chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Peripheral swelling, Vaccination site discolouration
Clinical narrative: left arm was swelling/his arm swelled up all this week; had some shoulder pain/shoulder hurt all week; his arm has a mustard looking color about 3- 4 inches long on his left arm which is where the vaccine was injected; it is making it kind of hard to sleep; This is a spontaneous report from a contactable consumer (patient himself). An 83-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH COVID-19 Vaccine), via an unspecified route of administration in the left arm on 18Jan2021 as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient stated that a couple of days after the administration of the first dose of the Pfizer COVID vaccine, on an unspecified date, he noticed his left arm was swelling and he had some shoulder pain. His arm swelled up and his shoulder hurt all that week and it started to go down. According to him, it was also kind of making it hard to sleep on an unspecified date. He also stated that his arm had a mustard looking color about 3- 4 inches long (also reported as across) on his left arm which was where the vaccine was injected and he can see where the injection was. The patient would like to know if this was normal and if he has to worry about it. He was scheduled for the second dose on 12Feb2021 and he will get the second dose on the right arm at that time. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Contusion, Epistaxis, Haemoptysis, International normalised ratio, Mouth haemorrhage
Clinical narrative: bleeding in her mouth/bleeding from her mouth and nose; nasal bleeding/bleeding from her mouth and nose; when she spit blood come out; bruise; This is a spontaneous report from a contactable nurse. This Nurse reported for an 83-year-old female patient (mother). An 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 immunisation and warfarin (COUMADIN) via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose as  blood thinner. Patient's medical history and concomitant medications were not reported. On an unknown date, caller asked if the patient (mother) should receive the second dose of the vaccine if she has bleeding in her mouth at night and nasal bleeding. Reporter mentioned that the patient takes Coumadin but has never had bleeding until now. It was reported that the patient had a normal INR prior to getting the vaccine but started having bleeding from her mouth and nose after she received the first vaccine dose. Patient's after having the vaccine was 3.1 The reporter asked for more information about patient's on blood thinner. Reporter also asked for information about if the second vaccine dose is given more than 21 days apart. It was then clarified that patient got the Covid vaccine on Saturday (unspecified date) at 1:00. Reporter stated that the patient had bleeding in her mouth that night. Stated that on Monday (unspecified date) patient had another bleeding during the night and when she spit blood come out. Reporter called just now and mentioned that patient had nasal bleeding. Stated that the patient never had bleeding before and that patient had been on blood thinners for years. Stated that sometimes, the patient had bruise. It was also reported that patient's INR was 3.1 before the Covid vaccine which is in acceptable range. Reporter mentioned that she is not sure if patient should have the second dose. Stated that she is on a low dose of warfarin. Outcome of the events was unknown.  Information on Lot/Batch has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip blister, Pain
Clinical narrative: Lip blistering; Severe headache; body aches; This is a spontaneous report from a contactable healthcare professional. A female patient of an unspecified age received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration on the left arm on 19Jan2021 at a single dose for COVID-19 immunization. Medical history included high blood pressure and allergies penicillin. The patient is not pregnant. Concomitant medication included felodipine and losartan. The patient received the first dose of BNT162B2 on 30Dec2020 06:30, lot number: EL1283 for COVID-19 immunization. The patient experienced lip blistering, severe headache and body aches on 20Jan2021 15:00. The outcome of the event was not recovered.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Feeling hot, Heart rate, Heart rate increased
Clinical narrative: felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76.  Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: felt a little dizzy; felt a wave of heat from my head to my feet; my heartrate elevated; blood pressure as 132/90; This is a spontaneous report from a contactable other healthcare professional (patient). A 40-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247 and expiration date not provided), intramuscular in the right arm on 27Jan2021 09:30 at a single dose for COVID-19 immunization. Medical history included asthma and Seasonal Allergies. The patient is not pregnant. The patient had no known allergies. The patient did not receive any other vaccine in 4 weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), fexofenadine hydrochloride (ALLEGRA), and budesonide, formoterol fumarate (SIMBICORT TURBUHALER). After receiving the vaccine on 27Jan2021 09:30, the patient walked to the waiting room, sat down and felt a little dizzy, then felt a wave of heat from her head to her feet and her heart rate elevated. This lasted for the first ~5 minutes immediately receiving the vaccine, then completely subsided. From the firefighter's report: blood pressure as 132/90 and pulse of 76.  Treatment was not provided in response to the events. The outcome of the events was recovered on 27Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, SARS-CoV-2 antibody test negative
