chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Appetite disorder, Balance disorder, Discomfort, Ear discomfort, Ear pain
Clinical narrative: upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Swollen throat; Left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) as single dose via an unspecified route of administration on left arm on 11Mar2021 at 18:30 (at the age of 46-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that none other medications received by the patient within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not been diagnosed with COVID-19. On 11Mar2021 at 20:30, the patient experienced hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain and also reported left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin. The patient says no fever and it was a week after 1st dose and symptoms still existed and she felt like she was overdosed. The patient visited Doctor or other healthcare professional office/clinic and she reported the same to physician and waiting for response. Therapeutic measures taken was unknown. The clinical outcome of events hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain, left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin were not recovered. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia, Lymphadenopathy, Maxillofacial operation, Nausea
Clinical narrative: upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Swollen throat; Left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) as single dose via an unspecified route of administration on left arm on 11Mar2021 at 18:30 (at the age of 46-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that none other medications received by the patient within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not been diagnosed with COVID-19. On 11Mar2021 at 20:30, the patient experienced hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain and also reported left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin. The patient says no fever and it was a week after 1st dose and symptoms still existed and she felt like she was overdosed. The patient visited Doctor or other healthcare professional office/clinic and she reported the same to physician and waiting for response. Therapeutic measures taken was unknown. The clinical outcome of events hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain, left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin were not recovered. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck surgery, Pharyngeal swelling, Swelling, Swelling face, Thirst
Clinical narrative: upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Swollen throat; Left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) as single dose via an unspecified route of administration on left arm on 11Mar2021 at 18:30 (at the age of 46-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that none other medications received by the patient within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not been diagnosed with COVID-19. On 11Mar2021 at 20:30, the patient experienced hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain and also reported left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin. The patient says no fever and it was a week after 1st dose and symptoms still existed and she felt like she was overdosed. The patient visited Doctor or other healthcare professional office/clinic and she reported the same to physician and waiting for response. Therapeutic measures taken was unknown. The clinical outcome of events hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain, left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin were not recovered. No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: upper back pain; neck pain; Thirsty; hungry; Nausea and feeling of vomit; Wrist /Hip/ joint pain; Swollen throat; Left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received a first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199) as single dose via an unspecified route of administration on left arm on 11Mar2021 at 18:30 (at the age of 46-years-old) for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that none other medications received by the patient within 2 weeks of vaccination. The patient did not have any allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to and since vaccination, the patient was not been diagnosed with COVID-19. On 11Mar2021 at 20:30, the patient experienced hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain and also reported left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin. The patient says no fever and it was a week after 1st dose and symptoms still existed and she felt like she was overdosed. The patient visited Doctor or other healthcare professional office/clinic and she reported the same to physician and waiting for response. Therapeutic measures taken was unknown. The clinical outcome of events hungry, nausea and feeling of vomit, neck pain, swollen throat, thirsty, upper back pain, wrist /hip/ joint pain, left under arm lymph node swollen, swollen lymph node behind ears near jaw and below chin were not recovered. No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Nausea, Neck pain
Clinical narrative: swollen  axillary lymph nodes; tender axillary lymph nodes; sore neck on the side of the injection.; Lots of nausea; This is a spontaneous report received from a contactable other Health care professional. A 35-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204), via an unspecified route of administration in her left arm on 16Mar2021 at 13:15 (at the age of 35-years-old), for covid-19 immunisation. The patients medical history included penicillin allergy. Past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9266), via an unspecified route of administration in her left arm on 23Feb2021 at 13:45 for covid-19 immunisation. Concomitant medications were not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient has not tested positive for COVID-19 since having the vaccine. The patient has not diagnosed with COVID-19 prior to vaccination. On 16Mar2021, the patient experienced lots of nausea and on 18Mar2021 the patient experienced swollen and tender axillary lymph nodes and also had sore neck on the side of the injection. The clinical outcome for the events experienced nausea, swollen and tender axillary lymph nodes and sore neck was not recovered. The patient did not receive any treatment for the reported events. No follow-up attempts are needed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Depressed mood, Fatigue
