chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Lymph node pain, Lymphadenopathy, Pain in extremity
Clinical narrative: arm pain; light headedness; abdominal pain; swollen, tender lymph node left axillary area; swollen, tender lymph node left axillary area; This is a spontaneous report from a contactable nurse (patient). A 60-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK4176; expiration date: unknown), via an unspecified route of administration left arm on 08Jan2021 08:30 at a single dose for covid-19 immunization. The patient medical history was not reported. The patient has no known allergies. There were no concomitant medications. The patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK5730; expiration date: unknown), via an unspecified route of administration left arm on 18Dec2020 10:30 at a single dose for covid-19 immunization. The patient experienced arm pain, light headedness, abdominal pain and swollen, tender lymph node left axillary area on 08Jan2021 04:00 PM. The patient received treatment for the adverse events includes acetaminophen (TYLENOL) and ibuprofen (MOTRIN). The outcome of the events was recovered on in Jan2021.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Influenza like illness
Clinical narrative: chills; body aches/aching all over; headaches; tired; not resting well last night/didn't rest well last night; a temperature of 99.9F/ fever; where he got the shot was achy; feels like he has a bad case of the flu; tremoring; muscles are achy; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date: unknown), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol since 90s and was taking medication to keep it down, and ongoing neuropathy in the feet back in the 90s. Patient seemed to be okay after the vaccination until he didn't rest well last night on 13Jan2021. The morning of 14Jan2021, he had chills and was aching all over. He has a headache, and he was pretty tired on 14Jan2021. His temperature was 99.9. and wanted to make sure he was okay. They gave him the sheet of side effects but was wondering how long it was going to last. He also had fever and chills on Jan2021. He has been just resting all day long which was all he felt like doing. Patient felt he has a bad case of the flu. When his chills started, he noticed he was tremoring and shaking and his muscles are achy on Jan2021. He usually waits until his temperature is over 100 to take something and noticed where he got the shot was achy on Jan2021. During the night he went to aching more. He was not too excited about getting up and doing anything now. He was tired on 14Jan2021, because he didn't rest well last night and slept in late today. He finally got around, and ate cereal and stuff. He has just been sitting. He would still get the second vaccine, which was not exciting. Outcome of the events aching all over, headaches, and tired are not recovered while for the remaining events was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Restlessness, Tremor
Clinical narrative: chills; body aches/aching all over; headaches; tired; not resting well last night/didn't rest well last night; a temperature of 99.9F/ fever; where he got the shot was achy; feels like he has a bad case of the flu; tremoring; muscles are achy; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date: unknown), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol since 90s and was taking medication to keep it down, and ongoing neuropathy in the feet back in the 90s. Patient seemed to be okay after the vaccination until he didn't rest well last night on 13Jan2021. The morning of 14Jan2021, he had chills and was aching all over. He has a headache, and he was pretty tired on 14Jan2021. His temperature was 99.9. and wanted to make sure he was okay. They gave him the sheet of side effects but was wondering how long it was going to last. He also had fever and chills on Jan2021. He has been just resting all day long which was all he felt like doing. Patient felt he has a bad case of the flu. When his chills started, he noticed he was tremoring and shaking and his muscles are achy on Jan2021. He usually waits until his temperature is over 100 to take something and noticed where he got the shot was achy on Jan2021. During the night he went to aching more. He was not too excited about getting up and doing anything now. He was tired on 14Jan2021, because he didn't rest well last night and slept in late today. He finally got around, and ate cereal and stuff. He has just been sitting. He would still get the second vaccine, which was not exciting. Outcome of the events aching all over, headaches, and tired are not recovered while for the remaining events was unknown.