chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Loss of consciousness
Clinical narrative: Woke up feeling weak and tired; Woke up feeling weak and tired; Lost consciousness/passed out for several minutes; This is a spontaneous report from a non-contactable consumer (patient).   A 26 years-old male patient received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0173) in the left arm, at single dose, on 04May2021, at 08:45 AM, for COVID-19 immunisation. COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient had not received any other medications within 2 weeks of vaccination. Prior to vaccination, was not the patient diagnosed with COVID-19. Relevant medical history and concomitant medications were unknown. It was reported that the patient received the first dose of vaccine in left arm, then 5 minutes later, on 04May2021, lost consciousness/passed out for several minutes. Woke up feeling weak and tired on an unspecified date. Emergency Room Visit /department or urgent care required. Post the vaccination, the patient has not been tested for COVID-19. Clinical outcome of the events was unknown at time of this report.   No follow-up attempts possible. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsey of left side of face; This is a spontaneous report from a contactable consumer (patient).   A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Mar2021 at 11:00 (Lot Number: EN6199) (at the age of 54-year-old) as single dose for COVID-19 immunisation. The patient was not pregnant. Medical history included rheumatoid arthritis (RA), fibromyalgia, gastrooesophageal reflux disease (GERD) and high blood pressure, all from an unknown date and unknown if ongoing. The patient was not diagnosed with COVID-19 before vaccination and since vaccination has not tested positive to COVID-19. Concomitant medications included oxycodone hydrochloride/oxycodone terephthalate/paracetamol (PERCOCET); valsartan (DIOVAN); levothyroxine sodium (EUTHYROX); orphenadrine and quetiapine, all concomitants were taken for an unspecified indication, start and stop date were not reported.  The patient previously took ALUPENT and ADVAIR.  The patient experienced Bell's palsy of left side of face on 29Mar2021. The event required doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event and included treatment with steroids and antiviral. The patient outcome of the event was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Erythema, Feeling abnormal, Headache
Clinical narrative: Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling across face just above upper lip; face and neck turned red and swollen/ arms turned red under sleeves; face and neck turned red and swollen; dizzy; brain fog; Existing Tinnitus in left ear is louder; This is a spontaneous report from a contactable consumer reported for herself.   This 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:15 (Batch/Lot Number: Unknown) as single dose (at 47 years old) for COVID-19 immunisation.  Medical history included fibromyalgia from (previously diagnosed as Rheumatoid Arthritis). Concomitant medications included fenofibrate, escitalopram, hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), herbal sup, all taken for an unspecified indication, start and stop date were not reported. The patient previously took monosodium glutamate and experienced allergy, hydroxychloroquine sulfate and experienced allergy. On 27Apr2021 15:15, the patient experienced anaphylaxis, vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen/ arms turned red under sleeves, dizzy, brain fog, existing tinnitus in left ear is louder, all with outcome of not recovered (as reported). Therapeutic measures were taken as a result of the events included Diphenhydramine, Epinephrine, Famotidine, Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that: "Sent to ER via ambulance: Diagnosed with Anaphylaxis. Vocal cord tightened, immediate severe headache on left half,  tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen, arms turned red under sleeves, dizzy, brain fog. Existing Tinnitus in left ear is louder, and as of 04May2021, I still have the headache". Seriousness criteria of the events was reported as serious due to disability.  The information on the Lot / Batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Swelling, Swollen tongue, Tinnitus, Vocal cord disorder
Clinical narrative: Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling across face just above upper lip; face and neck turned red and swollen/ arms turned red under sleeves; face and neck turned red and swollen; dizzy; brain fog; Existing Tinnitus in left ear is louder; This is a spontaneous report from a contactable consumer reported for herself.   This 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:15 (Batch/Lot Number: Unknown) as single dose (at 47 years old) for COVID-19 immunisation.  