chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, SARS-CoV-2 test negative
Clinical narrative: Headache, fatigue, chills, dizziness, lightheadedness worsening not getting better; Headache, fatigue, chills, dizziness, lightheadedness worsening not getting better; Headache, fatigue, chills, dizziness, lightheadedness worsening not getting better; Headache, fatigue, chills, dizziness, lightheadedness worsening not getting better; This is a spontaneous report from a contactable Other Health Professional (patient). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EH9899), via an unspecified route of administration on 22Dec2020 13:30 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. The patient medical history was not reported.  The patient was not allergies to medications, food, or other products. There was no other vaccine received by the patient within 4 weeks prior to the COVID vaccine. Concomitant medication included emtricitabine, tenofovir alafenamide fumarate (DESCOVY), finasteride, gabapentin. The patient experienced headache, fatigue, chills, dizziness, light-headedness worsening not getting better on 22Dec2020 14:30. The patient was not received treatment for these events. The patient did not have Covid prior vaccination. Covid tested post vaccination via Nasal Swab on 23Dec2020 was Negative. The outcome of the events was not recovered.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site swelling
Clinical narrative: Swelling at injection site - roughly golf ball size, lasted about 12 hours; Slight chills roughly 4 hours post injection - lasted about 8 hours.; This is a spontaneous report from a contactable healthcare professional (patient). A 77-year-old non-pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Lot number: EK9231), via an unspecified route of administration at left arm on 24Dec2020 10:00 at a single dose for COVID-19 immunisation. The patient received COVID-19 vaccine in a hospital facility. Medical history included known allergies to penicillin and bee/wasp stings. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included thyroid (ARMOUR THYROID), rabeprazole, vitamin d3, and acetaminophen. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Dec2020 14:00, the patient experienced swelling at injection site - roughly golf ball size, lasted about 12 hours. The patient also experienced slight chills roughly 4 hours post injection and lasted about 8 hours. The patient did not receive treatment for the adverse events. The outcome of the event vaccination site swelling was recovered on 25Dec2020 02:00, while for chills was recovered on 24Dec2020 22:00.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Malaise, Nausea, Pain
Clinical narrative: Fever/ as high as 101; body aches; nausea; headache; arm pain; Malaise; slight pain at the injection site; This is spontaneous report from a contactable nurse (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 15Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included hypertension (HTN), COVID-19 diagnosed prior to vaccination in 2020, known allergies: NKDA. The patient's concomitant medication was not reported. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 15Dec2020 18:00, the patient reported he started running fever several hours after the vaccination that last throughout the next day (16Dec2020) going as high as 101, body aches, nausea, headache, arm pain which was expected for him, and malaise. He felt great on the second after the shot with all symptoms resolved besides slight pain at the injection site. No treatment was received for the adverse events. The events were non-serious per the reporter. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Dec2020.  Information about the lo/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Fever/ as high as 101; body aches; nausea; headache; arm pain; Malaise; slight pain at the injection site; This is spontaneous report from a contactable nurse (patient). A 31-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 15Dec2020 15:00 at single dose for COVID-19 immunization. Medical history included hypertension (HTN), COVID-19 diagnosed prior to vaccination in 2020, known allergies: NKDA. The patient's concomitant medication was not reported. The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 15Dec2020 18:00, the patient reported he started running fever several hours after the vaccination that last throughout the next day (16Dec2020) going as high as 101, body aches, nausea, headache, arm pain which was expected for him, and malaise. He felt great on the second after the shot with all symptoms resolved besides slight pain at the injection site. No treatment was received for the adverse events. The events were non-serious per the reporter. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was recovered in Dec2020.  Information about the lo/batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dental examination normal, Oral pain, X-ray dental normal
