chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Left eye had swollen up; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 2-month-old male patient (age at vaccination: 9 weeks) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, Lot number: CM1132; Expiration date: 31May2022), intramuscularly on the left thigh on 23Jul2020 at 0.5 mL, single to vaccinate/immunize against pneumonia. The patient had no relevant medical history and concomitant medications. On 23Jul2020, approximately four hours after the vaccination, the patient's left eye had swollen up. The outcome of the event, 'left eye had swollen up', was recovered in Jul2020.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
experience itching at vaccine site; Patient complains of itching of skin; This is a spontaneous report from a non-contactable other health care professional. A 33-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266), via intramuscular route of administration in left arm on 12Feb2021 (at the age of 33 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. During her 15-minute waiting period after the injection, the patient began to experienced itching at vaccine site on an unspecified date in Feb2021. She denied difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, lightheadedness, dizziness, facial swelling, lip swelling and tongue swelling. The patient complains of itching of skin. The patient denies facial swelling, sore throat, frequent throat clearing, chest tightness, shortness of breath and wheezing. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
adult patient was administered PROQUAD by accident.; No Adverse Event; This spontaneous report was received from a nurse refers to a 70-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-JUN-2023, the patient was vaccinated with the first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous (lot #, expiration date, exact dose, and anatomical location were not reported) for prophylaxis.  It was reported, that an adult patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) by accident (product administered to patient of inappropriate age). No additional adverse event reported (no adverse event).
This spontaneous report as received from a consumer refers to her daughter, a female patient of unknown age. On an unknown date the patient was vaccinated with the first dose of GARDASIL (lot # not reported). It was reported that the GARDASIL had not been stored at the correct temperature. No adverse event symptoms were reported. It was unspecified whether the patient sought for medical attention. GARDASIL was not discontinued. The outcome was unknown. Additional information has been requested.
Pt was given first dose Covid vaccine 3/4/2021. then had seizure like activity 3/5/2021. Became unresponsive. Does have a Hx of seizure X1. strong family Hx of seizures. was transported to Hospital Via EMS, Admitted to ICU.
I got the shot at 5:30 pm. Starting early the next morning (around 3 or 4am), I began to experience intense fever and headache. I got up to get Advil and had a seizure. I have epilepsy, and had not missed a dose of my medication. My last seizure before this was 2 years ago. After recovering, taking Advil, taking a shower, and going back to sleep for about 4 more hours, I woke up feeling fine.
arm hurt; chills; fever of 99.9 degrees F; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (arm hurt), CHILLS (chills), PYREXIA (fever of 99.9 degrees F) and MYALGIA (body aches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (which she contracted from her husband), Chronic fatigue, Chronic bronchitis, Chronic pneumonia, Degenerative joint disease, Seasonal allergy and Penicillin allergy. Concomitant products included FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Allergy, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Degenerative joint disease, BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) for HIV disease, EPINEPHRINE (EPIPEN) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm hurt), CHILLS (chills), PYREXIA (fever of 99.9 degrees F) and MYALGIA (body aches). On 28-Feb-2021, VACCINATION SITE PAIN (arm hurt), CHILLS (chills), PYREXIA (fever of 99.9 degrees F) and MYALGIA (body aches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Feb-2021, Body temperature: 99.9 (High) 99.9 degree F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-337239 (Patient Link).
Red mark, warm feeling and after a week it started itching. And where I was scratching there is a bruise.