Clinical narrative: More Tired; More Sad; Lot of Chills; This is a spontaneous report from a non-contactable, other healthcare professional. A 36-years-old female patient received an UNKNOWN dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot/Batch Number: UNKNOWN), via an unspecified route of administration at an unspecified site on 06Mar2021 (at the age of 36-years old) for COVID-19 immunisation. The past medical history of the patient included diagnosis with COVID-19 prior to the vaccination. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccine within four weeks before the COVID-19 vaccine and received the birth control patch within two weeks of the vaccination. On 06Mar2021, the patient experienced chills, tiredness, and feeling sad. The patient reported that she was feeling a lot of chills since she received the vaccine, and was more tired, and sad. The clinical outcome of the events, chills, tiredness, and feeling sad was unknown.    Information about lot/batch number cannot be obtained. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feeling crummy; This is a spontaneous report from a contactable other healthcare professional and consumer (patient). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) at the age of 81 years old as 2nd dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported that following the injection of the second dose of COVID vaccine on 11Mar2021, the patient was feeling crummy. Unsure if MD was aware. The outcome of the event was unknown.  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: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Irritable bowel syndrome
Clinical narrative: Vaccine triggered IBS symptoms; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: en6206), via unspecified route of administration in left arm on 18Mar2021 at 9:30 (at the age of 26-year-old at vaccination) as a single dose for COVID-19 immunisation. Medical history included IBS (irritable bowel syndrome). The patient had no allergies to medications, food or other products. Concomitant medications included ADDERAL, CLARITIN, LOESTRIN Fe, PROBIO and VITAMIN D (MANUFACTURER UNKNOWN); all for an unknown indication started since unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, the patient was not tested for COVID-19. On 18Mar2021 at 11:00, the vaccine triggered irritable bowel syndrome for the patient. The patient experienced diarrhoea an hour post injection and it was following every two hours. No therapeutic measures were taken for the events. The clinical outcome of the event irritable bowel syndrome aggravated was not resolved at the time of this report. No further information is expected. No follow-up is possible.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 99 degree fever; This is a spontaneous report from a contactable consumer or other non-health care professional, the patient. A 43-year-old male patient received BNT162B2(PFIZER- BIONTECH COVID-19 mRNA Vaccine, lot number: En6204), Dose: 1 on the left arm via an unspecified route of administration on 16Mar2021 at 12:45 PM (at the age of 43-years-old), as a single dose for COVID-19 immunisation. The patient did not have any known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to the vaccination. Since the vaccination, the patient had not tested for COVID-19. On 18Mar2021 at 3:15 PM, the patient experienced 99 degrees fever. As a therapeutic measure took Tylenol at home Prior to vaccination. The clinical outcome of 99-degree fever was recovering at time of reporting. No follow-up attempts are needed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: developed insomnia.; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (Age: 74, Unit: Unknown) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 02Mar2021 (Lot number was not reported) as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient received his first Pfizer Covid vaccine on 02Mar2021. Immediately after the vaccine he developed insomnia. For the next 10 days he reported he would get about 1-2 hours of sleep. Patient is scheduled for the second Pfizer Covid vaccine on 30Mar2021 and he was asking if he should receive the second Pfizer Covid vaccine. Patient wanted to know if he should expect the same reaction with the second vaccine and if so how long. If same reaction is expected with second vaccine patient wanted to know what he can take for the Insomnia. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: Chills; headache; fever; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in her left arm on 16Mar2021 at 14:00 (at the age of 55-years-old), for covid-19 immunisation. The patients medical history was reporetd as none. Past drug history included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in left arm on 23Feb2021 at 14:00 for covid-19 immunisation. The patient has reported no allergies to medications, food or other products. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received other medications within 2 weeks of vaccination. The patient has not tested positive for COVID-19 since having the vaccine. The patient has not diagnosed with COVID-19 prior to vaccination. On 17Mar2021, the patient experienced chills, headache and fever. The patient did not receive treatment for the reported events. The clinical outcome for the events experienced chills, headache and fever recovered on unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus
Clinical narrative: chin hot, red, itchy and warm; chin was hot; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received BNT162B2 (Pfizer BioNTech Covid 19 mRNA Vaccine; lot number: EN6203,) administered in Arm Left for COVID-19 immunisation on 02Mar2021 at 01:45 Pm. The patient medical history included High blood pressure, brain aneurysm, gall bladder removed. The concomitant drug history of the patient was Hydrochlorothiazide (MANUFACTURER UNKNOWN) for an unknown indication. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. On 02Mar2021 at 14:30 Pm she experienced chin hot, red, itchy and warm. The clinical outcome of the event chin hot, red, itchy and warm was not recovered/resolved at the time of  this report.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Joint stiffness, Joint swelling, Musculoskeletal stiffness, Pain
Clinical narrative: Pain; swelling in both hips; stiffness in both hips; lower back pain and stiffness; lower back pain and stiffness; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6207) via unspecified route of administration, in the left arm on 17Mar2021 at 08:45 (at the age 49-year-old) as a single dose for COVID-19 immunisation. Medical history included coronary artery disease. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication includes LIPITOR from an unknown start date and for an unknown indication. The facility where the most recent COVID-19 vaccine was administered was at pharmacy. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 18Mar2021 at 16:00, the patient experienced pain, swelling and stiffness in both hips with lower back pain and stiffness. The patient did not receive treatment for adverse events. The clinical outcome of the events pain, swelling in hips, stiffness in hips, lower back pain and back stiffness was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: fast heart rate, of approximately 137 bpm, with littlemovement; This is a spontaneous report from a contactable consumer, the patient. A 55-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in left arm on 04Mar2021 at 15:00 hours (at the age of 55-years) as a single dose for COVID-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EM9809) via an unspecified route of administration in left arm on 09Feb2021 at 15:30 hours as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to Sudafed. Concomitant medications included levothyroxine 112 mg (MANUFACTURER UNKNOWN), Lumigan 0.01 percent (MANUFACTURER UNKNOWN) and multivitamin (MANUFACTURER UNKNOWN). The patient took these medications with 2 weeks of vaccination and exact therapy dates and indication of these medications were not provided. Prior to 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 4 weeks prior to the COVID vaccine. On 05Mar2021 at 05:00 hours, approximately 12 to 14 hours after the second vaccine was injected, the patient experienced a fast heart rate, of approximately 137 bpm, with little movement. The patient was given an intravenous (IV) and baby aspirin. The clinical outcome of the event increased heart rate was resolved.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Body Aches; Chills; Fatigue; This is a spontaneous report from a contactable consume, the patient. A 29-Year-old adult female patient was received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot no: EL3247) via an unspecified route of administration in right arm on 23Feb2021 at 10:00 hours for COVID-19 immunisation. Patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE; lot no: EL3247) via an unspecified route of administration in right arm on 16Mar2021 at 10:00 hours for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19, Since the vaccination, patient was not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 15Mar2021 at 22:00 hours, the patient experienced body aches, chills and fatigue. No therapeutic measures were taken as a result of events. The clinical outcome of body aches, chills and fatigue were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Developed Shingles.  Diagnosed by Primary Care provider; This is a spontaneous report from a contactable consumer, the patient. A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number- UNKNOWN) via an unspecified route of administration in left arm on 02Mar2021 at 14:30 (at an age of 60-years-old) as single dose for COVID-19 vaccination. Medical history included heart disease, unspecified from an unknown start date and unknown if continuing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient didnt have any allergies to medications, food, or other products. The patient didnt receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included AVODART, Statins (MANUFACTURER UNKNOWN), Blood pressure medicine (MANUFACTURER UNKNOWN); all taken for unknown indication from an unknown start date and unknown if ongoing. On 10Mar2021, the patient developed Shingles. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received included famciclovir (MANUFACTURER UNKNOWN) taken for Shingles from an unknown start date. The clinical outcome of Shingles was not recovered. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain in extremity, Pyrexia, Throat irritation
Clinical narrative: throat itchy and scratchy; hard to breathe; fever; fatigue; arm pain; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA vaccine; Lot number: unknown), via an unspecified route of administration in the right arm on 16Mar2021 at 12:00 pm (at the age of 31 years old) as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 1:15pm the patient developed itchy throat and scratchy, found hard to breathe (difficulty breathing), fever, fatigue and arm pain. The patient did not receive treatment for the events. The clinical outcome of itchy throat, difficulty breathing, fever, fatigue and arm pain was not resolved.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; nasal/head congestion; This is a spontaneous report from a non-contactable consumer, the patient. A 63-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot Number: Unknown) via an unspecified route of administration in the right arm on 02Mar2021 as a single dose for COVID-19 immunisation. Patients medical history included thyroid. Concomitant medications included levothyroxine 0.125 mcg qd, and baby ASA qd from unspecified date for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination the patient underwent a COVID-19 virus test (spit test) on 08Mar2021, the result found to be negative. The patient experienced fever, nasal/head congestion on 06Mar2021. The event 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 was recovered on 10Mar2021.    No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, Epistaxis, Middle ear effusion, Sneezing
