chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Myalgia, Nausea, Vaccination site pain
Clinical narrative: disoriented; ran a red light when driving; don't feel right; Anxiety; Euphoria; Nausea; pain around site; Muscle pain; chills; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 09Aug2021 at 15:30 as a single dose for COVID-19 immunisation. Medical history included diabetic and bone on bone. Concomitant medications included cortisone acetate (CORTISONE) taken for bone on bone and unspecified heart medications (as reported: and stuff). The patient experienced disoriented, ran a red light when driving, don't feel right, anxiety, euphoria, nausea, pain around site, muscle pain, and chills on 10Aug2021. The clinical course was reported as follows: She had to leave work on 10Aug2021 because of anxiety, euphoria, nausea, and pain around site. She had to finish most of her job. She was just trying to report the muscle pain and soreness at site. She wanted to go into work on 11Aug2021, but she was not one hundred percent. She works night shift. She went to have a cortisone injection put in the knee and that was the main reason she went in. While she was there, she got the BNT162B2 vaccine. That evening she had to stay home and iced it. She took ibuprofen (MANUFACTURER UNKNOWN) that night and iced her knee. She works shift work from 14:30 to 23:00. On 10Aug2021, she had to leave at 20:30 which was two and a half hours early because she was so disoriented in a way. She shouldn't have been driving. She made it to the house. She still didn't feel right. The patient clarified her symptoms started about 18:00. It started coming on and she pushed through and finished the job. She had to sit down because she was disoriented. It was so bad that she ran a red light when driving. Everyone was sitting at the red light. She wasn't just taking off and going through it. They were just sitting there and a person did a U-turn and she just went ahead and went. That was about nine something at night. She is not going to get on the road. She also iced her arm. The patient stated she knows that it was not the cortisone injection as she has had them before. She had one 8 months prior to this one in the right knee as both of her knees have bone on bone. Therapeutic measures were taken as a result of pain around site, muscle pain, and chills as aforementioned. The clinical outcome of disoriented, ran a red light when driving, don't feel right, anxiety, euphoria, nausea, pain around site, muscle pain, and chills was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Gait disturbance, Lower limb fracture
Clinical narrative: falling; couldn't walk; broke leg; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of bnt162b2, via an unspecified route of administration, administered in Left arm on 14Apr2021 14:15 (at the age of 71-year-old) (Lot Number: ER8735) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced couldn't walk after falling, broke leg (all hospitalization from 04May2021 to 06May2021, medically significant, resulted in emergency room) on 04May2021. The patient received her first dose Pfizer Covid Vaccine and was scheduled to receive the second dose Pfizer Covid Vaccine on 05May2021. On 04May2021 the patient broke leg and ended up going to the hospital and rehab. The patient received the second dose Pfizer Covid Vaccine in the rehab center on 17May2021. The patient received the second dose of bnt162b2, via an unspecified route of administration, administered in right arm on 17May2021 4:15 or 5:00 (at the age of 71-year-old) (Lot Number: GW0168, not sure if it is the letter o or the number 0 in the lot number) as single dose for covid-19 immunisation. The patient went to the emergency room because she couldn't walk after falling on the night of the 04May2021. The patient was hospitalized for two days. On 04May2021, the patient was going down the stairs to feed the cat. The patient was going down the stairs and missed the last step. The patient remembers holding onto the rail and telling herself not to hit head or hips. The patient rolled onto the floor and felt something awkward in the leg like an electricity shock and The patient made out a yell. The patient laid down in the floor and got up and fed the car and went back upstairs to her room for one hour. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Depression
Clinical narrative: Depression; This is a spontaneous report from a contactable consumer or other non hcp.  A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: was not reported; Expiry Date of COVID Vaccine: unknown), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced depression on an unspecified date.  It was reported that the patient got into depression and she didn't go to take her second dose; it's been 90 days since she took the first dose. Reporter seriousness for the event was unspecified. The patient denied to answer any question when asked about batch number.  