chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Foetal growth restriction, Maternal exposure during pregnancy
Clinical narrative: detected NO GROWTH since 4/22 ultrasound; identical imagining in size; Miscarriage / pregnancy loss; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported information for both mother and fetus. This is the fetal report.  A fetus patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), transplacental on 02Apr2021 12:00 (batch/lot number: EL9263) as 1st dose, single, and transplacental on 23Apr2021 10:00 (batch/lot number: ER8735) as 2nd dose, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother experienced miscarriage / pregnancy loss on 28Apr2021 15:30. It was further reported that confirmed pregnancy on 22Apr2021 at OBGYN via blood test, urine test, and ultra sound. Pfizer 2nd dose COVID vaccine administered on 23Apr2021. Began miscarriage on 28Apr2021. On 28Apr2021, OBGYN medical professionals detected no growth since 22Apr2021 ultrasound. Identical imagining in size. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021494131 maternal case
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Speech disorder
Clinical narrative: lips started swelling; can hardly talk; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number and expiry date unknown), via an unspecified route of administration, administered in the left arm on Apr2021 as a single dose for COVID-19 immunization.  Medical history included lip fillers, anxiety and depression all from an unknown date and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19 on an unknown date. The patient had no known allergies. Concomitant medications  included escitalopram oxalate (LEXAPRO); quetiapine fumarate (SEROQUEL) and spironolactone (manufacturer unknown) all 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. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 27Apr2021, at 08:00 about 2 1/2 weeks the patient's first dose, her lips started swelling. They are now so swollen that the patient can hardly talk and was now going to urgent care. The patient received prednisone injection as treatment for the events. The events resulted in a doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering. The event were reported as non-serious. The patient recevied the second dose of bnt162b2 on Apr2021 on the left arm for COVID-19 immunization.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the events, Lip swelling and speech disorder cannot be completely ruled out. The impact of this report on 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, Ethic committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Headache, Peripheral swelling, Rash, Swelling face
Clinical narrative: her face was swollen; Extreme pain in her head, not like a migraine (she has had migraines) it came suddenly and the pain grew stronger and she though her head was going to explode; Swollen legs accompanied brusing rash; brusing rash; Swollen legs accompanied brusing rash; Effects were similar to blood clot symptoms; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 04May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) at 2nd dose, single for COVID-19 immunization. The patient's medical history included migraines. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on unspecified date for COVID-19 Immunization. The patient experienced side effects after getting the 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE, 2nd dose was given on 30Apr2021. The patient had a bad reaction, she called to report it last night, she may have a CT scan for follow-up of the residual vaccine,  the effects were similar to blood clot symptoms, she had a extreme pain in her head, not like a migraine (she has had migraines) it came suddenly and the pain grew stronger and she though her head was going to explode, she almost went to the emergency room (ER). Assuming all these side effects were attributed effects that may be similar to blood clotting symptoms. Side effects experienced were as follows: Extreme headache characterized by a painful somehow compared to by the patient as she was grabbing her head and thought it would explode. She almost went to the ER for this and the pain lasted for 9 hours starting from the same night at 21:30, when she got the vaccine (30Apr2021). She mentioned she took Ibuprofen 600 mg for this and it slowly eases the pain until it went away. Swollen legs accompanied by bruising rash. This happened alongside the extreme headache (30Apr2021). Her face was swollen as well the next day (01May2021). She thought that all the mentioned above side effects were characteristics of blood clotting side effect. The outcome of the event headache was recovered on 01May2021; and unknown outcome for the other events.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: her face was swollen; Extreme pain in her head, not like a migraine (she has had migraines) it came suddenly and the pain grew stronger and she though her head was going to explode; Swollen legs accompanied brusing rash; brusing rash; Swollen legs accompanied brusing rash; Effects were similar to blood clot symptoms; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 04May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) at 2nd dose, single for COVID-19 immunization. The patient's medical history included migraines. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on unspecified date for COVID-19 Immunization. The patient experienced side effects after getting the 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE, 2nd dose was given on 30Apr2021. The patient had a bad reaction, she called to report it last night, she may have a CT scan for follow-up of the residual vaccine,  the effects were similar to blood clot symptoms, she had a extreme pain in her head, not like a migraine (she has had migraines) it came suddenly and the pain grew stronger and she though her head was going to explode, she almost went to the emergency room (ER). Assuming all these side effects were attributed effects that may be similar to blood clotting symptoms. Side effects experienced were as follows: Extreme headache characterized by a painful somehow compared to by the patient as she was grabbing her head and thought it would explode. She almost went to the ER for this and the pain lasted for 9 hours starting from the same night at 21:30, when she got the vaccine (30Apr2021). She mentioned she took Ibuprofen 600 mg for this and it slowly eases the pain until it went away. Swollen legs accompanied by bruising rash. This happened alongside the extreme headache (30Apr2021). Her face was swollen as well the next day (01May2021). She thought that all the mentioned above side effects were characteristics of blood clotting side effect. The outcome of the event headache was recovered on 01May2021; and unknown outcome for the other events.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Headache, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: her face was swollen; Extreme pain in her head, not like a migraine (she has had migraines) it came suddenly and the pain grew stronger and she though her head was going to explode; Swollen legs accompanied brusing rash; brusing rash; Swollen legs accompanied brusing rash; Effects were similar to blood clot symptoms; The initial case was missing the following minimum criteria: unidentifiable reporter. Upon receipt of follow-up information on 04May2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 30Apr2021 (Batch/Lot number was not reported) at 2nd dose, single for COVID-19 immunization. The patient's medical history included migraines. Concomitant medications were not reported. The patient previously took the first dose of BNT162B2 on unspecified date for COVID-19 Immunization. The patient experienced side effects after getting the 2 doses of the PFIZER-BIONTECH COVID-19 VACCINE, 2nd dose was given on 30Apr2021. The patient had a bad reaction, she called to report it last night, she may have a CT scan for follow-up of the residual vaccine,  the effects were similar to blood clot symptoms, she had a extreme pain in her head, not like a migraine (she has had migraines) it came suddenly and the pain grew stronger and she though her head was going to explode, she almost went to the emergency room (ER). Assuming all these side effects were attributed effects that may be similar to blood clotting symptoms. Side effects experienced were as follows: Extreme headache characterized by a painful somehow compared to by the patient as she was grabbing her head and thought it would explode. She almost went to the ER for this and the pain lasted for 9 hours starting from the same night at 21:30, when she got the vaccine (30Apr2021). She mentioned she took Ibuprofen 600 mg for this and it slowly eases the pain until it went away. Swollen legs accompanied by bruising rash. This happened alongside the extreme headache (30Apr2021). Her face was swollen as well the next day (01May2021). She thought that all the mentioned above side effects were characteristics of blood clotting side effect. The outcome of the event headache was recovered on 01May2021; and unknown outcome for the other events.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hallucination, Lymphadenopathy, Muscle spasms
Clinical narrative: possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: possible hallucinations; severe chills; severe back spasm; nausea; dizziness; the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball.; This is a spontaneous report from contactable consumer (patient). A 44-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EP7533) via an unspecified route of administration, administered on the right arm on 30Apr2021 09:15 (Batch/Lot Number: EP7533) as unknown, single for COVID-19 immunization. The patient had no medical history. Concomitant medication included ascorbic acid, betacarotene, biotin, boron, calcium, calcium pantothenate, chloride, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, iron, lycopene, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine, tin, tocopheryl acetate, vanadium, vitamin k nos, zinc (CENTRUM MEN). The patient had severe chills, severe back spasm, nausea, dizziness, possible hallucinations, and the lymph node under my right arm (the arm that was injected) was swollen to the size of a softball on 30Apr2021 07:00 PM. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: had multiple seizures over a few day; This is a spontaneous report from a contactable (patient) via COVID-19 Vaccine Adverse Event Reporting System (COVAES). A non-pregnant 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in the left arm on 23Apr2021 at 10:45 AM (Lot Number: Ewo172), at the age of 48 years, as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 The patient had prior history of epilepsy, petit mal seizures. None for the last 20 years. The patient did not receive any other medication within 2 weeks of vaccination  Past drug events included penicillin [benzylpenicillin], ampicillin, amoxicillin, clindamycin, vancomycin. The patient reported that on 27Apr2021 at 08:30, four days after vaccine she  had multiple seizures over a few days. No treatment was given for the event. The clinical outcome of the event was recovered. She reported "I am now seizure free again". It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Fatigue, Nausea, Neuralgia
Clinical narrative: very sore arm at injection site as well as her left elbow; very sore arm at injection site; burning around her elbow; woke up to a very sore arm--at injection site as well as her left elbow; nerve pain; felt slightly nauseated; I was fatigued that night; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 27Apr2021 15:00 (received at 45-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccines. Medical history included hypothyroidism, arthritis, broken elbow 11 months ago (from 2020), and dairy sensitivity. She had no COVID prior vaccination and was not tested post vaccination. She was not pregnant. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:15 (received at 45-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient got her 2nd shot on 27Apr2021 and felt slightly nauseated at first. This went away. She was fatigued that night. The next morning, on 28Apr2021 07:00 AM, she woke up to a very sore arm at injection site as well as her left elbow (that she broke 11 months ago). She had dull aching pain, as well as burning around her elbow. She has been told that it's nerve pain. It is slowly getting better. As corrective treatment, the patient received Motrin, ice, and physical therapy. Outcome of the event was recovering.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: very sore arm at injection site as well as her left elbow; very sore arm at injection site; burning around her elbow; woke up to a very sore arm--at injection site as well as her left elbow; nerve pain; felt slightly nauseated; I was fatigued that night; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received the second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: ER8731), via an unspecified route of administration, administered in Arm Left on 27Apr2021 15:00 (received at 45-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccines. Medical history included hypothyroidism, arthritis, broken elbow 11 months ago (from 2020), and dairy sensitivity. She had no COVID prior vaccination and was not tested post vaccination. She was not pregnant. Concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2, Lot Number: EW0150), via an unspecified route of administration, administered in Arm Left on 06Apr2021 15:15 (received at 45-years-old) as 1ST DOSE, SINGLE for COVID-19 immunisation. The patient got her 2nd shot on 27Apr2021 and felt slightly nauseated at first. This went away. She was fatigued that night. The next morning, on 28Apr2021 07:00 AM, she woke up to a very sore arm at injection site as well as her left elbow (that she broke 11 months ago). She had dull aching pain, as well as burning around her elbow. She has been told that it's nerve pain. It is slowly getting better. As corrective treatment, the patient received Motrin, ice, and physical therapy. Outcome of the event was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Eye haemorrhage, Feeling hot, Head discomfort, Headache
Clinical narrative: Blood stain in her right eye; Felt her right eye was pounding a little; Her arm was hurting a little bit; Her arm was very hot, extremely hot; Headache; A lot of pressure to her head; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 01May2021 16:10 as 1st dose, single for COVID -19 immunization. Medical history and concomitant medications were not reported. The patient reported she had her COVID vaccine on 01May2021 at 16:10 in the afternoon and about an hour later the headache started. In some occasions it felt like a lot of pressure to her head. On 03May2021, she felt her right eye was pounding a little and then when she woke up in the morning of 04May2021, she saw the blood stain in her right eye. The pounding in her eye was not pounding as much in the afternoon for quite a while but then it stopped that same day on 03May2021. On 01May2021, it was also reported that her arm was hurting a little bit and it stopped on 03May2021; and on 01May2021, her arm was very hot, extremely hot. No events required a visit to emergency room or physician office. The outcome of the events headache, "blood stain in her eye", and "a lot of pressure to her head" was not recovered, "felt her right eye was pounding a little " and "her arm was hurting a little bit" recovered on 03May2021, and "her arm was very hot, extremely hot" recovered on 01May2021.  