chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Body aches; Sever muscle ache; Fatigue; Joint pain; Mild fever; Chills; Sweats; Severe Headache; Aches in arms and legs; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Right (deltoid) on 21Jun2021 11:15 (at the age of 23-years-old) (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included PTSD (Posttraumatic stress disorder) from an unknown date and unknown if ongoing, ongoing depression and ADHD (Attention deficit hyperactivity disorder). Concomitant medication included fluoxetine hydrochloride (PROZAC) taken for depression from Jan2019 and ongoing, dexamfetamine sulfate (DEXEDRINE) taken for an unspecified indication, start and stop date were not reported and lisdexamfetamine mesilate (VYVANSE) taken for ADHD from Nov2020 and ongoing. Patient previously took first dose of bnt162b2 (Lot number: EW0191) administered in Arm Right (deltoid) on 01Jan2021 11:00 AM (at the age of 23-years-old), intramuscular for covid-19 immunisation. Patient did not have pregnancy at time of vaccination. On 21Jun2021 20:00, the patient experienced chills, sweats, severe headache, aches in arms and legs, nausea and vomiting. On 21Jun2021 23:15, the patient experienced mild fever, severe muscle ache, fatigue, joint pain. On 22Jun2021 12:30, the patient experienced body aches. Patient received no treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not underwent for any prior vaccination and relevant tests. Seriousness of events were reported as non serious by reporter. Outcome of events chills, sweats, severe headache, aches in arms and legs, nausea, vomiting were recovering while outcome of events mild fever, sever muscle ache, fatigue, body aches and joint pain were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Body aches; Sever muscle ache; Fatigue; Joint pain; Mild fever; Chills; Sweats; Severe Headache; Aches in arms and legs; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Right (deltoid) on 21Jun2021 11:15 (at the age of 23-years-old) (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included PTSD (Posttraumatic stress disorder) from an unknown date and unknown if ongoing, ongoing depression and ADHD (Attention deficit hyperactivity disorder). Concomitant medication included fluoxetine hydrochloride (PROZAC) taken for depression from Jan2019 and ongoing, dexamfetamine sulfate (DEXEDRINE) taken for an unspecified indication, start and stop date were not reported and lisdexamfetamine mesilate (VYVANSE) taken for ADHD from Nov2020 and ongoing. Patient previously took first dose of bnt162b2 (Lot number: EW0191) administered in Arm Right (deltoid) on 01Jan2021 11:00 AM (at the age of 23-years-old), intramuscular for covid-19 immunisation. Patient did not have pregnancy at time of vaccination. On 21Jun2021 20:00, the patient experienced chills, sweats, severe headache, aches in arms and legs, nausea and vomiting. On 21Jun2021 23:15, the patient experienced mild fever, severe muscle ache, fatigue, joint pain. On 22Jun2021 12:30, the patient experienced body aches. Patient received no treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not underwent for any prior vaccination and relevant tests. Seriousness of events were reported as non serious by reporter. Outcome of events chills, sweats, severe headache, aches in arms and legs, nausea, vomiting were recovering while outcome of events mild fever, sever muscle ache, fatigue, body aches and joint pain were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Body aches; Sever muscle ache; Fatigue; Joint pain; Mild fever; Chills; Sweats; Severe Headache; Aches in arms and legs; Nausea; Vomiting; This is a spontaneous report from a contactable consumer (patient). A 23-years-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 2 intramuscular, administered in Arm Right (deltoid) on 21Jun2021 11:15 (at the age of 23-years-old) (Batch/Lot Number: EW0196) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included PTSD (Posttraumatic stress disorder) from an unknown date and unknown if ongoing, ongoing depression and ADHD (Attention deficit hyperactivity disorder). Concomitant medication included fluoxetine hydrochloride (PROZAC) taken for depression from Jan2019 and ongoing, dexamfetamine sulfate (DEXEDRINE) taken for an unspecified indication, start and stop date were not reported and lisdexamfetamine mesilate (VYVANSE) taken for ADHD from Nov2020 and ongoing. Patient previously took first dose of bnt162b2 (Lot number: EW0191) administered in Arm Right (deltoid) on 01Jan2021 11:00 AM (at the age of 23-years-old), intramuscular for covid-19 immunisation. Patient did not have pregnancy at time of vaccination. On 21Jun2021 20:00, the patient experienced chills, sweats, severe headache, aches in arms and legs, nausea and vomiting. On 21Jun2021 23:15, the patient experienced mild fever, severe muscle ache, fatigue, joint pain. On 22Jun2021 12:30, the patient experienced body aches. Patient received no treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient did not underwent for any prior vaccination and relevant tests. Seriousness of events were reported as non serious by reporter. Outcome of events chills, sweats, severe headache, aches in arms and legs, nausea, vomiting were recovering while outcome of events mild fever, sever muscle ache, fatigue, body aches and joint pain were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Pruritus, Rash erythematous, Skin warm
