chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lip swelling at site of previously administered HA filler; This is a spontaneous report from a contactable Physician. A 25-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number and Expiration date was not reported), via intramuscular on 10Feb2021 16:30 as single dose for covid-19 immunisation. Medical history included previously administered HA filler from 26May2020 to an unknown date (had Restylane Silk injected in lips 26May2020). There were no concomitant medications. Historical vaccine included first dose of BNT162B2 via Intramuscular on Jan2021 for covid-19 immunisation. Other vaccine in four weeks and other medications in two weeks reported as none. Patient did not have covid prior vaccination. Patient did not test for covid post vaccination. The patient experienced lip swelling at site of previously administered HA filler on 11Feb2021 04:00 PM. Patient did not receive treatment for the adverse event. The outcome of the event was recovering.  Information about lot/batch number has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Swelling face
Clinical narrative: Swollen face; red rash on face and torso front and back; This is a spontaneous report from a contactable consumer (patient). A 63-year-old non pregnant female patient received second dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9263), via an unspecified route of administration, administered in left arm on 04Feb2021 09:00 as single dose for covid-19 immunisation. Medical history included Post hemopetic stem cell transplant in 2016 and allergic to Penicillin. Concomitant medication included ascorbic acid, ergocalciferol, nicotinamide, retinol, riboflavin, thiamine hydrochloride (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]). Historical Vaccine included first dose of BNT162B2 (Batch/Lot Number: EL3246) in left arm on 14Jan2021 09:00. The patient experienced swollen face and red rash on face and torso front and back on 10Feb2021 12:00. Therapeutic measures were taken as a result of the events with antihistamine said by occupational health nurse. Outcome of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever; Pain in bones; Headache; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9262), via an unspecified route of administration, administered in arm right on 11Feb2021 09:00 AM (at the age of 70-years-old) at a single dose for covid-19 immunisation. Medical history included HBP (High blood pressure). The patient had no known allergies. The patient had unspecified other concomitant medications in two weeks. The patient previously took first dose of BNT162B2 (lot number: EL1284) via an unspecified route of administration on 29Jan2021 at 09:00 AM (at the age of 70-years-old) in left arm at a single dose for covid-19 immunisation. The patient stated that she experienced fever, pain in bones headache, nausea and vomiting on 11Feb2021 09:00 PM. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse events. The outcome of the events was recovering.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: shingles; This is a spontaneous report from a contactable pharmacist reporting for herself. This 36-year-old female patient (non-pregnant) received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL 9263) on 24Jan2021 at 00:15, in left arm, for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included hypothyroidism. Allergies to medications, food, or other products: no. Prior to vaccination she was not diagnosed with COVID-19. Concomitant medication included levothyroxine sodium. The patient underwent a nasal swab on 01Feb2021 which was negative. On 09Feb2021 the patient right temple started hurting on and she had severe pain radiating down to my jaw. She was diagnosed with shingles on 13Feb2021. The event required Doctor or other healthcare professional office/clinic visit and treatment with tizanidine, amoxicillin, ibuprofen, then valaciclovir (VALTREX) and gabapentin. The event had not yet resolved. Pfizer COVID 19 vaccine: Herpes zoster (shingles): related.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient's son) reported that a 78-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration on 05Feb2021 as a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter was asking for his father who received the 1st dose of the vaccine on 05Feb2021. He was scheduled to take the 2nd dose on 26Feb2021 but has developed shingles on an unspecified date. He was asking whether if it would be safe if he can still take the vaccine on the scheduled date. The consumer mentioned that his father did not experience any side effects of the vaccine and that it went great. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: burning feeling, red streak just above, it was blistering/diagnosed it as shingles; This is a spontaneous report from a contactable nurse (patient).  A female patient of an unspecified age (age: 76; unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was asking whether she is okay to get her 2nd dose with a shingles outbreak on her back. She received the 1st dose of the Pfizer covid vaccine on 04Feb2021. On Saturday or Sunday (Feb2021), she had a burning feeling and red streak just above the flank. By Monday, it was blistering and on Tuesday, even more. Her doctor diagnosed it as shingles and prescribed medication for it. She only has a day or 2 of medication left. Her 2nd dose of the covid vaccine is due on 25Feb2021. Outcome of the event was unknown.  Information about lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Stress
