chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Almost immediately after the shots (MMR and VAR)he developed some mild diarrhea, then became extremely picky eater, we repetitively went to the doctor's office about his eating issues. He stopped developing and progressively start showing symptoms of ASD. He was evaluated at 18 months old with a diagnosis of PDD - Autism. 10/26/09 Medical records received for date range 8/8/07 to 9/17/08. SX: parent states pt. was normal infant, normal development till age 1. At that time pt. became limited with diet tolerance, picky eater. Speech became delayed, poor eye contact, repetitive behaviors, sensitive to loud noises, developmentally delayed. Noted around age 1 pt traveled out of country while having stomach virus. Pt was fed yogurt and fruit juices. Upon return from trip, feeding difficulties began. Consults with speech therapist DX: receptive and excessive language impairment, avoidance behavior at mealtime, decrease tolerance at age appropriate diet. Developmental and behavior peds health consult: DX: pervasive development disorder, delay developmental milestones, speech disturbance, dyspraxia. ENT consult DX: otitis media, Eustachian tube dysfunction. F/u hearing test WNL. Neuro consult: seen for possible seizures. DX: seizure, encephalopathy. GI consult: c/o loose stool 1-3x day, abdominal distention with bloating, increase flatulence. Parent states increase in eye contact when on gluten free diet and not as lethargic on dairy free diet. Assessment: rash noted on cheeks, PE: WNL. DX: IBS, change in BM, developmental delay, feeding difficulties, eosinophilic esophagitis vs. eosinophilic enteritis, food sensitivity, pervasive developmental delay spectrum vs. autism w/ assoc. gut issues. 12/31/09 Medical records received for dates 12/30/09 and 4/2/09. 4/2 DX: rash. Presenting SX: rash on belly x1wk. Assessment: raised erythematous rash. 12/30 Well child exam. DX: coordination disturbance, speech disturbance, pervasive developmental disorder.  Parent express concern for aggressive behavior, lack of eye contact, speech delay, social anxiety. Assessment: part from parent: atypical behaviors, spinning himself, humming while stick finger in ears, toe walking, picky eater. Pt receiving speech therapy.
After the injection the patient spoke within 2-3 seconds her head was on the table them within 2-3 seconds she was speaking. Appeared to have fainted and came to within a matter of seconds applied cool compressed to face, neck and hands. Patient waited 15 min then walked around for about 10 min.
Patient received her 2nd vaccine at around 9am 5/4/2021. She immediately complained of pain at the injection site. She was reluctant to move her arm and said it hurt "really bad". I counseled her to use an ice pack at the injection site and tylenol or ibuprofen if necessary. She went to the post-vaccine waiting area and then left. Her mother called at about 2pm and wanted to know what she can do to help her daughter because the pain  was becoming much worse.  I asked if she had taken anything yet or used an ice pack. She had not, so I suggested it again.
This spontaneous report as received from a Register Nurse refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 29-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX (route, dose and anatomical location were not reported), (lot # reported as L001329 expiration date 13-JAn-2017). There was no concomitant therapy reported. No adverse effects reported. This is one of several reports received from the same reporter.
Systemic: Confusion-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild
On 8/20/01 at 10:40, pt received shots. At 14:05, pt wakes mom from nap crying. His left leg is red and swollen. At 14:20, mom gives pt Tylenol. At 14:30, child is still crying. At 15:00, spoke with mom again and child has continued to cry. On 8/21/01 at 08:00, mom states child cried on and off until 22:00. Child is better today and leg is much less swollen.
Patient given 0.5 mL Moderna Bivalent Booster vaccine. Based on vaccination history, should have been given 0.25 mL (or 0.2 mL Bivalent Booster (6 m - 5 yr).
This spontaneous case reported by a healthcare professional, describes the occurrence of administered expired product (administration of one dose from the expired vial to a patient) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 037C21A) for COVID-19 immunization. No medical history reported. On Jun 22, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 22, 2021, patient administered expired product (administration of one dose from the expired vial to a patient). On Jun 22, 2021, administered expired product (administration of one dose from the expired vial to a patient) resolved. The reporter did not provide any causality assessments, concomitant medication or treatment information.
