chrisvoncsefalvay/vaers-outcomes huggingface dataset:
itchy; dime sized hives/lesions that are painful; dime sized hives/lesions; dime sized hives/lesions; Mild pain on my right chest, right shoulder, right neck; Mild pain on my right chest, right shoulder, right neck; Mild pain on my right chest, right shoulder, right neck; This non-serious case was reported by a consumer and described the occurrence of hives in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included diabetes, hyper ldl cholesterolemia, hypothyroidism, multiple allergies, neuropathy, vaginal edema and hypertension. Concomitant products included metformin hydrochloride + sitagliptin (Janumet), rosuvastatin calcium (Crestor), levothyroxine, cetirizine hydrochloride (Zyrtec) and pregabalin (Lyrica).   On 23-MAY-2023, the patient received Shingrix (left arm). In MAY-2023, less than a week after receiving Shingrix, the patient experienced chest pain (Verbatim: Mild pain on my right chest, right shoulder, right neck), shoulder pain (Verbatim: Mild pain on my right chest, right shoulder, right neck) and neck pain (Verbatim: Mild pain on my right chest, right shoulder, right neck). On 30-MAY-2023, the patient experienced hives (Verbatim: dime sized hives/lesions) and skin lesion (Verbatim: dime sized hives/lesions). On an unknown date, the patient experienced pruritus (Verbatim: itchy) and pain (Verbatim: dime sized hives/lesions that are painful). The outcome of the hives was not resolved and the outcome of the skin lesion, chest pain, shoulder pain, neck pain, pruritus and pain were not reported.   It was unknown if the reporter considered the hives, skin lesion, chest pain, shoulder pain, neck pain, pruritus and pain to be related to Shingrix.     It was unknown if the company considered the hives, skin lesion, chest pain, shoulder pain, neck pain, pruritus and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-JUN-2023 The patient self-reported this case. Concomitant product included Elavil for vaginal edema and Nevibial for hypertension. Mild pain on patient right chest, right shoulder, right neck started even before the hives appeared. Approximately 3 days later, a dime sized hives/lesions that were painful and itchy.  The patient had not used any treatment and asked for suggestions. The reporter consented to follow up.
1/12/12 - 9:30 am - awoke with "film coating" in mouth. 1/13/12 - 12:00 am - complaint of (L) side of mouth drooping unable to pucker lips together. 1/13/12 - 9:00 am - (L) eye with blurred vision & drooping eyelid - wont closed all together.
extremely tired-much difficulty in arousing for feeding x 24hrs & cranky but not irritable 24-48hrs; mom reported @ PE today 26SEP95
No adverse event, patient previously received their first dose Moderna on 4/25/21. This is their second dose.
Mother states child c/o HA, feeling tired and dizziness in a.m. on 10-26-09. Received H1N1 vaccine @ approx 6:30 pm on 10-25-09. States child resolved sx by 10-27-09 0700. Did not seek medical attn or notify pediatrician. States called per nurse instruction to report sx of dizziness. States hx: migraine HA - sees neurologist.
20 minutes later after the vaccination I had a very sore arm (left) that lasted 72 hours, I had a migraine and that lasted 3 days. I still get migraines every now and then where I have to shut myself in a dark room.
Tingling and swelling of tongue and inner-upper lip. Called on-call physician and was instructed to go to ER. Some heart burn. Went to ER in evening for treatment (steroid and Benadryl) for symptoms and monitored for 4 hrs.
Woke up the next day with severe headache, chills  and a temperature of 101.2 (8:30 am) 12:30 pm Temperature was at 101.3
Acute appendicitis with perforation and localized peritonitis, without abscess or gangrene  Indication for Admission: Patient is a 41 year old healthy male who presents with abdominal pain. Pain first started 2 weeks ago in the RLQ. Pain worse with laying on abdomen at night. No alleviating factors. Denies nausea, vomiting anorexia, and  fevers. No similar episodes previously. Having regular BMs. Patient denies vomiting, obstipation, constipation, urinary symptoms. Patient stated that he would prefer not to have surgery at this time and instead have antibiotics for a possible elective appendectomy at a later date.  In the ED, patient HDS w/ HR 97, BP 118/71, T 36.9C. Labs significant for WBC 14.9, Hgb 12.3, Cr 1.2. CT demonstrated 1.9cm appendix with perforated tip and fat stranding consistent with phlegmon but no abscess. No appendicolith.. See Epic Charting (Consult/H&P note by Surgery resident for further details).  Hospital Course:  Admitted to surgery for perforated appendicitis, remained NPO/IVF, treated with zosyn. Patient's symptoms gradually improved, diet was advanced, leukocytosis decreased. Antibiotic was transitioned to Augmentin x 10 days. By the time of discharge, the patient was tolerating a regular diet, pain was controlled with po medications, and activity was at baseline. The patient was deemed stable for discharge. Patient meets discharge criteria per approved protocol.
