chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Migraine, Pyrexia, X-ray
Clinical narrative: I ended up having a grand mall seizure; Severe migraine; I then had a fever; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at the age of 51-years-old), dose 2 via an unspecified route of administration, administered in arm left on 04Jun2021 16:00 (Batch/Lot Number: EW 0178) as DOSE 2, SINGLE for COVID-19 immunisation. The patient's medical history included known allergies (unspecified) and seizure disorder. The patient's concomitant medications were not reported. The patient previously took BNT162B2 (at the age of 51-years-old) dose 1 administered in arm left on 28Apr2021 12:00 PM (Batch/Lot Number: EW0176) for COVID-19 immunisation. The patient was not pregnant. She had no other vaccine in four weeks. She had no covid prior vaccination. She had not been covid tested post vaccination. The patient experienced severe migraine and then she ended up having a grand mall seizure and this was actually about 4-4 1/2 hours after she had her second COVID19 vaccination done. She then had a fever that lasted about two and a half days before it broke. Granted she does have a seizure disorder and she wasn't too surprised about having a seizure, however she usually have at least a couple of seconds that she saw stars and she knew that she was going to have one but she was standing up and she had no idea it was happening. The events occurred on 04Jun2021 at 08:00 PM. The events resulted to doctor or other healthcare professional office/clinic visit. The patient recovered from the events with lasting effects. She mentioned that X-Rays were done with unknown results on an unspecified date to make sure that she didn't have. Therapeutic measures were taken as a result of the events. The outcome of grand mall seizure and severe migraine was recovered with sequelae on an unspecified date while fever was recovered on an unspecified date.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Diarrhoea, Fatigue, Food poisoning
Clinical narrative: swollen lymph nodes/tissue under left arm. This felt like cotton balls stuffed under the skin for about a week. It was visibly swollen.; I felt like I had food poisoning after eating dinner; I experienced extreme vomiting and diarrhea; I experienced extreme vomiting and diarrhea; My stomach continued to hurt for the next 4+ days; My fever peaked at 103.2/fever of 99.1; nausea/vomiting; I am extremely tired; lymph nodes are still sore; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 49 years old) via an unspecified route of administration, administered in Arm Left on 03Oct2021 14:15 (Batch/Lot Number: fl2588) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included breast cancer - right side. The patient has no Covid-19 prior to vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and tamoxifen. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 10:15 (at the age of 49 years old) (Batch/Lot No: er8727) and the second dose on 07Apr2021 17:30 (Batch/Lot No: en0151); both via an unspecified route of administration in the left arm for Covid-19 immunization. The patient previously took aspirin and experienced allergies: Reye's syndrome at age 12. The patient had no other vaccine in four weeks. The day after the shot, on 04Oct2021 at 12:30, the patient experienced swollen lymph nodes/ tissue under left arm. The patient stated that it felt like cotton balls stuffed under the skin for about a week. It was visibly swollen. One week post shot (Oct2021), she felt like she had food poisoning after eating dinner. That night, she experienced extreme vomiting and diarrhea. Her stomach continued to hurt for the next 4+ days. Her fever peaked at 103.2 before she called a doctor, and they prescribed a medicine to alleviate the nausea/vomiting. This allowed her to take Tylenol which brought the fever down over the next 2+ days. She was 5 days out now and her stomach still hurts, and she has a fever of 99.1 this AM, her normal temp runs around 97.6. The patient also stated that she was extremely tired, even though she just woke up from sleeping 11 straight hours. The lymph nodes are still sore to the touch but not as swollen as they were. The events resulted in doctor or other healthcare professional office/clinic visit and were treated including medicine to stop vomiting. The patient was not tested for Covid-19 post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Nausea, Pyrexia, Vomiting
