chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Bell Palsy; sever leg pain; This is a spontaneous report from a contactable nurse (patient). A 51-years-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in the right arm on 12Jan2021 (Batch/Lot Number: EL3246) as a single dose for COVID-19 immunization. Medical history was reported as none. The patient had no known allergies and no other medical history. The patient had no Covid prior vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK 5730) in the right arm on 22Dec2020 at 11:00AM for COVID-19 immunization. The patient had no other medications in two weeks and no other vaccines in four weeks. The patient experienced Bell Palsy and sever leg pain on 28Mar2021. The patient was hospitalized for the events for 1 day. The patient was tested post vaccination. The patient underwent lab tests and procedures on 31Mar2021 which included Nasal Swab: negative. Treatment for the events included steroids and antiviral as well as antibiotics. The events had not resolved.
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Mental status changes, Pain of skin, Pruritus, Skin reaction
Clinical narrative: terrible skin reaction; it is all over his body; really bad skin issues on back, head, arms, legs, not itchy but stinging and painful; it's an itch but not a mosquito itching, its not like a normal itch; its interfering with his daily life/was having a problem getting through the day because it was so bothersome and painful.; "to the point that he was going crazy"; This is a spontaneous report from a contactable consumer (husband) via Pfizer- sponsored program COVAX SUPPORT. A male patient of an unspecified age received BNT162B2 (BNT162B2 Covid-19 Vaccine, Solution for injection, Batch/lot number: Not provided, NDC number: Not Provided, Expiry Date: Not Provided) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not provided. The caller was calling about Pfizer COVID injection on behalf of her husband. Caller and patient both got the COVID injection, but the patient had a disturbing reaction. The patient had a terrible skin reaction- it was all over his body, chest, arm, legs and it was not blisters or anything, it was an itch but not a mosquito itching, it was not like a normal itch, its interfering with his daily life. Caller's husband was having terrible side effect "to the point where he was going crazy" he had been to 3 doctors with bad skin issues on back, head, arms, legs, not itchy but stinging and painful. Caller stated husband was having a problem getting through the day because it was so bothersome and painful. The caller wanted to know has Pfizer had any incidents regarding the epidermis or something else in our system like this. The caller declined to file a safety report, no further information or details were captured at this time. The caller declined the department contact information. Outcome of the events was unknown. Investigation Assessment: Not Provided.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Rash
Clinical narrative: rash/cellulitis to bilateral hands and wrists; rash/cellulitis to bilateral hands and wrists; This is a spontaneous report from a contactable physician. A 56-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 56 years of age), dose 1 via an unspecified route of administration, administered in arm left on 31Mar2021 (Batch/Lot Number: EP7533) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), acetylsalicylic acid (ASPIRIN 81); vitamin d3; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), ubidecarenone (COQ10 [UBIDECARENONE]), trazodone, lisinopril and ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM;CHROMIUM;COLECALCIFEROL;COPPER;FOLIC ACID;IODINE;IRON;LYCOPENE;MAGNESIUM;MANGANESE;NICOTINAMIDE;PANTOTHENIC ACID;PHOSPHORUS;PHYTOMENADIONE;POTASSIUM;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN), all taken for an unspecified indication, start and stop date were not reported. The patient previously took lortab [loratadine], Lincocin [clindamycin], Wellbutrin and Chantix and experienced drug hypersensitivity with these. The patient experienced rash/cellulitis to bilateral hands and wrists on 01Apr2021 with outcome of unknown. Therapeutic measures were taken as a result of the events with Decadron Shot. The events resulted in Doctor or other healthcare professional office/clinic visit.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Chest pain, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: heart hurts; the feeling of fainting stopped; sore throat; trouble breathing; nasal congestion and felt very hot; nasal congestion and felt very hot; had chest pain/ heart hurts; seeing stars; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age (age 27, unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at 5:30 pm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. E-transmitting possible duplicate AE as caller stated they already reported AE to previous agent. Caller reporting on behalf of her daughter. The patient got the 1st dose at 5:30 pm, woke up with a jolt at 1:00 am with trouble breathing, a sore throat, nasal congestion and felt very hot. She took a COVID test since then which was negative. 5 days after that, this Monday 12Apr2021, she had trouble breathing again, that didn't get better, while in the shower. She had chest pain which she described as 'my heart hurts' when she got out of the shower started seeing stars. She put her head down and the feeling of fainting stopped. Both times, the trouble breathing lasted 5-10 minutes. And she felt okay after just a few deep breaths. On the 2nd time she felt better after deep breaths, cold water and felt fine. She had a Tele-visit with a different doctor than her usual physician. She was told to go to urgent care, where they did an X-ray and EKG (electrocardiogram) and COVID test, as mentioned earlier. By the time she went to urgent care she had no trouble breathing though. The outcome of the events trouble breathing and felt faint was resolved on an unspecified date, of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nasal congestion, Oropharyngeal pain, SARS-CoV-2 test, Visual impairment
