chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: complete loss of taste and smell; complete loss of taste and smell; severe aching all over; chills; fever; severe headache; vomiting; nausea; severe fatigue; This is a spontaneous report from a contactable consumer (patient).A 51-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in right arm on 12Mar2021 at 15:15 (at the age of 51-years) as dose 1, single for covid-19 immunization. The patient received Facility type vaccine at Public Health Clinic/ Administration facility. The patient medical history included degenerative disc disease. The patient had known allergies to Penicillin. The patient was not pregnant at the time of vaccination. The patient's Concomitant medications included clarithromycin (CLARITIN [CLARITHROMYCIN]); ibuprofen (IBUPROFEN); ascorbic acid, cyanocobalamin, ergocalciferol, nicotinamide, pyridoxine hydrochloride, retinol, riboflavin, thiamine mononitrate (ONE-A-DAY); Iron Supplement. The patient had not received any other vaccine within 4 weeks. One day following vaccination on 13Mar2021 at 17:30, the patient had experienced severe aching all over, chills, fever, severe headache, vomiting, nausea, severe fatigue. Two days following vaccination on 14Mar2021, the patient also had complete loss of taste and smell. Three days following vaccination, headache, loss of taste and smell continued. The patient had not received any treatment for the events. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Fever; body aches; Headache/her head hurt too bad; This is a spontaneous report from a contactable consumer (patient). A 78-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6205; Expiration Date: 30Jun2021) via an unspecified route of administration on 10Mar2021 at 14:00 (at the age of 78-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. concomitant medications included normal vitamins. Historical vaccine included bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL9266; Expiration Date: 31May2021) via an unspecified route of administration administered in left arm on 17Feb2021 (at the age of 78-years-old) as dose 1, single for COVID-19 immunisation. Patient also took Pneumonia booster and she had swelling in the arm on unspecified date. . Additional vaccines administered on same date of the Pfizer Suspect was reported as none. Prior Vaccinations (within 4 weeks) was reported as none. On 11Mar2021 the patient experienced chills, fever, body aches, headache/her head hurt too bad, and it was too much stress to look up addresses and stuff. Everything was fine last night but all of the patients symptoms started early this morning. The patients fever is now 101.5. The patient underwent lab tests and procedures which included body temperature 101.5 on unknown date in 2021. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face
Clinical narrative: Swelling of my throat; Face also looks little bit swollen; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling of my throat on Mar2021, face also looks little bit swollen on Mar2021.Limited information was available over the call. The outcome of the events pharyngeal swelling, swelling face was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Heart rate, Heart rate increased, Pyrexia, Vaccination site swelling
Clinical narrative: fever of 99.8 (normal runs around 97.0 F); heart rate around 90 bpm (normal runs around 60-70); swollen spot around vaccine site about 2 inches in diameter; This is a spontaneous report from a non-contactable consumer or other non hcp (patient reported for herself). A 29-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in arm left on 08Mar2021 (at the age of 29-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On an unspecified date in 2021, the patient experienced fever of 99.8 (normal runs around 97.0 F), heart rate around 90 bpm (normal runs around 60-70), swollen spot around vaccine site about 2 inches in diameter. The patient underwent lab tests and procedures which included fever was 99.8 fahrenheit, normal runs around 97.0 fahrenheit; heart rate was 90 bpm, normal runs around 60-70. Outcome of all the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Swelling
Clinical narrative: swollen lymph node on Left collarbone.; Pain; swelling; This is a spontaneous report from a contactable other hcp. A 36-year-old non-pregnant female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 09Feb2021 (at the age of 36-year-old) as dose 2, single for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing if COVID prior vaccination Yes. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient tested covid prior vaccination. Patient did not test covid post vaccination. Patient previously took bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3249), dose 1 via Intramuscular, administered in Arm Left on 19Jan2021 09:00 as dose 1, single for COVID-19 immunisation. On 11Feb2021 07:00, the patient experienced lymphadenopathy, pain, swelling. 2 days after 2nd dose of vaccine, swollen lymph node on Left collarbone. Pain and swelling. Pain subsided within 4 days, swelling slowly subsided. After 3 weeks patient went to her PCP out of abundance of caution because the lymph node was still swollen. No pain. PCP recommended watchful waiting for 2 addl weeks. Patuent going on week 5 post-first vaccine and lymph node is still swollen and present. The outcome of the event lymphadenopathy was not recovered, Pain with outcome recovered and swelling with outcome recovering.  No follow-up attempts are possible; No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal dreams, Asthenia, Blood pressure measurement, Body temperature, Fatigue