Clinical narrative: I experienced excruciating pain in my mouth.; This is a spontaneous report from a contactable pharmacist reporting for a herself. A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot # EK5730) via intramuscular in right arm on 16Dec2020 07:00 AM at single dose for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient received the vaccine in hospital. The patient medical history was not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received medications within 2 weeks of vaccination included birth control only. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced excruciating pain in her mouth at 17:00 on 20Dec2020. It lasted for four days. The patient visited a dentist, x rays and exam found no infection, no cavities, and no inflammation. Methylprednisolone (MEDROL) dose pack and antibiotic were given even though nothing was found. The event resulted in "doctor or other healthcare professional office/clinic visit". Since the vaccination, the patient had not been tested for COVID-19. The outcome of event was recovering.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: chills; malaise; This is a spontaneous report from a contactable physician (patient). A 39-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685), intramuscularly on 23Dec2020 at single dose on right arm for COVID-19 immunization. Medical history was reported as none. Concomitant medication included escitalopram. The patient received the vaccine on Wednesday and has been experiencing chills and general malaise since Thursday (24Dec2020), Friday and then 26Dec2020. The patient took ibuprofen 25Dec2020 as the treatment. The events outcome was not recovered. The paitent would like to know how long the symptoms would last and at what point should he be tested for COVID.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Fatigue, Limb discomfort, Nausea, Vomiting
Clinical narrative: vomiting profusely and missed work; vomiting profusely and missed work; Nausea; stomach pain/ stomach hurt; fatigue; sore arm; This is a spontaneous report from a contactable consumer.  A 57-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: Unknown), via an unspecified route of administration on 23Dec2020 at 11:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. There were no concomitant medications. On 23Dec2020, the patient experienced: sore arm (non-serious). On 25Dec2020 at 05:00, the patient experienced: vomiting profusely and missed work (non-serious), nausea (non-serious), stomach pain/ stomach hurt (non-serious), and fatigue (non-serious). The clinical course was reported as follows: The consumer called on behalf of the patient (his wife). The 57-year-old patient had a reaction to the COVID-19 vaccine and was reported to the Pfizer Drug Safety Unit. The patient received her vaccine on 23Dec2020 at 11:00. The patient initially had no symptoms other than a sore arm (for 40 hours as reported). Then, 41 hours later, at 05:00 on 25Dec2020, the patient began vomiting profusely and missed work. It lasted several hours with nausea, stomach pain, and fatigue. At the time of the report, the patient seemed fine. The consumer further reported: "I have a question, I looked at the data of the original participants and looked at the side effects and I'm a little confused as to my wife had the vaccine the other day she is an ICU nurse." The consumer reported that the patient was fine; she had a sore arm for 40 hours and she woke up in the morning "at 41 hours" vomiting profusely. The patient had to miss work and her stomach hurt. The clinical outcome of the event was recovered on 26Dec2020.  The batch/lot numbers for the vaccine, bnt162b2, were not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Candida infection, Tongue discomfort
Clinical narrative: my tongue started burning and I developed thrush symptoms. On the tongue only.; my tongue started burning and I developed thrush symptoms. On the tongue only.; This is a spontaneous report from a contactable healthcare professional.  A 53-year-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular on the left arm on 23Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "on 24Dec2020, my tongue started burning and I developed thrush symptoms. On the tongue only".  The patient received no treatment. The outcome of recovered with sequelae.   Information about lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cyanosis, Fatigue, Headache, Injection site pain
Clinical narrative: Fingers and hands turned blue in certain areas; Head, neck, and shoulders extremely sore and achy; Head, neck, and shoulders extremely sore and achy; Head, neck, and shoulders extremely sore and achy; Extremely tired; Pain/burning about an inch under the shot site down to elbow for a few hours after receiving vaccine; This is a spontaneous report from a contactable Other HCP (patient).  A 29-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), intramuscular in arm left on 21Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included hydromyelia. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient previously took pregabalin and experienced 'Known allergies: Pregabalin'.  Pain/burning about an inch under the shot site down to elbow for a few hours after receiving vaccine on 21Dec2020 16:30. Day 1 (22Dec2020)- Extremely tired. Day 2 (23Dec2020)- head, neck, and shoulders extremely sore and achy. Day 3 (24Dec2020)- fingers and hands turned blue in certain areas. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Case was non-serious.The outcome of the events was recovering.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain
Clinical narrative: Fingers and hands turned blue in certain areas; Head, neck, and shoulders extremely sore and achy; Head, neck, and shoulders extremely sore and achy; Head, neck, and shoulders extremely sore and achy; Extremely tired; Pain/burning about an inch under the shot site down to elbow for a few hours after receiving vaccine; This is a spontaneous report from a contactable Other HCP (patient).  A 29-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685), intramuscular in arm left on 21Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included hydromyelia. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported.  The patient previously took pregabalin and experienced 'Known allergies: Pregabalin'.  Pain/burning about an inch under the shot site down to elbow for a few hours after receiving vaccine on 21Dec2020 16:30. Day 1 (22Dec2020)- Extremely tired. Day 2 (23Dec2020)- head, neck, and shoulders extremely sore and achy. Day 3 (24Dec2020)- fingers and hands turned blue in certain areas. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Case was non-serious.The outcome of the events was recovering.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Aches; chills; fatigue; low grade fever; injection site swelling, pain, and redness; injection site swelling, pain, and redness; injection site swelling, pain, and redness; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), intramuscularly on 14Dec2020 at 16:45 on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included Von Willebrand disease. No known allergy, no allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced aches, chills, fatigue, low grade fever, as well as significant injection site swelling, pain, and redness on 15Dec2020 at 14:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  Information on the lot/Batch and expiration date has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aches; chills; fatigue; low grade fever; injection site swelling, pain, and redness; injection site swelling, pain, and redness; injection site swelling, pain, and redness; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date not provided), intramuscularly on 14Dec2020 at 16:45 on Left arm at single dose for COVID-19 immunization in hospital. The patient medical history included Von Willebrand disease. No known allergy, no allergies to medications, food, or other products. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced aches, chills, fatigue, low grade fever, as well as significant injection site swelling, pain, and redness on 15Dec2020 at 14:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.  Information on the lot/Batch and expiration date has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea
Clinical narrative: Reporting some side effects that I had a extremely painful migraine with the vaccine along with bad nausea too; Reporting some side effects that I had a extremely painful migraine with the vaccine along with bad nausea too; This is a spontaneous report from a contactable nurse (patient). A 25-year-old female non-pregnant patient received her first dose of bnt162b2 (COVID-19 VACCINE), via intramuscular on 24Dec2020 09:45 at single dose on right arm for covid-19 immunization. The patient had no known allergies and other medical history. The patient had not received within 2 weeks of vaccination. It was reporting some side effects that the patient had an extremely painful migraine with the vaccine along with bad nausea too on 26Dec2020. The patient was not received any treatment. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Limb discomfort
Clinical narrative: Redness in skin near injection site if any pressure is applied in area. Redness faded after 2 hours.; Fatigue; pounding headache; arm soreness; This is a spontaneous report from a healthcare professional. A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2020 13:45 at single dose for COVID-19 immunization. Medical history included allergies gluten intolerant, mildly allergic to cow's milk and autoimmune atrophic gastritis from an unknown date and unknown if ongoing. Concomitant medication included cyanocobalamin (VITAMIN B12). The facility where the most recent COVID-19 vaccine administered was in the hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 24Dec2020, the patient experienced fatigue, pounding headache, arm soreness for next 24 hours and redness in skin near injection site if any pressure is applied in area. Redness faded after 2 hours. No treatment was given to the patient for the events. The outcome of the events was recovered in Dec2020. The events were considered non serious as it did not results in death, was not life threatening, did not cause/prolonged hospitalization, was not disabling/Incapacitating and had no congenital anomaly/birth defect.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: 36 hours after vaccination, broke out in hives on each arm and torso.  Measuring 5-8mm, round, raised, red and itchy.; This is a spontaneous report from a contactable Nurse reporting for himself. A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELO142), intramuscular on 23Dec2020 12:15 at single dose for covid-19 immunization. Vaccine location was left arm and it was the first dose. The COVID-19 vaccine was administered at Hospital. Medical history included coronary artery disease (CAD), prior myocardial infarction (MI), asthma and hypertension (HTN). There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 36 hours after vaccination, broke out in hives on each arm and torso. Measuring 5-8mm, round, raised, red and itchy on 24Dec2020 23:45. No treatment received for the event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the event was not recovered.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Feeling abnormal, Headache, Heart rate increased
