chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 12/7/17 my husband picked up our son from the sitter and noticed a few hives on his hand. Once they got home he changed clothes and diaper, there he discovered hives all over his body and face. Our son was running a fever of 102. My husband called me at work and sent me photos. I called our sitter to see what our son ate that day thinking it was an allergic reaction to a food. The sitter confirmed our son had not eaten any of the food we sent nor any food at her home and had slept most of the day. She had not noticed any hives. My husband initially treated with 5ml BENADRYL thinking he must have touched something he was allergic to or he was developing a new allergy. The fever we treated with ibuprofen. The fever went down but the hives did not. When I arrived at home around 6:00 p.m. I gave another dose of BENADRYL 5ml. I considered giving him his EPIPEN thinking it was an allergic reaction to something but his breathing was fine and had no other side effects besides the fever. His hives did go away temporarily with the 2nd dose of BENADRYL. Our son was irritable and fussy and did not eat much for dinner. He did sleep but when he awoke the next morning on 12/8/17 the hives were everywhere again and his fever was 103. I treated with BENADRYL and Ibuprofen again. And continued to treat him all throughout the day with the hives and fever continuously returning every 3-4 hours. I started thinking back to did he have an illness or what happened recently? Then I remembered he had his vaccinations a week prior to start of all the reactions. The hives and high fever of 102-103 continued on 12/9/17 and 12/10/17 which we continuously used BENADRYL, ibuprofen and TYLENOL. The hives/high fever reactions lasted a total of 4 days upon inception. Out of all his allergic reactions this seemed nothing like anything we have experienced and we have never had a food allergic reaction last 4 days or be accompanied by high fever. We had an appointment with our new allergist on Tuesday, 12/12/17 and I shared with her our photos of hives and symptoms. She said it was definitely a severe adverse reaction from the MMR vaccination and I needed to report it to the CDC and our doctor, asap.
Moderna COVID-19 Vaccine EUA: Itchy, red "bullseye" rash with swelling (lump the size of circumference of rash) with some heat to touch at vaccination site one week post injection; Itchy hives from elbow to shoulder (with some heat) of injected arm 4 days after that, and Itchy, prickly red rash (resembles pimples)  from elbow to shoulder of injected arm another 2 days after that.
No adverse events reported, however;  Moderna vaccine give to female aged 17 years, 10 months
Flare up of recurrent Epstein Barr and Fibromyalgia, dizziness loss of balance weakness muscle pain, joint pain, burning pain, vision changes, nausea/vomiting low grade temp
Began to experience severe body aches, mental fog and chills ~21 hrs after Covid 19 injection.  Sore shoulder prior to on set of body aches and chills. Symptoms lasted ~24 hrs. Mental fog continued for ~72 hrs.
Injection given 02/09/2006 in left arm outer aspect.  02/10/2006 patient developed weakness, shivering and eventually inability to walk.  Patient has cerebral palsy.  Had right hemisphrectomy 03/21/2001.  Mom refused pneumoccal vaccine in the past.  History of status epilepticus.  Had fever to 101, treated with Motrin.  Recovered 02/11/2006.
Tested positive for Covid on 3/4/2021. Dose 2 of vaccine given 1/26/2021.
Information has been received from a licensed practical nurse concerning a 62 day old female patient who on 28-DEC-2010 was vaccinated with a dose of ROTATEQ (Lot # 668341/0526Z, expire date 28-APR-2012), per oral. Licensed practical nurse stated that on 28-DEC-2010 the patient immediately vomited almost all of the ROTATEQ and her last feeding. Subsequently, on 28-DEC-2010 the patient recovered. There were no laboratory diagnostics tests performed. The patient sought unspecified medical attention. Additional information has been requested.
02/11/2021-Dr. visit with some swelling in both legs, on and off burning areas in both legs, tingling areas, legs felt heavy, not enough symptoms to check further.  February 25, 2021, 2nd Moderna shot - March 2, 2021 - Dr. Visit:  Left leg very swollen, couldn't stand on it, right leg some swelling, burning and tingling areas on both legs.  Ultrasound, blood clots in both legs, femoral, popliteal and calf veins.
flu; Initial information received on 18-Jan-2022 regarding an unsolicited valid  non-serious social media case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced flu while receiving vaccine INFLUENZA VACCINE.   The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer at an unknown dose (lot number, expiry date, strength, form, frequency: not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event "flu" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Got the flu shot and 2 months later catched the flu , don't get it, it's a scam ! Totally useless".  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu).  At time of reporting, the outcome was Unknown for the event flu.
