chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Psychomotor hyperactivity, Vomiting
Clinical narrative: my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; my right leg was still bothering me, It feels a little bloated, so I am walking slower than usual; I was afraid I was having a heart attack; Initial hyperactivity; tiredness; chest pains; urge to vomit; body aches all over; This is a spontaneous report received from a contactable consumer (patient herself). A 49-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was unknown), via an unspecified route of administration in left arm on 01Apr2021 at 16:00 (at the age of 49-year-old) as a single dose for COVID-19 immunization. The patient's medical history included issues with anemia in the past and known allergies: Tree nuts was all that I am aware of (allergies to medications, food, or other products: Tree nuts was all that I am aware of). Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccine within four weeks of vaccination. The patient did not receive other medications within two weeks of vaccination. Since the vaccination, the patient has not been tested for COVID-19. No COVID prior vaccination. The patient was not tested for COVID post vaccination. It was reported that the, initial hyperactivity on 04Apr2021 (patient think it was the anticipation of the shot), followed by tiredness that evening on 04Apr2021, Friday, Saturday, and Sunday. With the exception of having lunch with a friend on Saturday and stopping by to check on her mom, patient stayed home all weekend because she was feeling very tired. Late Sunday night after going to bed she awoke with chest pains and the urge to vomit on 04Apr2021. Patient was up and down vomiting for several hours and began to experience body aches all over on 04Apr2021. At one point she was afraid she was having a heart attack on 04Apr2021. On Monday morning and throughout the day she was still experiencing body aches and stayed home from the office. Patient slept propped up on the living room sofa Monday night because lying down made her body aches worse. Today, Tuesday 06Apr2021, her right leg was still bothering her, it feels a little bloated, so she was walking slower than usual. Otherwise she feel normal. The events were considered as serious (life threatening, hospitalization) by the consumer. No treatment medications were received for the adverse events. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Deafness, Feeling abnormal, Headache, Vertigo
Clinical narrative: experiencing right ear losing/hearing loss; vertigo; My head is cloudy; I have headaches also; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 22Mar2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 23Mar2021, the patient was experiencing right ear losing/hearing loss in volume. She had vertigo and her head was cloudy. She had headaches also. Patient was suggested to consult with her doctor/healthcare provider about what you have experienced/are experiencing. The outcome of the events was unknown.  Follow-up attempts are possible; Information about lot/batch number is requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Headache, SARS-CoV-2 antibody test
Clinical narrative: Bell's Palsy with headache; Bell's Palsy with headache; This is a spontaneous case from a contactable consumer (patient). A 35-year-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EN6204, expiration date unknown), via an unspecified route of administration, administered in left arm on 17Mar2021 at 15:00 at the age of 35-year-old at a single dose for COVID-19 immunisation at doctor's office/urgent care. Medical history included pcos (Polycystic ovarian syndrome), obese and bactrim allergy. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. The patient experienced bell's palsy with headache on 28Mar2021 at 23:30. Adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Received prednisone medication for the adverse events. Prior to vaccination, patient was not diagnosed with COVID-19. Patient has been tested for COVID-19 after the vaccination. Covid test type post vaccination: Nasal Swab, Covid test name post vaccination: covid test on 26Mar2021. Covid test result: negative. The patient was recovering from the events.  Follow up attempts are needed. Information on batch/lot number was obtained.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain in extremity, Paraesthesia
