chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Burning sensation, Flatulence, Gastric pH decreased, Neck pain
Clinical narrative: a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration at Left arm on 04Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included irritable bowel syndrome.  Concomitant medication included amoxicillin, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), colecalciferol (VITAMIN D), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). No other vaccine in four weeks. The patient had allergies to ciprofloxacin(CIPRO). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.Since the patient got the vaccine, she had been experiencing a huge amount of gas and bloating as well acid and burning sensation in her throat and neck and chin on 04Jan2021 15:00. The outcome of the events was not recovered. No treatment received for the events.  Information about Lot/Batch number is requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; Since I got the vaccine I've been experiencing a huge amount of gas and bloating as well acid and burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; burning sensation in my throat and neck and chin; This is a spontaneous report from a contactable consumer. A 41-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown) via an unspecified route of administration at Left arm on 04Jan2021 09:30 at SINGLE DOSE for covid-19 immunization. Medical history included irritable bowel syndrome.  Concomitant medication included amoxicillin, ascorbic acid, calcium carbonate, calcium pantothenate, calcium phosphate, chromium, cyanocobalamin, folic acid, magnesium carbonate, magnesium hydroxide, manganese gluconate, nicotinic acid, potassium bicarbonate, potassium carbonate, potassium phosphate dibasic, pyridoxine hydrochloride, quercetin, riboflavin sodium phosphate, sodium bicarbonate, sodium phosphate, thiamine hydrochloride, thioctic acid, zinc ascorbate (EMERGEN C), colecalciferol (VITAMIN D), bifidobacterium bifidum, bifidobacterium lactis, bifidobacterium longum, lactobacillus acidophilus, lactobacillus rhamnosus (PROBIOTIC). No other vaccine in four weeks. The patient had allergies to ciprofloxacin(CIPRO). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19.Since the patient got the vaccine, she had been experiencing a huge amount of gas and bloating as well acid and burning sensation in her throat and neck and chin on 04Jan2021 15:00. The outcome of the events was not recovered. No treatment received for the events.  Information about Lot/Batch number is requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Headache, Nausea, Pain
Clinical narrative: achiness; Headache; Dizziness; Disorientation; Nausea; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, expiration date: Mar2021), via an unspecified route of administration at the left arm on 05Jan2021 12:10 at a single dose for COVID-19 immunization in the hospital. The patient has not had any vaccines in four weeks. The patient has no medical history. There were no concomitant medications. The patient received the COVID vaccine on 05Jan2021 and confirmed that it was the first dose she received of the COVID vaccine. She clarified that she started to have dizziness, disorientation, nausea, achiness and headache. The dizziness, disorientation and nausea started about 8 hours after she received the vaccine, 05Jan2021 20:10. She stated that she was just trying to push through with the side effects. She woke up in the morning, 06Jan2021, feeling both achy and with a headache. She stated that she had the achiness that was regular and knew would normally come along with it. However, she also had a headache. The outcome of the events was not recovered.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Pain in extremity
Clinical narrative: Arm pain; headache; tiredness; extreme weakness; This is a spontaneous report from a contactable consumer (reported for herself). A 73-year-old female patient (not pregnant at the time of vaccination) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 05Jan2021 13:15 at single dose at left arm for COVID-19 immunization. Medical history included High cholesterol, Fibromyalgia, Protein S Deficiency, Anxiety, known allergies: Scallops. Concomitant medications received in two weeks included warfarin, esomeprazole magnesium (NEXIUM [ESOMEPRAZOLE MAGNESIUM]), fluoxetine, clonazepam (KLONOPIN), rosuvastatin calcium (CRESTOR), fenofibrate (FENOFIBRAT). Facility where the most recent COVID-19 vaccine was administered: Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 06Jan2021, the patient experienced Arm pain, headache, tiredness, extreme weakness. No treatment was received for the adverse events. The report was non-serious per the reporter. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Urticaria
Clinical narrative: localized urticaria, immediate onset; responsive to diphenhydramine with recurrence next days. No systemic anaphylactic reaction on full review of systems by allergist 1/11/2021. Previous tolerance to annual flu immunizations, including FluLaval preservative free past 3 years.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Nervousness, Pain, Pain in extremity
