chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Company was having their annual flu shots for all the employee's. They were set up with several stations and hundreds of people were feeding through the flu shot stations. When it was my turn, I went to the next available person. It was a male EMS guy. He rubbed the alcohol swab on my arm and injected the flu shot in my right arm. The needle going in was more painful than in the past, but when he pulled it out of my arm, it hurt so bad! Instantly, I could feel the pain radiating down my arm. About an hour later I could not move my arm very much. I noticed the band-aide that he put on my arm was really high on my shoulder. I pulled the band-aide off to see the needle hole. I was shocked at how high he placed the shot in my arm. I waited a few days hoping the pain would go away. The pain never went away, it only got worse. I went to the clinic at work and told them what happened. They started me on some NSAIDS and told me to come back for follow up. I came back with no relief. I was instructed to continue the NSAIDS and do some arm exercises at home. Again, I came back with no relief. Finally, they referred me to an outside Orthopedic Surgeon who gave me a Cortisone shot and then made me go through physical therapy. After the physical therapy was done (and the Cortisone shots was still effective), I was told to come back if the pain returned once the shot wore off. Well the pain came back and I went back to see the doctor. An MRI was ordered and now I am in the process of preparing for shoulder surgery.
This spontaneous report was received from a nursing assistant referring to a patients of unknown age and gender. Since 03-AUG-2015, the patients were vaccinated with doses of improperly stored GARDASIL 9 (dose and route of vaccination were not reported, lot # L004741 exp. date: 04-MAR-2017). No adverse events have been reported. Additional information has been requested.
Patient presents with complaints of feeling lethargic, and with low energy after getting the Bexsero vaccine on 07/03/2023.  Within hours she developed pain and redness at the site of the injection.  Cool compresses were applies.  She does take Xyzal nightly.  Ibuprofen was taken for a headache that developed.  She does have a history of Migraines and Imitrex was given even though she didn't feel it was consistent with her typical migraine.  The Imitrex wasn't effective.  She proceeded with alternating Tylenol and Ibuprofen.   The headache has improved.  She take Benadryl which didn't change the erythema, in fact it's now migrating to the axilla.  A fever developed today.  Tmax was 102 degrees F.      She did not have a reaction or similar symptoms after getting Bexsero #1 on 06/24/2022.
This spontaneous report was received from a pharmacist regarding a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 17-APR-2018 the patient was vaccinated with an expired dose of VAQTA lot # N012324 with expiration date: 05-APR-2018 (dosing details and route of administration was not reported) for prophylaxis (expired product administered). No adverse effects were reported.
No adverse event. Pt received 2 varicella vaccines - now with active chicken pox.
rashes near injection site; cellulitis near injection site; 2 weeks arm still sore; This non-serious case was reported by a physician via sales rep and described the occurrence of rash in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced rash (Verbatim: rashes near injection site), cellulitis (Verbatim: cellulitis near injection site) and pain in arm (Verbatim: 2 weeks arm still sore). The outcome of the rash and cellulitis were not reported and the outcome of the pain in arm was not resolved.   It was unknown if the reporter considered the rash, cellulitis and pain in arm to be related to Arexvy.   It was unknown if the company considered the rash, cellulitis and pain in arm to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-NOV-2023 The patient received Arexvy at pharmacy.  The doctors examined patient after complaints of rashes/cellulitis near injection site and 2 weeks arm still sore. The reporter agreed to follow up from GlaxoSmithKline. The case had been linked to US2023AMR151909, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR151909:same reporter, different patient
Aches, Pains; Couldn't walk well; Hot; Swollen; Red; Brain fog; Couldn't lay on arm, couldn't touch arm, arm felt like it was broken; Vomiting; Shaky; Ran temperature of 99 degrees; nausea; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PAIN (Aches, Pains), GAIT DISTURBANCE (Couldn't walk well), FEELING HOT (Hot), SWELLING (Swollen) and ERYTHEMA (Red) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 30-Dec-2020. Concomitant products included PARACETAMOL (TYLENOL), CEFTRIAXONE SODIUM (ROCEPHIN), SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (Aches, Pains), GAIT DISTURBANCE (Couldn't walk well), FEELING HOT (Hot), SWELLING (Swollen), ERYTHEMA (Red), FEELING ABNORMAL (Brain fog), PAIN IN EXTREMITY (Couldn't lay on arm, couldn't touch arm, arm felt like it was broken), VOMITING (Vomiting), CHILLS (Shaky), PYREXIA (Ran temperature of 99 degrees) and NAUSEA (nausea). At the time of the report, PAIN (Aches, Pains), GAIT DISTURBANCE (Couldn't walk well), FEELING HOT (Hot), SWELLING (Swollen), ERYTHEMA (Red), FEELING ABNORMAL (Brain fog), PAIN IN EXTREMITY (Couldn't lay on arm, couldn't touch arm, arm felt like it was broken), VOMITING (Vomiting), CHILLS (Shaky), PYREXIA (Ran temperature of 99 degrees) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Dec-2020, SARS-CoV-2 antibody test: positive (Positive) Positive. On 21-Jan-2021, Pyrexia: 99 (High) 99 degree Celsius.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was not hospitalized but was recommended to by healthcare professional. Treatment information include Tylenol, Rocephin, Dactrim.