Child developed pallor, nausea and vomiting and listlessness approx 2 minutes after vaccinations today. Used O2 at 1.5 then 2 liters for about 7 minutes. Vomited x 2 without sign of aspiration. Observed for 30 minutes. Child left with parent. Child sleepy but responsive and normal coloring on departure. Asked parent to watch closely for abnormal behavior. Called parent at 3:50 P.M. 2/12/2010: states daughter slept for two hours then awoke, feeling normally. C/O sore arms. Recommended TYELNOL for discomfort. Parent thanked us for the phone call.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Mar-2021 at 3:17 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 3:05 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In March 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was reported as 31.36 on 03-Mar-2021 and 31.44 on 31-Mar-2021. Concomitant products were not provided. Batch 014M20A, on 03-Mar-2021, Excursion time was 09 AM, 11 AM, 12 PM, 1 PM, 2 PM, 3 PM, 4 PM and 5PM temperature was 33, 35, 35, 35, 35, 34, 34 and 35 total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-Feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. Batch 030B21A, on 31-Mar-2021, Excursion time was 08 AM, temperature was 32 total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 04 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. Excursion time was 09 AM, temperature was 32, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 30-Mar-2021, vial was moved to clinic on 31-Mar-2021. 14 vials were sent to clinic. Vaccine BUD date was 29-Apr-2021.  Batch 014M20A, on 03-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 51, 10 AM: 34, 11 AM: 44, 12 AM: 46, 1PM: 35, 2 PM: 36, 3 PM: 36 and 4 PM: 36. Batch 030B21A, on 31-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 31, 9 AM: 32, 10 AM: 40, 11 AM: 42, 12 AM: 43, 1PM: 44, 2 PM: 46, 3 PM: 46, 4 PM: 44 and 5 PM: 44. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.
Booster; headache; lower back pain on right side of body; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 16Dec2021, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset Dec2021, outcome "unknown", described as "headache"; BACK PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "lower back pain on right side of body".  Additional information: Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Telephone conversation  01/25/2021: He reports after left arm injection on 01/17/2021 he had sore arm (no redness) and fatigue. He reports symptoms went away after 2-3 days . Then  he reports injection site of left arm started itching  01/24/2021 and then site became red, hot and puffy. He denies fever, chills, SOB, cough, diarrhea . He reports redness extends from the shoulder area to the bicep. Denies break in skin. He reports his temperature is 98f. He reports took his arm temperature at the site of injection and it is 101.6. He reports has full ROM and strength of arm.  Pain on scale of 1-10 is 1-2 per his reports. Advised RICE, benadryl /Zyrtec. If not better advised  go to Urgent Care/ED for evaluation.
Arm pain, excessive fatigue, nausea, confusion, dizziness, sweats, cold, pain in joints. started Monday and continues today, 5 days later
Developed heart palpations (skipping an occasional heartbeat) a three weeks after receiving second shot. Scheduled to see cardiologist on 8/23/2021.
MMR administered SC in left arm 11/13/06, returned 2 days later 11/15/06. Slight redness, warm to touch, size of 50 cent piece reaction. Referred to MD treated with Benadryl 1 steroids PRN, no known allergies.
Awoke to chest pain on 5/24 @ 1AM. Waited 24hrs with pain fluctuations. Went into ED 5/25 @0630, with continued chest discomfort.  Was given nitro, ibuprofen, colchicine. Was diagnosed with Myocarditis.
Still has a bad cough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of cough in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced cough (Verbatim: Still has a bad cough).  The outcome of the cough was not resolved.   It was unknown if the reporter considered the cough to be related to Arexvy.     It was unknown if the company considered the cough to be related to Arexvy.   Additional Information: GSK Receipt date: 03-OCT-2023 This case was reported by patient via (open field AE monitoring) interactive digital media. Follow up was not possible, as no contact details were available.
patient received Moderna as a 2nd dose, 1st dose was Pfizer.  Patient has not had any symptom other than a sore arm at injection site
several pt recv vax & 6-8wk later had false positive test results for infectious mononucleosis using test kits manufactured by reporter's company;
Pt stated skin was rasied, red mark, and lots of pain.  Pt believes this was due to improper placement of immunization.  awaiting more information at this time from the patient.
