chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Chills; Aches; Very tired; This is a spontaneous report from a non-contactable consumer, the patient. A 57-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6203), via unspecified route of administration on left arm on 12Mar2021 (at the age of 57-year-old), as a single dose for COVID-19 immunisation. Medical history included Penicillin allergy. Concomitant medications included multivitamin (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin C (MANUFACTURER UNKNOWN) for unknown indication from unknown date. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: el3247) via unspecified route of administration on left arm on 17Feb2021 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 and since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 at 11:30, the patient experienced chills, aches, and became very tired. The patient did not receive any treatment for reported events. The clinical outcome of reported events chills, aches and tiredness was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Decreased appetite, Fatigue, Myalgia, Pyrexia
Clinical narrative: fever; aches in joint; aches in muscle; loss of appetite; extreme exhaustion; soreness at injection site; This is a spontaneous report from a non contactable consumer, the patient. A 44-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207), via an unspecified route of administration in the left arm on 17Mar2021 at 15:45 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included thalassemia minor. The patient had egg allergy. The concomitant medications included Liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and zoloft (MANUFACTURER UNKNOWN) for unknown indication from unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 01:00 AM, the patient experienced fever, aches in joints and muscles, loss of appetite, extreme exhaustion, soreness at injection site. After vaccination patient was unable to get out of bed. On second day after vaccination patient still felt sick to go to work even though severity of symptoms had been decreased. The clinical outcomes of events fever, aches in joints and muscles, loss of appetite, extreme exhaustion and soreness at injection site were recovering. No follow-up attempts are needed. No further information is expected
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: fever; aches in joint; aches in muscle; loss of appetite; extreme exhaustion; soreness at injection site; This is a spontaneous report from a non contactable consumer, the patient. A 44-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6207), via an unspecified route of administration in the left arm on 17Mar2021 at 15:45 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included thalassemia minor. The patient had egg allergy. The concomitant medications included Liothyronine (MANUFACTURER UNKNOWN), levothyroxine (MANUFACTURER UNKNOWN) and zoloft (MANUFACTURER UNKNOWN) for unknown indication from unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 01:00 AM, the patient experienced fever, aches in joints and muscles, loss of appetite, extreme exhaustion, soreness at injection site. After vaccination patient was unable to get out of bed. On second day after vaccination patient still felt sick to go to work even though severity of symptoms had been decreased. The clinical outcomes of events fever, aches in joints and muscles, loss of appetite, extreme exhaustion and soreness at injection site were recovering. No follow-up attempts are needed. No further information is expected
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: itching and rash; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2(PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EP6955), via an unspecified route of administration in the left arm on 18Mar2021 at 8:30 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medication were not reported. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: EN6200), via an unspecified route of administration in the left arm on 25Feb2021 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not been tested for COVID-19 since the vaccination. On 18Mar2021 at 11:00, the patient experienced itching and rash. The patient did not receive treatment for the reported event. The clinical outcome of the itchy rash was recovered on an unknown date.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Injection site pain; fever; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 18Mar2021 at 11:15 as a single dose for COVID-19 immunisation. The patient medical history included benign prostatic hypertrophy. Concomitant medications included tamsulosin (MANUFACTURER UNKNOWN) and vitamin c (MANUFACTURER UNKNOWN). The patient previously took her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on left arm on 25Feb2021 at 11:15 as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021 the patient experienced injection site pain and fever. The clinical outcome of the injection site pain and fever recovering/resolving at the time of report. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Furuncle
