chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Axillary pain, Body temperature, Dizziness, Epistaxis
Clinical narrative: elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Folliculitis, Headache, Heart rate, Heart rate increased
Clinical narrative: elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Intestinal haemorrhage, Mobility decreased, Myalgia, Nausea, Parosmia
Clinical narrative: elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sleep disorder, Taste disorder, Vaccination site hypoaesthesia, Vaccination site pain
Clinical narrative: elevated resting heart rate; dizziness; nausea; Injected arm went numb; bad stomach cramps; fever; smell altered on and off; taste altered on and off; muscle pain; headache; all over pain first 36 hours preventing sleep; a little bleeding from bowel at 24 hrs and nose at 36 hrs; Burning like fire at injection site; Hair follicle pain; a little bleeding from bowel at 24 hrs and nose at 36 hrs; extreme armpit pain like torn muscles; no use of arm first two days; fatigue; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number ER 8733) via an unspecified route of administration at left arm on 27Mar2021 15:15 at a single dose for Covid-19 immunization. Medical history of patient was not reported. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included multivitamin, calcium and fish oil (other medications the patient received within 2 weeks of vaccination). Patient stated as injected arm went numb within 15 minutes and stayed that way 48 hrs, extreme armpit pain like torn muscles began at 48hrs, bad stomach cramps first 24 hours, a little bleeding from bowel at 24 hrs and nose at 36 hrs, no use of arm first two days could not even put a robe on, fever that climbed to 101.7 until breaking first 48 hrs, smell and taste altered on and off. Burning like fire at injection site 12 hours later that came and went in waves for another 36 hrs. Hair follicle paint at 12 hrs when headache started, headache lasting 72 hours, all over pain first 36 hours preventing sleep, nausea began within first hour lasting about 40 hours, muscle pain first 48 hrs, fatigue begins at 36 hrs and continues, elevated resting heart rate since first night, dizziness and light headedness from 1st hour. The patient underwent lab tests and procedures which included body temperature was 101.7 and heart rate was elevated (elevated resting heart rate since first night) on 27Mar2021. Prior to vaccination, the patient was not diagnosed with COVID-19 and also not been tested for COVID-19 after vaccination. The outcome of event was recovering.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Three days after receiving the vaccine, I developed a blood clot in the lining of my stomach.; This is a spontaneous report from a contactable consumer. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 11:30 as SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. Concomitant medication(s) included ethinylestradiol, norgestimate (SPRINTEC) taken for an unspecified indication, on an unspecified date. On 18Mar2021 05:30 the patient experienced three days after receiving the vaccine, developed a blood clot in the lining of her stomach (thrombosis). The patient was hospitalized for three days after receiving the vaccine, developed a blood clot in the lining of her stomach for 3 days. Therapeutic measures with blood thinners were taken as a result of three days after receiving the vaccine, developed a blood clot in the lining of her stomach. The outcome of the event was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling hot, Loss of consciousness
Clinical narrative: lost consciousness; Standing and suddenly felt hot; lightheaded/dizzy; This is a spontaneous report from a contactable consumer (patient). A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 30Mar2021 at 07:00 as a single dose for COVID-19 vaccination. The patient's medical history included anxiety, Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient had taken other medication in two weeks are Prozac, Taytulla. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 18:00 patient experienced standing and suddenly felt hot, lightheaded, dizzy and lost consciousness. The patient did not receive any treatment for the events. The outcome of the events was recovering.  Follow up information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Chest discomfort, Dyspnoea, Generalised tonic-clonic seizure, Myalgia
Clinical narrative: neurological grand mal seizures; difficulty breathing; tight chest; sore achy bones, muscle; sore achy bones, muscle; This is a spontaneous report received from a contactable consumer (patient). A 54-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8737), via an unspecified route of administration at the left arm on 27Mar2021 12:45 pm at single dose for COVID-19 immunization. The patient's medical history included juvenile rheumatoid arthritis, asthma, diabetic Type 2, neurological seizure disorder from traumatic brain injury. The patient had known allergies to penicillin, tetracycline, sulfonamide. Concomitant medications included methotrexate (withheld for 2 weeks 25mg injection). On 28Mar2021 1:15 AM, the patient experienced neurological grand mal seizures, sore achy bones, muscle, tight chest, and difficulty breathing. The patient was treated with nebulizer for difficulty breathing. It was reported that patient had no covid prior vaccination nor tested post vaccination. Outcome of events was reported as not recovered.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fear, Haematochezia