Clinical narrative: dizzy; insane vertigo/could barely sit up in bed and the whole room was spinning/I woke up at 6 AM and it was awful/ bad terrible vertigo; bad headache/My head hurt really, really bad; nausea/Nauseous; tachycardia/rapid heart beat; anxiety; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received first dose of BNT162B2 (Lot number: EH9899), via an unspecified route of administration in left arm on 18Dec2020 at single dose for COVID-19 immunization. There is no past medical history. The concomitant medication included vitamins. The patient took maybe couple times a week. The nurse received her first dose on Friday 18Dec2020. On Tuesday 22Dec2020 she started feeling dizzy, which then led to "insane vertigo, bad headache with nausea, could barely sit up in bed and the whole room was spinning." She also reported tachycardia/rapid heart beat and anxiety. She stated that this lasted for 4 days. She did go to Urgent Care but she had not yet spoken with her Primary Care Provider. She wanted to know if she should get the second dose, "booster shot" that was scheduled for 08Jan2021. The nurse was calling to report a possible side effects on the vaccine that received on 18Dec2020, then on 22Dec2020 night she started feeling a bit dizzy, it kind a little bit worse started maybe like 7 and went better around 10 like the room kind of like a spinning so she went to bed just a little and then she woke up at 2 AM and it was worse and then she woke up at 6 AM and it was awful. She couldn't open her eyes without, the whole room spinning she felt terrible, she was really nauseous and her head hurt really, really bad and then whole day she couldn't open her eyes and she couldn't get out of her bed because it was really bad terrible vertigo and since then every day she went to urgent care and they said just kind of wait. She had been taking meclizine and Tylenol and everyday slowly getting better just little by little so now waiting for Monday for, she was finally able to sit up and text on her phone but she still feel significantly dizzy, so her concern was that it was from the vaccine but the doctor said that was there was really no way to know and her other concern was about getting the second shot because it was really awful experience and she didn't know if it was the vaccine, it was like if she got the booster or how much worse it would be and this a little bit apprehensive getting the second shot, so she just wonder talk to somebody about that. The treatment of the events included Tylenol and Meclizine. When probed for the causality, the nurse stated "I mean I am not sure, I was thinking possibly because that's the only thing I have done differently. When probed for if the Nurse underwent any Emergency Room or Physician Office, Nurse stated she went to Urgent Care. The outcome of the events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased, Nausea, Sleep disorder, Tachycardia, Vertigo
Clinical narrative: dizzy; insane vertigo/could barely sit up in bed and the whole room was spinning/I woke up at 6 AM and it was awful/ bad terrible vertigo; bad headache/My head hurt really, really bad; nausea/Nauseous; tachycardia/rapid heart beat; anxiety; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received first dose of BNT162B2 (Lot number: EH9899), via an unspecified route of administration in left arm on 18Dec2020 at single dose for COVID-19 immunization. There is no past medical history. The concomitant medication included vitamins. The patient took maybe couple times a week. The nurse received her first dose on Friday 18Dec2020. On Tuesday 22Dec2020 she started feeling dizzy, which then led to "insane vertigo, bad headache with nausea, could barely sit up in bed and the whole room was spinning." She also reported tachycardia/rapid heart beat and anxiety. She stated that this lasted for 4 days. She did go to Urgent Care but she had not yet spoken with her Primary Care Provider. She wanted to know if she should get the second dose, "booster shot" that was scheduled for 08Jan2021. The nurse was calling to report a possible side effects on the vaccine that received on 18Dec2020, then on 22Dec2020 night she started feeling a bit dizzy, it kind a little bit worse started maybe like 7 and went better around 10 like the room kind of like a spinning so she went to bed just a little and then she woke up at 2 AM and it was worse and then she woke up at 6 AM and it was awful. She couldn't open her eyes without, the whole room spinning she felt terrible, she was really nauseous and her head hurt really, really bad and then whole day she couldn't open her eyes and she couldn't get out of her bed because it was really bad terrible vertigo and since then every day she went to urgent care and they said just kind of wait. She had been taking meclizine and Tylenol and everyday slowly getting better just little by little so now waiting for Monday for, she was finally able to sit up and text on her phone but she still feel significantly dizzy, so her concern was that it was from the vaccine but the doctor said that was there was really no way to know and her other concern was about getting the second shot because it was really awful experience and she didn't know if it was the vaccine, it was like if she got the booster or how much worse it would be and this a little bit apprehensive getting the second shot, so she just wonder talk to somebody about that. The treatment of the events included Tylenol and Meclizine. When probed for the causality, the nurse stated "I mean I am not sure, I was thinking possibly because that's the only thing I have done differently. When probed for if the Nurse underwent any Emergency Room or Physician Office, Nurse stated she went to Urgent Care. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Injection site pain, Myalgia, Nasal congestion
Clinical narrative: soreness at injection site; muscle aches; chills; sore throat; light headedness; heart palpitations; stuffy nose; cold like symptoms; This is a spontaneous report from a non-contactable other healthcare professional (HCP).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 16Dec2020 at 12:00 at single dose for COVID-19 immunisation. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks. The patient had no relevant medical history. Concomitant medications were not reported. On 18Dec2020 at 03:00, the patient experienced soreness at injection site, muscle aches, chills, sore throat, light headedness, heart palpitations, stuffy nose and cold like symptoms. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and loratadine/pseudoephedrine hydrochloride (THERA FLU). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient had not recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Oropharyngeal pain, Palpitations