Clinical narrative: Nausea; Jumpiness; body aches; Chills; arm hurting; Fever; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231/expiration date Apr2021), dose number 1, via an unspecified route of administration on 04Jan2021 14:30 at a single dose on the left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient previously had a flu shot for immunization and experienced fever, body aches, jumpiness, and arm hurting. She had no concomitant medications. She did not have any vaccination within 4 weeks prior the administration of the suspect vaccine. The patient was reporting side effects with the Pfizer vaccine. The events started in the morning of 05Jan2021 with the feeling of nausea. She also experienced jumpiness. In the evening, she had body aches, chills, and arm hurting. She also had fever, but it was not a very high fever. She took Tylenol on 05Jan2021 and on 06Jan2021, she had no body aches or fever yet. She felt much better on 06Jan2021. Her second dose is scheduled on the 25Jan2021. The patient received the vaccine at a workplace clinic. The outcome of the event was recovering.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; Jumpiness; body aches; Chills; arm hurting; Fever; This is a spontaneous report from a contactable consumer. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EK9231/expiration date Apr2021), dose number 1, via an unspecified route of administration on 04Jan2021 14:30 at a single dose on the left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient previously had a flu shot for immunization and experienced fever, body aches, jumpiness, and arm hurting. She had no concomitant medications. She did not have any vaccination within 4 weeks prior the administration of the suspect vaccine. The patient was reporting side effects with the Pfizer vaccine. The events started in the morning of 05Jan2021 with the feeling of nausea. She also experienced jumpiness. In the evening, she had body aches, chills, and arm hurting. She also had fever, but it was not a very high fever. She took Tylenol on 05Jan2021 and on 06Jan2021, she had no body aches or fever yet. She felt much better on 06Jan2021. Her second dose is scheduled on the 25Jan2021. The patient received the vaccine at a workplace clinic. The outcome of the event was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: recently got vaccinated unwillingly knowing she had Covid; recently got vaccinated unwillingly knowing she had Covid; This is a spontaneous report from a contactable Other healthcare professional (HCP) reporting for herself. A female patient of an unspecified age received her first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. The patient recently got vaccinated unwillingly knowing she had covid on an unspecified date. The patient wanted to known if she should get her second dose still and in the same timely manner. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of suspect BNT162B2 cannot be completely excluded for reported event.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pains; Joint pains; This is a spontaneous report from a contactable consumer. An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL1284/expiration date unknown), dose number 1, via an unspecified route of administration on 05Jan2021 at a single dose on the left arm for vaccination. The patient had no relevant medical history and no concomitant medications. The patient volunteers at a local hospital. She reported muscle pains and joint pains after Pfizer COVID-19 vaccine. She had onset of muscle pains and joint pains around 1:00am on 06Jan2020. Muscle pains and joint pains worsened around 5:30am on 06Jan2021. She was taking 500 mg of Equate Acetaminophen every 4 hours for the muscle pains and joint pains, but the Equate Acetaminophen does not seem to be helping the muscle pains and joint pains. Her second dose was scheduled on 26Jan2021. The outcome of the events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: 20 minutes after dose pt experienced some chest tightness, trouble breathing, and headache. Patient was still talking so gave her 50mg Benadryl and ice water, had her sit down and continue drinking water for another 30 minutes. 30 minutes after Benadryl was given patient's symptoms subsided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Pain
Clinical narrative: full day of full body aches; chills; headache; miserable; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female (not pregnant at the time of vaccination) patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL0142), via an unspecified route of administration at left arm on 04Jan2021 14:45 at single dose for COVID-19 immunization at a workplace clinic. The patient's medical history was reported as none, no known allergies to medications, food, or other products and no other medical history. Concomitant medication in two weeks included progesterone, testosterone, colecalciferol (D3), calcium, "C", "E", and "Ty". No other vaccine within four weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. On 04Jan2021 the patient received the injection. And on 05Jan2021, the patient experienced full day of full body aches, chills, headache, and miserable. No fever. The events started on 05Jan2021 05:00. On 06Jan2020, the patient felt great. No treatment was received for the events. The outcome of the events was recovered on 06Jan2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gait disturbance, Headache, Impaired work ability, Pain
