chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Loss of hearing in left ear; Ringing in left ear; This spontaneous case was reported by a non-health professional and describes the occurrence of DEAFNESS (Loss of hearing in left ear) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No recorded medical history).   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced DEAFNESS (Loss of hearing in left ear) (seriousness criterion medically significant) and TINNITUS (Ringing in left ear). At the time of the report, DEAFNESS (Loss of hearing in left ear) and TINNITUS (Ringing in left ear) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  Company Comment - Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
developed humming in left ear 18 days after second dose of vaccine.  two days later developed ringing in right ear.  humming in left ear eventually went away but ringing in right ear persists as of today, June 29, 2021.  had both ears checked for wax, both were clear.  took a regimen of steroids and allergy drugs, but no improvement.
excursion vaccine was administered with no adverse event; vaccine Act-HIB for which cold chain break is reported with no reported adverse event; Initial information received on 19-Apr-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves Infant and unknown gender patient who was administered HIB (PRP/T) vaccine [ACT-HIB] for which cold chain break and and excursion is reported with no reported adverse event.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (expiry date and batch number unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization) for which cold chain break and and excursion is reported with no reported adverse event (product storage error) (poor quality product administered) (same day latency). Information on the batch number was requested.  It was reported that children received doses of ActHIB that was deemed unusable later due to arrival of the shipment outside the acceptable 2-day window.  It is unknown if there were lab data/results available.   Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event excursion vaccine was administered with no reported adverse and was Unknown for the event act-hib for which cold chain break is reported with no reported adverse event.  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 the guidelines. 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.; Sender's Comments:  US-SA-2023SA124713:master case
I had tingling, warmth, and swelling of the left half of my bottom lip. It self resolved within one hour. I have had the exact reaction one time prior, 3 years ago, after eating a kiwi.
Gardasil and Menactra given 9/10/08 - On 9/11/08 patient reports headache and vomiting.
The vaccinee received his 2nd dose of vax even though the adverse reactions from the first dose had not resolved. Blood work was performed the day of the vax. The pediatrician called the vaccinee's family 1-2 days later and notified them that the vaccinee's white blood cell count was elevated. The vaccinee was admitted to the hospital. It was thought that the pt had some rare form of leukemia, specifically juvenile monocytic leukemia. Tests were evaluated by several specialists but the dx was not confirmed. An allergist and immunologist identified something problematic with the antibodies. The pt was taken home and resumed breast feeding. The parents decided not to further immunize their child as symptoms started after immunizations began. All symptoms reported resolved over the next 3-4 months. Hypersensitivity reactions continue.
My wife had a serious-severe-case of shingles in Oct. 07. Nothing could be done to alievate the pain and discomfort because of the lateness of getting it diagnosed. In december we both got the shot to prevent myself from getting shingles and she to prevent shingles from reacuring. Over a month ago or a Sunday I developed sever stomach pains ,no vomiting or gastro problems. Getting ready for bed we observed a slight rash on my left side. Within hours it flaired up and by Monday when I went to the doctors I had a full blown case. I was given an anti viral med. Wether this eased my discomfort or what my condition was nothing compared to that of my wife-still has the discomfort in her right side. As I write this report, after a month, I am tried, lack energy and have been taking Hydrocodone to relieve the pain at night, and during the day when needed. I have just started my refill and have been told that if the pain persists I will have to put on something other a narcotic.
Dizzyness, pain at injection site and pain throughout arm that was injected. Very tired and headache the entire day after.