Medical history included fibromyalgia from (previously diagnosed as Rheumatoid Arthritis). Concomitant medications included fenofibrate, escitalopram, hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), herbal sup, all taken for an unspecified indication, start and stop date were not reported. The patient previously took monosodium glutamate and experienced allergy, hydroxychloroquine sulfate and experienced allergy. On 27Apr2021 15:15, the patient experienced anaphylaxis, vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen/ arms turned red under sleeves, dizzy, brain fog, existing tinnitus in left ear is louder, all with outcome of not recovered (as reported). Therapeutic measures were taken as a result of the events included Diphenhydramine, Epinephrine, Famotidine, Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that: "Sent to ER via ambulance: Diagnosed with Anaphylaxis. Vocal cord tightened, immediate severe headache on left half,  tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen, arms turned red under sleeves, dizzy, brain fog. Existing Tinnitus in left ear is louder, and as of 04May2021, I still have the headache". Seriousness criteria of the events was reported as serious due to disability.  The information on the Lot / Batch number has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Electrocardiogram, Magnetic resonance imaging head
Clinical narrative: Bell's palsy; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 28Apr2021 at 13:30-13:40 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included Hashimoto's thyroiditis and fibromyalgia, both diagnosed over 20 years ago, overweight, and arthritis. Concomitant medications were not reported, but the patient did state she took something for arthritis and thyroid for years prior to the vaccination. There were no prior vaccinations within 4 weeks of the vaccine. On 02May2021, at 15:30-16:00, the patient was diagnosed with Bell's Palsy. She went to the emergency room on 02May2021, where they performed an EKG & MRI of the head to make sure it was not a stroke, which were all negative. The patient was not admitted to the hospital. She tried to speak slow because her words were slurred. The patient was not treated for the event. The clinical outcome of Bell's Palsy was not resolved.   Information on lot number has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Pain, Peripheral swelling, Thrombosis, Ultrasound joint
Clinical narrative: numerous blood clots below the knee; left leg swelling/ It got so swollen/left foot swelling; pain with walking left leg; This is a spontaneous report from a contactable nurse reporting for herself.    A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm  on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation (Age at vaccination 78 years).  The patient medical history was not reported.  On 04Feb2021 the patient received the first dose of BNT162B2 and experienced sore arm.   The patient's concomitant medications were not reported.  The patient experienced pain with walking left leg  on 28Feb2021 with outcome of recovering , left leg swelling/ it got so swollen/left foot swelling  on 03Mar2021 with outcome of not recovered , numerous blood clots below the knee  on 04Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included blood test: unknown results,  ultrasound joint: numerous blood clots below the knee   on 04Apr2021   , vital signs measurement: unknown results.  Course of the event: The patient  waited for the timeframe after the second dose and had no problems. 4 days after, she experienced pain with walking in her left leg.  She took Aleve for a few days.  It got so swollen, she should have gone then to her Primary Medical Doctor, but she did not go until 25Mar2021. She was sent to  Hospital for an Ultrasound of her leg on 04Apr2021.  After the Ultrasound, she was taken to the Emergency Department at the hospital. The doctor told her she had numerous blood clots below the knee.  Was prescribed Eliquis 5mg.  She was instructed to take 2 tablets or 10mg twice a day, 8hrs apart for 1 week and then 1 tablet twice a day for the remainder of the 74 tablets. She completed that. She was out of them and got a refill of Eliquis 5mg on 26Apr2021. She received 60 tablets and can refill for 5 times. She is really concerned. The swelling is still so bad and so that could that mean blood clots are still in there. The ER doctor told her that the medication is dangerous.  It thins the blood and can cause bleeding and the blood clot can go to her heart.  Follow up information has been requested.; Sender's Comments: The causality has been assessed as related to bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm  on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunization, based on temporal association and profile of the product.,Linked Report(s) : 2021499984 same patient/drug, diff dose/event
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vital signs measurement
Clinical narrative: numerous blood clots below the knee; left leg swelling/ It got so swollen/left foot swelling; pain with walking left leg; This is a spontaneous report from a contactable nurse reporting for herself.    A 78-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm  on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunisation (Age at vaccination 78 years).  The patient medical history was not reported.  On 04Feb2021 the patient received the first dose of BNT162B2 and experienced sore arm.   The patient's concomitant medications were not reported.  The patient experienced pain with walking left leg  on 28Feb2021 with outcome of recovering , left leg swelling/ it got so swollen/left foot swelling  on 03Mar2021 with outcome of not recovered , numerous blood clots below the knee  on 04Apr2021 with outcome of not recovered.  