Clinical narrative: Shortly after 2nd dose, started seeing red rash on my legs.  Did not go away after week, so saw my dermatologist, who prescribed me with a cream. Did not help. Few weeks later started getting some sor; Few weeks later started getting some sores on my upper legs and back; my skin gets very hot and itchy; my skin gets very hot and itchy; fatigue is a favor; This is a spontaneous report from a contactable consumer (patient). A 66-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9810, Expiration date not reported), via an unspecified route of administration, administered in right arm on 12Feb2021 14:15 (at the age of 66 years) as dose 2, single for covid-19 immunization. Medical history included obstructive sleep apnea, thyroid cancer, and known allergy to penicillin, all from an unknown date and unknown if ongoing. Patient previously took first dose of bnt162b2 (Lot number: EL3247, Expiration date not reported) via an unspecified route of administration, administered in right arm on 22Jan2021 14:30 (at the age of 66 years) as dose 1, single for covid-19 immunization. Concomitant medications taken within in two weeks included diltiazem; levothyroxine sodium (LEVOTHYROXIN); and sertraline hydrochloride (ZOLOFT), all taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of vaccination. No other vaccine in four weeks. No COVID prior vaccination and not COVID tested post vaccination. On 19Feb2021, shortly after 2nd dose, patient started seeing red rash on her legs. They did not go away after week, so she saw her dermatologist, who prescribed her with a cream. However, it did not help. Few weeks later patient started getting some sores on her upper legs and back on 19Feb2021. Patient saw her MD who started her on antibiotic, but it did not go away. Then patient went back to dermatologist, and he prescribed a stronger cream. It was reported that, along with the rashes and sores, her skin got very hot and itchy, and fatigue was a favour on 19Feb2021. Now 4 months later rash was a little better, but the other symptoms still bothered her every day. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and patient received treatment with unspecified creams and antibiotic. The outcome of event started seeing red rash on my legs was recovering and rest of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Gait disturbance
Clinical narrative: shortness of breath; difficulties after a five-minute walk where I'm having difficulties; have a small cough which I started after the first shot and two months past the second shot and it just seems to be getting a little worse; This is a spontaneous report from a contactable consumer (Patient). A 54-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534), via an unspecified route of administration, administered in right arm on 14Mar2021 (at the age of 54 years old) as a single dose for COVID-19 immunisation. The patient's medical history was none reported. The patient had penicillin allergies. The patient's concomitant medications were none reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested COVID post vaccination. The patient took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6200) via an unspecified route of administration, administered in left arm on an unspecified date as a single dose for COVID-19 immunization and experienced small cough. On 14Mar2021 at 20:30 the patient experienced shortness of breath, difficulties after a five-minute walk where I'm having difficulties and have a small cough which I started after the first shot and two months past the second shot, and it just seems to be getting a little worse. The patient reported that patient had problems with breathing after only 5 or 10 minutes of exercise which patient did not have before and took the first shot the patient also had a small cough which patient started after the first shot, and it seems to have not gone away. The patient did not receive any treatment for the events. The reporter reported the events as non-serious. The patient visited physician office due to events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Rash pruritic
Clinical narrative: On 6/21/2021 I developed a itching blistery rash 3"×3" in diameter in the exact location where both vacine were administered, putting the reaction almost exactly 2 months after my second dose of the v; On 6/21/2021 I developed a itching blistery rash 3"×3" in diameter in the exact location where both vacine were administered, putting the reaction almost exactly 2 months after my second dose of the v; This is a spontaneous report from a contactable consumer or other non hcp. A 38-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0172 and expiration date were not reported), via an unspecified route of administration, administered in left arm on 25Apr2021 (Age at vaccination was 38 years) as dose 2, single for covid-19 immunisation. facility type where vaccine was administered was School or Student Health Clinic. The patient's concomitant medications were not reported. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was ER8737 and expiration date was not reported), via an unspecified route of administration, administered in left arm, on 25Apr2021 at 10:00 AM as dose 1, single for COVID-19 immunization. Patient did not received any other vaccines within 4 weeks prior to the covid vaccine. Patient did not received any other medications within 2 weeks of administration of vaccine. Patient did not have allergies. On 21Jun2021 the patient developed a itching blistery rash 3 by 3 inches in diameter in the exact location where both vaccine were administered. Patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination patient was not tested for COVID-19. Patient reported that "putting the reaction almost exactly 2 months after my second dose of the vaccine". No treatment was received for the events. The outcome of events was not recovered.   Information about batch/lot number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: fever and flu like symptoms; fever and flu like symptoms; This is a spontaneous report from a contactable other health care professional (patient). A 67-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EN6202, Expiry date : not reported), via intramuscular route of administration in Deltoid Left on 24Feb2021 11:15 (at the age of 67-years) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypothyroidism from 2013 to an unknown date. Concomitant medications included levothyroxine sodium (SYNTHROID, Formulation, Batch/Lot Number and Expiry date : not reported) taken via oral route of administration for hypothyroidism from 2003 and ongoing. The patient did not receive any prior vaccinations. The patient has received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Batch/Lot Number: EN7534, Expiry date : not reported), via intramuscular route of administration in Deltoid Left on 17Mar2021 14:30 as DOSE 2, SINGLE for covid-19 immunisation. On 24Feb2021 15:30, the patient experienced fever and flu like symptoms. No initiation of new medication/other treatment/procedure was reported was required for event. Relevant test was reported as none. The outcome of the events was recovered on 01Mar2021. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Coughing and feeling pain in my throat.; Coughing and feeling pain in my throat; This is a spontaneous report from a contactable consumer. This is the second case of two split cases.  A 54-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0173) via an unspecified route of administration on 08May2021 as dose 1, single and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0180) via unspecified route of administration on 24May2021 as dose 2, single for COVID-19 immunization. Medical history included hypertension and blood cholesterol increased. Concomitant medication included aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) taken for blood cholesterol increased, start and stop date were not reported; simvastatin (SIMVASTATIN) taken for blood cholesterol increased, start and stop date were not reported; duloxetine hydrochloride (CYMBALTA) taken for blood cholesterol increased, start and stop date were not reported; losartan (LOSARTAN) taken for hypertension, start and stop date were not reported. On 10Jun2021 patient started coughing /coughing is so annoying and feeling pain in throat. Still experiencing side effect: whole time in morning and when he goes back in 8 PM start experiencing the worse. Patient didn't receive any treatment for adverse events. The clinical outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gastrointestinal pain, Headache, Hepatic pain
Clinical narrative: they moved me to the ER. Because I experienced the shortness of breath; pain modest site in gut bowled was so painful in the side of gut and the liver; pain modest site in gut bowled was so painful in the side of gut and the liver; experienced headache almost in after the modest was 15 minutes; I get the vaccine that day and the whole week I was feel like tired and not feeling well; I get the vaccine that day and the whole week I was feel like tired and not feeling well; This is a spontaneous report from a contactable consumer or other non-health care professional.   A 54-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 08May2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing hypertension; ongoing blood cholesterol increased. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)) taken for blood cholesterol increased; simvastatin (SIMVASTATIN) taken for blood cholesterol increased; duloxetine hydrochloride (CYMBALTA) taken for blood cholesterol increased; buprenorphine hydrochloride (BELBUCA; Cinnamomum verum (CINNAMON); lansoprazole (ALBERTA); montelukast (MONTELUKAST); salbutamol sulfate (VENTOLIN ACCUHALER); cholecalciferol (VITAMINS D3). On an unspecified date, the patient experienced the shortness of breath, pain modest site in gut bowled was so painful in the side of gut and the liver, experienced headache almost in after the modest was 15 minutes, patient got the vaccine that day and the whole week patient was feel like tired and not feeling well. The consume was nostalgic on first dose. The outcome of the events was unknown.  "This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected."
