chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever of 105.2 degree Fahrenheit; Nausea; Vomiting; Chills; Body aches; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever of 105.2 degree Fahrenheit), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Body aches) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PYREXIA (Fever of 105.2 degree Fahrenheit), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at a dose of 2 extra strength and IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 200 mg twice a day. At the time of the report, PYREXIA (Fever of 105.2 degree Fahrenheit), NAUSEA (Nausea), VOMITING (Vomiting), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105.2 degree fahrenheit (High) 105.2 degree Fahrenheit initially.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.     This case was linked to MOD-2021-303261 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Body temperature added
pt recv vax & some time p/vax pt devel n/v, cramping & h/a;
Patient received vaccine and returned to lobby for observation period. Within about 5 minutes patient became light headed and fainted while seated. Patient was given water and moved to immunization room where he could lay down. Patient's parents were contacted to come pick him up. At the time of their arrival the patient was alert and oriented and feeling better.
11/9/15 - first ever flu vaccine given LVL. 11/10/15 - vomit x 1 , rash to left wrist, red bumps then spread to right arm, left foot, to back, no trouble breathing, no fever. 11/11/15 - saw doctor for vomiting, hives, doctor unsure if it was a reaction vs. viral illness. BENADRYL given in clinic.
Caller said the patient fainted and became unresponsive about 5 to 10 minutes after receiving the dose. EKG was then performed in the office which showed some abnormalities so patient was sent; became unresponsive about 5 to 10 minutes; EKG was abnormal; This spontaneous report has been received from a nurse referring to a 4-year-old male patient.  The patient's pertinent medical history, drugs reactions or allergies and concomitant medications were not provided.  On 10-JAN-2023, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-Merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, 0.5 milliliters, lot number W010524 has been verified to be a valid lot number with expiration date on 25-SEP-2023  (vaccination scheme, frequency, route of administration and anatomical site of injection were not provided) administered as routine vaccination. On the same date, about 5 to 10 minutes after receiving the dose the patient fainted and became unresponsive (syncope) (unresponsive to stimuli), an electrocardiogram (EKG) was then performed in the office which showed some abnormalities (electrocardiogram abnormal), following the patient was sent to emergency room. No further information was provided.  The outcome and causality assessment of the events was not provided.  Upon internal review the events syncope and unresponsive to stimuli were determined to be medically significant.
Patient states the day following his vaccine 8/13 and 9/10 he has had severe exacerbation of his chronic nerve pain in his hands, left arm, and neck. He had to go to the emergency room 8/13, 8/14, 8/15, and 8/16 for severe pain, numbness, and tingling in the hands and arm. He has been encouraged to go to ER for his current severe pain.
Numbness in arm immediately after the shot was administered. Followed by pain within 20 minutes in the left arm. Hard to lift arm on the drive home. Within 45 minutes I experienced a lightheaded feeling that progressively worse and made it feel like I was drunk while driving home. I was slurring my words like I was drunk. When I got home, I fell asleep almost immediately.  Slept through the night and into the morning.  Still a sore arm, light headed and have periodic sweats, diarrhea, and dizzy spells and still tired. I took some tylenol at noon.
Arm became sore, developed watery blister (first noticed 11/11/10) still present 11/12/10.
ACHE; CHILLS; FEVER; This spontaneous report received from a parent concerned a 24 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 30-APR-2021, the subject experienced ache. On 30-APR-2021, the subject experienced chills. On 30-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, fever and ache was not reported. This report was non-serious.
