chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Myocarditis, Nausea, Oropharyngeal pain
Clinical narrative: Heart inflammation; Dry mouth; Sore throat; Chills; Nausea; Fatigue; Cramped legs; Sore arm; Joint pain; Muscle pain; Extreme anxiety; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:30 at 35-years-old (Batch/Lot Number: ER8729) as 1st dose, single for COVID-19 immunization. There was no medical history. Patient was not pregnant. 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 paracetamol (TYLENOL). The patient had dry mouth, sore throat, chills, nausea, fatigue, cramped legs, sore arm, joint pain, muscle pain, extreme anxiety, chronic chest pain lasted for 5 days constantly and ER visit Dr. says it was due to the vaccine: heart inflammation. Happened to 50% of chest pain ER visitors due to vaccine 3-4 days after vaccine dose. And should only last 6 days. Heart inflammation should be added to info packet and more studies should be done asap. All events started on 22Apr2021 03:30. No treatment given. Outcome of events was recovered in 2021.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Heart inflammation; Dry mouth; Sore throat; Chills; Nausea; Fatigue; Cramped legs; Sore arm; Joint pain; Muscle pain; Extreme anxiety; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:30 at 35-years-old (Batch/Lot Number: ER8729) as 1st dose, single for COVID-19 immunization. There was no medical history. Patient was not pregnant. 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 paracetamol (TYLENOL). The patient had dry mouth, sore throat, chills, nausea, fatigue, cramped legs, sore arm, joint pain, muscle pain, extreme anxiety, chronic chest pain lasted for 5 days constantly and ER visit Dr. says it was due to the vaccine: heart inflammation. Happened to 50% of chest pain ER visitors due to vaccine 3-4 days after vaccine dose. And should only last 6 days. Heart inflammation should be added to info packet and more studies should be done asap. All events started on 22Apr2021 03:30. No treatment given. Outcome of events was recovered in 2021.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm right on 06May2021 09:00 (at age 51-years-old) (Batch/Lot Number: EW0173) as 1st dose, single for covid-19 immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. There were no other medication received withing 2 weeks and no vaccine withing 4 weeks prior to vaccination. The patient was diagnosed with bell's palsy on 23May2021 09:00 which resulted in emergency room visit. Unspecified medication for 7 days was given as treatment. Outcome of the event was unknown. The patient was skeptical in taking the 2nd dose and her physician stated to postpone it. She was asking if she should take the 2nd dose. Patient was not diagnosed with covid prior to vaccination and has not been tested post vaccination.  Information on Lot/Batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rectal haemorrhage
Clinical narrative: rectal bleeding; sensation/pain in her right arm; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW1051), dose 1 via an unspecified route of administration, administered in Arm on 15May2021 17:30 (at the age of 79years) as 1st dose, single for Covid-19 immunization. Medical history included allergic to lemons, vinegar and white wine, severe reaction to some eye drops 4-5 years ago, vomiting, and diarrhea, rectal bleeding, stomach hurt, and felt like her head was going to explode. The patient's concomitant medications were not reported. The patient reported that she was allergic to lemons, vinegar and white wine and can't take any pills because they make her stomach hurt, she now only takes natural medicines. She had a margarita the week before the vaccine that had some lemon juice in it, and she had rectal bleeding for a few days. She also had a severe reaction to some eye drops 4-5 years ago, she does not know the name of the medication, just that it was a generic. Half an hour after putting it in one eye she said it felt like her head was going to explode and thought she was going to die. The ambulance was called but refused to go in and had her friend take her in. She also experienced vomiting and diarrhea. On 16May2021, the day after the shot (Covid vaccine) she had some rectal bleeding similar to a light period but only for one day.  She also had the shot in the left arm but had a sensation/pain in her right arm that went away quickly. The patient was unsure if that happened because she also had 2 margaritas and they made it with lemons which she is allergic to so it might have been that. The patient asked if the vaccine have any vinegar or wine in it. The patient also asked if she could get the second dose of the vaccine if she's had a severe reaction to some eye drops 4-5 years ago. She doesn't remember name of medication but had severe side effects including her head felt like her head was going to explode, vomiting, and diarrhea. The outcome of event rectal bleeding was recovered on 17May2021, while the outcome of event sensation/pain in her right arm was recovered on an unspecified date.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Dyspnoea, Influenza like illness, Musculoskeletal chest pain, Oropharyngeal pain
