chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Nausea, Vaccination site pruritus
Clinical narrative: a rash on the vaccine area on the left arm; terrible headache; chills; a rash on the vaccine area on the left arm. It started terribly itching; nausea; I sweat the first night, noticed it when got up to use the restroom; The injection site area was hot; This is a spontaneous report from a contactable Consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2) via an unspecified route of administration in left arm on 26Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 2nd dose on 26Jan2021 at 9am, in the evening, started with terrible headache and chills, then itching started, in between she was having nausea, her arm had a rash on the vaccine area on the left arm. It started terribly itching, she had to scratch, she took a diphenhydramine (BENADRYL), didn't do much. The first side effect she had headache chills nausea, subsided after the second day. They were lower by second day and she still had the nausea that ended on the 4th day. On 02Feb2021 she still had some itching, not as bad but still itches. When she had the chills, when they would stop she would sweat a little, but she didn't feel like got hot, she sweat the first night, noticed it when got up to use the restroom. The rash was really uncomfortable. She tried using cold water in the area and it seemed to relieve some of what she was feeling. The injection site area was hot, it started when the itching started and lasted when it went down, she still had a little bit of the rash, it was a little hotter then the rest of her arm, but not as bad as it was. She asked her doctor if she could take diphenhydramine, he said it could help her if it was an allergic reaction, but it didn't do much for her. The outcome of events a rash on the vaccine area on the left arm, terrible headache, chills was recovering, outcome of event itching was not recovered, outcome of events nausea was recovered, outcome of events sweat, the injection site area was hot was unknown.   Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: a rash on the vaccine area on the left arm; terrible headache; chills; a rash on the vaccine area on the left arm. It started terribly itching; nausea; I sweat the first night, noticed it when got up to use the restroom; The injection site area was hot; This is a spontaneous report from a contactable Consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2) via an unspecified route of administration in left arm on 26Jan2021 09:00 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 2nd dose on 26Jan2021 at 9am, in the evening, started with terrible headache and chills, then itching started, in between she was having nausea, her arm had a rash on the vaccine area on the left arm. It started terribly itching, she had to scratch, she took a diphenhydramine (BENADRYL), didn't do much. The first side effect she had headache chills nausea, subsided after the second day. They were lower by second day and she still had the nausea that ended on the 4th day. On 02Feb2021 she still had some itching, not as bad but still itches. When she had the chills, when they would stop she would sweat a little, but she didn't feel like got hot, she sweat the first night, noticed it when got up to use the restroom. The rash was really uncomfortable. She tried using cold water in the area and it seemed to relieve some of what she was feeling. The injection site area was hot, it started when the itching started and lasted when it went down, she still had a little bit of the rash, it was a little hotter then the rest of her arm, but not as bad as it was. She asked her doctor if she could take diphenhydramine, he said it could help her if it was an allergic reaction, but it didn't do much for her. The outcome of events a rash on the vaccine area on the left arm, terrible headache, chills was recovering, outcome of event itching was not recovered, outcome of events nausea was recovered, outcome of events sweat, the injection site area was hot was unknown.   Information on Lot/Batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive after receiving the vaccine; tested positive after receiving the vaccine; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The nurse reported that the patient was tested positive after receiving the vaccine. The nurse asked if this had been an increasing occurrence. The nurse asked if someone was positive for covid but was unknowing positive was asymptomatic and did take the vaccine, what are the dangers. The nurse asked for information on efficacy if the interval is longer than 21 days, if it is the same efficacy. The outcome of the events was unknown.     Information about batch/lot number has been requested.; Sender's Comments: The causal relationship between BNT162B2 and the events drug ineffective and Covid 19 cannot be excluded as the information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the right arm, on 02Feb2021 at 10:00 (at the age of 42-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma, allergy to animals, allergy to pineapple, and allergy to raw onion. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included levocetirizine dihydrochloride (XYZAL).  The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced allergy. The patient experienced sore arm at injection site on 02Feb2021 at 17:00. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm at injection site was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth swelling
