chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Body temperature, Chills, Fatigue, Headache
Clinical narrative: very sore arm 4-16 hours; fevers and chills 12-36 hours (max temp = 101.9); fevers and chills 12-36 hours (max temp = 101.9); headache starting approx 19 hrs; insomnia 12-24 hrs; significant fatigue 24-48 hours and more mild fatigue 48-72 hours (the mild fatigue being more than my baseline constant fatigue); migraine; This is a spontaneous report from a contactable patient. A 43-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular, administered in Arm Left on 21Jan2021 at 08:00 (Batch/Lot Number: EL3246) as 2nd dose, single dose for covid-19 immunization. Medical history included obese (BMI approx 30), seasonal allergies and breastfeeding.Concomitant medications included prenatal vitamins ,fexofenadine hydrochloride (ALLEGRA) and probiotics (PROBIOTICS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks of the vaccination. Post vaccination, the patient had not been tested for COVID. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular, administered in Arm Left on 22Dec2020 at 13:00 (Batch/Lot Number: EH9899) as 1 st dose, single dose for covid-19 immunization and experienced mild-mod sore arm. In Jan2021, after the second dose, the patient had very sore arm 4-16 hours (reported this because more sore than other vaccines she had received, over all she was not concerned about sore arm though), fevers and chills 12-36 hours (max temp was equal to 101.9), headache started approx. 19 hours, insomnia 12-24 hours(unsure from vaccine or fevers/rigors themselves), significant fatigue 24-48 hours and more mild fatigue 48-72 hours (the mild fatigue being more than baseline constant fatigue) and intermittent headache (tension vs mild migraine) for 1week. It was unclear if was vaccine related vs normal fatigue/stress/weather. The patient underwent lab tests which included BMI: approx 30 and temperature: 101.9. The event fever and headache was treated with ibuprofen. The outcome of events was resolved in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Migraine, Pain in extremity, Pyrexia
Clinical narrative: very sore arm 4-16 hours; fevers and chills 12-36 hours (max temp = 101.9); fevers and chills 12-36 hours (max temp = 101.9); headache starting approx 19 hrs; insomnia 12-24 hrs; significant fatigue 24-48 hours and more mild fatigue 48-72 hours (the mild fatigue being more than my baseline constant fatigue); migraine; This is a spontaneous report from a contactable patient. A 43-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular, administered in Arm Left on 21Jan2021 at 08:00 (Batch/Lot Number: EL3246) as 2nd dose, single dose for covid-19 immunization. Medical history included obese (BMI approx 30), seasonal allergies and breastfeeding.Concomitant medications included prenatal vitamins ,fexofenadine hydrochloride (ALLEGRA) and probiotics (PROBIOTICS). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks of the vaccination. Post vaccination, the patient had not been tested for COVID. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), intramuscular, administered in Arm Left on 22Dec2020 at 13:00 (Batch/Lot Number: EH9899) as 1 st dose, single dose for covid-19 immunization and experienced mild-mod sore arm. In Jan2021, after the second dose, the patient had very sore arm 4-16 hours (reported this because more sore than other vaccines she had received, over all she was not concerned about sore arm though), fevers and chills 12-36 hours (max temp was equal to 101.9), headache started approx. 19 hours, insomnia 12-24 hours(unsure from vaccine or fevers/rigors themselves), significant fatigue 24-48 hours and more mild fatigue 48-72 hours (the mild fatigue being more than baseline constant fatigue) and intermittent headache (tension vs mild migraine) for 1week. It was unclear if was vaccine related vs normal fatigue/stress/weather. The patient underwent lab tests which included BMI: approx 30 and temperature: 101.9. The event fever and headache was treated with ibuprofen. The outcome of events was resolved in 2021.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: mild nausea; Headaches; leg pain/ She has problems with her right leg,she hurt it; This is a spontaneous report from a contactable other-HCP (patient, self-reported). A 73-year-old female patient (age at vaccination: 73 year) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EK9231 and expiry date was not reported), via an unspecified route of administration, on 01Feb2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was asking if she could take Tylenol for headaches and leg pain that she experienced after the shot and Meloxicam for hip pains that were not related to the vaccine. She wanted to know could she take Tylenol or Tums and also if she could take Melaxicam, she thought that was how you