The patient underwent lab tests and procedures which included blood test: unknown results,  ultrasound joint: numerous blood clots below the knee   on 04Apr2021   , vital signs measurement: unknown results.  Course of the event: The patient  waited for the timeframe after the second dose and had no problems. 4 days after, she experienced pain with walking in her left leg.  She took Aleve for a few days.  It got so swollen, she should have gone then to her Primary Medical Doctor, but she did not go until 25Mar2021. She was sent to  Hospital for an Ultrasound of her leg on 04Apr2021.  After the Ultrasound, she was taken to the Emergency Department at the hospital. The doctor told her she had numerous blood clots below the knee.  Was prescribed Eliquis 5mg.  She was instructed to take 2 tablets or 10mg twice a day, 8hrs apart for 1 week and then 1 tablet twice a day for the remainder of the 74 tablets. She completed that. She was out of them and got a refill of Eliquis 5mg on 26Apr2021. She received 60 tablets and can refill for 5 times. She is really concerned. The swelling is still so bad and so that could that mean blood clots are still in there. The ER doctor told her that the medication is dangerous.  It thins the blood and can cause bleeding and the blood clot can go to her heart.  Follow up information has been requested.; Sender's Comments: The causality has been assessed as related to bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Right Arm  on 24Feb2021 (Batch/Lot Number: EN6202) as single dose for covid-19 immunization, based on temporal association and profile of the product.,Linked Report(s) : 2021499984 same patient/drug, diff dose/event
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage
Clinical narrative: I have barely hit my hands on something and they start bleeding on my knuckles; This is a spontaneous report from a contactable consumer (patient). This 39-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in the left arm on 03May2021 (at the age of 39-year-old) (Lot Number: EW0176) as single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation and experienced heavy menstrual bleeding for 3 weeks following the first dose; very large clots. On 03May2021 at 15:00, after the second dose, the patient had barely hit her hands on something and they started bleeding on her knuckles. The patient had not recovered from the event. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498328 same patient/drug, different vaccine dose/AE
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Fatigue, SARS-CoV-2 test
Clinical narrative: Received first dose and then like three weeks later got second dose, then got Covid and ended up in the hospital; Received first dose and then like three weeks later got second dose, then got Covid and ended up in the hospital; Tired; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 07Apr2021 (Lot Number: EW0162) as single dose, dose 1 via an unspecified route of administration, administered in arm right on 17Mar2021 (Batch/Lot Number: ER8727) as single dose, both administered at the age of 58 years for covid-19 immunisation.  Medical history included ongoing lung carcinoma cell type unspecified stage iv diagnosed two years ago, recently broken collar bone on Feb2021, myocardial infarction from Oct2020 to an unknown date, severe allergic reaction to flu shot and something else can't remember years ago. The patient's concomitant medications were not reported. The patient received first dose and then like three weeks later got second dose, then on 07Apr2021 got covid and ended up in the hospital from 07Apr2021 to 19Apr2021. On an unspecified date the patient was tired. Caller was still tired but it was getting better. Caller states it has improved. Caller was diagnosed with Covid the same day the caller received the second dose Pfizer Covid Vaccine on 07Apr2021. Laboratory data included rapid test positive on unknown date. The outcome of the event got covid was unknown. The outcome of the event tired was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Seizure
Clinical narrative: full blown seizure and had several since then; little mini twitches on her face; This is a spontaneous report received from a contactable consumer reporting for his mother in law. An 89 years old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Feb2021, for COVID-19 immunisation. Medical history included pacemaker ongoing from 2015 and open heart surgery several years ago. The patient was very strong and lucid and could remember everything from the past. This lady was small. Until recently, she never took meds. Concomitant medications included alprazolam (XANAX) taken occasionally at 0.25 mg and maybe omeprazole (PROTONIX) for cholesterol. 2 to 3 days after the first vaccination, on an unspecified date in Feb2021, the patient started having little mini twitches on her face. They thought nothing of it. On the fifth day (in late Feb2021 or early Mar2021) she had a full blown seizure and had several since then and was hospitalized for like 20 days the first time. The reporter thought the patient had a total of about 4 or 5 seizures. When she experienced another seizure, they took her back and she was in the hospital for about 5 or 6 days, then released her. She had been back twice since then. The last time, they took her late at night and was out in the morning. That last time, she was not admitted. She was hospitalized at least 4 times, maybe a week or two apart, each time, all at the same hospital. They could not find out what was wrong with her. They put her on anti-seizure medication. They had tried several (the reporter thought more than 2). It was really a lot worse. It was really bad on her. The medications they had been giving her had really thrown her for a loop. They now believe she was way over medicated and sitting at home. They suggested for her to see a neurosurgeon who won't see her until the end of May. She had been having seizures and never had before. Seizures required ER visit. Events outcome was unknown. The hospital said they would give the second dose but they never did. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021501795 same drug/patient, different vaccine dose/AE
