chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swollen, tender, painful left deltoid since 11/11/2009 with induration at injection site, persistent since injection no erythema or signs of infection at injection site.
Information has been received from a pharmacist referring to a female patient of unknown age. The patient had no pertinent medical history and no known drug reactions/allergies. On 29-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (lot # K009199, expiration date 16-MAY-2015, dose and route not reported). There was no concomitant medication. The patient received ZOSTAVAX and experienced redness, itchiness, and a "knot" forming at the injection site. Patient sought medical attention via seeing the pharmacist. No lab diagnostics studies were performed. No treatment was given. At the time of the report, the patient's itchiness and the knot at the injection site went away but the redness was still there. Additional information  has been requested.
Numbness is lips, and tongue. Tightness is throat. Metallic taste in mouth. Heart palpitations.
This spontaneous report as received from a healthcare worker refers to an unknown number of patients of unknown age and gender. There was no information about concurrent condition, medical history or concomitant medication. On 08-MAR-2016, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L025738 and expiry date 14-AUG-2017; lot # L033343 and expiry date 17-SEP-2017) (dosing details unspecified). No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Details of temperature excursion: Temperature: 47.8F for 1 hour and 10 minutes. Previous temperature excursion: No. Data logger: Yes. Outcome: Supported. This is one of the several reports received from the same reporter. Additional information has been requested.
Dizziness; weakness; wheal at injection site, starting a few hours after injection. Wheal lasted 2 - 3 days - other symptoms 1 - 2 hours.
she received Expired vaccine; having pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (she received Expired vaccine) and MYALGIA (having pain all over her body) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A71A/038ANA) for COVID-19 vaccination.     No Medical History information was reported.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 06-May-2021, the patient experienced MYALGIA (having pain all over her body). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (she received Expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (she received Expired vaccine) and MYALGIA (having pain all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Patient mentioned her second dose of Moderna vaccine is due on 26May2021.
This spontaneous report was received from a pharmacist, referring to a 57 year old female patient. The patient's concomitant therapies were unknown by the reporter. The patient did not have any pertinent medical history. The patient's drug allergies/reaction included an unknown reaction to COMPAZINE. On 09-AUG-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly, Lot # R002354, expiration date 17-DEC-2019, for vaccination (strength, dose and frequency were not reported). On 10-AUG-2018 (reported as "on the following day"), the patient experienced a cough, sneezing and other cold symptoms. The patient did take MUCINEX for these symptoms (also reported as "treatment: No") and recovered on 16-AUG-2018. The patient did not seek medical attention and diagnostic laboratories were not performed. The pharmacist requested a Lot check and stated it was time sensitive. Additionally, the causality assessment between Nasopharyngitis and PNEUMOVAX 23 was not provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA007466: US-009507513-1808USA008021.
Back went into spasms; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Back went into spasms) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 03-Mar-2021, the patient experienced MUSCLE SPASMS (Back went into spasms). At the time of the report, MUSCLE SPASMS (Back went into spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient stated that she has had back issues and its not related to vaccine. she also stated  she had injections for it in November and December.
Sudden onset severe joint pain and swelling, lower extremity paresthesias. Lasted over 2 weeks. Required lumbar puncture to rule out Guillan Barre syndrome. Improved slowly overtime with prednisone.
1-27-12 developed fever 102, body aches, nausea. Reduced by "THERAFLU" medication. 1-30-12 c/o swollen throat, home from school. 1-31-12 circular rash around injection site (R) arm, generalized rash on entire body, and itching. Took BENADRYL. Has not sought medical care yet.
widespread hives with urticaria onset approx. 4 days after receiving first dose; Severe urticaria on legs, arms, torso, neck, and scalp occurred 4 days after the 1st dose.; This is a spontaneous report from a contactable consumer or other non hcp.   A 35-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EW0169), dose 1 intramuscularly, administered in Arm Left on 18Apr2021 15:00 as 1st dose, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included multivitamins. The patient previously took Augmentin [amoxicillin; clavulanic acid] for hypersensitivity and experienced rash. The patient was not pregnant at the time of vaccination.The patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID. It was Reported that, on 22Apr2021 17:00, Severe urticaria on legs, arms, torso, neck, and scalp occurred 4 days after the 1st dose. Required medical attention (steroids). widespread hives with urticaria onset approx. 4 days after receiving first dose. treated with prednisone tablets 5 mg x 7 days with outcome of recovered. Therapeutic measures were taken prednisone 5mg tablets as a result of severe urticaria on legs, arms, torso, neck, and scalp occurred 4 days after the 1st dose. (urticaria), widespread hives with urticaria onset approx. 4 days after receiving first dose (urticaria).  No further follow up attempts is needed. No further information is expected
"Woozy", hard time walking tongue feels "funny", headache, nervous, jittery, "drunk" hard time speaking, numbness in left pinkie.