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: they moved me to the ER. Because I experienced the shortness of breath; pain modest site in gut bowled was so painful in the side of gut and the liver; pain modest site in gut bowled was so painful in the side of gut and the liver; experienced headache almost in after the modest was 15 minutes; I get the vaccine that day and the whole week I was feel like tired and not feeling well; I get the vaccine that day and the whole week I was feel like tired and not feeling well; This is a spontaneous report from a contactable consumer or other non-health care professional.   A 54-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736; Expiration Date: 31Jul2021), via an unspecified route of administration, administered in Arm Left on 08May2021 as dose 1, single for COVID-19 immunization. Medical history included ongoing hypertension; ongoing blood cholesterol increased. Concomitant medication(s) included acetylsalicylic acid (ASPIRIN (E.C.)) taken for blood cholesterol increased; simvastatin (SIMVASTATIN) taken for blood cholesterol increased; duloxetine hydrochloride (CYMBALTA) taken for blood cholesterol increased; buprenorphine hydrochloride (BELBUCA; Cinnamomum verum (CINNAMON); lansoprazole (ALBERTA); montelukast (MONTELUKAST); salbutamol sulfate (VENTOLIN ACCUHALER); cholecalciferol (VITAMINS D3). On an unspecified date, the patient experienced the shortness of breath, pain modest site in gut bowled was so painful in the side of gut and the liver, experienced headache almost in after the modest was 15 minutes, patient got the vaccine that day and the whole week patient was feel like tired and not feeling well. The consume was nostalgic on first dose. The outcome of the events was unknown.  "This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected."
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Dizziness, Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0177, expiration date: Aug 2021), at the age of 72,  via an unspecified route of administration, in right arm, on Jun 15, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient previously took flu shot for immunization and experienced a problem with the needle. She has to put on an ice pack. On Jun 15, 2021, patient had injection site pain. On Jun 2021, tiredness, headache, muscle pain, chills, joint pain, dizziness and weakness. She doesn't know if she will get the second dose of the COVID-19 vaccine. She felt bad, sleepy, joint and muscle pain (got worse and worse). This resulted in a drive to the hospital. The outcome of injection site pain: recovering; for the rest of the events: unknown. Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Pain, Product dose omission issue
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0177, expiration date: Aug 2021), at the age of 72,  via an unspecified route of administration, in right arm, on Jun 15, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient previously took flu shot for immunization and experienced a problem with the needle. She has to put on an ice pack. On Jun 15, 2021, patient had injection site pain. On Jun 2021, tiredness, headache, muscle pain, chills, joint pain, dizziness and weakness. She doesn't know if she will get the second dose of the COVID-19 vaccine. She felt bad, sleepy, joint and muscle pain (got worse and worse). This resulted in a drive to the hospital. The outcome of injection site pain: recovering; for the rest of the events: unknown. Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 72-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0177, expiration date: Aug 2021), at the age of 72,  via an unspecified route of administration, in right arm, on Jun 15, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. Patient previously took flu shot for immunization and experienced a problem with the needle. She has to put on an ice pack. On Jun 15, 2021, patient had injection site pain. On Jun 2021, tiredness, headache, muscle pain, chills, joint pain, dizziness and weakness. She doesn't know if she will get the second dose of the COVID-19 vaccine. She felt bad, sleepy, joint and muscle pain (got worse and worse). This resulted in a drive to the hospital. The outcome of injection site pain: recovering; for the rest of the events: unknown. Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Movement disorder, Pain, Peripheral swelling, Swelling
