chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she tested positive/stated she was asymptomatic; she tested positive/stated she was asymptomatic; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (age 60, unit: unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration on 21Jan2021 (Batch/Lot Number: EL3249) at single dose, second dose via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EL9264) at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  The patient stated that she received both doses of the vaccine. She received the second dose yesterday (11Feb2021) and had to take a Covid test on the same day for an upcoming medical procedure and she tested positive. She asked if the vaccine can affect that test and have caused a false negative. She stated she was asymptomatic. She also asked if the vaccine would still work if someone was positive with Covid when they get the vaccine. The outcome of the event was unknown.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and asymptomatic COVID-19 cannot be ruled out.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination failure, X-ray
Clinical narrative: One week after the second dose, the patient tested positive for covid and since she is at a very high risk; One week after the second dose, the patient tested positive for covid and since she is at a very high risk; This is a spontaneous report from a contactable Physician. A 94-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiry date: unknown), 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. The patient previously took first dose of BNT162B2 on 28Jan2021 at single dose for covid-19 immunisation. It was reported that, patient who received the second dose of the Pfizer covid vaccine (first dose was given on 28Jan). One week after the second dose, the patient tested positive for covid and since she is at a very high risk and came back with abnormal xray results, she was given "bamlanomab". Her question is if the monoclonal antibody may potentially neutralize the vaccine and would this necessitate a repeat of the second dose. The patient underwent lab tests and procedures which included covid: patient tested positive for covid and x-ray: abnormal x-ray results on an unspecified date. The events were considered as serious. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Nausea, Productive cough
Clinical narrative: he has a congested cough that has increased recently; nausea; fatigue/ still very tired; He had chills; fever/ mild temperature; This is a spontaneous report from two contactable consumers (patient's wife and patient himself). An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EK4176, expiry date Jul2022) via an unspecified route of administration in arm right, at the age of 83-year-old, on 26Jan2021 12:00PM, SINGLE DOSE for covid-19 immunisation.  Medical history included ongoing chronic obstructive pulmonary disease (for 15 years or more), ongoing spinal stenosis in his lower back for about 15 years or more, and rotator cuff syndrome (left arm). Concomitant medication included ongoing sertraline hydrochloride (ZOLOFT). The patient did not receive other vaccines within 4 weeks. The patient experienced nausea on 28Jan2021 with outcome of not recovered, fever/ mild temperature on Jan2021 with outcome of not recovered, fatigue/ still very tired on 28Jan2021 with outcome of not recovered, he had chills on 28Jan2021 with outcome of not recovered, he has a congested cough that has increased recently on Feb2021 with outcome of not recovered. The patient went to his eye doctor for an eye exam, and he was not real comfortable because he was semi-nauseous. The patient had experienced fatigue, tiredness, and nausea since receiving his first COVID-19 Vaccine dose. The patient reported he also had chills. The patient had an increase in a congested cough recently. The patient continues to feel fatigued, tired, and nauseated. The patient felt like he should have gone to the Emergency Room, or seen his doctor when he experienced the side effects after the vaccine, but he didn't go. The patient has been taking cough medicine. The patient has COPD  and takes the cough medicine at night before he goes to bed. The patient clarified that he started taking the cough medicine because he had an increase in a congested cough recently. The patient clarified he has a sticky, yellowish phlegm that he coughs up. The patient said recently the phlegm changed to a reddish-brown color. The patient said his phlegm will go back and forth from the yellowish color to a dark brown color. The patient said he started the cough medicine about a week or so ago. The patient said it was a 4 ounce bottle of cough medicine. The patient said he takes a 20ml dose at night, so he doesn't start hacking while he sleeps. The patient just finished the 4 ounce bottle of cough medicine last night. The patient takes over-the-counter Tussin DM Max cough medicine. The patient is scheduled for his second COVID-19 Vaccine on 15Feb2021.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: he has a congested cough that has increased recently; nausea; fatigue/ still very tired; He had chills; fever/ mild temperature; This is a spontaneous report from two contactable consumers (patient's wife and patient himself). An 83-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot Number: EK4176, expiry date Jul2022) via an unspecified route of administration in arm right, at the age of 83-year-old, on 26Jan2021 12:00PM, SINGLE DOSE for covid-19 immunisation.  