chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Formication, Paraesthesia, SARS-CoV-2 antibody test, Vaccination site pain
Clinical narrative: I have been having a crawling sensation on both arms and both legs (it feels like something is on my skin but nothing is there) no insect bites are present.; I am still having pain sensations in both my arms at the injection sites.; I am still having pain sensations in both my arms at the injection sites. Sometimes it's a stinging sensation; 05Jun I have had a hard involuntary jerking motion of my left lower leg; I have had some tingling on the left side of my face and my left pointer finger.; This is a spontaneous report from a contactable other hcp. A 56-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EP7533) dose number unknown via an unspecified route of administration in Arm Left on 05Apr2021 09:30 (age at vaccination 56years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included sickle cell anaemia from an unknown date and unknown if ongoing. The patient did not have known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications in two weeks, prior to the COVID vaccine. The patient's concomitant medications were not reported. Since the vaccination, the patient had been tested positive for COVID-19. On 03May2021 09:00 the patient experienced I have been having a crawling sensation on both arms and both legs (it feels like something is on my skin, but nothing is there) no insect bites are present. I am still having pain sensations in both my arms at the injection sites. Sometimes it's a stinging sensation. June 5th, I have had a hard involuntary jerking motion of my left lower leg and I have had some tingling on the left side of my face and my left pointer finger. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 10May2021 Nasal Swab. The patient did not receive any treatment for the adverse events. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Facial spasm
Clinical narrative: Patient had facial spasms; This is a spontaneous report from a contactable physician. A 32-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 05May2021 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medication. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26May2021 the patient experienced facial spasms. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of facial spasm and included treatment with Klonopin. The clinical outcome of the event facial spasms was resolved on unknown date.   The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate decreased, Lymphadenopathy, Mass, Noninfective sialoadenitis
Clinical narrative: Swollen left node under ear; Diagnosed as Inflamed Salivary Gland; Lump still present; Low Heart Rate. Referred to a Cardiologist; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 at 12:15 (at the age of 70-year-old) as a single dose for COVID-19 immunisation. Medical history included kidney disease, blood pressure high and hypothyroidism. Concomitant medications included amoxicillin, clavulanic acid (AUGMENTIN) for unknown indication from unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Mar2021 at 00:00, the patient experienced swollen left node under ear, diagnosed as inflamed salivary gland, lump was still present and low heart rate. The patient was referred to a cardiologist. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with antibiotics on an unknown date. The clinical outcome of the events swollen left node under ear, inflamed salivary gland, lump still present and low heart rate was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex
Clinical narrative: Both shots activated HSV-1 that had been dormant for years.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date, as a single dose for COVID-19 immunisation and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15May2021 at 15:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included herpes simplex (HSV-1). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks prior to the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced both Pfizer shots activated HSV-1 (Herpes simplex virus-1) that had been dormant for years. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event which included treatment with unspecified medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event activated HSV-1 was unknown at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Pain in extremity, Swelling
Clinical narrative: Some pain in the arm where I received the shot but not at the injection site, more generalized upper arm soreness; I realized the area directly under my left armpit was swollen and tender.; I realized the area directly under my left armpit was swollen and tender.; After second dose on June 5th I experienced fatigue and spent June 6th in bed.; After second dose on June 5th I experienced fatigue and spent June 6th in bed.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route in the left arm on 05Jun2021 at 10:45 (at the age of 52-year-old) as single dose for COVID-19 immunisation. Medical history included asthma and allergies indoor or outdoor. Concomitant medication included cetirizine hydrochloride (ZYRTEC), naproxen sodium (NAPROXIN) and esomeprazole magnesium (NEXIUM) for unknown indication from an unknown date. The patient had no known allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route the left arm on an unknown date in May2021 (at the age of 52-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Jun2021, after the second dose the patient experienced fatigue and spent June 6th in bed. The patient also had some pain in the arm where she received the shot but not at the injection site, more generalized upper arm soreness which she just included as fatigue symptom. By Monday, 06Jun2021 at 10:00, the patient noticed increasing soreness in the same arm but this time when she raised the arm up to stretch in case, she slept on it funny. The patient realized the area directly under the left armpit was swollen and tender. When compared it to the other armpit, the patient realized it was only the left side. On the day of the report, it was still tender and swollen so the patient went online and found this survey. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fatigue, spent June 6th in bed, some pain in the arm where she received the shot but not at the injection site, more generalized upper arm soreness, area directly under left armpit was swollen and tender were not recovered at the time of this report.  The lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspepsia, Fatigue, Vaccination site pain
