chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Right side of my face went numb; This is a spontaneous report from a contactable consumer (Patient).  A 41-years-old female patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6206), via an unspecified route of administration on 11Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced right side of my face went numb on 11Mar2021 after 28minutes of vaccination. Communication company: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine. The outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration, administered in left arm on 02Apr2021 09:45 as single dose for COVID-19 immunisation. Medical history included type 2 diabetes, hypothyroidism, and allergy to: shellfish, penicillin, all narcotics, mold, catfish, vaccinium berries, peaches, somegrass and trees. Concomitant medications included levothyroxine sodium (SYNTHROID), cholecalciferol (D3), famotidine (PEPCID AC), biotin, and salbutamol sulfate (VENTOLIN ACCUHALER). On 02Apr2021 10:00, the patient experienced anaphylaxis. Treatment for the event included Ventolin, steroids antihistamines and nebulizer. The event result in Emergency room/department or urgent care. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of event was recovering.  Information about lot/batch number has been requested.; Sender's Comments: Due to a strong drug-event temporal relationship the company deems there is a reasonable possibility that the reported anaphylaxis is related to BNT162b2.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Feeding disorder, Headache
Clinical narrative: temperature/99.7; chills; body aches; headache; unable to eat; no interest in food; This is spontaneous report from 35-year-old contactable consumer (patient) reported herself. A 35-year-old female patient received second dose of bnt162b2 (BNT162B2, Lot Number: EP-6955) administered in left arm on 31Mar2021 13:45 as single dose for covid-19 immunisation. Medical history included chronic bronchitis, exercise induced asthma, Aspartame and Percoset allergy, had birth control ring. Prior to vaccination, the patient was diagnosed with COVID-19. Patient not pregnant at the time of vaccination. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) for birth control; acetylsalicylic acid, paracetamol (EXCEDRIN BACK & BODY). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received first dose of dose bnt162b2 (Lot Number: EL-3247) in left arm on 10Mar2021 11:00, and experienced mild arm soreness, felt thirsty, mild headache, fatigue. When patient woke up around 5am the day after receiving vaccine (on 01Apr2021) with chills and body aches. She took Acetominaphin. Around 7am temperature was 99.7. She had temperature approx. every hour throughout the day, the temperature was in the 99s most of the day with 2 readings in the 98s. In the afternoon, she had a severe headache as well. Patient was unable to eat all day with no interest in food whatsoever. By 5pm the headache started to subside. Patient tried to sleep as much as possible. By the next morning the chills and fever were gone and did not come back. Some minor body aches persisted through the next day. The outcome of chills and fever was recovered, headache was recovering, other events' outcome was unknown. Patient had not been tested for COVID-19 Since the vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: temperature/99.7; chills; body aches; headache; unable to eat; no interest in food; This is spontaneous report from 35-year-old contactable consumer (patient) reported herself. A 35-year-old female patient received second dose of bnt162b2 (BNT162B2, Lot Number: EP-6955) administered in left arm on 31Mar2021 13:45 as single dose for covid-19 immunisation. Medical history included chronic bronchitis, exercise induced asthma, Aspartame and Percoset allergy, had birth control ring. Prior to vaccination, the patient was diagnosed with COVID-19. Patient not pregnant at the time of vaccination. Concomitant medications included ethinylestradiol, etonogestrel (NUVARING) for birth control; acetylsalicylic acid, paracetamol (EXCEDRIN BACK & BODY). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received first dose of dose bnt162b2 (Lot Number: EL-3247) in left arm on 10Mar2021 11:00, and experienced mild arm soreness, felt thirsty, mild headache, fatigue. When patient woke up around 5am the day after receiving vaccine (on 01Apr2021) with chills and body aches. She took Acetominaphin. Around 7am temperature was 99.7. She had temperature approx. every hour throughout the day, the temperature was in the 99s most of the day with 2 readings in the 98s. In the afternoon, she had a severe headache as well. Patient was unable to eat all day with no interest in food whatsoever. By 5pm the headache started to subside. Patient tried to sleep as much as possible. By the next morning the chills and fever were gone and did not come back. Some minor body aches persisted through the next day. The outcome of chills and fever was recovered, headache was recovering, other events' outcome was unknown. Patient had not been tested for COVID-19 Since the vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Bedridden, Chills, Dizziness, Food aversion