Medical history included ongoing chronic obstructive pulmonary disease (for 15 years or more), ongoing spinal stenosis in his lower back for about 15 years or more, and rotator cuff syndrome (left arm). Concomitant medication included ongoing sertraline hydrochloride (ZOLOFT). The patient did not receive other vaccines within 4 weeks. The patient experienced nausea on 28Jan2021 with outcome of not recovered, fever/ mild temperature on Jan2021 with outcome of not recovered, fatigue/ still very tired on 28Jan2021 with outcome of not recovered, he had chills on 28Jan2021 with outcome of not recovered, he has a congested cough that has increased recently on Feb2021 with outcome of not recovered. The patient went to his eye doctor for an eye exam, and he was not real comfortable because he was semi-nauseous. The patient had experienced fatigue, tiredness, and nausea since receiving his first COVID-19 Vaccine dose. The patient reported he also had chills. The patient had an increase in a congested cough recently. The patient continues to feel fatigued, tired, and nauseated. The patient felt like he should have gone to the Emergency Room, or seen his doctor when he experienced the side effects after the vaccine, but he didn't go. The patient has been taking cough medicine. The patient has COPD  and takes the cough medicine at night before he goes to bed. The patient clarified that he started taking the cough medicine because he had an increase in a congested cough recently. The patient clarified he has a sticky, yellowish phlegm that he coughs up. The patient said recently the phlegm changed to a reddish-brown color. The patient said his phlegm will go back and forth from the yellowish color to a dark brown color. The patient said he started the cough medicine about a week or so ago. The patient said it was a 4 ounce bottle of cough medicine. The patient said he takes a 20ml dose at night, so he doesn't start hacking while he sleeps. The patient just finished the 4 ounce bottle of cough medicine last night. The patient takes over-the-counter Tussin DM Max cough medicine. The patient is scheduled for his second COVID-19 Vaccine on 15Feb2021.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: lightheaded and  dizzy; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 09Feb2021 13:20 (Batch/Lot number was not reported) at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE, first dose on an unspecified date for COVID-19 immunization. The patient experienced lightheaded and dizzy on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Feeling cold, Headache, Hyperhidrosis
Clinical narrative: Headache; Fever; wakes up in a sweat; cant get warm; no appetite; chills; This is a spontaneous report from Support. A contactable consumer (daughter) reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Feb2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced headache, fever, wakes up in a sweat,chills and cant get, warm, no appetite, all on an unspecified date. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Fever; wakes up in a sweat; cant get warm; no appetite; chills; This is a spontaneous report from Support. A contactable consumer (daughter) reported a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Feb2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced headache, fever, wakes up in a sweat,chills and cant get, warm, no appetite, all on an unspecified date. The outcome of the events was unknown.  Information about Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: a strain of blood came out of her arm; This is a spontaneous report from a Support. A contactable consumer reported that a female patient (reporter's wife) of an unspecified age received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date not reported), via an unspecified route of administration on the arm at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that after the injection of the Covid vaccine a strain of blood came out of her arm, about 6 inches. They put a bandaid on and the bleeding stopped, but the reporter wants to know if any of the vaccine came out and if that would be a problem. The outcome of the event was recovered.   Information about Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from Support. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 11Feb2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced severe headache on 12Feb2021 and wanted to know if he can take Tylenol. The outcome of the event was unknown.  Information of Lot/ Batch number have been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache has gotten worse; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A contactable consumer reported that a female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunisation. Medical history included ongoing headache. Concomitant medications were not reported. The patient reported that her headache has gotten worse on 12Feb2021. The patient took Zomig but wanted to take something else for the pain. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive with symptoms quarantined until Feb18; tested positive with symptoms quarantined until Feb18; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 14Jan2021 as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was vaccinated with the first dose on 14Jan2021 and was unable to get the second dose on 04Feb2021, since he tested positive with slight fever and was quarantined until 18Feb2021. The recommendation for him was to have the second dose. The outcome of the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: body chills; This is a spontaneous report from a contactable consumer.  A 41-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in the left arm on 09Feb2021 at 41-years-old at a single dose for COVID-19 immunization; administered in a nursing home (workplace).  The patient medical history was not reported.  There were no concomitant medications. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) for COVID-19 immunization on 19Jan2021.  