chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I experienced bleeding similar to menstruation; pateint recevied first dose on 02Apr2021 and the second one on 16apr2021; This is a spontaneous report from a contactable consumer (patient).   A 53-years-old non pregnant  female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 16Apr2021 10:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation.Age at vaccination 53 years  . No other medications the patient received within 2 weeks of vaccination. Medical history :menopause.The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of bnt162b2 on 02Apr2021 at age of 53 years on arm let at 10:30 AM.  The patient's concomitant medications were not reported.  The patient experienced i experienced bleeding similar to menstruation  on 05May2021 with outcome of recovered .The clinical course was reported as follows: I am a post menopausal women. I have been postmenopausal for over 2 years. I experienced bleeding similar to menstruation 2 1/2 weeks after my second vaccine. The adverse event resulted in Doctor or other healthcare professional office/clinic visit.Additional information: the patient was not diagnosed with COVID-19.Since the vaccination,  the patient has not  been tested for COVID-19  Information about Batch/Lot number has been requested.
This spontaneous report was received from a health care professional refers to a male patient of unknown age. On an unknown date tthe patient was vaccinated with MMR II dose 1 (dose, route and lot # unspecified). On 21-APR-2015 the patient was again vaccinated with MMR II lot # J003623; expiry: 22-MAR-2015, dose 2, subcutaneous (dose unspecified). No medical history and concomitant medications were provided. It was reported that the dose administered on 21-APR-2015 was an expired vaccine used in the series which was inadvertently administered to the patient. No adverse event was reported. The outcome of expired vaccine used and no adverse event is unknown. Additional informatino has been requested.
guy put the needle in and the man pushed when he put the needle in and i think he hit the bone and i cant lift my arm today., I don't have fever but i have chills, and body aches, i have tightness in my chest.
Site: Swelling at Injection Site-Mild, Systemic: Blood squirted from arm and hard knots at both injection sites-Mild, Additional Details: pt received flu and covid injection in same shoulder. first injection knot with dribble of blood. second injection knot and squirting blood
Nausea; tiredness; chills; feeling unwell; This is a spontaneous report from a non-contactable consumer or other non hcp.  A 21-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  On an unspecified date with outcome of unknown, The patient experienced nausea, tiredness, chills, feeling unwell. The outcome of the events was unknown.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information expected
Tooth infection; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: 30135BA), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (Dose: 01, Batch/Lot# EM9810, Anatomical site of injection: L arm), administration date: 06Feb2021, for Covid-19 immunization; BNT162b2 (Dose: 02, Batch/Lot# EN6202, Anatomical site of injection: L arm), administration date: 23Feb2021, for Covid-19 immunization. The following information was reported: TOOTH INFECTION (non-serious) with onset 24Mar2022, outcome "unknown". Therapeutic measures were taken as a result of tooth infection.  Additional information: Patient had treatment for tooth infection with root canal on 18Apr2022. No specific relevant test for thromboembolic events with thrombocytopenia was performed.  No follow-up attempts are possible. No further information is expected.
Pt. received FLUZONE influenza vaccine on 10-02-13, as part of our volunteer program. On 10-03-13, she notified our employee health dept that one hour after receiving the vaccine she developed a cough and ears felt plugged. She then felt feverish and used an oral thermometer and found her fever to be 103.5. She did not seek medical attention.
Event was not reported to me until 10/20/2010.  She reported that soon after she received the shot she noticed that her Lt. arm began to hurt.  It later began to swell.  Stated that swelling was from Lt. shoulder down to lt. hip and that it was painful.  Also, she reported that she had hives over her arm abdomen and back, that itched.  The duration was reported to be from 9-10 days after she received the hept B vaccine.  She did not report this to the Center Director and continued to work during the 9 - 10 days of the reaction.  I only heard about it today when I was planning to administer the 2nd dose of Hept B.  No further Hept B vaccine will be administered.  She stated that she had a reaction to a flu shot years ago and has not had a flu shot since.
The patient came in from the hospital with a confirmed Nonocclusive Deep Vein Thrombosis (DVT) in the lower left popliteal vein.