Clinical narrative: Asthma; Oxygen was 89; Shortness of breath/breathing difficulties; Ribs hurt; Felt like she was coming down with the flu; Head and sinus congestion; Head and sinus congestion; Throat was on fire, it hurt so bad; Throat was on fire, it hurt so bad; Seizure; Kind of achy/achy feeling; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in left arm on 22May2021 10:45 (at the age of 40 years old) as 1st dose, single for COVID-19 immunization, at a pharmacy. Medical history included epilepsy from an unknown date and unknown if ongoing (seizure free for two years; diagnosed in 2009 or 2010). Concomitant medications were not reported. On 23May2021, the patient was having breathing difficulties and had to go the emergency room (ER). The patient reported she went to the ER Monday, 24May2021 and was released 11 hours later. She also stated that on Sunday morning on 23May2021, she woke up at 0400 AM and her throat was on fire, it hurt so bad. This was Sunday at 0400, and her husband heard her, and they walked around the house, she had her hands over head, like when running and her ribs hurt. She raised her arms, and tried to take deep breaths, and it was working, to breathe, but it felt like she couldn't breathe, she couldn't catch her breath. She stated she went to work and in 1.5 hours came home, she called the pharmacy and said she can't breathe, then she was told this is not normal. She was told to go to the hospital, and she went and stated that her oxygen was 89 and then it shot up to 92 with standing and raising her arms up over her head, and they did 6 breathing treatments and 3 doses of steroids in her IV and oxygen and she went up to 98. She was sent home with a diagnosis of asthma with albuterol inhaler and nebulizer machine, treatments and said that she all of a sudden has asthma. She then added she had a seizure Sunday morning of 23May2021. She also felt like she was coming down with the flu. On 22May2021, Saturday night, she was kind of achy, then on Sunday, 23May2021, she felt like she was coming down with flu, she had head and sinus congestion, the achy feeling, all that was fine, it was the  breathing that scares her. The patient was not hospitalized due to the events. The outcome of the event seizure was unknown and for other events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Pain, Seizure, Sinus congestion
Clinical narrative: Asthma; Oxygen was 89; Shortness of breath/breathing difficulties; Ribs hurt; Felt like she was coming down with the flu; Head and sinus congestion; Head and sinus congestion; Throat was on fire, it hurt so bad; Throat was on fire, it hurt so bad; Seizure; Kind of achy/achy feeling; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in left arm on 22May2021 10:45 (at the age of 40 years old) as 1st dose, single for COVID-19 immunization, at a pharmacy. Medical history included epilepsy from an unknown date and unknown if ongoing (seizure free for two years; diagnosed in 2009 or 2010). Concomitant medications were not reported. On 23May2021, the patient was having breathing difficulties and had to go the emergency room (ER). The patient reported she went to the ER Monday, 24May2021 and was released 11 hours later. She also stated that on Sunday morning on 23May2021, she woke up at 0400 AM and her throat was on fire, it hurt so bad. This was Sunday at 0400, and her husband heard her, and they walked around the house, she had her hands over head, like when running and her ribs hurt. She raised her arms, and tried to take deep breaths, and it was working, to breathe, but it felt like she couldn't breathe, she couldn't catch her breath. She stated she went to work and in 1.5 hours came home, she called the pharmacy and said she can't breathe, then she was told this is not normal. She was told to go to the hospital, and she went and stated that her oxygen was 89 and then it shot up to 92 with standing and raising her arms up over her head, and they did 6 breathing treatments and 3 doses of steroids in her IV and oxygen and she went up to 98. She was sent home with a diagnosis of asthma with albuterol inhaler and nebulizer machine, treatments and said that she all of a sudden has asthma. She then added she had a seizure Sunday morning of 23May2021. She also felt like she was coming down with the flu. On 22May2021, Saturday night, she was kind of achy, then on Sunday, 23May2021, she felt like she was coming down with flu, she had head and sinus congestion, the achy feeling, all that was fine, it was the  breathing that scares her. The patient was not hospitalized due to the events. The outcome of the event seizure was unknown and for other events was recovering.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation, Upper respiratory tract congestion