Routing bloodwork shortly after revealed platelets had crashed; my husband is getting weaker; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program (005570).  A male patient received bnt162b2 (BNT162B2), administration date Jan2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PLATELET COUNT DECREASED (non-serious) with onset 2021, outcome "not recovered", described as "Routing bloodwork shortly after revealed platelets had crashed"; ASTHENIA (non-serious) with onset 2021, outcome "not recovered", described as "my husband is getting weaker". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of platelet count decreased.  Additional Information: It was reported that, her husband had his first Pfizer vaccination in Jan2021. Routing bloodwork shortly after revealed platelets had crashed. He was still battling, even after receiving platelet boosting meds. There has to be other people who have experienced this. They were running out of options, and her husband was getting weaker.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Headache but went away.  Nose bleeds 3 times so far within 7 days of injection.
Localized redness, lump, tenderness at right thigh. Fever 99-102.6. Vomiting x 1 on 1/14/09. Irritable and cranky. Treated with TYLENOL-MOTRIN. Symptoms started 1/14/09.
Moderna COVID-19 Vaccine EUA Rash formed on arm about 12 days after vaccine (first noticed it on this day). Press seems to be calling it "COVID Arm".
pt recvd vax 10NOV94,11NOV pt vomited 3 times; on 12NOV emesis x 2, fever to 102 adm for eval 13NOV; 15NOV stuffy nose then devel generalized sz (afebrile) last 20 mins; repeat x 1 & controlled w/meds; viral illness vs poss DTP react;
Intense vaginal bleeding two days after that lasted a week, before this it had been a year and a half since last cycle due to being on hormone replacement therapy.  From June 16th to June 23rd.
difficulty breathing; Light pains in my chest and arms felt like getting stabbed by a nail; Light pains in my chest and arms felt like getting stabbed by a nail; Swelling of my throat; This is a spontaneous report from a contactable consumer (patient himself). A 18-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left arm on 22Apr2021 10:45 (age at vaccination: 18 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included allergy to pollen and sulfa drugs. The patient's concomitant medications were not reported. The patient received the vaccine in a student health clinic. The patient did not receive any other vaccine in four weeks. On 22Apr2021 11:00, the patient experienced difficulty breathing, light pains in my chest and arms felt like getting stabbed by a nail only on the opposite side of the vaccine arm, swelling of throat. The adverse events resulted in physician's office visit. The patient received Benadryl injection as treatment for the adverse events. The patient did not have covid prior vaccination nor was tested for covid post vaccination. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Pt stated arm became swollen and red at injection site. Pt started on 2 antibiotics and an antifungal after seeking medical attention.
Sudden pain in my heart and then the pain disappear. It felt like someone quickly grabs my heart very hard.
Below freezing temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number c5jl7, expiry date 28th November 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th July 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The physician reported that a patient was administrated with Boostrix after a below freezing temperature excursion, which led to incorrect storage of drug. No adverse event was reported. The reporter consented to follow up. This case is one of the 28 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021164771:same reporter US-GLAXOSMITHKLINE-US2021164775:same reporter US-GLAXOSMITHKLINE-US2021164777:same reporter US-GLAXOSMITHKLINE-US2021164779:same reporter US-GLAXOSMITHKLINE-US2021164781:same reporter US-GLAXOSMITHKLINE-US2021164783:same reporter US-GLAXOSMITHKLINE-US2021164784:same reporter US-GLAXOSMITHKLINE-US2021164786:same reporter US-GLAXOSMITHKLINE-US2021164787:same reporter US-GLAXOSMITHKLINE-US2021164788:same reporter US-GLAXOSMITHKLINE-US2021164789:same reporter US-GLAXOSMITHKLINE-US2021164791:same reporter US-GLAXOSMITHKLINE-US2021164792:same reporter US-GLAXOSMITHKLINE-US2021164793:same reporter US-GLAXOSMITHKLINE-US2021164794:same reporter US-GLAXOSMITHKLINE-US2021164795:same reporter US-GLAXOSMITHKLINE-US2021164797:same reporter US-GLAXOSMITHKLINE-US2021164798:same reporter US-GLAXOSMITHKLINE-US2021164799:same reporter US-GLAXOSMITHKLINE-US2021164800:same reporter US-GLAXOSMITHKLINE-US2021164801:same reporter US-GLAXOSMITHKLINE-US2021164802:same reporter US-GLAXOSMITHKLINE-US2021164803:same reporter US-GLAXOSMITHKLINE-US2021164804:same reporter US-GLAXOSMITHKLINE-US2021164805:same reporter US-GLAXOSMITHKLINE-US2021164806:same reporter US-GLAXOSMITHKLINE-US2021164808:same reporter
Painful hematoma with large surrounding area of ecchymosis on back of left leg, eventually feeling more like superficial thrombosis/thrombophlebitis.  No trauma to leg prior to onset.  The thrombus and bruising resolved gradually, over about 3-4 weeks.