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: chills; body aches/aching all over; headaches; tired; not resting well last night/didn't rest well last night; a temperature of 99.9F/ fever; where he got the shot was achy; feels like he has a bad case of the flu; tremoring; muscles are achy; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3302 and expiry date: unknown), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history included ongoing high cholesterol since 90s and was taking medication to keep it down, and ongoing neuropathy in the feet back in the 90s. Patient seemed to be okay after the vaccination until he didn't rest well last night on 13Jan2021. The morning of 14Jan2021, he had chills and was aching all over. He has a headache, and he was pretty tired on 14Jan2021. His temperature was 99.9. and wanted to make sure he was okay. They gave him the sheet of side effects but was wondering how long it was going to last. He also had fever and chills on Jan2021. He has been just resting all day long which was all he felt like doing. Patient felt he has a bad case of the flu. When his chills started, he noticed he was tremoring and shaking and his muscles are achy on Jan2021. He usually waits until his temperature is over 100 to take something and noticed where he got the shot was achy on Jan2021. During the night he went to aching more. He was not too excited about getting up and doing anything now. He was tired on 14Jan2021, because he didn't rest well last night and slept in late today. He finally got around, and ate cereal and stuff. He has just been sitting. He would still get the second vaccine, which was not exciting. Outcome of the events aching all over, headaches, and tired are not recovered while for the remaining events was unknown.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Hypersomnia, Lacrimation increased, Nasal congestion
Clinical narrative: Watery drainage from her right eye; Nose feels full; congestion; Phlegm; Fever blister on her tongue (sore blister on the right side of her tongue); sores on her tongue; Feels a little weird; Dizzy or dizziness like vertigo (funny feeling like vertigo); Headache; Slept hard - she never sleeps that much; Drinking a lot of water; Fever; feverish; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, Expiration Date: 30Apr2021), via an unspecified route of administration, on 11Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history included colitis and diverticulitis (chronic; diagnosed years ago); and allergies. The patient's concomitant medications included chlordiazepoxide/ clidinium bromide (LIBRAX) for colitis, omeprazole (PROTONIX), levocabastine hydrochloride (ZYRTEC) for allergies, and cyanocobalamin (VITAMIN B12) for colitis. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899, Expiration Date: 31Mar2021) on 21Dec2020 for COVID-19 immunization and experienced a little sore on site; and varicella zoster vaccine (SHINGLES VACCINE) for immunization and it hurt and she got blisters at the injection side. The patient just got her second shot on Monday (11Jan2021) at 9 in morning. After a couple of hours (11 AM), the patient feels a little weird, dizzy or dizziness like vertigo (funny feeling like vertigo), and headache. That night, the patient took ibuprofen (MOTRIN) and paracetamol (TLENOL) and she just slept hard - she never sleeps that much, she is drinking a lot of water. The patient also had a fever that night and received treatment for this. On Tuesday (12Jan2021), the patient was okay but, in the evening, she started feeling feverish and has a fever blister on her tongue (sore blister on the right side of her tongue). The patient never had a fever blister before. Last night (13Jan2021), the patient was a little feverish, still has the sores on her tongue and she was having watery drainage from her right eye and her nose feels full; congestion and phlegm. The patient wanted to know if she should go to work tomorrow but was encouraged to reach out to a health care professional for medical advice. The patient asked health employee and they told her to call the company. Got the vaccine from work at a center. The patient recovered from "Dizzy or dizziness like vertigo (funny feeling like vertigo)" in Jan2021. The outcome of "Feels a little weird", "Headache", "Slept hard - she never sleeps that much", and "Drinking a lot of water" was unknown. The patient had not recovered from the remaining events.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Polydipsia, Productive cough, Pyrexia, Vertigo
Clinical narrative: Watery drainage from her right eye; Nose feels full; congestion; Phlegm; Fever blister on her tongue (sore blister on the right side of her tongue); sores on her tongue; Feels a little weird; Dizzy or dizziness like vertigo (funny feeling like vertigo); Headache; Slept hard - she never sleeps that much; Drinking a lot of water; Fever; feverish; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL1284, Expiration Date: 30Apr2021), via an unspecified route of administration, on 11Jan2021 at 09:00, at a single dose, for COVID-19 immunization. The patient's medical history included colitis and diverticulitis (chronic; diagnosed years ago); and allergies. The patient's concomitant medications included chlordiazepoxide/ clidinium bromide (LIBRAX) for colitis, omeprazole (PROTONIX), levocabastine hydrochloride (ZYRTEC) for allergies, and cyanocobalamin (VITAMIN B12) for colitis. The patient previously took the first dose of BNT162B2 (Lot Number: EH9899, Expiration Date: 31Mar2021) on 21Dec2020 for COVID-19 immunization and experienced a little sore on site; and varicella zoster vaccine (SHINGLES VACCINE) for immunization and it hurt and she got blisters at the injection side. The patient just got her second shot on Monday (11Jan2021) at 9 in morning. After a couple of hours (11 AM), the patient feels a little weird, dizzy or dizziness like vertigo (funny feeling like vertigo), and