Clinical narrative: soreness at injection site; muscle aches; chills; sore throat; light headedness; heart palpitations; stuffy nose; cold like symptoms; This is a spontaneous report from a non-contactable other healthcare professional (HCP).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 16Dec2020 at 12:00 at single dose for COVID-19 immunisation. Vaccination facility type: hospital. The patient did not receive other vaccines in four weeks. The patient had no relevant medical history. Concomitant medications were not reported. On 18Dec2020 at 03:00, the patient experienced soreness at injection site, muscle aches, chills, sore throat, light headedness, heart palpitations, stuffy nose and cold like symptoms. Corrective treatments taken as a result of the events included paracetamol (TYLENOL) and loratadine/pseudoephedrine hydrochloride (THERA FLU). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient had not recovered from the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain, Rash erythematous
Clinical narrative: Over course of next 24 hours, increased pain and LAD; No constitutional symptoms except for non-specific fatigue; Seems most consistent with VZV infection; erythematous lesions without obvious blisters on my left chin; erythematous lesions without obvious blisters on my left chin which were painful; erythematous lesions without obvious blisters on my left chin which were painful with unusual numbness and dysesthesia in surrounding area; erythematous lesions without obvious blisters on my left chin which were painful with unusual numbness and dysesthesia in surrounding area; This was followed by lymphadenopathy in my submandibular and high cervical glands; This is a spontaneous report from a contactable physician (patient).  A 60-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), intramuscular at left arm on 21Dec2020 15:30 at single dose for COVID-19 immunization at a hospital. The patient's medical history included hypothyroidism, and zoster outbreak previously about one year ago (2019). No prior medical history (hx) of allergies or adverse reactions to vaccination in childhood or as adult. No allergies to medications, food, or other products. Concomitant medication received within 2 weeks of vaccination included levothyroxine sodium (SYNTHROID). No other vaccines within 4 weeks prior to the COVID vaccine. For historical vaccine, the patient had taken usual Influenza vaccinations yearly and dTap. The patient was not diagnosed with COVID-19 prior to this vaccination, and since this vaccination, the patient been had not tested for COVID-19. It was reported that three days post-vaccine (24Dec2020 08:00), the patient developed erythematous lesions without obvious blisters on left chin which were painful with unusual numbness and dysesthesia in surrounding area. This was followed by lymphadenopathy in her submandibular and high cervical glands. Over course of next 24 hours, increased pain and "LAD". No auricular, nasal or ocular involvement. No facial palsy. No constitutional symptoms except for non-specific fatigue. Seems most consistent with VZV infection or possibly adverse drug reaction. The patient had zoster outbreak previously about one year ago but not in this dermatome. Given progression of symptoms, the patient discussed with her physician virtually and had started Valcyclovir and used Ibuprofen and Gabapentin for pain control. She had been taking these medications for 36 hours at time of this report without much change. The outcome of the events was not recovered.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Pyrexia
Clinical narrative: Low grade fever; pain at injection site; fatigue; This is a spontaneous report from a contactable Physician (patient). A 42-year-old female patient (not pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on 24Dec2020 09:30 at single dose for COVID-19 immunization. Vaccine location provided as Left arm. Medical history provided as none and there were no known allergies. The patient was not allergies to medications, food, or other products. There was no other vaccine received within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient did not diagnose with COVID-19 prior vaccination and since the vaccination, the patient did not have test for COVID-19. The patient experienced low grade fever, pain at injection site, fatigue on 24Dec2020 14:00. No treatment received for the adverse events. The outcome of the events was recovered in Dec2020.  Information on the Lot/Batch Number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Feeling abnormal, Musculoskeletal pain, Rash, SARS-CoV-2 test positive
Clinical narrative: COVID test positive two times; COVID test positive two times; Pain in bum, back; Pain in bum, back; Last night I was feeling so bad; Skin like a rash; This is a spontaneous report from a non-contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EK5730) on 21Dec2020 at 1:36 P.M., at single dose, for COVID-19 prevention. Medical history and concomitant medications were not reported. On an unspecified date in Dec2020 the patient experienced pain in bum, back, last night was feeling so bad, skin like a rash. On 22Dec2020 the patient did COVID test which was negative. She did another test on 23Dec2020 and it was negative. The patient did not feel any fever. But last night, on an unspecified date in Dec2020, when the patient went to the emergency for work, the lady did COVID test two times and the patient was positive. Events outcome was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Condition aggravated, Diarrhoea, Nausea