Clinical narrative: I woke up the day after receiving the vaccine with full body aches and severe joint pain, especially in the hips making it difficult to walk comfortably.  I also had a moderate to severe headache.  I was unable to work that day.  The pain lessened with ibuprofen but returned later in the day.  By the next day, symptoms were a lot better and after 2 days the symptoms completely resolved
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain in extremity, SARS-CoV-2 test, Vaccination site movement impairment
Clinical narrative: Right arm soreness; kinda like nerve pain; can't lift my arm up or reach the back; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: Ek5730, expiry date: unknown), intramuscular on the right arm on 16Dec2020 11:00 to at a single dose for an COVID-19 immunization. Medical history included hypertension, obesity, lymphadenopathy, and migraines. Patient was not pregnant at the time of vaccination. Concomitant medication included losartan, clonazepam (KLONOPIN), duloxetine hydrochloride (CYMBALTA), gabapentin (NEURONTIN), ascorbic acid, thiamine hydrochloride (VITAMIN B AND C COMPLEX), and zinc. The patient experienced right arm soreness, kinda like nerve pain and can't lift her arm up or reach the back on 16Dec2020. Outcome of the events was not recovered. No treatment was received for the events. The patient underwent lab test which included COVID test (nasal swab) on 19Dec2020 and 26Dec2020: both negative. The reporter considered the events non-serious.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Severe Arm Pain; This is a spontaneous report from a contactable nurse, the patient. A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK5730), intramuscular in the left arm on 17Dec2020 at 08:00 AM (at the age of 58-year-old) as a single dose for COVID-19 immunization.  Medical history included hypothyroidism, depression, and asthma. The patient did not have any allergies to medications, food, or other products.  The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included levothyroxine, montelukast sodium (SINGULAIR), bupropion hydrochloride (WELLBUTRIN), vitamin B complex, magnesium, vitamin D3, and ascorbic acid (VIT C). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 17Dec2020 at 6:00 PM, the patient experienced severe arm pain within hours of the first injection.  It was significantly reduced after a dose of Acetaminophen. The event was reported as non-serious. The clinical outcome of the event severe arm pain was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Dizziness, Fatigue, Headache
Clinical narrative: Dizziness, felt faint, racing heart, elevated bp about 5- 10 minutes after being vaccinated. This subsided after 10 -15 minutes, but then recurred for a total of 4 times for shorter periods of over the next 90 minutes. Had headache, felt fatigue, chills and feverish later that night.Fatigue continued for next several days lessening over time, headache continued for next several days, lessening over time.Soreness at injection site for a couple of days, but no swelling or redness.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Palpitations, Pyrexia
Clinical narrative: Dizziness, felt faint, racing heart, elevated bp about 5- 10 minutes after being vaccinated. This subsided after 10 -15 minutes, but then recurred for a total of 4 times for shorter periods of over the next 90 minutes. Had headache, felt fatigue, chills and feverish later that night.Fatigue continued for next several days lessening over time, headache continued for next several days, lessening over time.Soreness at injection site for a couple of days, but no swelling or redness.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: the patient began to experience dizziness and flushing; the patient began to experience dizziness and flushing; This is a spontaneous report from a non-contactable other healthcare professional. A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EK9231), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The female patient who was seen at (Clinic name) today on 06Jan2021 for her second dose of the COVID 19 vaccination. During her 15 minute waiting period after the injection, the patient began to experience dizziness and flushing on 06Jan2021. She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, lightheadedness, dizziness. The outcome of the events was unknown. This case was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Myalgia