Clinical narrative: experiencing symptoms similar to peripheral neuropathy; sharp pains shoot through my extremities; My whole body tingled.; This is a spontaneous report from a contactable consumer (patient herself). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EP7533), via an unspecified route of administration, administered in left arm on 05Apr2021 14:30 as single dose for covid-19 immunization at Pharmacy or Drug Store. Medical history included asthma, depression, Patient had allergies to medications, food, or other products included Corn, wheat, and sesame. Patient was not pregnant at time of vaccination. Family history included peripheral neuropathy, which runs in her family (sister, mother, maternal uncle, maternal grandmother). Concomitant medication(s) within 2 weeks of vaccination included fluoxetine hydrochloride (PROZAC); montelukast sodium (SINGULAIR). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6199), in left arm on 08Mar2021 14:30 for COVID-19 immunization. It was reported that starting about twelve hours after my second dose of the vaccine on 06Apr2021 03:00 AM the patient experienced symptoms similar to peripheral neuropathy, which runs in her family (sister, mother, maternal uncle, maternal grandmother). Her whole body tingled, and had sharp pains shoot through my extremities. Patient have never been diagnosed with peripheral neuropathy or experienced these symptoms before. It was 24 hours later. The sensations still persist but are less pronounced. The prozac that was on can cause leg twitches. Perhaps the vaccine was interacting with the prozac or triggering an underlying genetic condition. Since the vaccination, patient has not been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: bad psoriasis; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: en5318), via an unspecified route of administration in right arm on 06Feb2021 at 01:30 AM as single dose for COVID-19 immunization in Health Clinic. Medical history included allergies to mushrooms. The patient's concomitant medications were not reported. No other vaccine in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 at 02:00 AM patient experienced bad psoriasis and received treatment. The event resulted in Doctor or other healthcare professional office/clinic visit, disability or permanent damage. Post to vaccination, patient was not tested for COVID-19. Outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Vaccination site pain
Clinical narrative: bleeding; less soreness at the injection site; This is a spontaneous report from a contactable consumer. An 18-year-old female patient (non-pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8735, expiration date: unknown), via an unspecified route of administration administrated on left arm on 05Apr2021 at 16:00 at the age of 18-year-old at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. No other medications in two weeks. The patient did not have any known allergies. She received first dose of BNT162B2 (Pfizer Covid-19 vaccine, Lot number: EN6204, Expiry date: unknown) via an unspecified route of administration, administrated on left arm on 14Mar2021 at 15:00 (03:00 PM) at the age of 18-year-old at a single dose for COVID-19 immunization. On 05Apr2021 04:00 PM, reported that the 2nd dose of vaccine caused unusual amount of bleeding after needle was removed. The patient had to clean excess blood after the shot. The band aid was soaked with blood. The patient experienced less soreness at the injection site compared to the first vaccine shot. The concern is whether the vaccine was bled out due improper injection. She did not have any other vaccine in four weeks before the covid-19 vaccine dose. The patient did not receive any treatment for the events. She was not having COVID prior to the vaccination, neither was tested for Covid-19 post vaccination. The patient recovered from the events on an unspecified date in 2021.
Sex: F
Vaccine: COVID19
Symptoms: Pancreatitis relapsing
Clinical narrative: Being hospitalized with pancreatitis has nothing to do with the vaccine.  I've been dealing with this issue off and on for a long time, before getting the first dose of the vaccine.; This is a spontaneous report received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 19Mar2021 at single dose for COVID-19 immunization. The patient's medical history included pancreatitis. Concomitant medications were not reported. It was reported that patient had gotten home from being hospitalized for the last week with pancreatitis on an unknown date and fear that I may have to go back again. The patient wanted to get her second dose of the vaccine before I go back in and need to reschedule the appointment. It was reported that being hospitalized with pancreatitis has nothing to do with the vaccine. The patient was dealing with this issue off and on for a long time, before getting the first dose of the vaccine and stated that she need to get the second dose before going back to hospital. Outcome of event was unknown  Information on the lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Thrombosis, Ultrasound scan
Clinical narrative: small clot behind my left knee; left foot had swollen; This is a spontaneous report from a contactable consumer (patient). A 20-year-old female patient received BNT162B2 (lot number: ER2613) first dose on 20Mar2021 10:15 on left arm at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. Patient is not pregnant. No other vaccine in four weeks. No Covid prior vaccination, No known allergies. She took the vaccine around 10:00am and around 6:00pm (also reported as 06:30 PM) she noticed that her left foot had swollen. She consulted with her general physician and he requested that patient did an Ultra Sound exam of her left leg. The result of the exam reported a small clot behind her left knee. Therefore, doctor suggested that she reported these events to Pfizer so an evaluation is made to identify if similar events have occurred with other patients. She was concerned if she should take the second shot on 17Apr2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Patient received Eliquis 5mg (two times daily) as treatment. Patient had Nasal Swab on 01Apr2021 and tested negative. The outcome of the events was not recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Facial pain, Haemorrhage, Influenza like illness