On 10Feb2021, the patient experienced body chills (non-serious); with no treatment received.  The clinical outcome of the event was not recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Fatigued; Arm sore; Irritable; This is a spontaneous report from a non-contactable Other Health Professional (the patient).  A non-pregnant 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3249), via an unspecified route of administration, in the left arm on 09Feb2021 at 11:30 AM (at the age of 57 years) as a single dose for COVID-19 immunization. Medical history included covid-19, prior to vaccination. The patient did not have any known allergies to medications, food, or other products. Concomitant medication was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Feb2021, the patient experienced fatigued, arm sore, irritable. Therapeutic measures were taken as a result of fatigued, arm sore, irritable, which included 2 Tylenol. The clinical outcome of the events fatigued, arm sore, irritable was  recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: her knuckles are puffy; Hand swelling; This is a spontaneous report from a contactable consumer. This 94-year-old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number: EM9809/expiration date: unknown),  via an unspecified route of administration on 03Feb2021 10:20 at single dose (at age of 94 years old) on right arm for covid-19 immunisation at a hospital.  Medical history included hard of hearing for a while and wears hearing aids; she has trouble with her hands (her hands were falling asleep); she has vertigo and she had a stroke and heart attack three years ago, and heart disorder, all from an unknown date and unknown if ongoing. The patient had no prior vaccination within four weeks of COVID-19 vaccine. Concomitant medication included isosorbide 30mg; take one half daily by mouth  for heart and metoprolol 25mg; take one half daily by mouth  for heart and unknown thyroid medication.  The patient experienced right hand swelling on 07Feb2021 with outcome of not recovered , her knuckles are puffy on an unspecified date with outcome of unknown.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropod bite, Blood test, Contusion, Herpes zoster, Pruritus
Clinical narrative: itching around his waist; spider bite; the spot on his waist looked like shingles; spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle; spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle; This is a spontaneous report from a contactable consumer. This consumer reported events for two doses. This is the first of two doses.  A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular, administered in the left arm, on 16Jan2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. The patient had no medical history and no concomitant medication. The patient had "no problem" with his first COVID-19 shot.  A week after his first COVID-19 vaccine dose, he had itching around his waist. He thought he may have had a spider bite, because he had been working around an area that had hatched black widow spider eggs. While he was at an appointment with his urologist, his urologist said the spot on his waist looked like shingles. He had 1 spot on his waist. The spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle. He was putting on cream on the spot on his waist and has gone away slowly. His blood work was "OK, and there was nothing negative". The patient was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194671 Same patient, same drug with different vaccine dose, different AE
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: itching around his waist; spider bite; the spot on his waist looked like shingles; spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle; spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle; This is a spontaneous report from a contactable consumer. This consumer reported events for two doses. This is the first of two doses.  A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), intramuscular, administered in the left arm, on 16Jan2021 at a single dose (at the age of 66-years-old) for COVID-19 immunisation. The patient had no medical history and no concomitant medication. The patient had "no problem" with his first COVID-19 shot.  A week after his first COVID-19 vaccine dose, he had itching around his waist. He thought he may have had a spider bite, because he had been working around an area that had hatched black widow spider eggs. While he was at an appointment with his urologist, his urologist said the spot on his waist looked like shingles. He had 1 spot on his waist. The spot was a circle that turned black, and had a lot of dark spots, like bruises around the black circle. He was putting on cream on the spot on his waist and has gone away slowly. His blood work was "OK, and there was nothing negative". The patient was recovering from the events.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021194671 Same patient, same drug with different vaccine dose, different AE
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyskinesia, Headache, Pain in extremity
Clinical narrative: Chills; Involuntary jerking; Chest pounding; left arm was pulsating; chest and arm are now sore; chest and arm are now sore; Headache; This is a spontaneous report from a contactable consumer (reporting for herself). An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269, expiration date: unknown), via an unspecified route of administration, administered in right arm on 11Feb2021 at 09:56 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (lot number: EL1283, expiration date: unknown) on 21Jan2021 for COVID-19 immunization. On 11Feb2021, the patient stated getting a little headache and went to bed. On 12Feb2021, the patient got chills, stated that she started involuntary jerking that she could not control, her chest was pounding and her left arm was pulsating, going in and out. The patient also stated that her chest and arm were sore and it was pounding so hard. The patient was ready to go to the emergency room at 1:30 AM but did not. The patient was encouraged to reach out to her healthcare provider. The outcome of the event chills, involuntary jerking was recovered on 12Feb2021, chest pounding, left arm was pulsating was not recovered and unknown for the other events.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Sensory disturbance
