chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Pain, Presyncope, Vaccination site pain
Clinical narrative: pain in my arm where they gave me the shot; diarrhea; dizzy spells; almost fainted; I have been experiencing severe pain.; my vein is bends all like pop out early you know get real noticeable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 (Lot number: EN6208) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: METOPROLOL taken for blood pressure measurement, start date: 2018 (ongoing).  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in my arm where they gave me the shot"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy spells"; PRESYNCOPE (non-serious), outcome "unknown", described as "almost fainted"; PAIN (non-serious), outcome "unknown", described as "I have been experiencing severe pain."; VEIN DISORDER (non-serious), outcome "unknown", described as "my vein is bends all like pop out early you know get real noticeable". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: The patient has been experiencing severe pain for a like a week after she got her first shot in arm. That was setting a quality of her life. She cannot really use her left arm very much at all. She has a knot that was own one of her veins was bend all like pop out early got real noticeable. She had pain in her arm where they gave her the shot. She had diarrhoea for six days, a couple of weeks ago. She had experienced dizzy spells where she almost fainted there. Everything she did not know anything else that it could be a tribute to other than the shot because she was basically a healthy person. That was the first dose, on 20Mar2021 when she have it and has suffered terribly, almost every second was like a equator after she was having problems. The patient was still taking Tylenol, she has tried ice, heating pad and did anything to just ease it as much as she can. She don't remember when she first started taking Tylenol, that was when she was in pain almost constantly ever since about a week after so. When probed for any Treatment for the adverse event, all she has taken was Tylenol when she hurt.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vein disorder
Clinical narrative: pain in my arm where they gave me the shot; diarrhea; dizzy spells; almost fainted; I have been experiencing severe pain.; my vein is bends all like pop out early you know get real noticeable; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Mar2021 (Lot number: EN6208) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure. Concomitant medication(s) included: METOPROLOL taken for blood pressure measurement, start date: 2018 (ongoing).  The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in my arm where they gave me the shot"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy spells"; PRESYNCOPE (non-serious), outcome "unknown", described as "almost fainted"; PAIN (non-serious), outcome "unknown", described as "I have been experiencing severe pain."; VEIN DISORDER (non-serious), outcome "unknown", described as "my vein is bends all like pop out early you know get real noticeable". Therapeutic measures were taken as a result of vaccination site pain.  Additional information: The patient has been experiencing severe pain for a like a week after she got her first shot in arm. That was setting a quality of her life. She cannot really use her left arm very much at all. She has a knot that was own one of her veins was bend all like pop out early got real noticeable. She had pain in her arm where they gave her the shot. She had diarrhoea for six days, a couple of weeks ago. She had experienced dizzy spells where she almost fainted there. Everything she did not know anything else that it could be a tribute to other than the shot because she was basically a healthy person. That was the first dose, on 20Mar2021 when she have it and has suffered terribly, almost every second was like a equator after she was having problems. The patient was still taking Tylenol, she has tried ice, heating pad and did anything to just ease it as much as she can. She don't remember when she first started taking Tylenol, that was when she was in pain almost constantly ever since about a week after so. When probed for any Treatment for the adverse event, all she has taken was Tylenol when she hurt.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: sharp pain in lower back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 09:30 (Lot number: EW0162) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Car accident" (unspecified if ongoing), notes: had a car accident in my 20's that caused an issue there, but through physical therapy/yoga had healed it ; "Physical therapy" (unspecified if ongoing); "Yoga" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 15Apr2021, outcome "not recovered", described as "sharp pain in lower back". Therapeutic measures were not taken as a result of back pain.  Additional information: The patient had no known allergies. The patient had unspecified multivitamin within two weeks prior vaccination. The patient did not receive any other vaccines within 4 week prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination. The patient reported that the pain was definitely from the vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Nausea; vomiting; Sore arm on day of vaccine for both doses.; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 66-year-old male patient received BNT162B2 (BNT162B2), intramuscular, administered in arm left, administration date 31Mar2021 08:30 (Lot number: EP7533) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing); "Borderline AODM" (unspecified if ongoing); "Hypercholesterolemia" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; MVI [ASCORBIC ACID;DEXPANTHENOL;ERGOCALCIFEROL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]; ASPIRIN [ACETYLSALICYLIC ACID]. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovered" (01Apr2021), described as "Sore arm on day of vaccine for both doses."; NAUSEA (non-serious) with onset 02Apr2021 21:00, outcome "recovered" (03Apr2021 05:00), described as "Nausea"; VOMITING (non-serious) with onset 02Apr2021 21:00, outcome "recovered" (03Apr2021 05:00), described as "vomiting". Therapeutic measures were not taken as a result of pain in extremity, nausea, vomiting. Additional Information: The patient did not receive any other vaccine in four weeks. The patient took Losartan 50mg, Atorvastatin 40mg, MVI and Aspirin 81mg in two weeks. The patient experienced sore arm on day of vaccine for both doses and only lasted one day. The patient also experienced nausea and vomiting x7 starting at about 9pm on day 3 of first vaccination, lasted through the night, and ended about 5am on day 4. The patient has not been diagnosed with COVID prior vaccination and has not been tested for COVID prior vaccination. The patient has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021482033 same patient, different drug/AE
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EL3247), intramuscularly, on Jan 22, 2021, at 10:30, single dose, for COVID-19 immunisation. Medical history included cough (ongoing). No concomitant medications. The patient reported nasopharyngitis (had a cold in chest area), onset Jan 22, 2021, at 10:50, with outcome of recovered (2021). The event was evaluated at an emergency room visit. No therapeutic measures taken as a result of nasopharyngitis. Additional information: Patient had a cold in chest area, which lasted about five to ten minutes. No follow-up attempts possible. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: strong pain in left arm, right now I have a severe pain in my arm,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 01:00 (Lot number: EW0153) at the age of 39 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 15Apr2021 12:00, outcome "not recovered", described as "strong pain in left arm, right now I have a severe pain in my arm,". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: Patient reported for herself that Initially, a strong pain in left arm, right now I have a severe pain in my arm, if I try to grab something I must let it go because it drops off, I can't place my hand because of the strong pain. I haven't had such pain before. I'll be grateful if you help with my request.   No follow-up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Malaise
Clinical narrative: I am not well; This is a spontaneous report received from a contactable (patient).   A 24 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Apr2021 (Lot number: FW0172) at the age of 24 years as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I am not well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of malaise. Additional information: the patient after first shot, she had symptoms, she was not well. She took ibuprofen (ADVIL) and paracetamol (TYLENOL). Laboratory tests were done for the symptoms.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Muscle pain; Headache; Feeling like dizzy; dizziness; Weak; tired; Weak; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administration date 19Apr2021 (Lot number: EW0164) at the age of 41 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MYALGIA (non-serious) with onset 19Apr2021, outcome "recovered", described as "Muscle pain"; HEADACHE (non-serious) with onset 19Apr2021, outcome "not recovered", described as "Headache"; DIZZINESS (non-serious) with onset 19Apr2021, outcome "not recovered", described as "Feeling like dizzy; dizziness"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 19Apr2021, outcome "not recovered" and all described as "Weak; tired". Therapeutic measures were not taken as a result of myalgia, headache, dizziness, asthenia, fatigue.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in the arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 60 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Apr2021, outcome "unknown", described as "soreness in the arm".  Additional information: The patient was asking if she can take Tylenol to have a nice sleep.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Product administered at inappropriate site, Vaccination site erythema, Vaccination site pain