Clinical narrative: had my antibodies tested yesterday and I don't have any; This is a spontaneous report from a contactable physician (patient). A male patient of an unspecified age received second dose of BNT162B2 (Lot/batch number and expiry date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported It was reported that the patient received the 2nd Pfizer covid vaccine 15 days ago, he had his antibodies tested yesterday and he doesn't have any. This is not related to efficacy, it's more related to not developing antibodies. It's not apart of your clinical trial study, this is more related to the developing of antibodies. He asked if there any information related to not developing antibodies. The patient underwent lab tests and procedures which included Covid-19 antibody test: negative (don't have any) on an unknown date. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Nerve compression, Pain in extremity
Clinical narrative: sharp lower back pain; pain going down his right leg; feels almost like a pinched nerve; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1283 and expiry date: unknown), via an unspecified route of administration on the left arm, on 13Jan2021 11:00 at a single dose for COVID-19 immunization. There were no medical histories. The patient's concomitant medications were not reported. Patient had been having side effects such as sharp lower back pain going down his right leg on late thursday (14Jan2021) afternoon, but probably the morning of 15Jan2021, which he never had before. It feels almost like a pinched nerve, but hasn't done anything to exert himself since he received the COVID-19 Vaccine. He did not cause this pain himself and wanted to know if anybody else has reported this. Outcome of the event was unknown.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Malaise, Myalgia
Clinical narrative: Muscle/joint pain; Muscle/joint pain; 101.6 temp; chills; sicky feeling, stayed in bed 36 hours; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263; expiry date: unknown) via an unspecified route of administration in the left arm, on 22Jan2021, at 15:45, at a single dose, for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included hydrochlorothiazide, colecalciferol (VIT D3), cetirizine hydrochloride (ZYRTEC), and azelastine hcl. The patient previously took codeine and experienced allergies (itchy skin). The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Place of vaccination was reported as "other". On 23Jan2021, at 12:00 AM, the patient experienced muscle/joint pain, 101.6 temperature (temp), chills, and sicky feeling (stayed in bed for 36 hours). The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Muscle/joint pain; Muscle/joint pain; 101.6 temp; chills; sicky feeling, stayed in bed 36 hours; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9263; expiry date: unknown) via an unspecified route of administration in the left arm, on 22Jan2021, at 15:45, at a single dose, for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications included hydrochlorothiazide, colecalciferol (VIT D3), cetirizine hydrochloride (ZYRTEC), and azelastine hcl. The patient previously took codeine and experienced allergies (itchy skin). The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. Place of vaccination was reported as "other". On 23Jan2021, at 12:00 AM, the patient experienced muscle/joint pain, 101.6 temperature (temp), chills, and sicky feeling (stayed in bed for 36 hours). The events were considered non-serious. The patient did not receive treatment for the events. Outcome of the events was recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Rash
Clinical narrative: Rash- left calf, ankle to knee; Received BNT162B2 with medical history of Psoriatic arthritis; Received BNT162B2 with medical history of Psoriatic arthritis; This is a spontaneous report from a contactable consumer (patient).  A 77-year-old male patient received his first dose of bnt162b2 (BNT162B2 also reported as COVID 19 brand Pfizer, lot EJ1686), via an unspecified route of administration in the left arm on 20Jan2021 10:15 at SINGLE DOSE for Covid-19 immunisation. Medical history included type 2 Diabetic, Psoriatic arthritis and had heart disorder, allergic to sulfa drugs. He did not received any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included warfarin, sitagliptin phosphate, aspirin (acetylsalicylic acid). The patient experienced rash in the left calf, ankle to knee on 22Jan2021 08:00 (no treatment). The outcome of event was not recovered.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, SARS-CoV-2 test