spell that. She said the Melaxicam was like Ibuprofen, but it was 24 hours, she said basically she was talking about mild symptoms. She had problems with her right leg, she hurt it on an unknown date in Feb2021, so that was why she was wondering about the Tylenol. Then she had some nausea on 01Feb2021, a small amount and she didn't want to take something if she shouldn't take anything. The issue with her leg was happening before the vaccine. The nausea was began since the dose of the vaccine and it was mild, she went ahead and took Tums which she did if she had the occasional nausea and it helped but her daughter told her she shouldn't take over the counter medications because it could interfere with the vaccine, but she did not know if her daughter knew what she was talking about. She guesses the nausea began a little bit the day of the vaccine toward the end of the day and then some today but the main thing she wanted to find out was, was there going to be any interaction issues if she took the Tylenol and Tums. She said the nausea was about the same since yesterday, but it was off and on took. She took Tums and it went away but after a while it comes back. She had only taken the Tums 3 times and she took 2 but she just wanted to make sure. No further information provided. She thought she should go to physical therapy but to do that she needed to see the orthopedic but she didn't want to do that until after she gets the second shot, and she was supposed to do that 22Feb2021 so she was just hanging in there. She confirmed she thought she could benefit from physical therapy due to issues she had prior to getting the vaccine. She said that has nothing to do with the vaccine. Outcome of the event mild nausea was not recovered and for all other events, it was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Cough
Clinical narrative: started having events of asthmas and coughing type stuff; started having events of asthmas and coughing type stuff; This is a spontaneous report from a contactable consumer (Patient). A 76-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number was not reported), via an unspecified route of administration on 28Jan2021 as 1st dose, single for covid-19 immunisation (76 years old when vaccinated). The patient medical history included asthma and chest congestion. Concomitant medications were not reported. On 01Feb2021(patient reported as last night) he started having events of asthmas and coughing type stuff. The patient reported that he would normally get Prednisone for this but asks if it is contraindicated between the vaccine doses. The outcome of the events was unknown. Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Weight
Clinical narrative: her arm was not sore like it was with the first dose; This is a spontaneous report from a contactable pharmacist reporting. A 34-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 07Jan2021 (Batch/Lot Number: EL0142) as single dose for covid-19 immunisation. Medical history included intermittent asthma from Mar2020 to an unknown date. There were no concomitant medications. Patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on 29Jan2021 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. Patient stated she knew the vaccine was suppose to be administered in the deltoid muscle. Patient stated she thought her vaccine was administered subcutaneously and when nurse administered the vaccine she pinched her skin and she did not feel the injection like she did the first dose and she thought the needle may have slipped out the muscle. Caller stated the following day she felt itchiness and the next day she noticed her arm had a 2x2 inch raised area that was hot and firm which was one inch away from the injection site. Her arm was not sore like it was with the first dose on an unknown date in Jan2021. She believed the nurse gave the dose incorrectly, and the site of injection was not optimally at deltoid and colleague pinched her skin, so it was not where it is at. She said when her colleague injected it, she didn't feel any pain. She said she was thinking that the injection might have been done subcutaneously and not intramuscularly. Caller said she kept the site clean, and she didn't take Benadryl or anything, it was a slight itch, and she didn't want to disrupt anything. Caller said that she felt this was not serious. She said that she was curious if she will have full protection, since she has read studies about how IM meds that are injected subcutaneously stays in the fat for a longer period, and that enzymes can change the efficacy of the vaccine since vaccines that are given IM are meant to be where the blood supply is. She said she did not know if she would need a third dose. The patient underwent lab tests and procedures which included weight: 96-98 lbs. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected..