A mother reported that her son, now 4 years old, received HIB and MMRII vaccines on 9/15/98, at 15 months of age. He subsequently, developed a fever of 104F that lasted for 3 days. He also developed a measles-like rash that was "dx'd by the HCP". The reporter noted that prior to vaccine administration, her son showed signs of "sensory integration," and he was usually difficult to console. Six months, post vax, the child was dx'd with autism. Autism was considered "Medically Important". No further information was available at the date of this report. Follow-up info was obtained from the physician. this child is one of triplets (2 female, 1 male). When he was 5 months old, he was referred to a developmental clinic because his mother noted he was frequently inconsolable and "behind his sisters in motor skills." The child continued to fall behind developmentally and before he was 2 years old, he was referred to a specialist. A confirmation of pervasive developmental delay was made. The physician indicated that the child is receiving treatments and services and "is improving and doing much better now." Additional info received from the pt's relative noted that on an unknown date the pt developed fever, measles-like rash and autism. The pt's fever, measles-like rash and autism were considered to be other important medical events. Additional info has been requested.
Information has been received from a physician concerning a female patients between 20 - 25 years old was vaccinated IM with Gardasil. Subsequently all the patient experienced abdominal cramping "like premenstrual related symptoms". The patient did not seek medical attention. Additional information has been requested. This is one of several reports from the same source.
redness; aching; This case was reported by a consumer via call center representative and described the occurrence of erythema in a 75-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient mentioned that she had received the flu vaccine in the past and had experienced redness and aching. that lasted for couple days.  No other details were provided. The reporter consented to follow up. This case has been linked with case US2020096472, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020096472:same patient
VASOVAGAL REACTION: PATIENT BECAME EXCESSIVELY WARM WITH DIPHORESIS AND FAINTNESS. PATIENT REMAINED CONCIOUS AND SYMPTOMS RESOLVED WITHIN 30 MINS AFTER TREATMENT WITH FANS, AIR CONDITIONING, WATER, AND GLUCOSE (CANDY) PRN.
Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; Prior to vaccination, was the patient diagnosed with COVID-19?:Yes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP) from product quality group. The reporter is the patient.  A 34-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Jan2021 at 07:30 as dose 1, single (Lot number: EL1284), in left arm and on 26Jan2021 at 08:00 as dose 2, single (Lot number: EL1203) at the age of 32 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Cough Asthma with Exercise" (unspecified if ongoing); "Cough Asthma with Exercise" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies Amoxicillin". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Prior to vaccination, was the patient diagnosed with COVID-19?:Yes". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results.  No follow-up attempts are possible. No further information is expected.
At end of 15 minutes, pt collapsed and then had a seizure < 15 s.  No history of seizures.  Pt declined going to the hospital.  Wife drove him home.  Instructed to see physician prior to dose 2.
Tingling hands, difficulty breathing, face felling hot and swollen - started almost immediately after injection. Benadryl was given and EMT advised going to the hospital for observation. Heart rate and bp returned to normal a few hours later. Still feel dizzy and lightheaded when standing. Was informed that it was a vasovagal reaction. Arm is also very sorry at injection sight. Left arm where injection was placed it still tingling in hand, right hand feels normal.