Clinical narrative: Slight feeling of swelling within the mouth; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in the right arm, on 01Feb2021 at 11:00 (at the age of 78-years-old) at a single dose for COVID-19 immunisation. Medical history included high blood pressure, indolent follicular lymphoma (not under treatment, but being watched), and allergy to cat dander. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) on 11Jan2021 (at the age of 78-years-old), in the right arm, for COVID-19 immunisation and erythromycin estolate (ILOSONE) as an antibiotic and experienced allergy. The patient experienced slight feeling of swelling within the mouth on 01Feb2021 at 11:30. The event was reported as non-serious. It was reported that the patient felt the swelling in the mouth after the 15 minute wait. The patient did not receive treatment for the event. The clinical outcome of slight feeling of swelling within the mouth was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Drug ineffective, Headache, Hyperhidrosis
Clinical narrative: Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation.  Medical history included diabetes mellitus.  The patient's concomitant medications were not reported.  The patient experienced positive for covid and negative for the antibodies on 02Feb2021, chills, headache, severe sweats, nausea, runny nose, fever, vomiting on an unspecified date. The outcome of events was unknown.    Information about lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Rhinorrhoea, SARS-CoV-2 antibody test negative, SARS-CoV-2 test
Clinical narrative: Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation.  Medical history included diabetes mellitus.  The patient's concomitant medications were not reported.  The patient experienced positive for covid and negative for the antibodies on 02Feb2021, chills, headache, severe sweats, nausea, runny nose, fever, vomiting on an unspecified date. The outcome of events was unknown.    Information about lot/batch number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills; Headache; Severe sweats; Nausea; Runny nose; Fever; Vomiting; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; It was positive for Covid and negative for the antibodies the Nurse told me; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 at single dose for covid-19 immunisation.  Medical history included diabetes mellitus.  The patient's concomitant medications were not reported.  The patient experienced positive for covid and negative for the antibodies on 02Feb2021, chills, headache, severe sweats, nausea, runny nose, fever, vomiting on an unspecified date. The outcome of events was unknown.    Information about lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer (patient). This 66-year-old female consumer received her 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose via an unknown route on 26Jan2021 for Covid-19 immunization. Medical history included eczema and lowered the immune system. Concomitant drug included dupilumab (DUPIXENT) for eczema for 1.5 years (as of 02Feb2021) which she gives herself a shot in the stomach every 2 weeks.  She stated dupilumab affects the immune system and lowers the immune system.  She was previously unaware of this and took the first dose of the Pfizer Covid 19 vaccine and only had a headache as a side effect.   She took the dupixent either the day before, day of, or the day after the first dose of the vaccine, so the 25Jan2021, 26Jan2021, 27Jan2021, she had it on the 26Jan2021, and wondering if this impact the efficacy of the first dose. She was scheduled to take dupilumab on 09Feb2021 and second dose of the vaccine on 16Feb2021.  Patient had no kind of bad interactions, she had a headache which was her only symptom.  Outcome of the event was unknown.     Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: had covid; had covid; This is a spontaneous report from a contactable other health professional (patient's wife). A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose as Covid vaccine. The patient's medical history and concomitant medications were not reported. The patient had covid on 14Jan2021 and was due for his second vaccine today. He was advised not to get it because he got Remdesiver. The reporter wanted to know where he can get the second dose. The outcome of the events was unknown.  Information about the lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching (itching affected her upper body, face, shoulders and torso).; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team.  A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), via an unspecified route of administration at arm left on 13Jan2021 at 12:00 (at the age of 30 years) at single dose for COVID-19 immunization.  Medical history included pregnancy from an unknown date to an unknown date, dual venous thrombosis post pregnancy (from two years and four months ago) and blood thinner from an unknown date and ongoing.  Concomitant medication included warfarin oral at 7.5 mg once a day from an unknown date and ongoing for blood thinner.  The patient experienced itching (itching affected her upper body, face, shoulders and torso). The patient outcome of the event was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Nasal congestion, Rhinorrhoea, Suspected COVID-19
Clinical narrative: suspected COVID-19 with symptoms; suspected COVID-19 with symptoms; congestion; running nose; This is a spontaneous report from a contactable consumer reporting for his/her mother.  A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 19Jan2021 (when 70 years old) at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, congestion, running nose, chills, cough, covid 19 symptoms on 02Feb2021 with outcome of unknown. The reporter wanted to know what kind of the covid test should she get done and if the patient could take the second dose on 08Feb2021 or should she wait.  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Myalgia, Pain in extremity
