she continued with her patients and asked a co-worker did you taste/experience that, coworker stated "I've had covid"; she didn't get the vaccine taste metal in your mouth. The reported wanted to know if that is an expected side effect of the vaccine. She can smell everything. She still has taste buds. It was still there but not as strong. She stated that she felt fine, and doesn't feel anything. She doesn't feel bad. She was just wondering about the side effects.  She drank a lot of water. The patient added that all of the sudden her mouth was tasting funny like nickel. She added that she is allergic to metal; stated she can taste the tin in a tin can. She was working in the ER after having received the first dose injection at 8:00AM on 21Dec2020. She started to taste the funny taste about two hours later, 10:30AM or 11:00AM. She drank some ice water and it kind of rinsed her mouth out then she only tasted it a tiny bit. Then she felt like she had cotton mouth. It has improved but not gone away. She received the injection in her left arm. She is scheduled 11Jan2021 for the next dose. The patient was recovering from the events. The sample of the product is not available to be returned.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Head discomfort, Tinnitus
Clinical narrative: she started with ringing in her ears and it has not gone away; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, intramuscular (left deltoid) on 19Dec2020 18:00 at a single dose for COVID-19 immunisation. Medical history was reported as none. There were no concomitant medications. The patient reported it was nothing severe, but she had the first dose of the vaccine on Saturday evening at 6pm and about 6 hours after, she started with ringing in her ears and it has not gone away. She would like to know if that was one of the side effects. It was not listed on the sheet that was given to her; will it go away and should. She was just concerned. She does not want it to progress. It was like a ringing. It was not like a headache but was a steady discomfort from ear to temple. She works at a hospital and got invited to take it. It was just an annoyance since it was still there. Outcome of the event was not recovered.  Information on Lot/Batch has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pain, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: she started getting really bad body aches; she got really dizzy; nauseous; throw it up; her arm was sore where they gave the vaccination; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (21Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient reporting for herself). A 21-year-old female patient received bnt162b2 (also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 19Dec2020 18:00 on the left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she got the vaccine, the Covid-19 vaccine, Saturday 19Dec2020 around 6PM. On Sunday 20Dec2020, she went about her day and around mid day, about 5PM she started getting really bad body aches and then after she showered she got really dizzy, states she would try to eat and she would get nauseous and throw it up. She wanted to know how fast the symptoms are showing after vaccination. She went to get a COVID test today as well because she is not sure if this is due to the vaccine or what. She took Ibuprofen 400mg around 10PM last night 20Dec2020 because the body aches are so bad. States she took a shower last night and got really dizzy but that has resolved and has not happened since. On 21Dec2020, she ate some breakfast and at 11AM she got very nauseous and threw up. Initially (in Dec2020), her arm was sore where they gave the vaccination which she was expecting and then it started going all over her body, states it is like menstrual cramps but like all over. The events did not require a visit to Emergency Room and Physician Office. The event dizzy recovered on 20Dec2020. The outcome of her arm was sore where they gave the vaccination was unknown and the rest of the events was not recovered.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: she started getting really bad body aches; she got really dizzy; nauseous; throw it up; her arm was sore where they gave the vaccination; The initial case was missing the following minimum criteria: no adverse effect. Upon receipt of follow-up information on (21Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable nurse (patient reporting for herself). A 21-year-old female patient received bnt162b2 (also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 19Dec2020 18:00 on the left arm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she got the vaccine, the Covid-19 vaccine, Saturday 19Dec2020 around 6PM. On Sunday 20Dec2020, she went about her day and around mid day, about 5PM she started getting really bad body aches and then after she showered she got really dizzy, states she would try to eat and she would get nauseous and throw it up. She wanted to know how fast the symptoms are showing after vaccination. She went to get a COVID test today as well because she is not sure if this is due to the vaccine or what. She took Ibuprofen 400mg around 10PM last night 20Dec2020 because the body aches are so bad. States she took a shower last night and got really dizzy but that has resolved and has not happened since. On 21Dec2020, she ate some breakfast and at 11AM she got very nauseous and threw up. Initially (in Dec2020), her arm was sore where they gave the vaccination which she was expecting and then it started going all over her body, states it is like menstrual cramps but like all over. The events did not require a visit to Emergency Room and Physician Office. The event dizzy recovered on 20Dec2020. The outcome of her arm was sore where they gave the vaccination was unknown and the rest of the events was not recovered.