chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vomiting
Clinical narrative: sore arm; tired; headache; throw up; This is a spontaneous report from a contactable consumer, the patient. A 80-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) into left arm on 19Mar2021 at 10:30 (at the age of 80-years-old) as single dose for COVID-19 immunisation. The patient's medical history included open heart surgery. The patient's concomitant medications included atorvastatin 20 mg (MANUFACTURER UNKNOWN), levothyroxine 100 mcg (MANUFACTURER UNKNOWN) for and multivitamins (MANUFACTURER UNKNOWN) all for an unknown indication from an unknown date. The patient had an allergy towards amoxicillin. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been diagnosed with COVID-19. On 20Mar2021 at 07:00, the patient experienced sore arm, tiredness, throw up and headache. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events pain in arm, tiredness, throw up and headache was recovered on an unknown date. No follow-up attempts possible. No further information expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: left arm numbness; tingly; muscle aches; This is a spontaneous report from a non-contactable other healthcare professional. An 18-year-old female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE BIONTECH, Lot number: EN6207) via an unspecified route of administration on 18Mar2021 (at the age of 18-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 18Mar2021, during 15-minute waiting period after the vaccination, the patient experienced left arm numbness and tingly. The patient denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, light-headedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient also complained of muscle aches. The patient was treated with water and she had an excellent response to the treatment. The patient was stable to go home and follow up with primary care physician. The clinical outcome of the events arm numbness, tingly and muscle ache were unknown at the time of report.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Pyrexia, Vomiting
Clinical narrative: Fever; Flu like symptoms; Swollen lymph nodes; Threw up; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via unspecified route of administration in left arm on 17Mar2021 at 18:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. 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 24Feb2021 at 18:00 (at the age of 24-year-old) as a single dose for COVID-19 immunisation. The patient did not have any other medical history and any known 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 been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included LEXAPRO (escitalopram oxalate), metformin, YAZ (drospirenone, ethinylestradiol betadex clathrate), ZYRTEC (cetirizine hydrochloride), Vitamin b12 (cyanocobalamin), Vitamin d3 (colecalciferol), all taken for unknown indications from unknown dates. On 18Mar2021 at 05:00, 11 hours after vaccination, the patient threw up and had fever and flu like symptoms for the following 18 hours at 23:00 and also swollen lymph nodes. The patient did not receive treatment for vomiting, fever, flu like symptoms and swollen lymph nodes. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of vomiting, fever, flu like symptoms and swollen lymph nodes was recovered on an unspecified date.   Information about lot/ batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: concomitant drug updated, event onset time for events fever, flu like symptoms and swollen lymph nodes updated to 18Mar2021 23:00 and narrative updated accordingly.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Trigeminal neuralgia
Clinical narrative: the patient had trigeminal neuralgia real fast, like the reporter, and got worse with the second dose; This is a spontaneous report from a contactable consumer (patient's daughter). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: unknown and Expiration date: unknown) via an unspecified route of administration on an unspecified date in Jan2021 (reported as near the middle or end of January) (at the age of 61 years old) as dose 1, single for COVID-19 immunisation. The patient also received BNT162B2 (Lot number: unknown and Expiration date: unknown) via an unspecified route of administration on an unspecified date in Feb2021 (reported as the middle or end of February) (at the age of 61 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history included thyroid condition (patient had her thyroid removed on an unspecified date or when the reporter was like 8, about 20 years ago), and COVID-19 on an unspecified date in 2020 (patient had COVID before the end of Thanksgiving). Concomitant medications included levothyroxine sodium (SYNTHROID) for thyroid condition. The patient previously received shingles shot on an unspecified date in 2020 (the patient got the first shingles shot last year, at least over 8 months ago, but the patient didn't get the second dose) and flu shot (patient got the flu shot around the same time with the reporter) for immunisation. On an unspecified date in Jan2021, the patient had trigeminal neuralgia real fast, like the reporter, and got worse with the second dose. It wasn't known if it was shingles or what until they diagnosed that. The reporter claims that her mother never had symptoms before, and they started with the first dose and got worse with the second dose and claims that it became chronic neuralgia. It was reported that the symptoms happened the same day as the first dose, and then symptoms for the second immediately got worse. The reported events lead to a physician office visit. The patient took paracetamol (TYLENOL) and ibuprofen (ADVIL) as treatment. The patient was previously on naproxen sodium (ALEVE) but it gave