Clinical narrative: shingles; seven blisters; stress; This is a spontaneous report from a contactable consumer. A 103-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient had her first dose in January, second dose was scheduled on 19Feb2021. The patient did experience "mild' case of shingles following first dose and maintains seven blisters. The reporter asked if the patient is to receive second dose. It was further reported that "HCP indicated stress related" (pending clarification). The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Computerised tomogram, Culture, Dyspnoea, Herpes zoster
Clinical narrative: almost felt like shingles; difficulty breathing; lesser sense of taste; itchy; burning; rash; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date was unknown), via an unspecified route of administration, administered in the left arm on 04Feb2021 at 14:30 as a single dose for COVID-19 immunisation.  Medical history included hospitalized for pneumonia in Sep2020 and treated with "mega-doses" of prednisone, antibiotics (unspecified) and oxygen wherein he recovered, came off oxygen for 1.5 months, but then after Christmas 2020, went back on the oxygen, from 07Jan2021 through 12Jan2021 the patient was hospitalized again and CT scans and cultures were performed on his lungs which returned a diagnosis of MAC complex.  The patient is awaiting treatment for this after lung cultures mature. The patient also has chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing diagnosed 20 years ago, congestive heart failure (CHF), stomach issues, rash also on a portion of his face and eye sensitivity all from an unknown date and unknown if ongoing. The patient also had a heart attack and a triple bypass in May2020 and ongoing diverticulitis that has been going on forever since an unknown date. The patient is taking "a lot of other meds" (unspecified) for heart, lungs and digestive things. The patient previously got a regular flu shot (unspecified) and got feverish, chills, achy and his arm hurts. After the patient received the first dose of the vaccine on 04Feb2021, that day and night he had no symptoms. On 05Feb2021, the patient developed an itchy, burning, rash everywhere but legs and feet that "almost felt like shingles", which escalated over 5 days, tapered off a little on Wednesday, Thursday it was receding, by Friday 12Feb2021 it was basically gone.  The patient went to a dermatologist office and they did not know about the rash. He called his pulmonologist and they told him not to get the second dose due to his underlying conditions. He was in the hospital back in Jan2021 and they found something on his lung and he is now working with infectious disease people, they told him to see an allergist, he cancelled his appointment for the second dose. The patient wants to know if this rash is being reported and was hoping that maybe someone would have seen or heard of something like this. The patient also reported that he has a lessened sense of taste that started on an unspecified date, around Tuesday, and he has had some difficulty breathing during all of this as well, unsure if it is related to the vaccine or his underlying condition. The outcome of difficulty breathing and lesser sense of taste was not recovered. The outcome of the event almost felt like shingles was unknown while the outcome of the other events was recovering.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypogeusia, Pruritus, Rash
Clinical narrative: almost felt like shingles; difficulty breathing; lesser sense of taste; itchy; burning; rash; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date was unknown), via an unspecified route of administration, administered in the left arm on 04Feb2021 at 14:30 as a single dose for COVID-19 immunisation.  Medical history included hospitalized for pneumonia in Sep2020 and treated with "mega-doses" of prednisone, antibiotics (unspecified) and oxygen wherein he recovered, came off oxygen for 1.5 months, but then after Christmas 2020, went back on the oxygen, from 07Jan2021 through 12Jan2021 the patient was hospitalized again and CT scans and cultures were performed on his lungs which returned a diagnosis of MAC complex.  The patient is awaiting treatment for this after lung cultures mature. The patient also has chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing diagnosed 20 years ago, congestive heart failure (CHF), stomach issues, rash also on a portion of his face and eye sensitivity all from an unknown date and unknown if ongoing. The patient also had a heart attack and a triple bypass in May2020 and ongoing diverticulitis that has been going on forever since an unknown date. The patient is taking "a lot of other meds" (unspecified) for heart, lungs and digestive things. The patient previously got a regular flu shot (unspecified) and got feverish, chills, achy and his arm hurts. After the patient received the first dose of the vaccine on 04Feb2021, that day and night he had no symptoms. On 05Feb2021, the patient developed an itchy, burning, rash everywhere but legs and feet that "almost felt like shingles", which escalated over 5 days, tapered off a little on Wednesday, Thursday it was receding, by Friday 12Feb2021 it was basically gone.  