Clinical narrative: she had a cold chills through the day; she was in bed most of the day almost all those day; upset stomach; She is not been eating; She is not dehydrated; Dizziness; Headache; she already getting the flu; she ended up with such bad shake; she is allergic to lot of prescription medication; Vomited; This is a spontaneous report received from a contactable consumer. A 87-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 25Mar2021 at single dose for COVID-19 immunization. The patient's medical history included asthma, fibromyalgia, arthritis (patient had arthritis from long time) and high blood pressure. Concomitant medications included lisinopril 20 mg, 1x/day. It was reported that patient started to vomit few hours later and then she had a cold chill through the day. She had like on Thursday with a vaccine and here it is Monday this is Tuesday now really and she was getting better, but she was in bed most of the day almost all those days and she was upset stomach. It was reported that patient was on real like she gonna jump right out of the bed and she finally settle down. On 30Mar2021, patient had a very bad reaction, she had a shake. It was reported that patient was not been eating. She was not dehydrated she is not been drinking lot of water. The patient had took the dramamine for her upset stomach and motion sickness. The takes only when she needs it about twice a day mostly so far. It was reported that at first because of motion sickness in the car but it quite away we had to go and after that it was terrible, it just continued every day after that. She vomited first day very bad and rest of the day upset stomach then when she started taking dramamine. The patient also had like dizziness, headache and shake. The patient acted like she already getting the flu of some sort. It was reported that patient was allergic to prescription medication. She took Dramamine for upset stomach and then took Tylenol (Acetaminophen), 500mg each, every 4 hour 2 tablets for headache." It was reported that patient will not get second vaccine then because she does not want to experience this all over again. Outcome was reported as not recovered for chills, dizziness, headache, influenza and unknown for bedridden, upset stomach, vomiting, ended up with such bad shake, She is not been eating; She is not dehydrated and is allergic to lot of prescription medication  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Influenza, Tremor, Vomiting
Clinical narrative: she had a cold chills through the day; she was in bed most of the day almost all those day; upset stomach; She is not been eating; She is not dehydrated; Dizziness; Headache; she already getting the flu; she ended up with such bad shake; she is allergic to lot of prescription medication; Vomited; This is a spontaneous report received from a contactable consumer. A 87-year-old-female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 25Mar2021 at single dose for COVID-19 immunization. The patient's medical history included asthma, fibromyalgia, arthritis (patient had arthritis from long time) and high blood pressure. Concomitant medications included lisinopril 20 mg, 1x/day. It was reported that patient started to vomit few hours later and then she had a cold chill through the day. She had like on Thursday with a vaccine and here it is Monday this is Tuesday now really and she was getting better, but she was in bed most of the day almost all those days and she was upset stomach. It was reported that patient was on real like she gonna jump right out of the bed and she finally settle down. On 30Mar2021, patient had a very bad reaction, she had a shake. It was reported that patient was not been eating. She was not dehydrated she is not been drinking lot of water. The patient had took the dramamine for her upset stomach and motion sickness. The takes only when she needs it about twice a day mostly so far. It was reported that at first because of motion sickness in the car but it quite away we had to go and after that it was terrible, it just continued every day after that. She vomited first day very bad and rest of the day upset stomach then when she started taking dramamine. The patient also had like dizziness, headache and shake. The patient acted like she already getting the flu of some sort. It was reported that patient was allergic to prescription medication. She took Dramamine for upset stomach and then took Tylenol (Acetaminophen), 500mg each, every 4 hour 2 tablets for headache." It was reported that patient will not get second vaccine then because she does not want to experience this all over again. Outcome was reported as not recovered for chills, dizziness, headache, influenza and unknown for bedridden, upset stomach, vomiting, ended up with such bad shake, She is not been eating; She is not dehydrated and is allergic to lot of prescription medication  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain
Clinical narrative: tenderness in lymph nodes under the arm of the arm that received the shot; This is a spontaneous report from a contactable consumer reported for herself. A 60-year-old female patient received second dose of bnt162b2 (Lot Number: ER8732) via an unspecified route of administration in left arm on 29Mar2021 13:15 as single dose for covid-19 immunisation. Medical history included asthma, NAFLD (Fatty liver), high blood pressure, high cholesterol. Patient was not diagnosed with COVID-19 prior to vaccination. Patient not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, with unspecified medications the patient received within 2 weeks of vaccination. Patient received first dose of bnt162b2 (lot number: EN6205) on an unspecified date in Mar2020 10:15 PM in left arm. On 30Mar2021 09:00 AM, patient experienced tenderness in lymph nodes under the arm of the arm that received the shot. The event outcome was recovering. No treatment received. Patient had not been tested for COVID-19 since the vaccination.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pollakiuria
Clinical narrative: urinating constantly; up all night, back and forth; This is a spontaneous report received from a contactable female consumer (Wife) reported for her husband (Patient). This consumer reported similar events for two patients. This is the second of 2 reports.  A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose bnt162b2 on 05Mar21. On 28Mar2021 patient got his last shot with wife. The wife and patient have been urinating constantly, up all night, back and forth. The event outcome was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374640 Same reporter/ product, similar event, different patient
Age: 0.92
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Fever neonatal, Rash neonatal
Clinical narrative: fever; rash; nursing mom/ didn't know if it was from the vaccine or not; This is a spontaneous report from a contactable consumer (patient's mother). A 11-month-old patient received the first does of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) transmammary single dose for COVID-19 immunization in Mar2021, at 11-month-old. Medical history included: 'allergy to pen' and concomitant medication was not reported. The patient's mother was 28-year-old and was a nursing mom. The morning after patient received his mother's shot (31Mar2021), the patient woke up with a rash and fever. The patient's mother didn't know if it was from the vaccine or not. The patient was given paracetamol (TYLENOL) and he felt better. As of not the rash that behind his leg and on his thigh was going away. Outcome of the event was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021368558 mother and baby case
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, SARS-CoV-2 test
Clinical narrative: Bells palsy; This is a spontaneous report from a contactable Other Healthcare Professional (patient) reported for herself. A 29-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Feb2021 at single dose for covid-19 immunization. Medical history included allergies to sulfa, covid-19, prior to vaccination, the patient was diagnosed with COVID-19 (test positive). The patient's concomitant medications were none, the patient didn't receive any other medications within 2 weeks of vaccination and didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 on 25Jan2021 15:30 at 28 years old for covid-19 immunization. The patient experienced bells palsy on 13Mar2021. Therapeutic measures were taken as a result of bells palsy included steriods. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was not recovered.  Follow-up attempts are completed. Information about lot/batch number cannot be obtained.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Bell's Palsy cannot be totally excluded.   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: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Drug ineffective
Clinical narrative: COVID-19 pneumonia; COVID-19 pneumonia; This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program reported for a 67-year-old male consumer (patient) received first dose BNT162B2 (Solution for injection, lot number: EL3302) via an unspecified route of administration on 14Jan2021 at 13:00 at single dose for COVID-19 immunization. Patient medical history included ongoing Chronic obstructive pulmonary disease (diagnosed with COPD 3 years ago) and ongoing Cardiac failure congestive (diagnosed with congestive heart failure 4 years ago). Concomitant medication included ongoing oxygen (He has been on oxygen for two years) for Chronic obstructive pulmonary disease. He lives in an senior citizens building and they gave him his first dose on 14Jan2021. He went into the hospital on 02Feb2021 and stayed through 09Feb2021 with COVID pneumonia. Reporter seriousness for COVID-19 pneumonia was Hospitalization. Once he got out he went into quarantine again until the 16th. He was suppose to get his second dose on 24Feb2021. When he went to get it done they told him that he needs to wait 30 days after being in the hospital on an unspecified date in 2021. His question was how can he get the second dose of the vaccine without having to take the first dose again? Confirmed he was diagnosed with COVID when put into the hospital. He states he has asked around but everyone told you different answer about when to get his second COVID vaccine. He received the vaccine at drug store. He states he was given the first dose on 14Jan2021. He states that he just wants to know if he can get the second vaccine without having to get the first one again. It has been over 30 days and he just wants to know if he can get the second vaccine. Stated that he got the 1st dose last 14Jan2021 but 02Feb2021 he was admitted to the hospital and diagnosed with pneumonia and he went out after 7 days, and did the 14 days quarantine