chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Heart rate, Heart rate increased, Malaise
Clinical narrative: He is been sick all night/ Feeling unwell; Injection site pain; Headache; Chills; Fever; Fallen back to just sleep and a fast heartbeat; Fallen back to just sleep and a fast heartbeat; This is a spontaneous report from a contactable consumer (wife).  A 75-year-old male patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at the left arm 01Feb2021 11:15 at SINGLE DOSE for Covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. It was reported that "I am calling for about my husband (patient), well he took the Pfizer Vaccine (Covid-19 Vaccine) yesterday at 11:15 on the 01Feb2021 and he's been sick all night, he had the injection site pain, he has headache, chills, fever, he is just feeling unwell, I mean I think he is fallen back to just sleep and a fast heartbeat." For the treatment it was stated "Well, he in just on Tylenol, to keep his temperature down." There was no visit made to Physician Office/ Emergency Room and the reporter stated, "No, we haven't, I just wanted you to know there are some adverse effect that I am afraid people can't get through, I held it for 30 minutes, I don't know if you found out how many people get sick about it?" The reporter asked, "I kind of have a question, should the person if they have that much problem with that should he take the second shot." The outcome of the events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence, Vaccination site pain
Clinical narrative: He is been sick all night/ Feeling unwell; Injection site pain; Headache; Chills; Fever; Fallen back to just sleep and a fast heartbeat; Fallen back to just sleep and a fast heartbeat; This is a spontaneous report from a contactable consumer (wife).  A 75-year-old male patient (also the age at vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at the left arm 01Feb2021 11:15 at SINGLE DOSE for Covid-19 immunization. The patient medical history and patient's concomitant medications were not reported. It was reported that "I am calling for about my husband (patient), well he took the Pfizer Vaccine (Covid-19 Vaccine) yesterday at 11:15 on the 01Feb2021 and he's been sick all night, he had the injection site pain, he has headache, chills, fever, he is just feeling unwell, I mean I think he is fallen back to just sleep and a fast heartbeat." For the treatment it was stated "Well, he in just on Tylenol, to keep his temperature down." There was no visit made to Physician Office/ Emergency Room and the reporter stated, "No, we haven't, I just wanted you to know there are some adverse effect that I am afraid people can't get through, I held it for 30 minutes, I don't know if you found out how many people get sick about it?" The reporter asked, "I kind of have a question, should the person if they have that much problem with that should he take the second shot." The outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Pain in extremity
Clinical narrative: 2 lumps on the collarbone, in the front. She guesses, they were lymph nodes; arm hurting; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: EL8982), via an unspecified route of administration on 29Jan2021 (1:00-1:30pm) at single dose on the upper left arm (arm left) for COVID-19 immunisation (reported as "age 63, diabetes, is lucky to get being a part-time educator"). Vaccination facility type was school. Vaccine was not administered at military facility. Medical history included ongoing diabetes.The patient's concomitant medications were not reported. No other vaccines given the same day or 4 weeks prior. On 29Jan2021 (Friday), patient got her first COVID shot. On 01Feb2021, patient noticed she has 2 lumps on the collarbone, in the front. She guesses, they were lymph nodes. Patient called her doctor's office and was told to call Pfizer to ask for guidance. No other vaccines given the same day or 4 weeks prior. Patient had the usual arm hurting. In the past, she had the Shingles vaccine, felt kind of achy and a little tiredness, but never had this happen before (also reported as "AE(s) following prior vaccinations: arm hurt, kind of achy and a little tiredness). Patient was going to wait to see if they go away, hoping they would go away and then if not she would make an appointment. Patient has diabetes and takes medication for that, but does not provide any further details. She wanted to know if this is something others have experienced or if this side effect has been reported or to possibly be expected. The events did not require emergency room and physician office visit. There were no family medical history relevant to events and relevant tests. Outcome of the events was not recovered (reported as ongoing).