chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 9/3/09 at 10:30 a.m. I received a pneumonia vaccine in my left arm as recommended by my physician due to not having a spleen. That evening my arm around the injection site began to turn red and become very painful. I also began to feel light headed and dizzy. My arm was in so much pain that I could not sleep on my left side. I used a heat pad to try to alleviate some of the pain but it had no effect. Through the night and the next morning the symptoms became much worse. My arm was in so much pain that I was not able to dress myself or raise my arm more than a few inches. I was very nauseous, dizzy, light headed, weak and had general overall pain throughout my body. I was barely able to sit upright. I had to leave work for the day. My physician suggested I go to an urgent care to have it looked at, which I did. The physician there stated that it appeared I had some kind of infection in my left arm. At this point most of my upper arm and bicep was red, inflamed, and very painful. I was prescribed keflex tid and darvocet-n for the pain. The pain was so intense that the darvocet wore off within 3 hrs. and I could not take anymore for another 2 hrs. Over the next two days the pain and redness continued in my arm and moved through to the left side of my chest. I contacted the urgent care again and they said to give the antibiotic another day or two to work. By 9/8 the pain had subsided enough that I was able to return to work fully. At this point my upper arm was still red and painful but my dizziness had decreased. Over the next few weeks the pain in my arm slowly decreased and a layer of skin on my upper arm had peeled or flaked off. There was a hard mass under the skin as well where the injection site was but that is now gone. My arm now seems to be nearly back to 100%, it's still a bit sore to the touch but I have full range of motion.
The next day I awoke very weak; light-headed; slightly feverish; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (The next day I awoke very weak), DIZZINESS (light-headed), PYREXIA (slightly feverish), MYALGIA (body aches) and CHILLS (chills) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002b21a and 011m20a) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (aspirin) and Food allergy (soy milk). Concomitant products included CALCIUM, COLECALCIFEROL (CALCIUM PLUS D3) for Bone density decreased, CENTRUM SILVER WOMEN 50+ and ASCORBIC ACID, CUPRIC OXIDE, DL-ALPHA TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC OXIDE (PRESERVISION AREDS 2) for Vitamin supplementation, ATORVASTATIN for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Mar-2021, the patient experienced ASTHENIA (The next day I awoke very weak), DIZZINESS (light-headed), PYREXIA (slightly feverish), MYALGIA (body aches) and CHILLS (chills). On 22-Mar-2021, ASTHENIA (The next day I awoke very weak), DIZZINESS (light-headed), PYREXIA (slightly feverish), MYALGIA (body aches) and CHILLS (chills) had resolved.            No treatment was reported.   This case was linked to MOD-2021-029890 (Patient Link).
Patient's mother reported child had symptoms of itching on 10/18/14 in the evening, red rash started on toes, then feet on 10/19/14, rash seen on hands next with swelling, during the week progressed to back, arms and legs; rash did not appear on face, chest or neck; mild cough, watery eyes; mother treated with cortisone ointment and Benadryl at home, did not go to MD or clinic.
severe pressure in head, similar to sinus pressure in the middle of the night, gone after getting up; pressure lasted a few days for first vaccine. About ten days, I noticed rash appearing on upper right chest, like pimples without pus. Rash began to spread slowly. By the time I got second vaccine, rash was all over chest, and some on back, and moving to genital area, and down the legs.
Sore burning spot quarter-size  maybe two inches in front of injection site. Grew to cover entire bicep. Lasted 6 days also had pain in joints of that arm
Developed shingles rash October 2020 on left side of abdomen. Rash lasted 4 months diagnosed by Dr on Jan 5, 2021
Information has been received from a physician concerning a 15 month old male with an ear infection who on 27-NOV-2007 was vaccinated with hepatitis B virus vaccine rHBsAg (yeast) (+) Hib conj vaccine (OMPC) in his left leg. There was no concomitant medication. On 28-NOV-2007 the patient developed a large red lump on his left leg at the injection site and a fever. The physician also reported that the patients white blood cell count was 23,000 which he believed was rather high. No further information was reported. The patient recovered on an unspecified date. Additional information has been requested.
I went to the doctor for a checkup and my blood pressure was high. It was not high previously. My doctor started me on a blood pressure medication.
Information has been received from a licensed practical nurse referring to a patient of unknown age an gender. On 08-AUG-2016 a dose of improperly stored M-M-R II (lot# L032044, rHA, expiration date 24-AUG-2017) was given to the patient. No adverse effects reported. The temperature excursion was 48 degree Fahrenheit for 24 hours, data logger was used. There was no prior excursion. The temperature was back in range at the time of reporting. This is one of several reports received form the same source. Additional information is not expected as there is no consent to contact the physician.