Clinical narrative: Dizziness; Headache; Chills; Muscle Aches; Pain in right arm; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3249), via an unspecified route of administration on 02Feb2021 at 12:45 PM (at the age of 20-years-old) at single dose in right arm for COVID-19 immunisation. The patient was vaccinated at Public Health Clinic/Administration facility. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no known allergies. Medical history includes insomnia and migraines. Concomitant medications included eszopiclone (LUNESTA), melatonin, ibuprofen, bismuth subsalicylate (PEPTOBISMOL). On 02Feb2021 at 15:00 the patient experienced dizziness, headache, chills, muscle aches, pain in right arm. No treatment was given for the events. The events were resolving. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Erythema, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister.   A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation.  Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported.  In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Skin disorder, Throat tightness
Clinical narrative: her hands swelling and tightness; her hands swelling and tightness; underside of the forearms had a lacey honeycomb pattern of red with white blotches; her cheeks were bright red; top of her hands to her wrist and lower arms were very red; felt light headed/faint and dizzy; tightness in her chest; the tightness that she felt the day before was in her lungs or throat; This is a spontaneous report from a contactable Physician reporting for his/her sister.   A 59-year-old female patient received bnt162b2 (BNT162B2) via an unspecified route of administration at single dose in Jan2021 (12 days before reporting) for COVID-19 immunisation.  Medical history included Hashimoto's autoimmune disease, enlarged thyroid, goitre. The patient's concomitant medications were not reported.  In Jan2021, as soon as she got the injection, the patient felt both her hands swelling and tightness, underside of the forearms had a lacey honeycomb pattern of red with white blotches, top of her hands to her wrist and lower arms were very red, her cheeks were bright red, felt light headed/faint and dizzy, tightness in her chest and thought it was her heart. She was monitored for an hour but was told it probably wasn't an allergic reaction. Symptoms began to fade at that time. Next day she felt good and thought the tightness that she felt the day before was in her lungs or throat. The outcome of events was recovering. The events were reported as non serious. Reporter was referred to HCP or vaccination provider to determine if this was a severe allergic reaction and if she should receive the second dose of the vaccine.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: seasonal allergies; This is a spontaneous report from a contactable consumer reporting for herself. This female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Feb2021, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had her 1st vaccine and had seasonal allergies since an unknown date. The patient wanted to know if it was ok to take a Benadryl. Event outcome was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for 2 patients. This is 2nd of 2 reports.   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation. Medical history included disabilities which patient will be miserable from an unknown date and unknown if ongoing (patient's mother clarified patient had disabilities before taking the Pfizer Covid vaccine). The patient's concomitant medications were not reported.  It was reported that patient had the first Pfizer vaccine couple of weeks ago (unspecified date) and had no side effect except only had a sore arm. It was also reported that patient will have the second one next Wednesday (unspecified date). It was further reported that the next day (unspecified date), there was no soreness. Patient's mother stated that she read that it is not safe to take Ibuprofen or Tylenol because it will decrease effectiveness. Wanted to know if this is true. Outcome of the event was recovered.  Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107036 same drug/event/reporter, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. This consumer reported similar events for 2 patients. This is the 1st of 2 reports. A 66-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had her first vaccine a couple of weeks ago and had no side effects except only had a sore arm on an unspecified date and the next day there was no soreness. She heard that the side effects with the second one will be worst and that she read that it was not safe to take Ibuprofen or Tylenol because it will decrease effectiveness. She wanted to know if this was true as they will have the second one next Wednesday. Patient stated that she knows that the headaches and fevers were harder with second one. Outcome of event was recovered on unspecified date.   Information of lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107024 same reporter, drug and event; different patient.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cough, Disease recurrence, Dyspnoea
Clinical narrative: Shortness of Breath; Asthma; Cough; he is experiencing asthma, shortness of breath and a cough/he has had these symptoms previously but it was cleared up and then he had the shot and it hit him again last night; This is a spontaneous report from a contactable consumer (patient). A 76-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262, expiry date: May2021), via an unspecified route of administration on the left arm, on 28Jan2021 08:10, at single dose, for COVID-19 immunization, at the hospital. Medical history included cholesterol, blood pressure, coronary artery bypass in 2008, asthma, shortness of breath and cough which the patient already had before receiving the vaccine. Ongoing concomitant medications included rosuvastatin calcium (CRESTOR) for cholesterol and losartan for blood pressure. The patient did not receive any prior vaccinations within four weeks. On 01Feb2021, the patient experienced asthma, shortness of breath and cough. The patient stated that he already had these symptoms before receiving the vaccine and clarified he has had these symptoms previously, but it was cleared up and then he had the shot and it hit him again. He added that last night, on 01Feb2021, he had to sit in a chair all night due to the coughing. He did take some albuterol in his nebulizer and he was better on 02Feb2021. He was asking if he can take prednisone between doses of the Pfizer COVID 19 vaccine. His second dose was scheduled on 19Feb2021. The events did not require visit to a physician or emergency room. The outcome of the events was recovering.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Headache