This spontaneous report was received from a license vocational nurse and refers to a 6-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On an unknown date at 2 months of age, the patient received one dose of ROTARIX and, at 4 months of age, the patient was vaccinated with another dose of ROTARIX. Then, on an unspecified date at 6 months of age, the patient received a dose of ROTATEQ orally, lot # M042172, expiration date 08-JUN-2018 (dose was not reported). No side effects were reported. Product quality complaint was not involved. Additional information has been requested.
pt was very anxious and nervous about needles and had syncopal episode after vaccination. pt unconscious for about 30 seconds, then came to. pt remembered vaccine administration and pain, but had no recollection of fainting. once pt arousable, pt a/o x 3, stated she just felt shaky. vss 108/62, rr 16, hr 66.
pt recvd vax & 8SEP92 & devel 101 fever treated w/APAP; same day became limp, pale, eyelids turned blue; lasted 1 1/2 hrs; taken to ER; had 2nd episode; hospitalized; rx w/Cefotaxime; poss allergy to milk; on soy formula; milk-based formula
Patient reported cold sores to her right and central upper lip, under her tongue, and into the back of her throat that started a day after receiving the two vaccines.  She reports that today (5 days after vaccines and 4 days after onset of sores) that the pain is improving and she feels she is through the worst of it.  She experienced pain and problems being able to tolerate eating.  Prescribed viscous lidocaine to help with pain.  Denied fevers and body aches.
A report has been received from a Health Professional concerning a 2 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 14-Dec-2012. The patient experienced EXPIRED FLUMIST GIVEN which started on 14-Dec-2012. The outcome of the event of EXPIRED FLUMIST GIVEN is unknown. The patient was given some expired doses of FLUMIST. The report was considered to be non-serious.
I experienced a low grade fever (100.1), muscle aches, extremely bad headache, and nausea for 2 1/2 days following the first dose of the shot.  I also mad a lump about the size of a tennis ball where the injection occurred.  It was extremely sore, red, swollen, and hot to the touch.
Sudden hearing loss in right ear; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 26Feb2021 13:30 (Lot Number: EN6198) at a single dose, and the second dose via an unspecified route of administration in left arm on 19Mar2021 13:30 (Lot Number: EN6199) at a single dose for covid-19 immunization at the age of 53 years old. Medical history included hypertension and known allergies to sulfa, both from an unknown date and unknown if ongoing. The patient did not have covid prior vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included irbesartan taken for an unspecified indication, start and stop date were not reported. The patient experienced sudden hearing loss in right ear on 10Apr2021 12:00.  The event resulted in doctor or other healthcare professional office/clinic visit, and cased disability or permanent damage. The patient underwent lab tests and procedures which included covid-19 virus test (nasal swab): negative on 14Apr2021. Therapeutic measures were taken as a result of sudden hearing loss in right ear included steroid injection series into eardrum. The outcome of the event was not recovered.
Dizziness, vertigo, nausea3 days post vaccine 24 hour after vaccine chills shoulder pain on side of injection
We received on 29 NOV 2007 from the regulatory agency the following information: A 51-year-old female patient was vaccinated with influenza virus vaccine (manufacturer unknown) on 10 NOV 2007. On 13 NOV 2007 she developed iritis. The outcome is unknown. Vaccination history: The patient experienced iritis after vaccination in 2006 (see case nos. MA2007-1573 and MA2007-1574). See also case no. MA2007-1571 (200/2008). Company assessment: Seriousness criterion: medically significant. Causality: insufficient data. Initial iritis has been reported after first flu immunization and the same symptoms reappeared after the second flu vaccination. Iritis is known to be present in the context of rheumatoid dispositions, also in the context of HLA B27 disorders. There are literature reports on iritis after vaccinations. However, literature review showed controverse data on iritis/uveitis after flu vaccination. Data on the subject's medical history or epicrisis are insufficient to ultimately judge the case. Expectedness assessment according to manufacturer label: The described symptom is unexpected after vaccination with Fluvirin. No change in benefit-risk-ratio. No measures necessary. Regulatory authority no. ADR 20189179 It seems to be unlikely that Fluvirin was used as the vaccine was not distributed to the foreign market in this season.
child vomited. not accompanied by fever. still monitoring for fever or additional problems.  Gave her water to drink and nothing else. put her to bed for rest.