but unfortunately he was not able to take the 2nd dose. Right now he was asking if he will have the 2nd dose he was asking if he will start all over from 1st dose. Patient had emergency room visit. Outcome of event covi-19 pnemonia was recovered with sequale was recovered on 09Feb2021, while with other events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: received two doses 6 weeks ago and now she got COVID; received two doses 6 weeks ago and now she got COVID; This is a spontaneous report received from a contactable consumer. A 78-years-old female patient received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL3246), on 23Jan2021 and second dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number: EL9267) on 13Feb2021 both around 10 AM via an unspecified route of administration at a single dose for covid-19 immunization. Medical history included high blood pressure and over active thyroid. Concomitant medication included metoprolol, hydrochlorothiazide, valsartan (VALSARTAN/ HCTZ) and levothyroxine sodium (SYNTHROID). The patient underwent lab tests and procedures which included covid-19 positive on 26Mar2021. The patient received two doses 6 weeks ago and now she got covid on 26Mar2021. Caller wanted to report quality effectiveness on the COVID vaccine. She received two doses 6 weeks ago and now she got COVID. She is not very happy.  first and second shot of Her whole family had the Pfizer and a member of her immediate family is a cancer patient. Clarified caller is not a cancer patient. She states if anything happens to this person then everyone is going to hear from her. They are now in isolation, in separate rooms in their house. Pfizer needs to go back to the drawing board for research. She still fighting the first battle. She thought Pfizer made made some products but she guesses not. She follows all the rules, she only goes to the store just to get some food. She wears two masks, two gloves, sometimes one pair of gloves and now she wears a face shield and people are laughing at her like hahaha and she doesn't care because she is just there to get her groceries. Pfizer needs some quality control. She states this is a serious matter to her. The nature of her call to let you know what is going on, and if she can do something to improve the quality of the vaccine. Okay at least she is safe for a little while, instead of staying one room each, in her house, instead of all being together, they are stuck in isolation. The outcome of covid was recovering and other was unknown.  Follow up needed, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This is a spontaneous report from a contactable consumer reporting for his mother. A 73-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient medical history and concomitant medication was not reported. The patient suffered from headaches and took paracetamol (TYLENOL) on unknown date with outcome of unknown.  No follow-up attempts are needed. No further information is expected. Information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Mar2021 16:00 (Lot Number: EN6205, NDC number: 1000207028520) at SINGLE DOSE in Arm Left for covid-19 immunisation. Medical history included ongoing Rheumatoid arthritis, ongoing lupus , ongoing Osteoarthritis, ongoing autoimmune diseases.  The patient's concomitant medications were not reported. No Prior Vaccinations (within 4 weeks). The patient experienced soreness in her arm on 18Mar2021 with outcome of recovered on 19Mar2021.  It was probably less than 12 hours and the soreness was gone.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dry throat, Dysphonia, Hypersensitivity, Nasal congestion
Clinical narrative: allergies became very bothersome; sinuses felt raw and were burning; sinuses felt raw and were burning; nose very stuffy, and runny; nose very stuffy, and runny; Throat became dry; voice scratchy; intermittent dry cough; upper respiratory irritation; This is a spontaneous report from a non-contactable healthcare professional (patient). A 67-year-old male patient received bnt162b2 (BNT162B2), second dose via an unspecified route of administration, administered in the right arm in Feb2021 (lot number: EN6198) as single dose for COVID-19 immunization. Medical history included pollen allergies and hay fever. Ongoing concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and fluticasone propionate (FLONASE ALLERGY RELIEF); both taken for allergies, start and stop date were not reported. The patient took BNT162B2 first dose (lot number was not reported) in Feb2021 in the left arm (at the age of 67-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Mar2021, several days after receiving second vaccination shot, and while continuing with his allergy medications, the allergies became very bothersome, sinuses felt raw and were burning, nose very stuffy, and runny. Throat became dry, voice scratchy, intermittent dry cough, and upper respiratory irritation. It has been 4 weeks since his second Pfizer vaccination and still have symptoms, but over the last few days symptoms seemed to be lessening. The patient was hoping that the reduction in symptoms continues and to be back to normal soon. The patient did not receive any treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to the vaccine and has not been tested for COVID-19 since the vaccination. The patient considered the events to be non-serious. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Respiratory tract irritation, Rhinorrhoea, Sinus disorder, Sinus pain