Clinical narrative: injection site got tight and it's a little bit hard if you touch it; given it in her bicep muscle; Soreness and redness at the injection site; Soreness and redness at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 34 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 17:30 (Lot number: EW0173) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (unspecified if ongoing), notes: Verbatim: Pre-diabetic. The patient's concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 30Apr2021, outcome "not recovered" and all described as "Soreness and redness at the injection site"; MUSCLE TIGHTNESS (non-serious) with onset 01May2021, outcome "unknown", described as "injection site got tight and it's a little bit hard if you touch it"; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 30Apr2021, outcome "unknown", described as "given it in her bicep muscle".  Additional information: The reporter was concerned if there was any side effects or information about the vaccine given in the bicep as opposed to the deltoid. The reporter injection site got tight the next day and it was a little bit hard when touched. He wanted to know will the patient need two more vaccines or a booster. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. The AE(s) did not require a visit to Emergency room and Physician's office. Prior Vaccinations within 4 weeks was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE was Parents were diabetic. Relevant tests was none.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Vision blurred
Clinical narrative: Light-headed, Dizzy; Blurry vision; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: ER8733) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "Light-headed, Dizzy"; VISION BLURRED (non-serious) with onset 10Apr2021, outcome "not recovered", described as "Blurry vision".  Additional information: The caller was calling about Pfizer covid vaccine. The caller had been having some problems, it started last Saturday 10Apr2021. The caller took the vaccine on 07Apr2021. The caller had been light headed, dizzy, and had blurry vision. The caller thought it may go away in a few days, but the symptoms were still persisting. Should the caller be worried about this or take any precautions. When the caller was standing for a long time patient was afraid patient will fall. Patient confirmed with reporter that the correct spelling of his last name was (Name withheld), as indicated in formal field. Reporter's last name incorrectly listed as (Name withheld).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurt".  Additional information: The patient reported that the patient heard some people accidently got saline shots instead of second dose and concerned the patient was one of them. First shot arm hurt for days and mild symptoms for second shot nothing happened. No symptoms. Patient reported that arm didn't even hurt after the second dose. So the patient wanted to know if really got 2nd vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: soreness in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "soreness in arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021438554 Same patient, same drug, different dose
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Gait disturbance, Glycosylated haemoglobin, Lymphadenopathy, Muscle tightness
Clinical narrative: It is achy; tender; arm is a little warm to the touch; both of her legs puffed up; Both legs were that tight.; lymph node at the base of skull that was swollen; couldn't walk too well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 15:00 (Lot number: ER8731) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prediabetic" (ongoing), notes: A1C: over 6.5 and gave Glimepiride half tablet in morning and afternoon. Using for several years; "Overweight" (ongoing), notes: Verbatim: overweight; "Complex regional pain syndrome" (ongoing), notes: Verbatim: Reflex sympathetic dystrophy, Diagnosed 20 years. It took her out of the OR.; "Pacemaker", start date: 2015 (unspecified if ongoing), notes: has pacemaker due to conduction problems. It is in the left side subclavicle; "High blood pressure" (unspecified if ongoing), notes: usually controlled, but last night in the ER he listed her as hypertensive. Concomitant medication(s) included: GLIMEPIRIDE taken for glucose tolerance impaired (ongoing). Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6207, Expiry: unknown, Anatomical Location: left arm), administration date: 17Mar2021, for COVID-19 immunisation, reaction(s): "No adverse effect".  The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 14Apr2021, outcome "unknown", described as "Both legs were that tight."; LYMPHADENOPATHY (non-serious) with onset 14Apr2021, outcome "recovering", described as "lymph node at the base of skull that was swollen"; GAIT DISTURBANCE (non-serious) with onset 14Apr2021, outcome "unknown", described as "couldn't walk too well"; PERIPHERAL SWELLING (non-serious) with onset 14Apr2021 20:00, outcome "recovering", described as "both of her legs puffed up"; TENDERNESS (non-serious) with onset 15Apr2021, outcome "unknown", described as "tender"; FEELING HOT (non-serious) with onset 15Apr2021, outcome "unknown", described as "arm is a little warm to the touch"; PAIN (non-serious), outcome "unknown", described as "It is achy". The events "both legs were that tight." and "both of her legs puffed up" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was not affected by COVID. When she was in the ER last night and she tested positive for COVID antigens. She did not have COVID virus but had antigens when she was tested on 14Apr2021.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, SARS-CoV-2 test, Tenderness