Clinical narrative: slight headache; achy muscles in back behind ribs; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the first dose of BNT162B2 ( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL1283), on the left arm, intramuscularly on 01Feb2021 at 16:40 at single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient was taking an unspecified health pills. The patient receives a flu shot every year and has never had a problem. No vaccines were administered on the same day and no prior vaccinations within 4 weeks. The patient reported that he received the vaccine on 01Feb2021 and on the same night experienced a slight headache which recovered the next day on 02Feb2021. The patient also reported that he is achy in his back, states it is the muscles in his back behind his ribs that is achy on 01Feb2021. The achiness is mild right now, seems to be fading, states it has recovered about 50%. He has no fever. patient added that he had previously seen somewhere online that pre medicating for side effects prior to receiving the vaccine can reduce the effectiveness of the vaccine. He did not take anything prior to getting the vaccine. He heard from his daughter the second dose of the vaccine is a whopper. How soon after the vaccine can something like acetaminophen or ibuprofen be taken? The events did not require physician office or emergency room visit. The patient denies receiving treatment for the events. The patient was vaccinated in a hospital. The outcome of the event slight headache was recovered on 02Feb2021 while for the event muscles in his back behind his ribs that is achy was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Fever; myalgia; chills/rigor; severe headache; fatigue; dizziness; This is a spontaneous report from a Non-contactable Physician (patient). A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3248), via an unspecified route of administration on 29Jan2021 (at the age of 32-years) at single dose for COVID-19 immunisation. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. The patient received no concomitant medications. On 29Jan2021 the patient experienced fever, myalgia, chills, rigor, severe headache, fatigue and dizziness. Treatment was received for the events with Ibuprofen and Tylenol. The events had resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever; myalgia; chills/rigor; severe headache; fatigue; dizziness; This is a spontaneous report from a Non-contactable Physician (patient). A 32-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL3248), via an unspecified route of administration on 29Jan2021 (at the age of 32-years) at single dose for COVID-19 immunisation. No other vaccine was given within 4 weeks prior to the COVID vaccine. Medical history includes seasonal allergies. The patient received no concomitant medications. On 29Jan2021 the patient experienced fever, myalgia, chills, rigor, severe headache, fatigue and dizziness. Treatment was received for the events with Ibuprofen and Tylenol. The events had resolved. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I received the first dose on 27Jan and got diagnosed yesterday with Covid; His son tested positive for COVID-19 on Monday and he tested positive on Tuesday, 02 Feb 2021; Loss of smell; This is a spontaneous report from a contactable lawyer. A 55-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot no: EL8982, expiration date: May2021), intramuscular on the left arm on 27Jan2021 at a single dose for COVID-19 immunisation. The patient medical history was none. Prior Vaccinations (within 4 weeks) was none. Concomitant medications were not reported. The patient previously took penicillin and aspirin [acetylsalicylic acid] and experienced Allergies. The patient explained he was calling for some advice. He received the COVID-19 vaccine on 27Jan2021, time the vaccination was given was 10:30, maybe 10:45am. His son tested positive for COVID-19 on monday and he tested positive on tuesday, 02Feb2021. Patient was eligible to receive the monoclonal antibody therapy. He wanted to know since he had already one vaccine and questioned will this create any conflict with receiving the second vaccine. Patient also questioned will there be any danger with receiving the monoclonal antibody therapy since he already had the first COVID-19 vaccine. Reporter stated he worked with healthcare professional, but he was not one. He worked as an attorney and works in the hospital on occasion. Patient wanted to know what the best protocol was to protect him, will the vaccination he took protect him to some degree and will it interfere with him having monoclonal antibody therapy tomorrow morning questioned. He wanted to contact Pfizer first to see if there was anything he needed to know or if there was some sort of bad synergy with the injection. Description of complaint was patient stated he had a COVID-19 Rapid test done yesterday (02Feb2021) which was positive. He was certain he was positive. He loss his sense of smell the night before (01Feb2021). Patient stated he had COVID-19 PCR test too, but he had not got the results back yet. The outcome of the events was unknown.  No further information was provided or obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm soreness; Minor fatigue; This is a spontaneous report from a contactable consumer (reporting for herself).   A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL3247), via an unspecified route of administration single dose arm left (at the age of 30) on 02Feb2021 for covid-19 immunisation. No other vaccine was received in four weeks.  The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm soreness on 02Feb2021, minor fatigue on 02Feb2021. No treatment received. The events outcome was recovered.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Malaise, Vaccination site pain