This spontaneous report was received from a medical assistance referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of M-M-R II lot numbers: L039613, expiration date 08-OCT-2017; M000768, expiration date 05-JAN-2018; M011667, expiration date 08-MAR-2018; M014902, expiration date 18-MAR-2018 and lot number reported as M025185, expiration date 18-MAY-2018 (dose and route of administration were not provided) for prophylaxis. There was no adverse effect reported. Administered doses of M-M-R II were exposed to a temperature excursion of 29°F for 6 hours and 48°F for 3 hours. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA010876: US-009507513-1702USA010877.
jittery colds; slept all day long because; tired; urine is color brown; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (jittery colds), SOMNOLENCE (slept all day long because), FATIGUE (tired) and CHROMATURIA (urine is color brown) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urine color abnormal (urine is colored brown, like colored tea or beer). Concomitant products included DILTRAZEM, SPIRONOLACTONE, CETIRIZINE, FLUTICASONE and IBUPROFEN for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (jittery colds), SOMNOLENCE (slept all day long because), FATIGUE (tired) and CHROMATURIA (urine is color brown). At the time of the report, NASOPHARYNGITIS (jittery colds), SOMNOLENCE (slept all day long because), FATIGUE (tired) and CHROMATURIA (urine is color brown) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
NOTE: I was given "RECOMBIANT ZOSTER (SHINGLES) VACCINE". This was not on your list above  under vaccines.  About 3-5 minutes after injection. I felt "odd" with a kind of tunnel vision, not dizzy, Flushed, bilateral feet itched.  Nervous.  Subsided after sitting for 5-10 minutes and then I was ok.
heart problems / She knows there are other people like her.; breathing problems / She knows there are other people like her.; very bad joint pain / She knows there are other people like her.; chronic fatigue / She knows there are other people like her.; lost their energy / She knows there are other people like her.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart problems / She knows there are other people like her.), DYSPNOEA (breathing problems / She knows there are other people like her.), ARTHRALGIA (very bad joint pain / She knows there are other people like her.), FATIGUE (chronic fatigue / She knows there are other people like her.) and ASTHENIA (lost their energy / She knows there are other people like her.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 CARDIAC DISORDER (heart problems / She knows there are other people like her.), DYSPNOEA (breathing problems / She knows there are other people like her.), ARTHRALGIA (very bad joint pain / She knows there are other people like her.), FATIGUE (chronic fatigue / She knows there are other people like her.) and ASTHENIA (lost their energy / She knows there are other people like her.). At the time of the report, CARDIAC DISORDER (heart problems / She knows there are other people like her.), DYSPNOEA (breathing problems / She knows there are other people like her.), ARTHRALGIA (very bad joint pain / She knows there are other people like her.), FATIGUE (chronic fatigue / She knows there are other people like her.) and ASTHENIA (lost their energy / She knows there are other people like her.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been received from a physician concerning his son, a 42 month old male who was vaccinated on an unspecified date with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). Subsequently the pt experienced a "speech impediment" which was characterized by "stammering and stuttering". The physician reported that this condition returned to "normal" the morning after administration of a "homeopathic detox." The physician also reported that another son experienced pain in his legs and a rash after vaccination with (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported) (WAES #0302USA02304). Additional info has been requested.  Follow up on 12/04/03: "Further follow up obtained from the responsible physician who reported that she was not aware of an adverse event after MMRII as nothing was noted on the child's chart.  She reproted that nothing abnormal had been found on exams and the child has met all of his developmental milestones as appropriate.  IT was noted that the child had been seen the office on 11/10/2001 for a physicial exam and the mother had not mentioned an adverse event after the vaccination.  The physician reported that the child was last seen on 06/28/03 and nothing was reported at that visit either, nor was anything noticed to be abnormal.  The physician also reported that another son experienced pain in his legs, a rash and on follow up reported the pt had experienced a slight limp in right leg after vaccination with MMRII (Lot # not reported) (WAES#0302USA02304).  No further information is available."