The patient called, her initial question was about her mother who live in withheld (Further clarification was unknown, hence COI was captured as withheld by default), was instructed to take the second vaccine 3 months later. She said that she received the vaccine 90 days ago and reported that, she received the Pfizer COVID Vaccine 90 days ago and she was instructed to come back it's been 3 months to receive the second vaccine and she was calling from (privacy). The patient said she did not go for second dose and asked what she should do and if not taking the second dose would work. She reported she got into depression, not because of the vaccine in unclear words. She reported as 90 days was crossed from the first dose can she take the second dose and would she be protected. She said that she read something that stated that it was supposed to take maximum 42 days after first dose. She was frustrated with the calls being on hold and transferred. She wanted the answer if the second dose after 90 days would protect her. She asked to transfer her call to someone who could respond to her query. Outcome of the event was unknown.  Follow-up activities closed. Batch/lot number not available.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer. A non-contactable 55-year-old female consumer (patient) reported for herself.  Solicited report by a consumer of an adult male with an event of   Non-serious rheumatoid arthritis flares after second pfizer covid shot with rinvoq (upadacitinib). There was no reported medical history. On an unknown date, the patient experienced rheumatoid arthritis flares after second pfizer covid shot. on an unknown date, rheumatoid arthritis flares after   second pfizer covid shot resolved. COVID-19 VACCINE was also considered suspect.  The patient had flares following the second Pfizer Covid shot. He had not stopped  The Rinvoq as directed by the physician.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unknown    Causality assessment: Causality assessment between the event Rheumatoid arthritis flare up with RINVOQ (upadacitinib) was No reasonable possibility by the reporter, with COVID VACCINE was Not Reported.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  The lot number for BNT162b2 was not provided and will be requested during follow up; Sender's Comments: Based on the available information in the case, the causal association between the event rheumatoid arthritis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Not Happy that pfizer is not as effective as Moderna I had Pfizer; This is a spontaneous report from a Pfizer sponsored program Pfizer.com - General Company Information. A contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. It was mentioned that, patient was not happy that pfizer was not as effective as Moderna patient had Pfizer. Get the ball going now on a booster and vaccines for all ages. Push the FDA. No time to waist. Very disappointed in Pfizer. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Somnolence
Clinical narrative: Really really lethargic; Really really lethargic or tiredness because it seems like I am just sleeping and that was about; Really really lethargic or tiredness because it seems like I am just sleeping and that was about; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 10Aug2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On an unspecified date in Aug2021, after first dose of vaccination (received 18 hours ago-from the report time), patient was really lethargic or had tiredness because it seems like patient was just sleeping. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: female died 3 days after receiving the first COVID vaccine shot of a massive stroke; This is a spontaneous report from two contactable consumers. A 81-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  It was reported the female died 3 days after receiving the first COVID vaccine shot of a massive stroke. Healthy patient. It was not reported if an autopsy was performed.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: female died 3 days after receiving the first COVID vaccine shot of a massive stroke.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Burning sensation, Cerebrovascular accident, Computerised tomogram, Head discomfort
Clinical narrative: stroke-like symptoms; her arm went numb/her face went numb; fire burning through her body; her head feels like her brain was laying dead and her brain feels to her like deadweight; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm (unsure if right or left arm) on 02Aug2021 at 17:00 (Lot Number: FC3180, at the age of 45-year-old) as single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. There were no prior vaccinations (within 4 weeks). Patient took the 1st dose of the vaccine 9 days ago (on 02Aug2021 at 17:00) and 5 minutes after taking the vaccine (on 02Aug2021 at 17:05) her arm went numb and she had been going back and forth to the emergency rooms for the past couple of days; the patient had stroke-like symptoms, her face went numb along with something she described like fire burning through her body and her head felt like her brain was laying dead and her brain felt to her like deadweight. The patient had been going back and forth to different emergency rooms and had several records to show it and her other healthcare professional primary care did all a bunch of blood tests and nothing had come back so far out of the ordinary. The patient kept having the symptoms since she took the Pfizer COVID Vaccine. The patient was in excellent shape and had no health issues in the past before and took the Pfizer COVID vaccine at 5:00pm and by 5:05pm started having the symptoms and by 5:30pm was in the emergency room and it had been that way since then. When she laid down for an extended period of time sometimes it calmed down a little bit regarding her symptoms and then when she got up or started moving or any movement the symptoms kick back in so she had been laying down since then. The patient had been to the emergency room three times in a few days and had hospital visits and then clarified she had not had an overnight stay in the hospital but they pulled her blood and did computerised tomogram (CT) scans and magnetic resonance imaging (MRI) and they were there 6, 7, or 8 hours and then were back home and then went back to the same place but he did not have the additional dates of the emergency room dates to provide. The blood work, CT scans and MRI on Aug2021 that everything came back normal and nothing out of the ordinary and she was in perfect shape before this and takes no medications. The adverse events require a visit to emergency room and physician office. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: stroke-like symptoms; her arm went numb/her face went numb; fire burning through her body; her head feels like her brain was laying dead and her brain feels to her like deadweight; This is a spontaneous report from a contactable consumer. A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm (unsure if right or left arm) on 02Aug2021 at 17:00 (Lot Number: FC3180, at the age of 45-year-old) as single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. There were no prior vaccinations (within 4 weeks). Patient took the 1st dose of the vaccine 9 days ago (on 02Aug2021 at 17:00) and 5 minutes after taking the vaccine (on 02Aug2021 at 17:05) her arm went numb and she had been going back and forth to the emergency rooms for the past couple of days; the patient had stroke-like symptoms, her face went numb along with something she described like fire burning through her body and her head felt like her brain was laying dead and her brain felt to her like deadweight. The patient had been going back and forth to different emergency rooms and had several records to show it and her other healthcare professional primary care did all a bunch of blood tests and nothing had come back so far out of the ordinary. The patient kept having the symptoms since she took the Pfizer COVID Vaccine. The patient was in excellent shape and had no health issues in the past before and took the Pfizer COVID vaccine at 5:00pm and by 5:05pm started having the symptoms and by 5:30pm was in the emergency room and it had been that way since then. When she laid down for an extended period of time sometimes it calmed down a little bit regarding her symptoms and then when she got up or started moving or any movement the symptoms kick back in so she had been laying down since then. The patient had been to the emergency room three times in a few days and had hospital visits and then clarified she had not had an overnight stay in the hospital but they pulled her blood and did computerised tomogram (CT) scans and magnetic resonance imaging (MRI) and they were there 6, 7, or 8 hours and then were back home and then went back to the same place but he did not have the additional dates of the emergency room dates to provide. The blood work, CT scans and MRI on Aug2021 that everything came back normal and nothing out of the ordinary and she was in perfect shape before this and takes no medications. The adverse events require a visit to emergency room and physician office. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Her face is almost paralyzed or something like that; This is a spontaneous report from a contactable consumer or other non HCP.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number and Expiration date was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation and experienced no reaction on previous exposure to drug. On an unspecified date in 2021, the reporter stated that patient face is almost paralyzed or something like that. Patient was having all kind of complications. The case assessed as serious (medically significant). The outcome of the event was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 37-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date in Apr2021 (at the age of 37 years) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the patient received no other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced PCR Covid Positive and related symptoms of disease (medically significant) on unspecified date in Aug2021. The patient received treatment of Advil in response to event. The patient been tested for COVID-19 since the vaccination. the patient underwent lab test included PCR/Nasal Swab with positive result on unspecified date in Aug2021. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate, Heart rate increased, SARS-CoV-2 test
Clinical narrative: I began to feel faint; rapid increase in heart rate; shortness of breath; This is a spontaneous report from a contactable consumer (patient).  This 42-year-old male consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number EW016) on 16Apr2021 at 10:00, at the age of 42 years, as the first single dose, in left arm, for COVID-19 immunisation. Medical history included COVID-19. There were no known allergies. Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. About 8 minutes after the first dose (16Apr2021), the patient began to feel faint, rapid increase in heart rate and shortness of breath. Major symptoms subsided after a couple of minutes. The events resolved on 16Apr2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101060826 same patient, different vaccine dose and events
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism
Clinical narrative: Pulmonary embolism; This is a spontaneous report from a contactable consumer. A 53-year-old male patient received BNT162B2 via an unspecified route of administration on 02Mar2021 (at 53-year-old) (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No other vaccine received in four weeks. The patient experienced pulmonary embolism on 10Aug2021. The event resulted in Emergency room/department or urgent care, Hospitalization for 2 days, Life threatening illness (immediate risk of death from the event). Anticoagulant as treatment. No COVID prior vaccination, no COVID tested post vaccination. The outcome of the event was resolving.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait inability, Myalgia, Pruritus
Clinical narrative: unable to walk due to extreme knee pain; unable to walk due to extreme knee pain; Extreme itchiness all over body; shooting muscle pain all over body; This is a spontaneous report from a non-contactable Healthcare professional (patient herself). A 30-year-old female patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via unspecified route of administration on the left arm on 05Aug2021 at 03:30 PM (at the age of 30-year old) at single dose for COVID-19 immunization at pharmacy/drug store. Relevant medical history was none. Concomitant medications were not reported. On 07Aug2021, 24-48 hours after shot the patient was unable to walk due to extreme knee pain. One week after shot the patient experienced extreme itchiness and shooting muscle pain all over body. No treatment was received due to events. They resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer. A 74-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, formulation: solution for injection, batch/lot# not reported), via an unspecified route of administration, on an unspecified date in Feb 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Reportedly, on an unspecified date, after the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine, he had hives and was not able to get the second dose. The reporter asked if the patient could still get the vaccine as doctors could not give an answer. The reporter wanted to know an answer as the healthcare providers were not helping them and was frustrated. The outcome of the event: unknown. Information on lot number/batch number requested.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diverticulitis, Swelling, Vaccination site haemorrhage
Clinical narrative: diverticulitis; Vaccination sites (both) still bleed and have not fully healed; Swelling; to the point of not being able to eat for days.; This is a spontaneous report from a contactable consumer reported for himself  A 49-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01May2021 13:15 (Batch/Lot Number: ew0170) as DOSE 1, single and dose 2 via an unspecified route of administration, administered in Arm Left on 22May2021 13:15 (Batch/Lot Number: ew0182) as DOSE 2, SINGLE for covid-19 immunisation. Facility type vaccine: Pharmacy or Drug Store. Dose 1 of bnt162b2 was administered on 01May2021 for covid-19 immunisation. Medical history included abdominal hernia, hypertension, immune-mediated adverse reaction, mycotic allergy, implantation complication. Concomitant medication included carvedilol (COREG CR). The patient previously took sulfur and experienced drug hypersensitivity, erythromycin and experienced drug hypersensitivity. The patient experienced diverticulitis (medically significant) on 02May2021 14:00 with outcome not recovered, vaccination sites (both) still bleed and have not fully healed (non-serious) on 02May2021 14:00 with outcome not recovered, swelling (non-serious) on 02May2021 14:00 with outcome not recovered, to the point of not being able to eat for days (decreased appetite) (non-serious) on 02May2021 14:00 with outcome not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Aspergillus infection, Pulmonary mass
Clinical narrative: now has a fungal infection, Aspergillus, that is a nodule in her lung; now has a fungal infection, Aspergillus, that is a nodule in her lung; This is a spontaneous report from a contactable consumer (herself).  A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an un-specified date as dose 2, single for covid-19 immunisation. Medical history included, chronic obstructive pulmonary disease. The patient's concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), on an unspecified date as  dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced "now has a fungal infection, aspergillus, that is a nodule in her lung. It was reported that the patient received both doses of the vaccine and she now has a fungal infection, Aspergillus, that is a nodule in her lung. She was now taking Voriconazole and wants to know if she can receive a third Covid shot. She was researching that there may be a possible connection to the infection and the vaccine. Her main concern is that she would like to receive a third shot is that ok to do or should she wait. She stated she also has COPD which makes her vulnerable to infection. The patient asked if the third dose is approved, would there be any reason not to get the vaccine as she has Aspergillus. The patient reported the event as non serious. Treatment was received for the events. Outcome of the events were unknown.  Information about lot/batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Blood thyroid stimulating hormone