bad joint pain in hip, knee; pain in lower back; headache; new chronic migraines; concentrated pain above right eye; This case was reported by a pharmacist via other manufacturer and described the occurrence of headache in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included lenvatinib mesilate (Lenvima) unknown (batch number 11111111, expiry date unknown) for thyroid neoplasm and TOZINAMERAN (COVID-19 VACCINE PFIZER) for prophylaxis.   The patient's past medical history included chronic migraine and hand and foot syndrome.   On an unknown date, the patient received Shingles vaccine. On 29th March 2022, the patient started Lenvima (oral) 20 mg at an unknown frequency. On an unknown date, the patient received COVID-19 VACCINE PFIZER. On 20th June 2022, less than 4 months after receiving Shingles vaccine, the patient experienced headache, chronic migraine and facial pain. On an unknown date, the patient experienced joint pain and low back pain. The patient was treated with paracetamol (Tylenol) and excedrin (nos) (Excedrin). The action taken with Lenvima was unknown. On 24th June 2022, the outcome of the headache was recovered/resolved. On an unknown date, the outcome of the chronic migraine was recovered/resolved and the outcome of the facial pain, joint pain and low back pain were unknown.   It was unknown if the reporter considered the headache, chronic migraine, facial pain, joint pain and low back pain to be related to Shingles vaccine.      Additional Information: receipt date :12 July 2022 Reporters comment: The patient indicated they have been experiencing new chronic migraines that last for days after adjusting her dosing schedule of Lenvima. The patient indicated that about 6-8 weeks ago the patients specialist took patient off Lenvima for 3 weeks after she was recovering from hand and foot syndrome. After restarting the medication the specialist instructed the patient to take medication for 3 weeks on 1 week off. The patient advised that when starting back on the medication she had headache that lasted the entire week Monday through Friday with concentrated pain above right eye. The patient indicated no relief with Tylenol and Excedrin but the headache got better and went away by the end of the week. The patient also indicated she had been experiencing bad joint pain in hip, knee, and lower back while taking Lenvima and patient indicated these symptoms only began shortly after patient received Pfizer Covid 19 vaccinations and shingles vaccination. It was unknown if the reporter considered the headache, chronic migraine, eye pain, joint pain and low back pain to be related to COVID-19 VACCINE PFIZER and Lenvima. The patient stated that no relief with Tylenol and Excedrin but the headache got better and went away by the end of that week The patients prescriber was aware of all the patients side effects.
Crying inconsolable for 2 1/2 hrs after injection area at injections site red, both right and left thigh no lump noticed.
Information has been received from a registered nurse concerning a male who in January 2006, was vaccinated with a first dose of pneumococcal 23v polysaccharide vaccine.  In January 2006, after the vaccination, the patient developed a swollen arm and difficulty breathing.  The patient was treated with unspecified antibiotics and diphenhydramine hydrochloride (BENADRYL).  At the time of this report, the patient was recovering.  Additional information has been requested.
A report has been received from a Health Professional concerning a patient, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on an unknown date. It was reported that sixty five year old received FLUMIST. The outcome of the event of 65 year old received FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
Vaccine given on 4/30/08.  Patient called back approximately 3 hours later with complaints of blurred vision and tingling in arm.  Dr. seen patient again.  Advised Benadryl and call back next day.  Patient called on 5/2/08 and seen again.  6mm by 2mm thick irregular but smooth bordered erythema and tenderness.  Tingling fingers and lips and blurred vision.  See attached note.
Injection site reaction of redness about 6 inches in diameter, mild swelling, warm to the touch, and lasting longer than than one week before seeing physician. Reaction has not resolved to date.
nerve pain; shaking; weakness/cannot hold coffee; pain across biceps; This spontaneous case was reported by a nurse and describes the occurrence of NEURALGIA (nerve pain), TREMOR (shaking), ASTHENIA (weakness/cannot hold coffee) and MYALGIA (pain across biceps) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEURALGIA (nerve pain), TREMOR (shaking), ASTHENIA (weakness/cannot hold coffee) and MYALGIA (pain across biceps). At the time of the report, NEURALGIA (nerve pain), TREMOR (shaking), ASTHENIA (weakness/cannot hold coffee) and MYALGIA (pain across biceps) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medications were reported.
In 1998, the vaccinee received "a series" of Engerix-B. Subsequently, he "had" unspecified antibodies and then "lost them". On 3/19/02, the vaccinee received his 4th dose of Engerix-B (lot ENG5270A4; expiry 8/17/03). On 8/21/02, he was found to have Hep-B surface antigen positive. The reporter stated that the event was probably related to Engerix-B. As of 3/29/02, the event was unresolved. The pt was hospitalized for an unrelated, unspecified reason.