Clinical narrative: Left hand got very swollen; Left wrist got very swollen; Could barely move his fingers without any pain; She give her husband an Aleve to ease some of the pain; This is a spontaneous report from a contactable consumer (Patients Wife). A 75-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number was EW0181 and expiration date was not reported), via an unspecified route of administration, administered in left arm on 20Jun2021 at 10:30 (Age at vaccination was 75 years) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included atorvastatin taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took flu vaccine vii, shingrix, pneumococcal vaccines. On 22Jun2021 about two days after receiving the first covid vaccine patients wife stated that her husband had his first vaccine this past Sunday and yesterday (22Jun2021) he noticed in the same arm he received the vaccine, his left hand and left wrist very swollen and he could barely move fingers without any pain. She wrapped it in a ace bandage and she don't know if that's ok or not. She also give her husband an Aleve to ease some of the pain but had heard that it might not be ok to give with the Covid 19 vaccine. She wasn't sure what the time parameters were before she could give him some Aleve or if she could give him some Tylenol. Patients injection site did not bother him at all. She isn't sure if this was from the Covid 19 vaccine but her husband doesn't remember doing anything to make his hand and wrist swell. She reports her husband gets his flu vaccine every year and has never had a reaction. He was had the pneumonia and the shingles vaccines and did not have reactions to either of those. She have appointments in Jul2021 with their new primary healthcare provider. Vaccination facility type was drug store. The patient did not perform any relevant test. Therapeutic measures were taken as a result of pain. The outcome of the events was not recovered.  Follow up attempts are needed; Additional information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Insomnia, Pyrexia
Clinical narrative: Chills; Fever; Couldn't sleep; super tired, completely zonked; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 2. A 53-year-old male patient of received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EN6206) via an unspecified route of administration, administered in left arm on 12Mar2021 10:00 (at the age of 53-year-old) as dose2, single for COVID-19 immunisation. Medical history included ongoing primary progressive multiple sclerosis from 2018. The patient's concomitant medications were not reported. The patient took previously bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EN6198) via an unspecified route of administration, administered in left arm on 19Feb2021 10:00 (at the age of 53-year-old) as a dose1, single for COVID-19 immunisation and experienced sick. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Mar2021 around 23:00 the patient experienced chills, fever, he could not sleep. He was just like super tired, completely zonked. The patient did not have any laboratory test. The patient did not receive any treatment for events. Outcome of events was unknown.  No follow-up attempts possible. No further information expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report from a non-contactable consumer or other non-health care professional reported for herself (Patient) in response to HCP letter sent in cross referenced case.    A 20-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3246; Expiration date was not reported), via unspecified route of administration, in arm on 28Jan2021 (at age of 20-years-old) for COVID-19 immunization. Medical history included asthma (childhood infant asthma, that she grew out of as she aged), food allergy (banana), latex allergy, sulfonamide allergy and Avaco drug allergy along with COVID-19 (before vaccination). Concomitant medications included sertraline hydrochloride (ZOLOFT) and birth controls prior to the event being reported. The patient did not receive any other vaccines around the time of Pfizer-BioNTech COVID-19 vaccine vaccination or in four weeks. Patient did not receive any recent vaccines for any other conditions prior to the event being reported. The patient did not receive any recent vaccines for SARS-CoV2 other than Pfizer-BioNTech COVID-19 vaccine prior to the event being reported. On 01Feb2021, patient experienced rash after 4 days of first vaccination. Patient was not hospitalized nor admitted to an intensive care unit. Therapeutic measures were included took 2 Benadryl internally this worked to stop worse reaction and antihistamine. The outcome of rash was reported as unknown.     Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Gastrointestinal pain, Headache, Malaise
Clinical narrative: Experienced the shortness of breath.; Pain modest site in gut bowled was so painful in a side of gut and the Liver.; Tired and not feeling well; Headache; not feeling well; This is a spontaneous report from a contactable consumer (patient). A patient female of unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: ER8736 and expiry date: 31Jul2021), via an unspecified route of administration, in Arm Left on 24Apr2021 as single dose for COVID-19 immunisation. The patient medical history included rheumatoid arthritis, fibromyalgia, asthma, high blood pressure, high cholesterol and morbid obesity from an unknown date and unknown if ongoing. Concomitant medications included oxycodone for rheumatoid arthritis and fbromyalgia, duloxetine hydrochloride (CYMBALTA), fexofenadine hydrochloride (ALLEGRA), gabapentin enacarbil (HORIZANT) 1200 mg, losartan , magnesium, amoxicillin, cyanocobalamin (VITAMIN B12), curcuma longa rhizome, piper nigrum fruit (TURMERIC), amlodipine besilate, famotidine, certolizumab pegol (CIMZIA), metoprolol, trazodone, cinnamomum verum (CINNAMON) 100mg, colecalciferol (VITAMINS D3) 5000 units/day; salbutamol sulfate (VENTOLIN INHALER), Albertan, Singular Montelukast, Bebuca 300 mg for an unspecified indication, start and stop date were not reported. The patient received second dose of BNT162B2 on 24May2021 for COVID-19 immunisation. The patient reported that, on an unspecified date, she experienced shortness of breath, pain modest site in gut bowled was so painful in the side of gut and the liver, headache almost in after the modest was 15 minutes. She got the vaccine that day and the whole week she was felt like tired and not feeling well after that everything was normal. The patient had visited to emergency room for the events. Outcome of the events, shortness of breath, pain modest site in gut bowled was so painful in the side of gut and the liver, headache and felt tired was recovering and outcome of the event not feeling well was recovered on an unspecified date in 2021.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: extreme, heavy menstrual bleeding; I am still bleeding  going on 34 consecutive days; This is spontaneous report from a contactable consumer (patient). A 48-year-old female patient (age at vaccination: 48 years) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0187 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 22May2021 at 01.00 PM, as dose 1, single dose for COVID-19 immunization and second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0187 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 12Jun2021 at 12:45 PM, as dose 2, single dose for COVID-19 immunization at pharmacy or drug store. The patient was not pregnant at the time of vaccination. The patient's medical history included mild asthma and fibroids. The patient did not have any known allergies. Concomitant medications included norethisterone acetate (NORETHINDRONE) and sertraline (SETRALIN SANDOZ). The patient did receive any other vaccine in four weeks. It was unknown if the patient was diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient began with normal menstruation cycle two days before receiving first vaccine. Then extreme, heavy menstrual bleeding began around one week after that first vaccine on 29May2021 at 02:00 PM. She was still bleeding today, going on 34 consecutive days and counting. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest discomfort, Fatigue, Pain in extremity
Clinical narrative: Right hip pain (moderate); Fatigue (moderate); Chest tightness (mild); Left arm soreness (mild); This is a spontaneous report from a contactable nurse (patient). A 58-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) via an unspecified route of administration, administered in Arm Left on 04May2021 13:45 (Lot Number: EW0179) as DOSE 2, SINGLE (at the age of 58-year-old) for covid-19 immunisation. Medical history included Endometriosis, eczema. Known allergies reported as Mold, dust, seasonal allergies. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) via an unspecified route of administration at left arm as dose 1, single on 13Apr2021 11:30 (at the age of 58-year-old) for covid-19 immunisation. Concomitant medication(s) included estradiol, norethisterone acetate (COMBIPATCH). No other vaccine in four weeks. The patient experienced fatigue, chest tightness, left arm soreness on 05May2021, right hip pain on 06May2021. No treatment received. No covid prior vaccination. No covid tested post vaccination. The outcome of the event for Fatigue was recovered on 10May2021, Chest tightness (mild) was recovered on 06May2021, Left arm soreness (mild) was recovered on 07May2021, Right hip pain (moderate) was recovered on 03Jun2021.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Bumps on her skin that are red and itchy; Bumps on her skin that are red and itchy/bumps are on her arms and legs; This is a spontaneous report from contactable consumer (patient) from a Pfizer sponsored program  support. A 62-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EW0178, Expiration date: Unknown), via an unspecified route of administration, administered in the left arm on 12Jun2021 at 14:40 (at the age of 62-years-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications was not reported. On an unspecified date in Jun2021, after first dose of vaccination, patient experienced bumps on her skin that are red and itchy. The patient stated that the bumps are on her arms and legs. This was first noticed either last Sunday or the following Monday, that is on 13Jun2021 or 14Jun2021. She explained that it was getting worse at the time of report, at first she thought it was bug bites. The patient receive treatment for the events includes anti itch cream. She has started no new medication or tried no new foods, nothing is different. No Emergency Room or Physician Office visit. Patient was supposed to take the second dose on 03Jul2021 but was going to take it on 05Jul2021 due to the holiday and she was not sure if she should take it. The clinical outcome of the events was not recovered at the time of report.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Discomfort, Neck pain, Spondylitis, X-ray