Clinical narrative: has an ear infection currently; fluid in the ear; sneezing badly; nose got bloody; This is a spontaneous report received from a contactable other hcp. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 (Batch/Lot number was not reported) as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced an ear infection currently and fluid in the ear. In Mar2021 she was sneezing badly, and her nose got bloody. She wanted to know if she can take stool softener after getting vaccine. She had an ear infection currently/fluid in the ear that was a recurring issue and was happening before she got the first dose of the Pfizer Covid 19 vaccine. She states it was not due to the vaccine. She was using a prescribed topical ear drop however she may possibly have to take oral amoxicillin. The pharmacist told her that it would not be a good idea to take antibiotic two weeks prior or post vaccine administration. Her doctor did not feel it was an issue. She wanted to know if she takes amoxicillin and get the second dose of the vaccine. On 12Mar2021, she was prescribed amoxicillin by her Doctor because her Doctor wanted to take the fluid out in her ears. But a pharmacist told her that she should not take the amoxicillin because she already took the 1st dose. She did not take the amoxicillin because her Doctor told to take that when they see an infection after they take the fluid out. She mentioned as well that last 13Mar2021 she woke up sneezing very bad that her nose got bloody. Escalating this because the caller was sneezing badly after she got the 1st dose. The outcome of events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 70.0
Sex: F
Vaccine: COVID19, UNK, UNK
Symptoms: Feeling abnormal, Stress
Clinical narrative: She is under a lot of stress; She has not felt herself in the last two weeks/feels silly; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A 70-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), at the age of 70-years-old, at 2nd dose, single dose for COVID-19 immunisation and started to receive tofacitinib citrate (XELJANZ XR) in Dec2020 and ongoing for rheumatoid arthritis; methotrexate sodium on an unspecified date. Medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient had not felt herself in the last two weeks, prior the report, in May2021. She asked if this was common with rheumatoid arthritis or the product. She had been told it could be the weather. She felt silly. She was under a lot of stress and it could be the stress. She asked if there were any reactions from methotrexate sodium, tofacitinib citrate and BNT162b2 combined in the system. The action taken with tofacitinib citrate and methotrexate sodium was unknown. The outcome of the events was unknown.   Pfizer is a marketing authorization holder of methotrexate sodium in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of methotrexate sodium has submitted the same report to the regulatory authorities.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Vaccination site erythema
Clinical narrative: 2 big circles where the shot went in. It was kind of red; This is a spontaneous report from a contactable consumer (patient) via Pfizer RxPathways and from a Pfizer sponsored program COVAX US support.  A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), on Feb2021 at single dose in arm for covid-19 immunisation; celecoxib (CELEBREX 100 mg), via an unspecified route of administration from an unspecified date to an unspecified date, at 100 mg unknown frequency for an unspecified indication. The patient medical history and concomitant medications were not reported. Previously the patient took celecoxib and experienced chest hurt. On an unspecified date in Mar2021, the patient experienced 2 big circles where the shot went in, around injection site and both circles were a different color; it was kind of red, now it was kind of brown and the outside of it was kind of light pink. The outcome of the event was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Vaccination site pain
Clinical narrative: soreness at site of injection; lethargy; Tiredness; This is a spontaneous report received from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Not unknown) via an unspecified route of administration on 17Mar2021 at 09:45 (at an age of 49-year-old) as a single dose for COVID-19 immunisation. Medical history included spherocytosis and spleen removed at age of 2. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received one dose of ADVIL on Mar2021 (previous week) within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 17Mar2021 at 11:00, the patient experienced tiredness, lethargy and soreness at site of injection. The patient did not receive treatment for the reported events. The clinical outcome for the tiredness, lethargy and soreness at site of injection was recovering.   Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity
Clinical narrative: two allergic reactions; This is a spontaneous report from a contactable pharmacist via Pfizer-sponsored program. This is 2nd of two reports. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534) via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the pharmacist reporting that two allergic reactions with two separate patients within 30 minutes of each other, same lot of vaccine, lot #EP7534. The outcome of the event was unknown. No follow up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021323765 same reporter and product / different patients
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Headache, Hypersensitivity, Pain