pt recv vax 15OCT96 & 1hr later devel fever 102, rigors @ noc became dysarthric, could not remember names, can't put sentences together & speech still impaired today 17OCT96;
Case number PHHY2016US092226 is an initial literature report received on 09 Jun 2016. The author discussed about a Guillain Barre Syndrome (GBS) case following influenza vaccination in an elderly patient with antecedent Salmonella infection. This report refers to a 77 year old female patient. Her medical history was not reported. Her current conditions included Salmonella infection, chronic kidney disease stage III and hypothyroidism. Her concomitant medications were not reported. She was vaccinated with influenza vaccine (manufacturer and batch number: not reported) four weeks ago. She was presented with falls from general weakness in the setting of a diarrheal illness. She endorsed non-bloody watery diarrhea twice a day for the past 9 days without vomiting, pain or fever. She developed lower extremities (LE) weakness and numbness 1 day prior to presentation and upper extremities (UE) weakness and difficulty with silverware on the day of presentation. Examination revealed normal vital signs, non tender abdomen, decreased extremity sensation, decreased strength (plantar flexion R 3/5, L 2/5; dorsiflexion R 1/5, L 0/5, straight leg raise both 2-3/5, hand grip both 2-3/5, triceps both 2/5 and biceps both 3/5) and areflexia. Laboratory results showed leukocytes 6.4000/muL , hemoglobin 10.3 g/dL, platelets: 475,000/muL, creatinine: 1.23 mg/dL and normal thyroid stimulating hormone (TSH), B12 and Lyme reflex. Stool cultures grew Salmonella group D. Spine magnetic resonance imaging showed degenerative changes without compression. Lumbar puncture was performed given suspicion for Guillain-Barre Syndrome (GBS) and the cerebral spinal fluid (CSF) analysis revealed normal results with protein 36 mg/dL and nucleated cells 1/muL. Antibiotics were held as diarrhea resolved shortly after admission. Five days of empiric intravenous immunoglobulin (IVIG) treatment led to improvement in neurologic exam (3/5 in LE, 4/5 in UE). CSF eventually returned positive for oligoclonal bands consistent with GBS. Nerve conduction studies (NCS) were scheduled as an outpatient. The outcome of GBS, areflexia, general weakness, fall, numbness and hemoglobin decreased was not reported. The seriousness of hemoglobin decreased was not reported. The causality of events to influenza vaccine was not reported. The author concluded the article stating that the trigger for this patient's GBS was likely her antecedent Salmonella infection.
At the time of the vaccination, I experienced a sore arm for about 48 hours, and muscle aches and chills for about 12 hours.   7 days after receiving the vaccination, I noticed a rash at the injection site. It was somewhat itchy for 2 days, and continue to grew in size for 4 days. The rash was improved by taking over the counter allergy medicine (Allegra 24 hour). It was slightly raised and swollen the first 2 days, but decreased over the following days although the rash itself got larger.  I did not seek medical attention because I did not have any other symptoms or side effects with the rash, and was able to self-treat with allergy meds.
9 employees completed a series of vax w/Engerix-B; all 9 pts recvd same lot for each dose; serological testing showed that 4 employees did not reach seroprotection but had converted;
One hour after receiving H1N1 nasal spray, pt c/o blurry vision to R eye which resolved over 24 hours later.
Periodic ringing in my ears starting approximately 30 to 45 minutes after receiving the first dose and continuing to this day.
A report was received from a consumer on 11/21/2003 concerning a 39 year old male vaccinee who experienced seizures 2 days after receiving Fluvirin on 10/14/2003.  The vaccinee had not been vaccinated for influenza previously and has no known allergies.  Concomitant medications taken included levothyroxine sodium.  On 10/16/2003 the vaccinee experienced a seizure.  A complete work-up was conducted including blood work, magnetic resonance imaging, and electrocardiogram, the results of which were unremarkable.  On 11/16/2003 the vaccinee experienced another seizure.  Following the seizure the vaccinee presented to an ER.  Blood work and an electrocardiogram was obtained, the results of which were unremarkable.  Follow up pending.
Day 2  mild arm soreness. Day 8 extreme fatigue, redness and  hardened  lump in injection site. Under arm soreness. Some nausea, no fever.
This spontaneous report was received from a medical assistant refers to a patient of unknown age gender. Medical history, concurrent conditions and concomitant medications were not reported. On 13-JUN-2016, the patient was vaccinated with expired dose of PNEUMOVAX23, lot # K024976, expiry date 09-JUN-2106. No adverse effect reported. The outcome of the events was unknown. No product quality complaint (PQC) was involved. No further information was provided. Additional information has been requested.
