chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lacy looking rash/rash in thighs/adbominal rash; This case was reported by a nurse via call center representative and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th April 2019, the patient received Shingrix. On 30th April 2019, 3 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The nurse practitioner stated last night the patient developed a lacy looking rash on her abdomen and inner thighs.  The patient denied of pain, itching, shortness of breath, pustules, and papules.  The patient had not been evaluated in the office as of the time of this call. The lot number was not available.  The dose was not given at the office, it was given in a pharmacy.
Information has been received from a physician concerning a 4 year old female who on 6/12/00 was vaccinated with a dose of varicella virus vaccine live (lot # 634512/0436K). On approximately 4/5/04 the patient experienced mild fever and cough. On 4/12/04 the patient experienced moderate vesicular rash. The patient was treated with OTC topical products and acetaminophen. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
Pt admitted to Hospital with lower extremity weakness & subsequently diagnosed with Guillain Barre Syndrome. Infectious Diseases & Neurology consult teams could not find causative medication or infection other than influenza vaccine administered 2 to 3 weeks prior to admission. Information from discharge summary states apnea, convulsions, pneumonia, neuropathy.
Body itches starting 2/3, rash on stomach. Pt is taking Benadryl around the clock which helps calm it down some.  Pt was advised to call doctor for further evaluation.
With in hours of the vaccine experienced nerve pain; exacerbate an old nerve condition/ continued to get worse with the second dose; experienced serious insomnia; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 09Mar2021 at 04:00 (at the age of 65-year-old) and a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN28730) via an unspecified route of administration in the left arm on 28Mar2021 (at the age of 65-year-old) as a single dose for COVID-19 immunisation. Medical history included steroid sensitivity, tumour excision and nerve pain (it appeared to exacerbate an old nerve condition that occurred after having a large tumour removed from a nerve in back). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. On 10Mar2021 at 17:00, within hours of the vaccine, patient experienced nerve pain. It appeared to exacerbate an old nerve condition that occurred after having a large tumour removed from a nerve in her back. With the second dose on an unknown date in Mar2021, the patient experienced it continued to get worse. Three weeks later, still had pain and also experienced serious insomnia. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the events and included treatment with temporary pain medications (meds). The clinical outcome of the events with in hours of the vaccine experienced nerve pain, exacerbate an old nerve condition/ continued to get worse with the second dose and experienced serious insomnia were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Initial information received on 18 February 2010 from a health care professional.  A 43 year old patient developed numbness and tingling in her arms, legs, and occasionally her face one hour after she received PANDEMIC INFLUENZA VACCINE (manufacturer unknown) on 27 January 2010.  The numbness and tingling comes and goes.  The patient required a doctor's visit; date not provided.  The patient had not recovered by the time of the report.  List of Documents held by Sender: none.
Patient experienced heart palpitations. Pulse was 135 SpO2 99. Calmed patient to pulse 70. BP 132/84. Patient reported to feel better after 10 min. No other intervention needed.
2nd dose of Pfizer 0.2ml vaccine was administered on 11/28/21. Immediately after receiving vaccination patient stood up and collapsed on the ground, falling face forward. The patient was assessed and monitored by the site lead and nursing staff for one and half hours. Patient C/O dizziness and head pain. 911 was called at 1:36, and EMT took the patient and the parent to the nearest hospital for further evaluation.
This spontaneous report was received from a other health professional via field employee refers to a 9 months old male patient. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy was unknown. On Thursday, 08-FEB-2018 the patient was inadvertently vaccinated with VAQTA (dose, units and frequency were unknown) (lot # N023953 and expiration date 05-NOV-2018) for prophylaxis. No adverse effects reported. The outcome of events accidental exposure to product and no adverse effects was unknown. The causal relationship between the events accidental exposure to product, no adverse effects and VAQTA was not provided by the reporter. There was no product quality compliant reported.
10 days after vaccine, patient erupted with small amount of  vesicular lesions at site of injection
A spontaneous report has been received from a pharmacist concerning a 7 years old patient of unknown gender. The patient's medical history and concomitant medications were not provided. Patient had received nasal FLUMIST (intranasal), unknown dose for unknown indication. Pharmacist reported that on 20-Nov-2014 patient had received the entire dose of FLUMIST in one nostril. The outcome of the event of full dose up one nostril was unknown. Reporter considered the event of full dose up one nostril to be non serious.