Clinical narrative: heart hurts; the feeling of fainting stopped; sore throat; trouble breathing; nasal congestion and felt very hot; nasal congestion and felt very hot; had chest pain/ heart hurts; seeing stars; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age (age 27, unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at 5:30 pm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. E-transmitting possible duplicate AE as caller stated they already reported AE to previous agent. Caller reporting on behalf of her daughter. The patient got the 1st dose at 5:30 pm, woke up with a jolt at 1:00 am with trouble breathing, a sore throat, nasal congestion and felt very hot. She took a COVID test since then which was negative. 5 days after that, this Monday 12Apr2021, she had trouble breathing again, that didn't get better, while in the shower. She had chest pain which she described as 'my heart hurts' when she got out of the shower started seeing stars. She put her head down and the feeling of fainting stopped. Both times, the trouble breathing lasted 5-10 minutes. And she felt okay after just a few deep breaths. On the 2nd time she felt better after deep breaths, cold water and felt fine. She had a Tele-visit with a different doctor than her usual physician. She was told to go to urgent care, where they did an X-ray and EKG (electrocardiogram) and COVID test, as mentioned earlier. By the time she went to urgent care she had no trouble breathing though. The outcome of the events trouble breathing and felt faint was resolved on an unspecified date, of other events was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: heart hurts; the feeling of fainting stopped; sore throat; trouble breathing; nasal congestion and felt very hot; nasal congestion and felt very hot; had chest pain/ heart hurts; seeing stars; This is a spontaneous report from a contactable consumer (patient's parent). A female patient of an unspecified age (age 27, unit: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at 5:30 pm at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. E-transmitting possible duplicate AE as caller stated they already reported AE to previous agent. Caller reporting on behalf of her daughter. The patient got the 1st dose at 5:30 pm, woke up with a jolt at 1:00 am with trouble breathing, a sore throat, nasal congestion and felt very hot. She took a COVID test since then which was negative. 5 days after that, this Monday 12Apr2021, she had trouble breathing again, that didn't get better, while in the shower. She had chest pain which she described as 'my heart hurts' when she got out of the shower started seeing stars. She put her head down and the feeling of fainting stopped. Both times, the trouble breathing lasted 5-10 minutes. And she felt okay after just a few deep breaths. On the 2nd time she felt better after deep breaths, cold water and felt fine. She had a Tele-visit with a different doctor than her usual physician. She was told to go to urgent care, where they did an X-ray and EKG (electrocardiogram) and COVID test, as mentioned earlier. By the time she went to urgent care she had no trouble breathing though. The outcome of the events trouble breathing and felt faint was resolved on an unspecified date, of other events was unknown.  Information on the lot/batch number has been requested.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, SARS-CoV-2 test
Clinical narrative: stroke; This is a spontaneous report from a contactable consumer. An 84-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 07Feb2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included high blood pressure. The patient has no known allergies and no covid prior vaccination. Concomitant medications included clopidogrel bisulfate, amlodipine, vitamin d [vitamin d nos] and "levoth" (as reported). The patient has no other vaccine in four weeks. On 21Feb2021 at 12 AM, the patient had a bad stroke "14 days" after he's first shot. They think it's the vaccine. The event resulted in hospitalization for 25 days and disability or permanent damage. The patient was covid tested post vaccination via nasal swab on 17Mar2021 which was negative. The outcome of the event was not recovered.  Information on the Lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head injury, Loss of consciousness, Malaise, Migraine