Prior to the adverse event. Patient experienced Diaherrea, Fatigue, and Vomitting. Period, lasted 2 days longer than normal. Prior to the Vaccine, Patient experienced swelling, on both legs from the 2nd dose. It was ruled out that it was not a Bloof Cot
1.5 inch below inject site - (R) arm with 4 inch diameter erythema with firmness and tenderness, raised. Occasional numbness to (R) hand thumb and 2nd digit. Onset 2 days post vaccination. Tx for cellulitis as preventative.
pt recvd MMR vax 6AUG91 & 1 wk following vax pt devel a fever & c/o burning of eyes; no further details were provided;
This spontaneous report has been received from a pharmacist, via a company representative, referring to an unspecified 65 years old patient of unspecified gender. The patient's pertinent medical history, concomitant medications and information about any drug reactions or allergies experienced by the patient were not provided. The pharmacist reported to the company representative that, on unspecified dates, the unspecified patient had already received a dose of pneumococcal 13v conj vaccine (CRM197) (reported as "PCV13") for an unknown indication; and two previous doses of PNEUMOVAX 23 for prophylaxis (concentration, dose, route and anatomical location of administration, lot number and expiration date were unknown by the pharmacist) (extra dose administered). No adverse effects were reported. Further information was not provided.
Information has been received from a physician concerning a 19 year old female with a history of ovarian cysts who sometime in December 2007 was vaccinated with the first dose of Gardasil.  In December the patient's period came approximately 3 weeks late.  A pregnancy test was done and the patient was not pregnant.  The patient sought unspecified medical attention.  Subsequently, the patient recovered.  No product quality complaint was involved.  Additional information has been requested.
Patient reports severe pelvic pain after the injections, she stated she was bed-ridden for a few days, but did not seek medical care.
Two hours post vax, the pt experienced generalized joint aches, which lasted one day and then resolved.
Urinary tract infection; Pain; unable to walk; lack of mobility and that it take 1 and sometimes 2 people to assist her; becoming more depressed and hopeless; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 09Mar2021 (Batch/Lot number was not reported) (at the age of 70-year-old) as dose number unknown, single for covid-19 immunisation; alglucosidase alfa (ALGLUCOSIDASE ALFA), intravenous from 16May2006 (Batch/Lot number was not reported) and ongoing, at 2200 mg every other week, then from 04Jun2021 at unspecified dose for Pompe's disease. Medical history included Pompe's disease. The patient's concomitant medications were not reported. On 19Mar2021, patient was admitted for a urinary tract infection and pain (both assessed as serious due to hospitalization) and the medical team was concerned about her lack of mobility and that it take 1 and sometimes 2 people to assist her (serious: disability) and because of that, the medical team was recommending patient go to a skilled nursing facility. Therapy with alglucosidase alfa was ongoing. On 09Mar2021 the patient received Pfizer biontech covid-19 vaccine, unknown formulation, dose, route and frequency (with an unknown batch number). On 10Mar2021 after a latency of 14 years 9 months 22 days, the patient could not walk for which patient was hospitalized and was sent to a nursing home and was now living in assisted living. The patient will not restart the treatment as she cannot walk and was in assisted living. And patient is increasingly becoming more depressed and hopeless. The action taken in response to the events for alglucosidase alfa was unknown. The outcome of events was unknown. Reporter causality: unassessable for depression and couldnt walk, not reported for rest events. Company causality: not reportable for all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
My blood appears to be thick and clotting causing a slow draw and issue upon attempt to donate blood.
Headache, fever, chills, flu-like achiness, excessive pain in vaccination site (no previous site pain that lasted more than a few hours).
This case was reported by a consumer via sales rep and described the occurrence of shingles in a 63-year-old female patient who received SHINGRIX for prophylaxis. Previously experienced adverse reactions included sickness. Previously administered products included SHINGRIX (fever and shingles after receiving 1st dose on 2nd April 2018, refer case US2018GSK142353)). On 3rd July 2018, the patient received the 2nd dose of SHINGRIX. In July 2018, 3 days after receiving SHINGRIX, the patient experienced shingles, fever and sickness. In July 2018, the outcome of the fever and sickness were recovered/resolved. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles, fever and sickness to be related to SHINGRIX. Additional details were reported as follows: The patient waited for the allotted time before receiving 2nd dose of SHINGRIX vaccine after the 1st dose. The patient was sick with fever for 2 days before she broke out with shingles on the 3rd day after vaccination. The patient consistently had shingles outbreaks every 2 to 2 ½ weeks since then. One outbreak was starting to clear up when the next outbreak was beginning. The patient requested to help and asked what was happening to her. The patient stated that she had no insurance and paid over 300 dollars out of pocket and she was a senior citizen. The patient asked, if it would not going to help, and obviously made things worse, then she would like to get refund. The patient had send the receipts from the vaccines given by the pharmacy.