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills for about 2 hrs; body soreness; light headache; This is a spontaneous report from a contactable consumer (patient). A 50-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number EL3248; Expiration date was not reported), via an unspecified route of administration, administered in left arm on 01Feb2021 08:00 hr (at the age of 50-years-old) as 2nd dose, single dose for COVID-19 immunisation. Medical history included none. The patient previously took erythromycin and experienced drug hypersensitivity. Concomitant medication included sumatriptan (MANUFACTURER UNKNOWN), via an unspecified route of administration on an unspecified date at unknown dose and frequency for an unspecified indication. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number EL3248; Expiration date was not reported) via an unspecified route of administration, administered in left arm on 12Jan2021 16:00 hr for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Feb2021 01:00, the patient experienced chills for about 2 hrs, body soreness and light headache for about 4 hours. Patient received no treatment for the events. The clinical outcome of the chills for about 2 hrs, body soreness and light headache were recovered on 02Feb2021.  Follow-Up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Neck pain, Pain in extremity, Vaccination site pain
Clinical narrative: Sore arm; sore arm, shoulder, neck; sore arm, shoulder, neck; Mild abdominal cramping; Pain at injection site (arm); This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 01Feb2021 (at age of 34-years old) as single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was unknown that patient receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID. On 01Feb2021(same day of vaccination), the patient experienced pain at injection site. On 02Feb2021, the patient had sore arm, shoulder, neck and mild abdominal cramping. The Outcome of events was not recovered.    No follow up attempts are possible. Information about Lot and batch number could not be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling extremely tired for a week and 2 days now.; This is a spontaneous report from a non-contactable consumer. An 81-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient was feeling extremely tired for a week and 2 days. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: Genital herpes; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number : unknown), via an unspecified route of administration on an unspecified date as a 1st dose, single dose for COVID-19 immunisation. The patient's medical history included food allergies with white sugar and white flour. The patient's concomitant medications were not reported. On an unknown date, the patient experienced genital herpes. She stated that, she experienced genital herpes and she had some food allergies with white sugar, white flour and was asking if there was a concern in receiving the second shot on the 17Feb2021. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up was being submitted to notify that the lot/batch number was not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information was expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pruritus
Clinical narrative: itching in feet; it's not normal; brain fog like she had a couple of drinks; This is a spontaneous report from a contactable consumer (patient's mother). A female patient (daughter) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot Number: unknown, expiration date: unknown) via an unspecified route of administration on Feb2021, as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergy. Caller reported that her daughter (patient) got the Covid-19 vaccine today i.e. on an unknown date in Feb2021 and they could not get a hold of the place she got it and patient was experiencing itching in the feet and it was not normal, brain fog like she had a couple of drinks and reporter had concerned if these were normal side effects. Reporter stated that patient also has a penicillin allergy, but not a bad one. The outcome of the event was unknown.   Information on the lot/batch number has been requested.   Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Fatigue
Clinical narrative: she lost her taste and smell; she lost her taste and smell; tired; This is a spontaneous report received from contactable consumer (patient) via a Pfizer sponsored program.  A female patient of unspecified age received the first dose of bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration on 30Jan2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021 (reported as Saturday), the patient felt tired and on 01Feb2021 yesterday (as per report) she lost her taste and smell and asked if that is normal. The outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: after the first dose which is her arm is sore; light headedness; This is a spontaneous report from a Pfizer Sponsored Program Pfizer First Connect. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced some side effects few hours after the first dose which is her arm is sore and she had light headedness. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: hip pain; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (COMIRNATY, Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on 02Feb2021 at afternoon as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date after vaccination, the patient experienced hip pain. Outcome of the event was unknown.  Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Experienced Arm Numbness; This is a spontaneous report received from a contactable consumer via Pfizer-sponsored program. A female patient of unspecified age received first dose of BNT162B2 (Solution for injection, lot number and Expiration date: unknown), via an unspecified route of administration, on 02Feb2021 as a single dose for COVID-19 immunisation. The patients medical history and concomitant medications was not reported. On 02Feb2021 (today), the patient had experienced arm numbness after taking the 1st dose of the vaccine. The outcome of the event was reported as unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms after the second dose; This is a spontaneous report from a non-contactable physician. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number and Expiration date: Not reported), via an unspecified route of administration on an unspecified date as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu like symptoms after the second dose but simply rested on the couch watched some tv and was fine. The clinical outcome of flu like symptoms was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Vaccination site pain
Clinical narrative: injection site pain; my neck was stiff 2 days after receiving my second dose; my left arm began to become sore as if it had been injected into the left arm again; This is a spontaneous report from a contactable Nurse reported herself. A 50-year-old non-pregnant female patient received second dose of bnt162b2 (BNT162B2- PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via intramuscular, administered in Arm Right on 30Jan2021 at 18:30, (at the age of 50 year and patient was not pregnant at the time of vaccination) as 2nd dose SINGLE DOSE for covid-19 immunisation at hospital. Medical history included hypertension, type 2 diabetes mellitus from an unknown date and unknown if ongoing, covid-19 and musculoskeletal stiffness from Nov2020 to an unknown date. Patient had known allergies. The patient's concomitant medications were not reported. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. Patient's historical vaccine includes first dose of BNT162B2 via intramuscular, administered in Left arm on 06Jan2021at 12:00 PM for COVID-19 immunization and experienced the event vaccination site pain and left arm began to become sore. The patient experienced my left arm began to become sore as if it had been injected into the left arm again on 30Jan2021, injection site pain and my neck was stiff 2 days after receiving my second dose on 01Feb2021 at 13:00. It was reported that, she received 1st vaccine in left arm and second in right arm. About 10 minutes or so after receiving the second vaccine, my left arm began to become sore as if it had been injected into the left arm again. That went away later that night. She started injection site pain the next day which lasted only a few hours, while with the 1st injection it lasted 3 or 4 days. This afternoon she noted that neck was stiff 2 days after receiving my second dose. The only reason mention that was when she was sick with covid-19 in November, the stiff neck was one of the first symptoms noticed. Since vaccination patient not tested for covid-19. Therapeutic measures were not taken as a result of the events. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Headache, Pain in extremity, Pruritus, Rash
Clinical narrative: rash; hives/Hives on her upper legs, buttocks, and stomach; Her ears were purple and inflamed; itchy; sore arm; headache; This is a spontaneous report received from a Contactable consumer. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730 and Expiration date was not reported), via an unspecified route of administration, in Arm left, on 30Dec2020, Wednesday (at the age of 53 years), as a single dose for COVID-19 immunization. The patient medical history included Blood pressure and Cholesterol. Concomitant medications included Losartan with Hydrochlorothiazide for Blood pressure, Crestor for cholesterol. There was no patient history and no Investigation Assessment. On an unknown date, the patient stated that she had a delayed reaction. Three to four days later, she developed a rash and hives. That night, on the vaccination day she developed headache and a sore arm on 30Dec2020. She doesn't know if it was related or not, but on 02Jan2021, she became itchy. On 03Jan2021, she had hives on her upper legs, buttocks, and stomach. On 03Jan2021, her ears were purple and inflamed. She was supposed to get the second shot, but she was not sure if she should or shouldn't get it. She was scheduled three weeks after her first, but didn't go because she was afraid. She works at a nursing home, and now some of the residents are getting their first shot so she has the option to get her second today. Her headache started during her sleep. She just took Advil for the headache. She still has little headaches on and off so she is unsure if they are related. It took about 3 days for the arm soreness to go away. She went to urgent care, and they gave her prednisone for 5 days. It was Friday the 8Jan2021 when she stopped itching and having hives. She didn't really want to get the vaccine in the first place but did because she works in healthcare. Outcome of the event rash was reported as unknown and headache, itchy, hives, sore arm, ear infection was reported as recovered.  Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: rash; hives/Hives on her upper legs, buttocks, and stomach; Her ears were purple and inflamed; itchy; sore arm; headache; This is a spontaneous report received from a Contactable consumer. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK5730 and Expiration date was not reported), via an unspecified route of administration, in Arm left, on 30Dec2020, Wednesday (at the age of 53 years), as a single dose for COVID-19 immunization. The patient medical history included Blood pressure and Cholesterol. Concomitant medications included Losartan with Hydrochlorothiazide for Blood pressure, Crestor for cholesterol. There was no patient history and no Investigation Assessment. On an unknown date, the patient stated that she had a delayed reaction. Three to four days later, she developed a rash and hives. That night, on the vaccination day she developed headache and a sore arm on 30Dec2020. She doesn't know if it was related or not, but on 02Jan2021, she became itchy. On 03Jan2021, she had hives on her upper legs, buttocks, and stomach. On 03Jan2021, her ears were purple and inflamed. She was supposed to get the second shot, but she was not sure if she should or shouldn't get it. She was scheduled three weeks after her first, but didn't go because she was afraid. She works at a nursing home, and now some of the residents are getting their first shot so she has the option to get her second today. Her headache started during her sleep. She just took Advil for the headache. She still has little headaches on and off so she is unsure if they are related. It took about 3 days for the arm soreness to go away. She went to urgent care, and they gave her prednisone for 5 days. It was Friday the 8Jan2021 when she stopped itching and having hives. She didn't really want to get the vaccine in the first place but did because she works in healthcare. Outcome of the event rash was reported as unknown and headache, itchy, hives, sore arm, ear infection was reported as recovered.  Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Headache, Injection site mass, Injection site pruritus, Pain
Clinical narrative: Large lump at site of injection with itching. Low body temperature 95.2-96.8 ongoing since vaccination. Body aches, chills, headache, skin pain.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin
Clinical narrative: Large lump at site of injection with itching. Low body temperature 95.2-96.8 ongoing since vaccination. Body aches, chills, headache, skin pain.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Paraesthesia
Clinical narrative: Tingling sensation around right knee, then it was developed to muscle twitching around the same area. It happened randomly. No treatment for this condition.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Chest pain, Cough, Echocardiogram, Electrocardiogram
Clinical narrative: Acute pericarditis - cough and chest pain for 2 days prior to ED visit with diagnosis. Improved over time with treatment via colchicine.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pericarditis, Troponin
Clinical narrative: Acute pericarditis - cough and chest pain for 2 days prior to ED visit with diagnosis. Improved over time with treatment via colchicine.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein normal, Chest pain, Dyspnoea, Red blood cell sedimentation rate increased, Troponin I increased
Clinical narrative: Possible myocarditis (progressive chest pain and dyspnea starting the day of the second vaccine), currently 9 days out with lab results as listed below.  At the time of this submission, patient is being admitted to the hospital for further diagnostic work-up, to include echocardiogram and cardiac MRI.  He
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: All dairy products have a strong odor too them, lackluster and taste spoiled.  Member had this reaction after first dose and states second dose made it worse.  Member did also have covid positive in January.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Oxygen saturation, Oxygen saturation abnormal
Clinical narrative: anxious; her oxygen levels have been lower than usual/Oxygen dropping; This is a spontaneous report from a contactable consumer (patient, self-reported). A 67-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9263 and expiry date: May2021), via an unspecified route of administration, in Arm Left, on 27Jan2021, as a single dose for COVID-19 immunization. The patient's medical history included ongoing diabetes from 2020 and COPD from 2018. Concomitant medication included prednisone. The patient took COVID vaccine because she believes science was safe; anything was better than how things were now. The patient said she had COPD. She was on oxygen 24/7. 3 Liters in day and 4 Liters at night. She had the first dose of the Pfizer vaccine on 27Jan2021 and was scheduled for the second on 17Feb2021. At first, she had no reaction that she knew of. Then 4 days ago, on 05Feb2021, she was on the exercise bike and she noticed her oxygen dropped lower than usual, which it did, but it dropped quickly and was very slow to recover. She waited a few minutes and it just kept dropping. Now it still drops, even with little exercise- like walking across to another room. It has gotten as low as 90. She was unsure if it was connected with the vaccine or not. She will be seeing her new doctor at the end of the month, and she was getting a CT scan this week. Her new doctor she sees on 22Feb2021. She was wondering if this was something that Pfizer was finding. The patient confirmed that she had COPD and was already on oxygen prior to getting the Pfizer Vaccine. This was still occurring, and