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Disorientation, Dyspnoea, Pyrexia
Clinical narrative: tested positive for COVID; Disorientated; Difficulty breathing; Fever; cough; This is a spontaneous report from a contactable consumer (the patient's wife) received from a Pfizer-sponsored program. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 02Apr2021 (also reported as 03Apr2021) around 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no adverse events following prior vaccinations. The patient tested positive for COVID on 10Apr2021 and went to the hospital.  The patient also experienced fever, disorientated, and difficulty breathing.  The patient's wife clarified that the patient went to the emergency room and was hospitalized for four days, from 16Apr2021 to 20Apr2021, for all three symptoms of fever, disorientated, and difficulty breathing. The patient was hospitalized for COVID. It was also reported that fever was from 11Apr2021 to 18Apr2021, disorientated from 16Apr2021 to 17Apr2021, difficulty breathing from 14Apr2021 to 24Apr2021, cough from an unspecified date. On 10Apr2021, COVID test results were positive. On 24Apr21, COVID test results were negative. For treatment at home, the patient took acetaminophen (TYLENOL), ibuprofen (ADVIL), and an albuterol inhaler. When he was admitted to the hospital, he was given IV fluids, TYLENOL, dexamethasone, a blood thinner (did not know the name). He also took cough medicine called guaifenesin at the hospital. When the patient was released from the hospital, he was given 6 days of prednisone to take. The patient did not have an appointment yet for the second dose. All events were considered medically significant. The outcome of cough was unknown. The other events recovered on the following dates: tested positive for COVID- on 24Apr2021, fever- on 18Apr2021, disorientated- on 17Apr2021, difficulty breathing- on 24Apr2021.  Information on lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498996 same drug/similar event, different patients;US-PFIZER INC-2021502035 same drug/similar event, different patients;US-PFIZER INC-2021502065 same drug/similar event, different patients
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tested positive for COVID; Disorientated; Difficulty breathing; Fever; cough; This is a spontaneous report from a contactable consumer (the patient's wife) received from a Pfizer-sponsored program. A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the left arm on 02Apr2021 (also reported as 03Apr2021) around 16:00 (at the age of 55-years-old) as a single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no adverse events following prior vaccinations. The patient tested positive for COVID on 10Apr2021 and went to the hospital.  The patient also experienced fever, disorientated, and difficulty breathing.  The patient's wife clarified that the patient went to the emergency room and was hospitalized for four days, from 16Apr2021 to 20Apr2021, for all three symptoms of fever, disorientated, and difficulty breathing. The patient was hospitalized for COVID. It was also reported that fever was from 11Apr2021 to 18Apr2021, disorientated from 16Apr2021 to 17Apr2021, difficulty breathing from 14Apr2021 to 24Apr2021, cough from an unspecified date. On 10Apr2021, COVID test results were positive. On 24Apr21, COVID test results were negative. For treatment at home, the patient took acetaminophen (TYLENOL), ibuprofen (ADVIL), and an albuterol inhaler. When he was admitted to the hospital, he was given IV fluids, TYLENOL, dexamethasone, a blood thinner (did not know the name). He also took cough medicine called guaifenesin at the hospital. When the patient was released from the hospital, he was given 6 days of prednisone to take. The patient did not have an appointment yet for the second dose. All events were considered medically significant. The outcome of cough was unknown. The other events recovered on the following dates: tested positive for COVID- on 24Apr2021, fever- on 18Apr2021, disorientated- on 17Apr2021, difficulty breathing- on 24Apr2021.  Information on lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021498996 same drug/similar event, different patients;US-PFIZER INC-2021502035 same drug/similar event, different patients;US-PFIZER INC-2021502065 same drug/similar event, different patients
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Lip swelling, Periorbital swelling, Swelling