pt recv vax 17OCT95 & 18OCT95 devel a diffuse rash characterized as red,punctate & w/a halo around it;pt was tx w/DPH;addtl info recv 30NOV95: pt was dx w/pseudomonas rash
lost sense of smell; lost sense of taste; 98.7F in the am, my normal temp 97.6; not feeling better; right superficial cervical lymph nodewas painful on touch and inflamed; Feels like bad sinus infection; felt excessive thirst; stuffed nose; dry throat; felt unusually energized; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 09Apr2021 at 18:45 (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included a sinus surgery in 1993. The patient did not have allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included paracetamol(TYLENOL) for unknown indication, two days prior to vaccination. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 11Apr2021 at 08:00, the patient experienced feeling of unusually energized, no body aches, no fever on day 1 and exactly after 24 hours of the shot, 18:45, the patient felt excessive thirst and on day 2 the patient woke up with stuffed nosed and dry throat, lymph nodes not inflamed but on day 3-4, the patient experienced 98.7F in the am whereas the patient normal temp was 97.6 and the patient felt only right superficial cervical lymph node was painful on touch and inflamed, felt like bad sinus infection. While on day 5 the patient had one lymph node still inflamed, was not feeling better, lost sense of smell and taste for about 12 hours, took a COVID test. On day 6, the sinus infection was getting worst. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the adverse event. On 19Mar2021, the patient underwent nasal swab and the result was negative. The clinical outcome of the event felt unusually energized was recovered within 24hours. The clinical outcome of the events lost sense of smell and lost sense of taste was recovered in about 12 hours. The clinical outcome of the events felt excessive thirst, stuffed nose, dry throat, right superficial cervical lymph node was painful on touch and inflamed, feels like bad sinus infection, not feeling better and 98.7F in the am, my normal temp 97.6 were not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a pharmacist via a company representative refers to a 80 year old male patient. No medical history was reported. On an unknown date in December 2012, the patient was vaccinated with a dose of ZOSTAVAX (lot#, expiry not reported). No concomitant medications were reported. On an unknown date, the patient experienced shingles. Patient sought medical attention (unspecified). The outcome of shingles was unknown. Additional information has been requested.
Redness, soreness, swelling, hotness, itching at the site of injection which spread to about 6 inches or more down my arm. Infection set in had to go to the emergency room and was given RX for clindamycin (every 6 hours for 10 days).
Shortness of Breath, known exposure to COVID positive Husband, dry cough, body aches, fevers, generalized weakness, poor appetite, change in taste and smell. O2 87% on room air
dose was given greater than 12 hours after first puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose was given greater than 12 hours after first puncture) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose was given greater than 12 hours after first puncture). On 06-May-2021, EXPIRED PRODUCT ADMINISTERED (dose was given greater than 12 hours after first puncture) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EXPIRED PRODUCT ADMINISTERED (dose was given greater than 12 hours after first puncture) to be not applicable.    No concomitant medication was reported. No treatment information was provided.
Reports left arm red and swollen from shot site to elbow. Pt received pneumonia shot yesterday. Recommended she apply ice pack 15 min at a time 3 or 4 times daily to help with swelling. Recommended Benadryl prn itching. Let me know if no better over next 24 to 48 hours.  6/23/2004: spoke to pt and states arm much better. Swelling has gone down, there still is a little redness. Took 1 Benadryl before bed.
Pt called on 1/6/23 around 10am saying he experienced fever,aches,headache,cough,fatigue 1-2 days after getting the shots. Side effects ressolved but he still have fatugue.
erythema, induration, tenderness rt upper arm-inject site of DT vax; started around 24 hrs (or less) p/inject treated w/Cprio;
This spontaneous report was received from a registered pharmacist and refers to a 60 year old patient of unknown gender. Information regarding pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 11-AUG-2017, the patient was vaccinated with an improperly stored ZOSTAVAX, lot number M041087 with expiration date 03-JAN-2018 (dosage schedule, anatomical location and route of administration not provided) for prophylaxis, reconstituted with properly stored diluent (MRK INJ). The administered vaccine was exposed to a temperature of 6 degree Fahrenheit to 14 degree Fahrenheit for 1 hour. Previous temperature excursion was reported as 6 degree Fahrenheit to 14 degree Fahrenheit for 45 minutes. The call was because of a data logger. No adverse effects were reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010696: US-009507513-1708USA010732: US-009507513-1709USA014569: US-009507513-1709USA014570: US-009507513-1709USA014571: US-009507513-1709USA014572: US-009507513-1709USA014573: US-009507513-1709USA014574: US-009507513-1709USA014575: US-009507513-1709USA014576.