Clinical narrative: Injection site pain; fatigue; Heartburn; chest pain; chest pressure; This is a spontaneous report from a contactable consumer. A 13-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 05Jun2021 at 08:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma exercise induced, COVID-19. The patient had no known allergies. The patient received other medications within two weeks of vaccination, names unspecified. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 15May2021 at 08:30 (at the age of 13-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Jun2021 at 20:00, the patient experienced injection site pain, fatigue, heartburn, chest pain, chest pressure. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the events injection site pain, fatigue, heartburn, chest pain, chest pressure was not recovered.   Information on the lot/batch number has been requested
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Arm pain; Fever on 2nd day; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Jun2021 at 15:45 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. Other medical history was reported as none. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 15May2021 at 14:00 (at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Jun2021, the patient experienced arm pain and fever on second day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events arm pain and fever was recovered on an unknown date in Jun2021.  The batch/lot numbers for BNT162b2, was not provided and will be requested during follow up.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Contusion, Pain, Spinal pain, Sunburn
Clinical narrative: Tremendous pain; My entire spine hurts; My skin feels bruised and badly sunburned at the same time; My skin feels bruised and badly sunburned at the same time; This is a spontaneous report from a Pfizer sponsored program via Regulatory Authority. A contactable consumer reported for a 52-year-old patient of an unspecified gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 08Apr2021 (at the age 52-year-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included fibromyalgia, myofascial pain syndrome from an unknown date. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2, 1st dose (at the age 52-year-old) for COVID-19 immunisation. The patient experienced tremendous pain, my entire spine hurts, my skin feels bruised and badly sunburned at the same time, my skin feels bruised and badly sunburned at the same time. Patient stated that "I received my 2nd dose of your vaccine 08Apr2021 and have been in tremendous pain ever since. I have had to see my Doctor, have had 2 courses of steroids and she put me on gabapentin. Nothing is helping. My entire spine hurts. My skin feels bruised and badly sunburned at the same time. There are days I have to stay in bed because of the pain. My Doctor confirmed it is side effects from the shot. Please help me feel better". Therapeutic measures were taken as a result of tremendous pain (pain), my entire spine hurts (spinal pain), my skin feels bruised and badly sunburned at the same time (contusion), my skin feels bruised and badly sunburned at the same time (sunburn). Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: Terrible headache; Chills; Severe body aches; The second dose is administered 14 days after the first dose.; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Jun2021 at 12:30(at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient medical history was reported as none. The patient did not have any known allergies. The patient did not receive any other medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24May2021 at 12:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 08Jun2021 at 13:00, the patient experienced terrible headache, chills and severe body aches. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event terrible headache, chills and severe body aches was not recovered at the time of this report.   The information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: weakness; This is a spontaneous report from a contactable Other HCP. A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. Patients medical history included rheumatoid arthritis from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient reported blood work being just fine 2 months ago; however, an abdominal test finding showed white fatty liver and some bladder stones; missing 2-3 days of xeljanz due to running out of refills on her script (prescription) but also skipped one day of xeljanz for the first dose of the covid-19 vaccine; patient experienced weakness after the first dose and then experienced major headaches and body weakness after the second covid-19 (vaccine) dose. Patient was advised to notify MD. Patient underwent lab test for blood work, results: blood work being just fine 2 months ago; and an abdominal test finding showed white fatty liver and some bladder stones on an unspecified date. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Musculoskeletal stiffness, Myalgia, Neuralgia, Pain in extremity