Clinical narrative: There was a big amount of blood in the stool and the next day there was blood too; scared; This is a spontaneous report from a contactable consumer (patients son). A 64-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6266), via an unspecified route of administration in the left arm on 06Mar2021 at 08:30 as SINGLE DOSE for covid-19 immunisation. On 27Mar2021, at 08:30 the patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8733), via an unspecified route of administration in the left arm as SINGLE DOSE for covid-19 immunisation. Medical history reported as None. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. No other vaccine in four weeks. The patient didn't receive other medication in two weeks. On 09Mar2021, three days after getting the first shot of vaccine, there was a big amount of blood in the stool and the next day there was blood too, he was scared and never mentioned until 30Mar2021. The event resulted in a visit to Doctor or other healthcare professional office/clinic visit. The clinical outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, COVID-19, Oxygen saturation, SARS-CoV-2 test
Clinical narrative: He was so weak he could not get up; Blood pressure dipped; positive COVID-19 test with symptoms; This is a spontaneous report from a contactable consumer. A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 16Mar2021 (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got exposed to Covid on 14Mar2021; on 16Mar2021 he got the Pfizer COVID Vaccine. On 22Mar2021, he started showing COVID symptoms. He tested positive for COVID a few days later and today (29Mar2021) he was rushed to hospital by the ambulance because he was so weak he couldn't get up, his blood pressure dipped and his oxygen level 96, or whatever the EMT would have done. The reporter asked if the vaccine would help at all at this point and would the patient be eligible for the antibody treatment since he already had a dose of the vaccine, and stated "But it really hasn't even been 2 weeks, it's been 2 weeks tomorrow". The patient was hospitalized in response to the events (from an unspecified date to an unspecified date). The outcome of events was unknown.  Information about lot/batch number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Lethargy, Neuropathy peripheral
Clinical narrative: Extreme lethargy; Exacerbated symptoms of peripheral neuropathy; Difficulty sleeping; This is a spontaneous report from a non-contactable consumer (patient) via a Pfizer representative. An 87-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 28Mar2021, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 for COVID-19 immunization. On Sunday (28Mar2021), the patient had exacerbated symptoms of peripheral neuropathy throughout the evening with difficulty sleeping. Day 1 post-vaccination (Monday, 29Mar2021), the patient experienced extreme lethargy. The outcome of the events was unknown.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Cerumen impaction, Dizziness, Otitis media, Physical examination, SARS-CoV-2 test
Clinical narrative: acute sinus infection; bilateral cerumen impaction; Bilateral otitis media; Had a syncopal episode; Dizzy; This is a spontaneous report from a contactable physician. A 18-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730), dose 1 intramuscular, administered in right arm on 24Mar2021 as single dose for covid-19 immunisation. Medical history included dysmenorrhoea, menometrorrhagia, obesity, guillain-barre syndrome. Concomitant medication's included ethinylestradiol, levonorgestrel (LUTERA) taken for an unspecified indication, start and stop date were not reported. The patient previously took fluconazole (known allergies). Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for Covid test post vaccination on 25Mar2021 show the negative result. Patient claimed she became dizzy within 15 minutes of the vaccine and had a syncopal episode. She stated that it occurred twice since the vaccine. This MD conducted physical exam on 30Mar2021 and found bilateral cerumen impaction that was cleared. She reported that this revealed bilateral otitis media and she was diagnosed with acute sinus infection and treated. Although her symptoms can be explained by these findings, this MD was continuing work up for Guillain-Barre. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event are supportive care, antibiotic for sinus infection and clearance of impacted cerumen. The outcome of the events were recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event syncope  is assessed as possibly related to the suspect vaccine BNT162B2  based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Syncope