Clinical narrative: Chills; Involuntary jerking; Chest pounding; left arm was pulsating; chest and arm are now sore; chest and arm are now sore; Headache; This is a spontaneous report from a contactable consumer (reporting for herself). An 81-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9269, expiration date: unknown), via an unspecified route of administration, administered in right arm on 11Feb2021 at 09:56 as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took the first dose of bnt162b2 (lot number: EL1283, expiration date: unknown) on 21Jan2021 for COVID-19 immunization. On 11Feb2021, the patient stated getting a little headache and went to bed. On 12Feb2021, the patient got chills, stated that she started involuntary jerking that she could not control, her chest was pounding and her left arm was pulsating, going in and out. The patient also stated that her chest and arm were sore and it was pounding so hard. The patient was ready to go to the emergency room at 1:30 AM but did not. The patient was encouraged to reach out to her healthcare provider. The outcome of the event chills, involuntary jerking was recovered on 12Feb2021, chest pounding, left arm was pulsating was not recovered and unknown for the other events.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got sick with it; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration, administered in the right arm on 09Feb2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced got sick with it (minor). The outcome of the event was not recovered per report "it is still lasting".  Information about lot/batch has been requested.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles (shooting and sharp pain in back and chest/ ash on his chest back on rt side and under his armpit, inflamed and bubble-like); This is a spontaneous report from a contactable consumer. This 78-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot number: EN5318/exp. date May2021), intramuscular on 04Feb2021 at 07:15AM at single dose on left arm (at age of 78 years old) for covid-19 immunisation at a hospital.  Medical history included was none.  There were no concomitant medications.  It was reported that Patient received 1st dose of BNT162B2 on Thursday, 04Feb2021. Sunday night, he started experiencing shooting and sharp pain in back and chest (on 07Feb2021). On 09Feb2021, as he was getting ready for bed, he found a rash on his chest and back on the right side and under his armpit. It was inflamed and bubble-like. He went to the doctor office this morning (10Feb2021), took his shirt off and the doctor immediately said "you got shingles". The patient was told the COVID-19 vaccine opened the door for the shingles virus to come out. He stated that the doctor put in a prescription for Valacyclovir, dose is unknown and has to take it for a week. Patient has not had prior vaccination within 4 weeks of COVID-19 vaccine.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Urinary tract infection
Clinical narrative: Urinary tract infection; Arm bothered her with first shot, it was just very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 21Jan2021 at single dose as the patient didn't want to get Corona and die. Medical history included compromised immune system, asthma which was diagnosed in the late 80's or early 90's, fibromyalgia from 2000 and ongoing, and being sensitive to Bandaids. Concomitant medication was reported as none. The patient received the first shot 3 weeks ago on 21Jan2021. She mentioned that she was fine and the only thing that bothered her was her arm, but it was fine, like she knew she had a shot. Her arm bothered her with the first shot, it was just very sore on 21Jan2021 and lasted about maybe 24 hours. The patient also experienced urinary tract infection last week (Feb2021) and took CIPRO for 10 days which she was still on. She told her doctor she would get the second shot and said that it was not a problem. The outcome of the event pain in arm was recovered on 22Jan2021 and unknown for urinary tract infection.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Diarrhoea, Eating disorder, Headache, Illness
Clinical narrative: Urinary tract infection; Arm bothered her with first shot, it was just very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 21Jan2021 at single dose as the patient didn't want to get Corona and die. Medical history included compromised immune system, asthma which was diagnosed in the late 80's or early 90's, fibromyalgia from 2000 and ongoing, and being sensitive to Bandaids. Concomitant medication was reported as none. The patient received the first shot 3 weeks ago on 21Jan2021. She mentioned that she was fine and the only thing that bothered her was her arm, but it was fine, like she knew she had a shot. Her arm bothered her with the first shot, it was just very sore on 21Jan2021 and lasted about maybe 24 hours. The patient also experienced urinary tract infection last week (Feb2021) and took CIPRO for 10 days which she was still on. She told her doctor she would get the second shot and said that it was not a problem. The outcome of the event pain in arm was recovered on 22Jan2021 and unknown for urinary tract infection.