Clinical narrative: Second dose same pain muscle from the left arm for a few days; then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain; Then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain; Then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain; Injection site right arm then over all muscle and stiffness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable other health professional (patient). A 41-yeas-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 (at the age of 41 years old) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroid (hypothyroid is on normal levels). Concomitant medication received within two weeks included quetiapine (QUETIAPINE), sertraline hydrochloride (SERTRALINE ALPHARMA), lisdexamfetamine mesilate (VYVANSE), metformin (METFORMIN), lamotrigine (LAMOTRIGINE), levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 14:00 (at the age of 41 years old) as single for COVID-19 immunisation and experienced myalgia, vaccination site pain, musculoskeletal stiffness. The patient previously took gluten, zolpidem and experienced allergy. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced as, second dose same pain muscle from the left arm for a few days, then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain, injection site right arm then over all muscle and stiffness on 24May2021 18:00, inappropriate schedule of vaccine administered on 02Apr2021. No treatment were received for adverse events. Patient was not tested for COVID post vaccination. Outcome of the event Second dose same pain muscle from the left arm for a few days, then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain, general muscle stiffness were recovering.  Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Second dose same pain muscle from the left arm for a few days; then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain; Then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain; Then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain; Injection site right arm then over all muscle and stiffness; Inappropriate schedule of vaccine administered; This is a spontaneous report from a contactable other health professional (patient). A 41-yeas-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 (at the age of 41 years old) as dose 2, single for COVID-19 immunisation. Medical history included hypothyroid (hypothyroid is on normal levels). Concomitant medication received within two weeks included quetiapine (QUETIAPINE), sertraline hydrochloride (SERTRALINE ALPHARMA), lisdexamfetamine mesilate (VYVANSE), metformin (METFORMIN), lamotrigine (LAMOTRIGINE), levothyroxine sodium (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) all taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 02Apr2021 14:00 (at the age of 41 years old) as single for COVID-19 immunisation and experienced myalgia, vaccination site pain, musculoskeletal stiffness. The patient previously took gluten, zolpidem and experienced allergy. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced as, second dose same pain muscle from the left arm for a few days, then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain, injection site right arm then over all muscle and stiffness on 24May2021 18:00, inappropriate schedule of vaccine administered on 02Apr2021. No treatment were received for adverse events. Patient was not tested for COVID post vaccination. Outcome of the event Second dose same pain muscle from the left arm for a few days, then nerve pain around left hip and nerve like pain in the top of the foot and smaller toes, foot pain, general muscle stiffness were recovering.  Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache
Clinical narrative: weakness; headaches; This is a spontaneous report from a contactable Other HCP. This Other HCP reported for a 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date (at age of 50-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) for COVID-19 immunization. The patient's concomitant medications were not reported. It was reported that, missing 2-3 days of Xeljanz due to running out of refills on her script (prescription) but also skipping one day of Xeljanz for the first dose of the COVID-19 vaccine on an unspecified date patient experienced weakness after the first dose and then experienced major headaches and body weakness after the second COVID-19 (vaccine) dose. Patient advised to notify MD. Patient's abdominal test finding was white fatty liver and some bladder stones. The patient underwent lab tests and procedures which included blood test; her blood work being just fine 2 months ago. The outcome of both the events was unknown.   Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Delusion, Nausea, Vomiting
Clinical narrative: Nausea,; Vomiting; Delusions; Extreme anxiety; This is a spontaneous report from a contactable consumer (patient). A 27-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 06Jun2021 at 11:00 (at the age of 27 years old) as single for covid-19 immunisation. Medical history included post-traumatic stress disorder (PTSD). The patient had no history of known allergies. Concomitant medications included aripiprazole (ABILIFY); methadone for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jun2021, the patient experienced nausea, vomiting, delusions and extreme anxiety. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The outcome of events was not recovered at the time of reporting.  The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL1283, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 05Jan2021 (at the age of 36-years-old) as dose 2, single for COVID-19 immunisation. The patient has no relevant medical history and relevant tests. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EK5730, Expiration date: Mar2021), intramuscularly (administered on the right arm) on 17Dec2020 at 16:30 (at the age of 36-years-old) for COVID-19 immunisation and experienced events which included swollen lymph in my neck and my arm pits, elevated pulse, sweating, severe sore throat, weakness, body ache, couldn't even function and get out of bed, kind of feeling off, fatigue, couldn't swallow, chills, and joint pain. On an unspecified date, the patient experienced chills and joint pain. The events did not require a visit to Physician office. The outcome of the events was unknown. No follow-up attempts are possible. No further information expected.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Illness, Pyrexia