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Poor quality sleep, Vaccination site pain
Clinical narrative: aching/he is feeling a little achy/ he feels achy; he has not slept well; he is just tired; His arm did hurt for 2 days after; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old male patient started received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730, expiry date: 31Mar2021), via an unspecified route of administration in left arm, on 16Dec2020, at single dose, for COVID-19 immunization. There were no medical history and  concomitant medications. The patient reported he got the COVID Vaccine on 16Dec2020 (Wednesday) and now he is feeling a little achy. He is wondering if that is a side effect. He said it is not a big deal and that maybe he is just tired. He also reported he has not slept well so maybe he could just be tired. Although it could be a side effect. He clarified he did not start feeling achy until 21Dec2020 (today). He reported his arm did hurt after for 2 days. The outcome of the event vaccination site pain was recovered on an unspecified date in Dec2020, pain was not recovered, and the remaining events was unknown.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Hypogeusia, Hyposmia, Nasal congestion
Clinical narrative: Cough; congestion/stuffed nose; runny nose; chills; sore arm; decreased sense of smell; decreased sense of taste; This is a spontaneous report from a contactable physician. A 49-year-old female patient receive first dose of bnt162b2 (BNT162B2), intramuscular on left arm on 17Dec2020 10:15 SINGLE DOSE for COVID-19 immunization. Medical history included Cough variant of asthma, prediabetes. The patient's concomitant medications were not reported. On 18Dec2020 10:00, the patient experienced Cough, congestion, runny nose, chills, sore arm, stuffed nose, decreased sense of smell, decreased sense of taste. No COVID prior vaccination. The patient has been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included nasal swab test: pending on 21Dec2020. The outcome of the events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test, Viral test
Clinical narrative: Cough; congestion/stuffed nose; runny nose; chills; sore arm; decreased sense of smell; decreased sense of taste; This is a spontaneous report from a contactable physician. A 49-year-old female patient receive first dose of bnt162b2 (BNT162B2), intramuscular on left arm on 17Dec2020 10:15 SINGLE DOSE for COVID-19 immunization. Medical history included Cough variant of asthma, prediabetes. The patient's concomitant medications were not reported. On 18Dec2020 10:00, the patient experienced Cough, congestion, runny nose, chills, sore arm, stuffed nose, decreased sense of smell, decreased sense of taste. No COVID prior vaccination. The patient has been tested for COVID-19 post vaccination. The patient underwent lab tests and procedures which included nasal swab test: pending on 21Dec2020. The outcome of the events was recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: broke out in hives on my chest and upper back.; This is a spontaneous report from a contactable other healthcare professional (patient). A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot: EJ1685) intramuscularly on 18Dec2020 10:45 at a single dose for covid-19 immunisation. Medical history included moyamoya disease, asthma and allergies to crustaceans. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.) and azithromycin. The patient previously took prochlorperazine maleate (COMPAZINE) and experienced drug allergy. On 18Dec2020 23:59, the patient reportedly broke out in hives on the chest and upper back. Outcome of the event recovered on an unspecified date on Dec2020.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: 102.5 F fever; Chills; Headache; Dizziness; Body aches; Fatigue; Nausea; This is a spontaneous report from a contactable Other HCP (patient). This 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 12:00 at single dose on left arm for COVID-19 immunization. Medical history was not reported. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX) and levothyroxine, both received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine was administered in 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 hasn't been tested for COVID-19. The patient experienced 102.5 F fever, chills, headache, dizziness, body aches, fatigue, nausea on 19Dec2020 23:00. The outcome of 102.5 F fever, chills, headache, dizziness, body aches, fatigue was recovering, of nausea was unknown. No treatment received for the adverse event. The events were assessed non-serious.   