About 7 hours after receiving the second dose I had chills all night, low grade temp. The next day my arm was sore, chills, nausea, muscle aches and a slight headache.
the shakes; fever which was worst on the second dose; headaches; Second dose was the worst; After all the doses of the vaccine her whole body was cramping; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (After all the doses of the vaccine her whole body was cramping), TREMOR (the shakes), CONDITION AGGRAVATED (Second dose was the worst), PYREXIA (fever which was worst on the second dose) and HEADACHE (headaches) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 002A21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PNEUMOCOCCAL VACCINE. Past adverse reactions to the above products included No adverse event with PNEUMOCOCCAL VACCINE.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2021, the patient experienced MUSCLE SPASMS (After all the doses of the vaccine her whole body was cramping). In February 2021, the patient experienced CONDITION AGGRAVATED (Second dose was the worst). On an unknown date, the patient experienced TREMOR (the shakes), PYREXIA (fever which was worst on the second dose) and HEADACHE (headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at a dose of 200 milligram. In January 2021, MUSCLE SPASMS (After all the doses of the vaccine her whole body was cramping) had resolved. At the time of the report, TREMOR (the shakes), CONDITION AGGRAVATED (Second dose was the worst), PYREXIA (fever which was worst on the second dose) and HEADACHE (headaches) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient has received hepatitis vaccines in the past. With the cramps it would prevent her from sewing. That lasted for 08-10 hrs. No concomitant medication was reported.   This case was linked to MOD-2023-748279 (Patient Link).
Initial unsolicited report received from Physician on 25-Jan-2018. This case involves a two-month-old male patient, who was vaccinated with 0.5 ml first single dose of PENTACEL (batch number: C5370AA, expiry date was not reported) in left thigh via intramuscular route an unknown date. Patient medical history and concomitant medications were not reported. On unknown date, following the vaccination the patient had extensive swelling at the injection site and the entire left leg. Lab data was not reported. As corrective treatment no medical treatment was prescribed. The event outcome was reported as unknown. Follow-up report received from Physician (pediatrician) on 04-Apr-2018. The patient (age was updated as four-months) was vaccinated with a dose of PENTACEL on 17-Jan-2018. The patient had no history of allergies, underlying disease/immunological disorder, overweight or any history of adverse events reactions to prior vaccines. On an unknown date, following the vaccination, the patient developed injection site cellulitis and circumferential swelling with associated erythema, warmth and pain. The latency for the event "extensive swelling of vaccinated limb" was reported as four-days and duration was reported as one-hour. On an unknown date, the patient recovered from the events (reported as "resolved on one"). No further information was provided. List of documents held by sender: none.
Narrative: COVID infection following COVID vaccine series 12/30/2020, Pfizer, dose #1 01/21/2021, Pfizer, dose #2 10/18/2021, Pfizer, dose #3 1/2/2022 COVID swab, result: detected 12/26 pt admit ED cc: Cough, chest congestion dx: Acute viral syndrome, COVID-19 LOS: 1 day 12/26 CXR impression: No acute cardiopulmonary findings. 12/23 pt cc: cough, fatigue, myalgias, rhinorrhea exposure: unknown
This is a spontaneous report from a contactable nurse. A patient of unspecified age, ethnicity and gender received TRUMENBA, via an unspecified route of administration, on an unspecified date, at single dose. The patient's medical history and concomitant medications were not reported. The patient experienced a very large local reaction on an unspecified date with outcome of unknown. Follow-up (11AUG2016): Follow-up attempts are completed. No further information is expected.
MILD SIDE EFFECTS THAT WERE ECLECTIC; This spontaneous report received from a patient via Social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. 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 mild side effects that were eclectic. (Dose number in series:1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (Dose number in series:2) (suspension for injection, route of admin, and batch number: Unknown, Expiry: Unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The patient did not experienced any adverse event following the covid-19 vaccine ad26.cov2.s (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of mild side effects that were eclectic was not reported. This report was non-serious.