Clinical narrative: Chills; mild headache; loss of appetite; muscle pain; severe fatigue; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 07Dec2020 15:00 (lot# EH9899), second dose on 04Jan2021 08:00 (lot# EL1284), both intramuscular in left arm at single dose for covid-19 immunization.  Medical history reported as none. Allergies to medications, food, or other products: No. There were no concomitant medications.  The patient experienced Chills, mild headache, loss of appetite, muscle pain, severe fatigue, all on 04Jan2021 18:00 with outcome of recovering. Pregnant at the time of vaccination: No. Facility where the most recent COVID-19 vaccine was administered: Hospital. If the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: no. Treatment received for the adverse event: paracetamol (TYLENOL).  Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No. AE was not resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Serious: No. Seriousness criteria-Results in death: No. Seriousness criteria-Life threatening: No. Seriousness criteria-Caused/prolonged hospitalization: No. Seriousness criteria-Disabling/Incapacitating: No. Seriousness criteria-Congenital anomaly/birth defect: No.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Stinging pain when injected. Swelling at injection site--hard bump about size of an egg. Redness. Soreness. Swollen lymph nodes under left arm and in neck
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: Fever; chills; headache; fatigue; This is a spontaneous report from a non-contactable other HCP (patient) reported for herself. A 60-years-old female patient received first dose of BNT162B2 (lot number unknown), via an unspecified route of administration, in left arm, on 05Jan2021 13:00 at single dose for COVID-19 immunization. Reason why batch/lot is unknown was misplaced/discarded. The patient was not pregnant at the time of vaccination. Medical history included known allergies: Penicillin. Prior to vaccination, the patient was diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was other. No other vaccines were received within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. The patient experienced fever, chills, headache, fatigue on 06Jan2021 01:00 AM. No treatment was received for the events. The outcome of the events was recovering. Since the vaccination, patient hasn't been tested for COVID-19.   No follow-up attempts are possible, information about lot/batch cannot be obtained.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hot flush, Injection site pain, Pain
Clinical narrative: 4-48 hours post administration, experienced headache, body aches, low grade fever, fatigue and injection site soreness. Roughly 48 hours after administration, experienced hives covering the entirety of the anterior thighs bilaterally. 4 days after administration, experienced hot flashes and low grade fever
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Urticaria
Clinical narrative: 4-48 hours post administration, experienced headache, body aches, low grade fever, fatigue and injection site soreness. Roughly 48 hours after administration, experienced hives covering the entirety of the anterior thighs bilaterally. 4 days after administration, experienced hot flashes and low grade fever
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Within a few minutes of 1st dose of vaccine I felt a sudden increase in HR - resolved on its own within 10 - 15 minutes; This is a spontaneous report from a contactable nurse (patient). A 47-years-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK5730), via an unspecified route of administration at left arm, on 19Dec2020 13:00 at single dose for COVID-19 immunization. Medical history included myasthenia gravis, allergy to IV contrast used for CT scans. Concomitant medication included pyridostigmine bromide (MESTINON), melatonin, ibuprofen (ADVIL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within a few minutes of the vaccine, on 19Dec2020 13:00, the patient felt a sudden increase in heart rate (HR) and resolved on its own within 10 to 15 minutes on 19Dec2020. No treatment received for the adverse events. No COVID prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. It was not reported as serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: she received the first dose of the vaccine on the 22nd of December and tested positive on the 28th; she received the first dose of the vaccine on the 22nd of December and tested positive on the 28th; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer(patient) reported that a female patient of an unspecified age received first dose BNT162B2, via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on the 22nd of December and tested positive on the 28Dec2020, she was scheduled to get the 2nd dose on Jan 12th. The reporter wanted to know if it was safe for her to take the 2nd dose. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Headache, Inappropriate schedule of product administration