Clinical narrative: became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Swelling face, Vaccination site pain, Vaccination site pruritus
Clinical narrative: became faint and passed out onto the floor; hit my chin and jaw so hard it was bleeding; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; hit my chin and jaw so hard it was bleeding and obviously very sore and swollen; nauseous; light headed; chills; flu like symptoms; arm felt sore/arm at site of injection remains sore; at site of injection remains sore and itchy; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (lot number: ER8733) first dose on 30Mar2021 12:30 PM on left arm at single dose for COVID-19 immunisation. Medical history included IDDM (Type 1 diabetes mellitus) and MS (Multiple sclerosis). Patient is not pregnant. No other vaccine in four weeks. No known allergies. Concomitant medications in two weeks included Insulin for IDDM, dimethyl fumarate (TECFIDERA) for MS. Had vaccine at 12:30pm. At 3am (31Mar2021), arm felt sore and felt both nauseous and light headed as well as having chills and flu like symptoms. Went to bathroom and on way back to bed, became faint and passed out onto the floor. Patient hit chin and jaw so hard it was bleeding and obviously very sore and swollen. It's been nearly a week since that incident and arm at site of injection remains sore and itchy. She still feel nauseous at times and her face is still swollen from falling onto the floor and passing out. She was now fearful of having the second dose on 20Apr2021 as due since her reaction to 1st dose was so severe. The outcome of the events was recovering. No treatment for the events. No Covid tested post vaccination.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Back pain, Blood pressure increased, Blood pressure measurement, Discomfort
Clinical narrative: seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysgeusia, Fatigue, Muscle spasms, Nausea, Neck pain
Clinical narrative: seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Seizure, Tremor, Vaccination site pain
Clinical narrative: seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Discomfort, Dysgeusia, Electrocardiogram normal, Gait disturbance
Clinical narrative: seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hemiparesis, Hypertension, Hypotension, Pulse abnormal, Seizure
Clinical narrative: seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.
Age: 28.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: seizures/Convulsions; weird metal or acidic taste in my mouth; felt heavy; feel shaky; back spasms; blood pressure spiked to higher than normal levels; nauseous; weakness on my left side; pain at the injection site; pain at the injection site, my back, and neck; pain at the injection site, my back, and neck; feel super tired; This is a spontaneous report from a contactable consumer (patient). A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 06Apr2021 11:15 (Batch/Lot Number: EP7533) as single dose for COVID-19 immunisation. Medical history included axenfeld reigers, bilateral congenital iris coloboma, bilateral glaucoma, hearing loss. Known allergies: peanut, albuterol, amoxicillin-pot clavulante, doxycycline, fentanyl, levosalbutamol (LEVALBUTEROL), oxycodone-acetaminophin, sedation. Concomitant medications in two weeks: cryofood (unspecific), folic acid, cyanocobalamin (B12), timolol and dorzolamide hydrochloride/timolol, all from unknown date for unknown indication. First, patient had a weird metal or acidic taste in mouth. Following that, patient felt heavy. Next, began to feel shaky having back spasms. His blood pressure spiked to higher than normal levels and started feeling shakey dropped. Patient was laid down by nursing staff and blood pressure dropped. After being laid down, patient started having seizures/convulsions, paramedics were called and patient was given midazolam hydrochloride (VERSED, anti-seizure meds) and was taken to the ER (emergency room). Once patient arrived at the ER, he felt nauseous and was given anti-nausea medication, after about 4 hours patient was released. But he was experiencing weakness on left side and pain at the injection site, back, and neck, and felt super tired. AEs onset at 11:30 of 06Apr2021. Outcome of the events was resolving. Patient had no COVID prior vaccination and had no COVID tested post vaccination.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain, Constipation, Dehydration, Fatigue