Clinical narrative: swollen lymph nodes/tissue under left arm. This felt like cotton balls stuffed under the skin for about a week. It was visibly swollen.; I felt like I had food poisoning after eating dinner; I experienced extreme vomiting and diarrhea; I experienced extreme vomiting and diarrhea; My stomach continued to hurt for the next 4+ days; My fever peaked at 103.2/fever of 99.1; nausea/vomiting; I am extremely tired; lymph nodes are still sore; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (at the age of 49 years old) via an unspecified route of administration, administered in Arm Left on 03Oct2021 14:15 (Batch/Lot Number: fl2588) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. Medical history included breast cancer - right side. The patient has no Covid-19 prior to vaccination. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and tamoxifen. The patient had the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 10:15 (at the age of 49 years old) (Batch/Lot No: er8727) and the second dose on 07Apr2021 17:30 (Batch/Lot No: en0151); both via an unspecified route of administration in the left arm for Covid-19 immunization. The patient previously took aspirin and experienced allergies: Reye's syndrome at age 12. The patient had no other vaccine in four weeks. The day after the shot, on 04Oct2021 at 12:30, the patient experienced swollen lymph nodes/ tissue under left arm. The patient stated that it felt like cotton balls stuffed under the skin for about a week. It was visibly swollen. One week post shot (Oct2021), she felt like she had food poisoning after eating dinner. That night, she experienced extreme vomiting and diarrhea. Her stomach continued to hurt for the next 4+ days. Her fever peaked at 103.2 before she called a doctor, and they prescribed a medicine to alleviate the nausea/vomiting. This allowed her to take Tylenol which brought the fever down over the next 2+ days. She was 5 days out now and her stomach still hurts, and she has a fever of 99.1 this AM, her normal temp runs around 97.6. The patient also stated that she was extremely tired, even though she just woke up from sleeping 11 straight hours. The lymph nodes are still sore to the touch but not as swollen as they were. The events resulted in doctor or other healthcare professional office/clinic visit and were treated including medicine to stop vomiting. The patient was not tested for Covid-19 post vaccination. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Dysgeusia, Head discomfort, Tinnitus
Clinical narrative: ears ringing pressure in head; Taste changed can''t eat bell peppers that I used to love, numerous other foods taste like decomposed metallic taste; ears ringing pressure in head; This is a spontaneous report from a non-contactable consumer. A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 2 via an unspecified route of administration on Sep2021 (Batch/Lot Number: fdo809) as dose 2, single (at the age of 59 years old) for COVID-19 immunisation.  The patient had no medical history. There were no concomitant medications. Patient had no known allergies. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 on Oct2021 (Batch/Lot Number: ewo168) for COVID-19 immunisation. The patient experienced taste changed and can't eat bell peppers that he used to love, numerous other foods taste like decomposed metallic taste, ears ringing pressure in head on an unspecified date. The events were reported to have led to disability. The patient received no treatment. The outcome of the events was not recovered.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Palpitations, Product preparation error
Clinical narrative: The dose was undiluted and the entire vial was administered to the patient.; he dose was undiluted and the entire vial was administered to the patient.; The patient experienced her heart racing and was sent to the Emergency Department; This is a spontaneous report from a contactable nurse.  A 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EW0202 and expiration date: not reported), via an unspecified route of administration, on 15Oct2021, as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter seeking guidance about a Booster dose of the Pfizer Covid-19 Vaccine she gave on 15Oct2021, to a 26-year-old, 4 months post-partum female.  The dose was undiluted, and the entire vial was administered to the patient. The reporter further stated that, accidentally injected the full vial in to somebody, the vaccine instead, without being diluted.  The patient experienced her heart racing and was sent to the Emergency Department. The reporter is asking for guidance about inadvertent higher than recommended dose administered. The outcome of the event Heart racing was unknown at time of report.