Clinical narrative: Asthma; Oxygen was 89; Shortness of breath/breathing difficulties; Ribs hurt; Felt like she was coming down with the flu; Head and sinus congestion; Head and sinus congestion; Throat was on fire, it hurt so bad; Throat was on fire, it hurt so bad; Seizure; Kind of achy/achy feeling; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0186), via an unspecified route of administration, administered in left arm on 22May2021 10:45 (at the age of 40 years old) as 1st dose, single for COVID-19 immunization, at a pharmacy. Medical history included epilepsy from an unknown date and unknown if ongoing (seizure free for two years; diagnosed in 2009 or 2010). Concomitant medications were not reported. On 23May2021, the patient was having breathing difficulties and had to go the emergency room (ER). The patient reported she went to the ER Monday, 24May2021 and was released 11 hours later. She also stated that on Sunday morning on 23May2021, she woke up at 0400 AM and her throat was on fire, it hurt so bad. This was Sunday at 0400, and her husband heard her, and they walked around the house, she had her hands over head, like when running and her ribs hurt. She raised her arms, and tried to take deep breaths, and it was working, to breathe, but it felt like she couldn't breathe, she couldn't catch her breath. She stated she went to work and in 1.5 hours came home, she called the pharmacy and said she can't breathe, then she was told this is not normal. She was told to go to the hospital, and she went and stated that her oxygen was 89 and then it shot up to 92 with standing and raising her arms up over her head, and they did 6 breathing treatments and 3 doses of steroids in her IV and oxygen and she went up to 98. She was sent home with a diagnosis of asthma with albuterol inhaler and nebulizer machine, treatments and said that she all of a sudden has asthma. She then added she had a seizure Sunday morning of 23May2021. She also felt like she was coming down with the flu. On 22May2021, Saturday night, she was kind of achy, then on Sunday, 23May2021, she felt like she was coming down with flu, she had head and sinus congestion, the achy feeling, all that was fine, it was the  breathing that scares her. The patient was not hospitalized due to the events. The outcome of the event seizure was unknown and for other events was recovering.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Feeling abnormal, Hypoaesthesia, Pain
Clinical narrative: numbness in his fingers/right leg went numb; fog brain; aches and pains; This is a spontaneous report from a contactable consumer (patient's parent). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) (at the age of 53-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included cardiac pacemaker insertion. The patient's concomitant medications were not reported. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (at the age of 53-years-old) for COVID-19 immunisation. The patient said that his son felt no real results from the second dose of COVID-19 vaccine shot but in 2 weeks his son had numbness in his fingers and what his son called fog brain. He said his son also had aches and pains and went to the Emergency Room. The caller said while in the Emergency Room, they drew blood from his son and couldn't find anything. He said his son has been to doctors and his son can't seem to get any help from his symptoms. He said yesterday, his son's right leg went numb. The caller said he was worried for his son and would like some medical help for his son. The patient's mother said they wanted information so her son won't die. The patient's father said his son had read a lot of people who received the COVID-19 vaccine and experienced side effects 2 weeks after the COVID-19 vaccine shot. The patient's father said it was almost exactly 2 weeks after his son received his second COVID-19 vaccine shot that his son experienced his weird problems. Outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Taste disorder, X-ray
Clinical narrative: Pain in the right arm; affected the rotator cuff; taste and smell were affected; my taste and smell were affected; This is a spontaneous report from a non-contactable other healthcare professional (patient).  