Information on the batch/lot number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Blood stain in her right eye; Felt her right eye was pounding a little; Her arm was hurting a little bit; Her arm was very hot, extremely hot; Headache; A lot of pressure to her head; This is a spontaneous report from a contactable consumer (the patient) via medical information team. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 01May2021 16:10 as 1st dose, single for COVID -19 immunization. Medical history and concomitant medications were not reported. The patient reported she had her COVID vaccine on 01May2021 at 16:10 in the afternoon and about an hour later the headache started. In some occasions it felt like a lot of pressure to her head. On 03May2021, she felt her right eye was pounding a little and then when she woke up in the morning of 04May2021, she saw the blood stain in her right eye. The pounding in her eye was not pounding as much in the afternoon for quite a while but then it stopped that same day on 03May2021. On 01May2021, it was also reported that her arm was hurting a little bit and it stopped on 03May2021; and on 01May2021, her arm was very hot, extremely hot. No events required a visit to emergency room or physician office. The outcome of the events headache, "blood stain in her eye", and "a lot of pressure to her head" was not recovered, "felt her right eye was pounding a little " and "her arm was hurting a little bit" recovered on 03May2021, and "her arm was very hot, extremely hot" recovered on 01May2021.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Alanine aminotransferase increased, Blood test, Headache, Hepatic enzyme increased
Clinical narrative: headache; nausea; liver enzymes became elevated 20 times what was normal (liver enzymes was 208 and ALT 165); liver enzymes became elevated 20 times what was normal (liver enzymes was 208 and ALT 165); This is a spontaneous report from a contactable consumer (the patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0172), via an unspecified route of administration in the left arm on 29Apr2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient received the second dose of her Pfizer COVID vaccine on 29Apr2021 and reported headache and nausea (unspecified date). She also stated that her blood test done on 03May2021, showed her liver enzymes became elevated 20 times what was normal (liver enzymes was 208 and ALT (alanine aminotransferase) 165). She had the same bloodwork done on 15Apr2021, and everything was normal. She asked if these side effects were normal and how long should they last for? The outcome of headache and nausea was unknown. The outcome of other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: headache; nausea; liver enzymes became elevated 20 times what was normal (liver enzymes was 208 and ALT 165); liver enzymes became elevated 20 times what was normal (liver enzymes was 208 and ALT 165); This is a spontaneous report from a contactable consumer (the patient). A 65-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EW0172), via an unspecified route of administration in the left arm on 29Apr2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. There was no medical history or concomitant medications. The patient received the second dose of her Pfizer COVID vaccine on 29Apr2021 and reported headache and nausea (unspecified date). She also stated that her blood test done on 03May2021, showed her liver enzymes became elevated 20 times what was normal (liver enzymes was 208 and ALT (alanine aminotransferase) 165). She had the same bloodwork done on 15Apr2021, and everything was normal. She asked if these side effects were normal and how long should they last for? The outcome of headache and nausea was unknown. The outcome of other events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: bell's palsy twice in one side; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as unknown, single for COVID-19 immunization. Medical history included shingles went to eye two years ago. The patient's concomitant medications were not reported. The patient experienced bell's palsy twice in one side on an unspecified date with outcome of unknown.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Cough, Hypoaesthesia, Lymphadenopathy
Clinical narrative: Bell's palsy; Cough; Whole face is numb; Lymph node in the back of the ear; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 05Mar2021 (Batch/Lot Number: EM9810) as 2nd dose, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of BNT162B2 (lot number: EL9265) on 02Feb2021 for Covid-19 immunization. The patient stated that she got her first Pfizer Covid vaccine on 02Feb2021 and the second one on 05Mar2021. A week and a half later, she got Bell's palsy (Mar2021-pending clarification). She wanted to know if there have been other reports of it. The patient further reported that she got the second dosage on 05Mar2021, a week and a half later she got the cough, her whole face is numb, like she has dopey eyes. The patient added that it was hard for her to talk, as she still wants to cough and it was really impossible to talk, it hurt a lot. The patient further stated that she got lymph node in the back of the ear (pending clarification) and went to the hospital on 22Mar2021. She added that she has all the medical records. The outcome of events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Pulmonary embolism, SARS-CoV-2 test, Thrombosis