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Cough, Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: exposed to someone who was diagnosed today with Covid; I had symptoms and chills; I now have a something in my chest; I do have little cough in my chest; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she has questions, they received their first, she and her husband were senior citizen they received their first Pfizer Covid 19 vaccine on 21Jan2021 and they have been exposed to someone who was diagnosed today with Covid. She had symptoms and chills days ago, chills and she now has something in her chest you know she was kind of, she was not, she doesn't have a fever, she has not run a fever or she doesn't feel horrible but she does have little cough in her chest. So, her question was since she and her husband had their test over a week and half ago, and this person who was now tested positive had their test too, had their first shot of Pfizer Covid vaccine two and half weeks ago, but now they were positive with Covid, what was their, how do they (she and her husband) proceed here, with their health concerns, he was definitely quarantined, okay, for 10 days but (incomplete sentence). The patient stated she already contacted her healthcare provider just waiting for a call from them but she thought maybe you would have some kind of input or information, you know if the shot was going to be affective if she tests positive or was this going to be affective for him, was it going to be affective for them or was it not going to be affective at all, and why did he get sick after getting the first shot. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown results on Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: exposed to someone who was diagnosed today with Covid; I had symptoms and chills; I now have a something in my chest; I do have little cough in my chest; This is a spontaneous report from a contactable consumer (reported for herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated she has questions, they received their first, she and her husband were senior citizen they received their first Pfizer Covid 19 vaccine on 21Jan2021 and they have been exposed to someone who was diagnosed today with Covid. She had symptoms and chills days ago, chills and she now has something in her chest you know she was kind of, she was not, she doesn't have a fever, she has not run a fever or she doesn't feel horrible but she does have little cough in her chest. So, her question was since she and her husband had their test over a week and half ago, and this person who was now tested positive had their test too, had their first shot of Pfizer Covid vaccine two and half weeks ago, but now they were positive with Covid, what was their, how do they (she and her husband) proceed here, with their health concerns, he was definitely quarantined, okay, for 10 days but (incomplete sentence). The patient stated she already contacted her healthcare provider just waiting for a call from them but she thought maybe you would have some kind of input or information, you know if the shot was going to be affective if she tests positive or was this going to be affective for him, was it going to be affective for them or was it not going to be affective at all, and why did he get sick after getting the first shot. The patient underwent lab tests and procedures which included SARS-CoV-2 test: unknown results on Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Dry mouth, Fatigue, Taste disorder
Clinical narrative: Terrible burning sensation immediately after injection; Weird taste in mouth; Fatigue; Very thirsty; Mouth was dry; a little weak; Has a little anxiety every now and then; This is a spontaneous report from a contactable consumer (patient). A 69 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263, expiration date:May2021), via an unspecified route of administration (on left arm) on 31Jan2021 09:15 (at the age of 69 -years-old), single dose for COVID-19 immunization. Medical history included ongoing chronic kidney disease and asthma. The patient's concomitant medications were not reported. Patient had Sore arm, left arm. Confirmed left arm received the COVID-19 Vaccine. Arm is still sore, but not as bad as the first and second day. Terrible burning sensation immediately after injection. Asked if that was normal. Felt injection going in. Patient had weird taste in mouth, very thirsty, mouth was dry. Could have been nerves because has a little anxiety every now and then. Today can taste blueberries and oatmeal. Almost like taste buds are back to normal. Patient had fatigue after he got home from the injection. Felt a little weak. Subsided for the most part and felt better yesterday afternoon. All the events started 31Jan2021. The outcome of the event vaccination site burning was not recovered, other events are unknown. No prior vaccination within 4 weeks, no adverse events following prior vaccinations.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Thirst, Vaccination site pain
Clinical narrative: Terrible burning sensation immediately after injection; Weird taste in mouth; Fatigue; Very thirsty; Mouth was dry; a little weak; Has a little anxiety every now and then; This is a spontaneous report from a contactable consumer (patient). A 69 -year-old male patient received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263, expiration date:May2021), via an unspecified route of administration (on left arm) on 31Jan2021 09:15 (at the age of 69 -years-old), single dose for COVID-19 immunization. Medical history included ongoing chronic kidney disease and asthma. The patient's concomitant medications were not reported. Patient had Sore arm, left arm. Confirmed left arm received the COVID-19 Vaccine. Arm is still sore, but not as bad as the first and second day. Terrible burning sensation immediately after injection. Asked if that was normal. Felt injection going in. Patient had weird taste in mouth, very thirsty, mouth was dry. Could have been nerves because has a little anxiety every now and then. Today can taste blueberries and oatmeal. Almost like taste buds are back to normal. Patient had fatigue after he got home from the injection. Felt a little weak. Subsided for the most part and felt better yesterday afternoon. All the events started 31Jan2021. The outcome of the event vaccination site burning was not recovered, other events are unknown. No prior vaccination within 4 weeks, no adverse events following prior vaccinations.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Agitation, Arthralgia, Balance disorder, Confusional state, Decreased appetite
