chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore arm; Fatigue; Little disoriented; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Mar2021 at 00:00 as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN); from an unknown date for an unknown indication and was unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 08Mar2021 at 15:00, the patient experienced sore arm, facial muscles, fatigue and a little disoriented. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events sore arm, facial muscles, fatigue and little disoriented was recovered on an unknown date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient's father called the hospital on 04/09/2018 around 2130 to report patient's upper lip being swollen. Patient had received his one year vaccinations earlier in the day. He was concerned about patient's upper lip being an adverse reaction to the vaccinations. He says he just gave him BENADRYL 10 minutes prior to calling. Reported patient to be acting completely normal and showing no signs of respiratory distress. Dr. notified of phone call. Per instruction of Dr, nurse told father to closely monitor for wheezing, increased respiratory rate, or other signs of respiratory distress. Can give him TYLENOL or MOTRIN as needed. As well as POPSICLE or something cold on his lip. Said to monitor for signs of a rash as well. Father verified he understood these instruction and will either call back with further concerns or bring patient in to be seen if needed. Patient's mother brought patient into the clinic on 4/10/18 at 10:00 to see PCP. Upper lip swelling is improving and patient continues to show no signs of respiratory distress. Mother will continue to monitor and vaccine nurse will report event to VAERS.
Pentacel was exposed to 27Farenheit for more than 3 hours due to the temperature in the refrigeratorwas manually changed and also the vaccine was administered to 15 months old patient, no AE; Initial information received on 01-Jul-2020 regarding an unsolicited valid non-serious case from other health professional.  This case is linked to cases 2020SA172973, 2020SA172697, 2020SA174885, 2020SA174942, 2020SA174941, 2020SA174940, 2020SA174906, 2020SA174932, 2020SA174911, 2020SA174910 and 2020SA173110(same reporter).  This case involves a 15 months old male patient who was vaccinated with the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL], that was exposed to 27 Fahrenheit for more than 3 hours and the excursion occurred due to temperature of the refrigerator was manually changed.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 19-May-2020, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U6615AA and expiration: 20-Mar-2021) via unknown route in unknown administration site as prophylactic vaccination.  It was an actual medication error case due to Product storage error temperature too low.  No adverse event reported at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Patient reported lip and facial swelling on the left side. Patient also reported headache. Residual speech issue with pronouncing "s". Numbness down but not fully resolved. Did not report until weekend of 9/28/18.
Fever to 103 degrees, body aches, nausea started < 24 hours later. Pt seen 2 dy later. Advised to use TYLENOL, fluids, rest.
Pt received vaccines on 9/27/00 and returned to clinic triage on 9/28/00 at 17:30 with a large swollen area at site of injections on both legs. Left thigh with 1 1/2" X 1 1/2" and right thigh with 1" X 1" areas, warm to touch; 2 small spots (red) noted near left knee. Clinic was closed, but pt was examined briefly by doctor. Told to use Tylenol every 6 hours and ice packs. No systemic symptoms noted like shortness of breath only local.
Mom states had localized reaction to left leg, red swollen, no fever, no streaking, mom gave him Benadryl resolved in 24 hrs. Mom states she's allergic to thimerosal.
Information has been received from a physician concerning a 19 year old male patient who on 14-FEB-2006 was vaccinated with the first dose of MMR II. On 02-OCT-2008 the patient was vaccinated with the second dose of MMR II. On 08-NOV-2009 the patient experienced mumps. The date diagnosed was 10-NOV-2009. The patient had no fever and lump under left ear. The parotitis was on the left side. At the time of report the patient's status was unknown. Additional information has been requested.
Patient's left arm became markedly swollen and red at the injection site. Patient noticed this about 24 hours following the vaccinations. Patient went to the urgent care and recived a cortisone shot and 2 prescriptions (Prednisone 50mg and Triamcinolone cream).
Experiencing red, swollen, itchy, warm left arm at site of vaccination beginning 48 hrs after receiving vaccine.
Unusual soreness, nausea, chills, fever. Lasted 30 hours.
patch of hives on right lower face and on left bend of arm immediately after injection.  No shortness of breath, dizziness, or any other symptoms.   monitored patient for 30 minutes after.