Information about lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: 102.5 F fever; Chills; Headache; Dizziness; Body aches; Fatigue; Nausea; This is a spontaneous report from a contactable Other HCP (patient). This 24-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 12:00 at single dose on left arm for COVID-19 immunization. Medical history was not reported. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX) and levothyroxine, both received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine was administered in 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 hasn't been tested for COVID-19. The patient experienced 102.5 F fever, chills, headache, dizziness, body aches, fatigue, nausea on 19Dec2020 23:00. The outcome of 102.5 F fever, chills, headache, dizziness, body aches, fatigue was recovering, of nausea was unknown. No treatment received for the adverse event. The events were assessed non-serious.   Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: arm pain; Fever; body aches; fatigue; This is a spontaneous report from a contactable other HCP (patient).  This 29-years-old female patient started to receive BNT162B2, on 17Dec2020 09:15 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported. Multi vitamins received in in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Facility that the most recent COVID-19 vaccine was administered is Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever, body aches, fatigue, arm pain on 18Dec2020. The outcome was not recovered. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): negative on 11Dec2020.  The events were assessed non-serious. No treatment received for the adverse event.  Information on the Lot/Batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Fatigue, Flushing
Clinical narrative: Flushing and Dizziness within 10 minutes of administration that resolved after drinking water.; Flushing and Dizziness within 10 minutes of administration that resolved after drinking water.; Injection site tenderness; Tiredness; headaches/headaches were markedly increased; muscle aches; fever to 101.1; Slight chest  discomfort; chest pain/chest pain and headaches were markedly increased; This is a spontaneous report from a contactable nurse. This nurse reported for a 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EK5730) via intramuscular route on 20Dec2020 10:30 at single dose on the right arm for COVID-19 immunization. Medical history included COVID in Apr2020, post COVID syndrome and migraines. No allergies to medications, food, or other products. Concomitant medications included topiramate (TOPAMAX), topiramate (TROKENDI), gabapentin, magnesium, vitamin b complex (VITAMIN B), all received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 20Dec2020 10:30, the patient experienced flushing and dizziness within 10 minutes of administration that resolved after drinking water. Injection site tenderness. Tiredness, headaches, muscle aches, fever to 101.1. Slight chest discomfort (patient had COVID in April 2020. She had all these symptoms with in the acute phase and still have intermittent chest pain/headaches. With the vaccine, the chest pain and headaches were markedly increased on the day after receiving it). Outcome of the events was recovered in Dec2020. No treatment received for the adverse events. The events were assessed non-serious.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Flushing and Dizziness within 10 minutes of administration that resolved after drinking water.; Flushing and Dizziness within 10 minutes of administration that resolved after drinking water.; Injection site tenderness; Tiredness; headaches/headaches were markedly increased; muscle aches; fever to 101.1; Slight chest  discomfort; chest pain/chest pain and headaches were markedly increased; This is a spontaneous report from a contactable nurse. This nurse reported for a 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (Lot number: EK5730) via intramuscular route on 20Dec2020 10:30 at single dose on the right arm for COVID-19 immunization. Medical history included COVID in Apr2020, post COVID syndrome and migraines. No allergies to medications, food, or other products. Concomitant medications included topiramate (TOPAMAX), topiramate (TROKENDI), gabapentin, magnesium, vitamin b complex (VITAMIN B), all received within 2 weeks of vaccination. Facility that the most recent COVID-19 vaccine was administered in Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. On 20Dec2020 10:30, the patient experienced flushing and dizziness within 10 minutes of administration that resolved after drinking water. Injection site tenderness. Tiredness, headaches, muscle aches, fever to 101.1. Slight chest discomfort (patient had COVID in April 2020. She had all these symptoms with in the acute phase and still have intermittent chest pain/headaches. With the vaccine, the chest pain and headaches were markedly increased on the day after receiving it). Outcome of the events was recovered in Dec2020. No treatment received for the adverse events. The events were assessed non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Injection site nodule, Injection site pain