Pt reports no issues with prior COVID vaccinations. Pt believes it was the combination of the first Shingrix and COVID second booster (dose 4) that caused this adverse event. No issues immediately following vaccination on 4/3/22. The morning of 4/4/22 the patient was found unconscious. CAT scan did not show any stroke or aneurysm, but pt reported having a brain bleed after the fall that left the patient unconscious.
Off-label use; booster; swelling; This is a spontaneous report from a contactable consumer (patient) via a Pfizer sponsored program 002591. A 57-year-old female patient received a booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration as a single dose on an unspecified date (lot number unknown) for COVID-19 immunization. The patient previously received COVID-19 Vaccine on unspecified date (Primary Immunization series complete but unknown manufacturer). The patient had history included ongoing stage 3 kidney failure and ongoing auto-immune disease. Concomitant medications included tofacitinib citrate (XELJANZ 5 mg tablet) and ongoing Amoxicillin. The patient took Covid booster shot and was off Xeljanz for a week. She was experienced swelling. The event onset date, details, and outcome were not reported.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
21 year old patient received Smallpox vaccine and anthrax vaccine on 31 July 2016. On post vaccination day 21 the patient developed a generalized popular and vesicular dermatitis with popular lesions to both arms, legs and trunk. Pt also reported he has lesions on his fingers and palms. On post vaccination day 22 patient developed oral vesicular lesions. He was seen at a community ER and prescribed a pain relieving mouthwash. Overall the patient feel well. Patient has history of a similar rash with the oral lesions last summer (2015) and did not receive vaccine at that time. He has no medical history, surgical history, and does not smoke or drink. He reports he gets oral vesicular lesions, and one identified trigger is consumption of peanut butter. He cannot identify an new exposures such as foods, medications or topicals. The inoculation site had an intact eschar, is healing well and has no peripheral induration or vesicles. He is unsure how many doses of anthrax he has previously received.
3AM woke up with high fever, headache, muscle ache from shoulders up. Treated with Tylenol to reduce fever, symptoms continued through the day. 2PM discovered large patch of hives on back from right shoulder to waist approximately 4 inches wide at the top and narrowing to 1 inch wide at the bottom. Treated with my go-to allergic reaction kit: Xyzal, Benadryl, Prednisone, and Pepcid. Hives started fading after 1 hour and were mostly gone within 3 hours, followed by 12 hours of sleep.
pt recv vax 30DEC96 & pt exp soreness @ the inj site for about a day;7JAN97 pt devel a fever;
Fever 7 days post vaccination.  Seizure disorder and encephalitis of unknown etiology (dr suspects possible viral though tests negative) diagnosed 9 days post vaccination. Patient is now severely weak on her entire left side and is unable to verbally communicate and has difficulty swallowing...all secondary to encephalitis. Was treated at Hospital in PICU for a week and then two weeks in regular hospitalization. Was treated with acyclovir q 8 hrs for 21 days, is now on kepra for seizures.  will require months of PT/ST/OT to try to get her back to "normal". Can provide more info if needed just call.  03/07/2007 MR received from pediatrician showing a well-child check on 12/26/2006. No c/o.  PE WNL. Meeting developmental milestones with the exception of walking alone. Proquad and Hep A vax given.  03/05/2007 MR received from hospital.  HPI:  Child presented to local ER in status epilepticus.  Father had found her in her crib unresponsive, with head and eyes turned to the right.  She was covered in various bodily fluids.   She was quickly transferred to the hospital PICU with admission DX of Complex febrile seizure with left hemiparesis.   Treated with Acyclovir, Rocephin, Fosphenytoin, Ativan, Keppra and IVIG. Seizure activity gradually decreased although a left hemiparesis and facial palsy remained. Feeding modifications made due to aspiration risk.  Discharged after 21 day stay. Discharge DX:  Focal encephalitis, possibly herpes simplex virus encephalitis. Per information received from the annual follow up recipient has not recovered. Still has significant left side hemiparesis & significant congative delay-operating at 9-12 month level though now 25 months old. Case pending with VICP. Parents not recovered either.
Patient reported a fainting episode roughly 12 hours after being vaccinated.  Also notified his physician of the episode.