Clinical narrative: acute sinus infection; bilateral cerumen impaction; Bilateral otitis media; Had a syncopal episode; Dizzy; This is a spontaneous report from a contactable physician. A 18-years-old female non-pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8730), dose 1 intramuscular, administered in right arm on 24Mar2021 as single dose for covid-19 immunisation. Medical history included dysmenorrhoea, menometrorrhagia, obesity, guillain-barre syndrome. Concomitant medication's included ethinylestradiol, levonorgestrel (LUTERA) taken for an unspecified indication, start and stop date were not reported. The patient previously took fluconazole (known allergies). Patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was tested for Covid test post vaccination on 25Mar2021 show the negative result. Patient claimed she became dizzy within 15 minutes of the vaccine and had a syncopal episode. She stated that it occurred twice since the vaccine. This MD conducted physical exam on 30Mar2021 and found bilateral cerumen impaction that was cleared. She reported that this revealed bilateral otitis media and she was diagnosed with acute sinus infection and treated. Although her symptoms can be explained by these findings, this MD was continuing work up for Guillain-Barre. The adverse event result in Emergency room/department or urgent care. Treatment received for the adverse event are supportive care, antibiotic for sinus infection and clearance of impacted cerumen. The outcome of the events were recovered with lasting effects.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The event syncope  is assessed as possibly related to the suspect vaccine BNT162B2  based on strong temporal association, but consider also possible contributory effects from patient's medical history and/or concomitant medications. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Give me insomnia for four nights in a row I have bipolar it would have been nice to know this was a possible side effect; This is a spontaneous report from a contactable consumer (patient). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: En6199), via an unspecified route of administration on 04Mar2021 at 03:45 as SINGLE DOSE for covid-19 immunization. Medical history included bipolar. The patient had no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lamotrigine (LAMICTAL and lamotrigine. On 04Mar2021 22:00, the patient experienced insomnia for four nights in a row. The patient wanted to know if this was a possible side effect. Since the vaccination, the patient was not tested for COVID-19. The event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the event was recovering.  Information about lot/batch number was provided. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hypoaesthesia, Laboratory test
Clinical narrative: prone to strokes; both her legs felt numb; This is a spontaneous report received from a contactable consumer (patient reported for herself). An elderly female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. After receiving Pfizer covid vax, 4 days later (date unspecified), the patient reported that both her legs felt numb. She was elderly and prone to strokes so they rushed her to hospital (dates unknown). All tests were negative (date unspecified) so now they suspect it may be related to the vaccine. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Dyskinesia, Electroencephalogram, Feeling abnormal, Magnetic resonance imaging
Clinical narrative: Arm and legs are shaking; Jerking; Joints are painful; joint pain especially in the finger; Feeling weird; This is a spontaneous report from a contactable consumer (patient's husband). An 81-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265), via an unspecified route of administration, on 27Jan2021 at 11:45, at a single dose, for COVID-19 immunization; and rosuvastatin, via an unspecified route of administration, in Feb2021 for 3 days, at an unspecified dose and frequency, for blood cholesterol. The patient's medical history included high blood pressure. The patient's concomitant medication included ongoing amlodipine for high blood pressure. The patient's husband was calling about the COVID-19 vaccine and he is not sure if what the patient was experiencing was because of the vaccine or a prescription drug (rosuvastatin) she took but her arm and legs are shaking like jerking and joints are painful on 04Feb2021. The medication the patient's husband was referring to is rosuvastatin which the patient takes for cholesterol. The patient took this for 3 days and she started feeling weird in Feb2021, so she stopped taking. The patient's husband not sure what to do since the patient went to the doctor and the doctor did not find anything, she went to the emergency room. The patient was hospitalized for two days. The patient also saw a specialist neurologist who recommended to take more tests, but the patient is waiting for the tests. In 2021, the patient had a magnetic resonance imaging (MRI) and electroencephalography (EEG). The patient was experiencing joint pain especially in the finger at night still (the joint pain is not in the arm and legs but in her finger). This started a few days later and was still going on. It has stayed the same and some days are better and then some days are worse. The patient was admitted to the hospital in 2021 for 2 days due to events. No treatment was received for the events. The action taken in response to the events for rosuvastatin was permanently withdrawn in Feb2021. The outcome of "Feeling weird" was unknown. The patient had not recovered from "Joints are painful; joint pain especially in the finger". The patient was recovering from the remaining events.