A 54-year-old female patient (not pregnant at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/Lot number was not reported) administered in Arm Right in Feb2021 as 2nd single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 in Jan2021 (at the age of 54years) for Covid-19 immunization. Medical history included lupus, fatty liver disease (genetic, not caused by any other issues), asthma, heart disorder, rheumatoid arthritis, various food allergy, latex allergy, and allergic to Sulfa drugs; all from an unknown date and unknown if ongoing. The patient's concomitant medications included fexofenadine hydrochloride (ALLEGRA) for an unspecified indication and salbutamol (ALBUTEROL) for asthma; start and stop date of both were not reported. The patient previously took Phenergan and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. In Feb2021, the patient experienced pain in the right arm following the 2nd dose that never went away, and instead got a lot worse. It has affected her rotator cuff and required a cortisone injection. In 6 weeks, if that has not worked, further testing will be done beyond the X-ray on an unspecified date. Also, following the 2nd dose, her taste and smell were affected, and she has not been able to handle the taste of coffee. She added that she has Lupus and genetic fatty liver disease. The hepatologist had her drinking coffee for that reason. The only thing off on her blood work related to not being able to drink the coffee (as reported). The patient also mentioned that she was having difficulty working at this point in time, because she works at a computer and it's affecting the arm she uses for the mouse. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The events were treated with cortisone injection and X-ray. She also has tested negative to Covid 19, and negative to the antibodies in Mar2021. The outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Assuming a plausible drug-event temporal association, the company cannot completely exclude a causal relationship between BNT162b2 administration and the onset of the reported, serious events. The event 'pain in extremity' is also expected in the safety profile of the suspect product.  The impacts 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Myocarditis, Peripheral swelling, SARS-CoV-2 test
Clinical narrative: potential myocarditis; severe fatigue; SOB; swelling of legs; This is a spontaneous report received from a contactable healthcare professional (patient) via COVAES. A non-pregnant 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in left arm on 23Feb2021 (at the age of 50 years old; Lot Number: EN6202, unknown expiration) as 1st dose, single for COVID-19 immunisation.  The patient medical history was not reported. Concomitant medications included paracetamol (TYLENOL); bupropion hydrochloride (WELLBUTRIN); esomeprazole sodium (NEXIUM); ascorbic acid, chromium, copper, folic acid, inositol, magnesium, manganese, nicotinamide, pantothenic acid, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, zinc (MULTI VIT); and curcuma longa rhizome, piper nigrum fruit (TURMERIC +).  The patient experienced potential myocarditis on 15Mar2021. The patient cannot get into cardiology to confirm severe fatigue, SOB, and swelling of legs, which all started on 15Mar2021. The patient underwent lab tests and procedures which included PCR (nasal swab): Negative on 17Mar2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The events resulted in emergency room/department or urgent care and doctor or other healthcare professional office/clinic visit.  The patient had not yet recovered from the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Current information is limited and does not allow a full medical assessment.  Myocarditis was not a confirmed diagnosis, but rather a provisional diagnosis based on reported symptoms.  Case will be reassessed once receiving additional information. 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: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Road traffic accident, Syncope
Clinical narrative: Unexpectedly fainting while driving; Crashed my car; This is a spontaneous report from a non-contactable consumer (patient). A 21-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in left arm on 26Mar2021 16:00 (at the age of 21-year-old) (Batch/Lot number was not reported) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The patient had no relevant medical history and no known allergies. Concomitant medication included birth control pill. On 18Apr2021 at 12:00, the patient experienced "unexpectedly fainting while driving, crashed my car." The reporter considered the events as non-serious. The events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment received for the events. The patient recovered with sequelae from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives all over her body; This is a spontaneous report from a contactable consumer (patient's mom). A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 22May2021 (Batch/Lot number was not reported) as single for COVID-19 immunisation. Medical history included anxiety and high functioning autism from an unknown date and unknown if ongoing. Concomitant medications included fluoxetine hydrochloride (FLUOXETIN) and hydroxyzine taken for an unspecified indication, start and stop date were not reported. The patient experienced hives all over her body on 22May2021. They look like mosquito bites, but are not, and are on her toes, hands, torso, legs, everywhere. They are little red bumps and itchy. Like dime-sized. Some are dime and some are nickel sized. Hives started about 4, maybe 6 hours after the vaccination. Outcome of the event was not recovered, reported as worsened. Therapeutic measures were taken. She was giving Hydroxyzine and putting on a topical ointment, as Hydroxyzine is an antihistamine, stronger than Benadryl. Event did not require a visit to Emergency Room or Physician Office.  