Clinical narrative: a mass on my mom chest above her left breast; This is a spontaneous report from a contactable consumer reporting for his/her mother.  A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration in the left arm on 28Dec2020 at a single dose for covid-19 immunization at a nursing home/senior living facility. Medical history included chronic obstructive pulmonary disease (COPD) and congestive heart failure. The patient has no allergies to medications, food, or other products. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), hydrocodone bitartrate, paracetamol (NORCO), mirtazapine (REMERON), cranberry, cholesterol, blood pressure meds, and stool softer. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccination. On 28Dec2020, the patient (reporter's mother) had the first shot in her left arm. On Wednesday, 30Dec2020, the reporter received a phone call from the institute informing of a mass on the patient's chest above her left breast which started on 28Dec2020. The reporter took pictures and felt it which is hard as a rock. The patient had a doctor or other healthcare professional office/clinic visit. No treatment was given. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has been tested for COVID-19 since the vaccination via nasal swab on 28Dec2020 which was negative. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Breast mass, Contusion, Joint range of motion decreased, Lymphadenopathy
Clinical narrative: Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at the left arm on 21Jan2021 09:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has previously been vaccinated with the first dose of BNT162B2 (lot number: Pfizer 1284) on 30Dec2020 11:00 at the age of 26-year-old, intramuscular at the left arm for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient experienced swollen Lymph nodes following second dose for five days, large lump underneath left armpit expanding into left breast formed and caused limited ROM, immense pain, and bruising on 21Jan2021. The patient did not receive any treatment for the events. The patient has recovered from the event swollen lymph nodes on 26Jan2021 and recovered on an unspecified date for the rest of the events.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Swollen Lymph nodes following second dose x five days; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; Large lump underneath left armpit expanding into left breast formed and caused limited ROM and immense pain and bruising; This is a spontaneous report from a contactable healthcare professional (patient). A 26-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249), intramuscular at the left arm on 21Jan2021 09:45 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has previously been vaccinated with the first dose of BNT162B2 (lot number: Pfizer 1284) on 30Dec2020 11:00 at the age of 26-year-old, intramuscular at the left arm for Covid-19 immunization. The patient was not pregnant at the time of vaccination. The patient experienced swollen Lymph nodes following second dose for five days, large lump underneath left armpit expanding into left breast formed and caused limited ROM, immense pain, and bruising on 21Jan2021. The patient did not receive any treatment for the events. The patient has recovered from the event swollen lymph nodes on 26Jan2021 and recovered on an unspecified date for the rest of the events.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic, Urticaria
Clinical narrative: Hives; itchy rash on her upper arm of the injection site; rash across her shoulder and both her chest and back and bottom of neck/it spread across her shoulder to right side of her chest, neck and upper right part of her back.; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9261, exp date not reported), via an unspecified route of administration (anatomical location: arm right) on 21Jan2021 10:45 given to protect against the virus (COVID-19 immunisation). Vaccination Facility Type: Hospital. Vaccine was not administered at military facility. Medical history included immediate, severe allergic reaction penicillin when she was a kid and she hadn't had it since. The patient had no other medical history and family medical history relevant to adverse event. The patient's concomitant medications were not reported. Patient had no other vaccines given that day or 4 weeks prior. No problems with vaccines in past. The patient was looking for guidance about getting the second dose of the Pfizer Covid vaccine. Had the first dose on 21Jan2021 (Thursday) and had no reaction until 24Jan2021, 3 days later (Sunday). That night she developed what she believed waas hives, an itchy rash on her upper arm of the injection site that spread across her shoulder and both her chest and back and there was also a rash at the bottom of her neck. The hives were still there the day of reporting and been there since.  Patient heard that when you have a severe allergic reaction to medicines in past it could be an indication. States she was not seen at the emergency room or at the doctor's office, she only called the doctor's office. They recommended her not to get the second dose, but she wanted to be sure and wanted more information. Relevant tests were not done. Patient would like to know if she should get the second dose of the covid vaccine after the reaction she experienced post 1st dose. The outcome of events was not recovered (ongoing).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling, Peripheral swelling, Pruritus