Clinical narrative: pulmonary embolism; Blood Clot; This is a spontaneous report from a contactable consumer (patient). A 59-yearold male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 07Apr2021 (Batch/Lot Number: ew0153) as 1st dose, single (at the age of 59 years) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has not had covid-19 prior to vaccination. The patient experienced pulmonary embolism on an unspecified date and blood clot on 22Apr2021 with outcome of not recovered. The patient was hospitalized for blood clot for 2 days. The patient underwent lab tests and procedures which included blood test: negative  on 26Apr2021. Therapeutic measures were taken as a result of the events incudes blood thinner. The outcome of the event blood clot was not recovered  and unknown outcome for the event pulmonary embolism. The patient was tested negative for Covid-19 on 23Apr2021 (post vaccination).  No follow-up attempts are possible; information about batch number already obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Blood creatinine, Blood urea, Glomerular filtration rate, Herpes zoster, Laboratory test
Clinical narrative: This is a spontaneous report received via medical information from a contactable consumer (patient's spouse). A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 59-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced shingles and kidney function is impaired. The clinical course of events was as follows: The patient received the first dose of the Pfizer Covid-19 vaccine on 07Apr2021 and was diagnosed with shingles 3 days later (10Apr2021). The reporter stated that  the patient's kidney function is impaired when the doctor ran lipid panels (unknown results) and urine panels in which the patient had "strange, high readings" on 10Apr2021 with her BUN was 26 (High), referencing at 24; creatinine level was 1.54 mg (High), referencing 1.00 mg; GFR (glomerular filtration rate) filtration rate was 37 ml/second (abnormal), referencing at >59 ml/second. The reporter stated she received more testing on 28Apr2021, in which the lab values had improved, but have not returned to her baseline on 28Apr2021 with her GFR was 64 ml/second (normal) and creatinine was 0.97 mg/deciliter (borderline). The reporter stated her GFR in November(2020) was 96 ml/second (Normal) and her lab values were all within normal range at her last doctor's appointment on 01Dec2020. The reporter states the only thing that has changed in her regimen was receiving the Covid-19 vaccine. He is concerned if his wife will make a full recovery and if her kidneys are damaged due to the vaccine. The patient has not fully recovered from shingles and still has aches, pains, and skin lesions that have not fully disappeared. He was also asking if she needs to recover fully before receiving the second dose. The clinical outcomes of the event "kidney is impaired" was resolving while the event "shingles" was not resolved.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lipids, Renal impairment
Clinical narrative: This is a spontaneous report received via medical information from a contactable consumer (patient's spouse). A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 59-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced shingles and kidney function is impaired. The clinical course of events was as follows: The patient received the first dose of the Pfizer Covid-19 vaccine on 07Apr2021 and was diagnosed with shingles 3 days later (10Apr2021). The reporter stated that  the patient's kidney function is impaired when the doctor ran lipid panels (unknown results) and urine panels in which the patient had "strange, high readings" on 10Apr2021 with her BUN was 26 (High), referencing at 24; creatinine level was 1.54 mg (High), referencing 1.00 mg; GFR (glomerular filtration rate) filtration rate was 37 ml/second (abnormal), referencing at >59 ml/second. The reporter stated she received more testing on 28Apr2021, in which the lab values had improved, but have not returned to her baseline on 28Apr2021 with her GFR was 64 ml/second (normal) and creatinine was 0.97 mg/deciliter (borderline). The reporter stated her GFR in November(2020) was 96 ml/second (Normal) and her lab values were all within normal range at her last doctor's appointment on 01Dec2020. The reporter states the only thing that has changed in her regimen was receiving the Covid-19 vaccine. He is concerned if his wife will make a full recovery and if her kidneys are damaged due to the vaccine. The patient has not fully recovered from shingles and still has aches, pains, and skin lesions that have not fully disappeared. He was also asking if she needs to recover fully before receiving the second dose. The clinical outcomes of the event "kidney is impaired" was resolving while the event "shingles" was not resolved.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Neck mass