Clinical narrative: passed out; fainted; migraine; feel body aches; fatigue; felt incredibly ill; nauseous; hitting head; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in Right Arm on 10Apr2021 11:30 (at age of 22 years old) at single dose for COVID-19 immunisation. Medical history included Seasonal allergies, asthma, Known allergies: peanuts (mildly). Concomitant drug was Yes. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8727) on 20Mar2021 11:30AM (at 22 years old) at Left arm at single dose for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. A few hours after second dose, on 10Apr2021 02:00PM, patient developed a migraine and began to feel body aches and fatigue. The next morning, patient felt incredibly ill. Shortly after rising, patient became severely nauseous and fainted, hitting head; patient became conscious and passed out again before being taken to the ER (Emergency room). All AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (IV and anti-nausea med. administered) received for all events. The outcome of the events was Recovering.  Information on the lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Syncope
Clinical narrative: passed out; fainted; migraine; feel body aches; fatigue; felt incredibly ill; nauseous; hitting head; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0153), via an unspecified route of administration, administered in Right Arm on 10Apr2021 11:30 (at age of 22 years old) at single dose for COVID-19 immunisation. Medical history included Seasonal allergies, asthma, Known allergies: peanuts (mildly). Concomitant drug was Yes. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8727) on 20Mar2021 11:30AM (at 22 years old) at Left arm at single dose for COVID-19 immunisation. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. A few hours after second dose, on 10Apr2021 02:00PM, patient developed a migraine and began to feel body aches and fatigue. The next morning, patient felt incredibly ill. Shortly after rising, patient became severely nauseous and fainted, hitting head; patient became conscious and passed out again before being taken to the ER (Emergency room). All AE resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Treatment (IV and anti-nausea med. administered) received for all events. The outcome of the events was Recovering.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test, Colitis, Computerised tomogram, Investigation
Clinical narrative: rectal bleeding; colitis; abdominal pain; UTI; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 10:30 at the age of 55-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included known allergies. There were concomitant medications in two weeks. The historical vaccine included 1st of BNT162B2 on 10Mar2021 09:30 am at left arm for COVID-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe abdominal pain and rectal bleeding 4 days after the shot (05Apr2021 00:30) and on the 4th day went to emergency room had multiple tests done including but not limited to bloodwork and urine work up and CT scan, finding colitis, rectal bleeding and urinary tract infection (UTI). Therapeutic measures were taken as a result of events. The events outcome was unknown. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.  Information about the Lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage, Urinary tract infection, Urine analysis
Clinical narrative: rectal bleeding; colitis; abdominal pain; UTI; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 10:30 at the age of 55-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included known allergies. There were concomitant medications in two weeks. The historical vaccine included 1st of BNT162B2 on 10Mar2021 09:30 am at left arm for COVID-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe abdominal pain and rectal bleeding 4 days after the shot (05Apr2021 00:30) and on the 4th day went to emergency room had multiple tests done including but not limited to bloodwork and urine work up and CT scan, finding colitis, rectal bleeding and urinary tract infection (UTI). Therapeutic measures were taken as a result of events. The events outcome was unknown. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19.  Information about the Lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood glucose, Dizziness, Dyspnoea, Fatigue
Clinical narrative: pass out; I started feeling dizzy little bit; really feel very fatigue; I start breathing hard/barely can breathe; start seeing everything turned yellow; soaking sweating; But couldn't move; sharp pain in my stomach; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration, administered in Left arm on 15Apr2021 at 16:30 (at the age of 34-year-old) at single dose for COVID-19 immunisation. Medical history reported as no other medical history, no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 5 min from taking the shot on 15Apr2021 at 16:35, patient started feeling dizzy little bit. He thought walking around the aisle. But he still really felt very fatigue. He wanted back and a suit and started breathing hard. He started seeing everything turned yellow and barely could breathe. Then he passed out. The stuff came and help put an alcohol by his nose. He was soaking sweating. But couldn't move. The ambulance came to check his heart, blood sugar and blood oxygen on 15Apr2021, all with unknown results. Then patient started having sharp pain in his stomach. He had lunch on 15Apr2021 at one but he had spinach broccoli and beans. Patient was healthy. He worked out four times a week. After 30 minutes of receiving care. Patient felt better but he was worry for tonight on 15Apr2021. Events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of event passed out included put an alcohol by his nose, treatment for the other events was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Hyperhidrosis, Investigation, Loss of consciousness, Movement disorder, PO2