Clinical narrative: muscle aches; nausea; joint pain; neck pain; headache; severe abdominal pain; vomiting; diarrhea; second dose on 04Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 16Dec2020 17:00, second dose on 04Jan2021 18:00, both via an unspecified in left arm route at single dose for covid-19 immunization in hospital. Medical history included gluten intolerance. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included birth control. The patient previously took nitrofurantoin and experienced allergies. The patient experienced muscle aches, nausea, joint pain, neck pain, and headache 24 hours post vaccination (as reported). She then experienced severe abdominal pain, nausea, vomiting and diarrhea 36 hours post vaccination (as reported). The adverse reaction was also reported started from 05Jan2021 7:00 AM. The events was reported as non-serious. There was no treatment for the events muscle aches, nausea, joint pain, neck pain, headache, severe abdominal pain, vomiting and diarrhea. The outcome of the events muscle aches, nausea, joint pain, neck pain, headache, severe abdominal pain, vomiting and diarrhea were resolved with lasting effects.   Information on the Lot/Batch number has been requested.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Neck pain, Vomiting
Clinical narrative: muscle aches; nausea; joint pain; neck pain; headache; severe abdominal pain; vomiting; diarrhea; second dose on 04Jan2021; This is a spontaneous report from a contactable other healthcare professional (patient). A 22-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose on 16Dec2020 17:00, second dose on 04Jan2021 18:00, both via an unspecified in left arm route at single dose for covid-19 immunization in hospital. Medical history included gluten intolerance. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included birth control. The patient previously took nitrofurantoin and experienced allergies. The patient experienced muscle aches, nausea, joint pain, neck pain, and headache 24 hours post vaccination (as reported). She then experienced severe abdominal pain, nausea, vomiting and diarrhea 36 hours post vaccination (as reported). The adverse reaction was also reported started from 05Jan2021 7:00 AM. The events was reported as non-serious. There was no treatment for the events muscle aches, nausea, joint pain, neck pain, headache, severe abdominal pain, vomiting and diarrhea. The outcome of the events muscle aches, nausea, joint pain, neck pain, headache, severe abdominal pain, vomiting and diarrhea were resolved with lasting effects.   Information on the Lot/Batch number has been requested.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal paraesthesia
Clinical narrative: 1320 Patient reports tingling lips and throat 1335 Administered 50mg PO 1400 Symptoms stable; patient released
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Myalgia, Pyrexia
Clinical narrative: Low grade fever; muscle and joint pain; muscle and joint pain; mild chills; This is a spontaneous report from a non-contactable physician (patient). A 60-year-old male patient receive first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration in left arm on 04Jan2021 14:00 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was workplace clinic. Medical history included none. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient experienced low grade fever, muscle and joint pain, mild chills on 05Jan2021 09:00. This case was non-serious. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. No treatment was received for the adverse event. The outcome of events was recovered in Jan2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia
Clinical narrative: Fever; chills; body aches; This is a spontaneous report from a non-contactable consumer. An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 prior vaccination. The patient's concomitant medications were not reported. The patient experienced fever, chills, body aches. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: facial rash/hives
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Sore arm, headaches; Sore arm, headaches; This is a spontaneous report from a non-contactable other HCP (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685), via an unspecified route of administration on 05Jan2021 at single dose for covid-19 immunization. Vaccine location was right arm. Patient is not pregnant. Patient received the first dose on 17Dec2020 05:45 PM also at right arm for covid-19 immunization. Lot number was also EJ1685. The facility type vaccine was hospital. Medical history included Celiac. Concomitant medication included pregabalin (LYRICA), celecoxib (CELEBREX), escitalopram oxalate (LEXAPRO), spironolactone. Known allergies: Penicillin, morphine, lactated ringers. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient experienced Sore arm, headaches at 05Jan2021 06:00 PM with outcome of recovered in Jan2021. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.  No follow up attempts are possible. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Fever; chills; muscle soreness; generalized weakness; took the first dose of bnt162b2 on 16Dec2020/the second dose on 05Jan2021; This is a spontaneous report from a contactable other health professional (reported for herself). A 24-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided) via an unspecified route of administration on 05Jan2021 16:45 at single dose at right arm for COVID-19 immunization. Medical history was none, no Allergies to medications, food, or other products. Concomitant medication received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient previous took the first dose of bnt162b2 (lot number: EK5730) on 16Dec2020 16:30 at single dose at right arm for COVID-19 immunization. Facility where 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. On 06Jan2021 12:00, the patient experienced fever, chills, muscle soreness, generalized weakness. No treatment received for the adverse events. The report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events "fever", "chills", "muscle soreness", "generalized weakness" was recovering.  