Clinical narrative: sore arm at injection site; tiredness; feeling unwell; loss of appetite; This is a spontaneous report from a contactable other healthcare professional (patient). A 61-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3247 and expiration date: unknown), via an unspecified route of administration on 02Feb2021 at 11:30 at a single dose for COVID-19 immunization. Medical history included likely COVID in Apr2020 based on a video call with his physician. Concomitant medications included celecoxib (CELEBREX), gabapentin (NEURONTIN), zinc (ZINC), aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]), ascorbic acid (VIT C), colecalciferol (VIT D3), and cyanocobalamin (VIT B12). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced sore arm at injection site, tiredness, feeling unwell and loss of appetite on 02Feb2021 at 18:00. 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 events had not resolved.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Lethargy, Paraesthesia
Clinical narrative: Numb and tingly face; Numb and tingly face; Fatigued; lethargic; This is a spontaneous report from a contactable consumer (patient).   A 51-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EN 5318), via an unspecified route of administration left arm single dose on 02Feb2021 14:30 (at the age of 51) for covid-19 immunisation. The patient medical history included covid 19 with mild symptoms on 29Dec2020. The patient's concomitant medications were not reported. No other vaccine was received in four weeks.  The patient experienced numb and tingly face, both on 02Feb2021 18:00, fatigued and lethargic on 02Feb2021 8-36 hrs after vaccination. The events outcome was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Restless legs syndrome
Clinical narrative: restless leg; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age (age: 71; unit: unknown) started to received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed a restless leg on unspecified date. The patient elevated it on some pillows and it subsided within a few hours. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected. Information regarding Lot/Batch No. cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Myalgia
Clinical narrative: nausea; vomiting; chills; joint and muscle pain; joint and muscle pain; headache; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 26-year-old, on an unspecified date, at SINGLE DOSE for COVID-19 immunization.  The patient medical history was not reported.  There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date, single dose for COVID-19 immunization. On an unspecified date, following administration of second COVID-19 vaccine, the patient experienced nausea and vomiting, chills, joint and muscle pain, headache, and fatigue. Onset of symptoms occurred approximately 5 hours after administration of medication and became progressively worse over the next 20-24 hours following administration of dose. Symptoms began to resolve around 26 hours post administration of medication. Outcome of the events was recovering at the time of the report.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: nausea; vomiting; chills; joint and muscle pain; joint and muscle pain; headache; fatigue; This is a spontaneous report from a contactable consumer (patient).  A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration, at the age of 26-year-old, on an unspecified date, at SINGLE DOSE for COVID-19 immunization.  The patient medical history was not reported.  There were no concomitant medications. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on an unspecified date, single dose for COVID-19 immunization. On an unspecified date, following administration of second COVID-19 vaccine, the patient experienced nausea and vomiting, chills, joint and muscle pain, headache, and fatigue. Onset of symptoms occurred approximately 5 hours after administration of medication and became progressively worse over the next 20-24 hours following administration of dose. Symptoms began to resolve around 26 hours post administration of medication. Outcome of the events was recovering at the time of the report.  No follow-up attempts are possible. Information about batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: the injection site was getting a little swollen; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect via a contactable consumer. The patient of unspecified age and gender received first dose BNT162B2 , via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Patient got first shot this morning on 02Feb2021. Right now, the injection site was getting a little swollen. Patient took a tramadol as treatment. Outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Rash macular
Clinical narrative: swelling in her hands; the underside of her forearms had a honey comb pattern, almost like a lattice, of redness, all over both forearms; her cheeks and face were a brighter, lighter red, but her hands were a darker red; This is a spontaneous report from a contactable healthcare professional (patient's brother) via a Pfizer-sponsored program, . A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown, via an unspecified route of administration on unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had a sort of immediate reaction. After the patient got the vaccine, immediately she started to feel her hand swell, and then both her hands were swollen, and she was unable to bend her fingers. They waited the standard 15 to 20 minutes after receiving the medication, and when the patient turned her arms over, the underside of her forearms had a honey comb pattern, almost like a lattice, of redness, all over both forearms. The top of the patients hands were very red, really red, and her cheeks and face were a brighter, lighter red, but her hands were a darker red. Reporter got the attention of someone, who turned out to be a Pharmacist, and the Pharmacist checked patient out to make sure she was okay. Patient was responsive, so in that aspect she was okay. The reporter was wondering about this, and wondering about if this is a known side effect of the product. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Headache