Clinical narrative: new small BOIL about 4" away from armpit.; BOILS appeared on left arm armpit. Currently about 20 small and one very large ,painful boil in armpit; This is a spontaneous report from a contactable consumer, the patient. A non-pregnant female patient of unspecified age received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: unknown), via an unspecified route of administration in the left arm on 16Mar2021 as a single dose for COVID-19 immunisation. Medical history included seasonal allergies to pollen and grasses. The concomitant medications included topiramate (MANUFACTURER UNKNOWN) and cetirizine (MANUFACTURER UNKNOWN) for unknown indication. 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. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021, boils appeared on left arm, armpit which were about 20 small and one very large, painful boils in the armpit (boils). It was also reported that on an unspecified date, one more new small boil was noticed about 4" away from the armpit(boil on arm). No treatment was received for the events. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the reported events boils and boil on arm was not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nightmare, Vaccination site pain
Clinical narrative: Pain in arm at injection site.; Nightmares; This is a spontaneous report from a non-contactable consumer, the patient. A 26-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 18Mar2021 (at the age of 26-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not provided. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not tested for COVID-19 since the vaccination. On 19Mar2021, the patient experienced pain in arm at injection site and nightmares. The patient did not receive any treatment for the reported events. The clinical outcomes of the events vaccination site pain and nightmares were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle atrophy
Clinical narrative: atrophy; shoulder sore; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6206), via an unspecified route of administration in the right arm on 10Mar2021 at 13:00 (at the age of 55-year-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. On an unspecified date at 13:00, the patient experienced his triceps muscle became like a ball. He had suffered atrophy and his arm became smaller as though, he had removed a cost after his hand was in a sling for several weeks. His shoulder was still sore from the injection. Therapeutic measures were not taken for the adverse events. The clinical outcome of extreme atrophy and shoulder soreness were not recovered at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: sore and aching around injection areaon left arm; Itching around injectionarea; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via unspecified route of administration in the left arm on 18May2021 at 08:15 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. The patient had a history of allergy to shellfish, Aspirin and Ibuprofen. The patient did not take any concomitant medications. Prior to vaccination the patient was not diagnosed with COVID-19.Since the vaccination, the patient had not been tested for COVID-19. On 18May2021 at 20:30, the patient experienced sore and aching around the injection area on left arm and itching around injection area. The patient reported that itching around the injection area initially lasted for an hour and then subsided and then again started. No therapeutic measures were taken. The clinical outcome of sore and aching around injection area on left arm and itching around injection area was not resolved.   No follow up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Intense migraine; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 04Mar2021 at 08:30 (at the age of 30-year-old) as a single dose for COVID-19 immunisation.  Medical history included prolactinoma, PCOS (Polycystic ovary syndrome). Concomitant medications included metformin (MANUFACTURER UNKNOWN), cabergoline (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN), vitamin d3 (MANUFACTURER UNKNOWN), all for unknown indication from unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via unspecified route of administration in the left arm on 04Feb2021 at 15:00 as a single dose for COVID-19 immunisation and took sulfonamide(sulfa) for unknown indication and experienced an allergy. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient had not diagnosed with COVID-19. Since the vaccination, the patient had not tested positive for COVID-19. The patient had intense migraine on 16Mar2021 at 13:00 PM, migraine came on suddenly and lasted 3 hours. No history of headaches. The patient did not receive treatment for the reported event. The clinical outcome of the migraine was recovered with sequelae.   Information about lot number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Headache; Fatigue; Fever; This is a spontaneous report from a contactable consumer, the patient.  A 42-years-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3248) via an unspecified route of administration in the left arm on 17Mar2021 at 13:15 (at an age of 42-years-old) as second single dose for COVID-19 immunisation.   The patient had no medical history. The patient had no allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks of vaccination.  The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation.   Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.   On 18Mar2021, the patient experienced headache, fatigue and fever.  The patient did not receive any treatment for the events.  The clinical outcome of headache, fatigue and fever were resolved on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a contactable consumer (patient).  An 83-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6200), via an unspecified route of administration in the left arm on 17Feb2021 at 00:00 (at the age of 83-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not tested positive for COVID-19 since having the vaccine.  