Information on the lot/batch number has been requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; chills; muscle soreness; generalized weakness; took the first dose of bnt162b2 on 16Dec2020/the second dose on 05Jan2021; This is a spontaneous report from a contactable other health professional (reported for herself). A 24-year-old female patient (not pregnant at the time of vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided) via an unspecified route of administration on 05Jan2021 16:45 at single dose at right arm for COVID-19 immunization. Medical history was none, no Allergies to medications, food, or other products. Concomitant medication received within 2 weeks of vaccination included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient previous took the first dose of bnt162b2 (lot number: EK5730) on 16Dec2020 16:30 at single dose at right arm for COVID-19 immunization. Facility where 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. On 06Jan2021 12:00, the patient experienced fever, chills, muscle soreness, generalized weakness. No treatment received for the adverse events. The report was non-serious per the reporter. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events "fever", "chills", "muscle soreness", "generalized weakness" was recovering.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: HEADACHE STARTED 17 HOURS POST VACCINATION TOOK TYLENOL,IBUPROFEN AND FIORCET (IT WENT AWAY 24 HRS LATER).  BODY ACHES STARTED 29 HOURS POST VACCINATION (WENT AWAY  48 HOURS POST VACCINATION) FEVER 100.4 AND CHILLS STARTED 52 HRS POST VACCINATION AND WERE GONE BY 36 HOURS.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in the left ear (tinnitus); This is a spontaneous report from a contactable Other Health Professional. This Other HCP reported same events for himself and other two patients. This is second of three reports, reported for the other one of two patients. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was mentioned that caller's patient and his coworker experienced this ringing in the left ear (tinnitus). Outcome of event was unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007848 same reporter/drug/event, different patient;US-PFIZER INC-2021009439 same reporter/drug/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain
Clinical narrative: Serious aches and pains all over her entire body; Second dose administered less than 21 days after the first dose administered; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported that a female patient of an unspecified age received bnt162b2 (lot number and expiry date were not provided), with first dose on 19Dec2020 and second dose on 05Jan2021, both via an unspecified route of administration at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Second dose administered less than 21 days after the first dose administered. The patient experienced serious aches and pains all over her entire body on an unspecified date. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: testing positive for COVID on nasal swab after first dose of COVID vaccine; testing positive for COVID on nasal swab after first dose of COVID vaccine; This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age and gender received 1st dose of BNT162B2 (reported as COVID vaccine), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced testing positive for Covid on nasal swab after first dose of Covid vaccine on an unspecified date with outcome of unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.  Pfizer is a marketing authorization holder of COVID vaccine in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID vaccine has submitted the same report to the regulatory authorities.; Sender's Comments: The reported testing positive for Covid on nasal swab after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: She thinks there has been more anaphylactic reactions than usual and said that a physician female friend had experienced one; This is a spontaneous report from a non-contactable Other Health Professional via Pfizer sales representative. A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. During a conference call, (Name) mentioned that she thinks there has been more anaphylactic reactions than usual and said that a physician female friend had experienced one. It was unclear whether it was after a Pfizer or Moderna vaccine. She did mention that her friend recovered without any issues. Outcome of event was recovered on an unspecified date.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of anaphylaxis cannot be excluded, considering the plausible temporal relationship and the known adverse event profile of the suspect product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Muscle aches, chills, joint pain, local swelling and pain, fatigue, nausea. First symptom of nausea onset 1hr after injection. Duration of symptoms 40 hours.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Swelling
