chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severe body aches; headaches; running a temperature 101.8F; swelling in her bottom lip and eye area; wasn't feeling well after receiving the second dose; swelling in her bottom lip and eye area; This is a spontaneous case received from a contactable consumer. A 27-year-old female patient  received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection; Lot number: UNKNOWN), via an unspecified route of administration on 18 Mar 2021 as single dose for covid-19 immunisation. The patient medical history included fibromyalgia. The patient concomitant medications were not reported. The patient was wasn't feeling well after receiving the second dose of Pfizer's COVID vaccine on 18 Mar 2021. She is having severe body aches, headaches (head pressure), and is running a temperature 101.8F, and swelling in her bottom lip and eye area. She was taking children's strength acetaminophen chewable and has taken a few doses today. The outcome of events were unknown.  Information on the lot/batch number has been requested.
This spontaneous report received from a patient concerned a 40-year-old female patient (weight: 200 pounds; height: 61 inches). The patient's concurrent conditions included: seasonal allergy. No concomitant medications reported. The patient received the 1st dose of the COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# 203A21A, expiry: Sep 21, 2021), on Jul 18, 2021 for immunization. On Jul 18, 2021, patient developed a big, red painful boil (right hip). On Jul 20, 2021, patient's skin was covered with dry, itchy black spots (all over entire body except for face). Rash started like raised, red patches that turned black. Laboratory data (dates unspecified) included: Lab test (NR: not provided). The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient has not recovered from a big, red painful boil (right hip); rash started like raised, red patches that turned black and skin covered with dry, itchy black spots (all over entire body except for face).
Initially had extreme fatigue and mild nausea.   Hives started on Sunday on torso and at injection site (LA) and continued to spread throughout the night.  Monday AM (4/19) spread to neck, chest, legs and arms.  Also have a dry cough.
suspected vaccination failure/had the shingles shot & got the shingles; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient's brother's wife. The age at vaccination was not reported. The patient had the shingles shot and still got the shingles bad. The reporter stated that they would not ever get the shingles shot as Medicare would not pay for it anyway and even if they did, they still would not get that crazy shot. Follow-up would not be possible as no contact details available. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case was linked with case US2021AMR231046, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR231046:same reporter
Vomiting, "difficulty breathing", no temperature at health department but temperature 102 at physician's office, gave Amoxicillin and suppositories for vomiting on 4/27/00. 4/28/00 mom and grandma spoke with nurse at health department and admitted that they forgot to tell that the pt got ill with other shots.
This case was reported by a consumer via call center representative and described the occurrence of tremor in a 81-year-old female patient who received BOOSTRIX. Previously administered products included Tetanus shot (received a couple years ago). Concomitant products included Influenza vaccine. On 27th September 2016, the patient received BOOSTRIX (intramuscular) .5 ml. On 27th September 2016, several hours after receiving BOOSTRIX, the patient experienced tremor and teeth chattering. On 28th September 2016, the patient experienced dry cough, general body pain, sweating and fatigue. On 29th September 2016, the patient experienced blood sugar increased. On 27th September 2016, the outcome of the tremor was recovered/resolved. On an unknown date, the outcome of the teeth chattering was recovered/resolved and the outcome of the dry cough, sweating and fatigue were not recovered/not resolved and the outcome of the general body pain and blood sugar increased were unknown. The reporter considered the tremor, teeth chattering, dry cough, general body pain, sweating and blood sugar increased to be related to BOOSTRIX. It was unknown if the reporter considered the fatigue to be related to BOOSTRIX. Additional details were provided as follows: the patient received BOOSTRIX at 17:30 pm on right arm. On 27th September 2016, the patient received influenza vaccine as concomitant medication on left arm, which was a non GlaxoSmithKline product. The caller reported that she received BOOSTRIX and a non GSK flu vaccine on Tuesday. By that evening she was shaking so bad her teeth were chattering. She had her daughter sleep over with her because she was afraid that she would need help. Her daughter said that the shaking stopped once she went to sleep. On 28th September 2016, in the morning, 1 day after receiving BOOSTRIX and flu vaccine, the patient was badly sweating so she had to change her clothing several times that day. She also had a dry cough and was so tired that she was unable get out of bed and her body was sore. On 29th September 2016 in the morning, the patient took her blood sugar and it was 171. She usually runs around 110-111. As per the recommended schedule by the PI tetanus shot can be received less than the 5 year interval. This case has been linked with case US2016GSK147230 as reported by same reporter.