Age: 70.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pruritus, Pyrexia, Retching
Clinical narrative: Urinary tract infection; Arm bothered her with first shot, it was just very sore; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 21Jan2021 at single dose as the patient didn't want to get Corona and die. Medical history included compromised immune system, asthma which was diagnosed in the late 80's or early 90's, fibromyalgia from 2000 and ongoing, and being sensitive to Bandaids. Concomitant medication was reported as none. The patient received the first shot 3 weeks ago on 21Jan2021. She mentioned that she was fine and the only thing that bothered her was her arm, but it was fine, like she knew she had a shot. Her arm bothered her with the first shot, it was just very sore on 21Jan2021 and lasted about maybe 24 hours. The patient also experienced urinary tract infection last week (Feb2021) and took CIPRO for 10 days which she was still on. She told her doctor she would get the second shot and said that it was not a problem. The outcome of the event pain in arm was recovered on 22Jan2021 and unknown for urinary tract infection.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gastrooesophageal reflux disease
Clinical narrative: Chills; acid reflux; This is a spontaneous report from a contactable consumer. A 79-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL8982, via an unspecified route of administration, administered in left arm on 05Feb2021 as single dose for COVID-19 immunisation. The patient had no medical history. There were no concomitant medications. Historical vaccine included first dose of BNT162B2 on 14Jan2021 (lot number: EK9231) for COVID-19 immunization. The patient mentioned that she had to go to the doctor with acid reflux on 06Feb2021. She was taking some medication for the acid reflux and it was getting better. On 12Feb2021, the patient was having some chills. The patient was feeling a little bit better because she took a Tylenol. The outcome of the events was recovering.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test, Laboratory test, Rash
Clinical narrative: Rash all over her body her back and front; some pain in her stomach; This is a spontaneous report from a contactable consumer (patient's husband). A 77-year-old female patient received her second dose of bnt162b2 (BNT162B2 reported as Pfizer COVID-19 Vaccine; lot number: EL9269; expiration date: unknown) at 77-year-old vaccination age via an unspecified route of administration on 07Feb2021 at a single dose for covid-19 immunisation. Medical history included prediabetes and slight blood pressure or something (blood pressure abnormal). Concomitant medication included hydrochlorothiazide and unspecified medication (reported as she takes all kind of medications), all on an unspecified dates and indication. The patient received her first dose of bnt162b2 (BNT162B2; unknown lot number and expiration date) at unknown vaccination age via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The reporter inquired for his wife because her body now. They had the second shot on 07Feb2021 (Sunday) and he wonder how many days it takes after the shot to have side effects. She has rash all over her body her back and front on Feb2021 so he wonders if the shot could cause that. They had the vaccine given to them in a hospital. The reporter mentioned that she just a blood test (unknown results) on the 8th Monday (08Feb2021). She went to the ER (emergency room) in the same hospital. They did the whole work/lab work (unknown results) because she had some pain in her stomach on Feb2021. The outcome of the events was unknown.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Hyperaesthesia, Hypoaesthesia, Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: Appears to be peripheral and sensory neuropathy.; Appears to be peripheral and sensory neuropathy.; Woke up in middle of night with numbness and tingling and discomfort in both feet; Woke up in middle of night with numbness and tingling and discomfort in both feet; Woke up in middle of night with numbness and tingling and discomfort in both feet; touch sensitivity; This is a spontaneous report from a  contactable  nurse.    A 77-years-old patient of an unspecified gender  received the first dose of  bnt162b2 (BNT162B2; Lot # EL9266), via an unspecified route of administration in the left arm on 18Feb2021 08:00 at single dose for covid-19 immunisation .  Medical history included atrial fibrillation , supraventricular tachycardia,  gastrooesophageal reflux disease  , ocular myasthenia , arthritis (2 joint eplacements) , hiatus hernia  , glucose tolerance impaired.  Concomitant medication included apixaban (ELIQUIS), flecainide (FLECAINIDE), metoprolol tartrate (METOPROLOL TARTRATE), atorvastatin (LIPITOR [ATORVASTATIN]), estradiol (ESTRADIOL).  