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: received both doses of the vaccine and ended up with Covid, and was in the hospital for 8 weeks almost dying; received both doses of the vaccine and ended up with Covid, and was in the hospital for 8 weeks almost dying; This is a spontaneous report, received from a contactable consumer. A male patient of an unspecified age received BNT162B2 (COMIRNATY, solution for injection), via an unspecified route of administration on an unspecified date (lot number and expiry date were not reported) as dose 2, single and via an unspecified route of administration on an unspecified date (lot number and expiry date were not reported) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received both doses of the vaccine and ended up with COVID, and was in the hospital for 8 weeks almost dying on an unspecified date. The patient was hospitalized for the events for 56 days (reported as 8 weeks). The outcome of the events was unknown.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling
Clinical narrative: red areas on face with swelling of lips; red areas on face with swelling of lips; This is a spontaneous report from a contactable pharmacist. A 32-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Left on 14Oct2021 (Batch/Lot Number: FE3592) (at the age of 32 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 on unknown date for covid-19 immunisation. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced red areas on face with swelling of lips on 14Oct2021 with outcome of recovered on Oct2021. Benadryl was used for the event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if the patient been tested for COVID-19  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, Thrombosis, Vaccination site pain
Clinical narrative: Possible blood clots; Numbness in tips of pinky finger and the finger beside it; Soreness at the injection site; States two days after that he felt soreness in his arm; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (COMIRNATY), via an unspecified route of administration, administered in left arm on 21Sep2021 15:30 (at the age of 45-year-old) (Lot Number: EWB161) as dose 1, single for COVID-19 immunization. Medical history included ongoing kidney cancer (diagnosed a year or two years ago and they went in and cut it out). Concomitant indications included none. Prior Vaccinations (within 4 weeks) were none. Two days after vaccination, patient felt soreness in his arm. The patient stated that two days after that on Monday or Tuesday of the next week. The patient stated his pinky finger was now feeling numb and the finger beside it also and the numbness was not going away; The patient stated if he felt this numbness and had just woken up then he would not be upset but it was now 15:30 and he has been up all day and still felt the numbness in his fingertips and it was concerning (patient stated that normally if he was asleep and when he slept on arms, his arms would get numb and the patient would wake up and move). The patient stated he was feeling some type of way and used his other hand to keep rubbing his fingers to get blood flow to it. The patient also said that he had soreness at the injection site and was good to go on that and could take a punch in the arm and it would not be sore. The outcome of injection site soreness and soreness in arm was recovered. The outcome of numbness was not recovered and the outcome of other event was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (lot number was not reported) dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced myocarditis on an unspecified date. The reporting physician requested information on incidence of myocarditis with Covid-19 vaccine. The outcome of the event was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "Myocarditis" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product 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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, COVID-19, Dizziness, Drug ineffective, Gait disturbance
Clinical narrative: sars-cov-2 test positive; sars-cov-2 test positive; Lips felt prickly; balance/dizziness; foot fell asleep and the feeling progressed up the right side of her body to her fingertips by the next morning; Lasted for 2 weeks but she still had intermittent feeling of her foot being asleep and balance issues that made it hard to walk or look at a computer screen without getting dizzy; Lasted for 2 weeks but she still had intermittent feeling of her foot being asleep and balance issues that made it hard to walk or look at a computer screen without getting dizzy; This is a spontaneous report from a contactable nurse (patient). This 41-years-old female patient (non-pregnant) received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Right on 06Jan2021 09:00 (Lot Number: Elt9899) at age of 41-years-old as dose 1, single for COVID-19 immunization.  Medical history included Allergy. Concomitant medication included probiotics NOS. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Multivitamin and probiotics. The patient experienced Lips felt prickly, balance/dizziness, foot fell asleep and the feeling progressed up the right side of her body to her fingertips by the next morning. Lasted for 2 weeks but she still had intermittent feeling of her foot being asleep and balance issues that made it hard to walk or look at a computer screen without getting dizzy on 06Jan2021 09:30 AM. The events resulted in Doctor or other healthcare professional office/clinic visit except sars-cov-2 test positive. Treatment received for the events included allergy medication except sars-cov-2 test positive. The patient underwent lab tests and procedures which included sars-cov-2 test (Binax Now): positive on 21Sep2021 (Nasal Swab), sars-cov-2 test (NAA): negative on 14Feb2021 (Nasal Swab). The outcome of the event sars-cov-2 test positive was unknown, of other events was recovered with sequel. No covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 and events COVID-19 and drug ineffective cannot be fully excluded.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia oral