Clinical narrative: pass out; I started feeling dizzy little bit; really feel very fatigue; I start breathing hard/barely can breathe; start seeing everything turned yellow; soaking sweating; But couldn't move; sharp pain in my stomach; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration, administered in Left arm on 15Apr2021 at 16:30 (at the age of 34-year-old) at single dose for COVID-19 immunisation. Medical history reported as no other medical history, no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 5 min from taking the shot on 15Apr2021 at 16:35, patient started feeling dizzy little bit. He thought walking around the aisle. But he still really felt very fatigue. He wanted back and a suit and started breathing hard. He started seeing everything turned yellow and barely could breathe. Then he passed out. The stuff came and help put an alcohol by his nose. He was soaking sweating. But couldn't move. The ambulance came to check his heart, blood sugar and blood oxygen on 15Apr2021, all with unknown results. Then patient started having sharp pain in his stomach. He had lunch on 15Apr2021 at one but he had spinach broccoli and beans. Patient was healthy. He worked out four times a week. After 30 minutes of receiving care. Patient felt better but he was worry for tonight on 15Apr2021. Events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of event passed out included put an alcohol by his nose, treatment for the other events was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: pass out; I started feeling dizzy little bit; really feel very fatigue; I start breathing hard/barely can breathe; start seeing everything turned yellow; soaking sweating; But couldn't move; sharp pain in my stomach; This is a spontaneous report from a contactable consumer (patient). A 34-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not reported), via an unspecified route of administration, administered in Left arm on 15Apr2021 at 16:30 (at the age of 34-year-old) at single dose for COVID-19 immunisation. Medical history reported as no other medical history, no known allergies. Prior to vaccination, patient was not diagnosed with COVID-19. Concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. After 5 min from taking the shot on 15Apr2021 at 16:35, patient started feeling dizzy little bit. He thought walking around the aisle. But he still really felt very fatigue. He wanted back and a suit and started breathing hard. He started seeing everything turned yellow and barely could breathe. Then he passed out. The stuff came and help put an alcohol by his nose. He was soaking sweating. But couldn't move. The ambulance came to check his heart, blood sugar and blood oxygen on 15Apr2021, all with unknown results. Then patient started having sharp pain in his stomach. He had lunch on 15Apr2021 at one but he had spinach broccoli and beans. Patient was healthy. He worked out four times a week. After 30 minutes of receiving care. Patient felt better but he was worry for tonight on 15Apr2021. Events resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, patient had not been tested for COVID-19. Therapeutic measures were taken as result of event passed out included put an alcohol by his nose, treatment for the other events was unknown. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Measles, Rash
Clinical narrative: And it most definitely looks like the measles; bad rash developing on her left arm between her elbow down to her wrist; This is a spontaneous report from a contactable consumer (patient). A 55-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in left arm on 02Apr2021 10:00 (Batch/Lot Number: EWO150) as single dose for COVID-19 immunisation. Medical history included lupus, ovarian cancer, trigeminal neuralgia, interstitial cystitis (IC), and idiopathic anaphylaxis. The patient has many, many prescription and OTC meds (unspecified). No other vaccine in four weeks. It was unknown if the patient had COVID prior to vaccination. The patient has not been tested for COVID post vaccination. The patient first noticed a bad rash developing on her left arm between her elbow down to her wrist on 08Apr2021. She chalked it up to the sun & warmer weather and the fact that she has lupus. A day or so later, she noticed very clearly, the same rash appeared on her left thigh. Just mid thigh to knee cap. And it most definitely looked like the measles. She added that nothing itched. And her thigh has not been exposed to any sun. She consulted her doctor via e-mail who has seen pictures of the rashes. She wanted her to get her blood work checked the next day (unknown results) to make sure her lupus hasn't been compromised by the Covid rash side effect. The event resulted in a doctor clinic visit. The patient has not recovered from the events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Neuralgia, Night sweats, Pain
