chrisvoncsefalvay/vaers-outcomes huggingface dataset:
High fever, lump in leg for over a month, stopped reaching milestone within a month, now has autism. Undergoing detox, 24hrs/wk of therapy. 7 months old at time of reaction.  12/8/08 Reviewed psychological evaluation of 07/17/2008. FINAL DX: PDD, global developmental delay Records reveal patient experienced delayed & atypical development, social & communication deficits, sterotyped repetitive play.  Recommended for increased early intervention services & additional testing.  1/23/09 Received PCP medical records of 1/7/2009. FINAL DX: delayed developmental milestones, motor hypotonia, cerebral palsy, speech delay, myopathy, ?ASD Records reveal patient recently in ER for dehydration secondary to emesis triggered by chelation therapy.  Hx of night time seizures & unable to walk following AM.  Being f/u w/neuro. Also referred for genetics, rehab & neuro 2nd opinion prior to medication for seizures.
On 8/9/01, approx. 10:30, mother brought child to the district to look at his left arm. Arm was edematous and slightly reddened, warm to touch inferior to injection sites. Pt was referred to MD and mom transported child at that time and to treat as recommended by MD.
Muscle stiffness in arm of injection site, low grade fever, fatigue. Received 2010 Flu Shot with TDAP vaccine, while visiting for UTI. Prescribed Septra DS for UTI.
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. Concomitant medication and current conditions were not reported. On 04-DEC-2014, the patient was vaccinated with an improperly stored dose of PEDVAXHIB (dose, route, lot number and expiration date were not reported). Concomitant medication was not provided. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Stopped breathing  on  11/10/2020 called ambulance Patient was taken to Hospital and tests were ran determining he had tested positive for COVID-19, he was monitored with a sleep apnea machine, Patient set the machine off several times where I as his mother saw his chest stop moving each time as the machine was going off, nurses told me it was not a true apneic episode because he did not stop breathing for over 30 seconds. Was discharged after 24 hours. Patient stopped breathing again on 04/11/2021 ambulance was called and were running low on trucks and said Patient would be fine until I called his PCP in the morning. When I talked to the staff I had to demand further testing which led to a pulmonology and cardiology referral per my demand.
pain on the arm where I got the shot; chills; body aches; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 68-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (did not remember any pain after the 1st dose).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm, chills and general body pain. On an unknown date, the outcome of the pain in arm, chills and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, chills and general body pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and had pain on the arm where got the shot, chills and body aches. The reporter wanted to know how long do the side effects last. The reporter would check with doctor if it does not get better in 24 hours.
No addiitional adverse events were reported; received possibly improperly stored vaccines due to lack of temperature readings; This spontaneous report was received from a healthcare worker, referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 12-APR-2022, the patient was vaccinated with a dose of  varicella virus vaccine live (oka/merck) (VARIVAX)  lot #u010396, expiration date: 01-APR-2023,  administered for prophylaxis (strength, dose, route of administration and anatomical location were not provided).  The reporter informed that the administered vaccine had been possibly improperly stored due to lack of temperature readings (product storage error). The refrigerator and freezer temperatures were not recorded since 10-JAN-2022 and temperature was unknown by the reporter. There was no previous temperature excursion. No additionally adverse events were reported, and no further information was provided.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA000544: US-009507513-2205USA000533: US-009507513-2205USA000524: US-009507513-2205USA000540: US-009507513-2205USA000467:
Gave pediatric does of Hepatitis A to this patient after shot gave was when the expiration was noted to be 6 days old. I checked the expiration date prior to shot it did not register as being 6 days expired before I gave the shot. Child is fine, no reaction from shot at all.
Itching, pain, swelling, and redness at injection site; fevers, myalgia, fatigue, malaise.
Immunization administered on 5/12/06. began running low-grade fever on 5/19/06.  The fever turned into a high-grade (104+) the evening of 4/20/06.  We are currently attempting to control the fever with Tylenol and Ibuprofen.  We will take her to the ER if the fever gets out of control.