Clinical narrative: back pain; abdominal pain; scrotum pain; dehydration of the kidneys; Fatigue; headaches; dehydration; Constipation; This is a spontaneous report received from a contactable  health care professional. A  report on behalf of her 66 years old husband who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at single dose at right arm for COVID-19 immunisation on 14Mar2021 at 14:00.  Relevant history included high blood pressure, Atrial fibrillation and memory problems. No family history.  Relevant concomitant drugs included ongoing Diltiazem at 120 mg once daily for high blood pressure and Atrial fibrillation,  ongoing Losartan at 25mg once a day for high blood pressure and Atrial fibrillation, ongoing Aspirin at 81mg at night.  The reporter stated her husband had severe side effects. Her husband was having low back pain, scrotum pain and abdominal pain and constipation. She did not know if this had anything to do with the vaccine. Her son was a doctor and thought that her husband may have been a passed kidney stone. She took him to the doctor and did an X-ray which showed dehydration of the kidneys. They were pumping him full of water.  She stated that the dehydration and constipation could have been self induced. This started about last week and was home all week. It may have been around 29Mar2021, about 2 weeks after the vaccination. On day 3, her husband had headaches and fatigue on 17Mar2021. The patient was taking Tylenol pretty much every four hours for a week because he was in so much pain. The patient wear APAP machine at night. No history of all previously immunizations. No additional vaccines administered on same date. No prior vaccinations within 4 weeks.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: The events was considered related to suspected vaccine BNT162B2 based on temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Renal atrophy, Scrotal pain, X-ray
Clinical narrative: back pain; abdominal pain; scrotum pain; dehydration of the kidneys; Fatigue; headaches; dehydration; Constipation; This is a spontaneous report received from a contactable  health care professional. A  report on behalf of her 66 years old husband who received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) at single dose at right arm for COVID-19 immunisation on 14Mar2021 at 14:00.  Relevant history included high blood pressure, Atrial fibrillation and memory problems. No family history.  Relevant concomitant drugs included ongoing Diltiazem at 120 mg once daily for high blood pressure and Atrial fibrillation,  ongoing Losartan at 25mg once a day for high blood pressure and Atrial fibrillation, ongoing Aspirin at 81mg at night.  The reporter stated her husband had severe side effects. Her husband was having low back pain, scrotum pain and abdominal pain and constipation. She did not know if this had anything to do with the vaccine. Her son was a doctor and thought that her husband may have been a passed kidney stone. She took him to the doctor and did an X-ray which showed dehydration of the kidneys. They were pumping him full of water.  She stated that the dehydration and constipation could have been self induced. This started about last week and was home all week. It may have been around 29Mar2021, about 2 weeks after the vaccination. On day 3, her husband had headaches and fatigue on 17Mar2021. The patient was taking Tylenol pretty much every four hours for a week because he was in so much pain. The patient wear APAP machine at night. No history of all previously immunizations. No additional vaccines administered on same date. No prior vaccinations within 4 weeks.   No follow-up attempts are needed. No further information is expected.; Sender's Comments: The events was considered related to suspected vaccine BNT162B2 based on temporal association and known safety profile of the drug. however, the contribution of age and underlying medical conditions cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: fainted/passed out; fainted/passed out; This is a spontaneous report from a contactable pharmacist. A contactable physician reported similar events for 3 patients. This is one of 3 reports. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: ER8729; Expiration Date: 20Jul2021), via an unspecified route of administration on 06apr2021 as SINGLE DOSE for covid-19 immunization and saline [sodium chloride] via an unspecified route of administration from on unspecified date (Batch/Lot Number: 6023228) for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient had just received the Covid 19 vaccine and was still being watched within the 15-minute post vaccination time. On 06Apr2021, the patient was fainted and passed out had some issues with vaccines in the past. HCP wants to know if there have been any reports of having these reactions associated with the specific lot number: ER8729. The events considered as medically significant with outcome unknown.; Sender's Comments: Based on the temporal association, a possible contributory role of vaccination with BNT162B2 to the reported events fainted and passed out cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified.