headache. That night, the patient took ibuprofen (MOTRIN) and paracetamol (TLENOL) and she just slept hard - she never sleeps that much, she is drinking a lot of water. The patient also had a fever that night and received treatment for this. On Tuesday (12Jan2021), the patient was okay but, in the evening, she started feeling feverish and has a fever blister on her tongue (sore blister on the right side of her tongue). The patient never had a fever blister before. Last night (13Jan2021), the patient was a little feverish, still has the sores on her tongue and she was having watery drainage from her right eye and her nose feels full; congestion and phlegm. The patient wanted to know if she should go to work tomorrow but was encouraged to reach out to a health care professional for medical advice. The patient asked health employee and they told her to call the company. Got the vaccine from work at a center. The patient recovered from "Dizzy or dizziness like vertigo (funny feeling like vertigo)" in Jan2021. The outcome of "Feels a little weird", "Headache", "Slept hard - she never sleeps that much", and "Drinking a lot of water" was unknown. The patient had not recovered from the remaining events.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Nausea, Swelling face
Clinical narrative: Face, neck, arms turned bright red; Face extremely swollen; Nausea; This is a spontaneous report from a contactable healthcare professional. A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142), intramuscular (left arm) on 12Jan2021 10:00 at a single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included lamotrigine. The patient experienced Face, neck, arms turned bright red, Face extremely swollen, Nausea; all on 12Jan2021 10:45 AM. The outcome of the events was recovering.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Fatigue; A visibly swollen lymph node in her neck; This is a spontaneous report from a contactable healthcare professional (the patient). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: KK9231, expiration date not reported), via an unspecified route of administration (reported left arm), on 13Jan2021 at 09:45 at a single dose for COVID-19 immunization. Medical history included psoriasis from an unknown date. Concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on 23Dec2020 on her left arm (lot number: EJ1685). After receiving the second dose of the vaccine on 13Jan2021 at 20:15, the patient experienced fatigue and a visibly swollen lymph node in her neck. The patient was recovering from the events. There was no treatment given for the events.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm was a little sore; This is a spontaneous report from a non-contactable consumer (reporter's husband). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history was not reported.  The patient's concomitant medications were not reported. The patient had her first dose too and her arm was a little sore but it felt better after her aerobics class and she was totally fine. The patient was recovering from the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate, Pain in extremity, Peripheral coldness
Clinical narrative: deltoid was still sore, but felt cold/entire arm and hand feels cold, worse when the area is rubbed; Deltoid still sore/soreness in the forearm; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ES1686), via an unspecified route of administration in the left arm on 04Jan2021 14:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D), probiotics, and elderberry [sambucus nigra]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's deltoid was still sore, but felt cold on day 3 (07Jan2021). By day 7 (11Jan2021), the entire arm and hand feels cold, worse when the area is rubbed. By day 8 (12Jan2021), the patient had soreness in the forearm and still unchanged at day 11. No weakness was noted. The patient had good pulses on Jan2021 and no visible change to the skin. No treatment was received for the adverse events. Outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood creatine phosphokinase normal, Blood immunoglobulin G, Blood immunoglobulin M, Feeling cold, Full blood count normal
Clinical narrative: deltoid was still sore, but felt cold/entire arm and hand feels cold, worse when the area is rubbed; Deltoid still sore/soreness in the forearm; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ES1686), via an unspecified route of administration in the left arm on 04Jan2021 14:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D), probiotics, and elderberry [sambucus nigra]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's deltoid was still sore, but felt cold on day 3 (07Jan2021). By day 7 (11Jan2021), the entire arm and hand feels cold, worse when the area is rubbed. By day 8 (12Jan2021), the patient had soreness in the forearm and still unchanged at day 11. No weakness was noted. The patient had good pulses on Jan2021 and no visible change to the skin. No treatment was received for the adverse events. Outcome of the events was not recovered.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site coldness, Injection site pain, Pain, Pain in extremity, Red blood cell sedimentation rate normal