Age: 81.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Tremor
Clinical narrative: Arm and legs are shaking; Jerking; Joints are painful; joint pain especially in the finger; Feeling weird; This is a spontaneous report from a contactable consumer (patient's husband). An 81-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL9265), via an unspecified route of administration, on 27Jan2021 at 11:45, at a single dose, for COVID-19 immunization; and rosuvastatin, via an unspecified route of administration, in Feb2021 for 3 days, at an unspecified dose and frequency, for blood cholesterol. The patient's medical history included high blood pressure. The patient's concomitant medication included ongoing amlodipine for high blood pressure. The patient's husband was calling about the COVID-19 vaccine and he is not sure if what the patient was experiencing was because of the vaccine or a prescription drug (rosuvastatin) she took but her arm and legs are shaking like jerking and joints are painful on 04Feb2021. The medication the patient's husband was referring to is rosuvastatin which the patient takes for cholesterol. The patient took this for 3 days and she started feeling weird in Feb2021, so she stopped taking. The patient's husband not sure what to do since the patient went to the doctor and the doctor did not find anything, she went to the emergency room. The patient was hospitalized for two days. The patient also saw a specialist neurologist who recommended to take more tests, but the patient is waiting for the tests. In 2021, the patient had a magnetic resonance imaging (MRI) and electroencephalography (EEG). The patient was experiencing joint pain especially in the finger at night still (the joint pain is not in the arm and legs but in her finger). This started a few days later and was still going on. It has stayed the same and some days are better and then some days are worse. The patient was admitted to the hospital in 2021 for 2 days due to events. No treatment was received for the events. The action taken in response to the events for rosuvastatin was permanently withdrawn in Feb2021. The outcome of "Feeling weird" was unknown. The patient had not recovered from "Joints are painful; joint pain especially in the finger". The patient was recovering from the remaining events.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Echocardiogram, Fatigue, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: she had numbness and tingling on the left side of the face, then her left arm; she was tired and sleepy; she was tired and sleepy; she felt a bit tingling in her right ankle; tingling on the left side of the face; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 subcutaneous, administered in left arm on 27Mar2021 09:15 (Lot Number: EP6955) as single dose for covid-19 immunisation at age 46 years old. Medical history was not reported. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified medications received within 2 weeks of vaccination. No other vaccines received within 4 weeks prior to COVID vaccine. The patient got the vaccine Saturday 27Mar2021, she felt a bit tingling in her right ankle in the evening. On Sunday, 28Mar2021, she was tired and sleepy. On Monday, 29Mar2021, around 10:00 she had numbness and tingling on the left side of the face, then her left arm. She called her primary care doctor and she was directed to go to urgent care.  She went to urgent care and the doctor sent her to the emergency room then she was admitted to the hospital. Multiple tests were done, CT-Scan, MRI, echo results came back negative and everything looked fine. She was discharged from the hospital Tuesday 30Mar2021. The patient was tested for COVID (nasal swab) post vaccination on 29Mar2021 with negative result. The patient recovered from the events.  Information on the batch number has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, SARS-CoV-2 antibody test, Somnolence
Clinical narrative: she had numbness and tingling on the left side of the face, then her left arm; she was tired and sleepy; she was tired and sleepy; she felt a bit tingling in her right ankle; tingling on the left side of the face; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 subcutaneous, administered in left arm on 27Mar2021 09:15 (Lot Number: EP6955) as single dose for covid-19 immunisation at age 46 years old. Medical history was not reported. No allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included unspecified medications received within 2 weeks of vaccination. No other vaccines received within 4 weeks prior to COVID vaccine. The patient got the vaccine Saturday 27Mar2021, she felt a bit tingling in her right ankle in the evening. On Sunday, 28Mar2021, she was tired and sleepy. On Monday, 29Mar2021, around 10:00 she had numbness and tingling on the left side of the face, then her left arm. She called her primary care doctor and she was directed to go to urgent care.  She went to urgent care and the doctor sent her to the emergency room then she was admitted to the hospital. Multiple tests were done, CT-Scan, MRI, echo results came back negative and everything looked fine. She was discharged from the hospital Tuesday 30Mar2021. The patient was tested for COVID (nasal swab) post vaccination on 29Mar2021 with negative result. The patient recovered from the events.  Information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: diagnosed with COVID-19 /tested positive for COVID-19; This is Spontaneous report from a contactable consumer. This consumer reported similar events for herself and 1 patient (her husband). This is a 2nd of two reports. A 52-years-old male patient received the first dose of BNT162B2( PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date were not reported), via an unspecified route of administration on 10Mar2021 as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fever on 15Mar2021, then the patient felt worse and had to go to a hospital, where he was diagnosed with COVID-19 and was prescribed medicine for the chills. The patient diagnosed with COVID-19 /tested positive for COVID-19 on an unspecified date in Mar2021. Outcome of the events was unknown.   Information about the Lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021350781 same product and event, different patient