Clinical narrative: Told has arthritis in neck from C3 or C4 to C6; Cannot get comfortable at night because of her neck; Arthritis at C3-C4 down to C6; Pain in neck; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 75-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: ER2613), via an unspecified route of administration on 25Mar2021 (at the age of 74-years-old) as DOSE 2, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior Vaccinations any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was reported as None. It was reported that patient was healthy at the time of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EN6205), via an unspecified route of administration on 03Mar2021 (at the age of 74-years-old) as dose 1, single for COVID-19 immunisation. Patient wants to speak with a medical professional about side effects she had since received the Covid 19 Vaccine. she stated that she had her second shot at the end of Mar2021. Six weeks later, in the middle of May, she started to experience pain in her neck. The pain continued and she went to the doctor. She had x-rays done and was told that she had arthritis in her neck from C3 or C4 to C6. Patient Stated that she never had a problem with her neck and it seems like it may be related to the vaccine. States she wants to know from a professional if that is a possibility. She was very frustrated and she cannot get comfortable at night because of her neck. The doctor told her to use Advil, it did not help a whole lot, just some. When she told the doctor that she thought it might be related to the Covid Vaccine he told her at least she didn't get Covid 19. The patient underwent lab tests and procedures which included x-ray: arthritis in neck on 2021. Therapeutic measures was taken for the events treatment received with Advil. The outcome of Pain in neck was not recovered and outcome of arthritis in neck from C3 or C4 to C6, cannot get comfortable at night because of her neck, Arthritis at C3-C4 down to C6 was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Illness, Pharyngitis streptococcal
Clinical narrative: sick; coughing; strep-throat; This is a spontaneous report from a Pfizer sponsored program support. A contactable female consumer (patient) reported that a 38-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0185), via an unspecified route of administration (left shoulder) on 12May2021 (at the age of 38 years old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. She received first shot on 12May2021, and wasn't able to get the second dose, it was scheduled after two weeks, but doesn't have exact date, and now it has been 42 days, yesterday, from first dose. Her second shot has been delayed due to strep-throat on May2021. She told it's been 43 days today and asks if she can take the second dose with the given time frame. If the second dose was given later than 6 weeks (42 days), the vaccination series does not need to be repeated. She was going to get it after two weeks, but then she got sick, her and her daughter got sick. She had strep throat, and was on antibiotics, and needed to finish antibiotics, and wait a few days after that, so it put her at this many days. Agent stated reporter was asking if she can still get second dose. She was unsure of the antibiotics she took, stated they are free at Publix there. She stated it's not a Z-pack, it's whatever they give her when have strep throat. She stated she did not take anything else for treatment and confirms she did not have any fever. Strep throat was in May2021 and has resolved, she was done with antibiotics. She still coughing, but just a tiny bit, but that's why she decided maybe today would be a good day to go. She stated the cough started about two weeks or more ago, and reports she was almost 100% better. She stated no tests were done, the doctor just looked at her. She stated she just went to the doctor for her yearly check-up, and she was getting sick, and the doctor looked at her throat, and said, it looked like she had strep throat, and gave her antibiotics. The strep-throat resulted in physician office visit. Therapeutic measures were taken as a result of strep-throat with antibiotics. The outcome of strep-throat was recovered on an unspecified date in 2021, coughing was recovering, sick was unknown.  Follow-Up (22Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Rash pruritic
