chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Flu shot left arm about 8am went to PCP at 9:30 am received pneumonia left arm also, PPD same time right forearm. later that night 6 or 7 pm. hurting left arm, nauseated, fever 101, red goose egg on left upper arm. Saw PCP on Wed 11/09/2005 stayed off work until Mon 11/14/2005 PCP took a picture of arm no treatment, arm sore today 11/16 feels ok otherwise.
This case was reported by a physician via a sales representative and described a child "under the age of 2" and of unspecified gender who did not respond to the diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combine (Pediarix) immunization series. The subject's family medical history included hepatitis (not specified). On an unspecified date in February 2005, the subject received the third injections of Pediarix. Approximately six months later, in August 2005,  unspecified titers were negative.
Red area size of softball, swollen, warm to touch, itchy, hard, and painful at site of injection.
Pain on left side of neck starting 2 days after first dose of Pfizer-BioNTech COVID-19 vaccine 0.3 mL IM in right deltoid. Pain progressed over the next 5 days to arm and left eye. Dizziness, mouth drooping, and numbness developed. Went to ED and diagnosed with Bell's Palsy. Evaluated in ED for possible causes. Vital signs stable. CVA ruled out. Patient given ketorolac, droperidol, and IV fluids for her headache. Prescribed steroids and acyclovir for Bell's Palsy treatment. Prescriber instructed patient to return to ED immediately if symptoms worsen or additional symptoms develop. Follow up with patient on 1/5/21 with patient reporting some improvement in symptoms.  Patient reported having a headache for 2 weeks straight prior to presenting to the ED on 1/3/21. Vaccine was administered on 12/28/21. Unsure if the Bell's Palsy was a result of the vaccine or some other inciting factor.
Right leg red warm and swollen with raised area 9mm X 8mm wide. Area noted at approximately 6pm on 6/13/01. Doctor gave pt benadryl and applied cold compresses. Leg free of S&S of adverse reactions on 6/14/01 reports pt's mother.
Four days following vaccination patient displayed a regression in fine motor skills.  He lost his ability to reach for and bat at objects, as well as his ability to grasp.  The loss of these abilities coincided with the onset of neurologically self-stimmulating behaviors.  These behaviors, coupled with the regression in fine motor skills, caused measurable developmental delay in a previously healthy child.  Despite the fact that patient had shown typical, appropriate development up until this point, he was not sitting at six months of age, and was still not using his arms or hands.  He began receiving physical therapy and occupational therapy through early intervention services and was referred to a neurologist for suspicion of seizures. 12/10/07-records received for DOS 6/06-8/14/07-developmental delay, questionable seizures. Shaking head from side to side. Unsuccessful attempts at MRI.  12/26/07-records received-office visit 2/26/07-seen for atypical development. Four days after immunizations obsrved rocking head side-to-side. Futher regression continued. 4/23/07 visit Receiving OT and PT and hypertonia has given way to hypotonia. Improving with therapy. Appears to have been a transient illness. 9/17/07- office visit-Demonstrating atypical signs in development. Consistent with autism. 11/12/07-receiving hyperbaric oxygen treatments. Finger nails bright pink. Per 60 day follow up: He has shown continued degredation of his nervous system including the loss of deep tendon reflexes in all extremities and the development of cortical thumbs. He was tested for metachromatic leukodystrophy (ruled out) and test results are pending for acrodynia (Hg poisoning). He has been accepted to palliative care at our local hospital. He has 2 additional VAERS reports-ID# 295018, filed by myself, and VAERS ID# 284671-1, filed by his pediatrcian.
2 hours after vaccination, I started having a bad headache.  Later, that night I started feeling my chest thumping.  The heart palpitations continued on for 2 days, after which I went to an urgent care facility.  At the urgent care I got an EKG and the doctor said my heart was beating fast and irregularly.  I then spent the next 2 days in the hospital getting intense treatment for my irregularly beating heart.  A week later I can still feel my heart beat and the headache comes and goes.
First dose on 19-AUG-2021 and second dose on 10-SEP-2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number TP2N2, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 10th September 2021, the patient received the 2nd dose of Shingrix. On 10th September 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient (who was not immunocompromised) received his first dose of Shingrix on 19th August 2021. The patient received his/her second dose on 10th September 2021, which led to drug dose administration interval too short. No further information reported. The reporter did not consent to follow up.
