chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; left ear has been clogged; he's experiencing tinnitus; My ear there is 20% hearing now; I've had sinus problems; There is numbness and tingling in my head; There is numbness and tingling in my head; I did have a fever the first week; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer of unspecified age and gender reported that:  A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced headache, left ear has been clogged, he's experiencing tinnitus, my ear there is 20% hearing now, I've had sinus problems, there is numbness and tingling in my head and i did have a fever the first week. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
HEART FAILURE   myocarditis shortness of breath . i was hospitalized for over a week. i cant work walk anything
Chest tightness and pain radiates to both rotator cuff; Weird; Dizziness; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Chest tightness and pain radiates to both rotator cuff), FEELING ABNORMAL (Weird), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced FEELING ABNORMAL (Weird), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea). On 05-Apr-2021, the patient experienced CHEST DISCOMFORT (Chest tightness and pain radiates to both rotator cuff). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, CHEST DISCOMFORT (Chest tightness and pain radiates to both rotator cuff), FEELING ABNORMAL (Weird), DIZZINESS (Dizziness), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.
Pt recvd MMR/DTP/OPV/HIB vax 9MAY91 & immed p/vax devel redness, swelling & inc temp @ inject site; pt was kept for observation & released upon recovery;
Sore arm, extreme myalgias and shivers/chills (no fever or rash) lasting 36 hrs.
pt recvd 1 dose of Engerix-B & devel yeast in urine;
it started to get a little pink; warm; hard; below where she got the shot, it was all red; her arm got really itchy; sore arm for 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm for 2 days), VACCINATION SITE DISCOLOURATION (it started to get a little pink), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PRURITUS (her arm got really itchy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm for 2 days). On 27-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (her arm got really itchy). On 28-Jan-2021, the patient experienced VACCINATION SITE DISCOLOURATION (it started to get a little pink), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (hard) and VACCINATION SITE ERYTHEMA (below where she got the shot, it was all red). At the time of the report, PAIN IN EXTREMITY (sore arm for 2 days) had resolved and VACCINATION SITE DISCOLOURATION (it started to get a little pink), VACCINATION SITE WARMTH (warm), VACCINATION SITE INDURATION (hard), VACCINATION SITE PRURITUS (her arm got really itchy) and VACCINATION SITE ERYTHEMA (below where she got the shot, it was all red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. patient took antibiotic and used warm compress to treat her symptoms, and purchased diphenhydramine to treat itchiness.   This case was linked to US-MODERNATX, INC.-MOD-2021-017586 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-017586:Wife case
Hypertensive crisis; This spontaneous case was reported by a nurse and describes the occurrence of HYPERTENSIVE CRISIS (Hypertensive crisis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERTENSIVE CRISIS (Hypertensive crisis) (seriousness criterion medically significant). At the time of the report, HYPERTENSIVE CRISIS (Hypertensive crisis) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Company comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious (medically significant) unexpected event hypertensive crisis, on an unknown date after the booster dose of mRNA-1273.  Patient receive treatment with blood pressure medications. Clinical course, diagnostic tests and additional treatment details were not provided. Event seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medications were reported.  The patient experienced hypertensive crisis from Moderna vaccine booster which could have caused a stroke.  Treatment information included that the patient was on blood pressure medications.   This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: Company comment: This is a spontaneous case concerning a female patient of an unknown age with no reported medical history, who experienced the serious (medically significant) unexpected event hypertensive crisis, on an unknown date after the booster dose of mRNA-1273.  Patient receive treatment with blood pressure medications. Clinical course, diagnostic tests and additional treatment details were not provided. Event seriousness captured as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a health professional concerning a 23 year old female who was vaccinated with her first dose of GARDASIL IM. The patient experienced a fever of 104. Subsequently, the patient recovered from the fever of 104. Additional information has been requested.
Information has been received from a registered pharmacist concerning a 69 year old female patient with sulfa and amoxicillin allergies who on 26-MAR-2012, was vaccinated with a dose of ZOSTAVAX (Merck) (dose and route not provided) (lot # 671144/1269AA, expiration date 05-NOV-2012). The pharmacist informed that the patient died approximately on 02-APR-2012 "around 1 week after receiving the ZOSTAVAX (Merck)". The pharmacist indicated that no adverse reaction was reported or any physical symptoms other than the death and that the patient did not seek medical attention. The cause of death was not provided. A lot check has been initiated. Additional information is not expected.
Patient experienced syncope shortly after receiving first dose of Pfizer COVID vaccine in the lobby during his 15 minute waiting period. Patient hit chin and did lacerate it; this was attended to by NP who was administering shots at the time. Patient mentioned that he "tasted like he threw up," was instructed to drink water. NP took vitals and patient showed no sign of concussion. In the mean time patient was trying to get ahold of a friend or family member to come pick him up. Still felt lightheaded 15 minutes after being attended to, at this time we called the squad. Before the squad could show up patients brother came to pick him up... was whisked away too quickly for us to stop him. Patient was adamant about us not calling squad because he does not have insurance.