Clinical narrative: Fairly sore arm; Woke up drenched in sweat and damp like you do feel after sweating; Felt clammy and damp like you do feel after sweating and having a fever; Lethargic; Feels weak, no energy and clammy sensation through body; Muscle pain in his back; Feels like he was dragging and drained; Feels tired all the time and doesn't feel like he should feel, wakes up feeling exhausted; Strangest most vivid dreams; This is a spontaneous report from a contactable consumer (patient).  A 68-years old male consumer (patient) reported himself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6198), via an unspecified route of administration, in left arm on 01Mar2021 (11 days ago he got first vaccination) (at the age of 68-years old) as dose 1, single for covid-19 immunization. Medical history included chronic back pain. Concomitant medications included blood pressure medications and medicinal marijuana for chronic back pain. He stated that 8 days before he got vaccination, he used to drink a couple of glasses wine, but he heard it could help so he stopped drinking and smoking the marijuana. On an unspecified date in 2021, he had a fairly sore arm he got the shot and went to bed and woke up drenched in sweat. He states that he changed clothes and moved to the other side of bed because his sheets were wet. He states that he woke up couple hours later and he damp, got up and took his temperature, it was 98.0, no fever at that time but felt clammy and damp like you do feel after sweating and having a fever. States that he also has muscle pain in his back, states he has dealt with it before, but it seems different. He states that he has been on ice packs all week. He states that at the time of report, he feels weak, dragging, lethargic, no energy and feels like after having a fever and sweated, just drained feeling and clammy sensation through body, he feels tired all the time and doesn't feel like he should feel. States that he has been feeling that way for the last 10 days. He has had the strangest most vivid dreams. Dinosaurs chasing him, snakes around his ankles, just crazy stuff, completely unusual and he wakes up and vividly remembers the dreams. States all week he has been having the dreams. States it was an unbelievable, strange reaction. Reporter stated that his second one was coming up and he said let's see how that works out and see if he returns to his normal self. He states he has been doing sun baths to charge his immune system and eating a hydrating, healthy diet, no meat in forty years, drinking fluid, hibiscus tea and meditates a lot and does yoga, just trying to get his body to feel energetic. The patient underwent labs tests and procedures which included blood pressure 115/65, heart rate 70, temperature 98.1 and 97.2, on 11Mar2021. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Hyperhidrosis, Lethargy, Myalgia
Clinical narrative: Fairly sore arm; Woke up drenched in sweat and damp like you do feel after sweating; Felt clammy and damp like you do feel after sweating and having a fever; Lethargic; Feels weak, no energy and clammy sensation through body; Muscle pain in his back; Feels like he was dragging and drained; Feels tired all the time and doesn't feel like he should feel, wakes up feeling exhausted; Strangest most vivid dreams; This is a spontaneous report from a contactable consumer (patient).  A 68-years old male consumer (patient) reported himself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6198), via an unspecified route of administration, in left arm on 01Mar2021 (11 days ago he got first vaccination) (at the age of 68-years old) as dose 1, single for covid-19 immunization. Medical history included chronic back pain. Concomitant medications included blood pressure medications and medicinal marijuana for chronic back pain. He stated that 8 days before he got vaccination, he used to drink a couple of glasses wine, but he heard it could help so he stopped drinking and smoking the marijuana. On an unspecified date in 2021, he had a fairly sore arm he got the shot and went to bed and woke up drenched in sweat. He states that he changed clothes and moved to the other side of bed because his sheets were wet. He states that he woke up couple hours later and he damp, got up and took his temperature, it was 98.0, no fever at that time but felt clammy and damp like you do feel after sweating and having a fever. States that he also has muscle pain in his back, states he has dealt with it before, but it seems different. He states that he has been on ice packs all week. He states that at the time of report, he feels weak, dragging, lethargic, no energy and feels like after having a fever and sweated, just drained feeling and clammy sensation through body, he feels tired all the time and doesn't feel like he should feel. States that he has been feeling that way for the last 10 days. He has had the strangest most vivid dreams. Dinosaurs chasing him, snakes around his ankles, just crazy stuff, completely unusual and he wakes up and vividly remembers the dreams. States all week he has been having the dreams. States it was an unbelievable, strange reaction. Reporter stated that his second one was coming up and he said let's see how that works out and see if he returns to his normal self. He states he has been doing sun baths to charge his immune system and eating a hydrating, healthy diet, no meat in forty years, drinking fluid, hibiscus tea and meditates a lot and does yoga, just trying to get his body to feel energetic. The patient underwent labs tests and procedures which included blood pressure 115/65, heart rate 70, temperature 98.1 and 97.2, on 11Mar2021. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fairly sore arm; Woke up drenched in sweat and damp like you do feel after sweating; Felt clammy and damp like you do feel after sweating and having a fever; Lethargic; Feels weak, no energy and clammy sensation through body; Muscle pain in his back; Feels like he was dragging and drained; Feels tired all the time and doesn't feel like he should feel, wakes up feeling exhausted; Strangest most vivid dreams; This is a spontaneous report from a contactable consumer (patient).  A 68-years old male consumer (patient) reported himself who received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number: EN6198), via an unspecified route of administration, in left arm on 01Mar2021 (11 days ago he got first vaccination) (at the age of 68-years old) as dose 1, single for covid-19 immunization. Medical history included chronic back pain. Concomitant medications included blood pressure medications and medicinal marijuana for chronic back pain. He stated that 8 days before he got vaccination, he used to drink a couple of glasses wine, but he heard it could help so he stopped drinking and smoking the marijuana. On an unspecified date in 2021, he had a fairly sore arm he got the shot and went to bed and woke up drenched in sweat. He states that he changed clothes and moved to the other side of bed because his sheets were wet. He states that he woke up couple hours later and he damp, got up and took his temperature, it was 98.0, no fever at that time but felt clammy and damp like you do feel after sweating and having a fever. States that he also has muscle pain in his back, states he has dealt with it before, but it seems different. He states that he has been on ice packs all week. He states that at the time of report, he feels weak, dragging, lethargic, no energy and feels like after having a fever and sweated, just drained feeling and clammy sensation through body, he feels tired all the time and doesn't feel like he should feel. States that he has been feeling that way for the last 10 days. He has had the strangest most vivid dreams. Dinosaurs chasing him, snakes around his ankles, just crazy stuff, completely unusual and he wakes up and vividly remembers the dreams. States all week he has been having the dreams. States it was an unbelievable, strange reaction. Reporter stated that his second one was coming up and he said let's see how that works out and see if he returns to his normal self. He states he has been doing sun baths to charge his immune system and eating a hydrating, healthy diet, no meat in forty years, drinking fluid, hibiscus tea and meditates a lot and does yoga, just trying to get his body to feel energetic. The patient underwent labs tests and procedures which included blood pressure 115/65, heart rate 70, temperature 98.1 and 97.2, on 11Mar2021. The outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Malaise
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Fever; Nausea; Feeling unwell; Vomited; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm, on 09Mar2021 14:00 (at the age of 69 years) as dose 2, single for COVID-19 immunization. Medical history included heart disease from 2016 and ongoing. There were no concomitant medications. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC was not reported, Batch/Lot number was not reported, Expiration date was not reported), via an unspecified route of administration, administered in right arm, on 14Feb2021 (at the age of 69 years) as dose 1, single for COVID-19 immunization. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior vaccination within 4 weeks. The patient received the second dose of the Covid-19 vaccine on Tuesday 09Mar2021. He was reporting on the side effects that he experienced. On 09Mar2021, patient experienced injection site pain. On 10Mar2021, patient experienced tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell, vomited. His temperature was first 99.1. At 6:00pm it was 100.1. At 7:00am on 11Mar2021 his temperature was 98.1 degrees. When he was nauseated, he threw up once and immediately felt better. He thinks the vaccine was starting to work. Adverse events experienced by patient did not require a visit to emergency or physician office. The outcome of injection site pain, tiredness, chills, nausea, feeling unwell, vomited was recovered on 10Mar2021. The outcome of headache, muscle pain, fever was recovered on 11Mar2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Fever; Nausea; Feeling unwell; Vomited; Injection site pain; This is a spontaneous report from a contactable