This spontaneous report has been received from the mother of a 9 month old female patient with anaemia as concurrent condition. The patient's medical history included difficulties during her birth, including being stuck, having a hard time keeping her body temperature up, had difficulty with unspecified thyroid levels, and low hemoglobin levels. The patient had not drug reaction/allergy or concomitant medications to be reported. It was reported that the administrators of the vaccine confused the patient room numbers on 28-FEB-2019, and the patient was vaccinated by mistake with GARDASIL 9, Lot # reported as R073111 with expiration date 29-APR-2021 (strength and route of administration were not provided) for prophylaxis. The reported stated on an unspecified date in 2019 (reported as shortly after being vaccinated), the patient began to experience constipation, which was treated with MIRALAX and then the patient on an unspecified date in 2019 developed diarrhea. The outcome of constipation and diarrhoea was reported as resolved as the patient had not had a more recent diaper change. At the reporting time, the causality between the events and GARDASIL 9 was not provided. Lot Number R073111 is NOT valid for GARDASIL 9.
Mild headache on first evening, followed by muscle aches, nausea, pain at injection site, sleepiness and fatigue, possible fever, chills. Patient did not vomit but slept for two days, waking intermittently. Pain at injection site gone on 5th day. No treatment. Full resolution by 5th day.
Injection Site Lump; Itching Moved Around; Body Aches Moved Around; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Injection Site Lump), PRURITUS (Itching Moved Around) and PAIN (Body Aches Moved Around) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE MASS (Injection Site Lump), PRURITUS (Itching Moved Around) and PAIN (Body Aches Moved Around). On 30-Mar-2021, PRURITUS (Itching Moved Around) and PAIN (Body Aches Moved Around) had resolved. At the time of the report, VACCINATION SITE MASS (Injection Site Lump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Reporter's address and Email address were added.
Monovalent vaccine administered for a booster on 9-2-22. Bivalent booster authorized by FDA on 8-31-22. Patient contracted, will return for bivalent booster in 2 months.
Information has been received from a licensed practical nurse concerning a female patient who on approximately 14-APR-2011 was vaccinated with a dose of GARDASIL (dose, route and lot number not provided). Concomitant therapy included DTaP and meningococcal vaccine (unspecified) administered at the same time. The licensed practical nurse who administered vaccines stated that on approximately 14-APR-2011 (one week ago) the patient passed out after the GARDASIL. The patient was really anxious before the injections. It was unknown if the patient sought medical attention. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Patient started experiencing tongue tingling and chest tightness approx. 1 hour after receiving medication and took a Benadryl and tongue tingling stopped but reports chest tightness remained throughout the day
No additional adverse effect reported; a 1 year-old male was inadvertently administered a dose of properly stored PROQUAD instead of M-M-R II; This spontaneous report was received from a Licensed Practical Nurse referring to a 1 year-old  male patient. The patient's pertinent medical history, concomitant medications, concurrent condition and drug reactions/allergies were not reported.   On 20-JAN-2020, the patient was vaccinated with a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S019583, expiry date: 25-JUN-2021, strength, dosage information, route of administration and anatomical locations were unknown) and also was inadvertently administered a dose of properly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), Albumin status rHA (recombinant human albumin), (lot # S017255, expiry date: 01-DEC-2020, strength, dosage information, route of administration and anatomical locations were unknown) instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (wrong product administered). Both varicella virus vaccine live (Oka/Merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) were reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT). No additional adverse effect reported. No additional information was reported.
Right shoulder and bicep area is very painful as if punched really hard. The pain started within a half hour of receiving the 2nd shot and has remained since.
After shots pt had spells of starving and decreased response. He refused to eat for 14 hours after shots. Some of the above persisted for several days. Mother notes occasional staring spells at present.
Fever of 101f; Chest congestion; Headache; Trouble with breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient himself).  A male patient of an unspecified age received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 28Oct2021 as dose number unknown (booster), single for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced fever of 101f within 24 hours, first week result in severe chest congestion and trouble with breathing, headache, trouble with breathing on an unspecified date in Oct2021. The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on Oct2021. She took over the counter drugs for the resulted events. She finally had return to almost normal condition after two weeks. The outcome of events was recovered on an unspecified date in Nov2021.   Follow-up attempts are completed. No further information is expected.