Clinical narrative: headache; really started aching but he couldn't breathe; really started aching but he couldn't breathe; Chills; allergic reaction after getting the 2nd dose of the vaccine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route on 23Mar2021 at 12:30, last night or 1:00 (age at vaccination: 72-year-old) as a single dose for covid-19 immunization. Medical history included asthma, allergic to iodine and had covid in Feb2019. The patient concomitant medications were not reported. Past drug history included inhaler (antihistaminic) for 3 times a day for 4 days, when he had Covid in 2019. He said it seems like it was on the cuff of being a threat to his life. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), via an unspecified route on 02Mar2021 as a single dose for covid-19 immunization. On 23Mar2021, patient experienced an allergic reaction after getting the 2nd dose of the vaccine. He mentioned that he experienced extreme difficulty breathing and he had chills, headache and really started aching but he couldn't breathe. He was wondering if he was going to die but he does not panic when he can't breathe because he has asthma but last night he was concerned. He had to take slow deep breaths through nose to survive it, but it wasn't working, and he wasn't getting enough air, but he fell asleep, and he got through it. He said the pharmacist said that people that who have had Covid have a harder reaction to the shot. He was struggling last night, and it was hard to breathe. He mentioned that his daughter, who is 47, and her family all got Covid infection, and she is having trouble breathing still, she can't even finish a sentence. He was wondering if this was something that ran in the family. He stated he is supposed to keep Benadryl with him, but it knocks him out and he was afraid if he went to sleep, he wouldn't wake up. He asked if this reaction was normal or if it was an allergic reaction. Therapeutic treatment taken as a result of the events included two antihistamines (ChlorTab 4 mg each), two Advil, and 2 shots of his albuterol inhaler and started coming around. The clinical outcome of aches and headache were not as bad and breathing is okay now, outcome of chills and allergic reaction was unknown.   Follow-up (24Mar2021): New information received from a contactable consumer included: dates of 1st and 2nd dose of vaccination added, events added, therapeutic medications updated and medical history updated.  No follow-up attempts are possible; Information about lot/batch number cannot been obtained.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Product use issue, Rash
Clinical narrative: first dose of the Pfizer Covid 19 vaccine on 21 March 2021/Her second dose is due this Saturday, 3 April 2021; first dose of the Pfizer Covid 19 vaccine on 21 March 2021/Her second dose is due this Saturday, 3 April 2021; She has a   rash that has not gone away; This is a spontaneous report from a contactable consumer (patient) via a pfizer sponsored program. An 88-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection); Lot/batch no: unspecified) via unspecified route of administration, as 2nd dose, single dose on 03Apr2021 for COVID-19 immunization (at the age of 88-years). The patient medical history was not reported. Concomitant medications were not reported. Historical vaccine included first dose of BNT162b2 on 21Mar2021, had no reactions or anything for COVID-19 immunization. Patient previously took tofacitinib citrate (XELJANZ XR) for Rheumatoid Arthritis. Patient has been taking Xeljanz XR (11 mg) for Rheumatoid Arthritis for about 3 years, but the patient was not sure if took Xeljanz while having first dose of vaccine. The patient took Pfizer covid 19 vaccine on 21Mar2021 and second dose on 03Apr2021 after which she had a rash on an unspecified date in 2021 that has not gone away. The clinical outcome for the events was unknown except the event rash which was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Headache, Pain, SARS-CoV-2 test
Clinical narrative: headaches; loose the smell; she had pain all over her body; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter stated that she was administered with the first dose of the vaccine on 24Mar2021 and the next day on 25Mar2021 she started to lose the smell, she had pain all over her body and headaches. The Consumer reports that she and her family were tested for COVId-19 the day the vaccine was administered, and the results were negative. The Consumer reports that the symptoms have been lowering down in intensity since the administration of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021 tested for Covid-19 the day the vaccine was administered, and the results were negative. The outcome of the events was reported as recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021377800 same drug and event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Anosmia, COVID-19, Headache, Pain
Clinical narrative: loose the smell, she had pain all over her body and headaches; loose the smell, she had pain all over her body and headaches; loose the smell, she had pain all over her body and headaches; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received 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 24Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced loose the smell, had pain all over her body and headaches on unspecified date in Mar2021.The reporter stated that, the patient was administered with the first dose of the vaccine on 24Mar2021 and he developed loose the smell, had pain all over her body and headaches after 5 days of vaccine administration. The reporter states the patient and the family were tested for COVId-19 the day the vaccine was administered, and the results were negative. The reporter stated that the symptoms have been lowering down in intensity since the administration of the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 24Mar2021 tested for Covid-19 the day the vaccine was administered, and the results were negative. The outcome of the events was reported as recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021365219 same drug and event, different patient