Patient had no concomitant medications. The patient did not receive any vaccine within 4 weeks prior to vaccine or any medication within 2 weeks of vaccination.  Past vaccine history included pneumococcal vaccine and had the same reaction to it.  On 18Feb2021, the patient experienced rash. Patient did not receive any treatment for rash. The clinical outcome of rash was recovered on an unknown date in 2021.  No follow up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: A vibrating, pulsing sensation off and on near her lower trunk; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the right arm on 04Mar2021 at 18:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient was not having any allergies to medications, food, or other products. Concomitant medication was not reported. On 05Mar2021 at 04:30, the day after shot, and every day since, she had a vibrating, pulsing sensation off and on near her lower trunk. It doesnt hurt, but was concerned as she never had it before. She cannot control it whatsoever. At first, she thought she was feeling a small earthquake, then thought that might be her phone in purse was vibrating, but it was her. She was very scared to take second shot. The clinical outcome of vibrating, pulsing sensation off and on near her lower trunk was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lethargy, Pain
Clinical narrative: Chills; Body aches; headache; lethargy; This is a spontaneous report received from a contactable consumer, the patient. A 66-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6202), via an unspecified route of administration in left arm on 10Mar2021 at 15:30 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history included hypertension and allergic to sulfa-based drugs. Prior to vaccination, patient was not diagnosed with COVID-19. The patient was receiving unspecified concomitant medications within two weeks prior to the COVID-19 vaccine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN5318) via an unspecified route of administration in the left arm on 17Feb2021 at 15:30 (at the age of 66-years-old) for COVID-19 immunisation. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 12Mar2021 at 1:00, the patient experienced chills, body aches, headache and lethargy. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the events chills, body aches, headache and lethargy. The clinical outcomes of the events chills, body aches, headache and lethargy were resolved on an unknown date in 2021.     No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Myalgia
Clinical narrative: Dizziness; Pain in joints; Pain in muscle; Fatigue; This is a spontaneous report received from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in right arm on 17Mar2021 at 17:15 (at the age of 30-year-old), as a single dose, for COVID-19 immunisation. The patients medical history included hypothyroidism, attention deficit hyperactivity disorder (ADHD), exercise induced asthma, eczema, hay fever, allergy to grass pollen. Past drug history included allergy to pramoxine. The patients concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), CONCERTA, montleukast (MANUFACTURER UNKNOWN) and WELLBUTRIN for an unknown indication since an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Mar2021, the patient experienced pain in joints and muscle, dizziness and fatigue. The clinical outcome of events pain in joints, muscle pain, dizziness and fatigue were recovering at the time of this report.  Information about lot number cannot be obtained. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Muscle twitching, Pain in extremity
Clinical narrative: Involuntary twitching; pain in arm; High blood pressure; headache; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch Number: unknown), via unspecified route of administration in the left arm on 18Mar2021 at 07:00 PM (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not included. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient was not tested positive for COVID-19 since the vaccination. On 18Mar2021 at 07:00 PM, the patient experienced twitching, pain in arm, blood pressure high and headache. The patient reported that involuntary twitching in her left arm since she received the vaccine 24 hours ago resulting in difficulty going to sleep, relaxing. Pain in arm resulting in difficulty raising her arm to lift, clean, dress. High blood pressure and headache lasted 24 hours. The Clinical outcomes of twitching, pain in arm and blood pressure high were not resolved; while that of headache was resolved.  No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough
Clinical narrative: chest congestion; Dry cough; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EN6203) via an unspecified route of administration in the right arm on 14Mar2021 at 12:00 (at the age of 59-year-old), as single dose for COVID-19 immunisation. There were no allergies to medications, food, or other products. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient received other vaccine from Pfizer on same day of COVID-19(14Mar2021). The patient experienced dry cough and chest congestion on 17Mar2021 at 16:45. The patient did not receive any treatment for the reported events. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of dry cough and chest congestion were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash all over back, chest, stomac, and upper leg; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old patient with unknown gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EP6955) via an unspecified route of administration on the left arm on 16Mar2021 at 13:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included dental implantation (Mar10 and 11th). The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included Vitamins unspecified (MANUFCTURER UNKNOWN), amoxycillin (MANUFACTURER UNKNOWN), tylenol, codeine (MANUFACTURER UNKNOWN) received within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18Mar2021 at 09:00 (2 days after receiving vaccine) the patient experienced rash all over. The patient stated that broke out in rash all over back, chest, stomach, and upper leg. The patient was prescribed with hydroxyzin hcl 25mg for the event. The event resulted to doctor visit. The clinical outcome of the event rash all over was not resolved at the time of the report. No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metal taste in mouth; This is spontaneous case report received from a contactable consumer, the patient. A 49-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: Bp7534), via an unspecified route of administration in the left arm on 19Mar2021 at 18:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications were not reported. The patient previously took amoxicillin and Advair and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. On 19Mar2021 at 18:15, the patient experienced metal taste in mouth. The patient did not receive any treatment for the reported event. The clinical outcome of metal taste in mouth was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chest discomfort
Clinical narrative: my chest is heavy like someone is sitting on me a bit. I can breathe. Just feels like pressure; stomach cramps day two; Sick to my stomach on and off; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non pregnant female patient received first dose of BNT162b2 (Pfizer BioNTech Covid19 mRNA lot number EN6207) via unspecified route of administration in the right arm on 16Mar2021 at 14.45 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included post cancer, mild COPD (coronary obstructive pulmonary disease) and mildly high BP (blood pressure) on unknown dates. Other medications the patient received within 2 weeks of vaccination was reported as yes. The patient previously received codeine (MANUFACTURER UNKNOWN), Gentamycin (MANUFACTURER UNKNOWN), and ropivacaine (MANUFACTURER UNKNOWN) and experienced drug allergy. 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. Since the vaccination the patient had not tested for COVID-19. The patient experienced stomach ache on17Mar2021, stomach cramps and chest heaviness in 18Mar2021. The patient was sick to her stomach on and off and stomach cramps day two. Also, day two her chest was heavy like someone was sitting on her a bit. She could breathe. Just felt like pressure. It was not known whether the patient received any treatment for the reported events. The clinical outcome for stomach pain and chest heaviness was recovering and of stomach cramps was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain
Clinical narrative: Severe nerve-like stabbing/poking pains throughout body and ache; Chills; Nausea; This is spontaneous report from contactable consumer, the patient. A 65-years-old non pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EN6198), via an unspecified route of administration in arm left on 17Mar2021, at 0930, (at the age of 65 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. Since the vaccination, the patient had not been tested for COVID-19. Medical history included sulfonamide allergy. Concomitant medications included (ZOLOFT), Vitamin-D (MANUFACTURER UNKNOWN), Calcium (MANUFACTURER UNKNOWN), and Baby aspirin (MANUFACTURER UNKNOWN), all for an unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch number: EN6198), via an unspecified route of administration in arm left on 24Feb2021, at 0900, (at the age of 65 years) as a single dose for COVID-19 immunisation. On an 18Mar2021, the patient experienced severe nerve-like stabbing/poking pains throughout body, aches, chills, nausea. The patient did not receive treatment for the event. The clinical outcome of events body pains, chills and nausea were recovering at the time of report. No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Heart rate increased, Hypoaesthesia, Nausea, Pain in extremity
Clinical narrative: Excessive heart beating; Nausea; overall weakness; numbness of left arm; soreness of left arm; This is a spontaneous report from a contactable consumer, the patient. A 34-year old, male patient received his unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in left arm on 15Mar2021 at 14:30 hours as single dose, for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. Prior to vaccination patient was not tested positive for COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient has no known Allergies to medications, food, or other products. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 15Mar2021 at 14:30 the patient experienced events, Excessive heart beating, nausea after food consumption - haven't been able to hold food as of morning 3/19, overall weakness, numbness and soreness of left arm during first 2 days since the vaccination. The patient didn't receive any treatment for the events. The clinical outcome for the events Excessive heart beating, nausea, overall weakness, numbness and soreness of left arm was recovering at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Infection, Inflammation, Localised infection, Mastitis