New acute leg numbness developed on 11/4 (7 days after receiving 1st dose of Shingrix vaccine) gradually worsening and leading to leg weakness requiring hospitalization, diagnosed with transverse myelitis via MRI and lumbar puncture, treated with IV steroids with gradual improvement of symptoms. Now discharged from hospital, but still requiring additional treatments with IV steroids for ongoing symptoms (leg numbness and weakness limiting mobility).
The day of 11/03/21 - fever, chills, sweating and all joints inflamed. This was for two days only. Painful muscular sensations that feels like I?ve been assaulted but no bruising - this was unpleasant but expected. This has been constant since the vaccination. As of 03/21/21 - extremely painful joints, affecting primarily my hands, feet, knees and lower back. The pain can only be described as if I?d been beaten up. Extremely painful to mobilise and simple functional movements such as holding a cup of tea or washing is causing a lot of pain..
This spontaneous report as received from a registered nurse refers to an unknown age female patient with unspecified medical history or concurrent conditions. On 11-JUL-2008, the patient was vaccinated with the first dose of (Oka/Merck) VARIVAX (dose, route and lot # were not reported). On 28-JUL-2011, the patient was possibly vaccinated with the second dose of (Oka/Merck) VARIVAX (dose, route and lot # were not reported) and on 15-MAY-2015, the patient was vaccinated with a third dose of (Oka/Merck) VARIVAX (dose, route and lot # were not reported). Concomitant therapy was not reported. No adverse effect reported. This is one of two reports from the same source. Additional information has been requested.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On and unknown date the patients were vaccinated with M-M-R II dose, indication, route of administration and lot# were not reported. On unknown date in 2014, the unspecified number of patients received M-M-R II which was inadvertently mixed with expired, sterile diluent (expiration was on 12-MAY-2014). No adverse effects were reported. Additional information has been requested.
itchiness all over; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "itchiness all over". Additional information: itchiness all over which started last night at 5:30 (not confirm if it was 5:30 PM or 5:30 AM) No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Narrative: COVID infections following completion of COVID vaccine series 01/18/21 COVID vaccine dose #1 02/09/21 COVID vaccine dose #2 07/27/21 Pt resents to screening reporting cough, fever headache, muscle pain that started 07/26; COVID POSITIVE 07/30/21 Pt reports loss of smell, minor dry cough, fatigue, runny nose, shortness of breath, sore throat 08/02/21 Pt reports mild chest congestion 08/05/21 Pt reports fatigue but is improving clinically resolved
Patient was feeling light headed and sweating.  Called the paramedics to check on patient. Patient blood pressure was taken by the paramedics
Patient is a 94 y.o. female with past medical history of dementia, depression, hyperlipidemia who presented from Alzheimer's facility  on 2/11/2023 with acute hypoxic respiratory failure secondary to COVID. Given her worsening Alzheimer's, family elected for comfort care and hospice. Now end of life care. Plan to return to facility with hospice.   Acute hypoxic respiratory failure COVID-19 positive swab 2/11/23 - Presented with significant hypoxia with O2 sats of 65% on arrival.  COVID-19 positive on arrival here, but supposedly was positive in December 2022 at memory care unit - completed remdesivir and steroids  - Required BiPAP and heated high flow O2, and now on nasal cannula 2 L - CCM followed, now comfort care.  Hypernatremia - as high as 147, and Suspect secondary to poor oral intake - Sodium normalized as of 2/14    Dysphagia, oropharynegeal - speech recommending pureed with thin for comfort feeds    Alzheimer's dementia Acute metabolic encephalopathy - Nonverbal at baseline.  Previously on Namenda and rivastigmine - plan to return to memory unit with hospice  - cont comfort measures
Onset at 11 hours after injection. Mild fever (less than 110º F), body aches and pains with fatigue.  Lasted between 36 and 42 hours.
BODY ACHE; SEVERE HEADACHE; NAUSEA; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow up to request batch/lot numbers. No concomitant medications were reported. On 05-APR-2021, the subject experienced body ache. On 05-APR-2021, the subject experienced severe headache. On 05-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from severe headache, body ache, and nausea. This report was non-serious.
Difficulty swallowing since vaccine given, since first dose and went away and after second dose started and never went away. Almost choking feeling and persistent dysphagia.
This spontaneous report as received from a pharmacist via company representative refers to a 60 year old female patient. Information regarding medical history and drug reactions or allergies was not reported. On 03-SEP-2014 the patient was vaccinated with ZOSTAVAX (1 injection, subcutaneous, lot# reported as: K003604, expiration date reported as: March 2015, dose, route of administration, anatomical location not reported). Concomitant medications were not reported. On 05-SEP-2014, the patient experienced "red streak down her arm" after being administered ZOSTAVAX and returning home. The company representative was not told how far down the streak appeared. No additional side effects such as pain or rash were associated with the "red streak". The outcome of the event was unknown. The patient sought medical attention by calling the pharmacist. The relatedness between the therapy with ZOSTAVAX and the event was not reported. Additional information has been requested.
