chrisvoncsefalvay/vaers-outcomes huggingface dataset:
20 year old patient received a pediatric dose; 20 year old patient received a pediatric dose; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number K329E, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2022, the patient received Engerix B pediatric 10 mcg and Engerix B Pre-Filled Syringe Device. On 11th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were 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 20 years old patient received pediatric dose of Engerix B, which led to underdose and adult use of a child product. The reporter consented to follow up.
He tested positive of Covid 19 vaccine last 23Mar.; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 17Mar2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that he got the first dose last 17Mar and second dose was scheduled on 14Apr (past 21 days). He tested positive of Covid 19 vaccine last 23Mar2021. He was asking if he needs to wait for 45 days before getting the second dose. The patient underwent lab tests and procedures which included Covid 19 (sars-cov-2 test): positive on 23Mar2021. The outcome of event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
This spontaneous report was received from a physician and refers to a 26 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On 23-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# L042846, expiration date 15-SEP-2017) 1 ml, intramuscularly in unspecified deltoid. No adverse events were reported. Administered dose of vaccine experienced the temperature excursion of 49 degrees Fahrenheit. This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
Patient's reaction(s) noted during COVID vaccine observation period: 15 minutes after Covid Vaccine received, patient states that she has tingling on her lips and arms, lightheadedness, and nausea.  Vitals taken;  0945: 148/86, HR 104, 100% RA, temp: 97.7 1015: 147/84, HR81, 100% RA, Temp: 98  Pt sitting comfortably in chair, drinking ice water.   No further evaluation, spouse drove patient home.    Disposition: Home
numbness un an unspecified arm; heart murmur; This spontaneous report was received from a physician, via a company representative, regarding a female patient of unknown age. The patient's drug reactions/allergies, concomitant medications and pertinent medical history were not reported.   On an unknown date, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis  On an unknown date, the patient experienced numbness in the arm after receiving HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9). She went to the hospital after experiencing the numbness, where she was later diagnosed with a heart murmur. The outcome of the events was not reported.  The causality assessment between HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) and the events was not reported.
Fever up to 101. Chills, weak, headache, tired, nausea
My baby got her 2 month old vaccine two weeks ago. The day after the shots, she started vomiting once every day in very large quantity. She never vomited before the vaccination. It was not projectile vomiting but it was at least 2-3 ounces at a time.
PATIENT RECEIVED J&J VACCINE ON 3.11.21 AND NOTED RASH AND SWELING OF THE FACE AND EXTREMITIES ON 03.12.21.  PRESENTED TO THE EMERGENCY DEPT FOR EVALUATION ON 03.13.21.  PATIENT WAS TREATED INTHE EMERGENCY DEPT WITH DECADRON 4 MG IM INJECTION AND BENADRYL 50 MG BY MOUTH. AT DISCHARGE FROM THE ER TO HOME THE PATIENT WAS GIVEN A PRESCRIPTION FOR MEDROL DOSE PACK.
Information has been received from a nurse concerning a 7 year old patient who on 9/2/98 was vaccinated with a dose of varicella virus vaccine live. On 5/11/04, the patient presented with chicken pox and had a fever of 100.9. The child was treated with hydroxyzine hydrochloride. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Initial and follow up information has been received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, drug reactions and allergies were not reported. On 25-AUG-2015, the patient received an improperly stored dose of VAQTA, lot # K007827, expiration date 09-DEC-2016 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effect was reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On 21-JUL-2016, the patient was vaccinated with a dose of VARIVAX (dose, route and lot # not reported). The pharmacist reported that the patient had a varicella antibody titers drawn on 25-AUG-2016 and the titer results showed high levels of positive antibodies. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Shortness of breath, audible wheezing-client took asthma inhaler without relief and at our direction family member drove her to urgent care.
I have extreme pain in upper left arm some time after Flu shot given at pharmacy. I can't remember the onset but I have a text on Oct 17 telling my sister about the pain in my upper arm where I got the Flu shot. She found other people suffered from same symptoms on internet. Doctor had x rays of neck done. Two doctors said it was from nerves coming from my neck. One prescribed physical therapy. I'm still having pain in the muscles and shoulder.
Severe headache and body aches began overnight.  Headache still present in morning after taking OTC pain relievers.