Clinical narrative: Return of intermittent episodes of atrial fibrillation; This is a spontaneous report from a non-contactable consumer (patient). A 61-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER8729), via an unspecified route of administration, administered in left arm on 25May2021 as single dose for COVID-19 immunisation. The patient's medical history included high blood pressure, high cholesterol, taking Synthroid due to thyroidectomy, and experienced atrial fibrillation from 2016 to 2016. The patient had no known allergies. The patient's concomitant medications included metoprolol tartrate; clonidine (CATAPRESS); levothyroxine sodium (SYNTHROID); enalapril; and atorvastatin calcium (LIPITOR). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0151), administered in left arm on 04May2021 for COVID-19 immunisation. The patient had no other vaccine in four weeks. On May2021, the patient experienced return of intermittent episodes of atrial fibrillation. Back in 2016, the patient experienced Afib that was ultimately found due to extremely high thyroid hormone levels. In 2016-2017, she took thyroid inhibitors, had thyroid ablation and ultimately thyroidectomy. The event resulted in  physician office visit. No treatment was received for the event. The patient had no COVID prior vaccination and has not been tested COVID post vaccination. The patient underwent lab tests and procedures which included blood thyroid stimulating hormone (TSH): normal on Apr2021. The outcome of the event was recovering.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Overdose, Platelet factor 4, Product preparation error
Clinical narrative: was administered the entire vial of the vaccine undiluted; was administered the entire vial of the vaccine undiluted; tired; This is a spontaneous report from a contactable Other HCP. A 35-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the right deltoid on 10Aug2021 (Batch/Lot Number: EW0191; Expiration Date: 30Sep2021) as single dose (at age of 35 years old) for prevention of COVID infection. There was no relevant medical history. Concomitant medication(s) included phentermine (PHENTERMINE) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously received her first dose of BNT162b2 on 19Jul2021 (Batch/lot number:EW0191, Expiration: 30Sep2021) for COVID-19 immunisation. On 10Aug2021, the patient was administered the entire vial of the vaccine undiluted (overdose). The patient reported she felt really tired the next day (11Aug2021), but she did not need treatment or medical care. The outcome of the event was unknown.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in shoulder/ Pain continue to migrate to elbows, wrists; pain in hand/feet; This is a spontaneous report from a contactable consumer. This 76-Year-old male consumer reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER2613) via intramuscular route of administration on 19Mar2021 at 12:45 (at 76-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included Heart disease-stent, Sluggish artery, Acid reflux (esophageal), Crohn's disease. The past drugs included atorvastatin that cased allergy. It was mentioned that no vaccine was received in four weeks. The patient received other medications in two weeks. The patient did not have COVID prior vaccination and was not tested for covid post vaccination. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 26Feb2021 (at 76-year-old), as dose 1, single for COVID-19 immunization and experienced pain in joints that was normal. On an unknown date in 2021 the patient experienced shoulder pain and pain continued to migrate to elbows, hands, wrists and feet. The patient received treatment with Mobic. The event resulted in physician office visit. The event outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: This is a spontaneous report from a contactable consumer. A male patient of unspecified age received first dose of bnt162b2 (COMIRANTY; Formulation: solution for injection; Lot number: not reported, Expiration date: not reported) via an unspecified route of administration on 20Jan2021 as DOSE 1, SINGLE for COVID-19 immunization and second dose of bnt162b2 (COMIRANTY; Formulation: solution for injection; Lot number: not reported, Expiration date: not reported) via an unspecified route of administration on 10Feb2021 as DOSE 2, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. Other vaccine administered in four weeks was unknown. Other medications administered in two weeks was unknown. Prior to vaccination, the patient was diagnosed with covid-19 was unknown. Since the vaccination, patient has been tested for COVID-19. On 10Aug2021, the patient started noticing COVID symptoms and tested positive for COVID on 11Aug2021. Reporter also stated patient had no symptoms after receiving the doses of the vaccine. AE resulted in doctor or other healthcare professional office/clinic visit. Treatment took for AE was unknown. Lab test included COVID test positive on 11Aug2021. The events was reported as non serious. Outcome of the events was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: generalized body aches "sore" today; This is a spontaneous report from a contactable other HCP. This other HCP reported for a 38-year-old female patient.  A 38-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 09Aug2021 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified date (at the age of 38-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. and concomitant medications include Paracetamol (TYLENOL) and Ibuprofen. On 10Aug2021, after the vaccination, the patient experienced generalized body aches "sore". The events assessed as non-serious. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101041000