Pain; Cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 50 year-old female patient received bnt162b2 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), when the patient was 50 years old, for COVID-19 immunization. The following information was reported: PAIN (non-serious) with onset May2021, outcome "unknown", described as "Pain"; NASOPHARYNGITIS (non-serious) with onset May2021, outcome "unknown", described as "Cold".  Additional information:The reporter  Wanted to know that patient can take cold medication or pain reliever. Cold transfer and created a manual AE form. It was unknown that the Reporter a Healthcare Professional HCP. It was unknown that the reporter the prescribing HCP.The reporter consent to further follow-up was  Unknown. The reporter's contact information available to you or a sub-contracted party was Yes. It was unknown that the patient/consumer/ caregiver provide consent to contact the prescribing HCP.There was not any unaddressed medical questions referred or forwarded to medical information.  Follow-up (12May2021): This is a follow up spontaneous report in response to m ail trail sent regarding the confirmation of below mentioned query. The response included that: Hello, Attached is an escalated comment from 09May2021 for CEP 159558.Please see the attached source document with a medical inquiry. AER# 2021530777.This is to confirm receipt of inquiry. Please document interaction number INT-00243597.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Mom states - few hours after immunization child screamed for one hour - took to ER.  No treatment.
Chills; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A male patient received bnt162b2 (BNT162B2), administration date 05Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset Mar2021, outcome "unknown", described as "nausea".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Fever and delirium for several hours starting 3-4 hrs post vaccines. Resolved spontaneously. 11/24/08 D/C summ received for DOS 11/12-15/2008 with D/C DX:  Pituitary Cystic Adneoma.  Episodic fever-resolved.  Incontinence-resolved.  Altered mental status-resolved. Hyperlipidemia.  HTN. Acute kidney failure-resolving.  Anemia. Pt presented to ER with fever, delium, confusion and urinary incontinence which began several hours after receiving flu and pneumonia vaccines. Pt admitted an by the following morning sx had resoved with abx.  The evaluation revealed other medical problems: Acute renal failure, blood pressure elevation, anemia and a Pituitary adenoma which will be followed as an outpatient.
arm turned red and splotchy; covid arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ERYTHEMA (arm turned red and splotchy) and VACCINATION SITE REACTION (covid arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 056A22A, 037F21A, 011M20A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (arm turned red and splotchy) and VACCINATION SITE REACTION (covid arm). At the time of the report, ERYTHEMA (arm turned red and splotchy) and VACCINATION SITE REACTION (covid arm) had resolved.            Patient had no known prior health conditions  No concomitant medication was provided.  Patient was given a steroid shot which cleared it up in a day.
Red, warm, tender rash at injection site. Size of 3inx3in square.
pt laid back on table whole body started jerking, pt was unresponsive lasted less than 1min;911 called & pt was transported to hosp;
G62.9 PERIPHERAL NEUROPATHY 4/17/2023 DIVERTICULITIS OF SIGMOID W PERFORATION G62.9 PERIPHERAL NEUROPATHY 4/17/2023 SEPSIS WO ACUTE ORGAN DYSFUNCTION G62.9 PERIPHERAL NEUROPATHY 4/17/2023 DIVERTICULAR ABSCESS
Vomited while on the bus on his way to pre-school. Mom states another child in the house reported feeling "sick" to her stomach this morning.
4-5 days after the first shot, felt a small area of numbness (lack of sensation ) on top of the left knee.     Over the course of about a week, the lack of sensation spread to involve the left leg (not past the ankle) and up the thigh, about mid-thigh mostly the front. No pain but had some itching/burn feeling in the left medial thigh. . there is no weakness nor other symptoms. Exam showed reduced sensation in  almost entirety of left leg suspected to be from spinal cord pathology
INFLAMMATORY ARTHRITIS ON JOINTS; This spontaneous report received from a patient concerned a 75 year old male. The patient's weight was 216 pounds, and height was 180.34 centimeters. The patient's concurrent conditions included iodine contrast allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient was previously treated with lisinopril, and prednisone. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: 25-MAY-2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. Concomitant medications included methotrexate. On 12-MAR-2021, the subject experienced inflammatory arthritis on joints. On 16-APR-2021, Laboratory data included: Laboratory test interference NOS (NR: not provided) inflammatory arthritis on his joints. Treatment medications included: prednisone acetate. Additional treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflammatory arthritis on joints. This report was non-serious.
eye irritation; very large puffing eye that I could not open; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EYE IRRITATION (non-serious), outcome "unknown", described as "eye irritation"; EYE OEDEMA (non-serious), outcome "unknown", described as "very large puffing eye that I could not open". The events "eye irritation" and "very large puffing eye that i could not open" were evaluated at the physician office visit. Therapeutic measures were taken as a result of eye irritation, eye oedema.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (PRD/SRD (18Feb2022): Follow-up activities closed. Batch/lot number not available.
Itchy, red lump at injection site - general itchiness. Have been fatigued this week as well (not severe).