Clinical narrative: Started with itching on left neck; swelling below left eye; hands were swelling; This is a spontaneous report from a contactable consumer (patient) reported that a 65-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm on 27Jan2021 14:30 at a single dose for covid-19 immunization. The vaccine was administered at the pharmacy. Patient was not pregnant at the time of vaccination. Medical history included sarcoidosis and hypertension both from an unknown date, and one unknown anaphylaxis a year ago (2020). 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. Concomitant medication included amlodipine besylate. On 27Jan2021 16:30, it was started with itching on left neck, then swelling below left eye and hands were swelling. The patient was concerned enough she took a Benadryl. The events result in doctor or other healthcare professional office/clinic visit. Treatment received for the events was Benadryl. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Myalgia, Pain, Product use issue
Clinical narrative: 3 days of body pain; muscle aches all over body and face; muscle aches all over body and face; other vaccine same date; This is a spontaneous report from a contactable consumer (patient). This 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 22Jan2021 at 09:00 (at the age of 51-years-old) as a single dose in the left arm for COVID-19. The patient had no medical history. She was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not take any concomitant medications. The patient received another unspecified vaccine on 22Jan2021. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient previously took penicillin from an unspecified date for an unspecified indication and experienced allergy. On 23Jan2021 at 06:00, the patient experienced 3 days of body pain and muscle aches all over body and face. The patient did not receive any treatment for the events. The patient was not hospitalized for the events. The outcome of 3 days of body pain and muscle aches all over body and face was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: chills; high temperature/fever 38 C; feeling tired; headache; This is a spontaneous report from a contactable consumer (the patient). A male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 26Jan2021 (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second dose of the vaccine yesterday 26Jan2021. He experienced chills, high temperature/fever 38 C, feeling tired, and headache the day after (27Jan2021). The patient took paracetamol (TYLENOL) to manage the symptoms. He asked if these are normal side effects and was looking for recommendations. The clinical outcome of chills, high temperature/fever 38 C, feeling tired, and headache was unknown.   Information about Lot/batch number requested.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Pain in extremity
Clinical narrative: very sore arm; very uncomfortable; This is a spontaneous report from a contactable consumer. An adult female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 26Jan2021 at a single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient is not pregnant at the time of vaccination. On 27Jan2021, the patient experienced very sore arm- had to have vaccine in dominant arm. The patient added that after 24 hours she was very uncomfortable. The events were assessed non-serious. The patient has not been diagnosed with Covid prior to vaccination and has not tested positive since the vaccination.  Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue
Clinical narrative: Burning right arm; fatigue; This is a spontaneous report from a contactable other healthcare professional (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 11Jan2021 09:30 at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. On 15Jan2021, the patient experienced burning right arm and fatigue. Treatment was received for the adverse events which included MRI, NCS, Blood work. The events resulted to a doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There were no other medications the patient received within 2 weeks of vaccination. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Urticaria
Clinical narrative: Itchy neck, arms, lower half of face; Hives on both arms.; Burning headache; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot number: EL8982), via an unspecified route of administration in the right arm on 27Jan2021 08:45 at a single dose for covid-19 immunization. Medical history included hypothyroid, allergies to nausea medication and COVID 19. Concomitant medication included levothyroxine. On 27Jan2021 12:00, the patient experienced itchy neck, arms, lower half of face., hives on both arms and burning headache. The patient did not receive treatment for the events. The events were assessed non-serious. The outcome of the events was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; This is a spontaneous report from a contactable Other Health Professional that reported for herself.  