Clinical narrative: anxiety; night sweat; fatigue/extremely fatigued; nerve pain; body aches; had a slight ringing in my ear; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in right arm on 25Mar2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included post viral syndrome (chronic fatigue), dry eye, known allergies included lactose intolerance and had adverse reactions to Botox. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications in two weeks included Vitamin B, D, Magnesium, zinc, copper, omega 3. No other vaccine was received in four weeks. On 25Mar2021 (pending clarification) by 2am the patient woke up with a horrible anxiety and night sweat. Evening two the patient had some fatigue, evening three I had a flare up of nerve pain and body aches, same issues night four. By night five the patient felt like her entire body was on fire with nerve pain. Day six on 30Mar2021 the patient was extremely fatigued and had a slight ringing in her ear that remained. The patient slowly regained her strength and functioning. The events resulted in "Doctor or other healthcare professional office/clinic visit, Disability or permanent damage". No treatment was received for events. The outcome of events was recovering.   Information on the lot/ batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: anxiety; night sweat; fatigue/extremely fatigued; nerve pain; body aches; had a slight ringing in my ear; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration administered in right arm on 25Mar2021 15:30 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included post viral syndrome (chronic fatigue), dry eye, known allergies included lactose intolerance and had adverse reactions to Botox. No COVID prior vaccination. No COVID tested post vaccination. Concomitant medications in two weeks included Vitamin B, D, Magnesium, zinc, copper, omega 3. No other vaccine was received in four weeks. On 25Mar2021 (pending clarification) by 2am the patient woke up with a horrible anxiety and night sweat. Evening two the patient had some fatigue, evening three I had a flare up of nerve pain and body aches, same issues night four. By night five the patient felt like her entire body was on fire with nerve pain. Day six on 30Mar2021 the patient was extremely fatigued and had a slight ringing in her ear that remained. The patient slowly regained her strength and functioning. The events resulted in "Doctor or other healthcare professional office/clinic visit, Disability or permanent damage". No treatment was received for events. The outcome of events was recovering.   Information on the lot/ batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary thrombosis
Clinical narrative: had two blood clots on her lungs; This is a spontaneous report from a contactable consumer. A 20-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 20-years-old via an unspecified route of administration, administered in arm left on 28Mar2021 12:30 (Batch/Lot Number: ER8730) as single dose for covid-19 immunisation.  Medical history included birth control from an unknown date and unknown if ongoing. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) taken for birth control from Dec2020 to 12Apr2021. The patient experienced had two blood clots on her lungs on 12Apr2021 18:00.  The patient was hospitalized due to the event from 12Apr2021 to 14Apr2021. The patient was recovering from the event.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: major flare of RA; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration into left arm on 01Apr2021 15:15 (at the age of 59-year-old) as single dose for COVID-19 immunisation. Medical history included ongoing rheumatoid arthritis (RA). The patient's concomitant medications were not reported.  The patient experienced major flare of RA on 03Apr2021 and was treated with pain medications. Outcome of event was not recovered.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Illness, Near death experience
Clinical narrative: felt like she was going to die; got really sick, a mess; can't breathe; chills but no fever; body really sore; head hurt every day; nose running really really bad but at first it was dry; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose in left arm for COVID-19 immunisation at the age of 44-year-old. Lot number was ER8733. Medical history included diabetes, Covid-19 in 2020. Concomitant medications included metformin for diabetes from 2019 and ongoing, insulin lispro (HUMALOG) for diabetes from 2019 and ongoing, insulin detemir (LEVEMIR) for diabetes from 2019 and ongoing. On 13Apr2021, patient felt like she was going to die, she could not breath. On 06Apr2021, the patient experienced got really sick, a mess, could not breath, chills but no fever, body really sore, head hurt every day, nose running really bad but at first it was dry. Since then, the patient has been very sick, like really sick, could not even be out of bed until the day before the report and the day of report she felt a little bit better. The patient has been drinking a lot of lemon juice; she also has been taking guaifenesin chest and runny nose congestion, guaifenesin Sinus Extra and acetaminophen. The husband of the patient got sick on Thursday or Friday; it was raining he got wet, so he was coughing; they have 3 kids, and the little one got sick same day as her. The patient did not recover from headache; the outcome of felt like she was going to die was unknown; the patient was recovering from other events. Patient stated that she was not saying it was because of the shot, but it was really confusing, she might get sick because her husband got sick for a few days and was outside working and it was raining and really really cold.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea
Clinical narrative: felt like she was going to die; got really sick, a mess; can't breathe; chills but no fever; body really sore; head hurt every day; nose running really really bad but at first it was dry; This is a spontaneous report from a contactable consumer (patient).  A 44-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 01Apr2021 at single dose in left arm for COVID-19 immunisation at the age of 44-year-old. Lot number was ER8733. Medical history included diabetes, Covid-19 in 2020. Concomitant medications included metformin for diabetes from 2019 and ongoing, insulin lispro (HUMALOG) for diabetes from 2019 and ongoing, insulin detemir (LEVEMIR) for diabetes from 2019 and ongoing. On 13Apr2021, patient felt like she was going to die, she could not breath. On 06Apr2021, the patient experienced got really sick, a mess, could not breath, chills but no fever, body really sore, head hurt every day, nose running really bad but at first it was dry. Since then, the patient has been very sick, like really sick, could not even be out of bed until the day before the report and the day of report she felt a little bit better. The patient has been drinking a lot of lemon juice; she also has been taking guaifenesin chest and runny nose congestion, guaifenesin Sinus Extra and acetaminophen. The husband of the patient got sick on Thursday or Friday; it was raining he got wet, so he was coughing; they have 3 kids, and the little one got sick same day as her. The patient did not recover from headache; the outcome of felt like she was going to die was unknown; the patient was recovering from other events. Patient stated that she was not saying it was because of the shot, but it was really confusing, she might get sick because her husband got sick for a few days and was outside working and it was raining and really really cold.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Loss of consciousness, Migraine, Myalgia
Clinical narrative: Passed out right after vaccine; muscle aches; tired; chills; migraine; This is a spontaneous report from a non-contactable consumer (patient). A 17-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in the left arm on 14Apr2021 at 14:15 (Batch/Lot number was not reported) as single dose for covid-19 immunization, administered at the Pharmacy or Drug store. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 17Mar2021 at 14:15 in the left arm for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient was not pregnant at the time of report and vaccination. The patient did not receive other vaccines in four weeks. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient passed out right after vaccine, also experienced muscle aches, tired, chills, and migraine; all on 14Apr2021 with outcome of unknown.  No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Dysarthria, Dyspnoea, Hypoaesthesia, Swollen tongue, Tinnitus
Clinical narrative: Ringing of ears intensified; Face was numb; Slurred speech; Slight swelling of tongue; Slight trouble breathing; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Er8735), via an unspecified route of administration, administered in left arm on 12Apr2021 as single dose for COVID-19 immunisation. Medical history included known allergies on certain beta blockers and macadamia nuts from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications were not reported.  The patient previously received the first dose of BNT162B2 (lot number= Er6204) on 22Mar2021 11:30 AM, on left arm, for COVID-19 immunisation, and experienced ringing in both ears. Upon receipt of the second shot, ringing of ears intensified and has continued to present. Additionally, approximately 25 minutes after the second shot on 12Apr2021, the patient's face was numb, had slurred speech and slight swelling of tongue, slight trouble breathing with wheezing. Face numbness subsided after 10 hours. The events resulted in disability or permanent damage. No treatment for the events was received. The patient has not recovered from the reported events.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Ringing of ears intensified; Face was numb; Slurred speech; Slight swelling of tongue; Slight trouble breathing; Wheezing; This is a spontaneous report from a contactable consumer (patient). A 52-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Er8735), via an unspecified route of administration, administered in left arm on 12Apr2021 as single dose for COVID-19 immunisation. Medical history included known allergies on certain beta blockers and macadamia nuts from an unknown date and unknown if ongoing. The patient has no history of COVID prior vaccination and was not COVID tested post vaccination. Concomitant medications were not reported.  The patient previously received the first dose of BNT162B2 (lot number= Er6204) on 22Mar2021 11:30 AM, on left arm, for COVID-19 immunisation, and experienced ringing in both ears. Upon receipt of the second shot, ringing of ears intensified and has continued to present. Additionally, approximately 25 minutes after the second shot on 12Apr2021, the patient's face was numb, had slurred speech and slight swelling of tongue, slight trouble breathing with wheezing. Face numbness subsided after 10 hours. The events resulted in disability or permanent damage. No treatment for the events was received. The patient has not recovered from the reported events.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Feeling abnormal, Feeling drunk