her an upset stomach so she switched to paracetamol (the strong dose, the 8 hour one). The patient's doctor prescribed her a pain reliever. The reporter thinks it was possibly gabapentin and doesn't know if that was to help the patient cope with the pain. The patient started taking it a week ago but was not helping. The reporter's seriousness criteria for COVID-19 vaccination and trigeminal neuralgia was not specified. The patient has not recovered from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sharp pain when got the injection which continued for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN via an unspecified route of administration in left arm on 21Mar2021 at 10:00 (at the age of 50-years-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 food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested positive for COVID-19. On 21Mar2021, the patient experienced sharp pain when got the injection which continued for 3 days (First day after injection couldn't raise her left arm by the end of the day). The events had not resulted in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. The patient had not received any treatment for events. The clinical outcome of event sharp pain when got the injection which continued for 3 days was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Tinnitus
Clinical narrative: increased blood pressure; profound tinnitus; This is a spontaneous report from a contactable nurse (patient). A 58-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (Age at vaccination was 58 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included gastrooesophageal reflux disease (GERD) from an unknown date and unknown if ongoing. No known allergies reported. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: el4236), via intramuscular in right arm on an unspecified date in Jan2021 at 08:00 AM. The patient was not received other vaccine in four weeks and other medications in two weeks. The patient not had Covid prior vaccination and not Covid tested post vaccination. On 11Feb2021 at 12:00 AM, the patient experienced increased blood pressure and profound tinnitus. The report was assessed as non serious. Outcome of the events was not recovered.  Information about lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Blood pressure measurement, Blood test, Dizziness, Epistaxis
Clinical narrative: Lightheaded; Fatigued/ very tired; Nosebleed; Sweaty feet; intense dreams; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 08:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was allergic to unspecified 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 prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Mar2021 at 08:00, after the injection the patient felt lightheaded and fatigued. The patient waited and monitored for 45 minutes before leaving. The patient had breakfast afterwards but very tired, went home and slept solid for 3 hours with intense dreams. The patient slept well the night before. The patient felt better as the day progressed. On 22Mar2021, at night, the patient went to bed early and woke up with a nosebleed, blood pooled in mouth from the nose bleed and sweaty feet. The patient underwent lab test which included blood test on an unknown date in Feb2021 and the result showed negative. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. Therapeutic measures taken for the adverse events included water and blood pressure check (result not provided). The clinical outcome of events lightheaded, fatigue, nosebleed, intense dreams and sweaty feet was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis
Clinical narrative: Lightheaded; Fatigued/ very tired; Nosebleed; Sweaty feet; intense dreams; This is a spontaneous report received from a contactable consumer, the patient. A 57-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP6955) via an unspecified route of administration in the left arm on 22Mar2021 at 08:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was allergic to unspecified 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 prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19. On 22Mar2021 at 08:00, after the injection the patient felt lightheaded and fatigued. The patient waited and monitored for 45 minutes before leaving. The patient had breakfast afterwards but very tired, went home and slept solid for 3 hours with intense dreams. The patient slept well the night before. The patient felt better as the day progressed. On 22Mar2021, at night, the patient went to bed early and woke up with a nosebleed, blood pooled in mouth from the nose bleed and sweaty feet. The patient underwent lab test which included blood test on an unknown date in Feb2021 and the result showed negative. The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. Therapeutic measures taken for the adverse events included water and blood pressure check (result not provided). The clinical outcome of events lightheaded, fatigue, nosebleed, intense dreams and sweaty feet was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Fatigue, Headache, Lymph node pain
Clinical narrative: Pain and lymph node swelling in right side neck; pain in armpit; General body soreness; discomfort; Soreness in right arm; lymph node swelling in right side neck and armpit; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8727,) via an unspecified route of administration in the right arm on 22Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had a history of allergy to codeine. The concomitant medications were not reported. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 22Mar2021, the patient experienced soreness in right arm, pain and lymph node swelling in right side neck and armpit, general body soreness, discomfort, headache, and fatigue. The patient did not receive any treatment for reported events. The clinical outcome of pain in arm, swollen lymph nodes, lymph node pain, armpit pain, general body pain, discomfort, headache and fatigue was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity
Clinical narrative: Pain and lymph node swelling in right side neck; pain in armpit; General body soreness; discomfort; Soreness in right arm; lymph node swelling in right side neck and armpit; headache; fatigue; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: er8727,) via an unspecified route of administration in the right arm on 22Mar2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient had a history of allergy to codeine. The concomitant medications were not reported. The patient did not receive any other medications or vaccines within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 22Mar2021, the patient experienced soreness in right arm, pain and lymph node swelling in right side neck and armpit, general body soreness, discomfort, headache, and fatigue. The patient did not receive any treatment for reported events. The clinical outcome of pain in arm, swollen lymph nodes, lymph node pain, armpit pain, general body pain, discomfort, headache and fatigue was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache
Clinical narrative: Dizzy; Headache; This is a spontaneous report received from a contactable consumer, the patient. A 17-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) in the left arm on 22Mar2021 (at the age of 17-years-old) as a single dose for COVID-19 immunisation. Medical history included alopecia and eczema. The patient was allergic to peanuts, tree nuts, sesame, shellfish, gluten, corn. Concomitant medication included ALLEGRA, PROBIOTIC, unspecified birth control pill and biotin. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 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 22Mar2021, within 20 minutes of vaccination, the patient was dizzy and had a headache. The event of dizziness lasted for a couple of hours. The patient did not receive treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of event dizziness and headache was resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: fever shot to 103; Vomiting; Headache; Body pain; Arm swoll to double its size from shoulder to elbow; Pain in my feet; Broke blood vessels in my upper body; Dry heaving.; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unknown route of administration on right arm the 20Mar2021 at 10:15 (age at vaccination 49-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took VIOXX, LEVEQUIN and DEMEROL; developed allergy for all the drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 10:30 (within 15 minutes), the patient experienced nausea, overwhelming headache, body pain, right arm was swollen to double its size from shoulder to elbow and the patient broke her blood vessels in upper body from dry heaving. At 11:00, nausea led to vomiting and the patient could not hold any liquids. At 12:30, the patient had fever 103 (units unspecified). The events of vomiting and nausea were debilitating for the next 24 hours and patient's overall body pain became unbearable. The major effects lasted more than 24 hours. On an unknown date in Mar2021 (72 hours after vaccination), the patient was still feeling nauseated, body pain was still off and on, and patient felt she was having flu at that point and stated first 24 hours was a nightmare. Therapeutic measures taken as results of events and included treatment with BENEDRYL or TYLENOL, but she couldn't hold down anything. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of events nausea, vomiting, headache, body pain, arm swollen, pain in feet, fever, Injury to blood vessel of head and neck and dry heaves were recovered with sequalae on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Retching, Vascular injury, Vomiting
Clinical narrative: fever shot to 103; Vomiting; Headache; Body pain; Arm swoll to double its size from shoulder to elbow; Pain in my feet; Broke blood vessels in my upper body; Dry heaving.; Nausea; This is a spontaneous report received from a contactable consumer, the patient. A 49-years-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206) via an unknown route of administration on right arm the 20Mar2021 at 10:15 (age at vaccination 49-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriatic arthritis. The patient received unspecified medications within 2 weeks prior to the COVID-19 vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient previously took VIOXX, LEVEQUIN and DEMEROL; developed allergy for all the drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 10:30 (within 15 minutes), the patient experienced nausea, overwhelming headache, body pain, right arm was swollen to double its size from shoulder to elbow and the patient broke her blood vessels in upper body from dry heaving. At 11:00, nausea led to vomiting and the patient could not hold any liquids. At 12:30, the patient had fever 103 (units unspecified). The events of vomiting and nausea were debilitating for the next 24 hours and patient's overall body pain became unbearable. The major effects lasted more than 24 hours. On an unknown date in Mar2021 (72 hours after vaccination), the patient was still feeling nauseated, body pain was still off and on, and patient felt she was having flu at that point and stated first 24 hours was a nightmare. Therapeutic measures taken as results of events and included treatment with BENEDRYL or TYLENOL, but she couldn't hold down anything. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of events nausea, vomiting, headache, body pain, arm swollen, pain in feet, fever, Injury to blood vessel of head and neck and dry heaves were recovered with sequalae on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: 4 minute Mild nose bleed.; This is a spontaneous report received from a contactable consumer, the patient. A 65-years-old unspecified aged patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6203) via an unspecified route of administration in the right arm on 08Mar2021 at 11:15 for COVID-19 immunisation. The patient medical history included hyperlipidemia, hypertension. The patient concomitant medication included Lisinopril (MANUFACTURER UNKNOWN), Amlodipine (MANUFACTURER UNKNOWN), Atorvastatin (MANUFACTURER UNKNOWN), Vit d3 (MANUFACTURER UNKNOWN) and coq1. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient been not tested for COVID-19. On 14Mar2021, at 20:30, on 6th day post vaccine the patient experienced spontaneous 4 minutes of mild nose bleed, it was his 1st occurrence in lifetime. No other sxs and he did not contact MD. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of nose bleed was recovered an unknown date.   No follow-up attempts possible. No further information expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: A small rash has formed on my neck that is somewhat painful, incredibly dry rash; very red, rash; This is a spontaneous report received from a contactable consumer, the patient. A 23-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6203) via an unspecified route of administration in the left arm on 17Mar2021 at 11:00 (at the age of 23-years-old) for COVID-19 immunisation. Medical history included obesity. The patient received birth control, iron multivitamin (MANUFACTURER UNKNOWN) within 2 weeks of vaccination. The patient did not receive any vaccination within four weeks prior to the COVID-19 vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 17Mar2021, the patient experienced small rash formed on his neck that is somewhat painful, very red, and became incredibly dry. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of painful dry rash neck and red rash was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Thirst
Clinical narrative: rash started on the back of my neck and the next day it was on my stomach and lower back.; very thirsty; This is a spontaneous report received from a contactable consumer, the patient. A 59-years-old non-pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via an unspecified route of administration in left arm on 16Mar2021 at 10:30 (at the age of 59 years old) as single dose, for COVID-19 immunisation. Medical history was reported as none. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. Concomitant medication included tuna oil (MANUFACTURER UNKNOWN), loratadine; pseudoephedrine (CLARITIN D 12 hour), ascorbic acid (VITAMIN C), and multiple vitamin (MANUFACTURER UNKNOWN) all drug started on an unknown date, and taken for unknown indications. The patient did not receive any other vaccines within 4 weeks, prior to the vaccination. On 22Mar2021 at 07:00, the patient experienced rash that started on the back of her neck and the next day it was on her stomach and lower back. Right after the vaccine, for approximately 6 days she was very thirsty (could not get enough water). The adverse event did not result in doctor or other healthcare professional office or clinic visit or emergency room visit. The patient did not receive any treatment for events. The clinical outcome of events generalized rash and very thirst were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dry mouth, Dyspnoea, Fatigue, Feeling abnormal
Clinical narrative: felt like dry lips; Dry mouth; Really thirsty; top lip was swollen; lips, tip of nose, and throat feel tingly now; felt tingly and dry underneath my lip; throat feel tingly; soreness on my arm; tightness on my chest with difficulty breathing; tightness on my chest with difficulty breathing; my mind was foggy.; it was hard for me to walk and I was incredibly tired; massive headache on my forehead; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time 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 did not receive other medications within 2 weeks of vaccination. On 20Mar2021 at 10:00 approx. 20 seconds after the vaccine, the patient experienced massive headache on her forehead, shortly after that felt like a huge load was pushing her back into her seat. The patient wasn't able to keep conversations and her mind was foggy. It was hard for her to walk and she was incredibly tired. She slept most of the afternoon. At night before going to bed (at 21:00), she had a tightness on her chest with difficulty breathing and this was on Saturday. On 21Mar2021 (Sunday), all she had was soreness on her arm. On 23Mar2021 (Tuesday), she woke up around 4:10 with a dry mouth and what felt like dry lips. She was really thirsty and grabbed a cup of water and used the restroom. When she was washing my hands, she saw her face and noticed the top lip was swollen. It was so big that it overlapped her bottom lip. She felt tingly and dry underneath the lip. The patient continued to drink water and the swelling decreased not completely but it did go down. On 23Mar2021 at 09:07, the swelling decreased. The patient reported that the lips, tip of nose, and throat felt tingly now. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, swollen lips, tingling lips, tingling and tingling throat. The clinical outcome of the event swollen lips was recovering while that of forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, tingling lips, tingling and tingling throat was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip dry, Lip swelling, Pain in extremity, Paraesthesia