I received a flu vaccine on Oct 20, 2015, and have been suffering severe pain on my shoulder where the vaccine was administered. I have bursitis, bicep tendonitis, and frozen shoulder, and will have to go through a surgery.
Patient came into clinic 5-13-08.  Thigh was swollen 9inch x 5 inches warm to touch ice pack applied.  BENADRYL and MOTRIN given (right thigh).  Patient will return in morning for follow up.
Information has been received from a Licensed Practical Nurse referring to a 45 year old patient of unknown gender with asthma. The patient had no drug reaction/allergies. On 23-SEP-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K008927 with expired date 17-MAR-2016; dose and route were unknown). No concomitant medication was taken. The reporter stated that the patient started with cough on an unspecified date following administration of the vaccine, then began to experience fatigue, decreased appetite, some wheezing and some nausea on an unspecified date in 2015. On 05-OCT-2015, the patient presented to the office for medical attention. The patient was given an unspecified nebulizer treatment while in the office and was started on unspecified antibiotics. No lab tests were performed. At the time of the report, the outcome of the events was unknown. The reporter indicated that the patient's unspecified physician believed that the reaction was in relation to PNEUMOVAX 23. Ths is one of two reports received from the same reporter (1510USA008310). Additional information has bene requested.
Elevated temperature of 103.7 degrees under the arm, lethargy, unresponsive, loss of appetite, 1/24/2019 3:45- Mom notices baby becomes very fussy around 3:45 pm. Takes temp and it is 100.8 under the arm. Mom administers 1.25mL of infant Motrin Baby is extra sleepy and goes to bed around 6:00pm. Baby is fussy through the night 1/25/2019 12:00am- Mom wakes up to baby crying. Notices baby is extremely hot. Tries to administer 1.25mL of Motrin when baby starts convulsing and throwing up 12:04- Mom takes temperature under the arm and it reads 103.7 degrees 12:12am- Mom calls the on call nurse at the pediatrician office. While on the phone baby convulses two more times. 12:13- calls 911 12:38- Arrive at ER roughly 3:30am- admitted to hospital As of 9:35 am.
cough; soar throat; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and OROPHARYNGEAL PAIN (soar throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (cough) and OROPHARYNGEAL PAIN (soar throat). At the time of the report, COUGH (cough) and OROPHARYNGEAL PAIN (soar throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided Concomitant product use was not provided by the reporter.   Reporter did not allow further contact
On 2/15/21 upon wakening both of his thighs, the front of them had a serious ache to a moderate pain that lasted for about 4-5 days and then dissipated.  Today, 2/24/21 there are no effects from it.  Duration was from 2/15/21 to 2/20/21.  He had no swelling or reaction at the injection site just this reaction that popped up and then left.  He did not take anything for it, and did not seek medical attention.
sore arm where shot was given; nauseous; shortness of breath; tongue tingly; right Eye bothersome; metallic taste; elevated heart rate; headache; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Lot number: EL 3257, Expiration date: unknown) via unspecified route on 30Jan2021 01:30 PM, in the left arm, deltoid at a single dose for COVID-19 immunization. The patient's relevant medical history included asthma and seasonal allergies. Concomitant medications included Nortriptyline, oxcarbazepin, montelukost. It was reported that the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient did not have COVID-19 prior to vaccination or tested since the vaccination. On 30Jan2021 at 02:00 PM the patient experienced very sore arm where shot was given, nauseous, shortness of breath, tongue tingly, right eye bothersome, metallic taste, elevated heart rate and headache. It was unknown if the patient had received any treatment for the events. Outcome of events was not resolved.
Grandmother states when patient woke up had red, raised, warm area on back of right arm that was "nickle sized" and states is where MMRV was given.  Pt. seen by PCP today for tonsillitis and advised to report this to HD.  Patient now with fever.  Site assessed by RN and noted to have red, raised area approx. 1 inch by 1/2 inch on back of right arm.  Also has red raised area approx. 5 mm in deltiod area of left arm.  Has red outline in bandaid shape on right deltoid.  Patient states these areas are sore.