Never got the 2nd one; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable to this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.  The patient asked could he/she had the vaccine shot again. The follow-up would not possible, as no contact details were available.
Initially didn't have a problem but later that evening, my left arm got really sore. I could barely lift it the next day. It was just muscle soreness, no redness or puffiness. By the end of that next day, it was much better and then it went away completely. After that I was fine until the 18th. At about 02:00 am or so, I woke up and was having chest pain and palpitations and shortness of breath. I thought I was in Atrial Fib, initially. My son took me to hospital to rule out stroke. They misdiagnosed me at the ER. They thought I was having a heart attack but then it wasn't showing, so they sent me home; they shouldn't have sent me home. I had mild chest pain and a little shortness of breath through Friday and then really early on Saturday morning I woke up early with the same symptoms but worse symptoms this time. The symptoms got worse on the way to hospital, and I ended up going by Ambulance part way there.  Doctor and Doctor CT scan, I had fluid around my heart. They made the diagnosis of Pericarditis. The effusion from the pericarditis was causing it. They admitted me and did an Echo; in the a.m. symptoms improved with Indocin and sent me home Sunday. I was really short of breath, still, though when I left the hospital. They gave me instructions to start tapering the Indocin and he wanted me to stop the Indocin and that is when symptoms came back really bad again. I was really fatigued and by end of week my symptoms came back, and I went into the walk-in clinic at my doctor's and saw my primary care provider on 3/3 and he wanted me to stop the Indocin and that is when symptoms came back really bad. My primary care provider on 3/3 (saw PCP in his office) and they referred me to cardiology. My first 4/29/2021 cardiology appt. The next day: on the 30th, repeat Echo because they didn't chart properly where the effusion was, he wanted to see where the posterior side of left ventricle, not a good place to be. The chest pain was under control, but I was still short of breath. My last appt with him, I've seen him once a month since then, the last one was the 28th of July. I had tapered the Indocin stopping and started the Colchicine. I am tapering that now. I am up to every three days on that so should be able to stop that soon. My next appt is in October with cardiologist. I talked to him about this to document in my medical record. He said that I don't meet the criteria for the age group, but I do meet the time frame for it being related to that second vaccine. The shortness of breath has now pretty much resolved. I am hoping to get off the Colchicine because it makes my toes numb. My fatigue is getting better too.
CLIENT RECEIVED PEDIATRIC PFIZER DOSE AT 12YO. CLIENT SHOULD'VE RECEIVED ADULT DOSE OF 0.3ML.
Febrile seizure seven days post vaccine with high fever unresponsive to ibuprofen/acetaminophen at home
This case was reported by a healthcare professional via a sales representative and described the occurrence of seizure in an adult female subject who was vaccinated with ENGERIX B (GlaxoSmithKline).  Concurrent medical conditions included a history of seizures.  Previous vaccination included 1st dose of ENGERIX B (GlaxoSmithKline) given on an unspecified date.  The subject experienced a seizure following the 1st administration which resolved.  On 17 October 2008, the subject received a 2nd dose of ENGERIX B (unknown).  At an unspecified time after vaccination with ENGERIX B, on 17 October 2008, the subject experienced a grand mal seizure.  This case was assessed as medically serious by GSK.  At the time of reporting the event was resolved.  In the reporter's opinion, the event was considered probably related to treatment with ENGERIX B.  The nurse reported to the sales representative that the subject experienced a seizure after the first dose of ENGERIX B (date not specified), but at the time of event, the seizure was not thought to be related to vaccination with ENGERIX B because of the subject's history of seizures.  Then after the second dose on 17 October 2008, the subject experienced another seizure.  For details regarding the 1st seizure, refer to suffix case A0754680A.