Clinical narrative: weakness; dizziness; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was experiencing weakness, dizziness and headache after receiving her first dose of COVID-19 Vaccine. The outcome of the event was not recovered at the time of report.  Information on lot/batch number has been requested.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Deltoid soreness; This is a spontaneous report from a contactable pharmacist (patient himself). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in left arm on 04Feb2021 10:00 AM at single dose for COVID-19 immunization in facility type of other. The patient's medical history included COVID-19 (the patient was diagnosed with COVID-19 prior to vaccination). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not been tested for COVID-19 since the vaccination. On 05Feb2021 05:00 AM, the patient experienced deltoid soreness. The event was considered as non-serious by the pharmacist. No treatment was received for the adverse event. The outcome of the event was recovering.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Malaise, Movement disorder, Nasopharyngitis, Ocular discomfort
Clinical narrative: She did not feel good; Eyes were blurry/ she felt pressure in them; Bad head cold; she couldn't bend over; Aches all over; Back pain; Eyes were blurry/ she felt pressure in them; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1687), via an unspecified route of administration on the left arm, at the age of 80 years, on 29Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included cataract, arthritis and seasonal allergy from an unknown date and unknown if ongoing. There were no concomitant medications.The patient stated that a couple of times she did not feel good and got very sore and could not bend over to pick things up and her eyes blurred up. After she got the shot, she gradually noticed aches all over and back pain. It was stated it hurt really bad in her back on the right side on the bone and she used the heating pad on it. Then the next day she was stiffer than ever and she couldn't bend over. She added her eyes were blurry, they felt like she had a cold in them, and she felt pressure in them. She added she always has this problem with her eyes but it got a little worse after the shot. All of that has gotten better now. It was stated they are telling her the second dose was worse and she was unsure about getting the second dose. Also mentioned they were saying you can wait a little longer and she was unsure if maybe she should wait. She wanted to ask about getting the second dose. She added she was scheduled to receive the second dose of the vaccine on 19Feb2021. The patient said it was right sided back pain. She said she applied heading pad and took ibuprofen. She also experienced "eye pressure" and "blurry eyes", "how you feel when you have a bad head cold". She said, "I have allergies-seasonal, so this isn't new to me".  Therapeutic measures were taken as a result of back pain (back pain). The outcome of the events did not feel good, eyes were blurry/ she felt pressure in them and  bad head cold was unknown while other events were recovered on 31Jan2021.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vision blurred
Clinical narrative: She did not feel good; Eyes were blurry/ she felt pressure in them; Bad head cold; she couldn't bend over; Aches all over; Back pain; Eyes were blurry/ she felt pressure in them; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1687), via an unspecified route of administration on the left arm, at the age of 80 years, on 29Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. Medical history included cataract, arthritis and seasonal allergy from an unknown date and unknown if ongoing. There were no concomitant medications.The patient stated that a couple of times she did not feel good and got very sore and could not bend over to pick things up and her eyes blurred up. After she got the shot, she gradually noticed aches all over and back pain. It was stated it hurt really bad in her back on the right side on the bone and she used the heating pad on it. Then the next day she was stiffer than ever and she couldn't bend over. She added her eyes were blurry, they felt like she had a cold in them, and she felt pressure in them. She added she always has this problem with her eyes but it got a little worse after the shot. All of that has gotten better now. It was stated they are telling her the second dose was worse and she was unsure about getting the second dose. Also mentioned they were saying you can wait a little longer and she was unsure if maybe she should wait. She wanted to ask about getting the second dose. She added she was scheduled to receive the second dose of the vaccine on 19Feb2021. The patient said it was right sided back pain. She said she applied heading pad and took ibuprofen. She also experienced "eye pressure" and "blurry eyes", "how you feel when you have a bad head cold". She said, "I have allergies-seasonal, so this isn't new to me".  Therapeutic measures were taken as a result of back pain (back pain). The outcome of the events did not feel good, eyes were blurry/ she felt pressure in them and  bad head cold was unknown while other events were recovered on 31Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: exhaustion; achiness; headache; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 29Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got vaccinated on Friday (29Jan2021). The patient experienced exhaustion, achiness, and headache on an unspecified date. Outcome of the events was unknown.  Information on the lot/batch number has been requested.