This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 07-JAN-2016, the patient received a dose of improperly stored VAQTA injection (lot # L017757 with expiration date 08-APR-2018; dose and route were not provided). It was exposed to temperature of 48.9F for 2 hours. There was no previous temperature excursion. The call was because of a data logger. No adverse effects were reported. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
I received the 1st dose of the Pfizer COVID vaccine on December 17th at 0640. I first started noticing some discoloration on the right side of my neck in a patch on January 1st. Over the course of the next 3 days the area became more red, dry, raised (but still maculopapular), and spread from the right side of my neck around the back of my neck to the left side and then the front. The area was mildly itchy. I had not had any new exposures including no new shampoos, soaps, clothes, sprays, sheets, detergent, etc. I have never had a rash that looked like this, nor have I ever had a rash on my neck. At it's fullest, the rash was a large patch of red, dry skin on my right with small maculopapular circles scattered on the rest of my neck. Around January 6-7th, when I got the second dose, the rash began to spread down my sides. That area was more itchy than my neck. The rash appearance was very consistent, as was the distribution with what I have seen of pityriasis rosea in my patients where you start with a Herald patch somewhere and then the rash spreads to other parts of the body. In January I had sought out an appointment through a virtual healthcare. they were hesitant to start steroids so as not to interfere with my immune response. I started over the counter hydrocortisone. In the few hours after I put it on the rash would be less itchy, less dry appearing and less red, but still noticeably pink, then would return. The rash has finally completely dissipated as of February 3rd morning, so it was present for a little more than a month.
Patient is currently 8 months pregnant. Within 12 hours of second vaccine dose administration, experienced sore arm at injection site, headache, and fatigue.
7JUN93 t101- light rash on abdo & back; 8JUN93 AM t102 generalized red rash head to foot; 8JUN93 PM t105 seen by MD dx w/sister like virus to measles; 10JU93 PM low grade fever (not measured) rash fading; yellowish color, nasal discharge;
Received vaccine at 1730, then just before midnight my heart began to pound hard and very fast, and it made me feel short of breath or as though I had to cough. After about a minute I thought it might be SVT so I did a valsalva maneuver and it stopped.  I was resting in bed, no alcohol or caffeine, and this has never happened to me before. Since then, I have felt at least one heart palpitation per day, sometimes many more. The last few days I have felt extremely fatigued and have had an odd sensation in my chest. On 1/7 I developed a dry cough, and was swabbed for Covid because I felt so bad. It was negative. This made me wonder if the odd sensation in my chest was related to my heart and not my lungs. I am due for my second vaccine today, and am unsure if I should get it.
Nausea, Diarrhea, Body Aches, Arm pain, Fatigue,Feel Unwell,Light Headed
This is a spontaneous report from a contactable consumer who reported for herself. A 74-year-old  female patient received PREVNAR 13, via an unspecified route of administration maybe in the right arm, on 06Dec2017 around 10:00 AM, at single dose, for immunisation. Patient was vaccinated in the physician's office. Relevant medical history included blood pressure high. Patient presented no illness at time of vaccination. Concomitant medications included Lisinopril/HCTZ from an unspecified date and ongoing for blood pressure high and Aspirin from an unspecified date and ongoing. The patient previously received an unspecified pneumococcal vaccine (but not PREVNAR 13, several years before, for immunisation, with no adverse effect. The patient experienced heart racing in Dec2017 with outcome of not recovered, hands and feet would be numb like they were asleep in Dec2017 with outcome of recovering, some premature ventricular contractions (PVC's) on an unspecified date with outcome of unknown, started waking up at night on an unspecified date with outcome of unknown. Very shortly after receiving the vaccine the patient started waking up at night with her heart racing. Heart racing was persisting, but this was concerning to her because it was getting a little more frequent. She feels it mainly at night, and it generally wakes her up. She has seen her physician and had a 24 hour heart monitor in the beginning of Jan2018. She didn't think that she had an episode of heart racing during the heart monitor, so all it showed was some PVC's. On 28Feb2018, she called the nurse line available through her insurance company because of the heart racing, and was told that she should go to the emergency room. She went to the emergency room that night and had an EKG and an X-ray that both came back okay. The patient also stated that since getting the vaccine, she would wake up and her hands and feet would be numb like they were asleep. She wasn't sure if this was from the vaccine, or from the new job that she started a few months before. This improved.