I had sharp pain in my left wrist that went into my hand and up my left arm into the shoulder.  After a few day, I contacted my doctor, but it was subsiding by the time I saw him.  In about a week, it flared up again so I made an appointment with a hand specialist.  He believes I have a carpel tunnel issue.  The pain went away on its own after another week or so.  It returned again after my second dose of the vaccine, as well as other side effects that I will report for the second dose.  I also had some pain at the injection site that lasted for only a few days.
It was like she had needles on her; A little blister came up and then they were like ring worms; The first day it burned; The first day it burned, and now it kind of gets real dry; Some of the rash are raised; she broke out in this weird looking rash/it popped, and then it got rounder and straight on her side, a straight line on her side from his breast down, and it looks like coded in ring worms/the rash is everywhere in her body/broke out in this rash; Knot on her arm; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Knot on her arm), PARAESTHESIA (It was like she had needles on her), BLISTER (A little blister came up and then they were like ring worms), BURNING SENSATION (The first day it burned) and DRY SKIN (The first day it burned, and now it kind of gets real dry) in a 53-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.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced SWELLING (Knot on her arm). On 02-Jul-2021, the patient experienced PARAESTHESIA (It was like she had needles on her), BURNING SENSATION (The first day it burned), DRY SKIN (The first day it burned, and now it kind of gets real dry), RASH PAPULAR (Some of the rash are raised) and RASH (she broke out in this weird looking rash/it popped, and then it got rounder and straight on her side, a straight line on her side from his breast down, and it looks like coded in ring worms/the rash is everywhere in her body/broke out in this rash). 02-Jul-2021, the patient experienced BLISTER (A little blister came up and then they were like ring worms). At the time of the report, SWELLING (Knot on her arm), PARAESTHESIA (It was like she had needles on her), BLISTER (A little blister came up and then they were like ring worms), BURNING SENSATION (The first day it burned) and DRY SKIN (The first day it burned, and now it kind of gets real dry) outcome was unknown and RASH PAPULAR (Some of the rash are raised) and RASH (she broke out in this weird looking rash/it popped, and then it got rounder and straight on her side, a straight line on her side from his breast down, and it looks like coded in ring worms/the rash is everywhere in her body/broke out in this rash) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No relevant concomitant medications were reported Treatment medications included shampoo and an ointment.
HEADACHES; PAIN AT INJECTION SITE; COUGH; LACK OF APPETITE; JOINT AND NECK PAIN; CHILLS; FEVER; FATIGUE; This spontaneous report received from a patient concerned a 45 year old female. he patient's height, and weight were not reported. The patient's concurrent conditions included hypothyroid, non smoker, and non alcohol user, and had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested.  Concomitant medications included levothyroxine for hypothyroid.  On 06-APR-2021, Laboratory data included: COVID-19 PCR test (NR: not provided) NEGATIVE (units unspecified), and COVID-19 virus test negative (NR: not provided) NEGATIVE (units unspecified). On 08-APR-2021, the subject experienced joint and neck pain. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, the subject experienced cough. On 09-APR-2021, the subject experienced lack of appetite. On 09-APR-2021, the subject experienced pain at injection site. On 15-APR-2021, the subject experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cough on 11-APR-2021, lack of appetite on 12-APR-2021, joint and neck pain, and fatigue on 09-APR-2021, chills, and fever on 08-APR-2021, headaches on 18-APR-2021, and pain at injection site on 14-APR-2021. This report was non-serious. This case, from the same reporter is linked to.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 08/17/2021. PATIENT FULLY VACCINATED ON 02/19/2021.