This is a spontaneous report from a contactable nurse via a Company representative. A patient of unspecified age ethnicity and gender received TRUMENBA, via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. On unspecified date after receiving meningococcal group b rlp2086 the patient experienced cellulitis for which required treatment. The outcome of the event was unknown.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
PAIN MIGRATE TO VARIOUS AREAS OF THE LOWER BODY (MOVES FROM ONE LEG TO THE OTHER); SEVERE PAIN IN BOTH LEGS (DULL DEEP PAIN LIKE A BROKEN BONE, PAIN IS AN OVERALL TIGHTNESS SIMILAR TO LACTIC ACID AS IF YOU HAD JUST RUN A MARATHON); VERY SHARP, STABBING PAIN IN THE MUSCLE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the patient experienced pain migrate to various areas of the lower body (moves from one leg to the other). On MAY-2021, the patient experienced severe pain in both legs (dull deep pain like a broken bone, pain is an overall tightness similar to lactic acid as if you had just run a marathon). On MAY-2021, the patient experienced very sharp, stabbing pain in the muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe pain in both legs (dull deep pain like a broken bone, pain is an overall tightness similar to lactic acid as if you had just run a marathon), very sharp, stabbing pain in the muscle, and pain migrate to various areas of the lower body (moves from one leg to the other). This report was non-serious.
Starting next day after 2 nd shot, sore shoulder at injection site (Assumed normal reaction).  But soreness did not  diminish as the days went by.  Also, mobility seems impaired and more pain with certain movements of the shoulder / arm.   Looked this up and discovered uncommon condition relating to vaccination shots called SIRVA (shoulder injury related to vaccine administration).  It?s now 8 days after shot and arm is still quite sore with mobility issues.  I will give it a few more days and if no improvement will seek medical help.
Pain/discomfort with redness and rash, slightly raised approx 1.5 in diameter area.
Mild allergic reaction; Tightness in chest; Shortness of breath; Numb tongue; This spontaneous case was reported by an other health care professional and describes the occurrence of HYPERSENSITIVITY (Mild allergic reaction), CHEST DISCOMFORT (Tightness in chest), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA ORAL (Numb tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Allergy (polysorbate 80) since an unknown date.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced HYPERSENSITIVITY (Mild allergic reaction), CHEST DISCOMFORT (Tightness in chest), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA ORAL (Numb tongue). At the time of the report, HYPERSENSITIVITY (Mild allergic reaction), CHEST DISCOMFORT (Tightness in chest), DYSPNOEA (Shortness of breath) and HYPOAESTHESIA ORAL (Numb tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment details were not provided.
Shoulder pain originating at site of vaccination. Pain is now radiating down arm to area of wrist. No redness noted at this site.  Treated with ice packs, Tylenol, Motrin, Aspirin & Bengay type Creme. Planning on visit to Doctor.  Out come unknown at this time.
she felt like she was having a very bad cold, or like she was getting the flu; she thought it was a combination of flu and allergies; she only had a runny nose; pain in her joints, her knees and elbows hurt; she noticed a big red circle in the injection site; she felt like she was having a very bad cold, or like she was getting the flu; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that she received the Pfizer Covid 19 vaccine at the pharmacy and the next day she felt like she was having a very bad cold, or like she was getting the flu. At first she thought it was a combination of flu and allergies, but she also experienced pain in her joints, her knees and elbows hurt and she noticed a big red circle in the injection site. The following day she felt okay, she only had a runny nose but she was not sure if it was a reaction to the vaccine or the weather. The patient wanted to know if these symptoms are normal after receiving the vaccine. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Complained of systemic reaction to smallpox vaccination. Fever of 102degF. Patient with cross contamination to lower arm and neck area. Patient learning reinforced.
Generalized urticaria reaction and swelling of legs and feet; treated with Prednisone 50mg/day; reaction faded within 24 hours. Medical record states allergic reaction. msv
No additional AE reported; Customer called for a temperature excursion and reported PROQUAD that had undergone temperature excursion was administered to patients before calling. No additional AE reported. No PQC reported. No patient demographics was provided. No further i; This spontaneous report was received from a medical assistant referring to a unknown number of patients of unknown age and gender. The patients' medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patients were vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019628, expiration date 19-DEC-2023 (dose and route of administration) for prophylaxis (product storage error). No adverse event was reported.  No information about the temperature excursion was provided.  Follow up information has been received on 10-MAR-2023.  varicella virus vaccine live (Oka/Merck) (VARIVAX) (Lot numberW018828 expiration date 14-JUN-2024), and  Lot number W006412 expiration date 23-FEB-2024) (dose and route of administration) for prophylaxis (product storage error), and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA)(PROQUAD) lot number W019627, expiration date 19-DEC-2023)  (product storage error).    This is a non-valid case due to the lack of patient identifiers.  Follow up information has been received from an other healthcare professional on 18-APR-2023. The reporter specified the patient's information. Therefore, this valid case was split from original case 2303USA002114. This spontaneous report was regarding a 12-month-old male patient. The patient's pertinent medical history, concomitant therapies and drug allergy or reactions were not reported. On 02-DEC-2022. the vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W018828, expiration date 14-JUN-2024) underwent temperature excursion for 30 min. The digital data logger was involved in recording excursion details. On 29-DEC-2022, the patient was vaccinated with the improperly stored vaccine varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot number W018828, expiration date 14-JUN-2024, strength and dose were not reported) intramuscularly (IM) at right thigh for prophylaxis at private doctor's office/hospital (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2303USA002114: US-009507513-2304USA007837:
a painful, burning zoster-like rash; postherpetic neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 04-MAR-2014, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (strength, dose, dose number, route, anatomical site of vaccination, lot number and expiration date were not reported). On an unknown date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)), the patient suffered a painful, burning zoster-like rash, she was ultimately diagnosed with post herpetic neuralgia. Besides, as a direct and proximate result of patient's use of the zoster vaccine live (ZOSTAVAX), the patient had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. In addition, she suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was considered not recovered. The events were considered related to zoster vaccine live (ZOSTAVAX).   Rash vesicular and post herpetic neuralgia were considered to be disabling.