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) injection for an unknown indication.     The patient's past medical history included No adverse event.    On an unknown date, the patient started mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.            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.   Reporter did not allow further contact; 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.
Pt received Dtap on 2/27/07. Lt dorsum of thigh, indurated erythematous local reaction.
Myalgia, Fever, Chills & chest tightness Narrative: reports she was seen by PCP.
Received vaccines 8/31/09. Fever 101 9/3/09. Fussy, cranky, poor eye contact. 9/4/09 listless, T 103+, lethargic, bad rash (mac. pap. L leg & trunk) taken to ER - IVF bolus 9/4/09. Poor eye contact, weak cry, dehydrated. Slowly improving, still not back to himself.
This will make four times I have wrote this statement so it will be kind of short. I am a paraplegic who had a flu vaccine and my right hand and from that day on I have not been able to transfer in or out of my chair without someone there. The pain is horrendous. I was on pain medication prior to that but it had to be increased and still does not take care of the pain in my right arm. I am limited to what I can do with my left arm because my shoulder is totally gone. I cannot lift the arm very. high . I use it for the control on  my wheelchair. There is so much more I need to say but I am not gonna write this and lose it again.
03/06/2021 - 1st Moderna vaccination caused drowsiness for 2 days, then a gastrointestinal  diverticular flare up 2 days later ... symptoms included stomach pain, bloating, acid buildup possibly caused by ingredient in the vaccine, Polyethylene glycol which I have had adverse reaction to in the past. 04/09/2021 - 2nd Moderna vaccination caused drowsiness for 3 days, then tireness and vision problems, which include sensitivity light, floaters, and blurred vision.
First dose: Had a very slightly sore arm a few hours after injection through the following morning. Then had a very slight headache for a couple hours. Then the day after that my neck was very sore on the side the vaccine was given. I watched TV on my laptop and had my elbows on my thighs for maybe 30 minutes and I often watch TV like this. When I went to the bathroom, I saw my thighs had multiple bruises where my elbows were (3 spots) while I was watching TV. The bruises and sore neck lasted another 2 days and I was fatigued more quickly during this time. After that I was fine, though 1 bruise spot still remains today 11 days after vaccination. The easy bruising and lasting bruising is not normal for me. I have dark color skin and also rarely bruise.
Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient has history of fainting upon seeing needles/injection. Patient became light headed and fell on the floor, bruising her buttocks. Patient was felt better after raising feet while lying down, drinking water and eating candy bars. Patient was able to leave on her own power after 30 to 40 minutes. Patient's spouse was with her.
Local reaction to immunization, redness at injection site, right thigh with 8x10cm erythema, faded on periphery, slightly warm, indurated, left 5x6 cm erythema.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 24-MAY-2013, the patient was who was schedule to receive VARIVAX (Merck), was inadvertently vaccinated with a dose of ZOSTAVAX (lot number, expiry date and dose were not reported), subcutaneously. No adverse effects reported. Additional information has been requested.
Approximately 7:30 pm started noticing a large red, swollen, warm bump at injection site. Painful to touch and move arm. Persisted over the next 3 days. Still painful to touch and large bruise noted at injection site a week later.
Headache, Myalgia, Arthralgia & Fever   Narrative:  Missed work following vaccine administration second dose due to headache, fever, myalgia, arthalgia.
On 10/22 I started feeling a sore throat. I saw my physician and was dx with Tonsillitis.
On 5/9 I noticed I had two small red bumps on my left side. They did not itch, there was no pain or discomfort. I assumed it was a bug bite from yard work earlier in the day. The next day I noticed there was one more larger spot close to the first two. I put clobetasol on that as well. By Tuesday evening I noticed that I had a couple more little spots. The following day I had another large spot. I noticed they had little pustules under, they were kind of raised. There was still little to no itching. On Thursday there was more itching and the spots continued in a linear fashion. I thought it was shingles but there was not discomfort. I went to see my primary care and she thought it was shingles as well. It now uncomfortable with pressure but minimal to no itching. She prescribed me a antiviral, valacyclovir.
Breakthrough bleeding 30 years after having last period; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, in May2021 at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced breakthrough bleeding 30 years after having last period on 18Aug2021. The patient reported that 3 months after receiving the first dose and 30 years after her last period, she had breakthrough bleeding and had to go to the gynecologist. The clinical outcome of breakthrough bleeding 30 years after having last period was recovering.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Erythematous raised rash on abdomen developed 1-2 days after admin of vaccine.