she thought so far it has stayed the same. She has not gotten back on the exercise bike yet. She was anxious too. She will be getting a full blood workup. Again, she was unsure if this was related to the vaccine, or if her condition was deteriorating, which she knew at some point it will. The patient said about Prednisone that she will not increase this until discussing with her doctor and investigating this aspect. At one point she had stopped the Prednisone because her blood sugar levels went up. But when she stopped it, it did not make a difference, so she went back on. But she only went back to taking it every other day, instead of everyday like she was. So, she has been taking it every other day for the last 4-5 months she thinks. She has been fine. Maybe she will be diagnosed with Alzheimer's. Outcome of the event anxious was unknown and for another event, it was not recovered.  Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Feel sleepy; Arm pain; This is a spontaneous report from a contactable consumer (patient) communicated through Pfizer sponsored program.   A 75-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date (75-year-old at the time of vaccination) as unknown, single dose for COVID-19 immunization. The patient's medical history was not reported. The concomitant medications included Tofacitinib citrate (XELJANZ XR) at 11 mg. During inbound call from the patient, the patient stated that the Pfizer Covid vaccine, patient experienced feel sleepy, arm pain. Patient was not transferred to Pfizer Safety. Patient was prescribed Xeljanz XR 11mg. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Peripheral coldness, Vaccination site pain
Clinical narrative: Soreness at injection site; dizziness; nausea (vomited once); nausea (vomited once); cold hands; slight chills; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9262) via an unspecified route of administration on 30Jan2021 at 14:00 in left arm as 1st dose, single dose for COVID-19 immunization. Medical history included epilepsy, elev. cholesterol (contr. By meds.). Concomitant medication included phenytoin, atorvastatin. Prior to vaccination, patient was not diagnosed COVID. Patient did not receive any other vaccine in four weeks. On 31Jan2021 at 04:30 PM, patient experienced soreness at injection site, dizziness, nausea (vomited once), cold hands, slight chills. No treatment was received for the adverse events. Patient had not been COVID tested post vaccination. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Soreness at injection site; dizziness; nausea (vomited once); nausea (vomited once); cold hands; slight chills; This is a spontaneous report from a contactable consumer (patient). A 69-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EL9262) via an unspecified route of administration on 30Jan2021 at 14:00 in left arm as 1st dose, single dose for COVID-19 immunization. Medical history included epilepsy, elev. cholesterol (contr. By meds.). Concomitant medication included phenytoin, atorvastatin. Prior to vaccination, patient was not diagnosed COVID. Patient did not receive any other vaccine in four weeks. On 31Jan2021 at 04:30 PM, patient experienced soreness at injection site, dizziness, nausea (vomited once), cold hands, slight chills. No treatment was received for the adverse events. Patient had not been COVID tested post vaccination. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This is a spontaneous report from a contactable consumer (Patient).   A 52-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number: EL92G1, Expiration Date: not reported) via an unspecified route of administration on 26Jan2021 as 2nd dose, single dose and via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported and known allergies were none. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced extreme fatigue on an unspecified date. Patient did not received any treatment for the event. The outcome of the event was recovered on an unspecified date.  Information on batch/lot number was requested.  As of 30Mar2021, lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Vaccination site reaction
Clinical narrative: Muscle twitching at site of injection; Muscle twitching at site of injection; This is a spontaneous report from a Non-contactable consumer. A 30-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number:EL9262) via an unspecified route of administration in the left arm on 29Jan2021 at 12:30 PM (at the age of 30-year-old) as single dose for COVID-19 immunization. The patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EL1283) via an unspecified route of administration in the left arm on 08Jan2021at 12:30 PM as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included multivitamins taken for an unspecified indication start date and stop date was not provided. The patient had no known allergies. On 02Feb2021 at 05:00 PM, the patient experienced muscle twitching at site of injection intermittently continues for minutes. The patient did not received treatment for the adverse event. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient was not tested for covid post vaccination. The outcome of both events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Musculoskeletal stiffness, Neck mass, Neck pain, Swelling