The patient went to a dermatologist office and they did not know about the rash. He called his pulmonologist and they told him not to get the second dose due to his underlying conditions. He was in the hospital back in Jan2021 and they found something on his lung and he is now working with infectious disease people, they told him to see an allergist, he cancelled his appointment for the second dose. The patient wants to know if this rash is being reported and was hoping that maybe someone would have seen or heard of something like this. The patient also reported that he has a lessened sense of taste that started on an unspecified date, around Tuesday, and he has had some difficulty breathing during all of this as well, unsure if it is related to the vaccine or his underlying condition. The outcome of difficulty breathing and lesser sense of taste was not recovered. The outcome of the event almost felt like shingles was unknown while the outcome of the other events was recovering.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Pain of skin, Rash, Skin burning sensation
Clinical narrative: almost felt like shingles; difficulty breathing; lesser sense of taste; itchy; burning; rash; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date was unknown), via an unspecified route of administration, administered in the left arm on 04Feb2021 at 14:30 as a single dose for COVID-19 immunisation.  Medical history included hospitalized for pneumonia in Sep2020 and treated with "mega-doses" of prednisone, antibiotics (unspecified) and oxygen wherein he recovered, came off oxygen for 1.5 months, but then after Christmas 2020, went back on the oxygen, from 07Jan2021 through 12Jan2021 the patient was hospitalized again and CT scans and cultures were performed on his lungs which returned a diagnosis of MAC complex.  The patient is awaiting treatment for this after lung cultures mature. The patient also has chronic obstructive pulmonary disease (COPD) from an unknown date and unknown if ongoing diagnosed 20 years ago, congestive heart failure (CHF), stomach issues, rash also on a portion of his face and eye sensitivity all from an unknown date and unknown if ongoing. The patient also had a heart attack and a triple bypass in May2020 and ongoing diverticulitis that has been going on forever since an unknown date. The patient is taking "a lot of other meds" (unspecified) for heart, lungs and digestive things. The patient previously got a regular flu shot (unspecified) and got feverish, chills, achy and his arm hurts. After the patient received the first dose of the vaccine on 04Feb2021, that day and night he had no symptoms. On 05Feb2021, the patient developed an itchy, burning, rash everywhere but legs and feet that "almost felt like shingles", which escalated over 5 days, tapered off a little on Wednesday, Thursday it was receding, by Friday 12Feb2021 it was basically gone.  The patient went to a dermatologist office and they did not know about the rash. He called his pulmonologist and they told him not to get the second dose due to his underlying conditions. He was in the hospital back in Jan2021 and they found something on his lung and he is now working with infectious disease people, they told him to see an allergist, he cancelled his appointment for the second dose. The patient wants to know if this rash is being reported and was hoping that maybe someone would have seen or heard of something like this. The patient also reported that he has a lessened sense of taste that started on an unspecified date, around Tuesday, and he has had some difficulty breathing during all of this as well, unsure if it is related to the vaccine or his underlying condition. The outcome of difficulty breathing and lesser sense of taste was not recovered. The outcome of the event almost felt like shingles was unknown while the outcome of the other events was recovering.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Headache, Memory impairment, Peripheral swelling, Pruritus
Clinical narrative: Arm is really swollen, is red and blotchy; Arm is really swollen, is red and blotchy; Arm is really swollen, is red and blotchy; some slight headaches not really bad but they seem to be getting a little bit stronger; Few little things going on like a little of forgetness; Itchiness; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up in this morning on 06Feb2021 patient's arm was really swollen, was red and blotchy. On an unknown date in Feb2021, the patient had some slight headaches not really bad but they seem to be getting a little bit stronger, then what they were. Patient had been taking Tylenol and just a few little things going on like a little of forgetness and Patient didn't want to go to the emergency room unnecessary, will this just will. They told patient would have some side effects but they said if got like such as itchy skin or shortness of breath, the patient was Not short of breath and the swelling of the face and tongue to go to the emergency room. So with the itchiness on an unknown date in Feb2021 what patient have been doing, patient took a cotton ball and put some alcohol on it and rub it and it seems to like kind of ease off. The outcome of the event headache was not recovered and the outcome of the other events was unknown.  