104 degree fever experienced by patient that evening after injection left arm still sore as of 7/16/22, over 1 month later Referred to md by us.
feeling of light headedness for 3 straight days; felt fatigue; hard to focus; This is a spontaneous report from a contactable consumer or other non hcp.A 65-years-old male patient received second dose of BNT162B2(BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 12Feb2021 10:30 as SINGLE DOSE for covid-19 immunisation.The patient medical history and concomitant medications were not reported.  Historical vaccine includes patient received first dose of BNT162B2(BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 at 11:00 as SINGLE DOSE for covid-19 immunization. Patient did not get other vaccine in four weeks and no other medications in two weeks. Patient does not have covid prior vaccination and does not tested covid post vaccination. Patient does not have any other allergies. On 14Feb2021 12:00, after 2 days of the second vaccine patient felt fatigue and a feeling of light headedness for 3 straight days hard to focus. The outcome of the events was resolved.  Information about lot/ batch number has been requested.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2015, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2016, the patient was treated by a nurse practitioner for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
This is a spontaneous report from a contactable pharmacist. An 80 year-old male patient received PREVNAR 13 (lot R48403, expiration date Apr2018, NDC 0005197102) via an unspecified route of administration on 17Mar2017 at 0.5 ml single for immunization. Medical history included ongoing benign prostatic hyperplasia, concomitant medications included finasteride at 5 mg once a day and tamsulosin at 0.4 mg once a day, both oral ongoing for benign prostatic hyperplasia. On 17Mar2017 the patient had some soreness for the first couple of days, the pain then on an unspecified day in Mar2017 was radiating to the back of the arm and the shoulder (pain was not in joint, but just below it) and the patient also had numbness and tingling that radiated to the fingers. The patient noticed it more when he laid on the side where he received the injection. No relevant tests were performed. Outcome of soreness was unknown, the patient was not recovered from the other reported events. The reporter did not believe it was the vaccine that was causing the patient's symptoms and said that it sounded more like a pinched nerve. Causality for events pain radiating to the back of the arm and the shoulder and numbness and tingling that radiated  to the fingers was reported as unrelated to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: Based on the information currently available, the events pain radiating to the back of the arm and the shoulder and numbness and tingling that radiated to the fingers are not related to the vaccination with PREVENAR 13 but more likely represent intercurrent medical conditions of nerves pinched.
The child developed a fever of 102 F and a red maculopapular rash (many 3-5 mm lesions) on the trunk on 9/21, 8 days after receiving MMR and other vaccines (DTaP, IPV, HIB, Prevnar, and Varicella).  Fever persisted for approx 3 days and rash persisted through visit on 9/24, with extension of skin lesions down the extremities.  A red nodule appeared.
Fever, pain in thigh, vomiting, diarrhea, sepsis, eventually died two weeks later. Time of death 6-11-21 1am
Large (2-3 inches) hard knot below skin  that was hot & itched.  It felt like a bug bite, only much larger.  No treatment.
2/25 shot at 10:20 am   same evening fever and chills    2/26 Headache and sleep all day   2/27 left arm red , rash,  ( like hives)  3/2 lighter in color still  rash with bumps.
Complained of sudden onset of generalized chills and "feeling of pressure and heaviness in my head" which lasted about 2 minutes. Symptoms resolved on own by 1305 same day.
woke up this morning with sinus pressure and a little bit of a nose bleed; woke up this morning with sinus pressure and a little bit of a nose bleed; Can taste blood in his throat and mouth; He has a headache and it seems like a sinus headache; This is a spontaneous report from a contactable consumer (patient). A 23-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0170) at the age of 23-years-old, via an unspecified route of administration in right arm on 22Apr2021 at 14:00 at single dose for COVID-19 immunization. Medical history included being a smoker (he vapes). The patient's sister has Addison's disease. There were no concomitant medications; no additional vaccines administered on the same date as BNT162B2 and there were no prior vaccinations within 4 weeks. The patient previously received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EB8733) at the age of 23-years-old, via an unspecified route of administration in right arm on 01Apr2021 at single dose for COVID-19 immunization. The patient received the second dose of the COVID vaccine on 22Apr2021 at 14:00. He woke up on 23Apr2021 and felt like he had sinus pressure, then he blew his nose and had a bit of a nosebleed. He also felt like he could taste blood in his throat and mouth. The nosebleed stopped, but there was still some pressure in his sinuses. He asked if he needed to go to the hospital. He has a headache and it seemed like a sinus headache. It was more on the right side where he had the nosebleed. He could still kind of taste a little bit of blood in his mouth and throat. There were no relevant tests, but he was trying to figure out if it's needed. The events did not require emergency room or physician office visit. He was not hospitalized but he was trying to decide if he needed to go to the hospital. The outcome of the event nose bleed was recovered on 23Apr2021 and not recovered for all other events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-up (23Apr2021): New information from a contactable consumer (patient) includes: patient details, medical history, historical vaccine, therapy details, reaction data ("Can taste blood in his throat and mouth" and "has a headache and it seems like a sinus headache" were added; outcome and onset were updated), and course of events.