Clinical narrative: Diarrhea; aches/tummy ache; sick; Fever; This is a spontaneous report from a contactable consumer (patient mother). A 17-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 14May2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. There were no concomitant medications. Patient did not receive any other prior Vaccinations (within 4 weeks). On 16May2021, the next day after the 15th patient experienced Diarrhea and patient felt sick between the 15th to the 20th. Patiet had a reaction for 4 days. It was 5 days with diarrhea and tummy. Then it went away. Treatment: Just diet and staying home. On 15May2021, The next day after vaccination patient experienced Fever. It was going away 5 days later. Patient received Gatorade and Tylenol for fever and aches. Any AE(s) did not require a visit to Emergency Room and Physician Office. Patient received second shot on 05Jun2021. The outcome of events was recovered on 20May2021.  Information on Lot/Batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Decreased appetite, Diarrhoea, Myalgia
Clinical narrative: Extreme stomach pain; Loss of appetite; Diarrhea; Muscle pain; Joint pain; Swelling at injection site; Bruising at injection site; This is a spontaneous report from a contactable healthcare professional, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 24Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and ADHD both from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included clonazepam (KLONOPIN), sertraline hydrochloride (ZOLOFT) , duloxetine hydrochloride (CYMBALTA) and cetirizine hydrochloride (ZYRTEC); all from unknown dates for unknown indications. The patient previously took amoxicillin and experienced a rash and itching. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 15:00, the patient experienced extreme stomach pain, loss of appetite, diarrhea, muscle pain and joint pain, swelling and bruising at injection site. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme stomach pain, loss of appetite, diarrhea, muscle pain and joint pain, swelling and bruising at injection site was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site swelling
Clinical narrative: Extreme stomach pain; Loss of appetite; Diarrhea; Muscle pain; Joint pain; Swelling at injection site; Bruising at injection site; This is a spontaneous report from a contactable healthcare professional, the patient. A 29-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 24Mar2021 at 15:00 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and ADHD both from unknown dates. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included clonazepam (KLONOPIN), sertraline hydrochloride (ZOLOFT) , duloxetine hydrochloride (CYMBALTA) and cetirizine hydrochloride (ZYRTEC); all from unknown dates for unknown indications. The patient previously took amoxicillin and experienced a rash and itching. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 22Apr2021 at 15:00, the patient experienced extreme stomach pain, loss of appetite, diarrhea, muscle pain and joint pain, swelling and bruising at injection site. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme stomach pain, loss of appetite, diarrhea, muscle pain and joint pain, swelling and bruising at injection site was not recovered at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I broke out in a rash. Small red bumpy circles all over my body; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 33-year-old male patient received second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0185), via an unspecified route in the left arm on 07Jun2021 at 09:00 (age at vaccination: 33-year-old), as a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included cetirizine hydrochloride (ZYRTEC). Historical vaccine included first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0175), via an unspecified route in the left arm on 17May2021 at 09:00 (age at vaccination: 33-year-old), as a single dose for covid-19 immunization. Patient has not taken any other vaccine in four weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. No known allergies were reported. On 08Jun2021 at 07:00, after the second dose, patient broke out in a rash: small red bumpy circle all over his body. Adverse event resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient received any treatment for the adverse event. The clinical outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting for several hours; This is a spontaneous report from a contactable consumer. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on an unknown date in Jun2021(at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via unspecified route of administration in the left arm on an unknown date in May2021(at the age of 16-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, it was unknown whether the patient diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient had tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On an unknown date in Jun2021, after receiving the vaccination, the patient experienced vomiting for several hours. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the event vomiting was recovered on an unknown date in Jun2021.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Fatigued; Some headaches; received BNT162B2 (BNT162B2, PFIZER-COVID-19 Vaccine, Solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (BNT162B2, PFIZER-COVID-19 Vaccine, Solution for injection, Lot number and expiration date: Not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunisation. It was reported that Mom felt fatigued with some headaches but the headaches have not persisted. any visual changes, numbness, tingling, galt changes, slurred speech, headaches that wake her from sleep or cognitive changes, She has been feeling latigued daily since receiving her COVID vaccine. She denies any fever or joint pain. There has been no recent Injury. Therapeutic measures were taken as a result of some headaches. The outcome of the event headache was recovered and other event was unknown.  No Follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Tinnitus
Clinical narrative: intermittent dizziness, buzzing in the ears ongoing since 3 days after initial vaccine; intermittent dizziness, buzzing in the ears ongoing since 3 days after initial vaccine; This is a spontaneous report received from a contactable consumer via COVAES. A 63-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: ER8727), dose 1 via an unspecified route of administration, administered in Arm Right on 18Mar2021 20:15 (at the age 63-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension, hyperlipidaemia, hypersensitivity (Verbatim: Skin hypersensitivity), barrett's oesophagus (Verbatim: Barrett's esophagus), hiatus hernia, obesity from an unknown date. The patient previously took levothyroxine and experienced drug hypersensitivity. The patient experienced intermittent dizziness, buzzing in the ears ongoing since 3 days after initial vaccine on 21Mar2021. Therapeutic measures were taken as a result of intermittent dizziness, buzzing in the ears ongoing since 3 days after initial vaccine. Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Pain in extremity