Immunizations 3/2/10. Fever started 3/5/10 but cranky since shot. AM 3/6/10 with generalized seizure and transient Rt hemiparesis and gaze deviation. Hospitalized for observation after initial (-) workup.
Two days after vaccine (9-30) noted red swollen area size of small apple at site of inject. Had chic pox at 4 yrs of age. No fever, no breathing problems, tired after current Varicella inject.
Dose given at 4 mo of age. Too early. In-office pediatrician and mom notified right away.  No reaction noted per mother
This spontaneous report was received from a physician and the mother of an unspecified child of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (the dosage regiment information was not reported) for prophylaxis. On an unknown date, the patient experienced fever. The fever did resolve, and the patient continued to complete the series without further incident. No relatedness assessment was provided.; Sender's Comments: US-009507513-1812USA009298:
1st dose: 3/5/21 J&J COVID vaccine, lot # 1805020,  2nd dose: 11/19/21 J&J COVID vaccine lot # 213D21A  Patient developed COVID-19 breakthrough infection nine months after receiving COVID-19 immunization. Treated and released from ED with follow-up on 12/10/21.
Pt recv vax on 3/3/99; post vax pt exp dizziness then fainted
Dizzy, tingling, lightheaded 5 mins after shot. Tx- lay down, H2O.
Patient noted knot in throat 24 hours after vaccines that lasted one week. Thirty hours after vaccines she noted pain in both large toes that lasted 1-2 weeks. She noted redness, stiffness and swelling in fingers of both hands 48 hours after vaccines. This seemed to migrate from finger to finger. She was placed on Vioxx for 5 weeks by PCP.
Pt was accidentally given 2 doses of PROQUAD - was supposed to get 1 proquad and 1 kinrix - once MA realized the mistake, notified doctor  - poison control was called to make sure no side effects = parents notified.
Increase / number of mix ups of Adult / and peds / hep B since you changed the look of your boxes; This case was reported by a pharmacist via call center representative and described the occurrence of product packaging confusion in a patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced product packaging confusion. On an unknown date, the outcome of the product packaging confusion was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that, they have notice an increase in the number of mix ups of adult (20mcg) and pediatrics (10mcg) Hepatitis  B since the look of the boxes were changed, which led to product packaging confusion. The pharmacist inquired that if anyone else had reported this or if they would consider different packaging. The information was received via webform. No other information was provided. The reporter consented to follow up.
muscle twitching; He still jerks quite a bit; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MUSCLE TWITCHING (muscle twitching) and DYSKINESIA (He still jerks quite a bit) in a 68-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 030G22B) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: FLUZONE [INFLUENZA VACCINE] (Flu shot one week before bivalent booster); for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with FLUZONE [INFLUENZA VACCINE] and Moderna COVID-19 Vaccine.    On 28-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (muscle twitching) and DYSKINESIA (He still jerks quite a bit). At the time of the report, MUSCLE TWITCHING (muscle twitching) had not resolved and DYSKINESIA (He still jerks quite a bit) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The patient states that took the Moderna bivalent booster last fall. After 4-5 weeks. patient noticed muscle twitching. It got worse and was more noticeable.  Patient had so many flu shots over the years.  The patient states that took 5 Moderna shots before getting the Moderna bivalent booster. patient got the Moderna bivalent booster on the same day.  No treatment medications were reported.   This case was linked to MOD-2023-708150 (Patient Link).
This spontaneous report was received from a healthcare worker refers to a multiple, unspecified patients of an unknown age and gender. The patients relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the multiple unspecified patients were vaccinated with improperly stored doses (temperature 15F for 3 hours) of ZOSTAVAX lot# L012477 (expiry date: 10-JUL-2016); lot# L000461 (expiry date: 18-MAR-2016) (dosage not reported). No adverse effects reported. The multiple, unspecified patients were exposed to previous temperature excursion: a high temperature of 21F for 14 hours. The cumulative time out of range was 17 hours, including this excursion. The temperature was back in range. Additional information has been requested.