On 11/13/09 this individual had H1N1 and Seasonal Flu shots at her OB visit. On 11/19/2009 she began cramping and had miscarriage on 11/21/09. She was diagnosed with H1N1 on 11/09/09 and treated with 5 day course of TAMIFLU.
muscle aches, joint aches. waves of nausea, foggy head, severe fatigue x3 days.  Ongoing waves of nausea, foggy head, fatigue. Taking OTC acetaminophen
Pt recvd 2 doses of Engerix-B & 1AUG92 devel nausea, abdo pain, epigastirc pain, fatigue, felt very tired (mono-like), looked a little jaundice, seen by MD treated w/Floxin for URI; liver function tests were run & enzymes were sl elevated;
Fever, chattering teeth, shaking, extreme sweating, severe headache, severe body pains, extreme fatigue, severe tinnitus
This spontaneous report as received from a doctor of pharmacy refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ZOSTAVAX 19400 PFU of lot # j006155 (expiry date 30-AUG-2014). No concomitant medications were reported. The call was reported originally on 04-NOV-2013 in which the reporter requested the stability for an improperly stored ZOSTAVAX. AT the time of the call it was reported that the ZOSTAVAX was exposed to 15F for an unspecified amount of hours but reported that no doses of ZOSTAVAX was administered. The reporter called back again on 05-NOV-2013, and stated that he thought that the ZOSTAVAX may have been stored improperly since May 2013 and that the temperature of the ZOSTAVAX has ranged between 15F and 20F for an unspecified amount of hours. At the time the reporter was unsure if the ZOSTAVAX was administered but stated that he thought the ZOSTAVAX would have been administered. On further investigation, the pharmacists reported that ZOSTAVAX has been improperly stored since about 10-OCT-2013 reaching a highest of 20F for a total time of 600 hours. It was reported that the patient had no adverse effects. Additional information has been requested.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications, drug reactions or allergies provided. On 20-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) injection (lot# K010437, expiration date 22-JUL-2016, dose, anatomical location and route of administration were not reported). No adverse events were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
My 3 ½ month old son was accidentally given a flu shot along with the Hib, Hepatitis B, Polio, PCV13, DTaP/DT/Td, and Rotavirus vaccinations due for his age. A few hours after the shots, he began to cry inconsolably. He started vomiting and had diarrhea. He began running a fever by 4PM (100.5°F). He suddenly became congested. I began using saline and trying to suction his nose with no success. He also developed a wet cough that seemed to choke him. I began giving him 3 mL of TYLENOL every 6 hours once his fever began. He refused to drink a bottle. He seemed like it hurt him to try and drink it. He was lethargic and seemed dazed. His fever peaked by midnight at 101.2°F. All throughout the night, his breathing was very rapid. He didn't sleep but for 10 -15 minutes at a time and didn't rest comfortably during those periods. His fever broke at 3:30AM the next morning. He was still registering over 99°F but not as high as before. He continued this behavior the entire day after the shots. His temperature increased to 100.7°F as the day progressed and he still refused a bottle. By 3PM, he had only had a portion of 2 4oz bottles and had begun to cry inconsolably again. I returned him to the Doctor's office to have him checked out. I was repeatedly told nothing he was experiencing had anything to do with him being mistakenly given the flu shot. I was told he has a viral infection. The doctor told me to basically do exactly what I had been doing with the TYLENOL, saline, suction and using a humidifier. My 3 ½ month old didn't have any problems or side effects from his first dose of the vaccinations when he was 2 months old. His older brother also has not had any adverse reactions from any of the vaccinations given to him except the flu shot. Every time my 2 ½ year old has ever gotten the flu shot, he has experienced a fever, congestion, vomiting and diarrhea. It would last a few days and he would feel better. My baby is on day 3 after the vaccinations and is still not feeling himself. The vomiting is better, he still has diarrhea, however, and is still congested. His temp hasn't reached 100°F again, but is not in his normal range either. He isn't as lethargic and not as dazed. He is trying to interact with me but will still whine and cry. He has taken a 5 oz bottle, although very slowly. It took him an hour to drink the entire bottle. His usual appetite is 6 oz every 2 ½ hours.
10 days after the vaccination, and concurrent with a febrile illness with pharyngitis, the child developed eye blinking tics and head-turning tics, which persist 3 weeks later.  There were no tics in the week following the vaccination.
A few hours after the shots, pt started to feel the pain, it started to expand to the armpit, side of the chest, pt feels pain when breathing, very tense after 24 hrs of the shots (left arm).
Pt experienced NVD, extreme cold sweats and chills, loose stools, loss of apetite and inability to keep food down, SOB, post nanal drip, body aches and fever for two days after recieving influenza nasal mist. Patient was admitted to the hospital for 3 days due to ashtma exacerbation.