Follow-up attempts are completed, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Arm is really swollen, is red and blotchy; Arm is really swollen, is red and blotchy; Arm is really swollen, is red and blotchy; some slight headaches not really bad but they seem to be getting a little bit stronger; Few little things going on like a little of forgetness; Itchiness; This is a spontaneous report from a contactable consumer (Patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 03Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient woke up in this morning on 06Feb2021 patient's arm was really swollen, was red and blotchy. On an unknown date in Feb2021, the patient had some slight headaches not really bad but they seem to be getting a little bit stronger, then what they were. Patient had been taking Tylenol and just a few little things going on like a little of forgetness and Patient didn't want to go to the emergency room unnecessary, will this just will. They told patient would have some side effects but they said if got like such as itchy skin or shortness of breath, the patient was Not short of breath and the swelling of the face and tongue to go to the emergency room. So with the itchiness on an unknown date in Feb2021 what patient have been doing, patient took a cotton ball and put some alcohol on it and rub it and it seems to like kind of ease off. The outcome of the event headache was not recovered and the outcome of the other events was unknown.  Follow-up attempts are completed, information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 05Feb2021 01:00 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had been vaccinated a shot of Pfizer yesterday like around noon time in (name) and around 1 o' clock in the morning, when he/she was back from office he/she started getting some diarrhea on 05Feb2021. So, the patient wanted to know that was this the side effect or not. The patient got diarrhea and it started about thirteen hours later and it was there whole night. The outcome of the event was not recovered.  Information about the lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Migraine; nausea; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 23-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 05Feb2021 13:30 (at the age of 23-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient was not pregnant at the time of vaccination. The patient had known allergies with penicillin. Concomitant medication included methylphenidate hydrochloride (CONCERTA) taken for an unspecified indication, start and stop date were not reported. The patient experienced migraine and nausea both on 06Feb2021 09:30 with outcome of recovering. The patient did not received treatment for the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain
Clinical narrative: Bilateral ear pain/ache; This is a spontaneous report from a non-contactable nurse (patient). A 39-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. The patient experienced bilateral ear pain/ache on 04Feb2021 20:00 with outcome of unknown. No treatment received for the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Off label use, Vertigo positional
Clinical narrative: Extreme vertigo 14 days after 2nd dose of vaccine/ MD visit diagnosed her with benign paroxysmal positional vertigo; First dos of BNT162B2 on 28Dec2020, second dose on 11Jan2021; First dos of BNT162B2 on 28Dec2020, second dose on 11Jan2021; This is a spontaneous report from a non-contactable pharmacist. A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EL3246), via intramuscular on 11Jan2021 at single dose for COVID-19 immunisation at the age of 44-year-old. The patient medical history and concomitant medications were not reported. It was unknown if there were other vaccine in four weeks. The patient had no COVID prior vaccination. It was unknown if COVID tested post vaccination. The patient previously received the first dose of BNT162B2 (lot number: EK5730) for COVID-19 immunization on 28Dec2020 at the age of 44-year-old. On 25Jan2021, patient started experiencing extreme vertigo 14 days after 2nd dose of vaccine. There were no new onset diseases diagnosed or new medications started within this period. She went to emergency room (ER) and medical doctor (MD) visit for care. MD visit diagnosed her with benign paroxysmal positional vertigo. She was still having episodes that were treated with meclizine. The outcome of the event benign paroxysmal positional vertigo was recovered with sequelae.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Nausea
Clinical narrative: Headache; nausea; red face; This is a spontaneous report from a non-contactable consumer (patient) for herself. A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL9265) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history included known allergies: shellfish. Concomitant medications were not reported. No other vaccine in four weeks. The patient was not pregnant. The patient experienced headache, nausea, red face; all on an unspecified date. No treatment received for events. The outcome of events was resolved on an unspecified date. No COVID prior vaccination and no COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Hyperhidrosis, Nasal congestion