Clinical narrative: A lot of pain in arm; GI issues/some GI upset; Diarrhea; Nausea; Woke up in the middle of my sleep; I have now like 101 fever; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included dehydration and COVID-19 in the end of November. The patient did have COVID-19 in Nov2020, it was a pretty bad case where the patient was in the hospital for like 6 days, not ventilated but the patient was on all those medications (unspecified medications), the patient had it pretty bad. The patient had pneumonia in both lungs and dehydration, the patient thought. The patient's concomitant medications were not reported. The patient got the vaccine on 24Dec2020 and the patient's symptoms that the patient was having with the COVID in the end of Nov2020, the patient hadn't have anything, any issues with COVID since then. The patient got the vaccine at the hospital on 24Dec2020 and overnight, the patient was having, like initially, right after the vaccine, the patient had a lot of pain in arm. And then the patient started getting GI issues with diarrhea and things like that which the patient did have when the patient had COVID, a month ago and nausea and starting like last night, overnight, the patient woke up in the middle of sleep, the patient started getting like fever. The patient was now like 101 fever, when the patient had COVID, it was like 103. So it was not as bad as when the patient had COVID, it was like 101 fever, it was like chills, and some GI upset. The outcome of events are unknown  Information on the lot/ batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sleep disorder
Clinical narrative: A lot of pain in arm; GI issues/some GI upset; Diarrhea; Nausea; Woke up in the middle of my sleep; I have now like 101 fever; Chills; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 24Dec2020 at single dose for COVID-19 immunization. Medical history included dehydration and COVID-19 in the end of November. The patient did have COVID-19 in Nov2020, it was a pretty bad case where the patient was in the hospital for like 6 days, not ventilated but the patient was on all those medications (unspecified medications), the patient had it pretty bad. The patient had pneumonia in both lungs and dehydration, the patient thought. The patient's concomitant medications were not reported. The patient got the vaccine on 24Dec2020 and the patient's symptoms that the patient was having with the COVID in the end of Nov2020, the patient hadn't have anything, any issues with COVID since then. The patient got the vaccine at the hospital on 24Dec2020 and overnight, the patient was having, like initially, right after the vaccine, the patient had a lot of pain in arm. And then the patient started getting GI issues with diarrhea and things like that which the patient did have when the patient had COVID, a month ago and nausea and starting like last night, overnight, the patient woke up in the middle of sleep, the patient started getting like fever. The patient was now like 101 fever, when the patient had COVID, it was like 103. So it was not as bad as when the patient had COVID, it was like 101 fever, it was like chills, and some GI upset. The outcome of events are unknown  Information on the lot/ batch number has been requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Right supraclavicular lymphadenopathy; This is a spontaneous report from a non-contactable physician (patient). A 26-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 17Dec2020 07:15 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient was not pregnant. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient experienced right supraclavicular lymphadenopathy on 23Dec2020 18:00. No treatment was received for the adverse event. Outcome of the event was not recovered. The event was considered non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: extreme soreness/pain at injection site; This is a spontaneous report from a contactable nurse.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), intramuscular on the left arm on 22Dec2020 06:00 at single dose COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced extreme soreness/pain at injection site on 22Dec2020 09:00.  The patient received no treatment. The outcome of the events was recovered on Dec2020.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: A 3"x4" rash at location of injection on upper left arm; This is a spontaneous report from a contactable consumer (patient's parent). A 22-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in upper left arm on 15Dec2020 at a single dose for COVID-19 immunization. The COVID-19 vaccine was administered in a hospital. The patient has no medical history and there were no concomitant medications. Patient has no allergies to medications, food, or other products. The patient experienced a 3"x4" rash at location of injection on upper left arm in Dec2020. The event was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Treatment was not received for the adverse event. The outcome of the event at the time of last observation was recovering.  Information about lot/batch number has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, SARS-CoV-2 antibody test positive, SARS-CoV-2 test negative