The patient previously took cortisone and experienced rash, zocor and experienced myalgia, erythromycin and experienced vomiting, augmentin  and experienced vomiting.  The patient  stated that woke up in middle of night with numbness and tingling and discomfort in both feet. Progressing (hands,legs,back) better in day but wake up at night. No diagnosis yet. Appears to be peripheral and sensory neuropathy. Hearing sensitivity, touch sensitivity. The events onset is 19Feb2021 01:00 the outcome is not recovered. The event peripheral neuropathy is an always serious event.  Further information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of peripheral and sensory neuropathy and other events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including nerve conduction tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral sensory neuropathy
Clinical narrative: Appears to be peripheral and sensory neuropathy.; Appears to be peripheral and sensory neuropathy.; Woke up in middle of night with numbness and tingling and discomfort in both feet; Woke up in middle of night with numbness and tingling and discomfort in both feet; Woke up in middle of night with numbness and tingling and discomfort in both feet; touch sensitivity; This is a spontaneous report from a  contactable  nurse.    A 77-years-old patient of an unspecified gender  received the first dose of  bnt162b2 (BNT162B2; Lot # EL9266), via an unspecified route of administration in the left arm on 18Feb2021 08:00 at single dose for covid-19 immunisation .  Medical history included atrial fibrillation , supraventricular tachycardia,  gastrooesophageal reflux disease  , ocular myasthenia , arthritis (2 joint eplacements) , hiatus hernia  , glucose tolerance impaired.  Concomitant medication included apixaban (ELIQUIS), flecainide (FLECAINIDE), metoprolol tartrate (METOPROLOL TARTRATE), atorvastatin (LIPITOR [ATORVASTATIN]), estradiol (ESTRADIOL).  The patient previously took cortisone and experienced rash, zocor and experienced myalgia, erythromycin and experienced vomiting, augmentin  and experienced vomiting.  The patient  stated that woke up in middle of night with numbness and tingling and discomfort in both feet. Progressing (hands,legs,back) better in day but wake up at night. No diagnosis yet. Appears to be peripheral and sensory neuropathy. Hearing sensitivity, touch sensitivity. The events onset is 19Feb2021 01:00 the outcome is not recovered. The event peripheral neuropathy is an always serious event.  Further information has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of peripheral and sensory neuropathy and other events due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including nerve conduction tests, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Groin pain, Pain
Clinical narrative: After 1st vaccine I started to have a little lower back, bilateral hip & groin pain.; After 1st vaccine I started to have a little lower back, bilateral hip & groin pain.; pain increased as time went on; This is a spontaneous report from a contactable Nurse, the patient. This is the first of two reports and captures events experienced after the first vaccine.   A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL9264,), via an unspecified route of administration on 28Jan2021 at 14:00 (at the age of 67-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history includes COPD and a history of failed lumbar fusions due to scoliosis. This was further reported as about three surgeries in the lumbar area for fusions due to scoliosis in the past years. The last one was about five years ago. Prior to the vaccination, the patient was not diagnosed with COVID-19. The vaccine was administered to the patient at a Health Clinic . Concomitant medications included roflumilast (DALIRESP), montelukast sodium (SINGULAIR), duloxetine (MANUFACTURER UNKNOWN), loratadine (MANUFACTURER UNKNOWN) and "SPIRI,"  all for unknown indications from unknown dates and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took meperidine (DEMEROL) and experienced allergy. The patient reported that after the first vaccine, she started to have a little lower back, bilateral hip and groin pain on 30Jan2021. The pain increased as time went on (dates not specified). The patient mentioned having to use "narcotics, heat, ice, Tylenol or Ibuprofen" (dates not specified) to control pain. The clinical outcomes of the events low back pain, groin pain and pain aggravated were reported as not recovered.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.    Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223014 same patient/drug, different vaccine dose/event
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Off label use, Product use issue