Information on lot/batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: Lack of drug effect; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. Medical history included leukaemia from 2014 to an unknown date. The patient's concomitant medication includes ibrutinib (IMBRUVICA) taken for leukemia. The patient experienced lack of drug on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chest pain, Electrocardiogram ambulatory, Heart rate decreased, Palpitations
Clinical narrative: premature ventricular contractions; a sharp pain in her chest; her heart started slowing down and then began hurting to beat; It was trying to beat so hard that the beat would start in her shoulder then press hard in her chest; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Right on 06Apr2021 09:30 (Batch/Lot number was not reported) (at age 31 years old) as single dose for covid-19 immunisation in a pharmacy or drug store. The patient's medical history was not reported. She was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. No other vaccines received within 4 weeks prior to COVID vaccine and no other medications received within 2 weeks of vaccination. On 06Apr2021 21:30, 12 hours after getting vaccine, the patient felt a sharp pain in her chest and her heart started slowing down and then began hurting to beat. It was trying to beat so hard that the beat would start in her shoulder then press hard in her chest. She went in and was hooked up to a holter monitor where they found 251 PVC (premature ventricular contractions) in 24 hours. It took 3 weeks for her heart to go back into normal sinus rhythm. She was given beta blockers as treatment. COVID test post vaccination (nasal swab/NBATT) on 10May2021 was negative. The patient was recovering from the event. She had not received the second dose and won't because of the first dose side effects.    Information on the batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: premature ventricular contractions; a sharp pain in her chest; her heart started slowing down and then began hurting to beat; It was trying to beat so hard that the beat would start in her shoulder then press hard in her chest; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Right on 06Apr2021 09:30 (Batch/Lot number was not reported) (at age 31 years old) as single dose for covid-19 immunisation in a pharmacy or drug store. The patient's medical history was not reported. She was not diagnosed with COVID-19 prior to vaccination. There were no concomitant medications. No other vaccines received within 4 weeks prior to COVID vaccine and no other medications received within 2 weeks of vaccination. On 06Apr2021 21:30, 12 hours after getting vaccine, the patient felt a sharp pain in her chest and her heart started slowing down and then began hurting to beat. It was trying to beat so hard that the beat would start in her shoulder then press hard in her chest. She went in and was hooked up to a holter monitor where they found 251 PVC (premature ventricular contractions) in 24 hours. It took 3 weeks for her heart to go back into normal sinus rhythm. She was given beta blockers as treatment. COVID test post vaccination (nasal swab/NBATT) on 10May2021 was negative. The patient was recovering from the event. She had not received the second dose and won't because of the first dose side effects.    Information on the batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Hyperhidrosis, Nausea
Clinical narrative: stomach aches; chills; sweats; nausea; This is a spontaneous report from a contactable physician (patient). A 65-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration on 29Apr2021 10:30 (Batch/Lot Number: EW0175) as 1st dose, single for covid-19 immunisation. Medical history included haemorrhoids and gastritis. The patient's concomitant medications were not reported. The patient previously took steroid drug and experienced gastritis; Rubella vaccine when the patient is 25-years-old and experienced intense reaction. On 29Apr2021, 5 hours after first dose, the patient experienced stomach aches, chills and sweats, very intense, that was almost like malaria, along with nausea, and a slight stomach ache but had no fever which lasted for 3 or 4 hours. The outcome of event chills, sweats, and nausea recovered on 29Apr2021; stomach aches was recovering; all other events was unknown.  Follow attempts are needed. Further information is expected
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Chills, Fatigue, Headache, Investigation, Nausea