Clinical narrative: after the second shot I got a rash on my arms, back and stomach 20 hours after, both were bumpy, itchy, and sore; after the second shot I got a rash on my arms, back and stomach 20 hours after, both were bumpy, itchy, and sore; after the second shot I got a rash on my arms, back and stomach 20 hours after, both were bumpy, itchy, and sore; This is a spontaneous report from a contactable consumer (patient). A 61-years-old female non-pregnant patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Batch/Lot Number: EW0185), via an unspecified route of administration, administered in left arm on 15Jun2021 16:30 (at the age of 61-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had allergies to penicillin, and high cholesterol medications. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Batch/Lot Number: EW0167), via an unspecified route of administration, administered in left arm on 25May2021 16:30 (at the age of 61-years-old), as a single dose for COVID-19 immunization and experienced got a rash on my legs and arms. The patient did not receive other vaccine in four weeks of COVID-19 vaccine. The patient did not have COVID prior to vaccination and has not been COVID tested post vaccination. On 16Jun2021 14:30, the patient experienced after the second shot I got a rash on my arms, back and stomach 20 hours after, both were bumpy, itchy, and sore. The patient did not receive any treatment for the event. The outcome for the event was recovering.  Follow-Up (06Sep2021): Follow-up attempts are completed. No further information is expected.  Follow up (20Sep2021): This is a follow-up spontaneous report received from a contactable other-HCP. This other-HCP reported in response to HCP along with  letter sent for a patient which included that: The patient did not provide information to the HCP regarding the reported adverse event(s) with the use of the product.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Musculoskeletal discomfort, Pain in extremity
Clinical narrative: Knee started hurting again; Tiredness; Headache; Causing incisions to flare up on back; Arm was killing her; This is a spontaneous report from a contactable consumer or other non healthcare professional. A 62-years-old female patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0168; Expiration Date: Aug2021), via an unspecified route of administration, administered in Arm Right on 17Jun2021 (at the age of 62 years) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included spinal operation on 13May2021 and COVID-19 (Covid in January). Concomitant medication included paracetamol (TYLENOL). She had back surgery, and her back had been feeling fine then it started hurting her on 17Jun2021. The incisions to flare up on back and it started later on in the day that she had the vaccine. The next day she could tell her back was starting to hurt right when she got out of bed. Her physician said it did not mess with the incision, and it affected whatever was inflamed in her body. He said it should go away. The pain was the same. First her arm was killing her on the day of vaccination and now it was normal. She had it from Thursday all the way to Monday. That started within an hour after getting the vaccine. She just developed like a knot. She had a headache on 18Jun2021 until Sunday (20Jun2021), and she still has back aches. Her knee started hurting again too on an unspecified date. The doctor explained that anywhere that the vaccine would attack anywhere that was already inflamed and cause it to flare up. The patient developed tiredness on 18Jun2021. As far as the tiredness, in the mornings she was still just tired. She had Covid and that was almost what it felt like. She had Covid in January, and the headaches felt like when she got dehydrated with COVID. She started drinking more water because that was exactly how she was feeling. She was still tired and it was the same. She had to motivate herself to get going. Before the shot she was peppy and going, and now she wants to stay in bed. She does get tired. She was getting off of her medications from surgery on the Friday before the shot and that had cleared out of her system and she was starting to feel better. The event outcome for causing incisions to flare up on back was reported as not recovered. On 21Jun2021 the patient recovered from arm was killing her. On 20Jun2021 the patient recovered from headache. The event outcome for knee started hurting again was unknown and event outcome for tiredness was reported as not recovered.   Follow up attempts are possible. Further information is expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Eye pain, Eye pruritus, Eye swelling
Clinical narrative: Left eye swelling/ Left eye swollen; Pain when she blinks/ Left eye in pain when she blinks; Itching/ Left eye itchy; Caller states this has progressed/ It progressed today this morning, and is more swollen; This is a spontaneous report from a contactable consumer (patient herself). A 26-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number EW0180, Expiry date was not reported), via an unspecified route of administration on 23Jun2021 as (at the age of 26 years old) dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported.  The patient states she woke up on 24Jun2021 morning the patient experienced left eye swelling/ left eye swollen, pain when she blinks/ left eye in pain when she blinks, itching/ left eye itchy, she states this has progressed/ it progressed today this morning, and was more swollen. She wanted to know if this was a common or rare side effect. She wanted to know what she should do about her side effect. She wanted to see if there was anything she can do. Advised to consult with health care practitioner. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.