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Eye disorder, Eye haemorrhage, SARS-CoV-2 test
Clinical narrative: developped a right eye bleed, 75% of my eye was covered with blood; developed a yellow cloud/ area on my right eye; This is a spontaneous report from a contactable consumer.  A 53-year-old male consumer reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number 59267-1000-1),  into the right arm on 03Mar2021 at 12:45 AM at single dose for COVID-19 immunization. The patient had known allergies to Bactrim/Sulfa. Concomitant drugs in two weeks were none. On 18Mar2021 at 06:00 AM the patient developed a yellow cloud/ area on his right eye , developped a right eye bleed on 18Mar2021 which lasted on off untill 27Mar2021. 75% of his eye was covered with blood. The blood was clearing but the cloud remained. The patient underwent eye exam and received eye drops/tears. The patient was Covid tested post vaccination with Nasal Swab and antigen with negative result.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Loss of consciousness, Vagus nerve disorder
Clinical narrative: blackout; issues with her vagus nerve; allergic reaction; head ache; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (Solution for injection) via an unspecified route of administration on 26Mar2021 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. On Friday 26Mar2021 her niece was administered a dose of the Pfizer COVID-19 vaccine at her local medical centre and within 5 minutes of receiving this suffered an extreme allergic reaction resulting in a blackout and issues with her vagus nerve that was over stimulated and caused her body to essentially 'reset'. This resulted in a trip to hospital where she was under observation for several hours although apart from a slight head ache all was good now and she was home. She was naturally keen to understand why this happened and if there was anything in the vaccine she might be allergic to. She just wanted to report this adverse reaction as remember from some compliance training they received several months ago that it was the right thing to do and her manager also advised her to do so and therefore if there was anything else you need from me please do not hesitate to contact me? Outcome of events blackout, issues with her vagus nerve, allergic reaction were recovered on an unspecified date in Mar2021, while with other event was unknown.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Erectile dysfunction
Clinical narrative: Erectile Disfunction after five days of receiving vaccination.; This is a spontaneous report from a contactable consumer (patient herself).   A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Lot Number: ER8727;Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:15 at SINGLE DOSE for covid-19 immunisation.  The patient had no medical history and no allergies to medications, food or other. Concomitant medication included alfuzosin HCL, Atorvastatin calcium, celecoxib.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination.  The patient experienced erectile disfunction after five days of receiving vaccination on 27Mar2021 21:30. The action taken in response to the event(s) for bnt162b2 was not applicable.Treatment was not received for the adverse event.The outcome of the event was not recovered.  More information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis
Clinical narrative: Cellulitis; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6199; Expiration Date: 20Jun2021) on 09Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Mar2021, after the first dose of vaccination, the patient had cellulitis. The event was assessed as serious (medically significant). The patient was on an unspecified antibiotic as treatment for the event. The outcome of the event, cellulitis, was unknown. The patient was scheduled to return for the second dose on 30Mar2021.  Information on lot/batch number was available. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Ear pain, Headache, Jaw disorder, Oral pain
Clinical narrative: cheek swelled up like he had mumps; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; body aches; low grade fever; dull ache was causing some headaches; sensitive area in lower right portion of jaw; parotid salivary gland infection; This is a spontaneous report received from a contactable consumer (patient himself). A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and lot number: EL9369), via an unspecified route of administration on 10Feb2021 as a single dose in the left arm for COVID-19 immunisation. Patient had no medical history and concomitant medications. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EL3246), on 20Jan2021 in left arm for COVID-19 immunization. On 10Feb2021 (about 6-8 hours after second dose), the patient developed body aches and low-grade fever. It was reported that at same time as body aches, he had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only. Stated everything went away after 36 hours except the ache in his jaw and ear, states it became very low grade, thought it was his ear and after a week, the dull ache was caused some headaches in 2021 and he went to doctor who told him to see an ENT, states he saw an ENT, they looked deeply, it was fine, states they did find there was a sensitive spot down by his jaw, told him to just take Ibuprofen. On 21Mar2021, patient cheek swelled up like he had mumps and went to the periodontist, he probed and found no infection, did find a sensitive area in lower right portion of jaw, prescribed cefalexin. Swelling went down, and then suddenly it came back and told him to go to oral surgeon specialist, oral surgeon did a CT, did not find an evidence of tumours or anything in 2021, based on symptoms he said he had parotid salivary gland infection in 2021, when it gets infected it creates a mump like condition and prescribed amoxicillin. Clarified the jaw pain started out severe dropped down to low grade annoying pain and stayed that way. then on the 21Mar2021 it got severe again with the swelling. Stated today, it seems to have gone away, still has 5 days of amoxicillin left. Outcome of body aches, low grade fever was recovered on 11Feb2021, dull ache was causing some headaches, cheek swelled up like he had mumps, sensitive area in lower right portion of jaw and parotid salivary gland infection was unknown and had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only was not recovered.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in jaw, Pyrexia, Sialoadenitis, Swelling face