Clinical narrative: Early pregnancy miscarriage; 2 lumps near neck; This is a spontaneous report from a contactable consumer (patient). A 31-years-old pregnant female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 09Apr2021 at 16:00 (Batch/Lot Number: Unknown) 1ST DOSE, SINGLE for covid-19 immunization.  Facility where the most recent COVID-19 vaccine was administered was a Pharmacy or Drug Store. The patient medical history was not reported.   There were no concomitant medications. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.   On 26Apr2021, The patient experienced early pregnancy miscarriage, 2 lumps near neck. The patient reported she became pregnant while taking bnt162b2.  The mother was 5 Weeks pregnant at the onset of the event and  was due to deliver on 22Dec2021.  The adverse events resulted in a Doctor or other healthcare professional office/clinic visit.  The clinical outcome of the event was reported as not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021501603 baby case
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Ear infection, Hypertension, Retinal vein occlusion, Vision blurred
Clinical narrative: ear infection; hypertension 168/98; Branch Retinal Vein Occlusion; blurry vision in my left eye; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:00 as 1st dose, single for COVID-19 immunization. There were no medical history and concomitant medications. No other vaccines in four weeks and no other medications in two weeks. No known allergies. No COVID-19 prior to vaccination and not tested post vaccination. On 25Mar2021 08:00, the patient had blurry vision in my left eye and was referred to a Retina Specialist. The patient was diagnosed with Branch Retinal Vein Occlusion and is receiving AVASTIN shots in the eye monthly in the hopes of getting the vision back to normal. On 02May2021, the patient visited a walk-in clinic for an ear infection and was diagnosed with hypertension. BP 168/98. Patient had several reading in this range after the visit. The patient visited his general practitioner (GP) and was started a regimen of Lisinopril 2.5 mg to help bring down the BP. The outcome of the events was reported as not recovered.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ophthalmological examination, Retinal vein occlusion
Clinical narrative: ear infection; hypertension 168/98; Branch Retinal Vein Occlusion; blurry vision in my left eye; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 24Mar2021 10:00 as 1st dose, single for COVID-19 immunization. There were no medical history and concomitant medications. No other vaccines in four weeks and no other medications in two weeks. No known allergies. No COVID-19 prior to vaccination and not tested post vaccination. On 25Mar2021 08:00, the patient had blurry vision in my left eye and was referred to a Retina Specialist. The patient was diagnosed with Branch Retinal Vein Occlusion and is receiving AVASTIN shots in the eye monthly in the hopes of getting the vision back to normal. On 02May2021, the patient visited a walk-in clinic for an ear infection and was diagnosed with hypertension. BP 168/98. Patient had several reading in this range after the visit. The patient visited his general practitioner (GP) and was started a regimen of Lisinopril 2.5 mg to help bring down the BP. The outcome of the events was reported as not recovered.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a Pfizer sponsored program, Pfizer . A contactable consumer (patient) of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number and expiration date unknown), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 vaccination. The medical history and concomitant medications were not reported. Two weeks after receiving my 2nd dose of your vaccine I developed shingles. I know 6 other people in my age group (50s - 60s) that also developed shingles as well, 14 days after your vaccine. I had to be hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in my body. This has been an extremely painful experience, but I still would have gotten the C19 vaccine. The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; This is a spontaneous report from a Pfizer sponsored program, Pfizer . A contactable consumer (patient) of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number and expiration date unknown), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 vaccination. The medical history and concomitant medications were not reported. Two weeks after receiving my 2nd dose of your vaccine I developed shingles. I know 6 other people in my age group (50s - 60s) that also developed shingles as well, 14 days after your vaccine. I had to be hospitalized for an afternoon and the doctors said that the vaccine could have definitely woke up the sleeping virus in my body. This has been an extremely painful experience, but I still would have gotten the C19 vaccine. The clinical outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19/still has "cold symptoms"; tested positive for COVID-19/still has "cold symptoms"; This is a spontaneous report from a Pfizer-sponsored program, Support from a contactable consumer (patient). A 51-year-old female patient received bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine), dose 1 via an unspecified route of administration on 14Apr2021 (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 tested positive for COVID-19 on an unspecified date. The patient was due to receive her second dose on 05May2021. However, in between these doses, she has tested positive for COVID-19. The patient has since been re-tested, which came back negative, and reports that she still has "cold symptoms" that she was told could go on for awhile. Caller would like to know if she is okay to get the second dose of the vaccine because of this. She states her doctor told her she should be fine because she quarantined for 14 days. Outcome of the events was unknown.  No follow-up attempts are possible; information on the lot number cannot be obtained. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Catheterisation cardiac, Myocardial infarction