Clinical narrative: deltoid was still sore, but felt cold/entire arm and hand feels cold, worse when the area is rubbed; Deltoid still sore/soreness in the forearm; This is a spontaneous report from a contactable other healthcare professional (patient). A 47-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: ES1686), via an unspecified route of administration in the left arm on 04Jan2021 14:45 at a single dose for COVID-19 immunization. There were no medical history. The patient was not pregnant at the time of vaccination. The patient had no known allergies to medications, food, or other products. Concomitant medications included colecalciferol (VITAMIN D), probiotics, and elderberry [sambucus nigra]. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient's deltoid was still sore, but felt cold on day 3 (07Jan2021). By day 7 (11Jan2021), the entire arm and hand feels cold, worse when the area is rubbed. By day 8 (12Jan2021), the patient had soreness in the forearm and still unchanged at day 11. No weakness was noted. The patient had good pulses on Jan2021 and no visible change to the skin. No treatment was received for the adverse events. Outcome of the events was not recovered.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on the belly; This is a spontaneous report from a contactable consumer.  An 80-year-old male patient (reporter's boss) received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EK9231) in the Hospital (a family member that works there and the worker's were allowed to pick one of their family members to give the vaccine to) via an unspecified route of administration on 10Jan2021 at 11:30 AM at a single dose on the left upper arm for COVID-19 immunization. The patient had no medical history. Concomitant medication included simvastatin (manufacturer unknown), dutasteride (manufacturer unknown) and montelukast (manufacturer unknown) all from an unknown date and unknown if ongoing. The reporter stated that her boss received the first dose on 10Jan2021 and developed a rash on the belly. She wanted to know if he could take the second dose as scheduled or if he needs to wait. He was scheduled in 3 weeks. He has a rash all over his belly and the doctor said it was like a reaction to the vaccine. She does not know if he has to go the ER or what. His primary care physician (PCP) ordered him Benadryl pills and ointment. The reporter confirmed that the patient was ordered both oral and ointment. The outcome of the event was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Lightheaded; Sore arm; This is a spontaneous report from a non-contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced lightheaded for an hour or so after and really sore arm about 12 hours later; both on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired than usual; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient experienced sore arm on day 1 and was a little more tired than usual on day 2, both on unspecified dates. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: soreness; stinging; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the dose on 31Dec2020, and experienced little soreness that lasted for 2 days and stinging that lasted for 2 hours. No other problems reported. The events resolved on an unspecified date.   Information about the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Aphthous ulcer, Body temperature, Body temperature increased, Fatigue, Gastrointestinal disorder
Clinical narrative: Arm pain; fatigue; slept nearly nonstop starting the night of injection; odd cheek canker; GI issues; increased temp; headache; body ache; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported, "Arm pain was worse than any previous immunizations I have had. Massive fatigue (slept nearly nonstop starting the night of injection), odd cheek canker, GI issues, increased temp, headache, body ache. Day 3 now, seem to be better!" on an unspecified date. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Somnolence
Clinical narrative: Arm pain; fatigue; slept nearly nonstop starting the night of injection; odd cheek canker; GI issues; increased temp; headache; body ache; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported, "Arm pain was worse than any previous immunizations I have had. Massive fatigue (slept nearly nonstop starting the night of injection), odd cheek canker, GI issues, increased temp, headache, body ache. Day 3 now, seem to be better!" on an unspecified date. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: colds; This is a spontaneous report from a contactable healthcare professional via a Pfizer sponsored program Pfizer First Connect and Medical information team. An adult female (reported as in her late 30s) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date, it was reported that the patient has colds but tested negative for COVID and was asking if she can get the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Pain in extremity