DEVELOPED SPASTICITY FROM THE VACCINE/BODY OVER THE EDGE; COULD NOT STAND TO WALK AFTER 15 MINUTE OBSERVATION PERIOD POST VACCINATION; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: spasticity in legs, multiple sclerosis relapse (Progressed to secondary progressive multiple sclerosis), pleural effusions, bedridden, pain, legs tired, tired, sees dots and bright stars, skin wrinkly, pericardial effusion, iron deficiency anemia, and wheely walker user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included melatonin, modafinil, tizanidine, and vaccinium macrocarpon. On APR-2021, the patient experienced developed spasticity from the vaccine/body over the edge, and could not stand to walk after 15 minute observation period post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from could not stand to walk after 15 minute observation period post vaccination, developed spasticity from the vaccine/body over the edge. This report was non-serious. This report was associated with a product quality complaint: 90000262551.
frequent crying, three green bowel movements that left rash then erythema multiforme appeared 3:00 PM and spread all over body
Hermetic stomatitis outbreak 3 days after 2nd shot (almost as severe as PHG upon initial contraction of HSV-1 in 2002) - sores in gums, hard palate. No external outbreak on lips.
fever, chills, sweats, nausea, diarhea, headache, muscle and bone soreness, fatigue
Pain in my brain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Pain in my brain) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Unknown. On an unknown date, the patient experienced HEADACHE (Pain in my brain). At the time of the report, HEADACHE (Pain in my brain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided.  No treatment information provided.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.
Symptoms:  swelling, pain and erythema of right lower extremity.  Started on or about 9/11/2021.  Urgent Care visited on 9/15/2021 at local HCF.  Diagnosed as superficial thrombophlebitis.  Treatments recommended:  Elevate leg above level of heart, warm compresses, NSAID as needed (eg, ibuprofen), anti-embolism stocking.  Leg slowly improved, but not yet back to normal.
INCREASING NODULE AT INJECTION SITE, FLU-LIKE SYMPTOMS, MALAISE AND JOINT PAIN
This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received INFANRIX (batch number 5A425, expiry date 27th February 2017). On an unknown date, the patient received INFANRIX. On an unknown date, an unknown time after receiving INFANRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: No adverse event reported.
Immunizations or injections Administered that day:  HEPATITIS B VACCINE  HPV, nonavalent  Meningococcal Cong Vac ACYW-135 (MCV4) Unspecified Formula  TDAP (Adacel) 10-64 YRS  Adverse Events were:  Sensory disturbance  Taste sense altered Transient alteration of awareness She starting getting ?migraines?, stiffness of the neck, numbness in the jaw/face with ?metallic taste? in her mouth as she described, along with numbness in her hands, affecting mostly the tips of her fingers. Her feet would go numb too and she had a tiny mass on the bottom of her left foot too. Additionally, she suffered from syncope episodes (fainting) post vaccines. One in which she passed out and hit her head while taking a shower. We took her to her Pediatrician (so it?s on record this happened after her vaccine) whom never told us these were side effects of the Gardasil. They referred her to a Peds Neurologist, and we obtained no concrete answers as to why this was happening. Diagnosis was inconclusive and the Peds Neuron said, these could be early signs of Epilepsy, and the metallic taste could be associated with seizures (so small we couldn?t tell)! Damage continues as she now suffers from chronic migraines, upper back, lower neck pain, transient sensory issues, visions problems, balance difficulties with dizzy spells, and numbness of her hands along with extreme fatigue, and has missed school a lot when her hands go so numb she can't even use her lap top or her pencil.  She has gone to the emergency room, to specialist and she never had any of these issue before.
Myalgia, chills, low grade fever occurring 12 hours after first injection and lasting for 10 hours after onset. Sx treated with Tylenol PRN
Please note - pt received Pneumovax 23 same visit - LOT T028093 IM Right Deltoid - could the combo of vaccines caused the following?   Middle of night 11/16-11/17 - woke with chills and diaphoresis - did not measure temp Woke this morning 11/17 - when putting on shoes, she became lightheaded and diaphoretic - woke up on the floor (syncope) not knowing how she got there - was helped to bed - had dizziness for 3 hours - then all symptoms resolved.
Fever with tonic clonic seizures lasting 30 seconds and occurring at 3 AM on November 14, 2007.  Paramedics were called to the house, child recovered, advised follow up.
Started off with nervousness in hands.  Progressed to numbness down the sides of both arms to little finger and finger next to little finger and arm pits.  Pain in arms and very difficult to sleep. In addition, had difficulty keeping my balance while walking or standing.  Wobbled when walking and was unable to run or stand on one leg.