Clinical narrative: Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Headache, Nasal congestion, Pain, Sneezing
Clinical narrative: Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Intense pain; intense joint pain; intense eye pain; intense headache; loss of balance; loss of appetite; stuffy nose; sneezing; drowsiness; confusion; agitation; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 49-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 9269) via unspecified route on left arm single dose for COVID-19 immunization on 01Feb2021, 04:00 PM at 49-year-old. Medical history included: osteoarthritis, guttate psoriasis, degenerative disc disease, fibromyalgia, COVID-19, known allergies. Concomitant medication was not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK923) left arm for COVID-19 immunization on14Jan2021, 01:30 PM at 49-year-old; had body aches, fever, sore arm and skin ach. No other vaccine received in four weeks. On 02Feb2021, 02:00 AM, the patient had intense pain, intense joint pain, intense eye pain, intense headache, loss of balance, loss of appetite, stuffy nose, sneezing, drowsiness, confusion, agitation. Outcome of the events was not resolved.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test false positive
Clinical narrative: had a positive PCR; This is a spontaneous report from a contactable healthcare professional reporting for herself. This female patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced COVID-19 virus test false positive on 22Jan2021. The patient had a positive PCR on 22Jan2021 and she was advised to go ahead and get her dose of the vaccine.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Lymphadenopathy, Pain
Clinical narrative: 101 fever; lymph node swelling in my arm; full body aches and chills; full body aches and chills; headache; This 27- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 16Feb2021 (at the age of 27-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2. Medical history and concomitant medications not reported. On 16Feb2021, the patient experienced a 101 fever, lymph node swelling in my arm, full body aches and chills, headache. The patient did not receive treatment for the events. The clinical outcome of the events 101 fever, lymph node swelling in my arm, full body aches and chills, headache was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101 fever; lymph node swelling in my arm; full body aches and chills; full body aches and chills; headache; This 27- year-old female patient contactable consumer (reported for herself) received the second dose BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 16Feb2021 (at the age of 27-years-old) as a single dose for COVID-19 immunization. The facility where COVID-19 vaccine was administered was at a Workplace clinic. She has had no other vaccines on the same day or in the past 4 weeks. The patient is not pregnant. Prior to the vaccination, the patient was not diagnosed with COVID-19. Historical Vaccine included first dose of BNT162B2. Medical history and concomitant medications not reported. On 16Feb2021, the patient experienced a 101 fever, lymph node swelling in my arm, full body aches and chills, headache. The patient did not receive treatment for the events. The clinical outcome of the events 101 fever, lymph node swelling in my arm, full body aches and chills, headache was recovering. It was reported that since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Muscle spasms, Neck pain, Pain in extremity
Clinical narrative: second dose soreness in left arm, Nightime pain in right arm; cold not full chills but cold; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; shoulder neck down to wrist very sharp pains like muscle cramps; This is a spontaneous report from a contactable 72-year-old female consumer reported for herself that she received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3247) single dose on 16Feb2021 09:00 AM at left arm for COVID-19 immunization. Medical history was not provided. Historical vaccine included 1st dose of BNT162B2 (EL3247) on 25Jan2021 at 11:30 AM at left arm for COVID-19 immunization. Concomitant drugs included lisinopril, levothyroxine sodium (LEVOTHYROXIN), pravastatin, vitamin D and vitamin K. The patient reported second dose soreness in left arm, cold not full chills but cold, Nightime pain in right arm, shoulder neck down to wrist very sharp pains like muscle cramps started on 17Feb2021 at 01:00 AM. No treatment was received for the events. Event outcome was recovered.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Fatigue, Vaccination site pain