Clinical narrative: Fatigue; Sore arm; Chills; Low-grade fever; Nausea; Headache; Vomiting; Fainting; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24May2021 12:15 (Batch/Lot Number: EW0173) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. Concomitant medication includes: Vitamin C supplements (reported as List of any other medications the patient received within 2 weeks of vaccination). The patient was previously vaccinated with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Ew0172) on 03MAY2021 01:00 PM for COVID-19 immunization. It was reported that the patient experienced Fainting on 24May2021 at 16:00. The patient also experienced Fatigue, Sore arm, Chills, Low-grade fever, Nausea, Headache and Vomiting on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination the patient has the patient been tested for COVID-19 which was negative on 07May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event fainting was recovering; for all other events was unknown.   No follow-up attempts are possible. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Pyrexia, Syncope, Vomiting
Clinical narrative: Fatigue; Sore arm; Chills; Low-grade fever; Nausea; Headache; Vomiting; Fainting; This is a spontaneous report from a non-contactable consumer (patient). A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 24May2021 12:15 (Batch/Lot Number: EW0173) as 2ND DOSE, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient is not pregnant at the time of vaccination. Concomitant medication includes: Vitamin C supplements (reported as List of any other medications the patient received within 2 weeks of vaccination). The patient was previously vaccinated with bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: Ew0172) on 03MAY2021 01:00 PM for COVID-19 immunization. It was reported that the patient experienced Fainting on 24May2021 at 16:00. The patient also experienced Fatigue, Sore arm, Chills, Low-grade fever, Nausea, Headache and Vomiting on an unspecified date. The patient was not diagnosed with COVID-19 prior to vaccination and since the vaccination the patient has the patient been tested for COVID-19 which was negative on 07May2021. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event fainting was recovering; for all other events was unknown.   No follow-up attempts are possible. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Pain in extremity, Pain in jaw, Tremor
Clinical narrative: Very Bad Chills; She is Shaking Right Now; Her Chest Hurt; Jaw Hurt; arm pain; This is a spontaneous report from a contactable consumer (patient mother).  A 19-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 24May2021 (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for COVID-19 immunization.  Medical history and concomitant medications were not reported.  On 24May2021, the patient was experiencing the very bad chills right now and her chest hurt, and her jaw also hurts. The patient received ibuprofen (MOTRIN) at 800 mg for the arm pain (noted in 2021). Outcome of the event of arm pain was unknown while not recovered on the remaining events.  Information regarding the lot/batch has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Pyrexia
Clinical narrative: Received really high fever which made me hallucinate; Received really high fever which made me hallucinate; This is a spontaneous report from a contactable consumer (patient). A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0170), via an unspecified route of administration, administered in left arm on 29Apr2021 14:00 as single dose for COVID-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported.  The patient received really high fever which made her hallucinate on 30Apr2021. Facility where the most recent COVID-19 vaccine was administered was reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the events. The outcome of the events were recovered.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Diarrhoea, Dyspnoea, Headache
Clinical narrative: found on the floor between the toilet and wall.; Shortness of breath; has a cough and is bring up cold stuff; She was so sick; Diarrhea; Chills; Fever; Nausea; Headache; couldn't get out of bed; remembered getting up and going to the bathroom but doesn't remember much after that; She was told she was allergic to the shot; pain in pelvis area; she was dehydrated; she was not able to give urine; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered into the arm on 01May2021 (at the age of 59-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease for 5 years, ongoing asthma for 5 years and smoking. The patient's concomitant medications were not reported. On 03May2021, patient was reportedly so sick, she was having diarrhea, chills, fever, nausea, headache and couldn't get out of bed; the patient remembered getting up and going to the bathroom but doesn't remember much after that, her husband found her on the floor between the toilet and wall. The ambulance was called and patient was brought to the emergency room. Patient