Clinical narrative: brain fog; "tipsy", floor appears to move; difficulty standing; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration, administered in Arm Right on 15Apr2021 10:45 (Batch/Lot Number: EWO169) as SINGLE DOSE for covid-19 immunization. Medical history included vestibular disorder from an unknown date. Concomitant medications included insulin (INSULIN), lisinopril (LISINOPRIL), acetylsalicylic acid (ASPRIN), lysine (LYSINE), ibuprofen (IBUPROFEN) and simvastatin (SIMVASTATIN) all taken for unspecified indications, start and stop dates were not reported. The patient previously took gabapentin and experienced drug hypersensitivity. The patient experienced brain fog, "tipsy", floor appears to move and difficulty standing on 15Apr2021 10:45. It was reported that the events resulted in Disability or permanent damage. Outcome of the events was not recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune thyroiditis, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Cough, Eczema
Clinical narrative: Triggered being positive for Hashimoto antibodies; elevated TSH; Genital Herpes outbreak; severe breakout eczema around mouth; Wheezing; coughing; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 14:30 (at the age of 58years) a as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 17Jan2021 13:30 (Batch/Lot Number: 3247) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient experienced triggered being positive for Hashimoto antibodies, elevated TSH (thyroid stimulating hormone), Genital Herpes outbreak, severe breakout eczema around mouth, wheezing, and coughing. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with Thyroid medication and Valacyclovir. Covid test post vaccination: Nasal Swab on 08Mar2021, result: Negative. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, SARS-CoV-2 test, Wheezing
Clinical narrative: Triggered being positive for Hashimoto antibodies; elevated TSH; Genital Herpes outbreak; severe breakout eczema around mouth; Wheezing; coughing; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EM9809), dose 2 via an unspecified route of administration, administered in Arm Left on 07Feb2021 14:30 (at the age of 58years) a as single dose for Covid-19 immunization. The patient received the first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 17Jan2021 13:30 (Batch/Lot Number: 3247) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Feb2021, the patient experienced triggered being positive for Hashimoto antibodies, elevated TSH (thyroid stimulating hormone), Genital Herpes outbreak, severe breakout eczema around mouth, wheezing, and coughing. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. The patient was treated with Thyroid medication and Valacyclovir. Covid test post vaccination: Nasal Swab on 08Mar2021, result: Negative. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected. Information on lot number already obtained.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Erythema, Pain in extremity, Peripheral swelling, Thrombophlebitis
Clinical narrative: Clotting; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunisation. Medical history included allergies and asthma. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for allergies. The patient previously received first dose of BNT162B2 on 17Feb2021 for COVID-19 immunisation; and experienced thrombophlebitis and leg swelled up and got very sore, painful, and red (lot number: EL9266 at 04:00 PM). About 2 weeks after the first dose, patient's leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis. She received the second dose on 10Mar, and her leg got worse a few days later. She visited the emergency room and was sent to a specialist who put her on blood thinners for clotting. Patient stated that the only significant change or occurrence in her life was that she received the vaccine. The events resulted to a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the event clotting was unknown, while not recovered for the other events.   Information on the lot/batch number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Clotting; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; Leg got worse/ leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on 10Mar2021 at a single dose for COVID-19 immunisation. Medical history included allergies and asthma. Concomitant medication included levocetirizine dihydrochloride (XYZAL) taken for allergies. The patient previously received first dose of BNT162B2 on 17Feb2021 for COVID-19 immunisation; and experienced thrombophlebitis and leg swelled up and got very sore, painful, and red (lot number: EL9266 at 04:00 PM). About 2 weeks after the first dose, patient's leg swelled up and got very sore, painful, and red. Doctors advised that it was likely thrombophlebitis. She received the second dose on 10Mar, and her leg got worse a few days later. She visited the emergency room and was sent to a specialist who put her on blood thinners for clotting. Patient stated that the only significant change or occurrence in her life was that she received the vaccine. The events resulted to a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. No known allergies. Patient was not pregnant. Outcome of the event clotting was unknown, while not recovered for the other events.   Information on the lot/batch number has been requested.