Clinical narrative: Chills; sweats; fever 100.5; headache; stuffy nose; body aches; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246) intramuscularly administered in left arm on 05Feb2021 12:00 pm (24-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history included COVID-19. No known allergies. The patient was not pregnant. Facility type Vaccine was at hospital. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced chills, sweats, fever 100.5, headache, stuffy nose, body aches; with start date on 06Feb2021 03:00 am. No treatment received for events. The outcome of events was unknown. No COVID tested post vaccination.  Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Chills; sweats; fever 100.5; headache; stuffy nose; body aches; This is a spontaneous report from a contactable nurse (patient) reported for herself. A 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3246) intramuscularly administered in left arm on 05Feb2021 12:00 pm (24-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history included COVID-19. No known allergies. The patient was not pregnant. Facility type Vaccine was at hospital. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced chills, sweats, fever 100.5, headache, stuffy nose, body aches; with start date on 06Feb2021 03:00 am. No treatment received for events. The outcome of events was unknown. No COVID tested post vaccination.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (pending clarification). A patient of unspecified age and gender received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first dose of the Pfizer COVID-19 vaccine on 08Feb2021. On 13Feb2021, the patient developed shingles and wanted to know if it was ok to take antivirals. The outcome of the event was unknown. The case was assessed as non-serious.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia
Clinical narrative: Severe Headache; Chills; General body aches; This is a spontaneous report from a contactable consumer (the patient). A 27-years-old non-pregnant female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on left arm on 01Feb2021 07:30 AM as a single dose for covid-19 immunization. The Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on left arm on 12Jan2021 as a single dose for covid-19 immunization. The patient medical history included amoxicillin-drug hypersensitivity(allergy) and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.The patient has not received other vaccine in four weeks and no other medications received within 2 weeks of vaccination. On 02Feb2021, the patient experienced severe headache, chills, general body aches. The patient did not receive any treatment. Outcome of the event was recovered in Apr2021.  Information about Lot/Batch number has been requested.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fell in the bathroom and wet himself and he could not get up; This is a spontaneous report from a contactable consumer (patient's wife, reported for her husband). An 83-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (batch/lot number was not reported) via an unspecified route of administration on 05Feb2021 (83-year-old at vaccination) at a single dose for COVID-19 immunization. Medical history and concomitant medications reported as none. The patient got up this morning on 06Feb2021 and fell in the bathroom and wet himself and he could not get up on 06Feb2021. The caller helped him get up and he was back in bed, he was sleeping but he took a nausea tablet (treatment). The caller did not know what she was supposed to do because she did not think something like this would happen to him. No treatment received for event. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body aches and pains all over; This is a spontaneous report from a non-contactable consumer(patient). A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 05Feb2021 08:30 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included hypotension, known allergies: latex and penicillin. The patient was not pregnant. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 22Jan2021 08:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. There was no other vaccine in four weeks. Other medications in two weeks reported as birth control. With second shot, the patient experienced body aches and pains all over starting around 10 pm day of vaccine. Adverse event start date was 05Feb2021 10:00 PM. No treatment received for the events. The outcome of the events was recovering. The patient had no covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: Headache starting about an hour after vaccine and lasting about 36 hours; Very drowsy; This is a spontaneous report received from a contactable consumer (Patient). A 38-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number not reported) via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:30 as Single Dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies. The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. Concomitant medication included vitamin D (received within two weeks). Patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID-19 Prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 05Feb2021, the patient experienced headache which started about an hour after taking vaccine and lasting about 36 hours, also she was very drowsy as well all-night Friday and Saturday morning. The events headache and drowsy were recovered on an unspecified date on Feb2021 without taking any medications.   Information about lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headaches; body aches.; This is a spontaneous report received from a non-contactable consumer (patient). A 24-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number el3248), via an unspecified route of administration on arm left on 05Feb2021 08:00 AM as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (lot number= EL3248; administration time= 03:45 PM; vaccine location= Right arm) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced headaches and body aches on 06Feb2021. The patient did not receive any treatment for the events. The events were assessed as non-serious by the reporter. The patient was not Covid-positive prior vaccination, and the test was not performed post vaccination. The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: About 36 hours after vaccination I got a red itchy raised rash on left underside of wrist and left rear shoulder.  