A 25 year old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 on 26Jan2021 09:00, as single dose (at the age of 25 years) via unspecified route in left arm for COVID-19 immunisation. The patient medical history was not reported.  Concomitant medication includes fluoxetine (FLUOXETINE).  Historical vaccine included dose one of BNT162B2, lot number EL0142, on 07Jan2021 11:30, unspecified route, vaccine location Left arm for COVID-19 immunization. The patient did not have Allergies to medications, food, or other products.  The patient was not pregnant at the time 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.  The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.  On 26Jan2021 at 20:00 the patient experienced chills, fever, muscle aches and nauseous. The patient vomited twice. No treatment was given.  The patient is recovering from Chills, fever, muscle aches and nauseous as well as vomited twice.  The case was reported as non-serious by the reporter.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; Chills, fever, muscle aches and nauseous. Vomited twice; This is a spontaneous report from a contactable Other Health Professional that reported for herself.  A 25 year old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL9262 on 26Jan2021 09:00, as single dose (at the age of 25 years) via unspecified route in left arm for COVID-19 immunisation. The patient medical history was not reported.  Concomitant medication includes fluoxetine (FLUOXETINE).  Historical vaccine included dose one of BNT162B2, lot number EL0142, on 07Jan2021 11:30, unspecified route, vaccine location Left arm for COVID-19 immunization. The patient did not have Allergies to medications, food, or other products.  The patient was not pregnant at the time 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.  The patient did not receive other vaccines within 4 weeks prior to the COVID vaccine.  On 26Jan2021 at 20:00 the patient experienced chills, fever, muscle aches and nauseous. The patient vomited twice. No treatment was given.  The patient is recovering from Chills, fever, muscle aches and nauseous as well as vomited twice.  The case was reported as non-serious by the reporter.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash face and neck; This is a spontaneous report from a contactable Other Health Professional that reported for herself.  A 53-year-old female patient received dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL8982 on 22JAN2021 15:00, as single dose (at the age of 53 years) via unspecified route in left arm for COVID-19 immunisation. The patient medical history was none. Concomitant medication was not reported. The patient was not pregnant at the time of vaccination.  There were no allergies to medications, food, or other products.  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.  Since the vaccination, the patient has not been tested for COVID-19. On 26Jan2021 at 06:00 the patient experienced Rash face and neck.  The patient received treatment (Benadryl and aloe).  The outcome rash face and neck are recovering. The case was reported as non-serious by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Ocular hyperaemia, Off label use, Rash
Clinical narrative: Eyes bloodshot; Rash over entire body...arms, legs, abdomen, back, neck; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; dose number= 1, administration date= 06Jan2021/dose number= 2, administration date=20Jan2021; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 20Jan2021 07:45 at single dose for COVID-19 immunization. Medical history included hypothyroidism. The patient was not pregnant at the time of vaccination. Concomitant medication included thyroid (WP THYROID), methocarbamol, and paracetamol (TYLENOL). The patient has known allergies to cefalexin (KEFLEX) and statins. The patient was previously vaccinated with the first dose of BNT162B2 on 06Jan2021 07:45 at the age of 61-year-old intramuscular at the right arm for COVID-19 immunization. The patient experiences rash over entire body, arms, legs, abdomen, back, neck, not on the face yet and eyes bloodshot; symptoms appeared over 8-hour period beginning at 7 am on 26Jan2021. The patient did not receive any treatment for the events. The outcome of the events rash over entire body and eye bloodshot were not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: fingers were numb and tingling; 12 hours post 2nd dose the left side of patient face and left ear were numb as well as both arms and both legs/fingers were numb and tingling; This is a spontaneous report from a contactable consumer. A 23-year-old female patient (not pregnant) received the second dose of bnt162b2 (BNT162B2 also reported as BIONTECH Covid vaccine, lot EL3247), via an unspecified route of administration in the left arm on 25Jan2021 at SINGLE DOSE for Covid-19 immunisation. The patient's medical history was not reported.  There were no concomitant medications. She received her first dose of bnt162b2 (lot EK9231) on 05Jan2021 in the left arm. On 26Jan2021, the left side of patient's face and left ear were numb as well as both arms and both legs and 800mg of ibuprofen was taken. Next morning (27Jan2021), the numbness in legs gone but the left arm from shoulder to fingers were numb and tingling. The outcome of events was recovered.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Off label use, Paraesthesia, Product use issue