Clinical narrative: After 12 hours from vaccine I had diarrhea; chill; swelling all my body; puffy both eyes and lips; puffy both eyes and lips; This is a spontaneous report from a contactable consumer (patient).  A 31-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 03May2021 14:00 (Batch/Lot number was not reported) as single dose at the age of 31-year-old for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. Patient was not pregnant. No other vaccine in four weeks. No COVID prior vaccination. No known allergies. Other medical history: she never had any reaction. On 04May2021 04:00 after 12 hours from vaccine she had diarrhea, chill, swelling all her body, puffy both eyes and lips. Events resulted in Emergency room/department or urgent care and Hospitalization. Therapeutic measures were taken as a result of events. COVID was not tested post vaccination. The outcome of events was recovered with sequelae.    Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program Support. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient developed symptoms of the COVID virus on an unspecified date after getting the first dose. She developed fatigue, body ache, headache, and she was getting worried about the loss of smell. The patient tested positive for the COVID rapid test, on an unspecified date. Right now, they were waiting for the COVID PCR (polymerase chain reaction) exam results. The outcome of positive COVID-19 test with symptoms was unknown.  Information on the lot/batch number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Status epilepticus
Clinical narrative: Numerous grand mal seizures, never before experienced,, including 2 instances of status epilepticus. Have had epilepsy since 2012 and current medication levels are in normal range.; Numerous grand mal seizures, never before experienced,, including 2 instances of status epilepticus. Have had epilepsy since 2012 and current medication levels are in normal range.; This is a spontaneous report from a contactable consumer reporting for self.   A 29-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Apr2021 at 13:30 (Batch/Lot number was not reported) as single dose (at the age of 29 years old) for COVID-19 immunization.  There was no other vaccination received in the 4 weeks prior. Medical history included epilepsy since 2012, autism spectrum disorder, respiratory illness in Nov2019 (not caused by the flu but with COVID-like symptoms), high blood cell count (previous treatment). There were no known allergies. Concomitant medication(s) included lamotrigine (LAMICTAL) and escitalopram oxalate (LEXAPRO), both taken for epilepsy, start and stop date were not reported.  On 25Apr2021 at 20:30, the patient experienced numerous grand mal seizures, never before experienced, including 2 instances of status epilepticus. The patient has had epilepsy since 2012 and current medication levels were in normal range. There was no treatment received for the adverse event. The events resulted in a Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19.  The outcome of the events grand mal seizures and status epilepticus was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Joint swelling, Pain in extremity, Paraesthesia
Clinical narrative: Extreme acute swelling of distal joint on index finger right hand; Extreme acute swelling of distal joint on index finger right hand; Pain in all joints of hands; Pain in all joints of hands; tingling of fingers; aching at prior fracture site; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EP7533), via intramuscular route of administration, in right arm on 06Apr2021 09:15 (at the age of 63-year-old) 2nd dose single for covid-19 immunisation. The. Patient medical history was not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. Patient drug history was none. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (BNT162B2, solution for injection) via intramuscular route of administration in left arm on 16Mar2021 12:00. On an unknown date, the patient experienced extreme acute swelling of distal joint on index finger right hand, Pain in all joints of hand , tingling of fingers , aching at prior fracture site. This case was serious due to disabling or Incapacitating. No treatment was reported. Outcome of the events were not recovered.  Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of joint swelling,finger swelling,Arthralgia,paresthesia,bone pain. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Extreme acute swelling of distal joint on index finger right hand; Extreme acute swelling of distal joint on index finger right hand; Pain in all joints of hands; Pain in all joints of hands; tingling of fingers; aching at prior fracture site; This is a spontaneous report from a contactable physician. A 63-year-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EP7533), via intramuscular route of administration, in right arm on 06Apr2021 09:15 (at the age of 63-year-old) 2nd dose single for covid-19 immunisation. The. Patient medical history was not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19, since the vaccination. Patient drug history was none. The patient received other medications within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (BNT162B2, solution for injection) via intramuscular route of administration in left arm on 16Mar2021 12:00. On an unknown date, the patient experienced extreme acute swelling of distal joint on index finger right hand, Pain in all joints of hand , tingling of fingers , aching at prior fracture site. This case was serious due to disabling or Incapacitating. No treatment was reported. Outcome of the events were not recovered.  