"fatal" COVID19 following vaccination with inflammation; Brain stroke; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 ("fatal" COVID19 following vaccination with inflammation) and CEREBROVASCULAR ACCIDENT (Brain stroke) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 ("fatal" COVID19 following vaccination with inflammation) (seriousness criteria death and medically significant) and CEREBROVASCULAR ACCIDENT (Brain stroke) (seriousness criteria death and medically significant). The reported cause of death was covid-19. It is unknown if an autopsy was performed.            No concomitant medications were reported.  Patient had 7 brain strokes and he had that knowledge to treat her symptoms. Patient was ruined without a job. Patient received natural medicine to treat event.  Company Comment This case concerns a 60-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of COVID-19 and cerebrovascular accident. The event occurred approximately on an unknown number of days after an unknown number of doses of mRNA-1273 and had a fatal outcome, with death occurring on an unknown date. No autopsy report was disclosed. The rechallenge was not applicable since the patient died.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 60-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of COVID-19 and cerebrovascular accident. The event occurred approximately on an unknown number of days after an unknown number of doses of mRNA-1273 and had a fatal outcome, with death occurring on an unknown date. No autopsy report was disclosed. The rechallenge was not applicable since the patient died.  The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Reported Cause(s) of Death: COVID-19
The patient received the third/booster dose of BNT162b2; A very sore arm.; Full body aches; Chills, shivering; Headache; Woke up sweating intermittently throughout the night; Sweating intermittently; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF8841) via intramuscular route of administration in the left arm on 12Nov2021 at 09:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications taken within two weeks of vaccination included norethisterone acetate/ethinylestradiol/ferrous fumarate (BLISOVI 24 FE), levocetirizine dihydrochloride (XYZAL) and fluticasone propionate (FLONASE); all for unknown indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the left arm on 28Jan2021 (at the age of 25-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via intramuscular route of administration in the left arm on 18Feb2021 (at the age of 26-years-old); both as single doses for COVID-19 immunisation. On 12Nov2021 at 09:00, immediately after vaccination, the patient had a very sore arm. Approximately 12 hours after vaccination on 12Nov2021, the patient experienced full body aches, chills, shivering, and a headache. The patient was still experiencing these symptoms when she went to bed around 22:30, and woke up sweating intermittently throughout the night on an unspecified date in Nov2021. When the patient woke up the next morning she still had a headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of headache which included treatment with ibuprofen (ADVIL) and the patient felt back to normal once it had started working. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events a very sore arm; approximately 12 hours after vaccination experienced full body aches, chills, shivering, and a headache; was still experiencing these symptoms when she went to bed around 22:30, and woke up sweating intermittently throughout the night; when the patient woke up the next morning she still had a headache was resolved on 13Nov2021.
I had a mammogram done as a part of a routine visit in December. I had cyst that I never had before that were more in the left breast but identified in both. I receive yearly mammogram and the cyst were never identified on the previous mammogram. They then did an ultrasound and advised me to return in 6 months to follow up.
muscle issues; feeling a lot of different sensations; pains in her back and stomach; pains in her back and stomach; soreness with my muscles; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Mar2021 (Lot number: EN6198) at the age of 56 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MUSCLE DISCOMFORT (non-serious), outcome "unknown", described as "muscle issues"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "feeling a lot of different sensations"; MYALGIA (non-serious) with onset 10Mar2021, outcome "not recovered", described as "soreness with my muscles"; BACK PAIN (non-serious), ABDOMINAL PAIN UPPER (non-serious), outcome "unknown" and all described as "pains in her back and stomach". Additional information: The patient received the vaccine via left shoulder (as reported). The patient's concomitant medication (not specified) was reported for blood pressure medicine.  No follow-up attempts are possible. No further information is expected.
Slight rash, itchiness of arm at injection site. Showed up 8 days after vaccination.
Covid arm/which she described as sore/heavy arm; Covid arm/which she described as sore/heavy arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 06Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single, Manufacturer unknown), for covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "Covid arm/which she described as sore/heavy arm".  Additional information: description of event: mentioned during an online class that we are both in that she had "Covid arm" following her second Pfizer covid shot which she described as sore/heavy arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few days after 2nd vaccine: heart pounding, shortness of breath, arrhythmia.
1 hr after shot, started breaking out (itching rash, red dots, all over). Per ER, rash only on LA at injection site, redness & warmth to touch. Benadryl given in ER.
patient fainted.  with normal breathing and pulse.  Paramedics checked patient Blood pressure and heart rate.  They are both normal
Four hours after shot was given pt states she began having severe arm pain where shot was given. An hour later pt began having neck pain, and back pain that radiated down to "tip of toe".  Pt started having a fever that evening around 10pm, 101.2. Pt self medicated with Motrin, then Bayer.  Yesterday morning pt states she woke up with red, painful spots on arm where shot was given.  Pt was seen by doctor today (08 July 15).  Pt was given rx for Tylenol 500mg and advised to rest.