UNABLE TO TOLERATE VIVOTIF; STOMACH DISCOMFORT; NAUSEA; This spontaneous case (PVX2019-830) was received from a nurse on 08-Apr-2019. It describes a 26-year-old female consumer who was unable to tolerate Vivotif and experienced stomach discomfort and nausea after the intake of oral Vivotif (one dose every other day) for typhoid fever prophylaxis.   Case report: The consumer took the first dose of Vivotif and unable to tolerate it. She experienced stomach discomfort and nausea.   She did not take any treatment for the adverse events.  Action taken with Vivotif for the events unable to tolerate Vivotif, stomach discomfort, and nausea was vaccine discontinued.  The clinical outcome of the events unable to tolerate Vivotif, stomach discomfort, and nausea was resolved.  Company's Comment: In this case, it was reported that the consumer was unable to tolerate Vivotif, and had stomach discomfort, and nausea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach discomfort, and nausea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible. ; Sender's Comments: Company's Comment: In this case, it was reported that the consumer was  unable to tolerate Vivotif, and had stomach discomfort, and nausea after intake of Vivotif. There seems to be a temporal association between the intake of the vaccine and the events. Also, stomach discomfort, and nausea are labelled as per CCDS. Hence, the causality of the events with Vivotif is assessed as possible.
Per patient, she called the pharmacy on 11/27/18 saying she had pain on deltoid muscle a couple days after the immunization. But now she thinks it has radiated to her shoulder and clavicle pain. She will see the doctor in a couple days, so I told her to discuss that with her PCP.
This may just be coincidental but the infrequent (several times a year) arrhythmia became more sustained and frequent at the end of February, just days after my vaccine. I ended up wearing a monitor, getting an ablation in August  for a flutter and then, after wearing a monitor again and the discovery that my heart paused during a day when I was experiencing arrhythmia I received a pacemaker two weeks ago.
Breakthrough case admission after 3 vaccines Moderna 2/18/21 lot# 023M20A; Moderna 3/18/21 lot# 002B21A;  Moderna 12/6/21 lot# 029H21B;
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K008931, expiration date 04-MAR-2017, exact doses and route of administration were not reported). It was reported that the vaccines were exposed to temperature of 31.8F during cumulative total of 28 hours. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Approx. a week after the last shot I developed a severe rash over my entire body, including my head, chest, arms, legs, feet on both the front and back of my body. This has continued up to today - 6.2.2021. Steroid shot and 4 day dose of steroids, steroid creams, famotidine, anti-histamines, and imipramine.
This spontaneous report was received from a registered nurse and refers to an 8-week-old patient of unknown gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 19-DEC-2018, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB lot # R014261, expiration date 25-MAR-2021 or lot # R005118, expiration date 28-NOV-2020 (dose and route of administration were not reported).  Administered dose of vaccine experienced the temperature excursion of 31.1 Fahrenheit degrees (F) (below 32 F/ 0 Celsius degrees) (30 cycles) for 35 hours 30 minutes. There were no previous excursions reported. The digital data logger was involved to capture the temperature excursion. No adverse effects were reported. This is one of multiple reports received from the same reporter (it was reported that it was unknown which lot numbers of each specific vaccine were administered to which patient).; Sender's Comments: US-009507513-1901USA000071:
Patient had an allergic reaction. onsite EMS was called vitals BP 170/96  100% O2 HR 88. Patient refused evaluation and care , released againt medical advice.
Seconds after receiving the vaccine the patient fainted while seated in the chair. Her father stood in front of her and held her head and rubbed her shoulders as he was aware this was going to happen as she always faints after receiving a vaccination.  I was not made aware of this prior to giving the vaccination but she came to within approximately 4 seconds and regained color. She remained seated in the consultation room with her father and brother until the observing time was over and she felt strong enough to walk out with her dad.
A 2 year old patient was given  the Pfizer Covid vaccine for age group 5- 11 year old. No side efeects as of yet
Pt describes a localized skin reaction as a 2" by 1" area that was raised and hot.  The next morning her "entire upper arm was raised to a 5" by 5" raised, itchy and burning hot area".  She also reports feeling "light-headed".   Today, 4/7/14, she reports the site is not swollen or hot just "very itchy" with a "light bruise".
Myoclonic jerking, fever' treated with ibuprofen in office when patient returned.