He missed the second shot/Missed 2nd shot  more than 6 months post first shot; About one month later, his leg was infected again; This spontaneous case was reported by a consumer and describes the occurrence of LOCALISED INFECTION (About one month later, his leg was infected again) and PRODUCT DOSE OMISSION ISSUE (He missed the second shot/Missed 2nd shot  more than 6 months post first shot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination.     The patient's past medical history included Leg infection (He has a Prostatic leg which caused infection in the left leg prior to vaccination.) in 2021. Concurrent medical conditions included Leg prosthesis user.    On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced LOCALISED INFECTION (About one month later, his leg was infected again). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (He missed the second shot/Missed 2nd shot  more than 6 months post first shot). At the time of the report, LOCALISED INFECTION (About one month later, his leg was infected again) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (He missed the second shot/Missed 2nd shot  more than 6 months post first shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not provided. Treatment information was not provided.  Patient had a Prostatic Leg which caused infection in the left leg prior to vaccination. While he was in the hospital, they administered the first dose of Moderna COVID-19 vaccine to him. About one month later, his leg was infected again and he went back to the same hospital. He missed the second shot. He stated that his leg infection had nothing to do with the vaccine.
I normally wouldn't have a period and I started on 04/05/21 and I started spotting and on 04/06/2021 it was an actual period which again is abnormal for me to have one because I've been 3 years menopausal. I contacted my gynecologist because it was time for a routine exam and on 04/16/21 I went to see my gynecologist and she did an ultrasound which showed my uterus was bigger than it should have been for my age and so she did an endometrial biopsy and called me that following Friday with results that it was cancer. I went to see the genecology oncologist surgeon and on 05/25/21 he removed my fallopian tubes, uterus, and lymph nodes in pelvic area. My uterus was the only place the cancer was and 1/3 through the wall he said. I'm just doing follow up treatment right now and had no chemo or radiation. No history of cancer in family. Doctor doesn't think it's going to come back but he doesn't know for sure. It was an OP procedure. I didn't go to work after that and waited 4 weeks before going back.
she experienced throat swelling, difficulty breathing, itching, flushing.  she self-administered Epi-Pen which she brought with her.  EMS was called.
Patient has visible swelling in arm below injection site (lower bicep area). And has difficulty moving arm. She has not seen her doctor about it and it was recommend she do so. She has been using ibuprofen/apap for pain and the pain has slowly been easing but it is still there.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient had no pertinent medical history or drug reactions/allergies. On an unknown date, "as a child (recently)" the patient was vaccinated with M-M-R II (dose, route, lot number and albumin status were not reported). Concomitant medications were not reported. On an unknown date, patient had titers drawn for measles, mumps and rubella for entrance into school, and the patient's titers were "lower than required". The patient's physician wrote a prescription for another dose of M-M-R II as treatment. The outcome of the event was  not reported.  The relationship between M-M-R II and the event was not reported. Additional information is not expected.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. The patients' medical history, current conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored VARIVAX (dose and route were not reported), lot # L032391 and expiry date: 26-AUG-2017. No adverse events were reported. There was no product quality complaint involved. No further information was provided. Additional information has been requested.
Dizziness and nausea, loss consciousness, lowered patient to floor, and patient regained consciousness, BP initially low and returned to 118/60 with standing
A non-serious spontaneous report of fever has been received from a physician concerning a 14-year-old male, subsequent to FLUMIST. Neither relevant medical history nor concomitant medications have been reported for this patient. On 10-Aug-2011, patient received FLUMIST. On 11-Aug-2011, patient experienced fever. No medical attention or other symptoms were reported. The outcome of event was unknown.
STAGE 3 UTERINE CANCER; This spontaneous report received from a consumer via another pharmaceutical company (Pfizer Inc.) concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported,1 total was administered on unspecified date for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced stage 3 uterine cancer. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of stage 3 uterine cancer was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230830921- stage 3 uterine cancer. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
On 25FEB92 slept late went back to sleep p/lunch for 2 hrs; went to bed early in evening; no fever noted; on 26FEB92 went to get pt up 8AM had vomiting all over self & bed; also watery diarrhea, t101 ax; seen by MD;
Started having body aches and runny nose with coughing. Took COVID-19 test at Employers Nursing Facility. Saw a NP at  Clinic. Was prescribed Cough Syrup. Had COVID-19 approximately 5 days.