hives; face flushed; allergic to vaccine; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ER8730), via an unspecified route of administration, administered in the left arm on 01Apr2021, at 09:30 (at the age of 51 years old) as first dose, single dose for COVID-19 immunisation. The patient has an allergy to muscles. However, it was also reported that patient had no medical history, family history, and concomitant medications. The patient had no other vaccines four weeks prior vaccination. On 01Apr2021, the patient experienced hives and face flushed that developed within 5 minutes after vaccination. She said it could have been sooner than 5 minutes but that was when she pushed her sleeves up and the hives were there when she did that. The patient also reported that her face flushed and all of it went away in minutes. The patient went to see an allergist and got an allergy test and it showed that she is allergic to the vaccine and they told her she could get the second dose, but they would be there with epinephrine (reported as Epi). It was reported that the allergist put fresh eye drops under her skin and told that she was allergic to the vaccine itself and PEG and polysorbate. The patient further stated that they did not provide her with a preservative name, the physician just said she was allergic to the preservative. The patient said she is not going to do the second one, but she is trying to find out if the company is going to come out something without the preservative because that was what they told her she was allergic to. The patient underwent lab tests and procedures which included allergy test: allergy to BNT162B2, PEG, and polysorbate on an unspecified date. The patient did not receive treatment in response to the events. The patient said that they were busy, so she did not tell anyone and just sat down for her waiting time; the events faded away while she was sitting. The patient recovered from the events on 01Apr2021.  No follow-up attempts are needed. No further information is expected.
Itching, redness, swelling approximately 3 inches wide and 4 inches long distal to injection site.
Redness over all of body.  Broken out in rash in neck, chest, back and in ears  with itching.  Some nausea for a short time.
Information has been received from a pharmacist referring to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions/allergies were not reported. On 09-NOV-2015 the patient was vaccinated with a dose of improperly stored PNEUMOVAX23 lot # L014458 with expiration date 11-FEB-2017, (dose and route were not reported). No adverse effect was reported. Additional information has been requested.
Client reported feeling diaphoretic, nauseous, and lightheaded 2-3 hours after receiving vaccine. She did not seek medical treatment. She reported the event on 12-10-07
The evening of the vaccination, 03/31/2021, mild swelling, redness, and mild pain from the injection site up to my shoulder.  The swelling of the redness you could see on the surface went away.  The pain from the middle of my upper arm, from the injection site (the muscles in that area), from there to my shoulder, the pain never went away.  I have to use my other hand to help move my arm.  It's worse in the morning and better during the day and I don't sleep on that side either.  Dr. looked at it and told me to get physical therapy and if that did not work he was going to offer me some injections.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Dec2021 as dose 2, single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Mast Cell Activation" (unspecified if ongoing); "POTS" (unspecified if ongoing); "Paralyzed right hemi diaphragm" (unspecified if ongoing); "restrictive airway disease" (unspecified if ongoing); "Multiple drug allergies/hyper sensitivities" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: Paxlovid Covid Rebound. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was treated for COVID-19 with anti-viral drug from 28Sep2022 to 03Oct2022. Patient took other medication in 2 weeks.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Individual arrived to post vaccine area moments after COVID 19 Pfizer vaccine dose 1. Individual noted some redness itching and hives to the forehead, neck, and arms bilaterally. Individual denied difficulty breathing, denied tongue lip or throat swelling. Individual had no issues handling saliva, no stridor/objective shortness of breath. Vital signs: 153/90 HR 71, O2 100% taken by post vaccine nurse. Individual given 25mg PO Benadryl at 11:20, monitored by post vaccine nurse until 12:40. At 12:35 symptoms resolved. Escorted by sister, instructed/agreed not to drive.
Information has been received from a Medical assistant concerning a multiple unspecified number of patients (ages and genders not reported) who on unknown dates were vaccinated with improperly stored doses of RECOMBIVAX HB (Batch and Lot No. L025738, exp. 14-AUG-2017; L029631, exp. 14-AUG-2017) (dose, route and site not reported). No adverse effects were reported. This report is linked to MARRS 1601USA001940, 1601USA001942, 1601USA001943, 1601USA001944 and 1601USA000936 from the same reporter. Additional information has been requested.
FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-OCT-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On 12-OCT-2021, the patient experienced fever. Laboratory data included: Body temperature (NR: not provided) Fever 102. The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
A week after covid injection, large red itchy patch on upper arm. Pain going into neck. No treatment; Wondering about 2nd shot, especially since more severe effect. Please contact me, for instruction on what to do.