Clinical narrative: develop a serious infection in my right breast and side; Because the vaccine creates inflammation which mimics breast cancer, is it possible that the vaccine was a catalyst for the infection; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration in left arm on 19Mar2021 at 08:30 as a single dose for COVID-19 immunization. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6200), via an unspecified route of administration in left arm on 24Feb021at 08:30 as a single dose for COVID-19 immunization. The patient's medical history included Allergies to medications, food, or other products: Sulfa, erythromycin, Breast cancer surviver, Lymphedema on the right side due to radiation treatment. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior medication included Lisinopril, Tamoxifen, Vitamin supplements. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. On 20Mar2021 at 11:00 pm, the night after the injection, she developed a serious infection in her right breast side. The patient stated that as vaccine creates inflammation which mimics breast cancer, the patient wanted to know whether it was possible that the vaccine was a catalyst for the infection. The patient was treated with antibiotics for the events. The outcome of the events was not resolved.  Follow-up (24Mar2021): Follow up was received from the same contactable consumer(patient) in response to trail mail sent included: medical inquiry. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Infection
Clinical narrative: He had an infection and headache after the first dose; He had an infection and headache after the first dose; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored Program. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient received first dose of Covid-19 vaccine on 26Feb2021 and has a schedule for a second dose on 19Mar2021. On an unspecified date he had an infection and headache after the first dose and took antibiotics because of the infection. Patient wanted to know if he can take second dose tomorrow. Therapeutic measures were taken as a result of infection with antibiotics. The outcome for the events was reported as unknown.   No follow up attempts are possible. Information about lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Discomfort, Swollen tongue, Throat tightness
Clinical narrative: my tongue was swollen; discomfort; Throat closed up; This is a spontaneous report from a contactable physician and consumer. A 55-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot No# EN6204) via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:20, as 1st dose, single dose for covid-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol increased from an unknown date. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taken for blood cholesterol increased from an unspecified start date and ongoing; metoprolol (METOPROLOL) taken for blood pressure measurement from an unspecified start date and ongoing. The patient experienced my tongue was swollen, discomfort and throat closed up on 24Mar2021. It was reported as, the patient had tongue was swollen so badly that could not see the back of throat and felt like throat was closing was proceeded to the nearest Emergency Room, arrived there at 1:20am. They administered medications, injection. They also prescribed an EpiPen, along with other meds to pick up at the pharmacy. Therapeutic measures were taken as a result of my tongue was swollen, discomfort, throat closed up. Outcome of the events were recovered on 24Mar2021.  No follow-up attempts are possible, no further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events swollen tongue, discomfort and throat constriction and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Swollen tongue, Throat tightness
Clinical narrative: my tongue was swollen; discomfort; Throat closed up; This is a spontaneous report from a contactable physician and consumer. A 55-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot No# EN6204) via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:20, as 1st dose, single dose for covid-19 immunisation. Medical history included blood pressure abnormal and blood cholesterol increased from an unknown date. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taken for blood cholesterol increased from an unspecified start date and ongoing; metoprolol (METOPROLOL) taken for blood pressure measurement from an unspecified start date and ongoing. The patient experienced my tongue was swollen, discomfort and throat closed up on 24Mar2021. It was reported as, the patient had tongue was swollen so badly that could not see the back of throat and felt like throat was closing was proceeded to the nearest Emergency Room, arrived there at 1:20am. They administered medications, injection. They also prescribed an EpiPen, along with other meds to pick up at the pharmacy. Therapeutic measures were taken as a result of my tongue was swollen, discomfort, throat closed up. Outcome of the events were recovered on 24Mar2021.  No follow-up attempts are possible, no further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events swollen tongue, discomfort and throat constriction and the suspect drug.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fracture, Gait inability