Information was received on 07-APR-2016 from a letter and pharmacy records received from a 73 year old consumer who is reporting on herself with a history of an allergy to Keflex. No other medical history or concomitant medications were reported. ON 30-AUG-2007, the patient received a dose of ZOSTAVAX (lot, dose and injections site not reported). In March 2014, the patient developed shingles on the right side of her head and they got in her right. After about a month, became of the weakened state of her eye, the herpes simplex also got in it. She states "it has been a battle ever since." She reports that her eye is still in "bad shape" and she requires 4 different drops daily and also takes pills to keep the shingles from returning. Pharmacy records indicate that that patient filled the following treatment medications on the following dates: acyclovir 400 mg 18-APR-14, 18-NOV-2014; acyclovir 800 mg: 02-JUN-2014, 30-SEP-2015; timolol maleate 0.5% ophthalmic 09-JUN-2014; trifluridine 1% ophthalmic 12-JUN-2014, 27-APR-2015, 11-AUG-2015, prednisolone AC 1% ophthalmic 09-JUN-2014, 18-SEP-2015, 05-JAN-2016; Besivance 0.6% ophthalmic 05-JAN-2016, Valsartan 160 mg 25-MAR-2015, levofloxacin 500 mg 02-FEB-2015; erythromycin ophthalmic ointment 29-MAY-2014, 12-JUN-2014; Gentak 0.3% ophthalmic 13-MAR-2014. Additional information has been requested.
tinnitus; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus) and FATIGUE (tiredness) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included Ear drum perforation (ruptured eardrum).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced FATIGUE (tiredness). On 20-Mar-2021, the patient experienced TINNITUS (tinnitus). At the time of the report, TINNITUS (tinnitus) and FATIGUE (tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported. No treatment medications were reported.
NAUSEA, VOMITING, DIARRHEA, "COVID ARM"-RED, ITCHY, WARM, RAISED, INVOLVED 80% OF ANTERIOR UPPER ARM
shortness of breath for about 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath for about 30 minutes) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced DYSPNOEA (shortness of breath for about 30 minutes). On 28-Feb-2021, DYSPNOEA (shortness of breath for about 30 minutes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
New onset: 5/5/21 acute onset moderate fatigue, moderately intense headache,  moderate brain fog 5/6/21  moderate fatigue, severe posterior headache, facial tingling, elevated BP,  moderate brain fog 5/7/21  severe fatigue and brain fog, moderate posterior headache, chills.  Staying home from work.
No additional AE reported; administration of an expired VAQTA; This spontaneous report was received from a pharmacist and referred to a patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant medication were not provided.   On 06-MAY-2022, the patient was vaccinated with 1 dose of expired Hepatitis A Vaccine, Inactivated (VAQTA) (strength, and route were not reported; valid lot# U003450 with expiration date: 02-MAY-2022) for prophylaxis (expired product administered). The vaccine was stored within the recommended storage range until the administration. No additional adverse event reported (no adverse event).  This case is non-valid due to the lack of patient's identifiers.
Lump on left breast close to armpit. Lasted for 2 weeks with pain.  Period started 2 weeks early..very unusual and has been heavier than usual.
Hospitalization for COVID19 5/13/21-5/18/21. Patient received Remdesivir 5/13-5/17 and dexamethasone 6 mg IV twice daily 5/13-5/18.
Patient received 4th full dose of vaccine, patient was immunocompromised.  Patient forgot that she had a third full at another pharmacy a few months ago.
Pt states had swelling of (R) cheek, and swelling of left eye, and mild swelling and pain to lips.
At site of injection, red, hot, hard, swollen. Patient went to MD. MD treated with CLARITIN. MD told patient to monitor, and call MD if redness spreads or feels fever/chills/nausea.
Within 15' developed sensation of dysphagia, lip swelling, facial swelling : transferred to ED  where sx resolved spontaneously. Observed for 4 hrs then d/c to home
Started getting red rash and red spots, worse at the R shoulder (injection site) and spreading throughout the day fully down arms (red spots) and injection shoulder (raised bumpy skin), and red spots on trunk .  Feels hot then cold, very much like sun burn and sun poisoning look and feel.  Shoulders and chest are the worst.  14 hours later I have heightened sensation all over the rash areas.  First night I felt extremely sore and stiff at injection site (similar to after first dose, when I could not roll over in bed on the R arm).  But Tuesday night (night of Dose #2), I couldn't roll over in bed without extreme myalgia in all my limbs and torso.  Have had a few headaches, but they don't last too long.  Occasional diffuse itchy feeling beyond rash areas.