Clinical narrative: Miscarriage; Pregnant at time of vacciation; Pregnant at time of vacciation; This is a spontaneous report from a non-contactable consumer. A 34-year-old female patient (16 weeks pregnant at time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Jan2021 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced miscarriage at a routine OBGYN visit on 19Feb2021. The patient was hospitalized for the miscarriage on an unknown date for 2 days. The clinical outcome of the event miscarriage was unknown. The patient had not had COVID prior to the vaccination and has not tested positive post vaccination.   Information about lot/batch has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Loss of consciousness
Clinical narrative: Dizziness; feels unsteady at times; nearly passed out/totally passed out; This is a spontaneous report from a contactable consumer. A 79-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EN6198), via an unspecified route of administration, administered in Arm Left on 27Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient's medical history was reported as none. There were no concomitant medications. It was reported that the patient received first COVID shot Saturday. She confirms the Pfizer COVID 19 Vaccine. She says 24 hours after she had the shot she nearly passed out, she got really dizzy and someone asked, are you okay, and she said no and they caught her before she totally passed out and she sat down. She is still having waves of dizziness and she feels unsteady at times, not every second but she is a little scared to drive a car. She just thought someone should know that. It was reported that dizziness began the next day on 28Feb2021 around 3pm. She closes her eyes and says she doesn't want to look at that. It is ongoing but it is not so bad after she gets up. It seems to have lessened after about 3 pm yesterday it is bothersome. She confirms it is ongoing but improved a little since it began. The outcome of the event dizziness was recovering, while unknown for the other events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Candida infection, Chills, Condition aggravated, Coordination abnormal
Clinical narrative: She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume.  A 70-years-old female patient  received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation .  Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing  She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections.   The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting,  swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Eating disorder, Feeling abnormal, Headache, Illness
Clinical narrative: She is legally blind in her good eye; Felt like crap; proverbial headache was reported as worsened/pain and tightness in both jaw lines was reported as worsened; I do have migraine; Hives; this is just a nightmare if this is not a normal problem; Can't think; pain and tightness in both jaw lines; pain and tightness in both jaw lines; thrush; proverbial headache/When I bend over I have a blinding headache; no coordination; Vomiting projectile/Throwing up right away; arm was hurting; swelling in arm; Chills; uncontrollable bladder gushing leaking; shaky arms; unable to eat anything; has been as sick as a dog; non stop coughing; Rib pain; This is a spontaneous report from a contactable consume.  A 70-years-old female patient  received bnt162b2 (BNT162B2) , via an unspecified route of administration on 2Feb2021 as a single dose, for covid-19 immunisation .  Medical history included arthritis from 1992 and ongoing Verbatim: Arthritis , fibromyalgia from 1994 and ongoing Verbatim: Fibromyalgia , gastrooesophageal reflux disease from 1992 and ongoing Verbatim: GERD , lactose intolerance from 1992 and ongoing Verbatim: Lactose intolerance , depression from 1994 to an unknown date Verbatim: Anxiety depression , hypertension from 1992 to an unknown date Verbatim: Blood pressure high , MRSA , water pollution from an unknown date and unknown if ongoing  She was unable to drink anything except sips of cold water and eat a few ice chips. She is unable to drink lukewarm water. This was prior to getting the vaccine , surgery from an unknown date and unknown if ongoing She had 22 surgeries in 4 years on her left eye. It started with pressure testing then infections.   The patient reported she is legally blind in her good eye, has been as sick as a dog, non stop coughing, , non stop coughing , thrush on 23Feb2021, proverbial headache/when i bend over i have a blinding headache, , no coordination, vomiting projectile/throwing up right away arm was hurting,  swelling in arm chills, uncontrollable bladder gushing leaking pain and tightness in both jaw lines unable to eat anything can't think felt like crap. The outcome of the events: Unknown: blindness, thrush, shaky arms, unable to eat anything, Can't think, Felt like crap, I do have migraine; Recovered, vomiting, swelling in arm; Recovoring illness, cough, rib pain, Not recovered headache, no coordination, uncontrollable bladder gushing leaking, pain and tightness in both jaw lines, pain and tightness in both jaw lines; Chills recovered with sequelae.