This spontaneous report was received from a Licensed Practical Nurse referring to two patients of unknown age and genders. Patients' medical history and concurrent conditions where not reported. On 05-OCT-2015, the patients were vaccinated with an improperly stored doses of ZOSTAVAX (lot # L002424, expiry date 23-APR-2016). No adverse effects were reported for any of these two additional unspecified patients. This is one of three reports from the same reporter source (MARRS linked cases 1510USA002521, 1510USA002650). Additional information has been requested.
patient returned with swelling , redness and itching in whole upper right arm starting the next morning after the vaccine. He did not report to pharmacy until the following day. The pharmacist instructed the patient to try tylenol/ibuprofen for pain and swelling and benadryl for the itching. If no improvement  within 24 to 48 hours, patient to contact us or physician. If worsening or anaphylaxis, call 911 or go to ER
Outbreak of cold sores in, on and around my nose with one on my cheek under left eye.; This is a spontaneous report received from a contactable consumer, a patient (reported for self). A 59-years-old (non-pregnant) female patient received the second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot no: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 19:45 (at the age of 59-years-old), as a single dose for COVID-19 immunisation. Medical history included transient ischemic attack (TIA) and hypertension. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), meloxicam (MANUFACTURER UNKNOWN), losartan (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASP) all for unspecified indications from unknown dates. The patient previously received first dose of BNT162b2 (PFIZER- BIONTECH COVID-19 m RNA vaccine, lot number: unknown) via unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 22Mar2021, approximately 3 days after second injection, the patient had an outbreak of cold sores in, on and around her nose with one on her cheek under her left eye. No cold related symptoms, so the patient was not sure if this was brought on by the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of cold sores was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
patient reported any allergies to medication or food.  patient signed consent for vaccine and vaccine administered per protocol then proceeded to designated wait area.  Patients wife called for assistance 10 minutes after vaccine was administered due to patient being faint and light headed. Medic and RN begin to assess vital signs and patient became unresponsive.  Patient was given EPI via EPI pen and 911 was called for assistance. Patient vitals continued to be assessed, patient was also given 50mg Benadryl IM, EMS arrived and assessed patient. Patient regained consciousness and was transferred to hospital for further assessment.
Within 5 minutes of patient receiving the vaccine during her monitoring period, she complained of nausea and dry mouth, then dizziness; initial blood pressure 172/98, HR 126, RR 24 and O2 Sat 99% RA; activated EMS at 2:13pm; patient assisted to lie down on a cot, at 2:18 pm BP 142/88, HR 109, O2 sat 97%; c/o difficulty swallowing and feeling tightness in throat, no rash or hives seen; EMS arrived on site at 2:23 pm and evaluated patient in vehicle and then transported; contacted patient by phone at 7 pm on 3/31/2020 - was transported to Seton ER on 38th Street and received an antihistamine and medication for nausea, discharged at 5:00 pm and given new prescription for Epi pen since the one she had was expired; pt stated she felt much better
Anthrax administered 1/19/03. Had erythema, redness, swelling, tenderness, edema, 3cm X 4cm nodule noted, itching and edema to elbow. Local reaction with injection site erythema, 1-5cm (dia) or mild tenderness within 24 hours. Systemic reaction.
Every time patient take flu shot he/she got the flu; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via.  This case involves an adult patient who got the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got a non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  The reporter asked that Why? Every time he/she take it he/she get the flu, worse then if did not take.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Booster (0.25cc)  dose of Moderna administered to patient  when in reality the patient was referred to our pharmacy for the second dose in series by the local health department.  Upon  entering the data into record system we realized that he patient had only received the first dose of the  Pfizer vaccine. and we had admdinistered booster dose of Moderna
Systemic: SCIATICA PAIN, RADIATING FROM SPINE TO LOWER BACK PROGRESSING TO THE THIGH/CALF AREA WITH CRAMPING-Medium
Patient received a full dose (0.5mL) of Moderna as a third dose due to his report of being moderately immunocompromised. However, it was later learned that patient did not meet the criteria of a moderately immunocompromised individual and he should have received the booster dose (0.25mL). Patient was monitored closely for one hour. No adverse symptoms were reported during this period.
I have had a really bad headache and very sore arm since the shot. I had a similar reaction to my second COVID shot.