Immediately upon injection earache and numbness in face and eyelids.. tingling. After approximately 5 minutes throat tightening sensation and a pain in my neck. Rapid heartbeat for approx 5 minutes and a feeling of flushes.  Sat for 30 minutes. Left and approx 45 minutes after shot I took a Benadryl which helped the throat.  Numbness in face persisted,  usually associated with migranes but was more pronounced. Resolved after 3 days.
Soreness at injection point radiating to elbow,.  Fatique, dry cough, dry mouth, hot and cold chills, metal taste in mouth.
She checked the box for Moderna on consent form but received Pfizer, she works for DPP.
Pt recvd 3 doses of Engerix-B & 16SEP91 it was determined that pt did not respond to the vax series;
7/29/11 Reports lump on site with pain & redness & "feeling itchy all over", she took BENADRYL. Advised to seek medical evaluation.
pt recv vax 11FEB99 & saw GYN d/t rash & erythema @ site a few days later;2 courses of Keflex;saw MD 12MAR99 w/abscess @ site-drained-sterile;
9 hours post vax, the pt broke out in hives and started running a fever of 39.5.
Patient felt throat tingling/tightness and metallic taste in mouth about 15 minutes after administration. 25mg of liquid Benadryl was given with a repeat dose 10 minutes later. Vitals were taken and all normal. Symptoms resolved and patient left 15 minutes after second dose of Benadryl administered. First dose patient reported feeling a tightness in throat that self resolved without any treatment. This was considered not to be anaphylactic. Patient also reported suffering from seasonal allergies and commented this could be related.
Shortly after vax, pt began to have swelling, induration and tenderness at shoulder/deltoid. Later, skin began to itch. Pt scratched & it began to bleed. Pt reported 11/23, slight swelling. Erythema w/induration at inject site.
Within 15 minutes of receiving the vaccine, I became tachycardic to the 150's (documented with Fitness Watch), with facial flushing and lightheadedness.  No shortness of breath or difficulty swallowing. Pulse corroborated by vaccine nurse.  walked over to Emergency Dept where at triage, my heart rate was 120s and I was hypertensive to 150's/100's. Labs sent- CBC/diff, metabolic panel, and troponin (all WNL) EKG X 2 (first with tachycardia to 120's, otherwise WNL, 2nd with HR 80's, otherwise WNL. 1 Liter of LR given IV and I was observed for about 2 hours before being discharged home. .
Pt recvd Engerix-B & exp hot flashes & became flushed @ the time of the inject; No tx given; Events resolved; Reporter indicated that this has happened several time a/to  pts;
Approximately 10 minutes after receving #1 Gardisil and 15 mintues after receiving #2 Hep , client suddenly lost consciousness while seated in the waitng area of the clinic. This lasted for about 1 minute. She slowly returned to consciousness, but was very diaphoretic and pale. Ammonia capsule used and client's color improved and diphoresis subsided. Within 20-30 minutes of initially losing consciousness she was able to walk out of clinic with family, fully alert and with no complaints. Principal complaint when able to speak about incident was that she felt very nauseated, had sudden abdominal cramping and then everything went black.
Narrative:  From patient's primary care telephone note dated 1/17: Wife states that he had a reaction to the flu shot he received. She states that he had a similar reaction in the past. He has had swelling and throat discomfort. She was encouraged to take the patient to the ER or urgent care for evaluation die to possible airway compromise is he's having an allergic reaction to the shot. She stated that he's doing a little better today. She might take him later, but she had to finish some things at home first. She was encouraged to go ahead without delay.
Severe arthritis symptoms 10/1/21 Swelling in fingers on both hands. Swelling in both knees November began to lose grip and drop things. Legs would give out. Beginning of December developed pins and needles feeling in left arm. 12/25/21 Extreme throbbing pain left arm. Felt as if circulation was cut off 12/26/21 Loss in sensation in left arm
101.1 fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (101.1 fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (101.1 fever). At the time of the report, PYREXIA (101.1 fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.1 (High) 101.1 fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medication has been reported.
Strong headache next morning (fixed w/ 2 325 mg. Tylenol and water - 2 hours); muscle pain at injection site (4 days)
Severe headache (curled up in dark room type) about 1-3 hours after injection. HA lasted 3-4 hours and slowly resolved. TX with ibuprofen-800 mg and TYELNOL 30 min later. Called Pharmacy where sot administered-no help-called GP and told to take MOTRIN/TYLENOL-Dr MD
High BP and dizzy, itching at the site right after the shot,  redness at the sit and warm to touch, nausea and light headedness,
lt arm swollen-extremly painful; c/o dizziness, nausea, hot flashes, fatigue; has taken Advil;