Additional information has been requested.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of joint swelling,finger swelling,Arthralgia,paresthesia,bone pain. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: received vaccine 8 days ago and now may have cancer; This is a spontaneous report from a Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (BNT162B2) via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received vaccine 8 days ago and now may have cancer on an unspecified date. A contactable consumer (patient's mother) was asking for timeframe information between covid vaccine and image screening for cancer, son recieved vaccine 8 days ago and now may have cancer, imaging not yet confirmed diagnosis. Outcome of the event was unknown.  Information on batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Ischaemia
Clinical narrative: Ischemia in left optic nerve causing permanent vision loss; Ischemia in left optic nerve causing permanent vision loss; This is a spontaneous report from a contactable (patient). A 43-years-old 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 18Jan2021 10:00 (Batch/Lot Number: EL3248) as 2ND DOSE, SINGLE for covid-19 immunization. Medical history included intervertebral disc protrusion, Bulging disc C-Spine, endometriosis, and allergy to sulfa. The patient was previously vaccinated with first dose of bnt162b2, in left arm (Lot number: EK5730) on 28Dec2021 at 12.00pm for covid-19 immunization. Concomitant medications included ashwagandha; loratadine (CLARITIN); vitamins NOS (MV) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 and has not been tested for COVID-19 Since the vaccination. On 06Feb2021 08:00 the patient experienced ischemia in left optic nerve causing permanent vision loss. The patient received treatment for adverse event and events result in Doctor or other healthcare professional office/clinic visit. The outcome of events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events blindness and ischemia and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clot in right leg; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received the first COVID vaccine on 15Apr2021, a week later (in Apr2021), the patient experienced a blood clot in right leg. The patient is currently on blood thinners and was scheduled to receive the 2nd vaccine on 06Mar2021. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fall, Head injury, Syncope
Clinical narrative: fainted; fell to the floor; hit his head; This is a spontaneous report from a contactable pharmacist. A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 30Apr2021 at 12:15 PM (Batch/Lot Number: EW0172) as the 2nd dose, single for COVID-19 immunization. The vaccination facility type was reported as the pharmacy/drug store; the vaccine was not administered at the military facility. The patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date. Relevant medical history included past experience with fainting on an unknown date. The patient had no known allergies. The patient's concomitant medications were not reported. The patient had vaccination on 30Apr2021 and then proceeded to the front of the store to check-out. On 30Apr2021 at 12:20 PM, he fainted and fell to the floor and hit his head. The 911 was called immediately. The reporter checked the blood pressure and gave patient some water. The paramedics arrived and took over. The patient refused paramedic transport to hospital. The patient's father picked him up from the store. It was unknown if the patient has ever had an adverse event following any previous vaccine. The patient underwent lab tests and procedures, which included blood pressure with unknown results on 30Apr2021. The outcome of the events was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Faint cannot be excluded.  The case will be reassessed if additional information becomes available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 68.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue, Herpes zoster, Immunodeficiency
Clinical narrative: Immunodeficiency / immune system low; feeling tired; JOINT PAIN; SHINGLES IN SCALP; This is a Solicited report received from a marketing program, FACILITATED COLLECT from a non-contactable consumer (patient). A 68-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular on 16Apr2021 (at the age of 68-years-old) at single dose for COVID-19 immunisation; also received co-suspect drug: upadacitinib (RINVOQ) via oral on unspecified date at unknown dose, daily for moderate to severe rheumatoid arthritis. Medical history included moderate to severe rheumatoid arthritis. Concomitant medications were not reported. Patient previously took first dose of BNT162B2 on unspecified date for COVID-19 immunization. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On unspecified date, the patient experienced immunodeficiency (immune system low), tiredness, and joint pain (described as: patient was feeling tired and felt his immune system was low on unspecified date, since he had been doing a lot of travelling and that his joints hurt a little bit in winter). On unspecified date in Apr2021, he broke out with shingles in his scalp and it went down the left side of his head to his neck. Outcome of the events joint pain was recovered on unspecified date; while event shingles recovered on unspecified date in Apr2021. Outcome of the event tiredness was not recovered; while outcome of the event immunodeficiency (immune system low) was unknown. The reporter's causality for the events (tiredness, joint pain and shingles in scalp and it went down left side of head to neck) with upadacitinib (RINVOQ) was no reasonable possibility; while for the reporter's causality for the event (immune system low) was not provided.   