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Syncope
Clinical narrative: fainted/passed out; patient passed out; This is a spontaneous report from a contactable pharmacist reporting same events for suspect products for 4 patients. This report is for the 4th patient. Follow-up (06Apr2021) was received from same reporter and processed together with initial information. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8729; Expiration Date: 20Jul2021), via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included saline [sodium chloride] (SALINE [SODIUM CHLORIDE]). The patient reported that after administering the Covid 19 vaccine on 06Apr2021, within about 20 minutes there were 4 patients with reactions. The patient experienced fainted/passed out on an unspecified date and patient passed out on 06Apr2021. Three people fainted and one had seizure after receiving the first dose of the Pfizer-BioNTech Covid-19 Vaccine. These patients had just received the Covid 19 vaccine and were still being watched within the 15-minute post vaccination time. All 4 patients received the Covid 19 vaccine from the same lot number but not from the same vial.  Seriousness of events was medically significant. The outcome of events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Considering close temporal association, a possible contributory role of bnt162b2 to the events fainted and passed out cannot be completely excluded. Relevant medical history and details of clinical course are missing for further assessment.   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 RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Bacterial vaginosis, Heart rate, Heart rate increased, Urinary tract infection
Clinical narrative: UTI; Bacterial vaginosis; had arrhythmia kicking off; heart rate was 110-120 and had arrhythmia and it would calm down and she is still fighting that and it is not as frequent as much; This is a spontaneous report received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: ER2612) as SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of Covid Vaccine on 02Mar2021 (also reported as Start: 01Mar2021). The patient experienced had arrhythmia kicking off  (medically significant) on 23Mar2021 with outcome of unknown, UTI (non-serious) on an unspecified date with outcome of unknown, bacterial vaginosis (non-serious) on an unspecified date with outcome of unknown, heart rate was 110-120 and had arrhythmia and it would calm down and she is still fighting that and it is not as frequent as much (non-serious) on Mar2021 with outcome of not recovered. Patient stated she got the shot 23Mar2021 and as soon as she got it she had arrhythmia kicking off. States her heart rate was 110-120 and had arrhythmia and it would calm down and she is still fighting that and it was not as frequent as much. Stated she had another problem she can't get rid of, she had a UTI and BV. Caller clarified BV as bacterial vaginosis. Stated she was finding she can't get rid of the UTI since she got the shot it keeps coming back and that she has never had that problem before. Patient stated she was wondering what do we suggest that she do because no matter what there was no winning the battle and keep going on antibiotics. Patient stated she got the shot on the 1st or 2nd day of antibiotics and she continued to finish the 7 days and didn't have a UTI and then she got the UTI. Patient stated it was screwing with her body. Stated she was diagnosed with the UTI, it was like 23Mar2021 and she did a week and it was a couple days ago, she did 7 days and was finishing the 5 days and so it was a couple days ago. Patient stated she was unable to complete a report at this time. No further information provided or clarified. Patient stated she got the 2nd dose of the Pfizer Covid vaccine on 23Mar2021 and the 1st dose 2Mar2021.  The patient underwent lab tests which included heart rate: 110-120 on unknown date.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive, Sinus congestion
Clinical narrative: tested positive on 20Mar2021; tested positive on 20Mar2021; mild sinus congestion; This is a spontaneous report received from a contactable consumer (Patient's wife). A 68-year-old male patient who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number unknown, Expiration date unknown), via an unspecified route of administration on 05Mar2021 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID-19 on 20Mar2021. The patient was scheduled to get his second vaccine dose on 26Mar2021. He experienced drug ineffective and COVID-19on 20Mar2021. The patient experienced some mild sinus congestion on an unspecified date in Mar2021. As per the reporter seriousness criteria for the event sinus congestion was medically significant. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021376241 same reporter/drug, different patient/AE
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, SARS-CoV-2 test