No adverse effect reported; patients received an improperly stored dose of MMR II on unspecified dates; This spontaneous report was received from a nurse practitioner referring to a 14-years-old male patient. The patient's pertinent medical history and previous drug reaction, and allergies were not reported. The patient's concomitant therapy included sterile diluent injection.  On 14-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (M-M-R II) of lot # R028382, expiration date reported as 02-OCT-2020, but upon internal validation established as 10-MAR-2020 (exact dose, dose number and route of administration were not reported) for prophylaxis (product storage error). The sterile diluent injection used to reconstitute the vaccine was stored in the recommended temperature range. On an unknown date, the vaccine administered to the patient was exposed to the temperature excursion of -58 degree Fahrenheit and +46 degree Fahrenheit (35.1 Fahrenheit (F)) for 30 minutes, and at highest temperature above 47.1 degree Fahrenheit (47.1 F) for 30 minutes. There was previous temperature excursion at -58 degree Fahrenheit and +46 degree Fahrenheit (-35.8 F) for 30 minutes. There was no adverse effect reported (no adverse event). Digital data logger was involved. No product quality complaint was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA006066: US-009507513-2003USA010168: US-009507513-2003USA010101:
This spontaneous report as received from a other health professional refers to a 11 year old patient. On 13-OCT-2014, at age 11 years, the patient received the first dose of GARDASIL. On  27-FEB-2015, the patient received the second dose of GARDASIL (lot K018149, expiry date 22-JUN-2016) and on 29-APR-2015, the patient received third dose of GARDASIL (lot L001442, expiry 04-NOV-2016) intramuscular for prophylaxis. On 29-APR-2015, 6 months 17 days after onset of therapy the patient experienced inappropriate schedule of drug administration. On an unknown date the patient experienced no adverse event.
Soon after receiving my Covid booster, I started experiencing a noise in my ears that sounds like crickets. At first it was intermittent, but as time went on it became a constant, shrill noise in both of my ears. Initially, I didn't make the association with the vaccines or booster and thought that I must have had wax build-up in my ears. I made an appointment with an ear, nose, and throat specialist and was shocked to learn that I didn't have any wax build up but could be experiencing this as a result of having the vaccines or booster! The ENT doctor immediately sent me for a hearing test with an audiologist and I learned that I have experienced hearing loss as a result! I had perfect hearing and never had any ringing in my ears before taking the vaccines/booster. The audiologist recommended hearing aids and tinnitus training but admitted that hearing aids may not help with the tinnitus. The ENT doctor said that he didn't know if hearing aids would help either. The tinnitus training is nothing more than trying to train your brain to ignore the constant ringing in your ears. I was told that there is NO CURE! I left that appointment completely shaken and feeling utterly hopeless and have been trying to wrap my brain around this since then.   I was a HUGE proponent of the vaccine. I put my trust in the drug companies, our government, and the "experts" and could now have a permanent, life-altering condition. I am beyond upset at the thought that I may have to live the rest of my life with this because I took vaccines and a booster! I was a happy, very active 61-year-old woman and was in perfect health before I took the vaccines/booster. Take come accountability and own up to the serious side effects of the vaccines and booster!
Zoster Vaccine administered to child instead of varicella.  No adverse symptoms noted at this time.  Vaccine was administered 4/15/2009 at 10:45 am.  Medical Director and Supervisor notified of incident.  Mother notified of wrong vaccine given as well as educated to watch for localized reaction.  Phone numbers given to contact Health Department.
Patient returned 30 min after immunization with hives.  Lungs CTA Heart Reg Benadryl 12.5mg given- pt observed x 20 min still with hives but active.
rash and heat radiating from injection site starting 3 days after immunization (8/11/19). Very itchy
Contracted Covid19  Symptoms first appeared on July 4 - fatigue, diarrhea, congestion/runny nose. Fatigue, diarrhea, congestion/runny nose continued on July 5. Fatigue, congestion/runny nose continued on July 6 - no more diarrhea. Fatigue, congestion/runny nose continued, as well as loss of taste/Smell on July 7, 2021 - contacted PCP who ordered a COVID19 test. Test was completed on 7/7/21 Confirmed positive with COVID19 on July 8, 2021.  Received monoclonal antibody infusion Friday July 9. Complete reversal of Symptoms by Sunday 7/11/21
pt recvd vax & was dx w/torn rotator cuff; MD stated pt may have begun twisting & flinging the arm to relieve post-vaccination soreness @ the site of inj & tore the rotator cuff; Reporter indicated vax was delivered to proper area of arm;
flu-like symptoms for about 32 hours including low-grade fever, muscle and joint pain, overall discomfort at about an 8 of 10 reduced to about a 5 w/ 400 mg Tylenol.  Still experiencing "brain fog" on day 4 post vaccination
pt recvd vax 10DEC93; that evening had a fever of 105; tx Advil-recovered;
severe itching within the area of the injection; This case was reported by a other health professional and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received Shingrix. In December 2020, less than a month after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was unknown.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient received the vaccine 3 weeks before reporting and was complaining of severe itching within the area of the injection.