Clinical narrative: felt a bump in my right neck located on the supraclavicular area on my neck; I felt another bump at the back of my right ear; makes my neck stiff a little bit; swollen and painful for like 4-5 days; swollen and painful for like 4-5 days; This is a spontaneous report from a contactable Nurse(patient).  A 39-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number was not reported) via intramuscular, administered on upper Arm Right on 18Jan2021 18:00 (age at vaccination: 39 years) as Single for COVID-19 immunization at Hospital. The patient Medical history included diabetes mellitus. No known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient Concomitant medications in two weeks included metformin (MANUFACTURER UNKNOWN); glimepiride (MANUFACTURER UNKNOWN). The patient has not received any other vaccines within four weeks. On 20Jan2021 18:00, the patient experienced 3-4 days after felt a bump in her right neck located on the supraclavicular area of her neck. It was swollen and painful for like 4-5 days. Today she felt another bump at the back of her right ear. It is a little sore and makes her neck stiff a little bit. She was not concerned of getting the second dose on 08Feb as this side effects had been happening to her. Therapeutic measures were taken as a result of event and included treatment with over the counter Tylenol. The outcome of the events was not recovered.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Epistaxis, Fatigue, Vaccination site pain
Clinical narrative: Sore at injection site; Bloody nose; Diarrhea; Fatigue; This is a spontaneous report from a non-contactable consumer (patient).  This 44-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EM9810), via an unknown route, on 02Feb2021 11:30 (at the age of 44-year-old) as single dose for COVID-19 immunisation, administered at hospital. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. The patient did not have a relevant medical history and concomitant medications. On 03Feb2021 at 10:00, the patient developed sore at injection site, bloody nose, diarrhea, and fatigue. The patient was not treated for the events. The patient had recovered from the events on unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Inflammation, Nausea
Clinical narrative: Nausea; Vomiting; diarrhea; headache; inflammation; fatigue; This is a spontaneous report from a non-contactable other healthcare professional (Patient).  A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. Medical history included allergies: shellfish, cashews, a few antibiotics. Concomitant medications included ergocalciferol (VIT D), melatonin, zinc and vitamin c (ascorbic acid). The patient did not receive any vaccination within 4 weeks of covid vaccine administration. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021, at 18:00 the patient experienced Nausea, Vomiting, diarrhea, headache, inflammation and fatigue. There was no treatment received for reported events. Outcome of the events Nausea, Vomiting, diarrhea, headache, inflammation and fatigue was reported as recovering.  No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nausea; Vomiting; diarrhea; headache; inflammation; fatigue; This is a spontaneous report from a non-contactable other healthcare professional (Patient).  A 53-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunisation. Medical history included allergies: shellfish, cashews, a few antibiotics. Concomitant medications included ergocalciferol (VIT D), melatonin, zinc and vitamin c (ascorbic acid). The patient did not receive any vaccination within 4 weeks of covid vaccine administration. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Jan2021, at 18:00 the patient experienced Nausea, Vomiting, diarrhea, headache, inflammation and fatigue. There was no treatment received for reported events. Outcome of the events Nausea, Vomiting, diarrhea, headache, inflammation and fatigue was reported as recovering.  No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: More tired than normal in the afternoon following the injection; Body aches and soreness; A 26-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 02Feb2021 09:00 (at the age of 26-years-old) as 2nd dose, single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included Vitamin C (ASCORBIC ACID) and Multivitamins (MULTIVITAMINS [VITAMINS NOS]) for women taken for an unspecified indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported) on 12Jan2021 09:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 02Feb2021, it was reported that patient was more tired than normal in the afternoon following the injection. Body aches and are soreness the next morning. Subsided by midday the day after injection. Tiredness and arm soreness more pronounced than with 1st injection. No treatment was given for the events. Outcome of the events was recovered on an unspecified date.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Discomfort, Rhinorrhoea, Throat irritation
Clinical narrative: Discomfort; tickle in throat; minimal mild cough that is not constant; slight runny nose; This is a spontaneous report from a contactable other health care professional (patient). A 41-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in arm left on 01Feb2021 at 15:00 as single dose for COVID-19 immunisation. The patient medical history included COVID. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no known allergies. On 02Feb2021, the patient experienced discomfort, tickle in throat, minimal mild cough that is not constant and slight runny nose not constant just brief episode. Therapeutic measures were taken as a result of events included cough drop. The outcome of all the events was unknown.  Follow-up attempts completed. No further information expected.