was told that she was allergic to the shot. Patient underwent MRI and X-ray to check her pelvis because she was in pain in the pelvis area but with unknown results on 03May2021. It was reported that due to dehydration she was not able to give urine on 03May2021. It was also reported that on 03May2021 she had shortness of breath, has a cough and is bring up cold stuff, that is why she was using a breathing machine. The patient received treatment for the events "found on the floor between the toilet and wall", "she was dehydrated", "she was not able to give urine" and "Nausea"; patient was kept for 12-13 hours in the emergency room treated with antibiotics and other medications. Outcome of events "shortness of breath", "has a cough and is bring up cold stuff", "headache" was recovering; events "found on the floor between the toilet and wall", "she was so sick", "remembered getting up and going to the bathroom but doesn't remember much after that", "she was dehydrated", "she was not able to give urine" and  "was told that she was allergic to the shot" recovered on an unspecified date; the outcome of all other events recovered on an unspecified date in May2021.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Illness, Loss of personal independence in daily activities, Magnetic resonance imaging, Memory impairment
Clinical narrative: found on the floor between the toilet and wall.; Shortness of breath; has a cough and is bring up cold stuff; She was so sick; Diarrhea; Chills; Fever; Nausea; Headache; couldn't get out of bed; remembered getting up and going to the bathroom but doesn't remember much after that; She was told she was allergic to the shot; pain in pelvis area; she was dehydrated; she was not able to give urine; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered into the arm on 01May2021 (at the age of 59-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease for 5 years, ongoing asthma for 5 years and smoking. The patient's concomitant medications were not reported. On 03May2021, patient was reportedly so sick, she was having diarrhea, chills, fever, nausea, headache and couldn't get out of bed; the patient remembered getting up and going to the bathroom but doesn't remember much after that, her husband found her on the floor between the toilet and wall. The ambulance was called and patient was brought to the emergency room. Patient was told that she was allergic to the shot. Patient underwent MRI and X-ray to check her pelvis because she was in pain in the pelvis area but with unknown results on 03May2021. It was reported that due to dehydration she was not able to give urine on 03May2021. It was also reported that on 03May2021 she had shortness of breath, has a cough and is bring up cold stuff, that is why she was using a breathing machine. The patient received treatment for the events "found on the floor between the toilet and wall", "she was dehydrated", "she was not able to give urine" and "Nausea"; patient was kept for 12-13 hours in the emergency room treated with antibiotics and other medications. Outcome of events "shortness of breath", "has a cough and is bring up cold stuff", "headache" was recovering; events "found on the floor between the toilet and wall", "she was so sick", "remembered getting up and going to the bathroom but doesn't remember much after that", "she was dehydrated", "she was not able to give urine" and  "was told that she was allergic to the shot" recovered on an unspecified date; the outcome of all other events recovered on an unspecified date in May2021.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pelvic pain, Productive cough, Pyrexia, Syncope
Clinical narrative: found on the floor between the toilet and wall.; Shortness of breath; has a cough and is bring up cold stuff; She was so sick; Diarrhea; Chills; Fever; Nausea; Headache; couldn't get out of bed; remembered getting up and going to the bathroom but doesn't remember much after that; She was told she was allergic to the shot; pain in pelvis area; she was dehydrated; she was not able to give urine; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered into the arm on 01May2021 (at the age of 59-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease for 5 years, ongoing asthma for 5 years and smoking. The patient's concomitant medications were not reported. On 03May2021, patient was reportedly so sick, she was having diarrhea, chills, fever, nausea, headache and couldn't get out of bed; the patient remembered getting up and going to the bathroom but doesn't remember much after that, her husband found her on the floor between the toilet and wall. The ambulance was called and patient was brought to the emergency room. Patient was told that she was allergic to the shot. Patient underwent MRI and X-ray to check her pelvis because she was in pain in the pelvis area but with unknown results on 03May2021. It was reported that due to dehydration she was not able to give