Clinical narrative: It is achy; tender; arm is a little warm to the touch; both of her legs puffed up; Both legs were that tight.; lymph node at the base of skull that was swollen; couldn't walk too well; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 15:00 (Lot number: ER8731) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prediabetic" (ongoing), notes: A1C: over 6.5 and gave Glimepiride half tablet in morning and afternoon. Using for several years; "Overweight" (ongoing), notes: Verbatim: overweight; "Complex regional pain syndrome" (ongoing), notes: Verbatim: Reflex sympathetic dystrophy, Diagnosed 20 years. It took her out of the OR.; "Pacemaker", start date: 2015 (unspecified if ongoing), notes: has pacemaker due to conduction problems. It is in the left side subclavicle; "High blood pressure" (unspecified if ongoing), notes: usually controlled, but last night in the ER he listed her as hypertensive. Concomitant medication(s) included: GLIMEPIRIDE taken for glucose tolerance impaired (ongoing). Vaccination history included: Bnt162b2 (dose 1, single, lot number: EN6207, Expiry: unknown, Anatomical Location: left arm), administration date: 17Mar2021, for COVID-19 immunisation, reaction(s): "No adverse effect".  The following information was reported: MUSCLE TIGHTNESS (non-serious) with onset 14Apr2021, outcome "unknown", described as "Both legs were that tight."; LYMPHADENOPATHY (non-serious) with onset 14Apr2021, outcome "recovering", described as "lymph node at the base of skull that was swollen"; GAIT DISTURBANCE (non-serious) with onset 14Apr2021, outcome "unknown", described as "couldn't walk too well"; PERIPHERAL SWELLING (non-serious) with onset 14Apr2021 20:00, outcome "recovering", described as "both of her legs puffed up"; TENDERNESS (non-serious) with onset 15Apr2021, outcome "unknown", described as "tender"; FEELING HOT (non-serious) with onset 15Apr2021, outcome "unknown", described as "arm is a little warm to the touch"; PAIN (non-serious), outcome "unknown", described as "It is achy". The events "both legs were that tight." and "both of her legs puffed up" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She was not affected by COVID. When she was in the ER last night and she tested positive for COVID antigens. She did not have COVID virus but had antigens when she was tested on 14Apr2021.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Chills, Headache, Tinnitus
Clinical narrative: Tinnitus; Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 (unknown manufacturer)), for Covid-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 10Apr2021, outcome "not recovered", described as "Tinnitus"; HEADACHE (non-serious), outcome "recovered", described as "Headache"; CHILLS (non-serious), outcome "recovered", described as "Chills". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient reported this on a computer already and the patient had a file. The patient also stated that 'MD' did not believed that it came from the shot and the patient ended up having a hearing test. The patient stated that the day after the 2nd shot the patient had chills, headache and severe ringing which they call tinnitus, in the ear. The chills and headache went away but the ringing in the ear had been 3 weeks now that is from April 10.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Oral pain, Pain in extremity, SARS-CoV-2 antibody test negative
Clinical narrative: 5 days later she got "really sick" on the 18th and has been sick for 10 days.; her arm was sore; she was tired.; I had a ton of mucous and I couldn't get it to go away; She now has sores in the roof of her mouth that are painful like ulcers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Apr2021, outcome "unknown", described as "her arm was sore"; FATIGUE (non-serious) with onset 14Apr2021, outcome "unknown", described as "she was tired."; ILLNESS (non-serious) with onset 18Apr2021, outcome "recovered" (28Apr2021), described as "5 days later she got "really sick" on the 18th and has been sick for 10 days."; SECRETION DISCHARGE (non-serious) with onset 2021, outcome "unknown", described as "I had a ton of mucous and I couldn't get it to go away"; ORAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "She now has sores in the roof of her mouth that are painful like ulcers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, fatigue, illness, secretion discharge, oral pain.  Additional information: Patient stated that she has taken Mucinex but it wasn't helpful.She has taken an antibiotic, doxycycline Hyc 100mg but she did not know if it helped or not. The duration of protection against COVID-19 is currently unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Secretion discharge
Clinical narrative: 5 days later she got "really sick" on the 18th and has been sick for 10 days.; her arm was sore; she was tired.; I had a ton of mucous and I couldn't get it to go away; She now has sores in the roof of her mouth that are painful like ulcers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 14Apr2021, outcome "unknown", described as "her arm was sore"; FATIGUE (non-serious) with onset 14Apr2021, outcome "unknown", described as "she was tired."; ILLNESS (non-serious) with onset 18Apr2021, outcome "recovered" (28Apr2021), described as "5 days later she got "really sick" on the 18th and has been sick for 10 days."; SECRETION DISCHARGE (non-serious) with onset 2021, outcome "unknown", described as "I had a ton of mucous and I couldn't get it to go away"; ORAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "She now has sores in the roof of her mouth that are painful like ulcers". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, fatigue, illness, secretion discharge, oral pain.  Additional information: Patient stated that she has taken Mucinex but it wasn't helpful.She has taken an antibiotic, doxycycline Hyc 100mg but she did not know if it helped or not. The duration of protection against COVID-19 is currently unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Hearing disability, Tinnitus