Clinical narrative: slept all day; very sore arm; woke up trembling with chills; terrible chills; headache/bad headache; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included major reaction to eating conch, and tested positive for COVID on 22Nov2020 There were no concomitant medications. Patient read that was not a good thing to do, to get the vaccine after only 2 months instead of 3 from diagnoses. When she had COVID she had major headache, chills, and diarrhea. After the vaccine she had had the same thing, terrible chills, bad headache and diarrhea on Jan2021. The side effects say that this was normal but she wants to know should she have waited the 90 days before getting the vaccine. Patient still had the headache and chills but she took an Imodium and the diarrhea was better. Patient had also fatigue in Jan2021,and slept all day yesterday (13Jan2021). She has had a very sore arm and at 2am she woke up trembling with chills on Jan2021. Outcome of the event chills and headache was not recovered, for diarrhea was recovering and for the remaining events was unknown. Patient had a major reaction to eating conch and wanted to make sure there was no shellfish involve in the vaccine.  Information on the batch/lot number has been requested.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Somnolence, Tremor
Clinical narrative: slept all day; very sore arm; woke up trembling with chills; terrible chills; headache/bad headache; fatigue; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 79-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on the left arm, on 12Jan2021 at a single dose for COVID-19 immunization. Medical history included major reaction to eating conch, and tested positive for COVID on 22Nov2020 There were no concomitant medications. Patient read that was not a good thing to do, to get the vaccine after only 2 months instead of 3 from diagnoses. When she had COVID she had major headache, chills, and diarrhea. After the vaccine she had had the same thing, terrible chills, bad headache and diarrhea on Jan2021. The side effects say that this was normal but she wants to know should she have waited the 90 days before getting the vaccine. Patient still had the headache and chills but she took an Imodium and the diarrhea was better. Patient had also fatigue in Jan2021,and slept all day yesterday (13Jan2021). She has had a very sore arm and at 2am she woke up trembling with chills on Jan2021. Outcome of the event chills and headache was not recovered, for diarrhea was recovering and for the remaining events was unknown. Patient had a major reaction to eating conch and wanted to make sure there was no shellfish involve in the vaccine.  Information on the batch/lot number has been requested.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer. An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3249, expiration date not reported) via an unspecified route of administration on 13Jan2021 15:00 at a single dose for COVID-19 immunization. Medical history included pernicious anemia from 2019 and ongoing (gets B12 shots). There were no concomitant medications. The reporter's mother had the Pfizer COVID vaccine at 3 o'clock in the afternoon of 13Jan2021. At 1 o'clock on 14Jan2021, she started experiencing dizziness. The caller's sister is with the patient as this time. The past 4 hours the patient has experienced dizziness. As she tried to get up, it gets worse. Outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: running a fever; This is a spontaneous report from a contactable consumer (patient's mother). A female patient of an unspecified age (age: 19, units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown), via an unspecified route of administration, on 09Jan2021, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's mother stated that the patient got the second dose of the Covid-19 vaccine on Saturday, 09Jan2021. The patient has been running a fever since possibly Saturday night 09Jan2021, but definitely since Sunday morning. The fever was mostly in the morning and at night around 7-8 pm. Fever in the morning lasts until 10 -11 am. The mother added that today was the first day the fever has lasted all day, and the patient had the fever at 3PM. The mother wanted to know if this was a typical response to the vaccine (i.e. the duration of the fever). The mother was concerned about the duration of the fever and she has given the patient ibuprofen and Tylenol. The mother asked for herself if she can use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The mother was responded per the interim guidelines, "Antipyretic or analgesic medications (e.g., acetaminophen, non-steroidal anti-inflammatory drugs) may be taken for the treatment of post-vaccination local or systemic symptoms, if medically appropriate. However, routine prophylactic administration of these medications for the purpose of preventing post-vaccination symptoms is not currently recommended, as information on the impact of such use on Pfizer-BioNTech COVID-19 vaccine-induced antibody responses is not available at this time." The mother was told to discuss this with her healthcare provider. The outcome of the event was not recovered.  Information about the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Vaccination site nodule, Vaccination site pain