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: pulsatile tinnitus; This is a spontaneous report from a consumer or other non Health Care Professional.   A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/ Lot number was not reported), via an unspecified route of administration on an unspecified date, as a dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, 12 days after receiving the vaccine, the patient had pulsatile tinnitus. It has been nonstop non ever since. Reporter wants to know if this was a temporary side effect. Reporter asking that, does Pfizer has any recommendation? It was quite severe, persistent and unrelenting. The event was non-serious. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected. Information on lot number/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's friend) via Pfizer-sponsored program. A 42-year-old male patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Aug 10, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The reporter called on behalf of her friend, who received the first dose on Aug 10, 2021 and experienced headache, dizziness, injection site pain, and nausea. The reporter stated patient was still dizzy with a slight headache and asked if we can recommend something like Dramamine for him to take. Reporter stated she already knew these are reported reactions from the papers they gave her for 1-3 days. The outcome of dizzy and slight headache events: not recovered; and the outcome of other events: unknown. Information on the lot/batch number requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Renal impairment, Urine analysis
Clinical narrative: abnormalities/decline with her kidney function; This is a spontaneous report from a contactable consumer.  A 77 year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 28Feb2021 (Batch/Lot number was not reported) as a single dose at the age of 77 years old, for covid-19 immunisation. Medical history and concomitant medications were not reported.  Patient reports that she completed the full series of the Pfizer Covid 19 vaccine on 28Feb2021.  She references when she completed the series, nothing was known.  Patient went in for a normal checkup where she had blood work and a urine sample collected yielding abnormalities/decline with her kidney function. Patient did not share specifics of results or date of checkup. With the concern of initial decline in kidney function patient was referred to Nephrologist. Her physician thinks there is a chance that her decline in kidney function could have been related to the Pfizer Covid 19 vaccine. That numbers being out of whack were due to injection.  Evaluated if the M spike was dangerous to her. More testing has been completed including urine test, numbers are down after they were elevated. stated that after taking the Covid shot that she had issues with her kidneys. Stated that she was being looked at by nephrologist, had bloodwork and then had to see a specialist.  Stated that she had her last shot in February, saw her doctor in April who stated it may be due to injection. Stated that she noticed the issues with her kidneys after the second shot. The outcome of the events was not reported.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.           .                The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Chest pain, Condition aggravated, Cough
Clinical narrative: she was sick; It really knocked her out . She had a really bad sense; testing positive for Covid-19; Itchy throat; Light headedness; Wheezing; Coughing; Weakness; chest on fire; Itchy throat, Light headedness, Wheezing, Coughing, Weakness, chest on fire was reported as worsened.; tickle in her throat; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration date: unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 02Aug2021, immediately after the receiving the covid-19 vaccine, patient felt a tickle in her throat, it became itchy, began to feel lightheaded, and was coughing and wheezing. patient stated that these symptoms became progressively worse, so was tested for Influenza and Covid-19. patient received a positive Covid-19 Viral Test Result and stated, "her lungs are killing, her right now." patient got progressively worse. On an unspecified date, it really knocked her out. patient had a really bad sense. Patient was so nervous, got tested again and got tested for the flu, and they did a rapid and PCR test for COVID. Patient was negative until yesterday. Patient got a positive for COVID test result today, was just confused and was trying to navigate what to do. Patient was coughing. Her chest was on fire., was weak and patient wasn't at home. She flew to (city) after getting her first dose. Her weight had been evaporating since she was sick on an unspecified date. She got her positive COVID result on 12Aug2021. The patient underwent lab tests and procedures which included Rapid test and PCR test: negative, She was negative until yesterday on 11Aug2021, Rapid test and PCR test: positive, she got a positive for COVID test result today. Positive Covid-19 viral test result after first dose on 12Aug2021. Outcome of events she was sick, tickle in her throat and it really knocked her out. patient had a really bad sense and tested positive for covid-19 was unknown and outcome of other events was not recovered.   Information on the Batch/Lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Illness, SARS-CoV-2 test, Throat irritation