Clinical narrative: sars-cov-2 test positive; sars-cov-2 test positive; Lips felt prickly; balance/dizziness; foot fell asleep and the feeling progressed up the right side of her body to her fingertips by the next morning; Lasted for 2 weeks but she still had intermittent feeling of her foot being asleep and balance issues that made it hard to walk or look at a computer screen without getting dizzy; Lasted for 2 weeks but she still had intermittent feeling of her foot being asleep and balance issues that made it hard to walk or look at a computer screen without getting dizzy; This is a spontaneous report from a contactable nurse (patient). This 41-years-old female patient (non-pregnant) received bnt162b2 (COMIRNATY), dose 1 via an unspecified route of administration, administered in Arm Right on 06Jan2021 09:00 (Lot Number: Elt9899) at age of 41-years-old as dose 1, single for COVID-19 immunization.  Medical history included Allergy. Concomitant medication included probiotics NOS. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included Multivitamin and probiotics. The patient experienced Lips felt prickly, balance/dizziness, foot fell asleep and the feeling progressed up the right side of her body to her fingertips by the next morning. Lasted for 2 weeks but she still had intermittent feeling of her foot being asleep and balance issues that made it hard to walk or look at a computer screen without getting dizzy on 06Jan2021 09:30 AM. The events resulted in Doctor or other healthcare professional office/clinic visit except sars-cov-2 test positive. Treatment received for the events included allergy medication except sars-cov-2 test positive. The patient underwent lab tests and procedures which included sars-cov-2 test (Binax Now): positive on 21Sep2021 (Nasal Swab), sars-cov-2 test (NAA): negative on 14Feb2021 (Nasal Swab). The outcome of the event sars-cov-2 test positive was unknown, of other events was recovered with sequel. No covid prior vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 and events COVID-19 and drug ineffective cannot be fully excluded.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Hip fracture
Clinical narrative: He fell and broke his hip; He fell and broke his hip; This is a spontaneous report from a contactable consumer (patient's wife) via the Pfizer-sponsored Program.  A 69-year-old male patient received the first dose of BNT162B2 (COMIRNATY) via an unspecified route of administration on Feb2021 (batch/lot number was not reported) at the age of 69 years old, as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer (patient's wife) called on behalf of her husband who got the first dose of the Pfizer COVID-19 vaccine on Feb2021. The patient fell and broke his hip on Mar2021, the day he was due for his second dose. He had been in the hospital and nursing facility since Mar2021 and until 04Aug2021. The long-term care facility wouldn't give him his second Pfizer dose. They only have the Johnson & Johnson and Moderna vaccines in the area and no one will give him Pfizer. The wife stated she's been trying to get her husband a vaccine since he got home in Aug2021. The patient was home and homebound; the county and city will give shots to homebound people and they only have Johnson & Johnson and Moderna as these are the only available vaccines in their area and no one will give him Pfizer. His Home health and Primary care physician doesn't give the vaccine. Because the patient had the Pfizer one already, they want him to get the same vaccine and are at their wits' end to get him the vaccine. The consumer asked for recommendation. She was advised and agreed to email attached document with link to CDC for information on how to get the vaccine. The consumer further reported that the fall had nothing to do with the vaccine and he already got treatment for that. The day he fell he was supposed to get the second shot and fell before he left the house. That was why he never got it. The hospital and long-term care facility didn't give the vaccine and she really wanted to get him vaccinated and he wanted to be vaccinated. The outcome of the events was unknown.  The batch/lot number for BNT162B2 was not provided and will be requested during follow-up.; Sender's Comments: Based on the current available information, the role of the suspect product BNT162B2 to the development of events Hip fracture and fall is assessed to be unrelated. 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: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID-19 but is asymptomatic; tested positive for COVID-19 but is asymptomatic; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), dose 3 via an unspecified route of administration on 04Oct2021 (at the age of 66-years-old) as dose 3 (booster), single for COVID-19 immunisation. The patient's medical history included acid reflux. The patient's concomitant medications included omeprazole. The patient previously received the first dose on 19Mar2021 and second dose on 09Apr2021 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was both unknown, not available/provided to reporter at the time of report completion) (at the age of 65-years-old), both for COVID-19 immunisation. The patient tested positive for COVID-19 but was asymptomatic on 14Oct2021. His wife was unvaccinated and contracted COVID pneumonia and was currently in critical condition in the hospital. No treatment was received for the events. The patient underwent lab tests and procedures which included COVID-19: positive on 14Oct2021. Facility where the most recent COVID-19 vaccine was administered was other. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain, Pain in extremity