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Laboratory test, Pain in extremity
Clinical narrative: A sore arm but no other issues so far; This is a spontaneous report received from a contactable other-HCP and a contactable consumer. A 51-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 05Apr2021 at single dose for COVID-19 immunisation. Relevant medical history was not reported. Concomitant medications included palbociclib (IBRANCE) taken orally from Dec2020 at 75mg daily 21 days on, 7 off for breast cancer. The patient was doing well on palbociclib, saw MD the day before and had labs. All were good so she was able to get COVID vaccine, had a sore arm in Apr2021 but no other issues so far. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: felt fatigue and headache after the second vaccine; felt fatigue and headache after the second vaccine; This is a spontaneous report received from a  program from a contactable nurse and consumer. A 52-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at 5 mg, twice a day for rheumatoid arthritis.  Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient was previously vaccinated with the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunization. It was reported that the patient held Xeljanz per MD instructions for COVID vaccine 72 hours prior to first vaccine and then resumed for approximately 5 days and then 72 hours prior to second vaccine and recently resumed. It was reported that the patient felt fatigue and headache after second vaccine and states "i have spoken with my MD and will speak with MD again next week we have a plan". The severity, any medication(s) patient was using at or around the time of the adverse event and dates of therapy and any relevant tests/laboratory data including dates were not applicable. The outcome of the events was unknown. The action taken in response to the event for tofacitinib citrate was post therapy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthropathy, Asthenia, Muscular weakness, Pain
Clinical narrative: More than moderate muscle and joint weakness for weeks now; More than moderate muscle and joint weakness for weeks now; weakness of legs, knees, hips; weakness of legs, knees, hips; now after 2, continues to be painful; This is a spontaneous report from a contactable consumer (patient). A 66-year-old non-pregnant female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN6201) via an unspecified route of administration on 10Feb2021 (at the age of 66-years-old) as a single dose in the right arm and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; solution for injection; Lot #: EN6198) via an unspecified route of administration on 03Mar2021 (at the age of 66-years-old)  as a single dose in the left arm, both for COVID-19 immunization. Medical history included known allergies: mild hay fever and some antibiotics- mild from unspecified dates and unspecified if ongoing. Other medical history was also reported as "normal aging". The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were none. It was reported that there were no other medications taken within two weeks of the COVID-19 vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. In Feb2021 the patient experienced more than moderate muscle and joint weakness for weeks now, weakness of legs, knees, hips and now after 2, continues to be painful. The events were reported as disabling. The clinical course was reported as follows: More than moderate muscle and joint weakness for weeks that was slight after vaccine dose 1, and now after dose 2 it continued to be painful with weakness of legs, knees, hips. The patient could usually walk normally, healthy. She was getting ready to report to her physician. The symptoms seemed disabling, she hoped it was temporary. No treatment was received for the adverse events. The clinical outcomes of the events more than moderate muscle and joint weakness for weeks now, weakness of legs, knees, hips and now after 2, continues to be painful were not recovered/not resolved. The patient was not tested for COVID-19 since vaccination.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dysstasia, Gait inability, Headache, Hypoaesthesia
Clinical narrative: blacked out from pain; blacked out from pain; Severe muscle cramping and pain; Severe muscle cramping and pain; unable to walk or stand; unable to walk or stand; Severe headaches; numbness and weakness in left arm still (7 days later); numbness and weakness in left arm still (7 days later); fever for 3 days; This is a spontaneous report from a contactable consumer (the patient). A 35-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Apr2021 at 09:30 (Lot Number: EL9264), at the age of 35 years, as a single dose for COVID-19 immunisation.  Medical history included traumatic brain injury (TBI), and neuropathy. The patient had no known allergies. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19 The patient's concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 (Lot Number: E18982) administered in left arm on 16Mar2021 at 2:15 PM. The patient did not receive any other vaccines within four weeks prior to the vaccination  On 09Apr2021 at 18:00 the patient experienced blacked out from pain, severe muscle cramping and pain, unable to walk or stand for 4 days, severe headaches, numbness and weakness in left arm still (7 days later), and fever for 3 days. The events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of blacked out from pain, severe muscle cramping and pain, unable to walk or stand, severe headaches, numbness and weakness in left arm still (7 days later), and fever for 3 days included lidocaine injections to head. The clinical outcome of blacked out from pain, severe muscle cramping and pain, unable to walk or stand, severe headaches, numbness and weakness in left arm still (7 days later), fever for 3 days  was reported as recovered with lasting effects. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.