Clinical narrative: sore at site of injection; had a knot there where it was given; This is a spontaneous report from a contactable consumer (patient). This 67-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unknown date in Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and the concomitant medications were not reported.  The patient received vaccine last Wednesday, didn't have any side effects.  It was sore at site of injection. Same day, it had a knot there where it was given.  The outcome was unknown.    Information on the lot/ batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site warmth
Clinical narrative: nodule formed at the injection site; the injection along with localized pain; reddened, warm area remained around the injection site; reddened, warm area remained around the injection site; This is a spontaneous report from a contactable nurse (patient). A 42-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899) intramuscular on right arm on 18Dec2020 17:30 at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant medication included the medications the patient received within 2 weeks of vaccination: Amlodipine, hydochlorathiazide, bupropion hydrochloride (WELLBUTRIN), zolpidem tartrate (AMBIEN). The patient previously took albuterol sulfate and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020, a nodule formed at the injection site about 12 hours after the injection along with localized pain. The nodule started to disappear, but a reddened, warm area remained around the injection site. The reddened area is about the diameter of an egg. It has been about 72 hours since the injection. No treatment was received for the adverse event. Events outcome was not recovered.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Unevaluable event
Clinical narrative: test positive post vaccination; test positive post vaccination; This is a spontaneous report from a contactable Nurse (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the Pfizer Covid-19 vaccine on the 17Dec2020. He would like to how likely is he to test positive post vaccination. He wants to know if the test results would be a false positive post vaccination. He is going to get tested at two different facility. Event outcome was unknown.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product to the development of Drug ineffective and COVID-19 cannot be excluded.  The case will be reassessed if additional information becomes available.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: test positive post vaccination; test positive post vaccination; This is a spontaneous report from a contactable Nurse (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 17Dec2020 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the Pfizer Covid-19 vaccine on the 17Dec2020. He would like to how likely is he to test positive post vaccination. He wants to know if the test results would be a false positive post vaccination. He is going to get tested at two different facility. Event outcome was unknown.; Sender's Comments: Based on the current available information and the consistency with the known safety profile of the suspect product BNT162B2, a possible contributory role of the suspect product to the development of Drug ineffective and COVID-19 cannot be excluded.  The case will be reassessed if additional information becomes available.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, Unevaluable event
Clinical narrative: He took the vaccine on 17Dec2020/he had a test come back positive.; This is a spontaneous report from a contactable nurse (patient).  A 62-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH89899), via an unspecified route of administration on the left deltoid on 17Dec2020 at SINGLE DOSE as COVID-19 immunization.  Medical history as none.  There were no concomitant medications.  He took the vaccine on 17Dec2020. The patient mentioned that he got COVID test twice a week at work where he works (unknown results) and he had a test come back positive on 21Dec2020. However, he has had no symptoms or anything. He stated he read everything before getting the test and nothing he read indicated this would occur. The patient queried if there was no dead virus or anything in the vaccine. He has not contacted his doctor yet about this. The patient was not hospitalized nor admitted to an intensive care unit. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: He took the vaccine on 17Dec2020/he had a test come back positive.; This is a spontaneous report from a contactable nurse (patient).  A 62-year-old male patient received the first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EH89899), via an unspecified route of administration on the left deltoid on 17Dec2020 at SINGLE DOSE as COVID-19 immunization.  Medical history as none.  There were no concomitant medications.  He took the vaccine on 17Dec2020. The patient mentioned that he got COVID test twice a week at work where he works (unknown results) and he had a test come back positive on 21Dec2020. However, he has had no symptoms or anything. He stated he read everything before getting the test and nothing he read indicated this would occur. The patient queried if there was no dead virus or anything in the vaccine. He has not contacted his doctor yet about this. The patient was not hospitalized nor admitted to an intensive care unit. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Heart rate increased, Hyperhidrosis