Lasted a few hours and then went away.; About 36 hours after vaccination I got a red itchy raised rash on left underside of wrist and left rear shoulder.  Lasted a few hours and then went away.; About 36 hours after vaccination I got a red itchy raised rash on left underside of wrist and left rear shoulder.  Lasted a few hours and then went away.; This is a spontaneous report from a non-contactable consumer. A 68-year-old female received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3248) administered at right arm on an unspecified date Feb2021 09:30 AM as single dose for COVID-19 immunization. The patient was not pregnant. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL3248) administered at left arm on an unspecified date Jan2021 at 08:30 AM as single dose for COVID-19 immunization. The patient medical history included high Blood Pressure, Arthritis, Skin Cancer, Lung Nodule and Liver Cyst. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was allergies to morphine and levofloxacin. Concomitant medications included Lisinopril (LISINOPRIL), Tramadol (TRAMADOL), Gabapentin (GABAPENTIN) and Levothyroxine (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]). On an unspecified date Feb2021 at 09:00 PM, the patient had experienced about 36 hours after vaccination patient got a red itchy raised rash on left underside of wrist and left rear shoulder. Lasted a few hours and then went away. No treatment was given. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date, the outcome of the events was recovered.  No follow up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia
Clinical narrative: I had severe headache for two days and fever one day; I had severe headache for two days and fever one day; This is a spontaneous report from a contactable other hcp. A 49-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3246), via unspecified route of administration on 27JAN2021 at 16:45 as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Concomitant medication included celecoxib (CELEXA [CELECOXIB]).On 29Jan2021 at 17:00 the patient experienced severe headache for two days and fever one day. The events were considered as non-serious. The outcome of the events was Recovered with lasting effects.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Depressed mood, Headache, Pyrexia, Vaccination site pain
Clinical narrative: headache; very sore at the injection site and under my arm (armpit and into my breast area days after); low grade fever (99.8); general feeling down; This is a spontaneous report from a non-contactable consumer (other HCP). A 35-year-old non-pregnant female patient received second dose of BNT162B2 (Pfizer Vaccine; Lot number: EM9809) via intramuscular route in the left arm on 03Feb2021 at 16:45 as a single dose for covid-19 immunization. Historical Vaccine included first dose of BNT162B2 (Pfizer Vaccine; Lot number: EK4176) via intramuscular route in left arm on 13Jan2021 at 16:30 as a single dose for covid-19 immunization. No known allergies were reported. Patient has not taken any concomitant medications in last two weeks. Patient has not taken any other vaccine in last four weeks. On 04Feb2021 (the following day), patient experienced headache, very sore at the injection site and under my arm (armpit and into my breast area days after), low grade fever (99.8) and general feeling down. The patient underwent lab test which included low grade fever: 99.8 on 04Feb2021. The clinical outcome of the events was recovered on an unknown date.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Musculoskeletal stiffness
Clinical narrative: Stiff neck; She might have shingles; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age (reported 75: units unknown) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BTN162B2 on an unspecified date, for COVID-19 immunization. On 14Feb2021, the patient experienced stiff neck, so much that she thought she might have shingles. She wanted to know if there is any interaction with the covid vaccine and antiviral/ shingles vaccine. She went to a doctor and wanted to know if it turns out to be shingles and if she can take the anti-virial medication. The outcome of the events was unknown.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Lymphadenopathy
Clinical narrative: Elevated heart rate; Lightheadedness; Lymphadenopathy; This is a spontaneous report from a contactable consumer. A 56-years old male consumer (patient) reported for himself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EN6201) via an unspecified route of administration on 11Feb2021 at 15:15 in left arm as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. As per the report no other vaccine was administered in four weeks. Covid tested prior vaccination or post vaccination was reported as no. On 11Feb2021 at 15:30, the patient experienced elevated heart rate, lightheadedness and lymphadenopathy. The patient underwent lab tests and procedures on 11Feb2021 which included heart rate as elevated. The outcome of all events was unknown.  No follow-up attempts are possible. No further information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Salivary hypersecretion