Date is approximate but my 15 year old daughter received the GARDASIL vaccine and did not have another period after. I figured it was temporary since she had had very light periods until then. Two years later, my daughter informs me she still hasn't had a period. We went to the pediatrician, who ordered lab work, which led to specialists, more lab work and imaging studies, leading to a diagnosis of autoimmune ovarian failure. At a subsequent visit we were told she has also developed Hashimoto's thyroiditis. She now has no ovaries to speak of and must take hormone replacement (Both reproductive and thyroid). Since she has no eggs, she cannot give birth to her own children.
feeling very dizzy, dizzy after second dose; 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 DIZZINESS (feeling very dizzy, dizzy after second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (feeling very dizzy, dizzy after second dose). At the time of the report, DIZZINESS (feeling very dizzy, dizzy after second dose) outcome was unknown.            No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Information has been received from a consumer concerning her daughter, a 15 year old female with a history of eczema, diabetes and no drug allergies who in December 2010 (also reported as November 2010), was vaccinated with her first dose of GARDASIL and in November 2010, was vaccinated with her second dose of VARIVAX while her annual physical. Concomitant therapy included LOESTRIN, triamcinolone acetonide, LOCOID LIPOCREAM and montelukast sodium. The consumer reported that her daughter started having increased thirst approximately on 4-FEB-2011 (reported as about 3 weeks before hospitalization). In February 2011, the daughter was hospitalized from 25-FEB-2011 to 27-FEB-2011. She was in diabetic ketoacidosis (DKA) and diagnosed with diabetes. Insulin was given for AE as treatment. The patient performed blood work and antibody screening. It was reported that the therapy with GARDASIL was discontinued and the AE did not improve. At the time of the report, the patient had not recovered. Additional information has been requested.
This spontaneous report as received from a medical assistant concerning multiple unspecified patients of unknown age and gender. No pertinent medical history, concurrent conditions, concomitant medications or drug allergies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (Lot # M004508, Expiry date : 29-JUN-2017, NDC# 0006-4047-41) (Strength, dose and route of administration were not reported) for prophylaxis (incorrect product storage). Other suspect therapies included sterile diluent(MERCK STERILE DILUENT)  as prophylaxis.   There was previous temperature excursions on 23-FEB-2016 to 24-FEB-2016, 27-FEB-2016 to 29-FEB-2016, 01-MAR-2016 to 04-MAR-2016, 08-MAR-2016 to 09-MAR-2016, 15-MAR-2016 to 20-MAR-2016, 23-MAR-2016 to 26-MAR-2016, 30-MAR-2016, 02-APR-201 to 04-APR-2016, 19-APR-2016 to 21-APR-2016 and 23-APR-2016 to 24-APR-2016 for 24 hours each. Data logger was involved.   On 27-APR-2016,12-MAY-2016, 24-OCT-2016, 13-NOV-2016, 06-DEC-2016 and 04-APR-2017 there was temperature excursions of -0.12, -0.46, -0.14, -0.24, +9 and -20.18 to +14 degree Celsius for 1 hour 15 minutes, 1 hour, 30 minutes, 45 minutes, 1 hour and 3 hours 30 minutes respectively. There was no product quality complaint involved. No adverse effects were reported.   This is 1 of 6 reports from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1706USA007802:
Pt received the shot within 15 min became nauseated, confused, tremulous, blurred vision then lost consciousness (was sitting at the time but hit his head, (all symptoms noted preceded the shot as an aura); all of this resolved and no systemic symptoms noted from the shot but an area of local pain from where his head was hit only on palpation.  911 was called evaluated he would be fine.
Painful swelling at injection site beginning 5 hours after injection and worsening as time progressed. After 1 day injection site an intense red and painful/warm to the touch
Soreness began five full days after injection in my left arm. Excruciating soreness starting from the base of my neck across the left shoulder down my upper arm to the elbow and below.  It lasted for 7 days and then  the soreness left as fast as it began.
s/p vaccine-15-20 mins patient was having shortness of breath- gargling- unresponsive for 1 min. no cpr done. no epi given, regained response in 1 mins- had vomitting after wards. vitals normal and WNL