Clinical narrative: sweating; itching palms; elevated HR; headache that lasted 24 hrs; fatigue; foggy feeling that also lasted 24 hrs; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685) intramuscular on right arm on 19Dec2020 14:45 at single dose for COVID-19 immunization. Medical history included DM type 2, irritable bowel syndrome, restless legs syndrome, insomnia. Other unspecified concomitant medications received in two weeks. The patient previously took thiomersal and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020, within 10 minutes of the reaction she experienced sweating and itching palms with elevated HR. Within 1 hr of the vaccine she had a headache that lasted 24 hrs with fatigue and a foggy feeling that also lasted 24 hrs. No treatment received for events. Events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: sweating; itching palms; elevated HR; headache that lasted 24 hrs; fatigue; foggy feeling that also lasted 24 hrs; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received the first dose of BNT162B2 (lot number: EJ1685) intramuscular on right arm on 19Dec2020 14:45 at single dose for COVID-19 immunization. Medical history included DM type 2, irritable bowel syndrome, restless legs syndrome, insomnia. Other unspecified concomitant medications received in two weeks. The patient previously took thiomersal and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Dec2020, within 10 minutes of the reaction she experienced sweating and itching palms with elevated HR. Within 1 hr of the vaccine she had a headache that lasted 24 hrs with fatigue and a foggy feeling that also lasted 24 hrs. No treatment received for events. Events outcome was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Injection site pain, Myalgia, Pain
Clinical narrative: felt hot; felt achy; Chills; generalized myalgias; high fever/her highest recorded temperature was 102.5; Deltoid soreness; This is a spontaneous report from a contactable Other HCP. This other hcp (patient) reported for herself that the 32-year-old female patient received bnt162b2 (BNT162B2, Solution for injection, Covid-19 Vaccine manufacturer: Pfizer BioNTech), intramuscular into her left deltoid on 17Dec2020 07:30 at single dose for covid-19 immunisation (Prophylaxis). Medical history included  Hypothyroidism, mood and sleep. Concomitant medications included Levothyroxine at 100mcg daily by mouth ongoing for Hypothyroidism started taking at 19 years old, escitalopram oxalate (LEXAPRO) at 10mg once a day by mouth from Dec2020 started it about 2 weeks ago ongoing for mood, zolpidem tartrate (AMBIEN) at 10mg as needed by mouth for sleep and was not taking this at the time. The patient experienced Deltoid soreness from 17Dec2020 to 18Dec2020, Chills from 20Dec2020 to 21Dec2020, generalized myalgias from 20Dec2020 to 21Dec2020, high fever from 20Dec2020 to 21Dec2020. The outcome of the events was recovered. Her vaccination cared is at her house. She received the product at the hospital she works at. The causality of the events Deltoid soreness, Chills, generalized myalgias and high fever was related. Caller is a nurse practitioner that reported that she wanted to report a possible side effect for herself with the Covid-19 vaccine. She said that she herself got vaccinated on Thursday 17Dec2020. She was doing fine except for the deltoid soreness that showed up about 12 hours after receiving the vaccine and lasted for about 12 hours and then it went away.  On Sunday, she had sudden onset of chills, generalized myalgias, and a high fever. Caller said that her highest recorded temperature was 102.5. Her symptoms started at  about 1430 and she said she had no other symptoms aside from what she reported. She said that her chills went away after about 3 hours and then she felt hot, and then she just felt achy and had the generalized myalgias. All were subsided by 0900 this morning. She said that she also had a low grade fever of 99.8 this morning, but it was all gone by 0900. Caller said that she is a emergency room employee and was given the vaccine at the hospital and they was no prescribing physician. Caller said that she has never had a reaction like this to a vaccine before. Vaccination Facility Type was hospital. Vaccine Administered at Military Facility was No. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No AE(s) was require a visit to ER or physician office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. Relevant Tests was None.  Information on the lot/ batch number has been requested.