consumer (patient). A 69-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in right arm, on 09Mar2021 14:00 (at the age of 69 years) as dose 2, single for COVID-19 immunization. Medical history included heart disease from 2016 and ongoing. There were no concomitant medications. Historical vaccine includes first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, NDC was not reported, Batch/Lot number was not reported, Expiration date was not reported), via an unspecified route of administration, administered in right arm, on 14Feb2021 (at the age of 69 years) as dose 1, single for COVID-19 immunization. The patient had no history of all previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient did not receive prior vaccination within 4 weeks. The patient received the second dose of the Covid-19 vaccine on Tuesday 09Mar2021. He was reporting on the side effects that he experienced. On 09Mar2021, patient experienced injection site pain. On 10Mar2021, patient experienced tiredness, headache, muscle pain, chills, fever, nausea, feeling unwell, vomited. His temperature was first 99.1. At 6:00pm it was 100.1. At 7:00am on 11Mar2021 his temperature was 98.1 degrees. When he was nauseated, he threw up once and immediately felt better. He thinks the vaccine was starting to work. Adverse events experienced by patient did not require a visit to emergency or physician office. The outcome of injection site pain, tiredness, chills, nausea, feeling unwell, vomited was recovered on 10Mar2021. The outcome of headache, muscle pain, fever was recovered on 11Mar2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Neck pain, Oropharyngeal pain, Tremor
Clinical narrative: shivers; pain in both shoulders and in his neck like aching pain; pain in both shoulders and in his neck like aching pain; a slight sore throat; he had shakes; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old male patient received bnt162b2 (BNT162B2), dose 1 (Lot Number: EN6206 expiry date was unknown) via an unspecified route of administration on 09Mar2021 11:18 as a single dose for covid-19 immunisation. Medical history included blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medication(s) included warfarin sodium (COUMADIN) taken for an unspecified indication, start and stop date were not reported. Additional Information for Concomitant Products Coumadin: He started taking that about 10 years ago. He takes 10 mg once daily 6 days per week and there is one day out of the week that he takes 7.5 mg once that day. Consumer was called about the got the Pfizer shot, he had the first one yesterday, he confirms the COVID 19 vaccine. He had it about 11:18 in the morning and had no side effects at that time but about 5 in the afternoon he started having pain in both shoulders and in his neck like an aching pain and he still has both of those and a slight sore throat. Then last night from about 9PM until midnight he had shaken and the shivers and turned over on his side and it went away in about hour or so, he doesn't have that any longer, but he still has the aching pain in his neck and in both shoulders. He asked what your advice about that is. Event details: He got the first dose 09Mar2021, it was given at 11:18 AM in the morning and his shoulders and neck started hurting the same day and that night at about 9 or 10 PM he started shivering like he was cold and a couple hours later that was gone, he confirms the chills and shivers have recovered completely at this time. Product details: He sees a number on the vaccine card PH2330171. He also sees Pfizer and then EN6206, he sees the date 09Mar2021 which is the date he got it, they did not write an expiration date. No NDC number, just a PH number. He was on a blood thinner, and he's got high cholesterol and he was on medication for that. His medication for blood thinner, in fact today once he gets off the phone, he was going to call his heart doctor, they are the ones that monitor his Coumadin numbers, he was going to call them to see if it is okay for him take something for the pain in his neck, he was going to see if there is anything he would be okay to take. Communication: Advised caller to follow up with his physician for medical    No follow up attempts are Possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Feeling hot, Illness, Rash
Clinical narrative: Beginning to get swelling and swelling eventually become the size of like half a golf ball, hard as rock, hot as fire and it was almost gone that day but there is still a little soft lump; I am sick with it; In the last few days I have noticed my blood sugar is a little higher than normal; swelling and swelling eventually become the size of like half a golf ball, hard as rock, hot as fire; Having this rash on and off ever since and yesterday the rash was back again really strong on my arms; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201; Expiration Date: 30Jun2021, NDC number and UPC number: unknown) via an unspecified route of administration on 04Mar2021 at 10:20 (at the age of 79-years-old) as a single dose for covid-19 immunization. Medical history included blood pressure high, type 2 diabetes mellitus both from an unknown date and unknown if ongoing. The patient had covid-19 last year in March, April, and half of May. Concomitant medication