Pt started having headaches since getting the flu shot, has HA approx. QOD, last an hour or so on those days, has taken Ibuprofen few times but usually self resolves, HA is bifrontal, no known hx of headaches otherwise, No red flags re pathological cause of HA. Has not had flu vaccine in the past, done this year due to MA mandate. was advised to try magnesium 600mg daily x1wk for prevention, or can continue to treat episodically as needed and to keep in touch with sxs, esp any worsening
3/14/21 complaints of low-grade fever, cough, chills and difficulty with taking in a deep breath after receiving his second COVID vaccine about 5 days prior. New diagnosis of pericarditis given based on symptoms and cardiac MRI
Potential TIA or migraine with aura; Potential TIA or migraine with aura; This is a spontaneous report from a contactable consumer (patient). A 37-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration in the left arm, on 23Mar2021 15:15, as single dose, for COVID-19 immunisation, at a pharmacy. There were no medical history and concomitant medications (no other medications received within 2 weeks of vaccination). The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient has no allergies to medications, food, or other products. On 25Mar2021 at 09:30, the patient experienced transient ischaemic attack (TIA) or migraine with aura which resulted to physician office and emergency room visits, and hospitalization for 1 day (unspecified date). The events were reported as life-threatening illnesses (immediate risk of death from the events). The patient did not receive treatment for the events. The patient recovered from the events on an unspecified date.  Information on lot/batch number was available. Additional information has been requested.
Vaginal mucosal bleeding and severe headaches hours after the vaccination, bleeding lasting for 8 days until stopped with tranexamic acid.
patient says at injection site its swollen and red for now on 3rd day. he had no other "immune response" or side effects but is concerned about that the injection went in sub-q and not IM.
His daugther may have received a total of 4 doses ofGARDASIL-9; His daugther may have received a total of 4 doses ofGARDASIL-9; His daugther may have received a total of 4 doses ofGARDASIL-9; This spontaneous report was received from a physician referring to his daughter, a female patient of unknown age. The patien's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On an unknown dates, the patient may had received a total of 4 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(strength, route, dose, frequency, anatomical location, indication, lot # and expiration date were unknown). No additional adverse effects were reported in the patient.
With in 13 minutes of vaccine administration, patient reported symptoms of anxiety and diaphoresis.  Seated and given fluids.  Vital signs within normal limits.  Cleared for discharge.
The vaccine was given 6 weeks and 6 days earlier than the recommended 6-18 month range; no adverse event; This spontaneous report was received from a nurse, concerning a currently 15-year-old patient of unknown age. No information was provided regarding the patient's pertinent medical history, concomitant medications and previous drug reactions or allergies.  On an unknown date, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) (dose, frequency, route of administration, anatomical location, vaccination scheme, lot number and expiration date were not reported) as prophylaxis. On an unspecified date, the patient received the second dose of hepatitis a vaccine, inactivated (VAQTA) (lot number T013205, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 03-DEC-2021) (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) as prophylaxis. According to the nurse, the second dose of the hepatitis a vaccine, inactivated (VAQTA) was given earlier than the recommendations in the prescribing information. The vaccine was given 6 weeks and 6 days earlier than the recommended 6-18 month range (inappropriate schedule of product administration). No additional adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
C/O "leg pain immediately, like shot followed a vein or hit a nerve. Fever, chills, sweating" after vaccination.
Itchiness, prickliness, all over,  despite 3 showers in 24 hours.   No visible rash. Just tingly like pins and needles.  Mild but noticeable. Happened late afternoon into evening and still true as I prepare to sleep.
Administered  vaccine past the 75 days of storage in the fridge to 25 days past BUD. I'm calling all 55 patients to let them know their options.
patient got an infection to his hand and it was a minor infection but antibiotics did not work.; Moderna vaccine is hindering antibiotics from working,no response to antibiotics; fever, temperature goes up and down again; A spontaneous report was received from a pharmacist concerning a 78-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event fever, temperature goes up and down again, patient got an infection to his hand and it was a minor infection but antibiotics did not work, infection spread and did not know where it spread and reported moderna vaccine is hindering antibiotics from working, no response to antibiotics.  The patient's current conditions included type 1 diabetes and heart problem. Concomitant medications included insulin pump for type 1 diabetes.  On an unknown date, prior to the onset of the event, the patient received the first of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection. On 16-FEB-2021, the patient received the second of two planned doses of mRNA-1273 via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event fever, temperature goes up and down again. The patient got an infection to his hand and it was a minor infection but antibiotics did not work. The caller stated that the infection spread and did not know where it spread, and patient has been in hospital for 2 weeks plus. The caller stated that vaccine is hindering his immunity since he has been on IV antibiotics and does not seem to be doing the job. The caller stated that patient does not have Covid-19 but think that the vaccine is hindering the antibiotics.   The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable.  The outcome of the event fever, temperature goes up and down again was not resolving. The outcome of events patient got an infection to his hand and it was a minor infection but antibiotics did not work, infection spread and did not know where it spread and reported moderna vaccine is hindering antibiotics from working, no response to antibiotics was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Swelling, redness and warmth on right upper leg (upper 1/3 of leg) where DTAP was given; can see injection site.