Clinical narrative: cheek swelled up like he had mumps; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only; body aches; low grade fever; dull ache was causing some headaches; sensitive area in lower right portion of jaw; parotid salivary gland infection; This is a spontaneous report received from a contactable consumer (patient himself). A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection and lot number: EL9369), via an unspecified route of administration on 10Feb2021 as a single dose in the left arm for COVID-19 immunisation. Patient had no medical history and concomitant medications. Patient historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, lot number: EL3246), on 20Jan2021 in left arm for COVID-19 immunization. On 10Feb2021 (about 6-8 hours after second dose), the patient developed body aches and low-grade fever. It was reported that at same time as body aches, he had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only. Stated everything went away after 36 hours except the ache in his jaw and ear, states it became very low grade, thought it was his ear and after a week, the dull ache was caused some headaches in 2021 and he went to doctor who told him to see an ENT, states he saw an ENT, they looked deeply, it was fine, states they did find there was a sensitive spot down by his jaw, told him to just take Ibuprofen. On 21Mar2021, patient cheek swelled up like he had mumps and went to the periodontist, he probed and found no infection, did find a sensitive area in lower right portion of jaw, prescribed cefalexin. Swelling went down, and then suddenly it came back and told him to go to oral surgeon specialist, oral surgeon did a CT, did not find an evidence of tumours or anything in 2021, based on symptoms he said he had parotid salivary gland infection in 2021, when it gets infected it creates a mump like condition and prescribed amoxicillin. Clarified the jaw pain started out severe dropped down to low grade annoying pain and stayed that way. then on the 21Mar2021 it got severe again with the swelling. Stated today, it seems to have gone away, still has 5 days of amoxicillin left. Outcome of body aches, low grade fever was recovered on 11Feb2021, dull ache was causing some headaches, cheek swelled up like he had mumps, sensitive area in lower right portion of jaw and parotid salivary gland infection was unknown and had intense pain up through his ear, lower jaw and upper part of his mouth on right hand side of his body only was not recovered.  Information on the lot/batch number has been requested.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Abnormal dreams, Asthenia, Balance disorder, Blood pressure decreased
Clinical narrative: in hot and sweaty; thought a truck hit him and he must've over done it. He said that as the day went one he felt worse.; headaches; he felt so bad; He has not moved around much at all; watery eyes; sneezing; abdominal pain; gas; tender if you touched directly at the injection site; in hot and sweaty; weight loss; Mucousy Mouth; Hoarse voice; low oxygen; weird dreams; can't sleep; blood pressure down; no appetite; breathing is shallow; muscle aches; imbalanced; Weakness; Fever; minimal injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 77-year-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL9209, Expiration date was not reported), via an unspecified route of administration on 06Mar2021 17:15 as single dose for covid-19 immunisation. Medical history included ongoing high cholesterol. Concomitant medication included levothyroxine, tablet via oral from unknown date 2018 at 100 uCi, once a day for chemical thyroid condition, atorvastatin calcium (LIPITOR, tablet) via oral 10 mg once a day for blood cholesterol increased. Historical vaccine included first dose of BNT162B2 on 13Feb2021 for covid-19 immunisation. The patient experienced mucousy mouth, hoarse voice, weight loss on 27Mar2021, low oxygen, weird dreams, can't sleep, blood pressure down, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, Fever 26Mar2021, patient hot and sweaty, in hot and sweaty, thought a truck hit him and he must've over done it. He said that as the day went one, he felt worse, headaches, he felt so bad, He has not moved around much at all, watery eyes, sneezing, abdominal pain, gas and tender if you touched directly at the injection site on an unspecified date, minimal injection site pain on 14Feb2021. As per the reporter seriousness criteria reported as medically significant. The patient underwent lab tests and procedures which included blood pressure measurement: 128/68 on 26Mar2021 and 132/76 on 28Mar2021, temperature: 100.8 on an unspecified date and 98.3 on 26Mar2021 and 98.3 on 28Mar2021, Pulse oximetry: 89 % on 26Mar2021, 95-96 % and 96 % on 29Mar2021. The outcome of the event mucousy mouth, hoarse voice, weird dreams, can't sleep, weight loss, no appetite, breathing is shallow, muscle aches, imbalanced, Weakness, fever was not recovered, minimal injection site pain was recovered on 15Feb2021, blood pressure down recovering and unknown for other events.