Clinical narrative: Fever, still has 100.5 temperature; Headache; Chills; This is a spontaneous report from a contactable consumer (patient; Nursing assistant). A 53-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), via an unspecified route of administration on 24Dec2020 09:00 at single dose for COVID-19 immunization Patient's medical history included hypertensive, cholesterol abnormal, chronic insomnia, and Covid-19 (last March). The patient's concomitant medications were not reported. The patient mentioned that he had Covid-19 last March. So, he stayed in hospital more than 2 weeks. The patient stated the hospital is giving vaccine to the hospital workers, he received the vaccine in their Institution. The patient reported that last night (Dec2020), he developed some fever, headache and chills until now he still has 100.5 temperature. He added that last two days ago he got the swab test and its negative and positive with the immunity. The patient stated he was just taking some acetaminophen 500mg, it is just like Tylenol. The outcome of events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling abnormal, Muscle discomfort, Muscle twitching, Nervousness
Clinical narrative: Facial twitching; facial muscle weirdness; her heart was kind of fast like anxious and nervous; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL0140, via an unspecified route of administration on left arm from 22Dec2020 to 22Dec2020 as single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) as Birth control pill. OnDec2020, the patient experienced some facial twitching just like a little bit. Her facial muscle felt like a little weird and stated she does not know if it was just from getting the vaccine or what not, but couple of hours after her heart was kind of fast like anxious and nervous, that lasted for couple hours. She stated it was nothing like super outrageous, that thing stopped. But the facial muscle weirdness is kind of, her face doesn't look weird, it just like feels a little different or weird and so she was calling to report. The patient stated she don't know if you guys advise whether to get the next one if she had the reaction. When asked for treatment, she stated, "No, I haven't done anything for that." The outcome of the event heart was kind of fast like anxious and nervous was recovered on Dec2020; while the other event was not recovered.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Facial twitching; facial muscle weirdness; her heart was kind of fast like anxious and nervous; This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL0140, via an unspecified route of administration on left arm from 22Dec2020 to 22Dec2020 as single dose for COVID-19 immunization. The patient has no medical history. Concomitant medication included ethinylestradiol, norgestimate (SPRINTEC) as Birth control pill. OnDec2020, the patient experienced some facial twitching just like a little bit. Her facial muscle felt like a little weird and stated she does not know if it was just from getting the vaccine or what not, but couple of hours after her heart was kind of fast like anxious and nervous, that lasted for couple hours. She stated it was nothing like super outrageous, that thing stopped. But the facial muscle weirdness is kind of, her face doesn't look weird, it just like feels a little different or weird and so she was calling to report. The patient stated she don't know if you guys advise whether to get the next one if she had the reaction. When asked for treatment, she stated, "No, I haven't done anything for that." The outcome of the event heart was kind of fast like anxious and nervous was recovered on Dec2020; while the other event was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: has noticed swelling, redness, and itchiness at the vaccination site/my injection site is little puffy and red and itchy; has noticed swelling, redness, and itchiness at the vaccination site/my injection site is little puffy and red and itchy/Little itchy on injection site and it is turning red; has noticed swelling, redness, and itchiness at the vaccination site/my injection site is little puffy and red and itchy/Little itchy on injection site and it is turning red; This is a spontaneous report from a contactable consumer (Patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 23Dec2020 at single dose for covid-19 immunization. Medical history reported as none. There were no concomitant medications. The patient had taken the vaccine last 23Dec2020 and had noticed swelling, redness, and itchiness at the vaccination site today on 26Dec2020. It was a little itchy on injection site and it is turning red and her injection site was little puffy and red and itchy. She was asking if this is normal. No treatment received for the events. The outcome of the events was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Moderate low back pain; This is a spontaneous report from a contactable physician (patient). A 49-year-old male patient received first dose of BNT162B2 (Lot number: ek5730), via an unspecified route of administration, in left arm, on 22Dec2020 07:30 A.M. at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. No other vaccine was received within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient was not tested for COVID-19. Medical history included mild asthma. No allergies to medications, food, or other products. Concomitant medication included esomeprazole sodium (NEXIUM), cetirizine hydrochloride (ZYRTEC), doxycycline, mometasone furoate (ASMANEX), ergocalciferol (VIT D). The patient experienced moderate low back pain on 25Dec2020 09:30 A.M. The event was reported as non-serious. Treatment of the event included ibuprofen and valium (for muscle relaxant effect). The outcome of the event was recovering.