Prt came in today for the COVID booster. Received at 12:30pm. Before this he was able to stand from w/c for PT and had no complaints other than bilateral knee pain.  Prt became generally weaker, not able to push himself back in the w/c at all c/o bilateral thigh pain and nausea. Given Tylenol 650mg and Zofran 4mg ODT. While seated AP not palpable and barely audible, manual bp not possible and pulse ox not reading and he was lethargic and responsive. Prt transferred to bed, elevated legs, BP 81/palp put on 4lpm 02 and he was more responsive. Prt sent via 911 to Hospital, from the site at 1:45PM.
Patient is a 38 Y female with past medical history of obesity, recent COVID infection with symptom onset 2/5/23, who was started on prednisone 40 mg a day for possible asthma given she had a cough with COVID no documented hypoxemia, who presented to the emergency department with nonexertional and reproducible chest pains as well as polyuria and polydipsia.  Patient currently chest pain-free.  No shortness of breath.  Sore throat is improved as well as rhinorrhea.  No sob. Cough resolved. Patient feels that her mouth has been very dry.  No other signs of infection.  No nausea vomiting   ED course: Blood sugar too high to register, on Chem-7 blood sugar 1140.  Bicarb 22.
After picking patient up from child care around 6:00 pm, His father and I had noticed our son had developed a stutter. He has never stuttered before or had any problems with his speech until after the influenza vaccine.
This case was reported in a literature article and described the occurrence of macrophagic myofasciitis in a 6-month-old female subject who was vaccinated with VARICELLA vaccine (manufacturer unspecified) and HEPATITIS B vaccine. This case corresponds to case 3 in the literature article. On an unspecified date, the subject received an unspecified dose of VARICELLA vaccine (administration site and route unknown, batch number not provided) and an unspecified dose of HEPATITIS B vaccine (administration site and route unknown, batch number not provided). She received all of her vaccinations including the vaccines mentioned above. At an unspecified time after vaccination with HEPATITIS B vaccine and VARICELLA vaccine, at the age of 6 months, the subject was diagnosed with developmental delay and failure to thrive with preserved language development. This case was assessed as medically serious by GSK. An extensive evaluation including a swallow study, endoscopy, esophageal pH monitoring, fecal fat analysis, stool and urine cultures, sodium sweat testing, thyroid function, chromosome karyotype, echocardiogram and hearing test were all normal. At 10-months-old, she required gastrostomy tube placement due to poor weight gain. She presented with motor delay. At 12.5 months-old, physical examination demonstrated hypotonia with height at the 25th percentile, weight, 50th - 75th percentile and head circumference, 5th percentile. Diagnostic testing demonstrated normal serum carnitine, lactate, EMG and brain MRI. Her CK was mildly elevated. She was unable to stand or crawl, but was able to sit unsupported and reach for objects. At 23 months-old, her left vastus lateralis was biopsied. It showed stereotyped demonstration of epi, peri and endomysium macrophagic infiltrates without muscle fiber necrosis. No histopathological evidence of ragged red fibers, fiber type atrophy, grouping or significant impairment of mitochondrial oxidative staining. No other organ system involvement was described. By the age of 5 years, she could carry on a conversation, understand cause and effect and was able to rise from the floor without Gower's maneuver, but was not toilet trained. At the time of reporting, the events were improved. The author considered that macrophagic myofasciitis was possibly related to vaccination with VARICELLA vaccine and HEPATITIS B vaccine. This case corresponds to 1 of the 3 cases reported in the literature article.
Patient had itching and swelling and the area was bright purple red next day and it was warm to touch per patient description but it faded away so when pt was at the pharmacy on 9/20/13 the injection area was slightly red (or pink) and not any visible swelling.
About a week after the shot the diarrhea, gas pains and bloating got worse.  I was having 15 plus bowel movements per day,  It kept oozing out of me and I needed to wear a pad constantly.  I went in for bloodwork,  gave stool samples, had a upper and lower GI.  All tests were negative.  I continue to have loose stools and oozing , gas p Dains and bloating however it is not as bad.
Inflammation in every joint, fatigue/exhaustion, post-exertional fatigue. This has all resolved except for the post-exertional fatigue.
Symptoms of dizziness/lighheadness started 5 min after injection. got severely worse over the next 5 min, culminating in me fainting. lost balance when i fainted. symptoms slowly improved over 30 min after lying down. it's now 7 hours later and minor dizziness/lightheadedness/minor cognitive symptoms persist.