Clinical narrative: Major increase in ringing in ears (tinnitus).; Left ear especially inconsistent high pitch ringing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A  52 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 20Apr2021 12:15 (Lot number: ER8736) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy: Latex" (unspecified if ongoing), notes: Latex. The patient's concomitant medications were not reported. Past drug history included: Azithromycin, reaction(s): "Azithromycin: Allergy". The following information was reported: TINNITUS (non-serious) with onset 21Apr2021 20:00, outcome "not recovered", described as "Major increase in ringing in ears (tinnitus)."; HEARING DISABILITY (non-serious) with onset 21Apr2021 20:00, outcome "not recovered", described as "Left ear especially inconsistent high pitch ringing". The events "major increase in ringing in ears (tinnitus)." and "left ear especially inconsistent high pitch ringing" were evaluated at the emergency room visit.  Additional information: Facility where the most recent COVID-19 vaccine was administered Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not  diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Caller submitted an adverse reaction report. Wanted information about what to expect. Stated that he has had tinnitus since he took the first dose. Wanted to know how often is it temporary or permanent or if had records of that. Stated that he did it a few days ago. Provided a report reference number of 0AC02965-7E45-450D-92CC-9C4D3F46020E. Is for Covid. Clarified that he has tinnitus in both ears but the left ear is worst.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms
Clinical narrative: spasm; back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 26Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1), for COVID-19 Immunization. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "spasm"; BACK PAIN (non-serious), outcome "unknown", described as "back pain". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Feeling abnormal, Pain
Clinical narrative: Severe pain/It was awful and pain was excruciating, 'it was like having a baby; Severe diarrhea; Stomach was upset for a week; It was awful and pain was excruciating, 'it was like having a baby; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 13Apr2021 11:30 (Batch/Lot number: unknown) at the age of 73 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset Apr2021, outcome "recovered" (2021), described as "Stomach was upset for a week"; PAIN (non-serious) with onset 13Apr2021 20:30, outcome "unknown", described as "Severe pain/It was awful and pain was excruciating, 'it was like having a baby"; FEELING ABNORMAL (non-serious) with onset Apr2021, outcome "unknown", described as "It was awful and pain was excruciating, 'it was like having a baby"; DIARRHOEA (non-serious) with onset 13Apr2021 20:30, outcome "unknown", described as "Severe diarrhea".  Additional information: on 13APR2021 y 8:30 that night she presented severe diarrhea and severe pain until 12:30 am, she was unable to get off the toilette. Stated that it was awful and pain was excruciating, 'it was like having a baby'. Stated that while she was giving blood yesterday someone else said that they were unsure if she should receive the second dose also. Her doctor said that if she only receives one dose of the Pfizer Covid-19 vaccine it would have like 85 percent efficacy.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold".  Additional Information: The patient received first dose and wanted to reschedule her appointment for the second dose because she has a cold. She mentioned that not only her who got a cold and wanted to reschedule but there were 3 others in her household as well. She was advised to reach out to the vaccination site.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Fibrin D dimer, Malaise, Nausea, Pain
Clinical narrative: Didn't feel well; felt achy; nauseated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 10:00 (Lot number: EN6207) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: 16Apr2021, for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 25Mar2021, outcome "recovered" (27Mar2021), described as "Didn't feel well"; PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (27Mar2021), described as "felt achy"; NAUSEA (non-serious) with onset 25Mar2021, outcome "recovered" (27Mar2021), described as "nauseated". The events "didn't feel well", "felt achy" and "nauseated" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She received her first dose on 25Mar2021 and for three days after that she didn't feel good. On 26Mar2021 and 27Mar2021 she didn't feel good. She felt achy and nauseated. But since she had COVID in DEC2020 her second dose of the COVID vaccine was the problem like how people's antibodies are already built up and had that reaction so that is why she was fine. She was just fearful of the new variants and wanted to be extra protected against those variants  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Troponin I, X-ray