Clinical narrative: chills; achiness; not feeling well; Right arm slightly sore; This is a spontaneous report from a contactable Nurse (patient). A 69-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 02Apr2021 (Lot Number: EW0151) (at the age of 68-year-old) as dose 2, single; received the third dose via an unspecified route of administration, administered in right arm on 13Oct2021 11:00 AM (Lot Number: 59267-1000-02) as dose 3 (booster), single for COVID-19 immunisation. The patient was no pregnant on the vaccination. She previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Mar2021 (lot number: EN6207) (at the age of 68-year-old) on the left arm for COVID-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), hypertension. No COVID prior vaccination, no COVID tested post vaccination. The patient's concomitant medications included flu shot (influenza vaccine) on 08Oct2021 for immunisation. The patient previously took ketamine and experienced drug allergy, took lisinopril and experienced drug allergy. On 14Oct2021 11:00 AM, 24 hours after receiving booster shot, had chills, achiness, not feeling well. Right arm slightly sore. Similar adverse events after receiving 2nd COVID shot but was a little more severe (on 2021), the patient did not report this. No treatment received for events. The patient was recovered from events on 2021.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Immunisation, Off label use, Pain, Pain assessment
Clinical narrative: Much pain 8 out of 10; my arm pit area next to my breast felt sore and swollen/noticeable swelling below arm pit next to breast; my arm pit area next to my breast felt sore and swollen/noticeable swelling below arm pit next to breast; tenderness; my arm started to feel throbbing / my arm pit area next to my breast felt sore; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received the third dose of BNT162B2 via an unspecified route of administration on the right arm on 16Oct2021 at 17:15 (Lot Number: EW 0191) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history included atrial fibrillation, asthmatic in winter and allergy to dust. The patient didn't received other vaccine in four weeks. The patient was not COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication was none. The patient previously received the second dose and the first dose of BNT162B2, the second dose on 09Feb2021 at 04:30 AM (Batch/Lot Number: EL9264), the first dose on 19Jan2021 at 04:30 PM (Batch/Lot Number: EL 3247), both via an unspecified route of administration on the right arm at the age of 54-year-old as single dose for COVID-19 immunization. On 16Oct2021 at 18:00, about 45 min after the patient got shot, her arm started to feel throbbing. On 16Oct2021 at 18:15, the patient experienced tenderness. On 16Oct2021 at 21:15, about 4 hours after shot, her arm pit area next to breast felt sore and swollen. On 17Oct2021 at 18:15, 24 hours later noticeable swelling below arm pit next to breast, much pain 8 out of 10. Swelling and tenderness still as of 10:25 am. But he can't fill out bottom portion of this sheet as he was awaiting to hear back from her doctor. It was unknown whether the patient received treatment. The outcome of booster and off label use was unknown. The outcome of other events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Tenderness
Clinical narrative: Much pain 8 out of 10; my arm pit area next to my breast felt sore and swollen/noticeable swelling below arm pit next to breast; my arm pit area next to my breast felt sore and swollen/noticeable swelling below arm pit next to breast; tenderness; my arm started to feel throbbing / my arm pit area next to my breast felt sore; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient (not pregnant) received the third dose of BNT162B2 via an unspecified route of administration on the right arm on 16Oct2021 at 17:15 (Lot Number: EW 0191) at the age of 55-year-old as single dose for COVID-19 immunization. Medical history included atrial fibrillation, asthmatic in winter and allergy to dust. The patient didn't received other vaccine in four weeks. The patient was not COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication was none. The patient previously received the second dose and the first dose of BNT162B2, the second dose on 09Feb2021 at 04:30 AM (Batch/Lot Number: EL9264), the first dose on 19Jan2021 at 04:30 PM (Batch/Lot Number: EL 3247), both via an unspecified route of administration on the right arm at the age of 54-year-old as single dose for COVID-19 immunization. On 16Oct2021 at 18:00, about 45 min after the patient got shot, her arm started to feel throbbing. On 16Oct2021 at 18:15, the patient experienced tenderness. On 16Oct2021 at 21:15, about 4 hours after shot, her arm pit area next to breast felt sore and swollen. On 17Oct2021 at 18:15, 24 hours later noticeable swelling below arm pit next to breast, much pain 8 out of 10. Swelling and tenderness still as of 10:25 am. But he can't fill out bottom portion of this sheet as he was awaiting to hear back from her doctor. It was unknown whether the patient received treatment. The outcome of booster and off label use was unknown. The outcome of other events was not recovered.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: If COVID prior vaccination: Yes; If COVID prior vaccination: Yes; This is a spontaneous report from a contactable healthcare professional (patient) received via Regulatory Authority. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 22Sep2021 at 11:00 (Batch/Lot Number: FC3183) (at the age of 55 years old) as dose 1, single for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. The patient was not pregnant at time of vaccination. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks. The patient experienced COVID-19 and Drug Ineffective on an unspecified date in 2021. The patient underwent laboratory tests and procedures which included: COVID-19: positive on an unspecified date in 2021. The outcome of events was unknown. The patient also received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) administered in left arm on 13Oct2021 at 10:00 (Batch/Lot Number: 301308A) for COVID-19 immunisation and experienced vision became blurry, could not focus on objects, could not read at all (It lasted about 15-20 minutes), a severe sinus headache came on shortly after her vision recovered, lasting approximately 24 hours.; Sender's Comments: Based on the reported information ,a causal relationship between the events Drug ineffective and Covid-19 and suspected drug cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy, CSF protein, CSF test, Electromyogram, Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome; Bell's palsy,bilateral facial nerve palsy; This is a spontaneous literature report.  A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on Mar2021, as dose 1, single, for COVID-19 immunisation. Medical history included mild asthma. The patient's concomitant medications were not reported. In the first few hours, he noticed muscle soreness, leg heaviness, and fatigue. Three days later, he developed a right facial droop. He presented to the emergency department on postvaccination day 7, where he was diagnosed with Bell's palsy and given oral steroids. Several hours later, he noticed a new left facial droop with paresthesias in his bilateral hands and feet. He was admitted to the hospital where his SARS-Cov-2 PCR testing was negative. His neurologic examination demonstrated bilateral severe facial nerve palsy and lower extremity areflexia with intact limb strength and sensation. MRI of the brain was unremarkable. Cerebrospinal fluid analysis demonstrated elevated protein of 116 mg/dL and no white blood cells, consistent with a diagnosis of Guillain Barre Syndrome. Electromyography (EMG) demonstrated bilateral facial nerve palsies with both demyelinating and axonal features, with normal nerve conduction velocities. He was treated with a five-day course of intravenous immunoglobulin (IVIG) resulting in mild improvement of his facial weakness. Conclusion(s): This variant of GBS occurring within one week of Pfizer- BioNTech vaccination suggests that this may be a rare complication of the vaccine. IVIG was the treatment of choice. Further observational studies were needed to better understand the association between vaccination and the GBS variant. Nevertheless, the benefits of the vaccine far outweigh its potential risks. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relation, the association between the events of Guillain Barre syndrome and Bell's palsy and the suspect product of BNT162B2 cannot be completely ruled out. 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.
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Neurological examination, SARS-CoV-2 test
Clinical narrative: Guillain Barre Syndrome; Bell's palsy,bilateral facial nerve palsy; This is a spontaneous literature report.  A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number and expiry date not reported), via an unspecified route of administration, on Mar2021, as dose 1, single, for COVID-19 immunisation. Medical history included mild asthma. The patient's concomitant medications were not reported. In the first few hours, he noticed muscle soreness, leg heaviness, and fatigue. Three days later, he developed a right facial droop. He presented to the emergency department on postvaccination day 7, where he was diagnosed with Bell's palsy and given oral steroids. Several hours later, he noticed a new left facial droop with paresthesias in his bilateral hands and feet. He was admitted to the hospital where his SARS-Cov-2 PCR testing was negative. His neurologic examination demonstrated bilateral severe facial nerve palsy and lower extremity areflexia with intact limb strength and sensation. MRI of the brain was unremarkable. Cerebrospinal fluid analysis demonstrated elevated protein of 116 mg/dL and no white blood cells, consistent with a diagnosis of Guillain Barre Syndrome. Electromyography (EMG) demonstrated bilateral facial nerve palsies with both demyelinating and axonal features, with normal nerve conduction velocities. He was treated with a five-day course of intravenous immunoglobulin (IVIG) resulting in mild improvement of his facial weakness. Conclusion(s): This variant of GBS occurring within one week of Pfizer- BioNTech vaccination suggests that this may be a rare complication of the vaccine. IVIG was the treatment of choice. Further observational studies were needed to better understand the association between vaccination and the GBS variant. Nevertheless, the benefits of the vaccine far outweigh its potential risks. The outcome of the events was recovering.; Sender's Comments: Based on the close temporal relation, the association between the events of Guillain Barre syndrome and Bell's palsy and the suspect product of BNT162B2 cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Off label use, Postmenopausal haemorrhage