The reporter's assessment of the causal relationship of the events (immune system low, tiredness, joint pain and shingles) with the suspect product (BNT162B2) was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Information on batch number has been requested.; Sender's Comments: The association between the reported events immune system low, tiredness, joint pain, and shingles with BNT162B2 can not be completely excluded. The history of rheumatoid arthritis might be contributory as well.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Eye irritation, Headache, Influenza like illness
Clinical narrative: chills; really high fever of 102; body aches; headache; feels like she has the flu; eyes burning; body shakes; feeling nauseated; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 04May2021 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, really high fever of 102, body aches, headache, feels like she has the flu, eyes burning, body shakes and feeling nauseated at 12 midnight (05May2021). The patient stated 'it feels like someone was sitting on her'. The patient reported that the fever was constant and it was 101 at the time of the report (05May2021). Patient asked if she could take Tylenol. Outcome of the event fever was not resolved and outcome of remaining events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Tremor
Clinical narrative: chills; really high fever of 102; body aches; headache; feels like she has the flu; eyes burning; body shakes; feeling nauseated; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A 33-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 04May2021 12:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills, really high fever of 102, body aches, headache, feels like she has the flu, eyes burning, body shakes and feeling nauseated at 12 midnight (05May2021). The patient stated 'it feels like someone was sitting on her'. The patient reported that the fever was constant and it was 101 at the time of the report (05May2021). Patient asked if she could take Tylenol. Outcome of the event fever was not resolved and outcome of remaining events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Condition aggravated, Fear of death, Hypersensitivity, Loss of personal independence in daily activities
Clinical narrative: I started having whole body hives which is like your body is like burning and itching; I started having whole body hives which is like your body is like burning and itching; I started having whole body hives which is like your body is like burning and itching; I am having this allergy; My skin has rashes and it is red and itchy; My skin has rashes and it is red and itchy; So, then after my second vaccination, I started to have it much often; After this vaccination my system went very down; I am scared to die after this vaccination; I can't work right now; This is a spontaneous report received from a contactable consumer (patient).A 31-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on 19Apr2021 (Batch/Lot Number: EW0170) as 2nd dose, single for covid-19 immunization.The patient received first dose of BNT162 (PFIZ-ER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ER8730, Expiration date: unknown), via unspecified route of administration on 22Mar2021 as 1st dose, single for covid-19 immunization.Medical history included on 28 March, the patient started to have hives on whole body and it was anytime, it was like at night ,like your body is like burning and itching, it got worse almost everyday and patient having this allergy. Concomitant medications were not reported. On an unspecified date after the second dose, patient started to have it much often, woke up with few little on my face and cannot work right now. It was reported that nothing really helped, not even allergy medicine (Benadryl). After this vaccination the patient's system went very down and she was scared to die after this vaccination. The patient's skin has rashes, and it was red and itchy. It was reported that patient got two doses and three days after her first dose, she started having whole body hives which is like your body is like burning and itching. So, then after second vaccination, she started to have it much often and today and woke up with few little on my face which (voice not clear). She cannot work right now and cannot contact her physician, and nothing really helped, not even her allergy medicine (Benadryl) and never ever had this before the vaccination. The patient further stated she need to report and need some help because she was scared to die after this vaccination. Her skin has rashes and it is red and itchy, she need to go doctor because it was very dangerous from allergy you can literally die and she cannot go because the doctor was out of country and it was very difficult to go out of this country right now. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.