Clinical narrative: Pain in the injection site on left arm; dizziness; fatigue; back pain; This is a spontaneous report from a contactable consumer (patient). A 38-year-old male patient received second dose of bnt162b2 (lot number: 3247), via an unspecified route of administration, at arm left, on 16Feb2021 09:45 at single dose for COVID-19 immunisation. The patient medical history was not reported. No allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication included fluticasone propionate (FLONASE) within 2 weeks of vaccination. Historical vaccine included first dose of bnt162b2 (lot number: 3247) at left arm on 26Jan2021 09:45 at 38-year-old for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Pain in the injection site on left arm; dizziness the next morning; fatigue; back pain on 17Feb2021. No treatment received for the adverse event. The case was reported as not serious.  The outcome of the events were not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Hyperhidrosis, Hypoaesthesia, Metamorphopsia, Muscle spasms
Clinical narrative: Within 1-2 minutes I experienced full body tingling; facial numbness; vision became distorted/blurry; vision became distorted/blurry; whole body was sweating; abdominal pain; lower extremity aching; nausea; experienced moderate to severe lower back spasms; sciatica; This is a spontaneous report from a contactable other health professional (patient). This 25-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# ELO739), via intramuscular on 04Feb2021 03:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history included medullary kidney disease, and allergies to iodized contrast and bees (both resulting in anaphylaxis). The patient did not received any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine administered was Public Health Clinic/Veterans Administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 1-2 minutes (03:15) patient experienced full body tingling and facial numbness. A minute later his vision became distorted/blurry and he began getting warn. A minute later his whole body was sweating, he was experiencing abdominal pain, lower extremity aching, and nausea. These symptoms other than the sweating persisted for another 5 days. After the 5th day, patient experienced moderate to severe lower back spasms and sciatica that resulted in an urgent care visit and a prescription for muscle relaxers and a mild pain reliever. The muscle spasms have been present for a week now and is slowly getting better. Patient was seen by an orthopedic urgent care where they recommended physical therapy and limited walking/sitting for extended periods of time. The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included diphenhydramine hydrochloride (BENADRYL) (day of vaccination) and muscle relaxers. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of whole body was sweating and sciatica was not recovered, outcome of moderate to severe lower back spasms was recovering, outcome of other events was recovered on an unspecified date in Feb2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on event-vaccine chronological association, a causal relationship between reported events and BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE) cannot be 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: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Paraesthesia, Sciatica, Vision blurred
Clinical narrative: Within 1-2 minutes I experienced full body tingling; facial numbness; vision became distorted/blurry; vision became distorted/blurry; whole body was sweating; abdominal pain; lower extremity aching; nausea; experienced moderate to severe lower back spasms; sciatica; This is a spontaneous report from a contactable other health professional (patient). This 25-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot# ELO739), via intramuscular on 04Feb2021 03:15 at single dose in the left arm for COVID-19 immunization. The patient's medical history included medullary kidney disease, and allergies to iodized contrast and bees (both resulting in anaphylaxis). The patient did not received any other medications within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine administered was Public Health Clinic/Veterans Administration facility. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 1-2 minutes (03:15) patient experienced full body tingling and facial numbness. A minute later his vision became distorted/blurry and he began getting warn. A minute later his whole body was sweating, he was experiencing abdominal pain, lower extremity aching, and nausea. These symptoms other than the sweating persisted for another 5 days. After the 5th day, patient experienced moderate to severe lower back spasms and sciatica that resulted in an urgent care visit and a prescription for muscle relaxers and a mild pain reliever. The muscle spasms have been present for a week now and is slowly getting better. Patient was seen by an orthopedic urgent care where they recommended physical therapy and limited walking/sitting for extended periods of time. The adverse event result in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Treatment received for the adverse event included diphenhydramine hydrochloride (BENADRYL) (day of vaccination) and muscle relaxers. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Outcome of whole body was sweating and sciatica was not recovered, outcome of moderate to severe lower back spasms was recovering, outcome of other events was recovered on an unspecified date in Feb2021.  Information on the lot/batch number has been requested.; Sender's Comments: Based on event-vaccine chronological association, a causal relationship between reported events and BNT162B2  (PFIZER-BIONTECH COVID-19 VACCINE) cannot be 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: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain
Clinical narrative: Chills; Body aches lasting a while; Joint pain everywhere; Head ache; This is a spontaneous report from a contactable consumer reported for herself. A 40-year-old female patient (not pregnant) received second dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 16Feb2021 10:00 AM (age at vaccination was 40 years old, vaccine location: Right arm) at single dose for COVID-19 immunisation. Previous vaccine included first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number EL3247 and Expiration Date unknown) via an unspecified route of administration on 26Jan2021 11:15 AM (vaccine location: Right arm) at single dose for COVID-19 immunisation. The patient's medical history included environmental allergies. The concomitant medications were reported none.Patient experienced chills, body aches lasting a while, joint pain everywhere and headache, all starting 14 hours and 30 mins after second dose on 17Feb2021.The outcome of events was recovering without treatment given.  Information on the batch/Lot number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: chills; headache; low-grade fever (100 F); This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (EN5318) in left arm on 16Feb2021 14:00 at a single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history was not reported. Allergies to medications, food, or other products was no. Pregnant at the time of vaccination was no. Prior to vaccination, was the patient diagnosed with COVID-19 was no. Concomitant medication included iron. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was no. List of any other medications the patient received within 2 weeks of vaccination was iron. Historical vaccine included the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot: EN5318) in left arm on 26Jan2021 14:00 for COVID-19 immunization. Patient experienced chills, headache and low-grade fever (100 F) on 17Feb2021 02:00 for about 16 hours. No treatment was received. The outcome of the events was recovered. Events was considered non-serious. Since the vaccination, has the patient been tested for COVID-19 was no.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the first dose of BNT162B2, via an unspecified route of administration on 02Feb2021 14:30 at single dose in Right arm for COVID-19 immunisation. Medical history included known allergies: Duck eggs, rheumatoid arthritis (RA), type 2 diabetes, all from an unknown date. Concomitant medications included RA injections. There was no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient experienced shingles on 08Feb2021. Covid was not tested post vaccination.  Therapeutic measures were taken as a result of shingles which included unspecified medication. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of event was recovering.  Information about lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Contusion, Headache, Petechiae, Platelet count
Clinical narrative: flare up of my autoimmune thrombocytopenia; Platelets dropped to 109k; legs covered in petechiae and bruising; legs covered in petechiae and bruising; After 2nd dose, 1 day of headache; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK4176 intramuscular in left deltoid on 07Jan2021 as single dose (at the age of 33 years) for COVID-19 immunisation.  Patient had history of ongoing Autoimmune Thrombocytopenia from May2020, ongoing migraines, depression/anxiety and ADHD, and COVID-19 21Apr2020 to "05May2021".  Concomitant medication included Sertraline Hydrochloride (ZOLOFT), Lisdexamfetamine mesilate (VYVANSE), Lorazepam  (Ativan), Ondasetron (ZOFRAN) and Sumatriptan succinate (IMITREX).  Historical information regarding dose 1 of BNT162B2 on 17Dec2020 included a moderate injection site reaction lasting 6 days worst on day three. Reaction was characterized by redness, swelling elevated rash surrounding injection site, aching pain radiating from neck to fingers and tenderness to palpitation.  1st dose Vaccine Lot Number: EJ1685, Vaccine Lot Expire Date: Mar2021, Time the Vaccination Was given: 08:00.  After the 2nd dose the patient experienced a moderate headache on 08Jan2021 12:00 for 1 day which responded well to APAP- caffeine and resolved on 09Jan2021 12:00 Patient had a flare up of my autoimmune thrombocytopenia as evidenced by legs covered in petechiae and bruising on 09Jan2021. Emergency room and physician office were not visited however, patient does have standing CBC orders from hematologist, so she had platelet count checked. It had dropped to 109K/uL, which is low for me but not dangerous. Patient originally developed autoimmune thrombocytopenia (ITP) May2021 after COVID Apr2021. Both instances of these side effects were manageable, but patient wanted to report them as there was no data yet available on ITP with the vaccine when she met with hematologist to discuss it. Patient received Acetaminophen 650mg PO (per oral) as treatment.  Lab data included Platelets 13Oct2020 124 kiU/L (normal 140-400) and on 12Jan2021 109 KiU/L.  Event flare up of my autoimmune thrombocytopenia resolved on 31JAN2021 00:00, Platelets dropped to 109k resolved on 31JAN2021 00:00, legs covered in petechiae and bruising resolved on 31JAN2021 00:00 and headache resolved 09Jan2021.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count decreased