The following day her arm was swollen; She could not breathe; Rashes all over her body/ she still has all this rashes over her; She has rashes all over her body and can't sleep at night because it's very itchy; She has rashes all over her body and can't sleep at night because it's very itchy; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (She has rashes all over her body and can't sleep at night because it's very itchy), RASH PRURITIC (She has rashes all over her body and can't sleep at night because it's very itchy), PERIPHERAL SWELLING (The following day her arm was swollen), DYSPNOEA (She could not breathe) and RASH (Rashes all over her body/ she still has all this rashes over her) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced INSOMNIA (She has rashes all over her body and can't sleep at night because it's very itchy), RASH PRURITIC (She has rashes all over her body and can't sleep at night because it's very itchy) and RASH (Rashes all over her body/ she still has all this rashes over her). 17-Feb-2021, the patient experienced DYSPNOEA (She could not breathe). On 18-Feb-2021, the patient experienced PERIPHERAL SWELLING (The following day her arm was swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 17-Feb-2021 for Breathing difficult, at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) on 17-Feb-2021 for Breathing difficult, at an unspecified dose and frequency. At the time of the report, INSOMNIA (She has rashes all over her body and can't sleep at night because it's very itchy), RASH PRURITIC (She has rashes all over her body and can't sleep at night because it's very itchy) and RASH (Rashes all over her body/ she still has all this rashes over her) had not resolved and PERIPHERAL SWELLING (The following day her arm was swollen) and DYSPNOEA (She could not breathe) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Patient stated that she can't take the second dose and afraid of it.
developed hives.  Unknown if it was something I came into contact with i.e. chemicals in hot tub (but had used often since booster) or plant in yard.  They appeared beneath collarbone, on arms, legs, face.  Had a cold sore develop during the week after hives began.
patient recieved a fluzone quadrivalent (multi dose vial from last season) vaccine that was expired, No AE; Initial information received on 20-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional.  This case involves a female patient (age not reported) who was vaccinated with an expired dose of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QUADRIVALENT] (lot UJ270AA and expiry date: 30-Jun-2020) via an unknown route at an unknown administration site for prophylactic vaccination on 20-Aug-2020 (expired product administered).  The patient's medical history, past medical treatment, past vaccination, family history and concomitant medication were not provided.  It was an actual medication error case due to expired vaccine used (latency same day).   It was reported that patient received this Fluzone Quadrivalent multi dose vial from last season.  At the time of this report, no adverse event was reported.  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 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.
8/15/18 0900 mom reports patient had fever of 102 along with warm, swollen, and reddened right arm. Evaluation by pediatrician determined to be a side effect. 8/16/18 mom reports patient developed rash, continued fever, redness, and swelling of right arm. Re-evaluation by pediatrician determined to be allergic type response to vaccines given.
Vaccine given 10/5 at 0700; temp increased 102 and projectile vomiting (multiple) - all on 10/6/07. Hypertensive.  02/18/2008 MR received for DOS 10/6-7/2007 with D/C DX: Self-limiting Acute Gastroenteritis.  Pt had RBBB on EKG. Pt presented to ER with c/o sudden onset severe abdominal cramping and projectile vomiting (8-9 episodes). Temp 101.9 in ER.  PE (+) for dry mucous membranes, otherwise WNL. TXd with IVF, Zofran, Compazine and Ativan with sx resolving by 10/7/07
This spontaneous report was received from a physician via a Company representative concerning to an unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. On 02-FEB-2016, the patients were vaccinated with an improperly stored doses of RECOMBIVAX HB lot # K020336, the expiration date: 17-AUG-2017 (dose and route were not reported). The total cumulative hours out of range were 360 hours with 34 degrees C and 168 hours with 33 degrees C as the lowest recorded temperature and the storage type was a refrigerator. There was no concomitant medication provided nor no Product Quality Complaint (PQC) involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Mother states that baby developed fever of 102 deg. F. and unconsolable crying post receiving shots. This continued through 03/25 and progressed to high pitched screaming. Seen in ER on 03/25 and no abnormalities found. Seen by pediatrician on 03/26 and urine/bloodwork-normal.
MIGRAINE; TROUBLE GETTING OUT OF BED; SEVERE HEADACHE; This spontaneous report received from a consumer concerned a 43 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 15:40 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced migraine. On 08-APR-2021, the subject experienced trouble getting out of bed. On 08-APR-2021, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from migraine, severe headache, and trouble getting out of bed. This report was non-serious.