Headache after second vaccine; Body aches, after second vaccine; Temperature, feels like she is burning up, after second vaccine; This is a spontaneous report received from a contactable consumer (Patient). A 63-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot number: ER6955) intramuscular on 18May2021 in right arm as a single dose for COVID-19 immunization. Patient's medical history included angioma (Caller re-ports it has been years, and used to go for MRI's, every 6 months and angioma has haemorrhaged in the past), Emphysema (It has been years and patient has one lung), High blood pressure (caller states years ago, then clarifies as 15 years ago at least) and still ongoing. Concomitant medications included high blood pressure pills, pain pills and a Vitamin D prescription. Patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Lot number: ER8729) on 17Apr2021 in left arm as a single dose for COVID-19 immunization. Patient had no Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. Patient had No Family Medical History Relevant to AE(s) she doesn't have any family left, they are dead. On 19May2021, the patient experienced Headache when she woke up, about 9 am, Body aches when she woke up in the morning, Temperature of about 102.2 degrees, like it is worse, like she is burning up when she got up in the morning, after second dose of vaccine and ongoing. Patient was not visited to emergency room and physician room. Caller asks if DSU agent has any recommendations as to how she can feel better. The patient underwent lab tests and procedures which included body temperature and result 102degrees. The outcome of event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Patient experienced near syncope 10 minutes after administration of vaccine. Patient transported back to exam room where attended by physician. Vitals were monitored. Pt was initially bradycardic with low blood pressure. Pt monitor closely for 30 minutes. Alert and oriented throughout. Mother present throughout. Vitals stable. Patient eating and drinking refreshments in office provided by staff. Walked out of clinic without any issues.
This non-serious initial spontaneous case, was received on 26-Nov-2017, from the other health care professional, concerning an adult female patient (reported as between the age 51-64). On an unspecified date (more than 20 years ago), the patient was administered influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported), at work place. On an unspecified date, after vaccination, the patient had fever, nausea, muscle aches and runny nose. The reporter assessed the events as related.
Information has been received from a nurse referring to an unspecified number of patients.  Information about concurrent condition, concomitant medication and medical history was not provided. The nurse reported that an unknown number of doses of GARDASIL, (Lot # L040460 Expiration date 27-MAY-2017) experienced a temperature excursion of -4F for 4 hours 31 minutes, and an unknown number of might have been administered to an unspecified number of patients. It was unknown if any patients experienced any side effects following administration of any of the vaccines. No other information was available. This report is one of the reports from same reporter. Additional information is not expected. because no consent to contact; Sender's Comments: US-009507513-1612USA004349: US-009507513-1612USA004348.
4/5/2021 Right Subconjunctival hemorrhage. - eye pain 9/25/2021 Bilateral Subconjunctival hemorrhage- eye pain
5ml syringes that had were used to draw up diluent for mixing the 5-11 year old Pfizer COVID-19 vaccine vial on 12/23/21.  Diluent drawn up and injected into the vaccine vial was 1.6ml rather than 1.3ml.  Diluent was measured on the 5ml syringes incorrectly:  Counting each mark as 0.1 rather than 0.2ml.  This resulted in the vial being mixed with 0.3ml extra diluent.  Vial had a bonus dose (so 11 doses total).  Patient was given a vaccine dose at 90% of the correct concentration.  Error has been reported to Pfizer.  Families are currently being contacted by letter and by phone to be alerted of the error and offered a re-dose if they would like this.  No adverse effects to patients have been reported.
7 days following injection, developed shortness of breath and chest pain. Unable to sleep for 2 nights waking up to "catch my breath".
Information has been received from a nurse concerning an 18 month old male child with a history of eczema who on 02/03/2003 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not reported). Within 2 days post vaccination, the child developed a pruritic, macularpapular rash on both legs extending to his abdomen. Treatment was topical cortizone cream. As of 02/13/2003, it was reported that the rash had not decreased and there had been no improvement. Unspecified medical attention was sought. Additional info has been requested.
Pt vaccinated w/TTOX developed 2" induration that is "hot" to touch, red in arm vaccine given. Vaccine given on 22JAN91 on 23JAN01 sx "not as bad". 24JAN91 mother called office describing the above. Don't know onset time.
Patient experiences chills, fatigue, nausea, migraine, and sore arm. This started the evening of vaccination and continued for approximately three days. Symptoms got worse until about day 2-3 when they began to subside more rapidly.
Information has been received from a pharmacist concerning a 65 year old female who on 27-JUN-2007 was vaccinated SC on left arm with a dose of Zostavax (Oka/Merck).  On 29-JUN-2007 the patient developed rash at the injection site.  The rash was described as red and itchy.  The patient was not evaluated by her physician and no treatment was ordered.  A medical attention was sought from the pharmacist.  A product quality complaint was not involved.  Additional information has been requested.