Clinical narrative: Didn't feel well; felt achy; nauseated; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 10:00 (Lot number: EN6207) at the age of 68 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), administration date: 16Apr2021, for COVID-19 immunization. The following information was reported: MALAISE (non-serious) with onset 25Mar2021, outcome "recovered" (27Mar2021), described as "Didn't feel well"; PAIN (non-serious) with onset 25Mar2021, outcome "recovered" (27Mar2021), described as "felt achy"; NAUSEA (non-serious) with onset 25Mar2021, outcome "recovered" (27Mar2021), described as "nauseated". The events "didn't feel well", "felt achy" and "nauseated" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She received her first dose on 25Mar2021 and for three days after that she didn't feel good. On 26Mar2021 and 27Mar2021 she didn't feel good. She felt achy and nauseated. But since she had COVID in DEC2020 her second dose of the COVID vaccine was the problem like how people's antibodies are already built up and had that reaction so that is why she was fine. She was just fearful of the new variants and wanted to be extra protected against those variants  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling under his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old male patient received bnt162b2 (BNT162B2), administration date 06May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Swelling under his arm".  Additional information: patient enquired was it a problem if he was on blood thinners. Reporter stated that, when vaccinating persons with increased bleeding risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021523838 same reporter/drug, different patient/event
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort
Clinical narrative: heavy feeling arm for a short time afterwards; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 01Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "COVID-19", start date: 2020 (unspecified if ongoing), notes: In Nov or Dec, Headache or Fever for a day. Runny nose next day.; "brain fog and Memory issues" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "heavy feeling arm for a short time afterwards".  Additional information: Caller had Covid, in November or December with a headache and fever for a day, and then had a runny nose the next day. Afterwards she had a brain fog and memory issues. And she still has these issues. April 1st, she had her first Pfizer Covid vaccine, and she had a heavy feeling arm for a short time afterwards. Her next vaccine was scheduled for April 29th but she had an overwhelming feeling not to get the 2nd shot, so she didn't, she was having a good day that day. reporter asked what should she do. She was afraid of getting the second shot. She asked are you studying this brain fog people are having. She did have an appointment with her doctor. Her daughter got the vaccine and only had the heavy feeling in her arm after the shot. She would like to talk to someone about this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510321 same reporter/drug, different patient.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort
Clinical narrative: heavy feeling in her arm after the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "heavy feeling in her arm after the shot".  Additional information: Patient's mother had Covid, in November or December with a headache and fever for a day, and then had a runny nose the next day. Afterwards she had a brain fog and memory issues. And she still has these issues. Patient's mother received her first Pfizer Covid on 01Apr2021, and she had a heavy feeling arm for a short time afterwards.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021510287 same reporter/drug, different patient.
Sex: M
Vaccine: COVID19
Symptoms: Antinuclear antibody, Blood pressure measurement, Body temperature, C-reactive protein, Cardiac imaging procedure
Clinical narrative: Myocarditis; Brief episode of supraventricular tachycardia; This is a literature report.  A 21 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "recovering", described as "Myocarditis"; SUPRAVENTRICULAR TACHYCARDIA (non-serious), outcome "recovering", described as "Brief episode of supraventricular tachycardia". The patient underwent the following laboratory tests and procedures: antinuclear antibody: 1:80; blood pressure measurement: 131/83 mmHg; body temperature: 98.9 Fahrenheit; cardiac imaging procedure: delayed hyperenhancement in the lateral epicardium, notes: and in the pericardium and epicardial surface of the anterior and lateral wall (B, arrowheads) consistent with myocarditis by the Lake Louise criteria; c-reactive protein: 3.8 mg/dl; echocardiogram: lvef 25%, mildly dilated rv, notes: and reduced systolic function, moderate mitral regurgitation, no pericardial effusion; lvef 50 to 55%, normal wall motion., notes: RV mildly dilated with mildly reduced function, mild mitral regurgitation; electrocardiogram: sinus rhythm with marked sinus arrhythmia, notes: diffuse ST segment elevation (II, III, aVF, V5 and V6) and ST segment depressions in aVR and V1; fibrin d dimer: 509 ng/ml; heart rate: 83, notes: beats/min; magnetic resonance imaging: unknown results; oxygen saturation: 96 %, notes: on room air; physical examination: unremarkable; polymerase chain reaction: negative; red blood cell sedimentation rate: 20, notes: mm/hr; respiratory viral panel: negative; rheumatoid factor: less than 10; sars-cov-2 antibody test: not performed; troponin: 17.0 ng/ml. Therapeutic measures were taken as a result of myocarditis, supraventricular tachycardia.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported event myocarditis with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.