Clinical narrative: Headache; excessive saliva; burning sensation in the throat.; This is a spontaneous report from a non-contactable other HCP (patient). A 39-year-old non-pregnant female patient reported for a herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: El8982) via an unspecified route of administration on her left Arm on 04Feb2021 (at the age of 39-years-old), at single dose for COVID-19 immunization. The patient's historical vaccine included received first dose of BNT162B2 (Comirnaty, formulation: Solution for injection; lot number=Ed0142) on 14JAN2021 at 12:00 pm via intramuscular route on left arm for COVID-19 immunization. The patient's medical history was not reported. It was reported that covid prior vaccination and covid tested post vaccination as No. Also, allergies was reported as no. The patient's concomitant medications included sertraline hydrochloride (Zoloft), bupropion hydrochloride (Wellbutrin), levothyroxine sodium (Levothyroxin), pregabalin (Lyrica) and spironolactone; all start and stop date were not provided and used for unknown indication. On 04Feb2021 at 02: 30 PM, the patient developed headache, excessive saliva and burning sensation in the throat for which she did not received any treatment. The outcome of all the events was recovered in Feb2021.  No follow-up attempts were possible. No further information was expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient). A 45-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262), via an unspecified route of administration in right arm on 06Feb2021 09:30 as single dose for covid-19 immunisation. Medical history included asthma and allergies, known allergies were Latex and bees. Concomitant medications included fluticasone propionate, salmeterol xinafoate (ADVAIR), reported as advir 500/50; bupropion hydrochloride (WELLBUTRIN); levocetirizine dihydrochloride (XYZAL) and BP medication, all concomitants were taken for an unspecified indication, start and stop date were not reported. Historical Vaccine included first dose of BNT162B2 via an unspecified route of administration, administered in right arm on 23Jan2021 09:30 (Batch/Lot Number: EK9231) for covid-19 immunisation. On 07Feb2021 01:00, the patient experienced major headache, body ache, fever, nausea and swollen lymph nodes. No other vaccine in four weeks.
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), via an unspecified route of administration on 01Feb2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On Thursday, 11Feb2021, he developed shingles. He is scheduled for his second shot on 26Feb2021. He planned to discuss further with his doctor. The outcome of the event was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature abnormal, Chills, Headache
Clinical narrative: intense headache; intensely achey in all of my joints; unable to regulate my body temperature; chilled; This is a spontaneous report from a contactable other health professional (patient). A 67-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration in right arm on 25Jan2021 at a single dose for covid-19 immunisation. Medical history included hypothyroidism and reported as, I never was diagnosed with Covid but think I had Feb2020. Known allergies were none. Concomitant medications included thyroid NP (THYROID), st john's wort, vitamin b complex (VITAMIN B), zinc and ergocalciferol (VIT D). Historical vaccine included first dose of BNT162B2 (Batch/Lot Number: ELO140), in right arm on 04Jan2021 11:30 for COVID-19 immunisation and experienced slight headache. On 25Jan2021 12:00, the patient experienced intense headache, intensely achey in all of my joints, unable to regulate my body temperature and chilled. The report received as, the second dose I started getting a very intense headache within 2 hours of the injection. I then got intensely achey in all of my joints and was unable to regulate my body temperature. I was chilled for the duration which lasted about 2 1/2 days. I took Acetaminophen, 2 tablets every 6 hours. I also took the homeopathic remedies Ledum 30C twice daily for the injection and Thuja 200 twice daily to offset adverse reactions, as per my physician. Therapeutic measures were taken as a result of the events. Outcome of the events was recovered on an unknown date in 2021.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable consumer (patient). An 89-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3248), via an unspecified route of administration, by injection once to the left deltoid on 21Jan2021 at the age of 89-years-old as single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced shingles on 07Feb2021. The patient reported that she had the first dose of the PFIZER-BIONTECH COVID-19 VACCINE last 21Jan2021 and she had shingles. The doctor advised that she could have the 2nd dose on 22Feb2021 instead of 11Feb2021, which was 3 weeks later after the 1st dose. The patient wanted to know if she will take her doctor's advice to have the 2nd dose later than 3 weeks since she was now getting better. The patient wanted to know how long after the shingles go away can she get the second vaccine. The patient reported that she had shingles after having 4 shingles vaccine shots. The first was when it first came out, the second she thinks has been about 1.5 years ago. She would have to check records on that. She hasn't been out of the country. The patient reported that she thinks her shingles was better. She was on an antiviral drug valaciclovir (VALTREX). When reading the vaccine paperwork, the patient stated she has a hard time reading. The shingles was on her face and her eye was affected. Having had all the vaccines, this took her by surprise. There was no investigation assessment. The outcome of the event was recovering.