Pt presented with rash approximately 2 weeks after receiving 15 month vaccines. Pt has visible rash on face, trunk, arms and legs. Pt. had a previous fever (max temp of 100.3), however was afebrile at time of visit. P.'s parent stated she had watery stools. Pt. went to urgent care 1 day prior to seeing Dr. Urgent care gave patient a diagnosis of tonsillitis and was given a prescription of KEFLEX. A rapid Strep test was also administered during urgent care visit which resulted as negative. Pt was seen by Dr. today, 11/6/17 for persistent rash after examination. Dr. diagnosed patient with an adverse reaction from MMR vaccine. Plan is to discontinue KEFLEX antibiotic prescribed by Urgent Care and to treat symptoms with BENADRYL.
rigors; muscle aches; head ache; pain in my inner ears; photophobia; feeling of exhaustion; too weak to walk further than the bathroom; This is a spontaneous report from a contactable other hcp. A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 09Jan2021 13:45 at a SINGLE DOSE for covid-19 immunisation. Medical history included hypertension and atrial fibrillation from an unknown date and unknown if ongoing. Concomitant medication included benazepril (BENAZEPRIL), diltiazem (DILTIAZEM), rivaroxaban (XARELTO) and estrogen/methyl te. The patient previously had the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 21Dec2020. The patient stated, "I woke from sleep about 12 hours later (10Jan2021) with rigors, muscle aches, head ache and pain in my inner ears as well as photophobia and feeling of exhaustion. The rigors had resolved by 8am but other symptoms persisted. I was too weak to walk further than the bathroom. I was able to consume only warm liquids, although I had no nausea, vomiting or diarrhea. Note that since onset post infectious irritable bowel symptoms in February after visiting a city, weeks before the pandemic was recognized, I have had very abnormal but not absent sense of taste and smell, making me wonder whether I was infected in February without the usual symptoms." The patient recovered from rigors on 10Jan2021, outcome of the event weakness was unknown while other events were not recovered.
First and second COVID 19 dose resulted in a red, puffy, warm arm. Both doses also caused patient to feel achy and have joint pain in her hands.
Left arm pain, swelling, itching and discoloration that started 2 days after receiving vaccine and has persisted to this day. All symptoms wax and wane, there appears to be no aggravating factors.
Initial information received on 13-Mar-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves an unknown demographic adult patient who experienced allergy to tetanus, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect Influenza Quadrival A-B Vaccine lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious allergy to vaccine (Unknown latency) following the administration of Influenza Quadrival A-B Vaccine. Other relevant tests were not reported. Final diagnosis was allergy to vaccine. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergy to vaccine. List of documents held by sender: none.
Pontine ischemic stroke with CSF pleocytosis (50 nucleated cells, 2400 RBC, protein 47)
tested positive after Moderna COVID vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive after Moderna COVID vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 SARS-COV-2 TEST POSITIVE (tested positive after Moderna COVID vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive after Moderna COVID vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     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.   No concomitant medications reported. No treatment information provided.
lung to hurt some when taking a really deep breath; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY PAIN (lung to hurt some when taking a really deep breath) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY PAIN (lung to hurt some when taking a really deep breath). At the time of the report, PULMONARY PAIN (lung to hurt some when taking a really deep breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Client c/o warmth feeling to the face.  Client seen and assessed by EMT and vital signs are as followed 173/62, HR 90, O2 99.  Client verbalized that she felt decrease in sensation then was cleared to go home by EMS.
The first dose of Pfizer was administered on 09/09/2021 and the second dose of Pfizer was administered on 09/23/2021.  This is an error due to the incorrect interval of only two weeks.
Late anaphylaxis-diaphoresis , SaO2 91% RA, chest tightness, dizziness at 12 hours after vaccine, plus large 4x4 local reaction and baseline dermatitis. Give epi IV, O2, transported to ER for Benadryl. Prednisone and observation.
erythema, induration w/myalgias lt deltoid area >13cm in size;no fever, chills etc;