Clinical narrative: Muscle aches, chills, joint pain, local swelling and pain, fatigue, nausea. First symptom of nausea onset 1hr after injection. Duration of symptoms 40 hours.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Vaccination site bruising
Clinical narrative: Caller was difficult to hear during call.; Bruise on injection arm; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 29Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. The patient experienced bruise on injection arm on 30Dec2020, caller was difficult to hear during call on an unspecified date. The outcome of events was unknown.  Information on the Batch/Lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Pain in extremity
Clinical narrative: arm pain; 1 degree increase in temperature; This is a spontaneous report from a contactable pharmacist (patient) via a Pfizer Sales Representative. A 40-year-old female patient (120 pounds) received first dose of BNT162B2, 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. The patient experienced arm pain and 1 degree increase in temperature on an unspecified date after receiving the first dose of the COVID 19 vaccine. The patient underwent lab tests and procedures which included body temperature: 1 degree increase on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ear; This is a spontaneous report from a contactable other healthcare professional. This other healthcare professional reported same event for himself and other two patients. This is the third of three reports. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced ringing in ear after getting the COVID vaccine on an unspecified date with outcome of unknown.    Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021007848 same reporter/drug/event, different patient;US-PFIZER INC-2021009229 same reporter/drug/event, different patient
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Fatigue, Migraine, Pain in extremity
Clinical narrative: Fever, tyneol lowered it. Cant break 99.0°. Cough. Fatigue. Joint pain in legs. Migraine. Tightness in right leg, very painful. Possible blood clot? Testing in process.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, tyneol lowered it. Cant break 99.0°. Cough. Fatigue. Joint pain in legs. Migraine. Tightness in right leg, very painful. Possible blood clot? Testing in process.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain, SARS-CoV-2 test
Clinical narrative: My scale aches and joint pain; My scale aches and joint pain; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received BNT162B2 (Lot/batch number and expiry date unknown), via an unspecified route of administration on 05Jan202115:00 at single dose in the left arm for COVID-19 immunization. There were no concomitant medications. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient reported that her scale aches and experienced joint pain, both on 05Jan2021 18:00. The patient did not receive any treatment for the events. The patient underwent lab tests and procedures which included nasal swab: pending result on 06Jan2021. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination and did not receive other medications in two weeks. The outcome of the events was not recovered.  The following information on the batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Shakes; fever; This is a spontaneous report from a contactable Physician. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), 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. The patient experienced shakes and fever on an unspecified date with outcome of unknown.    Information on the Lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: left sided facial numbness left sided numbness on the hand; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) on 07Jan2021 08:00 (lot number: EL1284) for the second dose and on 17Dec2020 08:00 (lot number: EH9899) for the first dose, both via intramuscular route in the left arm for COVID-19 immunization. Medical history included asthma and allergies to shellfish. The patient's concomitant medications were not reported. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. She was not diagnosed with COVID-19 prior to vaccination nor was she tested for covid post vaccination. The patient experienced left sided facial numbness and left sided numbness on the hand on 07Jan2021 08:30 with outcome of not recovered. The event was reported as non-serious with no treatment received.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Flushing, Myalgia
Clinical narrative: Onset was approximately 8 hours. Symptoms include fatigue, myalgia, and flushing. 1000mg of Tylenol PO was taken. 12 hours post injection symptoms progressed to nausea, diarrhea and chills. 2 tabs of Pepto PO taken.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Onset was approximately 8 hours. Symptoms include fatigue, myalgia, and flushing. 1000mg of Tylenol PO was taken. 12 hours post injection symptoms progressed to nausea, diarrhea and chills. 2 tabs of Pepto PO taken.