This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medication and drug reactions or allergies was reported. On 18-SEP-2015, the patient was vaccinated with improperly stored dose of ROTATEQ orally, lot # K010221, expiration date 12-MAY-2016 (strength and dose were not provided). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash developed within 24 hrs. Lower abdomen, across buttocks and right leg. Within 3 days, antibiotic treatment started; rash gone in 7 days; Percocet and Gabapentum for pain--no appetite
She felt panicky prior to injection.  Felt flush and panicky after injection.  Had ginger-ale and ice pack to help with flushing.  Left injection room approximately 35 minutes post-injection.  When walking down the hall, she said she started to feel more panicky and felt paresthesias near lower jaw--stated she doesn't normally feel that way during a panic attack.  Physical assessment normal.  Vitals signs normal.  Dexamethasone 4mg IM given.  Paresthesias stopped about 10 minutes after dexamethasone.  Went home and stated all had resolved by the time she got home and nothing has happened since.
Acute onset fever to 104, delirium, possible seizure with lip smacking, shaking and unresponsive.
1. Very sore arm that lasted for 10 days and went away.  2. Fatigue that lasted for two weeks and went away.  3. Loss of appetite that lasted for two weeks and went away.  4. Three weeks after vaccination, I  developed extreme back muscle tightness and spasms that have not resolved yet. The tightness runs from the base of the neck on either side of the spinal column down the length of the back. Massage therapy which has proven to be effective for previous issues of muscle tightness was not effective.  I have never experienced muscle tightness that went down the entire length of my back it cannot be resolved by muscular therapy.
Pt s/o of a red, diffuse rash over her upper extremities, face neck and back. She is attributing it to the MMR.
Bell's palsy started 5-6 days after dose #2 of Pfizer COVID vaccine.
Felt severe flulike (achy, tired, chills, nausea, fatigue, myalgias) symptoms 24 hours after receiving vaccination. Then a few days later, pt developed severe herpes outbreak-worst outbreak in life-with 3 subsequent outbreaks in 4 months (never had that frequent of outbreaks prior). The flulike symptoms lasted 4 days. And then developed profound exhaustion lasting for over a month until appointment with physician on 6/30/21 when pt received prescription for medrol dose pack. Symptoms of fatigue  resolved 5 days into course of steroids.
anaphylactic like reaction immediate flushing, redness, itching, disseminated, irregular breathing, nausea, dizziness,
Client reported feeling "dizzy, nauseous, and tingly" in the observation area approx 5 mins. after receiving 1st Pfizer dose. Client was led to wheelchair by EMT and placed in front of the area for closer observation. V/S taken at 2:30pm: HR 58, RR 22, BP 110/68, AOx3. V/S taken at 2:35pm: HR 66, RR 18, AOx3 BP 120/76 and client statement "feeling much better." At 2:45pm client walked away unassisted. No medication or treatment given.
Moderna COVID-19 Vaccine EAU After 7 days I had pain, swelling, red rash around injection site, and itchiness reappear.  Just took Tylenol and put Hydrocortisone topical cream on.
Resident received COVID-19 vaccination  on 1/6/21, 1/27 and 10/11/21.  The resident tested positive for COVID-19 on a PCR test on 10/22/21.  Additionally, the resident tested positive for COVID-19 on 4/28/21.  The resident is asymptomatic for COVID-19.  Reporting  completed d/t positive test after receiving vaccine.
Information has been received from a pharmacist concerning a 23 year old female who on approximately 21-JUN-2008 was vaccinated with the first dose of GARDASIL vaccine (dose, route, and lot # not specified). On approximately 21-JUN-2008, the patient developed itching, redness, swelling, and inflammation at the injection site that went away on an unspecified date. On an unspecified date the injection started swelling again and spread to the elbow from the upper arm. The patient sought medical attention by phone call to the office. At the time of the report, the patient had not recovered. Additional information has been requested.
Pain, swelling and redness at injection site that lasted 4 days.  Fever, chills, headache, body aches, nausea, insomnia - 36 hours.
My adverse event started on 05/2022 after getting exposed to COVID-19 infection. I experienced heart palpation. I felt it more often especially at bed time. I will have few episodes of my heart racing. It lasts 30-60 seconds then it comes back after few minutes. I had this before but it wasn't severe like this May 2 times a month. It was less noticeable but now it progressively got worse. Over the months of May, June, and July it got worse. I went to my Cardiologist on 12/09/2022 he listened to my heart. He diagnosed that there was a nerve which was causing the irregular heartbeat. He then prescribed me metoprolol and I had a follow up visit on 01/11/2023 I told the nurse the symptoms that I was having and difficulty sleeping so, she changed my medication to diazepam. On 02/10/2023 I called her since my medication supply for 30 days was finished. We discussed how I was doing and at that point I had more heart palpations so she increased diazepam from 120 to 180. My doctor ordered CT-scan which I will be getting it done on 04/10/2023 and my reevaluation with my doctor's office on June.