chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Friday day of shot shot was given in afternoon extreme nervousness 08-11-2007, 08-12-2007, 08-13-07, 08-14-2007} woke up with anal + vaginal rash - swollen doctor gynecology appointment Rx Estrogen: 08-17-2007 doctor - shins + arms tingling - Rx Val: 08-30-2007 doctor - swollen right leg - stop Estrogen; 09-08-2007 both legs swollen - knees to ankles - gums swollen in my mouth; 09-08-2007 tongue swollen; 09-12-2007 doctor - Rx BLM suspension first mouthwash; 09-15-2007 left big toe swollen; 09-18-2007 doctor - throat and tongue swollen - Rx Nystatin; 09-19-2007 doctor; 09-24-2007, 10-03-2007; doctor - oral surgeon 10-05-07 doctor ENT.  10/30/07 Received pcp medical records which reveal patient not seen by MD on day of vax.  RTC 8/17 with c/o nervous, genital soreness & swelling, incontinence, rectal irritation, tingling of arms & legs x 1 day.  Injection site w/swelling & warmth.  RTC 8/30 with c/o leg edema & aching but no edema evident on exam.  RTC 9/12, 9/18, 9/19 w/tongue swelling x 4 days w/blisters, pain & difficulty swallowing.  Exam revealed swollen tongue w/white patches. Tx w/nystatin.  10/3/07 continues to c/o sore throat but exam is WNL.  Referred to ENT & otolaryngeal surgeon. FINAL DX: atrophic vaginitis; UTI; glossodynia; anxiety reaction. 11/16/07 Received oral surgeon medical records which reveal patient experienced swollen & painful tongue x 2 wks when seen on 9/24/07.  Exam WNL.  Returned 10/3 w/increased s/s.  Exam still WNL. 11/27/07 Reviewed otolaryngology & neurotology clinic notes of 10/5/07 reveal dx of pharyngitis; sensorineural hearing loss & tinnitus.  Return to clinic of 10/18/07 & added dx of atypical glossodynia. Per 60 day follow up: I have extreme nervousness, a constant swollen tongue & (achy gums sometimes) and trouble staying asleep. I have't had any help or results with my doctor so I just suffer and I am really depressed. Can you help me? I need to see a doctor. Do you have any suggestions? 1/12/2010 Center of tongue on top still burning and swollen. Nervous and anxiety. Trouble going to sleep and staying asleep. Follow-up Information 21-NOV-2007: I have been to an oral surgeon  2 time - 10-3-07, 9-24-07, a Ear Nose and Throat (ENT) 2 time - 10-5-07, 10-18-07, an ophthalmologist for red eyes - 11-02-07 almost every weeks since to. Dr - 10-03-07, 10-22-07, 11-07-07, 11-13-07. I've had all kinds of blood test but 5 no end to a solution. My tongue, left big toe are swollen and sore. Plus my back had a pinched nerve for the last week. I have an allergy test set for 11-28-07 I have even quit drinking a acup of tea in the morning to calm my nerves a little. I haven't felt good since 2 hrs after I received the Zostavax injection for shingles. Do you know of anything to help me. I feel just awful
Patient was fussy, Dad was feeding him a bottle and his eyes were wide and rolled back in his head.  He had stiffening of his arms and legs and this lasted about 30-60 seconds.  EMS arrived and administered Versed.  He had right sided weakness after the episode.  Patient was then taken to the ER for further workup.  At the ER he had a CT scan, labs and a MRI.  Patient returned to normal functioning a couple hours later and was discharged home with the family.
Seizure:  Pt came home from school (early release around 1 pm), wanted to take a nap, body was very hot, M gave kids ibuprofen and pt laid down. Within 5 min M heard gasping noise. Found pt with saliva in mouth and puddle next to face. Limp, shaking (all arms and legs). Pale, whole body was white. Had enuresis. M felt that pt was gasping/trying to breathe. Called 911. Whole episode lasted 15-20 sec. After episode pt seemed "out of it" and not as responsive as usual, by time EMS put in IV she was fighting. Very sleepy upon arrival to hospital, took nap. Woke up and was pretty much back to normal self in ER.