Clinical narrative: flare up of my autoimmune thrombocytopenia; Platelets dropped to 109k; legs covered in petechiae and bruising; legs covered in petechiae and bruising; After 2nd dose, 1 day of headache; This is a spontaneous report from a contactable consumer. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EK4176 intramuscular in left deltoid on 07Jan2021 as single dose (at the age of 33 years) for COVID-19 immunisation.  Patient had history of ongoing Autoimmune Thrombocytopenia from May2020, ongoing migraines, depression/anxiety and ADHD, and COVID-19 21Apr2020 to "05May2021".  Concomitant medication included Sertraline Hydrochloride (ZOLOFT), Lisdexamfetamine mesilate (VYVANSE), Lorazepam  (Ativan), Ondasetron (ZOFRAN) and Sumatriptan succinate (IMITREX).  Historical information regarding dose 1 of BNT162B2 on 17Dec2020 included a moderate injection site reaction lasting 6 days worst on day three. Reaction was characterized by redness, swelling elevated rash surrounding injection site, aching pain radiating from neck to fingers and tenderness to palpitation.  1st dose Vaccine Lot Number: EJ1685, Vaccine Lot Expire Date: Mar2021, Time the Vaccination Was given: 08:00.  After the 2nd dose the patient experienced a moderate headache on 08Jan2021 12:00 for 1 day which responded well to APAP- caffeine and resolved on 09Jan2021 12:00 Patient had a flare up of my autoimmune thrombocytopenia as evidenced by legs covered in petechiae and bruising on 09Jan2021. Emergency room and physician office were not visited however, patient does have standing CBC orders from hematologist, so she had platelet count checked. It had dropped to 109K/uL, which is low for me but not dangerous. Patient originally developed autoimmune thrombocytopenia (ITP) May2021 after COVID Apr2021. Both instances of these side effects were manageable, but patient wanted to report them as there was no data yet available on ITP with the vaccine when she met with hematologist to discuss it. Patient received Acetaminophen 650mg PO (per oral) as treatment.  Lab data included Platelets 13Oct2020 124 kiU/L (normal 140-400) and on 12Jan2021 109 KiU/L.  Event flare up of my autoimmune thrombocytopenia resolved on 31JAN2021 00:00, Platelets dropped to 109k resolved on 31JAN2021 00:00, legs covered in petechiae and bruising resolved on 31JAN2021 00:00 and headache resolved 09Jan2021.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: External ear disorder, Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Pharyngeal swelling
Clinical narrative: swelling throat/ear canal on right side; swelling throat/ear canal on right side; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; right face numbness/spread to my lips and up into my eye and ultimately radiating throughout my head; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9265, expiry date not reported), via an unspecified route of administration at the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 30Jan2021 10:45, both times the patient had right face numbness (felt like Novocaine) that started in her right cheek and spread to her lips and up into her eye and ultimately radiating throughout her head, and also swelling throat/ear canal on right side. It was unknown if treatment was received for the events. Clinical outcome of the events was not recovered.
Age: 91.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Syncope, Vomiting
Clinical narrative: syncope; nausea; vomiting; This is a spontaneous report from a contactable consumer (patient). A 91-year-old male patient received the first dose of bnt162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration in right arm on 18Feb2021 13:00 at single dose for covid-19 immunization. Medical history included dementia, diabetes, chronic kidney failure, known allergies: pencillin. Concomitant medication included insulin, metoprolol, memantine, omeprazole (PROTONIX), apixaban (ELIQUIS). On 20Feb2021 21:00, the patient experienced syncope followed by nausea and vomiting lasting about 4 hrs. No treatment received. Events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on 21Feb2021 01:00.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis
Clinical narrative: Vomitting; severe abdominal pain secondary to pancreatitis; severe abdominal pain secondary to pancreatitis; This is a spontaneous report from a contactable Consumer (patient). A 72-years-old female patient (no pregnant) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration on 19Feb2021 10:15 at single dose at right arm for covid-19 immunisation. No pregnant at time of vaccination.  Medical history included Diabetes, three prior strokes, cardiac stent, Seafood and pollen allergy.  Concomitant medication included paracetamol (TYLENOL) and unspecified medication.  The patient experienced Vomitting, severe abdominal pain secondary to pancreatitis for nonalcoholic patient with no history of abdominal pain or gallstone on 19Feb2021 18:00, which lead to Emergency room/department or urgent care, Hospitalization. Hospitalization lasted 4 days. Therapeutic measures were taken as a result of events included unspecified therapy. The outcome of events was recovering.  information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Dizziness, Muscle twitching