PATIENT HAS A RAISED RED SPOT AT THE INJECTION SITE.  THE SITE IS WARM TO TOUCH AND SORE.  BENADRYL GIVEN ON 12/05/2009, AND CORTISONE CREAM APPLIED TO THE AFFECTED AREA.
About 9 days after receiving my first dose of the Pfizer vaccine, I experienced sinus congestion draining into my ears, vertigo, dizziness and imbalance on the left side, roaring tinnitus on the left side, both ears clogged, and difficulty with visual tracking/focus. I took my second shot on February 27, 2021. The clogged ears worsened. The tinnitus worsened from intermittent to constant. I developed brain fog and the sensation of not being in my body. I experienced anxiety and an inability to sleep for several weeks due to the loud tinnitus, and my daily activities were significantly curtailed.   I had a hearing test, was found to have mild hearing loss, and was prescribed hearing aids to help manage the tinnitus. I was tested for allergies and found to have new severe allergies to tree pollen, grass pollen, ragweed, mold, dust mites, and pet dander. I began taking allergy shots.  I had regular appointments with my primary care physician, ENT, audiologist, allergist, chiropractor, acupuncturist, physical therapist, and mental health therapist to manage the various symptoms. After a few months, the vertigo and dizziness reduced to mild imbalance with certain head movements. As of mid-July, I have not been troubled with vertigo, dizziness, brain fog or vision issues, and my ears are less clogged. The tinnitus is still present but quieter. I had a booster on December 3, 2021.
Palpitations, hypertension, lightheadedness, numbness/tingling from head to toe at 20-minute mark post-vaccination. Numbness/tingling resolved after 15 minutes, palpitations (HR 130-160) and feeling lightheaded persisted, went to ER for evaluation. Cardiac enzymes were normal. Inflammatory markers (WBC, etc.) elevated 6 hours post-vaccination. EKG showed sinus tachycardia. Received a 1L normal saline bolus, HR improved to 90's-110's, discharged home with a recommendation to follow up with a cardiologist for Holter monitor. An appointment made, has not occurred yet. Have continued to have issues with elevated HR post-vaccination, on day 4 post-vaccination, began to have burning sensations in my back intermittently, day 5 post-vaccination began to have generalized burning sensations, and numbness/tingling/burning in legs/feet. Went back to ER for evaluation. Strength remains equal and intact, the physician did not order imaging, sent home, and recommended follow up with neurologist if symptoms did not improve in 10 days. Still have paresthesias all over my body and tachycardia at rest.
Had the shot /dealing with internal singles/suspected vaccination failure; internal singles head and face right hand side to back of head; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported the case for herself/himself. The age at vaccination was not reported. The patient received shingle shot and was dealing with internal singles on head, face and right hand side to back of head. The patient stated that he/she was on medication. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation for shingles were unknown. The follow up would not be possible as no contact details were available.
Case PHEH2016US025479, is an initial spontaneous report received from a pharmacist on 30 Sep 2016. This is also a quality complaint report (QA reference number: 1017148). This report refers to a patient of an unknown age and gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUAD (batch number: 165902, expiry date: 30 Apr 2017) on 27 Sep 2016. The pharmacist stated that, she administered FLUAD to a patient and during the administration of the product, she noticed that part of the vaccine leaked out from between the needle and syringe. Patient did not receive a full dose. Also the patient (reported as customer) did not think the needle was tight. No  adverse event was reported following this maladministration (underdose and syringe issue).
Shortly after receiving the HPV vaccine Patient was diagnosed with Crohns Disease. We have no history in out family.
Patient stated her stomach lining started to severely hurt at about 5pm on the day of administration as the night progressed she started feeling her as if he chest was being squeezed and that sensation traveled to her head. She stated she almost passed out.
June 14, 2022, I woke up in the morning with a sore throat but I did not associate that with COVID-19 and around 19:00 that night I came down with a fever.  On  June 15, 2022 I wrote my doctor via my health portal and explained symptom's and told her I took an at home test that I received in the mail and it came back positive. I had a tele-visit  on the June 15th at 13:00. Dr. called me in a prescription  Hydrocodone-Chlorphener for the cough I developed.