included lisinopril (LISINOPRIL) and triamterene (TRIAMTERENE) both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization and had no problem. The patient reported that after taking the vaccine there was no problem for the first part of that day but after lunch, she took a nap for like 4 hours. She went to bed at 8'o clock that night and slept all through Friday, Saturday and Sunday (clarification unknown) and by the time on Friday she had or beginning to get swelling and swelling eventually became the size of like half a golf ball, hard as rock, hot as fire and it was almost gone that day but there was still a little soft lump developed, she had this on and off. She had covid last year and was sick with it. She had rash on and off. The rash was back again really strong on her arms. She took Benadryl as treatment and it subsided somewhat. She asked if it was a normal reaction. She reported that her blood sugar was a little higher than normal, it was 127. It had been under control with diet. The patient underwent lab tests and procedures which included blood glucose: 127 on an unknown date in 2021. The outcome of the events swelling, feeling hot and rash was recovering and for all other events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Beginning to get swelling and swelling eventually become the size of like half a golf ball, hard as rock, hot as fire and it was almost gone that day but there is still a little soft lump; I am sick with it; In the last few days I have noticed my blood sugar is a little higher than normal; swelling and swelling eventually become the size of like half a golf ball, hard as rock, hot as fire; Having this rash on and off ever since and yesterday the rash was back again really strong on my arms; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EN6201; Expiration Date: 30Jun2021, NDC number and UPC number: unknown) via an unspecified route of administration on 04Mar2021 at 10:20 (at the age of 79-years-old) as a single dose for covid-19 immunization. Medical history included blood pressure high, type 2 diabetes mellitus both from an unknown date and unknown if ongoing. The patient had covid-19 last year in March, April, and half of May. Concomitant medication included lisinopril (LISINOPRIL) and triamterene (TRIAMTERENE) both taken for an unspecified indication, start and stop date were not reported. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date for covid-19 immunization and had no problem. The patient reported that after taking the vaccine there was no problem for the first part of that day but after lunch, she took a nap for like 4 hours. She went to bed at 8'o clock that night and slept all through Friday, Saturday and Sunday (clarification unknown) and by the time on Friday she had or beginning to get swelling and swelling eventually became the size of like half a golf ball, hard as rock, hot as fire and it was almost gone that day but there was still a little soft lump developed, she had this on and off. She had covid last year and was sick with it. She had rash on and off. The rash was back again really strong on her arms. She took Benadryl as treatment and it subsided somewhat. She asked if it was a normal reaction. She reported that her blood sugar was a little higher than normal, it was 127. It had been under control with diet. The patient underwent lab tests and procedures which included blood glucose: 127 on an unknown date in 2021. The outcome of the events swelling, feeling hot and rash was recovering and for all other events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: secondary was itchy skin; This is a spontaneous report from a contactable Consumer or other non-HCP (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6Z08), dose 2 via an unspecified route of administration, administered in Arm Right on 10Mar2021 at 11:30 AM (at the age of 66-year-old), as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Environmental allergies, hypothyroidism and sleep apnea. The patient had no covid prior vaccination. The patient had no known allergies. Concomitant medication(s) included Sertraline; Azelastine hydrochloride (ASTELIN [AZELASTINE HYDROCHLORIDE]); Diphenhydramine hydrochloride (BENADRYL) and Fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]), all taken for an unspecified indication, start and stop date were not reported. The patient previously received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9262), via an unspecified route of administration, administered in Right arm on 17Feb2021at 09:30 AM (at the age of 66-year-old), as single for covid-19 immunisation and four days after, he experienced burning sensation on skin and Severe rash on neck. The patient received no other vaccine in four weeks. The patient had not been Covid tested post vaccination. On an unspecified date in Mar2021, after the second dose of vaccination, the patient experienced itchy skin. The patient outcome of the event was Unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Heart rate abnormal