Clinical narrative: Bell's Palsy; eye twitching; dizziness; This is a spontaneous report from contactable consumers (one was patient). A 56-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200, expiry date not reported), via an unspecified route of administration at the right arm on 20Feb2021 at single dose for COVID-19 immunization. Medical history included food allergy (reported as allergy to walnuts). The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was vaccinated at a workplace clinic. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (lot number: EL9265, expiry date: not reported) in the right arm on 30Jan2021 10:30 at single dose for COVID-19 immunization but experienced face numbness and swelling throat/ear canal on right side. It was reported that the second dose was even worse than the first time and involved continued eye twitching and significant dizziness. The patient had not sought medical attention yet, but if it continued to get worse, she would call her doctor or (helpline number). The patient reported that it almost feels like Bell's Palsy on an unspecified date. It was unknown if treatment was received for Bell's palsy. Clinical outcome of Bell's palsy was not recovered, while for eye twitching and dizziness was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Blood test, Speech disorder
Clinical narrative: Bell's palsy; She cannot talk real well right now; This is a spontaneous report from a contactable consumer reporting on behalf of the patient. A 67-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6200, unknown expiration), via an unspecified route of administration in right arm on 16Feb2021 at 10:55 at a single dose for COVID-19 immunisation in a hospital.  Medical history included chickenpox and measles (when she was a kid), COVID-19 in 2020 (last year), ongoing anxiety, ongoing blood pressure (abnormal), and ongoing insomnia.  Concomitant medications included pregabalin (LYRICA), celecoxib (CELEXA), and ongoing unspecified anxiety, blood pressure and insomnia medications. The patient received her first dose of BNT162B2 (lot number: EJ1686, unknown expiration) on 20Jan2021 at 11:33 in right arm for COVID-19 immunization. The patient's friend called on behalf of the patient because she cannot talk real well right now (Feb2021). The patient's friend confirmed that the patient went to emergency department and was told that she has Bell's palsy on 18Feb2021 at 14:00 and she has never had it before, and they did not know if it was a side effect from the COVID-19 vaccine or not. The patient received prednisone 20mg 3 times a day, Valpex, antibiotic, and eye drops for right eye as treatments. Blood test was taken on 18Feb2021 with unknown result. The patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebral haemorrhage, Fall, Haemorrhage intracranial, Platelet count, Skull fracture
Clinical narrative: suffered an intracranial hemorrhage; subdural hematoma; fell; skull fracture; hemorrhage to right cerebrum; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the 1st vaccine dose on 01Feb2021. The patient fell on 13Feb2021 with findings of a skull fracture and hemorrhage to right cerebrum and suffered an intracranial hemorrhage and subdural hematoma. The patient was hospitalized and was discharged on 16Feb2021. Her platelets were fine when she was discharged from the hospital. The patient has been home for 2 days and is scheduled to have her second dose of the vaccine on 22Feb2021. The physician wanted to know if the patient should postpone the 2nd dose and for how long or should she keep her appointment. Can the second vaccine dose be postponed past 21 days (as in 6 weeks or past 6 weeks instead of 3?). The outcome of the events was unknown. The patient fell, hit her head and had a brain bleed and fractured the back of her skull; the physician stated that it's not because of the Covid vaccine.   Information on the lot/batch number has been requested.; Sender's Comments: In agreement with the reporting physician, the company considered that the fall and subsequent skull fracture, hemorrhage to right cerebrum, intracranial hemorrhage and subdural hematoma were due to an intercurrent accident, unrelated to suspect vaccine BNT162B2. There is no evidence or argument to suggest a causal relationship between BNT162B2 and the events.
Sex: F
Vaccine: COVID19
Symptoms: Subdural haematoma
Clinical narrative: suffered an intracranial hemorrhage; subdural hematoma; fell; skull fracture; hemorrhage to right cerebrum; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. An 85-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on 01Feb2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received the 1st vaccine dose on 01Feb2021. The patient fell on 13Feb2021 with findings of a skull fracture and hemorrhage to right cerebrum and suffered an intracranial hemorrhage and subdural hematoma. The patient was hospitalized and was discharged on 16Feb2021. Her platelets were fine when she was discharged from the hospital. The patient has been home for 2 days and is scheduled to have her second dose of the vaccine on 22Feb2021. The physician wanted to know if the patient should postpone the 2nd dose and for how long or should she keep her appointment. Can the second vaccine dose be postponed past 21 days (as in 6 weeks or past 6 weeks instead of 3?). The outcome of the events was unknown. The patient fell, hit her head and had a brain bleed and fractured the back of her skull; the physician stated that it's not because of the Covid vaccine.   Information on the lot/batch number has been requested.; Sender's Comments: In agreement with the reporting physician, the company considered that the fall and subsequent skull fracture, hemorrhage to right cerebrum, intracranial hemorrhage and subdural hematoma were due to an intercurrent accident, unrelated to suspect vaccine BNT162B2. There is no evidence or argument to suggest a causal relationship between BNT162B2 and the events.