Clinical narrative: Arm sore at injection site; Hot to touch at injection site; Knot at injection site; Slight fatigue; Joint pain worse than normal; Occasional headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 12Jan2021 at 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included rheumatoid arthritis, eczema, depression, anxiety, slipped disc in back, overweight, and allergies to sulfa and latex. The patient had unspecified concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 (10:00 AM), for COVID-19 immunization (left arm). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 13Jan2021 at 4 AM, the patient experienced arm sore, hot to touch, and knot at injection site; slight fatigue; joint pain was worse than normal; and occasional headache. No treatment was administered for the events. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Arm sore at injection site; Hot to touch at injection site; Knot at injection site; Slight fatigue; Joint pain worse than normal; Occasional headache; This is a spontaneous report from a contactable nurse (patient). A 42-year-old female patient (non-pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3248), via an unspecified route of administration in left arm, on 12Jan2021 at 10:30, at a single dose, for COVID-19 immunization. The patient's medical history included rheumatoid arthritis, eczema, depression, anxiety, slipped disc in back, overweight, and allergies to sulfa and latex. The patient had unspecified concomitant medications. The patient previously took the first dose of BNT162B2 (Lot Number: EJ1685) on 21Dec2020 (10:00 AM), for COVID-19 immunization (left arm). The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital facility. On 13Jan2021 at 4 AM, the patient experienced arm sore, hot to touch, and knot at injection site; slight fatigue; joint pain was worse than normal; and occasional headache. No treatment was administered for the events. The patient has not been tested for COVID-19 post-vaccination. The patient had not recovered from the events.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site pain
Clinical narrative: Fever/Temperature running 99-100 during the day and running 101-102 for 6 nights now; Sore arm the first day; This is a spontaneous report received from a contactable nurse (who is also the patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142, expiry date: unknown), via an unspecified route of administration in the left arm, on 08Jan2021 11:00, at single dose, for covid-19 immunization, in the hospital. Medical history included asthma, Raynaud's phenomenon, eczema, environmental allergies, and COVID-19 (prior to vaccination). The patient is not pregnant. Concomitant medication included ergocalciferol (VIT D), calcium, ascorbic acid (VIT C), thiamine and zinc. The patient did not receive other vaccines in four weeks. The patient experienced sore arm the first day, on 09Jan2021. Fever started about 30 hours after injection, on 09Jan2021 at 17:00. Her temperature was running 99-100 during the day and running 101-102 for 6 nights now. The patient did not receive treatment for the events. The patient was not tested for COVID-19 post vaccination. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that after receiving the first dose of the vaccine, she experienced an allergic reaction on an unspecified date. She wanted to know if she should still receive the second dose despite this. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Hypersensitivity, Pain
Clinical narrative: Had an allergic reaction with Prevnar 13; The back of his legs started aching/his whole middle extremities were doing the same thing/it went down his arms and came back up; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received second dose of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, lot number and expiry date not reported), via an unspecified route of administration on 20Oct2020 at a single dose for immunization. The patient's medical history was not reported. There were no concomitant medications. Patient previously had the Pneumonia shot as immunization on an unknown date (first dose) (tradename unspecified, reported as Pfizer pneumonia vaccine). On 20Oct2020, patient had an allergic reaction with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) and was asking if he was safe to have the COVID 19 vaccine and will not have any allergic reaction as he had with pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein). Patient was asking for the ingredients of the vaccine. Received call from patient regarding the Pfizer COVID vaccine and Pneumonia shot. He had the second pneumonia shot Pfizer product on 20Oct2020, and never had a reaction before to a shot in his life. He left the doctor's office and walked outside. The back of his legs started aching (20Oct2020). By the time he got in the car, his whole middle extremities were doing the same thing. So, he parked his car and went back inside, then it went down his arms and came back up. It was pretty quick. They took his blood pressure and it was fine. He had no temperature, no rash, no nausea, no palpitations or anything like that. He just hurt like nothing he had before. It hurt more to sit down than stand up. They kept him an hour and he walked around and was fine. He went home and was fine. He did not have anything more happen. He was 72 years old and in good health. He doesn't take medications. He was reading that you should not get the Pfizer shot if you had an allergic reaction to a dose of the COVID or any ingredient in this vaccine. He talked to his doctor yesterday or again today (14Jan2021) and he suggested he call Pfizer to see what his options are and if should he get it. He did not wish to complete report and requested he be transferred to have his question answered. No further details provided. The outcome of the events allergic reaction and "the back of his legs started aching/his whole middle extremities were doing the same thing/it went down his arms and came back up" was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Gait disturbance, Ligament injury, Lymph gland infection, Skin disorder