Clinical narrative: felt like dry lips; Dry mouth; Really thirsty; top lip was swollen; lips, tip of nose, and throat feel tingly now; felt tingly and dry underneath my lip; throat feel tingly; soreness on my arm; tightness on my chest with difficulty breathing; tightness on my chest with difficulty breathing; my mind was foggy.; it was hard for me to walk and I was incredibly tired; massive headache on my forehead; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time 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 did not receive other medications within 2 weeks of vaccination. On 20Mar2021 at 10:00 approx. 20 seconds after the vaccine, the patient experienced massive headache on her forehead, shortly after that felt like a huge load was pushing her back into her seat. The patient wasn't able to keep conversations and her mind was foggy. It was hard for her to walk and she was incredibly tired. She slept most of the afternoon. At night before going to bed (at 21:00), she had a tightness on her chest with difficulty breathing and this was on Saturday. On 21Mar2021 (Sunday), all she had was soreness on her arm. On 23Mar2021 (Tuesday), she woke up around 4:10 with a dry mouth and what felt like dry lips. She was really thirsty and grabbed a cup of water and used the restroom. When she was washing my hands, she saw her face and noticed the top lip was swollen. It was so big that it overlapped her bottom lip. She felt tingly and dry underneath the lip. The patient continued to drink water and the swelling decreased not completely but it did go down. On 23Mar2021 at 09:07, the swelling decreased. The patient reported that the lips, tip of nose, and throat felt tingly now. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, swollen lips, tingling lips, tingling and tingling throat. The clinical outcome of the event swollen lips was recovering while that of forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, tingling lips, tingling and tingling throat was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia, Thirst
Clinical narrative: felt like dry lips; Dry mouth; Really thirsty; top lip was swollen; lips, tip of nose, and throat feel tingly now; felt tingly and dry underneath my lip; throat feel tingly; soreness on my arm; tightness on my chest with difficulty breathing; tightness on my chest with difficulty breathing; my mind was foggy.; it was hard for me to walk and I was incredibly tired; massive headache on my forehead; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534), via an unspecified route of administration in the left arm on 20Mar2021 at 10:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not have any allergies to medications, food, or other products. It was unknown if the patient was pregnant at the time 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 did not receive other medications within 2 weeks of vaccination. On 20Mar2021 at 10:00 approx. 20 seconds after the vaccine, the patient experienced massive headache on her forehead, shortly after that felt like a huge load was pushing her back into her seat. The patient wasn't able to keep conversations and her mind was foggy. It was hard for her to walk and she was incredibly tired. She slept most of the afternoon. At night before going to bed (at 21:00), she had a tightness on her chest with difficulty breathing and this was on Saturday. On 21Mar2021 (Sunday), all she had was soreness on her arm. On 23Mar2021 (Tuesday), she woke up around 4:10 with a dry mouth and what felt like dry lips. She was really thirsty and grabbed a cup of water and used the restroom. When she was washing my hands, she saw her face and noticed the top lip was swollen. It was so big that it overlapped her bottom lip. She felt tingly and dry underneath the lip. The patient continued to drink water and the swelling decreased not completely but it did go down. On 23Mar2021 at 09:07, the swelling decreased. The patient reported that the lips, tip of nose, and throat felt tingly now. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment for the events forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, swollen lips, tingling lips, tingling and tingling throat. The clinical outcome of the event swollen lips was recovering while that of forehead headache, foggy feeling in head, tiredness, chest tightness, difficulty breathing, pain in arm, dry mouth, dry lips, thirst, tingling lips, tingling and tingling throat was not recovered at the time of the report.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Swelling
Clinical narrative: Swelling on the left side of neck; Pain on the left side of neck; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 16Mar2021 at 11:45 (at the age of 43-years-old) as a single dose, for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 19Mar2021 at 09:00, the patient experienced swelling and pain on the left side of neck about half an inch below the jaw bone and extending back below ear. The patient did not receive any treatment for reported events. The adverse event 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 the events swelling on the left side of neck and pain on the left side of neck were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Fatigue, Pain