HISTORY OF PRESENT ILLNESS: This is a 20-year-old male with past medical history of asthma, who was brought to ED by ambulance for nausea, vomiting, generalized weakness, and fever. The patient received his second dose of Moderna vaccine 10 days ago. The patient is experiencing symptoms of nausea, vomiting, fatigue, poor p.o. intake for the last few days. He was at ED 4 days ago and had a negative workup. The patient had a fever with T-max of 103 at home. He also had 2 episodes of emesis in the last few days. He denies any diarrhea, chest pain, abdominal pain. He complains of headache. He denies any blurred vision or neck stiffness. At hospital, the patient was given 4 L of fluid and had multiple blood tests. Even echocardiograms were unremarkable. The patient is unable to ambulate because of generalized weakness and dizziness.
Rash initially started as a single itchy blister distal to injection site on anterior forearm. Rash multiplied into a shingles like rash- made a doctor's appointment and received antiviral medication. After 1 day of medication rash crossed the midline and was told it could be a poison ivy. Steroid cream prescribed and no relief given after several days. Rash continued to spread and evolved into a target lesion rash on both forearms, upper arms, chest, abdomen, thighs, calves, ankles, feet, toes, plantar surface, palms of hands, fingers, neck and face. Returned to doctor and was given a 12 day taper of prednisone. No relief of itching or spreading after 7 days. Rash started healing slowly and after finishing steroid,  rash reappeared on right and left forearms, abdomen and thighs. Was referred to an allergist while on the steroid. Dr. did a blood test for lyme disease and shingles iGg. Lyme was negative, shingles iGg was positive, but not high enough to indicate recent outbreak. Rash started resolving after several days. One week after resolution, rash reappeared and Dr. performed a biopsy. Results of biopsy were hypersensitivity reaction. Rash is still reoccuring as of 11/18/2021.
Horrible lymph node pain and ear pain for about three months, left with tinnitus in ear on the side of injection 6 months later
Information has been received from a registered nurse concerning a 17 year old female who on 17-OCT-2007, was vaccinated with a dose of Gardasil (possible lot#'s 0523U, 1425F, 0515U) that was improperly stored reaching 32 degrees F on 4 occasions 10/02/2007, 10/03/2007, 10/09/2007 and 10/11/2007.  No problems were reported.  It was unknown whether medical attention was sought.  There was no product quality complaint.  This is one of several reports from the same source.
Developed erythema and pain about 24 hours after injection. Blister appeared last night and was broke open this morning. Low grade fever last night Tmax 100.2. Mom marked area with a pen and redness is spreading well beyond boundaries this morning. Unable to site on area.
The patient was given the Pfizer vaccine at 10:22 am. There were no complications with administration. The patient was then told to sit in the waiting area for 20 minutes. After about 1 minute he fell out of his chair in the waiting area and passed out. He was out for about 2 minutes until he came to. The pharmacist on duty tended to him and put a frozen water bottle on his neck. He was helped into his chair where he sat for about 5 minutes until he started to feel light headed again. At this point he went back to laying on the floor for about 15 minutes.  Once he was feeling well enough again, he moved back up into the chair. After a total of 45 minutes the patient called a ride and left to return home.