PATIENT WAS GIVEN MODERNA AS HIS FIRST SHOT AND WAS ADV BY THE PHARMACY THAT 12 YEAR OLDS SHOULDNT BE GIVEN MODERNA... NO SYMPTOMS JUST YET
have been experiencing high pitched whistling in ears; tend to fall asleep in the middle of the day; have little energy; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 01Mar2021 at 10:00 (at the age of 73-year-old), as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Mar2021 (at the age of 73-year-old), as a single dose for COVID-19 immunisation. Medical history included type 1 diabetes mellitus for 50 years. The patient had no known allergies to medications, food, or other products. Concomitant medications included insulin lispro (HUMALOG), insulin glargine (LANTUS), atenolol (MANUFACTURER UNKNOWN), lisinopril (MANUFACTURER UNKNOWN) and simvastatin (MANUFACTURER UNKNOWN) all for unknown indications from an unknown date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 10:00, the patient had been experiencing high pitched whistling in ears, tend to fall asleep in the middle of the day and had little energy. The patient does not normally fall asleep in the middle of the day. The patient was retired; however, he paints houses, work on cars and play with grandchildren. So, what the patient was experiencing was not normal. The patient did not receive any treatment for these events. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. The clinical outcome of the events high pitched whistling in ears, tend to fall asleep in the middle of the day and little energy was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. Medical history and concurrent conditions were not provided. On 28-MAY-2015, the patient was inadvertently vaccinated with an improperly stored dose of GARDASIL lot # K009482 expiry date: 06-MAR-2017 (dose and route were not reported). No adverse effects reported or Product Quality Complaints (PQC) involved. There was no concomitant medication provided. This is one of several reports received from the same reporter. Additional information is not expected because the reporter refused additional contact.
This patient since the second covid vaccine on sept 1st 2021 has now skipped two periods with no previous issues before taking the covid vaccine.
Patient presented to the ED and was subsequently hospitalized for COVID 19, acute kidney injury within 6 weeks of receiving COVID vaccination.
16Dec89 pt vax;  devel rash on arms & wrists w/ burning and itching.  Devel gen urticaria & fatigue.  Tx w/ pres drugs w/out effect.  Prescribed cortisone pt refused.  Sx persisted as of 18Jul90.
This is a spontaneous report from a non-contactable consumer reporting on behalf of the mother. An 83-year-old female patient received PREVNAR 13 on 04Apr2017, in arm, at single dose, for immunisation. The patient medical history was not reported. The patient family history included unspecified adverse reactions and unspecified severe adverse reactions to new drugs. The patient's concomitant medications were not reported. Since an unknown date in Apr2017 (reported as 2 days after vaccination) the patient experienced swollen arm, hard knot, that before was red, hot and as big as a baseball, diarrhea, itching that came and went on her legs/thighs and was extremely fatigued. She used to walk on the treadmill and she was unable to do that now. The patient went back to the doctor and called him twice. The doctor said there was nothing he could give her. She could not get over it, she felt miserable. At the time of report she could barely feel the knot, when she was using her arm it got a little bigger but not like it was. Diarrhea, itching, knot and fatigue were resolving at the time of report. The outcome of the other reported events was unknown. No follow-up attempts possible. No further information expected.
Rash developed on opposite side of body 24 hours after vaccination (right side), below right armpit. Tennis ball sized and painful. On Day 4 small blisters developed.
side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (side effects). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were reported No treatment medications were reported
Received an Expired Dose of Heplisav-B; Initial Report Received on 29-SEP-2022  This is a spontaneous report, received from a patient care service regarding a female patient, aged 21 years, who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient. The patient had no known drug allergies.   Concomitant medications were not reported.  On 27-Sep-2022, a dose of HEPLISAV B (Lot #93584, expiration date 17-SEP-2022, NDC #43528-003-05), route not specified, was administered in the right deltoid for hepatitis B immunisation.   The dose was reported as being 10 days past the expiration date. The patient did not report any adverse reactions.  The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.