Patient has had 7 events of tachyarrhythmia lasting between 1 and 6 minutes.
pt recv vax 29OCT97 approx 215PM;30OCT97 rubbed arm & noted it was red & swollen saw MD 31OCT97;MD office checked temp-no fever, no drainage from site;dx as local rxn;instructed to use ice packs 20min out of every 3hr;take APAP;
patient that was under the age of 65 being administered FLUZONE HIGH DOSE QIV instead of the FLUZONE QIV at a flu clinic with no reported adverse event; patient that was under the age of 65 being administered FLUZONE HIGH DOSE QIV instead of the FLUZONE QIV at a flu clinic with no reported adverse event; Initial information received on 26-Oct-2022 regarding an unsolicited valid non-serious case from a consumer/non-hcp.  This case is linked to cases 2022SA447057(CLUSTER), 2022SA446385(CLUSTER), 2022SA446068(CLUSTER), 2022SA447385(CLUSTER), 2022SA447853(CLUSTER), 2022SA446195(CLUSTER), 2022SA447822(CLUSTER) and 2022SA448121(CLUSTER).  This case involves a 62 years old female patient who was under the age of 65 being administered INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] instead of the fluzone qiv at a flu clinic with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 04-Oct-2022, the patient received suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE at a dose of 0.7 ml total once(lot UT7729CA, expiry date: 30-Jun-2023) via intramuscular route in the left deltoid for immunisation.  On 04-Oct-2022 the patient under the age of 65 being administered fluzone high dose qiv instead of the fluzone qiv at a flu clinic with no reported adverse event (wrong product administered, product administered to patient of inappropriate age, latency: same day) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: Not applicable.  Outcome: Unknown for both the events.   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.
14 days after second vaccination, pt. had dizziness, blurred vision, memory loss; went to hospital x 3 days.  Tests were run.  Blood clot was never confirmed despite CT scans but was suspected.  Pt. is now on ASA 81mg daily maintenance and suffers no ill effects.  History was given by mom when her younger son had his vaccine.  This patient may have had a VAERS generated by the hospital.
1.5 hours post soreness at sight and left elbow fold; fatigue, left arm weakness, left neck stiff, right face numb, mouth numb more on left side similar to novacaine wearing off from dentist. Numbness and weakness lasted 30 minutes. Soreness over 24 hours. Friday evening generalized aches and chills. Saturday all day aches, chill, low grade  fever. Slept late afternoon due to exhaustion for 4.5 hrs. Sunday morning sweat and slight fever. Sunday evening site slight sore only.
fell sick; Went trough heck  and back, got all the symptoms, body ache, fever, coughing, diarrhea; it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea; it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea; it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea; had a minor sore from the injection and that's was it; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (had a minor sore from the injection and that's was it), ILLNESS (fell sick), PAIN (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), PYREXIA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) and COUGH (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) in a 69-year-old male 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 No adverse event (No reported medical history).    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced INJECTION SITE PAIN (had a minor sore from the injection and that's was it). On 24-Jan-2021, the patient experienced ILLNESS (fell sick), PAIN (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), PYREXIA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), COUGH (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) and DIARRHOEA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea). At the time of the report, INJECTION SITE PAIN (had a minor sore from the injection and that's was it), ILLNESS (fell sick), PAIN (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), PYREXIA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea), COUGH (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) and DIARRHOEA (it Went trough heck and back, got all the symptoms, body ache, fever, coughing, diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Tylenol was used for treatment.
This spontaneous report as received from a certified medical assistant refers to an unknown number of patients of unknown age and unknown gender. No pertinent medical history, drug reactions or allergies were reported. Since 12-AUG-2014, improperly stored PNEUMOVAX 23 was administered to an unknown number of patients (dose, dose number, dose schedule, route, anatomical location, lot number and expiration date were unspecified). No adverse effects were noted. No concomitant therapies were reported. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
As soon as I received my vaccine it made my fingers numb for a little bit, I stood up and felt rush go through me and it made me dizzy for a few minutes, I never felt better, I started getting stomach upset, runny stool, I woke up the next morning and my eye was swollen and red. I tried saline solution, my eye watered constantly. My eye was so swollen it pushed my eye downward. They prescribed antibiotic pills. Went to eye doctor to make sure that my eye was going to be ok. After a week or so my eye had returned to normal. I was advised to not get the vaccine.