Clinical narrative: patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse received Pfizer Covid 19 vaccine; Paresthesias to bilateral hands to elbows, right foot/leg; brain fog; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK-5730; expiration date: unknown) at 39-year-old age of vaccination intramuscularly in the left arm on 26Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included myelitis transverse from 2015 to an unknown date and depression. The patient has no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive other vaccine in four weeks but has other medications in two weeks. It was reported that the patient with myelitis transverse received Pfizer Covid 19 vaccine on 26Dec2020. On Dec2020, the patient had paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. Symptoms appeared approximately 12-18hrs after injection. There was no treatment receive for the adverse events. The events resolved 48 hours after. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test) with the result of negative on 22Jan2021. The outcome of the events was recovered on Dec2020.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: patient with myelitis transverse received Pfizer Covid 19 vaccine; patient with myelitis transverse received Pfizer Covid 19 vaccine; Paresthesias to bilateral hands to elbows, right foot/leg; brain fog; fatigue; This is a spontaneous report from a contactable nurse (patient). A 39-year-old female patient received her first dose of bnt162b2 (BNT162B2 reported as PFIZER COVID 19 VACCINE; lot number: EK-5730; expiration date: unknown) at 39-year-old age of vaccination intramuscularly in the left arm on 26Dec2020 11:30 at a single dose for covid-19 immunization. Medical history included myelitis transverse from 2015 to an unknown date and depression. The patient has no known allergies. The patient was not diagnosed with covid-19 prior to vaccination. The patient did not receive other vaccine in four weeks but has other medications in two weeks. It was reported that the patient with myelitis transverse received Pfizer Covid 19 vaccine on 26Dec2020. On Dec2020, the patient had paresthesias to bilateral hands to elbows, right foot/leg with brain fog and fatigue. Symptoms appeared approximately 12-18hrs after injection. There was no treatment receive for the adverse events. The events resolved 48 hours after. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test) with the result of negative on 22Jan2021. The outcome of the events was recovered on Dec2020.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hypoacusis, Muscle spasms, Nausea
Clinical narrative: she has a hearing problem; Constant chills; Cramps; Diarrhea; Nausea; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3248) via an unspecified route of administration on 25Jan2021 10:30 on the left arm at a single dose for COVID-19 immunization. The patient had no medical history. There were no concomitant medications. The patient stated that she did not experience any problems until 27Jan2021 around noon, in which she started experiencing chills, cramps, and diarrhea all afternoon. She would like to know if these reactions have been reported and if they continue to persist, can she take something like Imodium. She didn't have any effect at all from it on Monday or Tuesday, and at noon on 27Jan2021, she had nausea and constant chills and diarrhea, she doesn't think this was a side effect, but wanted to check and see. She was not terribly ill, just uncomfortable, is this something she should be reporting? Stated she has a hearing problem, wished for DSU agent to speak slower. Nausea: was off and on all the time since noon today, it is better, the main thing is diarrhea, and the nausea is connected Constant chills: improving, it came and went all afternoon, she doesn't know if it has gone away, she thinks it is still here, but she is not constantly bothered, it has been periodically since noon today. Diarrhea: better since she has nothing left; nothing was getting worse, she was reporting it because she thought it may be a side effect. Outcome of the events constant chills and nausea was recovering, diarrhea was recovered on an unspecified date while unknown for the other events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pharyngeal swelling, Swelling face, Swollen tongue, Urticaria
Clinical narrative: Tongue and throat swelling; Tongue and throat swelling; not able to breathe; right and left sided face swelling; hives from top of head to lower extremities; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 07Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tongue and throat swelling and took diphenhydramine (BENADRYL). Patient was also not able to breathe, had right and left sided face swelling, and hives from top of head to lower extremities. Patient reported that the doctor gave her an epi pen. Patient would like to know if she should get second dose. She is scheduled to receive second dose on 28Jan2021 also if she should get a pneumonia vaccine and was instructed to wait 14 days after the Pfizer Biotech Covid-19 vaccine administration. Outcome of the events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Pain, Swelling face