Clinical narrative: was diagnosed with a heart attack at the hospital; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01May2021 at 14:00 (Lot Number: EW0173; Expiration Date: Aug2021) as 1st dose, single for covid-19 immunisation. Medical history included cardiac catherization, 2 weeks ago (Apr2021). The patient's concomitant medications were not reported. The patient had his 1st dose of the Pfizer COVID Vaccine last Saturday, 01May2021 at 2:00PM and between 7:30 to 7:45 PM, he started having chest issues. He said he felt like something was pushing down on his chest, like he was having a heart attack. He sat and waited, and then the feeling got into his arm. He said as soon as the pain went into his arm, he knew it was a heart attack. He said he got 2 nitroglycerin and took them. He said the feeling in his chest and arm didn't go away, so he called 911, and an ambulance took him to the hospital and went to the ER. He said the first blood draw on 01May2021 that was done at the hospital didn't show anything. He said the second blood draw on 01May2021 showed his cardiac enzymes were elevated, and that he had a heart attack. He was diagnosed with a heart attack at the hospital. He said 2 weeks prior (Apr2021), he had a procedure done (clarified as a cardiac catheterization). He said his cardiologist checked his stents, and the stents were all OK, and there were no issues with his heart. He said his cardiologist just did the same procedure again (cardiac catheterization) on 01May2021, and it was normal, there was nothing there (in his heart). He said he was putting his heart attack as caused by the COVID-19 Vaccine shot. He said he knows about a study that reported people were having heart attacks after getting the COVID-19 Vaccine. Clarified that he had a cardiac catheterization through his wrist while at the hospital, and it was same procedure he had 2 weeks earlier with his cardiologist. He said both cardiac catheterizations didn't show anything wrong with his heart. He was asking that if should he get the second dose if he had a side effect after the first dose of the vaccine. The patient was hospitalized for the event from 01May2021 to 04May2021. Outcome of the event was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myocardial infarction
Clinical narrative: was diagnosed with a heart attack at the hospital; This is a spontaneous report received from a contactable consumer (patient). A 67-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 01May2021 at 14:00 (Lot Number: EW0173; Expiration Date: Aug2021) as 1st dose, single for covid-19 immunisation. Medical history included cardiac catherization, 2 weeks ago (Apr2021). The patient's concomitant medications were not reported. The patient had his 1st dose of the Pfizer COVID Vaccine last Saturday, 01May2021 at 2:00PM and between 7:30 to 7:45 PM, he started having chest issues. He said he felt like something was pushing down on his chest, like he was having a heart attack. He sat and waited, and then the feeling got into his arm. He said as soon as the pain went into his arm, he knew it was a heart attack. He said he got 2 nitroglycerin and took them. He said the feeling in his chest and arm didn't go away, so he called 911, and an ambulance took him to the hospital and went to the ER. He said the first blood draw on 01May2021 that was done at the hospital didn't show anything. He said the second blood draw on 01May2021 showed his cardiac enzymes were elevated, and that he had a heart attack. He was diagnosed with a heart attack at the hospital. He said 2 weeks prior (Apr2021), he had a procedure done (clarified as a cardiac catheterization). He said his cardiologist checked his stents, and the stents were all OK, and there were no issues with his heart. He said his cardiologist just did the same procedure again (cardiac catheterization) on 01May2021, and it was normal, there was nothing there (in his heart). He said he was putting his heart attack as caused by the COVID-19 Vaccine shot. He said he knows about a study that reported people were having heart attacks after getting the COVID-19 Vaccine. Clarified that he had a cardiac catheterization through his wrist while at the hospital, and it was same procedure he had 2 weeks earlier with his cardiologist. He said both cardiac catheterizations didn't show anything wrong with his heart. He was asking that if should he get the second dose if he had a side effect after the first dose of the vaccine. The patient was hospitalized for the event from 01May2021 to 04May2021. Outcome of the event was unknown.