Clinical narrative: Patient had very labored breathing; felt like heart would stop beating and like he would pass out; chills; This is a spontaneous report from a contactable consumer. A 76-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EN9581), via an unspecified route of administration, administered in right arm on 12Mar2021 at 10:30 (at the age of 76-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included doxazosin (DOXAZOSIN), rosuvastatin (ROSUVASTATIN) and fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported. The patient previously took erythromycin and aspirin [acetylsalicylic acid] and experienced drug hypersensitivity (Known allergies: erythromycin, aspirin product or NSAIDs). No COVID prior vaccination. No other vaccine in four weeks. Facility type vaccine at Public Health Clinic/Veterans Administration facility. On 15Mar2021 at 21:15 the patient experienced very labored breathing, felt like heart would stop beating and like would pass out and chills. No treatment received. No COVID tested post vaccination. The outcome of the events was recovered on Mar2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pain in extremity, Sneezing
Clinical narrative: Cold; sore arm; sneezed 30-40 times; nose is stuffed up; This is a spontaneous report from a contactable consumer (Patient). An unspecified age of female patient received first dose of bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date Mar2021, the patient experienced Cold, sore arm, sneezed 30-40 times, nose is stuffed up. It was reported that the caller declined stating she just has some questions, and she doesn't care to give out all of her information. The caller had her shot yesterday and she woke up and must have the severe "man cold thing" because she must have sneezed 30-40 times after waking up and her nose is stuffed up.The caller wants to know if it is normal to have a cold after receiving the vaccine. Are they doing anything to improve how sore this vaccine makes your arm? The caller mentions she is holding the phone with her sore arm and is tired of sitting with her phone to her ear.The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: he started breaking out in a rash that went under and down his arms to his torso where it stopped then on his stomach his around his waist and groin and thighs; his rash is incredibly itchy; rash or hives; This is a spontaneous report from a contactable consumer (patient's wife). A 70-year-old male patient [reporter's Husband] received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in right arm on 06Mar2021 Saturday (at the age of 70-year-old) as single dose for COVID-19 immunization. Patient was pretty healthy. Patient have not had any other recent vaccinations or started any new medications/concomitant. On 10Mar2021, Wednesday afternoon, patient started breaking out in a rash or hives that went under and down his arms to his torso where it stopped then on his stomach his around his waist and groin and thighs. His rash was incredibly itchy. Patient had not used a different laundry soap, so it was not contact dermatitis, and it was in odd different places. Patient went to the ER last night and they gave him steroids and told him to take Benadryl, which helped, and he was less itchy. Reporter stated that this morning it was prevalent and as bad as it was before, maybe worse, and they don't have any other explanation other than the vaccine. Coincidentally his shot site was not swollen or red. At the ER they gave him just one dose of steroid Decadron 6mg NDC/LOT/EXP not provided on paperwork from the ER. Decadron was administered orally, it was supposed to be an injection, but they just gave it to him orally and said it would work just as well. It did seem to work, sadly only for one day. Reporter stated that her husband had this rash or hives, so they also gave him a Pepcid, which she didn't know was an antihistamine of some kind, which was 20mg with a recommendation to take it one to two times a day, but they didn't send him home with anything. She says that they did not provide NDC/UPC/LOT/EXP for the Famotidine or the Benadryl 50mg that her husband was given at the ER. She says he was supposed to take Benadryl every 8 hours, which 50mg was not enough, this rash was itchy. She says both things they said for him to take are over the counter medications. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, Somnolence
Clinical narrative: Fever; Chills; Bodyaches; Sleepiness; This is a spontaneous report from a contactable consumer or other non HCP (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Caller reports her husband got second dose two and a half or three weeks ago, and on an unspecified date, he experienced the fever, chills, body aches, and sleepiness, he had typical effects. The patient's wife didn't remember feeling sleepy from it, where as her husband slept, and he had the common effects to where he knew his body responded to it. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Severe dizziness; Nausea; Intense headache; Fever 100.5; Minor injection site pain; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 08Mar2021 at 15:30 (at the age of 50-years-old) in left arm as a single dose for covid-19 immunization. Medical history included covid-19 prior to vaccination from an unknown date and unknown if ongoing. No known allergies were reported. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced minor injection site pain on 09Mar2021 at 13:00 and 24 hours later he also experienced severe dizziness, nausea, intense headache, fever 100.5 on 10Mar2021. Post vaccination, the patient had not been tested for covid-19. The patient underwent lab tests and procedures which included body temperature: 100.5 on 10Mar2021. The patient did not receive any treatment. The outcome of all the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Severe dizziness; Nausea; Intense headache; Fever 100.5; Minor injection site pain; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: unknown) via an unspecified route of administration on 08Mar2021 at 15:30 (at the age of 50-years-old) in left arm as a single dose for covid-19 immunization. Medical history included covid-19 prior to vaccination from an unknown date and unknown if ongoing. No known allergies were reported. The patient did not receive any other vaccine in four weeks or any other medications in two weeks. The patient's concomitant medications were not reported. The patient experienced minor injection site pain on 09Mar2021 at 13:00 and 24 hours later he also experienced severe dizziness, nausea, intense headache, fever 100.5 on 10Mar2021. Post vaccination, the patient had not been tested for covid-19. The patient underwent lab tests and procedures which included body temperature: 100.5 on 10Mar2021. The patient did not receive any treatment. The outcome of all the events was resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Myalgia
Clinical narrative: Muscle aches and pains; joint pain; headache; chills; general malaise; nausea; Significant pain at the injection site; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 15:15 (at the age of 57 year) as dose 1, single for COVID-19 immunisation at Hospital. Medical history included Lyme. Patient had known allergies to Trileptal. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient previously took Trileptal and experienced drug hypersensitivity. On 10Mar2021 at 06:30 patient experienced muscle aches and pains, joint pain, headache, chills, felt like have a fever but don't, general malaise, nausea and significant pain at the injection site. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: Muscle aches and pains; joint pain; headache; chills; general malaise; nausea; Significant pain at the injection site; This is a spontaneous report from a contactable consumer. A 57-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 at 15:15 (at the age of 57 year) as dose 1, single for COVID-19 immunisation at Hospital. Medical history included Lyme. Patient had known allergies to Trileptal. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient previously took Trileptal and experienced drug hypersensitivity. On 10Mar2021 at 06:30 patient experienced muscle aches and pains, joint pain, headache, chills, felt like have a fever but don't, general malaise, nausea and significant pain at the injection site. It was reported that no therapeutic measures were taken for the events experienced. The outcome of events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Headache, Heart rate
Clinical narrative: fever; injection site swelling; Injection site pain; chills; feeling unwell; fast heartbeat; weakness; muscle and body ache; muscle and body ache; headache; tiredness; nausea; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 25Feb2021 at 00:00 am (age at vaccination was 67 years) as dose 1, single for COVID-19 immunization. The patient's medical history included diabetes and high blood pressure from an unknown date. The patient did not have any known allergies. Concomitant medications the patient received within 2 weeks of vaccination included metformin, atorvastatin, glyburide and lisinopril all taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Feb2021 at 01:00 am, the patient experienced fever, injection site swelling/pain, chills, feeling unwell, fast heartbeat, weakness, chills, muscle and body ache, headache, tiredness and some nausea. The patient took acetaminophen extra strength. The patient recovered with lasting effects. The outcome of the events was resolved with sequel on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Myalgia, Nausea, Pain
Clinical narrative: fever; injection site swelling; Injection site pain; chills; feeling unwell; fast heartbeat; weakness; muscle and body ache; muscle and body ache; headache; tiredness; nausea; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 67-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 25Feb2021 at 00:00 am (age at vaccination was 67 years) as dose 1, single for COVID-19 immunization. The patient's medical history included diabetes and high blood pressure from an unknown date. The patient did not have any known allergies. Concomitant medications the patient received within 2 weeks of vaccination included metformin, atorvastatin, glyburide and lisinopril all taken for an unspecified indication. The facility where the most recent COVID-19 vaccine was administered was Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Feb2021 at 01:00 am, the patient experienced fever, injection site swelling/pain, chills, feeling unwell, fast heartbeat, weakness, chills, muscle and body ache, headache, tiredness and some nausea. The patient took acetaminophen extra strength. The patient recovered with lasting effects. The outcome of the events was resolved with sequel on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.