Clinical narrative: 2 weeks after 2nd dose, sudden profound hearing loss in left ear on 2/20/21; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Feb2021 18:00 (Batch/Lot Number: EM9809) as single dose for covid-19 immunisation. The COVID-19 vaccine was administered at health facility. Medical history included diabetes, high blood pressure. Prior to vaccination, the patient was not diagnosed. Concomitant medications included valsartan taken for an unspecified indication, start and stop date were not reported; nicametate dihydrogen citrate (NICAMETA) taken for an unspecified indication, start and stop date were not reported; dipyridamole taken for an unspecified indication, start and stop date were not reported and 'Novartis' product. The patient received the first dose of bnt162b2 (lot number: EL8982) on 15Jan2021 04:30 PM and around the time of the 1st shot, noticeable rapidly deteriorating hearing loss experienced, declining more in right ear according to audiometry test on 12Feb2021. The patient experienced 2 weeks after 2nd dose, sudden profound hearing loss in left ear on 20Feb2021 08:30 AM. Adverse event result in Doctor or other healthcare professional office/clinic visit, and Emergency room/department or urgent care. Treatment received for the adverse event included oral steroids, steroid injections into ear drum. The patient underwent lab tests and procedures which included Covid-19 RT-PCR test: negative on 01Apr2021. The outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Illness, Pyrexia
Clinical narrative: Difficulty breathing; He got sick he got Fever, Chills; He got sick he got Fever, Chills; He got sick he got Fever, Chills; This is a spontaneous report from a Pfizer-sponsored program. A male consumer (patient) of an unspecified age received bnt162b2 (BNT162B2), first dose via an unspecified route of administration on 29Mar2021,single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient got sick he got Fever, Chills and difficulty in breathing, all on 2021 and he got hospitalized because of those adverse events. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Inflammation, Pulmonary congestion, Pyrexia
Clinical narrative: lungs feel congested; Chest tightness; chills; fever; inflammation; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the second dose of bnt162b2, via an unspecified route of administration, administered in Right arm on 03Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included Asthma, hypertension, covid prior vaccination. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA); montelukast sodium (SINGULAIR); losartan; HCTZ; unspecified product "D". The patient previously took erythromycin and experienced allergy. The patient received the first dose of bnt162b2, at the age of 70-year-old, via an unspecified route of administration, administered in right arm on 13Mar2021 11:00 as single dose for covid-19 immunization and experienced fatigue and sore arm. The patient experienced lungs feel congested, chest tightness on 04Apr2021 03:00; chills, fever and inflammation on 03Apr2021. Chills and fever Sat. night into Sunday, fever lasted until Monday 05Apr. Chest tightness, lungs feel congested. Went to doctor, he thought inflammation from vaccine. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received. The patient was not pregnant. The outcome of the events Fever was recovered on 05Apr2021, other events was recovering.  Information on lot/batch number has been requested.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Body temperature, Body temperature increased, Electrocardiogram
Clinical narrative: passed out; body temperature rose fast; sweating; blood pressure and ECG went low; blood pressure and ECG went low; This is a spontaneous report received via COVAES from a non-contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose via an unspecified route of administration, administered in right arm on 01Apr2021 10:00 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin. Concomitant medication(s) included diphenhydramine hcl. Side effects started about 4 minutes after getting the shot. At first, the body temperature rose fast, and patient started sweating. Then, patient passed out, and both blood pressure and ECG went low. Patient was sent to the emergency room and released a few hours later. AE resulted in Emergency room/department or urgent care. Treatment included fluids. No Covid prior vaccination. No Covid tested post vaccination. The event outcome for events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Hyperhidrosis, Loss of consciousness
Clinical narrative: passed out; body temperature rose fast; sweating; blood pressure and ECG went low; blood pressure and ECG went low; This is a spontaneous report received via COVAES from a non-contactable consumer (patient). A 43-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, first dose via an unspecified route of administration, administered in right arm on 01Apr2021 10:00 (Lot Number: EP7534) as single dose for covid-19 immunisation. Medical history included allergies to penicillin. Concomitant medication(s) included diphenhydramine hcl. Side effects started about 4 minutes after getting the shot. At first, the body temperature rose fast, and patient started sweating. Then, patient passed out, and both blood pressure and ECG went low. Patient was sent to the emergency room and released a few hours later. AE resulted in Emergency room/department or urgent care. Treatment included fluids. No Covid prior vaccination. No Covid tested post vaccination. The event outcome for events was recovered.  No follow-up attempts are possible. No further information is expected.