low white cell count; fever; diarrhea; rash; low platelet count; This spontaneous report as received from a registered nurse refers to a 53-year-old female patient . The patient's concurrent conditions included: anxiety, atrial fibrillation, hypothyroidism, gastrooesophageal reflux disease, hyperchloraemia, hyperinsulinism, hypokalaemia, hypertension and hypersensitivity for the blue dye. The patient's drug allergies included: amoxicillin, metformin, diphenhydramine hydrochloride (BENADRYL) and escitalopram oxalate (LEXAPRO). The patient's concomitant medication included: aspirin, diltiazem, pantoprazole, potassium, cyproheptadine and unspecified thyroid medication.  On 15-MAY-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031679, expiration date 01-NOV-2020, subcutaneous for prevention of measles (exact dose and frequency were not provided). On 27-MAY-2019, the patient had unspecified blood work performed, with the results of low platelet count and low white blood cell count. Additionally, on the same day the patient experienced fever, rash and diarrhea. The patient sought medical attention in primary care on an unknown date, and received treatment for events on an unknown date. The outcome of events was unknown.  The reporter considered pyrexia, platelet count decreased, white blood cell count decreased, rash and diarrhoea to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
pt recv vax & 1wk post vax pt exp severe pain in lt shoulder, felt generally wiped out & devel a fever;pt exp cramps in lt deltoid & tricep muscles;
I went into atrial fibrillation on Thursday evening at about 9pm, after my second dose.  March of 2021.  On Friday morning my heart beat had not gone back to morning and my husband took me to the Hospital. I had another event after 3rd dose and on June 6th they did a cardioversion. Since then I have had another episode July 16th and ended up in the hospital again and struggled to get my heartbeat back to normal. The doctor said that it was the pain of several IV attempts that put my heart back to normal. Since then, I have had some increased heart beat episodes. I have been working  with an electrophysiologists and he gave me a heart monitor that I have to wear for 30 days.
51 year old patient administered Fluad by mistake. Unknown if patient had any additional signs/symptoms. Just discovered error 10/8
This spontaneous prospective pregnancy report as received from a physician refers to a 25 year old female patient. On an unknown date in April 2013 ("six months ago") the patient was vaccinated with a dose of VARIVAX (Merck), dose, frequency and route unspecified, a month prior to the patient being diagnosed as being pregnant on an unknown date in May 2013. The patient had become pregnant for 5 months (LMP: May 2013, EDD: March 2014). The pregnancy outcome was pending. Additional information has been requested.
Patient presented on 1/24 with acute onset weakness and numbness of the left leg so a stroke alert was activated. NIHSS 3. Head Ct and CTA head/neck were unremarkable. Not a candidate for tPA given on Eliquis. Initial exam was notable for weakness and sensory loss in the left leg, but a sensory level was also found to the umbilicus raising concern for a myelitis. Of note, the patient also reported that certain red colored things she looked at appeared black. Labs unrevealing- CBC, CMP unremarkable. ESR, CRP normal. UA and UCx positive for E. Coli UTI, she was treated with ceftriaxone. MRIs were done of her brain, cervical and thoracic spine which were unrevealing. On 1/25, her exam worsened including worsening weakness in the left leg and new numbness and paresthesias in the right leg. Reflexes were preserved. MRI L spine was done which was unrevealing. Lumbar puncture was done which showed 2 nucleated cells and mildly elevated protein at 50, but was otherwise unrevealing. IgG Index normal. No oligoclonal bands. She developed mild hyperreflexia in the left leg and continued to have a sensory level, now at around T5-6. Repeat imaging of her cervical and thoracic spine were completed on 1/28 which showed a contrast enhancing hyperintensity at T5. The patient was diagnosed with myelitis and she was started on IV methylprednisolone x5 days and sent to rehab. Patient is now significantly improved though continues to report some numbness in the left leg.
adm 22NOV coronary ICU: lung nodule, anemia, rapid progressive ascending motor weakness, GBS
Chills 3 hours, low grade fever 2 days, joints ached 2 days, exhausted, trouble sleeping, bloating continuing 9 days now. Took ibuprofen initially, as symptoms improved switched to acetaminophen.