Clinical narrative: Chest pains; Fever; Chills; Aches; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in left arm on 21Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included hydrochlorothiazide (manufacturer unknown), omeprazole (manufacturer unknown) and trazodone (manufacturer unknown), all on unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN via unspecified route of administration in left arm on 28Feb2021 at 11:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient previously received levofloxacin (LEVOQUIN) (manufacturer unknown) for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 22Mar2021, patient experienced chest pains, fever, chills, aches, joint pain and fatigue. No therapeutic measures were taken for the reported events. The clinical outcome of the events all the events was recovering at the time of reporting.   Information about lot number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient age at first dose.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chest pains; Fever; Chills; Aches; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in left arm on 21Mar2021 at 11:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included hydrochlorothiazide (manufacturer unknown), omeprazole (manufacturer unknown) and trazodone (manufacturer unknown), all on unknown dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN via unspecified route of administration in left arm on 28Feb2021 at 11:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. The patient previously received levofloxacin (LEVOQUIN) (manufacturer unknown) for unspecified indication and experienced drug allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. On 22Mar2021, patient experienced chest pains, fever, chills, aches, joint pain and fatigue. No therapeutic measures were taken for the reported events. The clinical outcome of the events all the events was recovering at the time of reporting.   Information about lot number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient age at first dose.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Hyperhidrosis, Lethargy
Clinical narrative: Fever; Chills; Sweating; Body aches; muscle fatigue; Very rapid heart beat. Myresting is in the 60s, today is the 80-90s. I have stood up, walked a fewfeet, and sat back down and my heartrate was 110.; Lethargy; This is a spontaneous report from a non-contactable health care professional, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 22Mar2021 at 07:45 AM (at the age of 21-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any concomitant medication. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks, prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced lethargy on 22Mar2021. The patient experienced fever, chills, sweating, body aches, muscle fatigue and very rapid heartbeat on 23Mar2021 at 03:00 AM. It was also reported that usually when the patient woke up, his heart rate was at 40s and the morning was at the 60s. Resting heart rate was 60s, but it was at 80-90s following vaccination. When the patient stood up, walked a few feet, and sat back down the heart rate was 110 (unit and reference range was not provided). The events resulted in a visit to the doctor or other healthcare professional office/clinic. The patient did not receive any treatment for the events. The clinical outcome of lethargy, fever, chills, sweating, body aches, muscle fatigue and rapid heartbeat was recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle fatigue, Pain, Pyrexia
Clinical narrative: Fever; Chills; Sweating; Body aches; muscle fatigue; Very rapid heart beat. Myresting is in the 60s, today is the 80-90s. I have stood up, walked a fewfeet, and sat back down and my heartrate was 110.; Lethargy; This is a spontaneous report from a non-contactable health care professional, the patient. A 21-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6206), via an unspecified route of administration in the left arm on 22Mar2021 at 07:45 AM (at the age of 21-years-old), as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient did not have any concomitant medication. The patient was not allergic to medications, food and other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks, prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced lethargy on 22Mar2021. The patient experienced fever, chills, sweating, body aches, muscle fatigue and very rapid heartbeat on 23Mar2021 at 03:00 AM. It was also reported that usually when the patient woke up, his heart rate was at 40s and the morning was at the 60s. Resting heart rate was 60s, but it was at 80-90s following vaccination. When the patient stood up, walked a few feet, and sat back down the heart rate was 110 (unit and reference range was not provided). The events resulted in a visit to the doctor or other healthcare professional office/clinic. The patient did not receive any treatment for the events. The clinical outcome of lethargy, fever, chills, sweating, body aches, muscle fatigue and rapid heartbeat was recovering at the time of reporting. No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Headache, Insomnia
Clinical narrative: Fever; chills; headache; muscle aches; joint pain; nausea; unable to sleep; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the left arm on 22Mar2021 at 08:45 (at the age of 68-years-old), as a single dose for COVID-19 immunisation. Medical history included hypothyroid, hypertension and hypercholesterolemia. The patient had a history of allergy to doxycycline, fragrance, pollen and grasses. Concomitant medication included levothyroxine sodium (SYNTHROID), simvastatin (UNKNOWN MANUFACTURER), metoprolol (UNKNOWN MANUFACTURER) and cetirizine hydrochloride (ZYRETEC) and iron (UNKNOWN MANUFACTURER) all for unknown indication received within two weeks of vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6202) via an unspecified route of administration on 01Mar2021 at 09:00 (at the age of 68-years-old), 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 the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 22Mar2021 at 18:00, the patient experienced fever (101.5) (unspecified units), chills, headache, muscle aches, joint pain, nausea and unable to sleep. The patient did not receive treatment for the reported events. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events fever (101.5), chills, headache, muscle aches, joint pain, nausea and unable to sleep was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.