Clinical narrative: Welt on her left groin; Maybe infected lymph node; Skin breakdown; Bruise; Could not walk on right foot; Ligament in back of right ankle felt injured; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in left arm, on 22Dec2020 at 10:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital. On 05Jan2021 at 04:45 PM (2 weeks after the first dose), the patient developed a welt on her left groin - maybe infected lymph node, and skin breakdown which later turned into a bruise that improved slowly with cleanse and bacitracin/ neomycin sulfate/ polymyxin B sulfate (NEOSPORIN). Though applied with bacitracin/ neomycin sulfate/ polymyxin B sulfate, the patient was still with visible bruising one week later. A few days later (Jan2021), the patient could not walk on right foot and ligament in back of right ankle felt injured. The patient was administered with the second dose of BNT162B2 (Lot Number: EL3302) on 12Jan2021 in left arm. The patient had not been tested for COVID-19 post-vaccination. The patient was recovering from "Skin breakdown". The patient had not recovered from the remaining events.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Welt on her left groin; Maybe infected lymph node; Skin breakdown; Bruise; Could not walk on right foot; Ligament in back of right ankle felt injured; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EH9899), intramuscular in left arm, on 22Dec2020 at 10:30, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior vaccination. No other vaccine was administered in four weeks. The vaccine was administered in a hospital. On 05Jan2021 at 04:45 PM (2 weeks after the first dose), the patient developed a welt on her left groin - maybe infected lymph node, and skin breakdown which later turned into a bruise that improved slowly with cleanse and bacitracin/ neomycin sulfate/ polymyxin B sulfate (NEOSPORIN). Though applied with bacitracin/ neomycin sulfate/ polymyxin B sulfate, the patient was still with visible bruising one week later. A few days later (Jan2021), the patient could not walk on right foot and ligament in back of right ankle felt injured. The patient was administered with the second dose of BNT162B2 (Lot Number: EL3302) on 12Jan2021 in left arm. The patient had not been tested for COVID-19 post-vaccination. The patient was recovering from "Skin breakdown". The patient had not recovered from the remaining events.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: nasal swab covid test result positive; nasal swab covid test result positive; This is a spontaneous report from a contactable Other HCP (for herself) reported that a 38-year-old female (not pregnant) received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot Number: EJ1685 and Expiration Date unknown) intramuscularly on 21Dec2020 01:45 PM at single dose (Left arm) for COVID-19 immunisation. The patient's medical history was known allergies: Penicillin, clindamycin, doxycycline. The concomitant medications was not reported. No other vaccine in four weeks. Patient experienced nasal swab covid test type post vaccination on 01Jan2021 was positive. The outcome was unknown with no treatment.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported nasal swab covid test positive based on the known safety profile. However the short duration of 10 days since the vaccine first dose is given it is unlikely patient would have fully developed immunity.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: urinary tract infection; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received the first dose of the Covid-19 vaccine and her second dose is scheduled on 26Jan2021. She has currently a urinary tract infection and she may receive an antibiotic (Nitrofurantoin) she would like to know if this would affect the vaccine. Patient also asked if it is okay if she does not take the second dose of the vaccine 21 days after the first dose, but a couple of weeks later. The outcome of the event was unknown. The event was assessed as non-serious.  Information about lot/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hot flush, Hypoaesthesia, Paraesthesia oral
Clinical narrative: Had a hot flash or flushing sensation; Had a hot flash or flushing sensation; Tingles and a decreased sensation around her lips/numbness and a tingling to her lips and nose; Numbness and a tingling to her lips and nose; This is a spontaneous report from a contactable nurse. A 34-year-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL3246), intramuscular (left arm) from 14Jan2021 16:30 to 14Jan2021 16:30 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported by the patient that 10 minutes after the injection, she had a hot flash or flushing sensation, as well as numbness and a tingling to her lips and nose. She explained having "tingles and a decreased sensation around her lips", which she also referred to as a "diminished sensation" during the interaction. She says that she has done no treatment for this. The outcome of the events was unknown.