Clinical narrative: Postmenopausal bleeding; third dose of BNT162b2; third dose of BNT162b2; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: 2590), administered in the left arm, on 12Oct2021 at 20:30 (at the age of 67-years-old) at dose 3 (booster), single for COVID-19 immunisation. The patient was not pregnant. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included multivitamins (vitamins nos), vitamin C (ascorbic acid), gabapentin (GRALISE 600mg) taken at 600 mg, colecalciferol (VITAMIN D); all reported as other medications the patient received within 2 weeks of vaccination. The patient received the first dose of BNT162b2 on 17Jan2021 and the second dose of BNT162b2 (lot number: EM9809) on 07Feb2021, both in left arm at the age of 66-years-old for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced postmenopausal bleeding on 17Oct2021. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if a treatment was received for the event. The outcome of the event was unknown.   Follow-up (19Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cough, Lethargy, Oropharyngeal pain, Pyrexia, Respiratory distress
Clinical narrative: lethargy; fever; coughing; sore throat; respiratory distress; This is a spontaneous report from a contactable consumer.  A 13-year-old male patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: unknown) intramuscular into left arm on  09Oct2021 03:00 PM (at the age of 37-year-old) as single dose for covid-19 immunisation.  The patient had received the first dose of  bnt162b2 (Batch/lot number: 301308A)  on 18Sep2021 Intramuscular Arm Left. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were none. Medical history included cold-induced asthma. Prior to vaccination, the patient was diagnosed with COVID-19. No relevant past drug history and no known allergies.The day after vaccine, patient had sore arm and was lethargic. Two days after vaccine, at 8:30am, patient received Flu shot and HPV shot and then experienced fever, coughing, respiratory distress, sore throat, lethargy. Symptoms continued for several days. The events resulted in Doctor  office/clinic visit. Rapid PCR (45 min) Nasal Swab  on 12Oct2021 was Negative. Dr prescribed one dose of decadrone (oral steroid) and daily albuterol. Day 8 patient was back to normal, no symptoms.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: lethargy; fever; coughing; sore throat; respiratory distress; This is a spontaneous report from a contactable consumer.  A 13-year-old male patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: unknown) intramuscular into left arm on  09Oct2021 03:00 PM (at the age of 37-year-old) as single dose for covid-19 immunisation.  The patient had received the first dose of  bnt162b2 (Batch/lot number: 301308A)  on 18Sep2021 Intramuscular Arm Left. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were none. Medical history included cold-induced asthma. Prior to vaccination, the patient was diagnosed with COVID-19. No relevant past drug history and no known allergies.The day after vaccine, patient had sore arm and was lethargic. Two days after vaccine, at 8:30am, patient received Flu shot and HPV shot and then experienced fever, coughing, respiratory distress, sore throat, lethargy. Symptoms continued for several days. The events resulted in Doctor  office/clinic visit. Rapid PCR (45 min) Nasal Swab  on 12Oct2021 was Negative. Dr prescribed one dose of decadrone (oral steroid) and daily albuterol. Day 8 patient was back to normal, no symptoms.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 13.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Lethargy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: lethargy; fever; coughing; sore throat; respiratory distress; This is a spontaneous report from a contactable consumer.  A 13-year-old male patient received second dose of bnt162b2 (COMIRNATY; Batch/Lot Number: unknown) intramuscular into left arm on  09Oct2021 03:00 PM (at the age of 37-year-old) as single dose for covid-19 immunisation.  The patient had received the first dose of  bnt162b2 (Batch/lot number: 301308A)  on 18Sep2021 Intramuscular Arm Left. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination were none. Medical history included cold-induced asthma. Prior to vaccination, the patient was diagnosed with COVID-19. No relevant past drug history and no known allergies.The day after vaccine, patient had sore arm and was lethargic. Two days after vaccine, at 8:30am, patient received Flu shot and HPV shot and then experienced fever, coughing, respiratory distress, sore throat, lethargy. Symptoms continued for several days. The events resulted in Doctor  office/clinic visit. Rapid PCR (45 min) Nasal Swab  on 12Oct2021 was Negative. Dr prescribed one dose of decadrone (oral steroid) and daily albuterol. Day 8 patient was back to normal, no symptoms.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Transient ischaemic attack
Clinical narrative: Transient Ischemic Attack; 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 on 27Sep2021 (Batch/Lot number was not reported) as DOSE 3 (BOOSTER), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced transient ischemic attack on 2021. The patient wanted to report what may not be a side effect by having receive the booster vaccine from the Pfizer. The patient stated, "Oh, side effect I think, I had a TIA which is a Transient Ischemic Attack, TIA." When asked if side effect is due to booster shot, the patient stated, "That is my thinking I got the booster shot on 27Sep2021 and I was in Emergency room at October the 10th (10Oct2021)." Outcome of the event was unknown.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Dyspnoea
Clinical narrative: I have COVID; I have COVID; hard to breath; This is a spontaneous report from a contactable consumer. A 64-year-old female patient received bnt162b2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had COVID and it is hard to breath. It was reported that the patient took the shots and still got it. The event COVID was assessed as serious (medically significant). The outcome of the events was unknown.  The information about the batch number has been requested.