SERIOUS SIDE EFFECTS; This spontaneous report received from a consumer via social media concerned multiple patients of unspecified age, sex, race and ethic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient previously received covid-19 vaccine from unspecified manufacturer (suspension for injection, route of admin, and batch number were not reported), 1 in total, dose was not reported, for prophylactic vaccination. (Dose number in series 1). It was unknown whether patient had any adverse event following covid-19 vaccine from unspecified manufacturer.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported 1 total administered for prophylactic vaccination. (Dose number in series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  Consumer reported that "And many of my coworkers have serious side effects present themselves, post-booster shot." (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of serious side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240501.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Fever persisting 36 hours with a peak temperature of 102.6 degrees, body aches and fatigue
No additional AE details provided; Medical assistant reports improperly stored vaccine was administered to a patient. Reported excursions occurred 8/3/2023, 8/4/2023 and 8/8/2023. Product was administered to one patient 8/24/2023.  Include in the Description (cut and paste with respon; This spontaneous report was received from medical assistant and referred to a patient of unknown age and gender. The patient's medical history, concurrent condition, and concomitant therapy were not reported.  On 03-AUG-2023, the vaccine hepatitis A vaccine, inactivated (VAQTA) injection had improperly stored temperature excursion with temperature from 36 Fahrenheit degrees ('also reported as '35.6F') to 46 Fahrenheit degrees for 2 hours 30 minutes and 0 seconds. On 04-AUG-2023, this vaccine had below 36 Fahrenheit degrees ('also reported as '35.4F') for 3 hours 0 minutes and 0 seconds. On 08-AUG-2023, this vaccine had temperature excursion from 36 Fahrenheit degrees ('also reported as '35.7F') to 46 Fahrenheit degrees for 9 hours 0 minutes and 0 seconds. On 24-AUG-2023, the patient vaccinated with hepatitis A vaccine, inactivated (VAQTA) injection (valid lot # 1971534 with reported expiry date 06-OCT-2024) (strength, dose description, route of administration were not provided) as prophylaxis (Product storage error). There was no additional adverse event details provided (No adverse event).
Rt arm area where varicella vaccine given warm and redness noted fever of 102.2
patient inadvertently received three doses of Fluarix within the same season; This case was reported by a physician via call center representative and described the occurrence of extra dose administered in a 19-month-old male patient who received Flu Seasonal QIV (Fluarix Quadrivalent 2022-2023 season) (batch number 953Y2, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included FLUARIX QUADRIVALENT (1st dose of Fluarix Quadrivalent 2022-2023 season received on 16th September 2022 with batch number 9XL7N and expiration date 30th June 2023). Concomitant products included INFLUENZA VACCINE INACT SPLIT 4V (FLUARIX QUADRIVALENT).   On 19th December 2022, the patient received the 3rd dose of Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On 19th December 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered 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 Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comments: The pediatrician reported that, the patient inadvertently received three doses of Fluarix within the same season.  The reporter consented to follow up. Additional Supportive Information: The patient received additional 3rd dose of Fluarix Quadrivalent, which led to extra dose administered.
30SEp98 pt was playing volleyball (4 games) starting just 2hr p/vax turned white as a ghost;c/o pain in neck & head was nauseated;went to bed 7PM;sl sore neck & h/a;lethargic;T101;sleepy;severe h/a;
Noted lump 9/28/09 Red and warm . Not feeling bad - Arm hurt. Redness and warmth upper arm was given sample XYZAL 5mg one daily. Symptoms resolved.
Breakthrough case. Patient completed series on 1/9/2021 and became positive 5/10/2021 after home cohabitant exposure.
Eight days post vax, pts parent noted 2-3 small red bumps on abdomen. The next day the sitter call parent saying the pt had red bumps on the face and abdomen.
Patient is allegedly having a hearing impairment after receiving the first dose of pfizer covid 19 vaccine
Pain/ swelling at injection site Dizzy about 4 hours after shot (lasted only a few hours) Drowsy the first and second night 24 hours: site also became itchy
PT CALLED AROUND 155PM BECAUSE OF BODY RASH DEVELOPED SINCE SUNDAY MORNING. SEEMS TO BE ALL OVER THE BODY , MOSTLY IN SKIN FOLDS (NECK, ARMS, ETC). NO OTHER REACTION BESIDES A SLIGHT FEVER. COUNSELED TO TAKE BENADRYL AND OR USE CORTAID. ALSO ADVISED TO SPEAK WITH PCP AND NOTIFY PHARMACY PRIOR TO ANY FUTURE COVID 19 VACCINATIONS
PATIENT'S WHOLE BODY STARTED ITCHING THE MORNING AFTER RECEIVING HER FLU SHOT