Clinical narrative: allergies became very bothersome; sinuses felt raw and were burning; sinuses felt raw and were burning; nose very stuffy, and runny; nose very stuffy, and runny; Throat became dry; voice scratchy; intermittent dry cough; upper respiratory irritation; This is a spontaneous report from a non-contactable healthcare professional (patient). A 67-year-old male patient received bnt162b2 (BNT162B2), second dose via an unspecified route of administration, administered in the right arm in Feb2021 (lot number: EN6198) as single dose for COVID-19 immunization. Medical history included pollen allergies and hay fever. Ongoing concomitant medications included cetirizine hydrochloride (ZYRTEC ALLERGY) and fluticasone propionate (FLONASE ALLERGY RELIEF); both taken for allergies, start and stop date were not reported. The patient took BNT162B2 first dose (lot number was not reported) in Feb2021 in the left arm (at the age of 67-years-old) for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Mar2021, several days after receiving second vaccination shot, and while continuing with his allergy medications, the allergies became very bothersome, sinuses felt raw and were burning, nose very stuffy, and runny. Throat became dry, voice scratchy, intermittent dry cough, and upper respiratory irritation. It has been 4 weeks since his second Pfizer vaccination and still have symptoms, but over the last few days symptoms seemed to be lessening. The patient was hoping that the reduction in symptoms continues and to be back to normal soon. The patient did not receive any treatment for the adverse events. The patient was not diagnosed with COVID-19 prior to the vaccine and has not been tested for COVID-19 since the vaccination. The patient considered the events to be non-serious. The patient was recovering from the events.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness transitory
Clinical narrative: hearing in his right ear was lost/Late the next morning, his hearing had mostly returned and had been getting better; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (reported as "COVID 19 vaccine"), via an unspecified route of administration on 31Mar2021 10:15 (Batch/Lot number was reported as not sure) (at the age of 46-year-old male) as single dose for covid-19 immunisation. Medical history reported as none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had no known allergies to medications, food, or other products and no other medical history. The patient's concomitant medications were not reported. The patient experienced hearing in my right ear was lost on an unspecified date. The reporter stated that not sure if qualifies as an adverse event, but around 7:00 p.m. yesterday (01Apr2021 19:00), his hearing in his right ear was lost. That was about 32 hours from receiving the second dose. Late the next morning (02Apr2021), his hearing had mostly returned and had been getting better. He was not aware this could be a side effect off event. No treatment was received for events. The outcome of the event was recovering.  Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: He was septic; This is a spontaneous report from a contactable consumer. An 83-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 28Jan2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was septic. It was reported that his other vaccination was closely 21 days after that's okay, so they took him to primary care physician. He will be perused in rehab and they were supposed to do on 04Mar2021. They were asking if his second shot is going to be good. His primary care said it to Johnson and Johnson, but it was not supposed to mix them. Outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Atrial fibrillation, Cardiac disorder
Clinical narrative: her husband is in atrial fibrillation right now/a fib after first dose of vaccine; heart problems; he developed arrythmia; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sponsored program. A male patient received bnt162b2 dose 1 via unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included a fib. The patient's concomitant medications were not reported. The patient had heart problems and went into atrial fibrillation after the first dose of Pfizer COVID vaccine, and he is due for his second dose on 05Apr2021. The reporter stated his doctor had advised that he still should receive the second dose despite being in atrial fibrillation. No information in USPI regarding atrial fibrillation after second dose and safety of receiving second dose. The reporter asked if this is okay. The patient developed arrythmia and was seeking medical care. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Therapeutic response unexpected