Death NOS; Initial information received on 20-Nov-2021 regarding an unsolicited valid serious case received from a Social Media via consumer non health care professional under reference number: US-SA-SAC20211127000105.  This case involves an unknown age and unknown gender patient who experienced death Nos (death) after receiving vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was unknown if the patient had any concomitant disease or risk factor.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiry date not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event death Nos (death) (unknown latency) following the administration of INFLUENZA VACCINE.  These event were assessed as medically significant and was leading to death.  Final diagnosis was (fatal) death nos.  It was unknown if the patient experienced any additional symptoms/ event.  It was unknown if there were lab data/results available  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the patient was Fatal for the event death.  It was unknown if an autopsy was done. The cause of death was reported as Death Nos.; Sender's Comments: This poorly documented case from Social media concerns a female patient who died after vaccination with INFLUENZA VACCINE, produced by unknown manufacturer. The time to onset is unknown. Additional information regarding patient's medical history, condition at the time of vaccination, concomitant medications, lab /radiological investigation excluding other etiologies and detailed autopsy report would be needed for complete assessment of the case. Based upon the reported information, the role of vaccine cannot be assessed.; Reported Cause(s) of Death: Death NOS
Recommendations changed during time period prevnar 20 unavailable so prevnar 13 was administered and pt must return for 2nd dose per previous guidelines. patient understands he must return for pneumovax 23 in 2023
p/vax pt pale; listless; dec tone; but able to awaken & did breast feed
got Fluzone QIV, instead of Fluzone HD (with no reported adverse event); Initial information received on 08-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 65 years old and unknown gender patient who experienced got fluzone qiv, instead of fluzone hd (with no reported adverse event) while receiving vaccine influenza quadrival a-b vaccine [fluzone qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect influenza quadrival a-b vaccine [fluzone qiv] lot number not reported via unknown route in unknown administration site for Immunisation.  On an unknown date the patient developed a non-serious got fluzone qiv, instead of fluzone hd (with no reported adverse event) (wrong product administered) (unknown latency) following the administration of influenza quadrival a-b vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event got fluzone qiv, instead of fluzone hd (with no reported adverse event).     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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Lot number: CaH9694), in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 06Apr2021 as dose 1, single (Lot number: ER8737), in left arm, on 28Apr2021 as dose 2, single (Lot number: EW0173), in left arm and on 11Nov2021 as dose 3 (booster), single (Lot number: FJ8762), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Breast cancer survivor", start date: 2015 (unspecified if ongoing), notes: breast cancer survivor (2015: chemo, Herceptin, surgery, and radiation); "chemo" (unspecified if ongoing); "surgery" (unspecified if ongoing); "radiation" (unspecified if ongoing).  Patient had no known allergies.The patient's concomitant medications were not reported. Past drug history included: Herceptin for breast cancer. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid from 05Sep2023 to 09Sep2023.
Starting on 3/21/21: Fever of 103.3° Body aches  Chills Headache Extreme Lethargy Treated with 400mg Ibuprofen and rest.   Starting on 3/28/21: Red, swollen, painful  injection site.
Patient was given Zostavax on 3/30/07; 4-4-07 developed rash, DX with shingles 4-7-07
This spontaneous report was received from a consumer reporting on his 68 years old with no medical history or drug reactions/allergies who on an unknown date was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not provided). There were no concomitant medications. On an unknown date, the patient developed an oozing red and hot sore at the injection site. No treatment was given for the events and no laboratory tests were performed. On an unknown date, the patient recovered from the events. The patient did not seek medical attention. Additional information has been requested.