0530 - woke up. nausea, dizziness, malaise, generalized significant joint and muscle pain. Unable to stand. 0535 - crawled to Bathroom in case of vomiting, tried to stand and had near LOC (vision completely black, only able to hear), dizziness, nausea, tingling and loss of function of hands/feet acc. by extremities twitching, hyperventilating, cold sweat. 0555 - husband helped me downstairs with plan to go to ER, but I refused and wanted to sit down. violent body shakes, nausea, hyperventilating, chills, dizziness. Ear temp 98.8. Was covered in blankets and drank ~8oz water. 0630 - body shakes stopped. mild waves of nausea/generalized malaise and muscle pain/lightheadedness continued.  0730 - same symptoms,  ear temp 100.1. Removed some blankets 0800 - ear temp 99.8, chills, lightheadedness, mild headache.
Nausea, cramps, diarrhea, exacerbated pre-existing conditions - magnified pain 1st & 2nd week. 3rd & 4th week - intermittent fever, transitory paralysis which escalated to loss of motor control, 2nd week they ran tests on my pain, which insurance would not cover 4 treatment. 3rd & 4th weeks I called 2 & 3 times a week, but was ignored and allowed to speak to the (a) doctor or any nurse or assistant, and was allowed to suffer alone.
The patient has had no problems with the vaccine. We were finishing vials of both Janssen and Pfizer at the same time at the end of the evening. He received a dose of Janssen when he should have received Pfizer since he will not be 18 years old for 4 months.
Patient came to ED and reported that he was diagnosed with COVID a few weeks ago. Patient presented with chest pain, fever, and shortness of breath. He was also having acute kidney injury and diabetic ketoacidosis. Patient tried taking ivermectin at home with orange juice. Started on decadron, pulmicort, then redemsivir and oxygen as he got worse. He was also given tylenol. Suddenly deteriorated with a respiration rate of 40 breaths per minute and dropping blood pressure with a 105F fever.  He was intubated.  Patient was transferred to hospice and passed away.
I've had low grade tinnitus due to hearing loss for years.  However, after my J&J vaccine in 03/2021 it has become extremely loud, bothersome, and much worse.
shaking; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shaking), CHILLS (chills) and PYREXIA (fever) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Hypertension since an unknown date.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021 at 4:00 AM, the patient experienced TREMOR (shaking), CHILLS (chills) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Chills, Fever and Shaking, at an unspecified dose and frequency. At the time of the report, TREMOR (shaking), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication taken by the patient included blood pressure medication. The patient took Tylenol to relieve the symptoms.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Upon internal review on 08-Dec-2022 non-significant corrections performed to update "case received from field" to blank; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Body aches Headache  Joint pain Chills  Fever (99-100.4) Fatigue
Pt presented with 6x9cm reddened area L delt. area warm to touch. Cellulitis.
shingles two weeks after Shingrix first dose; This non-serious case was reported by a physician via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: shingles two weeks after Shingrix first dose). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 27-Jun-2023 Medical information department had received a question which stated that reporter enquired if their was a correlation between a patient presenting with Shingles after receiving 1st dose of Shingrix, presenting with Shingles two weeks after 1st Shingrix dose. The reporter did not consent for follow up.
Patient called stating she was having, pain redness and warm to the touch at the site of her injection, which was Tdap. That she was on Monday May 15, 2017. Provider was notified and patient was given a appointment at 3pm to come in. Patient then stated she couldn't come in due to work and she would just wait until tomorrow since she has an appointment already
History of Present Illness  The patient presents with  50-year-old male with a history of hypertension and diabetes who presents via private vehicle with complaints of atraumatic left calf pain x4 hours.  Symptoms started while typing on computer at work sitting in chair.  Described as mild soreness to his left medial calf rating behind his knee.  No frank tenderness with palpation.  No fall, trauma, injury, or overuse syndrome including gym.  No swelling, edema, or asymmetry.  No associated motor/sensory disturbance able to wiggle and feel all digits with good pulses.  No chest pain, shortness breath, palpitation, lightheadedness, or syncope.  No spasms, cramps, or charley horses. Patient denies any history or DVT/ PE, hypercoaguable disorder, recent immobilization or surgery, recent long trips or travel, or active malignancy (w/ treatment in last 6 months) but does take prescribed clomiphene for androgen replacement/stimulation.  Discomfort scribed as soreness, minimal intensity, 2 out of 10 without provocative or palliative factors.