urine on 03May2021. It was also reported that on 03May2021 she had shortness of breath, has a cough and is bring up cold stuff, that is why she was using a breathing machine. The patient received treatment for the events "found on the floor between the toilet and wall", "she was dehydrated", "she was not able to give urine" and "Nausea"; patient was kept for 12-13 hours in the emergency room treated with antibiotics and other medications. Outcome of events "shortness of breath", "has a cough and is bring up cold stuff", "headache" was recovering; events "found on the floor between the toilet and wall", "she was so sick", "remembered getting up and going to the bathroom but doesn't remember much after that", "she was dehydrated", "she was not able to give urine" and  "was told that she was allergic to the shot" recovered on an unspecified date; the outcome of all other events recovered on an unspecified date in May2021.  Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary retention, X-ray
Clinical narrative: found on the floor between the toilet and wall.; Shortness of breath; has a cough and is bring up cold stuff; She was so sick; Diarrhea; Chills; Fever; Nausea; Headache; couldn't get out of bed; remembered getting up and going to the bathroom but doesn't remember much after that; She was told she was allergic to the shot; pain in pelvis area; she was dehydrated; she was not able to give urine; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered into the arm on 01May2021 (at the age of 59-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease for 5 years, ongoing asthma for 5 years and smoking. The patient's concomitant medications were not reported. On 03May2021, patient was reportedly so sick, she was having diarrhea, chills, fever, nausea, headache and couldn't get out of bed; the patient remembered getting up and going to the bathroom but doesn't remember much after that, her husband found her on the floor between the toilet and wall. The ambulance was called and patient was brought to the emergency room. Patient was told that she was allergic to the shot. Patient underwent MRI and X-ray to check her pelvis because she was in pain in the pelvis area but with unknown results on 03May2021. It was reported that due to dehydration she was not able to give urine on 03May2021. It was also reported that on 03May2021 she had shortness of breath, has a cough and is bring up cold stuff, that is why she was using a breathing machine. The patient received treatment for the events "found on the floor between the toilet and wall", "she was dehydrated", "she was not able to give urine" and "Nausea"; patient was kept for 12-13 hours in the emergency room treated with antibiotics and other medications. Outcome of events "shortness of breath", "has a cough and is bring up cold stuff", "headache" was recovering; events "found on the floor between the toilet and wall", "she was so sick", "remembered getting up and going to the bathroom but doesn't remember much after that", "she was dehydrated", "she was not able to give urine" and  "was told that she was allergic to the shot" recovered on an unspecified date; the outcome of all other events recovered on an unspecified date in May2021.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: feel like in a fog; severe headache/all over the top of my head and throbbing; chills; anxious; could not relax or sleep; Soreness at the injection site; Diarrhea for 3 hours; exhausting/fatigue; This is a spontaneous report from a contactable consumer (patient).  A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 24May2021 (Batch/Lot Number: ER8735) (at the age of 50-years-old) as 2nd dose, single dose for COVID-19 immunisation. The patient's medical history included COVID-19 prior to vaccination. Concomitant medications included fluoxetine; mirabegron (MYRBETRIQ); propranolol and lithium; all taken for an unspecified indication, start and stop date were not reported.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was previously administered with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: ER8735) on 03May2021 (at the age of 50-years-old) in the right arm for COVID-19 immunisation. Patient had vaccine number 2 in the afternoon. On 24May2021 at 23:00, patient began to experience a severe headache. It was all over the top of her head and throbbing. Patient had the chills, anxious and could not relax or sleep.  Patient was unsteady on her feet. Patient had soreness at the injection site and diarrhea for 3 hours. It was exhausting. This morning (date unspecified), she still have not had any sleep.  She had a slight headache and fatigued. She felt like she was in a fog. No treatment was given to the patient. Since the vaccination, patient has not been tested for COVID-19. Outcome of headache was recovering, diarrhea was recovered on 25May2021, while remaining events was not recovered.  Information on the lot/batch number has been requested.