The patient came in on Wednesday to get her Shingrix vaccine on 11/25/2020 and her daughter called on 11/27/2020 that her mother had a bad reaction to the vaccine. Her arm has a bubble on it and is warm to the touch. Her arm also is very sore today and red. I advised the patient to take some Benadryl that she may be allergic to a component in the vaccine and that I would fill out a VAERS on it. She is going to follow up with her PCP for further consulting.
pressure on my chest/like someone punched me in the sternum/punch kept pushing into my chest/it was just a flash; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (pressure on my chest/like someone punched me in the sternum/punch kept pushing into my chest/it was just a flash) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Patient never had COVID positive test or diagnosis.  Previously administered products included for Drug use for unknown indication: Pfizer (Dose Number: 1, Lot number: EL9266, Dose: unknown) on 16-Feb-2021, Pfizer (Dose Number: 2, Lot number: EN6206, Dose: unknown) on 09-Mar-2021, Pfizer (Dose Number: 3, First Booster dose, Lot number: FC3181, Dose: unknown) on 12-Sep-2021, shingles vaccine (shingles vaccine) in February 2022 and shingles vaccine (second singles in April or May). Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer, Pfizer, shingles vaccine and shingles vaccine. Concurrent medical conditions included Drug allergy (sulfur allergy), Allergy (garlic allergy) and Arthritis.    On 08-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In September 2022, the patient experienced CHEST DISCOMFORT (pressure on my chest/like someone punched me in the sternum/punch kept pushing into my chest/it was just a flash). In September 2022, CHEST DISCOMFORT (pressure on my chest/like someone punched me in the sternum/punch kept pushing into my chest/it was just a flash) had resolved.            Concomitant medication details were not reported by the reporter.  The patient had received second booster dose of Moderna COVID-19 vaccine on 10 Apr 2022, with lot number 048L21A and dose was unknown.  The patient stated that she had an unusual side effect after getting the bivalent vaccine. Patient stated that 36 hours after she got the vaccine, she felt that pressure on her chest like someone had punched her in the sternum and the punch kept pushing into her chest. That lasted for 5 seconds. Then 15-20 minutes later, she felt that again but felt much lighter. She does not seek medical attention because she only had two episodes that lasted no longer than 10 seconds. She stated that was just a flash.  The patient had not experienced a similar event in the past.   Treatment details was not reported by the reporter.
Patient had a seizure approximately 20 minutes after vaccination. Patient has a history of seizure disorder and family with her asked us not to call 911. Patient's seizure resolved after 2 minutes. Patient left facility of their own accord. Patient showed no signs of breathing issues or topical reaction to vaccine.
Patient came to the pharmacy the next morning after receiving a pneumonia vaccine complaining of redness, tender to touch, swollen, and pain in the area of the vaccine as well as pain under her arms and the other side of her arms.
Pt developed diarrhea 4 days post vaccination, emesis, nausea, slight headache, tenderness in axilla, fatigue, some dizziness/weakness, also with erythema and satellite lesions around smallpox vaccination site,  diminished appetite.
I was just falling asleep when my body started shaking.  It was not violent, but enough to wake me and confuse me.  I would call them tremors or convulsions but not sure if there's a better description.  It lasted about 1 minute.  The "tremors" were at a rate of roughly 2.5 per second somewhat like a very rapid heartbeat almost.  In fact, I checked my pulse with my watch thinking it may be a heart issue but it only registered 58 bpm.
Pain all over body, joint and muscles. Mild headache. Tiredness. Pain when walking
Localized reaction to (R) deltoid injection site with erythema, edema, pain, induration (Large).
Patient reported she had received a flu shot on 10/09/2017 and had no adverse effects until 10/15/17 morning. She described itching which lead to scratching and as a result of fingernails lead to scratches. Patient stated she felt a knot for the first time on 10/15/2017. Patient stated she had begun taking diphenhydramine for 2 doses on 10/15/17. Recommended pt to utilize ice on area and contact doctor.
Pt.  said throat was getting tight. Pt. was assisted into a wheelchair and taken to the recovery room Pt was was given .5 MI of Epi. Vitals and assessment was done After 20 mins Pt. said he felt better and left the facility