Clinical narrative: she was sick; It really knocked her out . She had a really bad sense; testing positive for Covid-19; Itchy throat; Light headedness; Wheezing; Coughing; Weakness; chest on fire; Itchy throat, Light headedness, Wheezing, Coughing, Weakness, chest on fire was reported as worsened.; tickle in her throat; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration date: unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 02Aug2021, immediately after the receiving the covid-19 vaccine, patient felt a tickle in her throat, it became itchy, began to feel lightheaded, and was coughing and wheezing. patient stated that these symptoms became progressively worse, so was tested for Influenza and Covid-19. patient received a positive Covid-19 Viral Test Result and stated, "her lungs are killing, her right now." patient got progressively worse. On an unspecified date, it really knocked her out. patient had a really bad sense. Patient was so nervous, got tested again and got tested for the flu, and they did a rapid and PCR test for COVID. Patient was negative until yesterday. Patient got a positive for COVID test result today, was just confused and was trying to navigate what to do. Patient was coughing. Her chest was on fire., was weak and patient wasn't at home. She flew to (city) after getting her first dose. Her weight had been evaporating since she was sick on an unspecified date. She got her positive COVID result on 12Aug2021. The patient underwent lab tests and procedures which included Rapid test and PCR test: negative, She was negative until yesterday on 11Aug2021, Rapid test and PCR test: positive, she got a positive for COVID test result today. Positive Covid-19 viral test result after first dose on 12Aug2021. Outcome of events she was sick, tickle in her throat and it really knocked her out. patient had a really bad sense and tested positive for covid-19 was unknown and outcome of other events was not recovered.   Information on the Batch/Lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: she was sick; It really knocked her out . She had a really bad sense; testing positive for Covid-19; Itchy throat; Light headedness; Wheezing; Coughing; Weakness; chest on fire; Itchy throat, Light headedness, Wheezing, Coughing, Weakness, chest on fire was reported as worsened.; tickle in her throat; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number and Expiration date: unknown), via an unspecified route of administration, administered in left arm on 02Aug2021 (at the age of 49-years-old) as dose 1, single for covid-19 immunisation. Medical history was none. There were no concomitant medications. On 02Aug2021, immediately after the receiving the covid-19 vaccine, patient felt a tickle in her throat, it became itchy, began to feel lightheaded, and was coughing and wheezing. patient stated that these symptoms became progressively worse, so was tested for Influenza and Covid-19. patient received a positive Covid-19 Viral Test Result and stated, "her lungs are killing, her right now." patient got progressively worse. On an unspecified date, it really knocked her out. patient had a really bad sense. Patient was so nervous, got tested again and got tested for the flu, and they did a rapid and PCR test for COVID. Patient was negative until yesterday. Patient got a positive for COVID test result today, was just confused and was trying to navigate what to do. Patient was coughing. Her chest was on fire., was weak and patient wasn't at home. She flew to (city) after getting her first dose. Her weight had been evaporating since she was sick on an unspecified date. She got her positive COVID result on 12Aug2021. The patient underwent lab tests and procedures which included Rapid test and PCR test: negative, She was negative until yesterday on 11Aug2021, Rapid test and PCR test: positive, she got a positive for COVID test result today. Positive Covid-19 viral test result after first dose on 12Aug2021. Outcome of events she was sick, tickle in her throat and it really knocked her out. patient had a really bad sense and tested positive for covid-19 was unknown and outcome of other events was not recovered.   Information on the Batch/Lot number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Severe menstrual bleeding that lasted for several weeks after the first dose. Second dose was not as severe but triggered another bleeding session; Severe menstrual bleeding that lasted for several weeks after the first dose. Second dose was not as severe but triggered another bleeding session; This is a spontaneous report from a non-contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 2 (at the age of 47 years old) via an unspecified route of administration, administered in left arm on an unspecified date (Batch/Lot number was not reported) as single for COVID-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient previously received 1st dose of bnt162b2 on 17Jun2021 in the left arm for COVID-19 immunisation and experienced severe menstrual bleeding that lasted for several weeks and fixed anemia. On 21Jun2021, the patient had severe menstrual bleeding that lasted for several weeks after the first dose. Second dose was not as severe but triggered another bleeding session on an unspecified date. Her cycle is extremely regular otherwise. The events resulted in doctor or other healthcare professional office/clinic visit. Treatment were iron and progesterone.  No follow up attempts are possible; information about lot/batch number cannot be requested. No further information is expected.