Clinical narrative: Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; Swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number: EL3247, unknown expiration), via an unspecified route of administration in right arm on 19Jan2021 at a single dose for COVID-19 immunization in a workplace clinic.  Medical history included hypothyroidism, idiopathic thrombocytopenic purpura (ITP), and previously administered dermal fillers in Jun2020.  The patient has no allergies to medications, food, or other products. Concomitant medications included levothyroxine, tamoxifen, and vitamin D.  The patient also received her first dose of BNT162B2 (lot number: EJ1685, unknown expiration) for COVID-19 immunization in right arm on 29Dec2020. The patient experienced swelling in the area of eyes and cheeks of previously administered dermal fillers (dermal fillers injected around Jun20) and pain, some redness on 21Jan2021. The patient received steroids and antihistamines. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient recovered from the events on unspecified date. The events were assessed as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Just a lot of soreness. After 2 hours I began to have a lot of pain; I was even having trouble raising my arm up because of the pain/soreness; I was even having trouble raising my arm up because of the pain/soreness; This is a spontaneous report from a contactable healthcare professional (patient). A 22-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL8982), intramuscular on 21Jan2021 10:00 at single dose (left arm) for covid-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food or other products and patient was not pregnant. There were no concomitant medications. On 21Jan2021, 12:00, the patient experienced a lot of soreness. After 2 hours, she began to have a lot of pain for the rest of the day. That same night, she was even having trouble raising her arm up because of the pain/soreness, but by the next day the soreness went a lot more down. There was no therapy for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and had no other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient underwent lab tests and procedures which included Sars covid test (Nasal Swab/Rapid Antigen) was negative on 22Jan2021. Outcome of events was recovered on an unspecified date.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Patchy red skin on both thighs. Slightly itchy.; Patchy red skin on both thighs. Slightly itchy.; This is a spontaneous report from a contactable consumer. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot and expiry not reported), via an unspecified route of administration on 21Jan2021 at 09:45 at a single dose on left arm for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced patchy red skin on both thighs, slightly itchy on 21Jan2021. Therapeutic measures were taken as a result of both events (steroid cream). The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Fatigue, Headache, Herpes zoster, Malaise
Clinical narrative: She started experiencing burning; Rash; Shingles; itching; Headache; Malaise; very tired; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: E13247) via an unspecified route of administration on 19Jan2021 11:30 at a single dose for COVID-19 immunization. Medical history included A-fib. Concomitant medication included apixaban (ELIQUIS). Had COVID-19 Vaccine on 19Jan2021 and everything was fine. Had a headache and a little bit of malaise on 20Jan2021. After two days was ok. On 21Jan2021, broke out in what she thinks was shingles. Not 100% sure if it was a major rash or shingles. Wanted to know if that was a possible side effect. Patient was taking Valaciclovir (VALTREX) for Shingles. Doctor suspected it was shingles, but it was possible she had shingles brewing before the COVID-19 Vaccine or the COVID-19 Vaccine brought the shingles out. Second COVID-19 Vaccine is scheduled for 09Feb2021, patient was scared and afraid of it. Doesn't know what to do. On 20Jan2021 she was very tired and had a headache. Next day was ok. On 21Jan2021 thought she had bug bites. Started itching. Then it began traveling and she realized it was not bug bites. She started experiencing burning. Went to two Urgent Care and her Internist. Was told it was basically shingles. Her internist was on the fence because she just had the COVID-19 Vaccine and wasn't certain. Caller stated it was ironic that she broke out after the vaccine. Caller's internist stated for any rash it would be treated the same with Valtrex. Internist stated chances were the rash was viral so if it's not shingles, would be treated with Valtrex. Rash and Itching: Wasn't very bad on Saturday, 23Jan2021, which was the first time she had someone look at it. On Sunday, 24Jan2021 it was full blown and really blossomed. Was initially treating rash as if it was bug bites. Was applying Benadryl tropical. On Sunday, 24Jan2021, started taking Valtrex. Outcome of the events headache, malaise, fatigue was recovered on n unspecified date, while unknown for the other events.