18MAR99 pt awoke @ 4AM w/aches & chills;5PM that evening pt checked arm because it felt swollen;area from inj site down to elbow red & very hot to touch;arm also very sore;19MAR98 site remains red & warm, does not hurt as much;
Swollen, red, indurated area over right anterior thigh, warm touch touch, placed on antibiotic for cellulitis with allergic reaction to DTaP. Temperature also.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: PT SAYS AT INJECTION AREA IS WARM AT TOUCH AND REDNESS AND LITTLE SWOLLEN
I had Covid diagnosed with Covid/I have the Pfizer vaccines which I have all 3 of them; I had Covid diagnosed with Covid/I have the Pfizer vaccines which I have all 3 of them; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: BREO ELLIPTA taken for asthma. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had Covid diagnosed with Covid/I have the Pfizer vaccines which I have all 3 of them". Clinical course: It was reported that, he had Covid diagnosed with Covid and when he diagnosed he called his doctor, doctor told because as patient have asthma your age and you got Covid recommend to try this new drug of Pfizer. Patient have the Pfizer vaccines which he have all 3 of them, as he said because you have asthma would recommend this drug (Paxlovid) and patient should go off everything he was taking, vitamins or anything longer taking be safe go off all of them.  The lot number for bnt162b2 was not provided and will be requested during follow up.
4 minutes post vaccine patient reported tingly mouth and "tight chest". pt escorted to urgent care given 0.3mg epi
Shortness of breath, chest pain, went to the hospital had 3 blood clots 2 in lungs, one behind right knee.  Was in the hospital for 4 days, was sent home on blood thinners.  Shortly after started getting painful joints and limited mobility, had to get on steroids and gavapentin, have been on steroids for 5 months, if I try to get off I immediately become swollen and immobile.
Left/arm shoulder pain. Evaluated here in the physician office.  Physician started him on Medrol Dose Pak 11/30/21 for inflammatory reaction. .and pain.
unspecified patient received an unspecified dose of GARDASIL 9 "while she was pregnant in her first trimester" on an unknown date; No adverse effects; This spontaneous prospective pregnancy report was received from a nurse via a company representative and refers to a female patient of unknown age. The patient's pertinent medical history, drug reactions, allergies and concomitant therapies were not provided.   On an unknown date, while she was pregnant in her first trimester, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose, frequency, route, site of adminstration, lot# and expiration date were not reported) for prophylaxis. The last menstrual period (LMP) date and estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending. No adverse effect were reported.
after the 1st one that they all felt really bad like they all had flu after they had the vaccine; had flu like issues; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (had flu like issues) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (had flu like issues). At the time of the report, FEELING ABNORMAL (after the 1st one that they all felt really bad like they all had flu after they had the vaccine) and INFLUENZA LIKE ILLNESS (had flu like issues) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. It was reported that after the first one they all felt really bad like they had the flu after they had the vaccine. Patient had flu like issues. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
pt recvd vax & exp severe language & speech delay & developed stradmonis (lazy eyes); no further details were provided;
Pt states shoulder began to ache several days to a week after injection. Injection technique appeared normal and there was no immediate pain.  Dull aching pain became worse over the next several weeks to months. Chronic shoulder pain was not cured by ibuprofen/ice/or heat.
Significant arm soreness immediately after for 2 days. Swollen and painful lymph node 5 days. 1 week after vaccine started to get redness and swelling again in the injection site with increased blotchiness around injection site. Sore throat (Covid test negative) started 1 week after as well.
26y G4P3 @ 29 wk 3d gestation presented to labor and delivery triage for preterm contractions approx 24h after 1st dose of PFizer COVID vaccine. Notably she was treated for bacterial vaginosis a week prior. She additionally complained of strong headache. She was afebrile, with normal exam. OB ultrasound was normal, and there was no cervical dilation. She was given IV hydration, morphine for pain, and discharged home after brief observation without evidence for preterm labor or preeclampsia. Unclear if contractions related to vaccination, suspect headache was likely due to vaccine.
A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Medical history included ongoing disability.  Concomitant medications were not reported. The patient experienced, chills, fever, cold and felt really sick all on an unspecified date with outcome of unknown. No follow-up attempts possible. No further information expected.