Swelling in lymph nodes and arm. Very lethargic, bad headache, tired, whole body aches
This spontaneous report as received from a pharmacist refers to a 58 years old male patient. The patient was vaccinated (route unknown) with ZOSTAVAX (lotnumber and expiry date not provided) on 19-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-NOV-2012 the patient experienced "a lump the size of a tennis ball" at the injection site, 3 days after onset of therapy, warmth at injection site and redness at the injection site. The pharmacist advised the patient to take ibuprofen. The patient called back on 26-NOV-2012, stating the lump had decreased in size to a "golf ball" however the injection site was now warmer than it had been the prior week. The outcome of "a lump the size of a tennis ball" at the injection site was reported as recovering/resolving. The outcome of redness at the injection site is unknown. The outcome of warmth at injection site was reported as not recovered/not resolved. The relatedness for "a lump the size of a tennis all" at the injection site, warmth at injection site and redness at the injection site is unknown for ZOSTAVAX. Additional information has been requested.
Information has been received from a licensed visiting nurse concerning a 13 year old female patient who on 16-JUL-2007 was vaccinated with the first dose of GARDASIL, on 14-OCT-2008 received the second dose of GARDASIL (lot # 661044/0548X) and on 13-MAR-2009 was administered IM with a 0.5 ml third dose of GARDASIL. On 13-MAR-2009, approximately 12 minutes after receiving the third dose of GARDASIL vaccine, the patient fainted. The patient was seen by the physician at the practice. On 13-MAR-2009 the patient recovered. Additional information has been requested.
Patient reports today that she began to experience SOA approximately 30 minutes after vaccination. Patient endorses constitutional and generalized pruritus, especially skin, throat, and eyes. Patient denies breaking out into a rash. She contacted A physician, who is affiliated with our hospital and is the patient's PCP. Patient is a nurse practitioner with our facility. She reports that her oxygen saturation reached values as low as 95%. She immediately gave herself inhaled albuterol sulfate. Under his direction, patient also took approximately 40 mg of oral prednisone and 10 mg PO loratadine HCl. She reported improvement of mild hypoxia and all constitutional symptoms within 30 minutes after medical interventions were completed. Reports she is back at baseline at this date.
A Patient that received an on-site flu shot on 10/14/08 between 9am and 10am at the Clinic called 10/20/08 to report an adverse reaction to the flu vaccine that was administered that morning by Clinic Nurse. Patient reported that she received her flu shot at approximately 9:15am that morning. Two hours post vaccination she started with a dry cough, tightness in her chest and throat, headache, malaise and general flu like symptoms. At that time she took at ALAVERT tablet. She ate her lunch which she brought from home despite feeling ill. She states that she continued to experience tightness in her throat, became flushed and pale and vomited. At that time, she was taken to the hospital by squad. At the hospital she was treated for an allergic reaction and given STEROIDS, BENADRYL, PHENERGAN and IV fluids. Labs were drawn. The patient ha no lab results to report. She then stated that she was feeling achy and was administered TORADOL. She was discharged to home at 5:30pm at which time she was extremely groggy. At home she was unable to sleep and experienced twitching in her lower limbs. She took ADVIL PM and states that she fell asleep between 3 and 4am. She complained of feeling congested and disorinte and had a sore throat the following day. She remained off work on Wednesday 10/15 and 10/16 and returned to work on Friday 10/17. She reported that she is feeling much better today, 10/20/08. Flu vaccine - Sanofi Aventis Lot #U2767AA
skin rash on stomach from boobs to belly button.  Red raised bumps and itchy with patches that were raised.  Treatment - Cortisone Cream and olive oil.  Weirdly enough the olive oil soothed it the best.  Duration - decreased after 24 hours, but not completely gone yet.
uncomfortable; Prickling feeling along my right face and forehead; numbess in my nose, eye and face; I got up this morning and was disoriented and very confused; forgetful; Neuralgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Lot number: EW0171) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: CONFUSIONAL STATE (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "I got up this morning and was disoriented and very confused"; MEMORY IMPAIRMENT (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "forgetful"; NEURALGIA (non-serious) with onset 30Apr2021, outcome "unknown", described as "Neuralgia"; DISCOMFORT (non-serious), outcome "unknown", described as "uncomfortable"; PARAESTHESIA (non-serious) with onset 30Apr2021 15:00, outcome "unknown", described as "Prickling feeling along my right face and forehead"; HYPOAESTHESIA (non-serious) with onset 30Apr2021 15:00, outcome "unknown", described as "numbess in my nose, eye and face". Therapeutic measures were taken as a result of neuralgia.  Additional Information: After the first dose, she got up that morning and was disoriented and very confused and forgetful, this lasted 2 hours. Around 3pm that afternoon she developed a neuralgia, prickling feeling along her right face and forehead, numbness in her nose, eye and face. The patient called HCP and stated that she was not having stroke. The patient took a couple of aspirin for the neuralgia to see if that would ease that up. The patient wanted to get over to medical information at that time. The patient had a reaction one time to an injection from her orthopaedic doctor for her knee. She had a knee that needed replacement. Her pharmacist told her she would be okay to get it. That the ingredient she had the reaction too was rooster comb. It was stated that second dose was scheduled in 3 weeks. The patient was concerned about getting the 2nd dose.  No follow-up attempts are possible. No further information is expected.