Clinical narrative: patient felt tired, sore arm, dizzy and headache; sore arm; dizzy; headache; This is a spontaneous report from a contactable consumer. A 12-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 06Jun2021(at the age of 12-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via intramuscular route of administration in the left arm on 16May2021(at the age of 12-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Jun2021 at 09:00, the patient experienced felt tired, sore arm, dizzy and headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if patient received any treatment for the events. The clinical outcome of the events felt tired, sore arm, dizzy and headache was recovered on unknown date in 2021.  information on lot/batch number has been requested
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Pyrexia
Clinical narrative: Multiple-day migraine ongoing; 6-hour fever (100.8 deg F) on 6/7/2021; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received an unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Jun2021 at 16:45 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included metoprolol succinate (TOPROL XL) for an unknown indication from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Jun2021 at 14:30 the patient experienced multiple-day migraine ongoing and 6-hour fever (100.8 deg F). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with ibuprofen (MANUFACTURER UNKNOWN) on an unknown date. The clinical outcome of the events migraine and fever were not recovered at the time of this report.   The lot number for, BNT162b2, were not provided and will be requested during follow up.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: Disrupted menstrual cycle starting after 2nd dose. Starting 21Apr2021 Extreme Menstrual bleeding for more than 50 days.; Disrupted menstrual cycle starting after 2nd dose. Starting 21Apr2021 Extreme Menstrual bleeding for more than 50 days.; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 23Feb2021 (Batch/Lot number was not reported) (at the age of 47 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included none. There were no concomitant medications. No other vaccine in four weeks. No known allergies. The patient experienced Disrupted menstrual cycle starting after 2nd dose from Mar2021. Starting 21Apr2021, Extreme Menstrual bleeding for more than 50 days from Mar2021. (despite taking progesterone, which has slowed, but not stopped it). Doctor says this is not within normal for perimenopause. The outcome of events was not recovered. Therapeutic measures were taken for the events. Events resulted in Doctor or other healthcare professional office/clinic visit.  No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Lymphadenopathy, Swelling
Clinical narrative: Swollen lymph node under left armpitSwollen lymph node left side of neck; Swelling bottom corner or left eye; Swollen toes; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6204) via an unspecified route of administration in the arm left on 23Mar2021 at 18:30 (at the age of 48-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0164) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included von willebrand's disease. Concomitant medication were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Apr2021 at 18:00, the patient experienced swollen lymph node under left armpit, swollen lymph node on left side of neck, swelling bottom corner or left eye and swollen toes. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events swollen lymph node under left armpit, swollen lymph node left side of neck, swelling bottom corner or left eye and swollen toes was not recovered at the time of this report.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Paraesthesia, Pyrexia
Clinical narrative: Fever; chills; fatigue; tingling in hands; back pain; This is a spontaneous report from a non-contactable consumer, the patient. A 43-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration on an unknown date and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the left arm on an unknown date (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 08Jun2021, the patient experienced fever, chills, fatigue, tingling in hands and back pain. No therapeutic measures were taken as a result of the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever, chills, fatigue, tingling in hands and back pain were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: 102.8 fever; Chills; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. An adolescent non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0217) via an unspecified route of administration on 08Jun2021 at 08:00 as a single dose for COVID-19 immunisation. The patients' medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. On an unknown date in Jun2021, the patient experienced fever 102.8 (unspecified units), chills and nausea. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fever 102.8 (unspecified units), chills and nausea were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site swelling
Clinical narrative: Today his arm is swollen; Swelling in the injection site; This is a spontaneous report from a contactable consumer. A male patient [reporter's husband] of unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 08Jun2021 as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration on 19May2021 as single dose for COVID-19 immunization and had no reaction. On 09Jun2021, one day after second dose of vaccination patient experienced swelling in the injection site and arm was swollen. Reporter asked what patient can apply on his arm. Outcome of the events were not resolved.  Follow-up attempts are possible. Further information is expected.