Colleague was exposed to his sister and ended up testing positive for COVID will symptoms.; Colleague was exposed to his sister and ended up testing positive for COVID will symptoms.; Accidental overdose; dose 1 administered on 28Jan2021 and dose 2 administered on 28Jan2021; This is a spontaneous report from a contactable other HCP. A 36-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN5318), intramuscular in left arm on 28Jan2021 (at the age of 35-years-old) as dose 1 single and dose 2 via an unspecified route of administration in left arm on 28Jan2021 (Batch/Lot Number: EN5318) (at the age of 35-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, the colleague was exposed to his sister and ended up testing positive for COVID symptoms on 16Jul2021. The patient did not require hospitalization for the event. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 test: nasal swab taken for the test which showed positive on 16Jul2021. The outcome of event the colleague was exposed to his sister and ended up testing positive for COVID symptoms was recovered on an unspecified date in 2021.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, Covid-19 Positive and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Information has been received from a registered nurse referring to four patients of unknown age and gender. The patients' pertinent medical history and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with oral, ROTATEQ (dose, dose number and lot# were not reported), which was improperly stored. No adverse effects were reported. On 19-OCT-2015, a telephone call was placed to the registered nurse, who was unable to provide the patients' identifiers at that time. Follow-up information has been received from the registered nurse on 20-OCT-2015. A 6-month-old patient (gender unknown) was vaccinated with an improperly stored dose of oral, ROTATEQ lot# K016261, on 31-AUG-2015. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 24-FEB-2014, the patient was vaccinated with ZOSTAVAX Lot # J021658; Expiration date: 10-JAN-2015, subcutaneous. Secondary and concurrent therapies were not reported. On 25-FEB-2041, the patient developed redness at the ZOSTAVAX injection site. At the time of the report, the patient had not recovered. Patient did not received treatment for the adverse event. No lab diagnostics studies were not performed. It was reported that the patient sought medical attention by seeing two physicians. Additional information has been requested.
-Fever -Chills -Headache -Nausea -Fatigue -Muscle aches
Initial report received on 19 August 2009 from a health care professional.  A 55 year old female patient experienced a reaction 7 days after receiving ADACEL (lot number C3250AA) in the right deltoid which was administered on 05 August 2009.  At the time of vaccination the patient had an injury to the left arm due to a fall.  On 12 August 2009 the patient was seen by a doctor for complaints of right deltoid pain which extended throughout the entire arm.  On 19 August 2009 the patient was seen again for worsened right arm and deltoid pain.  The patient was unable to sleep, work, and her range of motion was impacted due to the pain.  No other information was provided.  Follow-up information was received from the health care professional on 08 October 2009.  Upon receipt of this new information, it was determined that the case meets seriousness criteria.  The patient  was seen by her physician on August 12, 19, 20, and 27, and September 03, 2009.  She was subsequently referred for rehabilitation, and was "making slow progress" undergoing physical therapy.  She was also seen by an orthopedic specialist, and the working diagnosis was reported as subacromial bursitis.  X-rays of the shoulder had been performed;  results were not reported.  The patient continued to be out of work, and was continuing to follow-up with physical therapy and the orthopedist.  List of Documents held by Sender:  none.
Redness and swelling of left upper arm. Increased warmth and pain - no fever. Zyrtec - cool compress.
received 0.25 ml of bivalent dose; No Adverse event; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) in a 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (received 0.25 ml of bivalent dose).    Concomitant medication was not provided.  Nurse reported that 19 patients received the half doses on 15-Sep-2022, 22-Sep-2022, 29-Sep-2022, and 06-Oct-2022.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-662961, US-MODERNATX, INC.-MOD-2022-662973 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-662973:Same reporter US-MODERNATX, INC.-MOD-2022-662961:Same reporter
ProQuad received at well check up on 11/6/06. Patient presented to office on 11/27/06 with history of papular lesions 75 plus times 1 day. Afebrile
Child developed VRI symptoms with slight fever and rash around 7/4/12. He had small papules scattered on his back, upper chest and thigh. Lesions were itching & suspicious for chicken pox so a sample swab was done & sent to the lab after speaking with the department of health.
nausea; vomiting; Temp of 100.4; This is a spontaneous report from a non-contactable healthcare professional. An elderly male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) solution for injection, via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. Medical history included Covid-19 (patient was diagnosed with COVID-19 prior to vaccination). The patient's concomitant medications were not reported. The patient experienced nausea, vomiting, and a temp of 100.4 on 07Jan2021. Since the vaccination, the patient has not been tested for COVID-19. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
No additional AE; Pharmacist called stating they administered the adult formulation of VAQTA to a 14 year old. Caller stated the patient has not had any symptoms. No additional AE/no PQC.; This spontaneous report was received from a pharmacist and refers to a 14-year-old male patient. No information on patient's medical history, current conditions and concomitant medications was provided.     On 31-JUL-2023 the patient was vaccinated with adult dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (exact dose, dose number, route and site of administration, lot number and expiration date were not provided) (product administered to patient of inappropriate age and no adverse event).
7.5 cm x 5.0 cm erythema, 10.5 cm x 7.0 cm induration, began swelling day 2-3, itching began day 6.  PT currently being followed by TMC; following to r/o cellulitis.
Information has been received from a nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates the patients were vaccinated with doses of improperly stored MMRII (rHA, Lot # L012481 with expiration 10-APR-2017, Lot # L008684 with expiration 13-MAR-2017, Lot # K024824 with expiration 02-DEC-2016, lot# L024265 with expiration 01-JUL-2017, dose and route were not reported). The vaccines were exposed to two excursions: 9.8 Centigrade for 40 minutes and -1.7 Centigrade for 1 hour and 50 minutes. No adverse effect was reported. This is one of several cases received from the same source. Additional information has been requested.