Clinical narrative: fell and broke a bone near her hip and required surgery; fell and broke a bone near her hip and required surgery; unable to walk; This is a spontaneous report from a non-contactable consumer or other non hcp.  A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Mar2021 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient was scheduled to receive her second vaccine on 25th March. On an unspecified date in Mar2021, the patient fell and broke a bone near her hip and required surgery. She was unable to walk, and the reporter wanted to find out how best to ensure the patient second vaccine gets administered. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Redness at injection site.; Itching at injection site.; This is a spontaneous report from a contactable consumer, the patient. A 52-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route in left arm on 23Mar2021 at 00:00 (at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included psychological disorders. It was reported that the patient had some allergies to medications, food, or other products (unspecified). Concomitant medication within two weeks of vaccination was not specified. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6198), via an unspecified route of administration in the left arm on 02Mar2021 at 12:00 (at the age of 52-years-old), as a single dose for COVID-19 immunisation. 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 vaccination. Since the vaccination, the patient had not been tested positive for COVID-19.  On 24Mar2021, at 00:00, the patient experienced redness and itching at injection site. No treatment was received for the events. The clinical outcome of redness and itching at injection site were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 1 via an unspecified route of administration on 09Mar2021 as 1st dose, single for COVID-19 immunisation. On an unspecified date, the patient was diagnosed with UTI (urinary tract infection). The patient was taking antibiotics. Her second dose was scheduled for 01Apr2021. She moved her second dose as well on 05Apr2021 due to dental root removal on 01Apr2021 and might betaking antibiotics again after.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: UTI; This is a spontaneous report from a contactable consumer or other non hcp.     A female patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose single for covid-19 immunisation. The patient medical history and concomitant was not reported. It was reported that, on an unspecified date, the patient experienced urinary tract infection with outcome of unknown. Therapeutic measures were taken antibiotics as a result of uti (urinary tract infection).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Heart rate, Hypotension, Pain in extremity
Clinical narrative: Rapid heartbeat; Chills; Sore arm; My entire left arm was sore; low blood pressure and my blood pressure was 81/51; This is a spontaneous report from a contactable consumer or other non hcp. An 88-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 05Mar2021 14:20 (Batch/Lot Number: EN6198; Expiration Date: Jun2021) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included atrial fibrillation from an unknown date , gastrointestinal disorder from an unknown date. Concomitant medication(s) included apixaban (ELIQUIS) taken for anticoagulant therapy, start and stop date were not reported.  The patient experienced rapid heartbeat, chills, sore arm, His entire left arm was sore, low blood pressure and his blood pressure was 81/51.  The patient underwent lab tests and procedures which included blood pressure measurement: low on blood pressure measurement: 81/51 on heart rate: 60 heart rate: rapid  83. Therapeutic measures were taken as a result of rapid heartbeat with Diltiazem. The outcome of the events was unknown.  Additional Context: Consumer stated "I am calling I had the Pfizer vaccine on 05Mar2021 and I have a heart condition and I am calling to report a side effect that occurred about 11 hours, I became aware about a side effect of rapid heartbeat for about 11 hours, it was during the night. Is this the number where I can (incomplete sentence). I wanted to know if this is a common adverse event, side effect?"  When confirmed the consumer wanted to report the side effects, consumer stated, "Yes I wanted to report the side effect, I have atrial fibrillation and I take medication for that and 11 hours after my first vaccine I had rapid heartbeat even though I had medicine (Unspecified Medication) in my blood stream. I take medicine 24/7 to control, to prevent rapid heartbeat. Usually my heart rate would be, and this was during the night I woke up and it was my pulse was 83 and that is very rapid for me especially since I am under the influence of the heart medicine (Unspecified Medication) to keep it down. Usually that time at night my heart rate would be about 60 and I had to take additional heart pills during for about 12 hours (further clarification unknown)." When informed the role of Pfizer Drug Safety, consumer stated, "But you don't, do you have any feedback or response from all this massive inoculation as to whether this is the, it was not a sudden fast heart rate and it was not sudden because I am under the medication 24/7." Consumer was informed about Pfizer Medical Information and offered the number. Consumer was provided with the number of Pfizer Medical Information # and was requested to select option 3, timings as and 8 am to 11 pm Monday to Sunday as per (EST). Email: Consumer stated, "I don't, the device is broken."   No follow-up attempts are Possible. No further information is expected