Clinical narrative: increase discomfort in both my biceps arms; notice an immediate reduction in this discomfort that I have for many years in both of my arms and it is still to say now It's much better than that was; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration in Jan2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient's medical history includes: quite severe pain in upper arm muscles taking the biceps, they were also very weak and discomfort in both of arms. Concomitant medications were not reported. The patient actually had a very positive experience from the vaccine and not a negative. Further mentioned, had a positive reaction to the vaccine and the improvement of some condition that patient previously have, after having the second dose of the vaccine. For couple of days, there was increase discomfort in both biceps arm. When those symptoms went after second to third day, patient notice an immediate reduction in this discomfort that patient have for many years in both of arms and now it's much better than it was and put it down to a positive side effect of the vaccine. Consumer added, "It's not a co-incident, it's definitely the vaccine that did that for me so I just want to let you know in case your research and people interested." Outcome of events was reported as recovering.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest injury, Chest pain, Cough, Dyspnoea, Electrocardiogram
Clinical narrative: my chest hurt; I started coughing all of a sudden.; My heart started raising.; I had to lay on my stomach to relieve the pressure and pain in my chest.; I was having troubling breathing; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 18:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose (lot number: 6207) of the same vaccine on 09Mar2021 at 06:30 am in left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient reported that she had the second dose at 6:30 p.m. By 10:30 a.m. the next day she started coughing all of a sudden. Needed to take an inhaler to some what calm it down. Her heart started raising. That evening she had to lay on her stomach to relieve the pressure and pain in her chest. The following day went to the doctor because her heart was raising so much that she was having troubling breathing and her chest hurt. They did an EKG it was concerning of how fast her heart was beating. That same day the patient was sent to a cardiologist. Her heart was still raising and they did a EKG and the beats were about average. So then she had an Cardio gram and that was normal. The next day the doctor called and gave her the ECO reports and the cardiologist believed it was from the vaccine. The onset date of all adverse events was reported as on 31Mar2021 at 10:30AM. All events were reported as non-serious by reporter. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The outcome of all the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Investigation
Clinical narrative: my chest hurt; I started coughing all of a sudden.; My heart started raising.; I had to lay on my stomach to relieve the pressure and pain in my chest.; I was having troubling breathing; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 30Mar2021 at 18:30 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose (lot number: 6207) of the same vaccine on 09Mar2021 at 06:30 am in left arm for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient reported that she had the second dose at 6:30 p.m. By 10:30 a.m. the next day she started coughing all of a sudden. Needed to take an inhaler to some what calm it down. Her heart started raising. That evening she had to lay on her stomach to relieve the pressure and pain in her chest. The following day went to the doctor because her heart was raising so much that she was having troubling breathing and her chest hurt. They did an EKG it was concerning of how fast her heart was beating. That same day the patient was sent to a cardiologist. Her heart was still raising and they did a EKG and the beats were about average. So then she had an Cardio gram and that was normal. The next day the doctor called and gave her the ECO reports and the cardiologist believed it was from the vaccine. The onset date of all adverse events was reported as on 31Mar2021 at 10:30AM. All events were reported as non-serious by reporter. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The outcome of all the events was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: COVID positive on 4/2; COVID positive on 4/2; This is a spontaneous report from a contactable physician. A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on 13Mar2021 (Batch/Lot number was not reported) as single dose, and first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID 19. As reported, since the vaccination, the patient had been tested for COVID 19 on 02Apr2021 and the COVID test result was positive (COVID positive on 4/2). Test name was nasal swab. The COVID was tested post vaccination. The event was not resulted in death, Life threatening, causing/prolonging hospitalization, disabling/incapacitating or congenital anomaly/birth defect. The outcome of the event was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events of COVID-19 test positive and drug ineffective due to temporal relationship.  Case will be re-assessed upon the additional information provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: one eye is red like it has vessels like broken or bleeding in there; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was feeling ok and everything, but one eye was red like it had vessels like broken or bleeding in there on 02Apr2021, she said it didn't hurt. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Some blood clot on both of her legs; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received the 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 a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced some blood clot on both of her legs on an unspecified date. It was reported that patient would have a procedure on Friday and then she was going to go for the vaccination on Saturday. they would like to known if there was any problem for her to have the vaccination done. The outcome of the event was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Nasopharyngitis, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: diagnosis with upper respiratory tract infection; he came down with cold; sore throat; congestion/stuffy nose and head; This is a spontaneous report from a contactable consumer reporting on himself. A 71-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Approximately an unspecified date in 2021, (reported as on Thursday), the patient came down with cold, sore throat, congestion, stuffy nose and head, went to emergency room (ER) and the patient was diagnosis with upper respiratory tract infection and his temperature is 98.1. On an unspecified date in 2021, the patient was tested with COVID but not detected. Caller stated he was scheduled to get his second dose today in 3 hours. Caller wanted to know should he take his section dose today. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: diagnosis with upper respiratory tract infection; he came down with cold; sore throat; congestion/stuffy nose and head; This is a spontaneous report from a contactable consumer reporting on himself. A 71-year-old male patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection) via an unspecified route of administration on an unspecified date (Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Approximately an unspecified date in 2021, (reported as on Thursday), the patient came down with cold, sore throat, congestion, stuffy nose and head, went to emergency room (ER) and the patient was diagnosis with upper respiratory tract infection and his temperature is 98.1. On an unspecified date in 2021, the patient was tested with COVID but not detected. Caller stated he was scheduled to get his second dose today in 3 hours. Caller wanted to know should he take his section dose today. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: fever; HEADACHE; achy and sore; This is a spontaneous report from a non-contactable consumer. A 29-year-old male consumer reported for himself that he received a dose of BNT162B2 (COMIRNATY, Lot number: unknown, Expiry date: Unknown) on an unknown date as a single dose for COVID-19 immunization. The reporter mentioned that he is currently suffering achy and sore all over, slight fever and headache. The clinical outcome of the events were unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Developed Covid after vaccinataion; Developed Covid after vaccinataion; This is a spontaneous report received from contactable consumer (patient himself) reported that a  a male patient of an unspecified age received his 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 a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after the first dose, the patient experienced what he thought were side effects. He developed Covid after vaccination and wanted to know if this will affect efficacy and the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's husband). A 50-years-old female patient (wife) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested negative for COVID-19 before the vaccine and after getting the vaccine 4-5 days later then she got positive for the virus today (02Apr2021). The outcome was unknown. Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Cough, Fatigue, Headache, Pyrexia
Clinical narrative: tired; coughing; Minor fever; headache; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced tired, coughing, minor fever and headache on an unspecified date. The patient wanted to know if being tired, coughing, and minor fever are normal side effects after the COVID-19 vaccine dose. Outcome of the events was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fall, Lip injury, Myalgia
Clinical narrative: fainted after the first shot and fell down face forward and busted her lip; fainted after the first shot and fell down face forward and busted her lip; fainted after the first shot and fell down face forward and busted her lip; rash on arms, back and chest; Blurred vision; Joint and muscle pain.; Joint and muscle pain; Weak and having to walk with a cane.; This is a spontaneous report from a contactable consumer(patient). A 68 years old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient was having some symptoms and she need to talk to someone about what to do about them. She had nausea and diarrhea, severe pain in her abdomen feeling like a knife stabbing her mostly left side. It was excruciating. She got the second vaccine yesterday and all the above events started last night. She had chills, headache, mental clarity and can't think straight and weak after the second dose. She fainted after the first shot and fell down face forward and busted her lip. She had quite a few side effects. Blurred vision, rash on arms, back and chest. Joint and muscle pain. Weak and having to walk with a cane. The outcome of the events was unknown.  No follow-up attempts are possible; information about batch number cannot be obtained.