chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA injection, lot# L043209 with expiration date 17-SEP-2017 (dose and route of administration were not reported). Temperature and time frame of excursion were reported as 49.8 Fahrenheit (F) and 33.4 F for an unspecified amount of time. The vaccine had also previous temperature excursion of 48.1 F for 1 hour and 15 minutes. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
substantially unacceptable elevation of s/d  blood pressure value especially dark hours of each night every day
Patient receives SHINGRIX vaccine Thursday and comes back Monday saying she is still experiencing side effects. Diarrhea on and off for 3 days and is better now 6/27 after 6 days. Pain and swelling, hot to touch for 4 nights creating difficulty sleeping. Fever on and off for 3 days as well. Taking OTC to treat symptoms. Had denied the 2nd dose of SHINGRIX due to severe reaction to 1st dose.
SLEPT MOST OF THE DAY; SWEATED 3LB OF WATER; FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 11-APR-2021, the subject experienced slept most of the day. On 11-APR-2021, the subject experienced sweated 3lb of water. On 11-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from fever, slept most of the day, and sweated 3lb of water. This report was non-serious.
Pt developed severe HTN SBP>200, moderate tachycardia, and headache shortly after FLUVAX injection 10/5/17 (see LPN note). Vitals steadily normalized over the course of 15 minutes. Would use caution with administration of future flu vaccine.
Patient reported swelling in left arm for 1 day following the vaccination. She was advised to see the doctor to make sure it was not an infection. The doctor treated her with benadryl and told her it was likely a reaction to her shots. She followed up with us after her doctor's appointment and she said the swelling has significantly decreased.
Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2020, the patient received the 1st dose of Shingrix (intramuscular). On 9th May 2021, between 4 and 6 months after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported but could be 69 or 70 years. Patient got her first Shingrix vaccine and was scheduled to get her next vaccine tomorrow from the day of reporting but got Shingles 3 days ago. The reporter did not consented to follow up.
SWELLING IN LEG; BLOOD CLOT IN LEFT CALF; ITCHING; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's past medical history included old fracture in tibula or fibula, and concurrent conditions included social alcohol drinker and non smoker. The patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with levofloxacin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A and expiry: UNKNOWN) dose was not reported, 1 total administered on 02-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  After receiving vaccine immediately the patient was fine but about a week later on 9-APR-2021, the patient experienced itching. The patient spoke with her doctor who said it could or could not be related to the vaccine so the patient took allergy pills, Zyrtec 10mg a day, and itching got stopped. The patient reported that she had an old fracture in her tibula or fibula that she has had for 14 years that swells occasionally. The patient recently traveled and when came back, swelling in her leg had not gone down so the patient spoke with doctor who advised her to go to the ER (emergency room) for imaging. On 28-JUL-2021, the patient was diagnosed with a blood clot in left calf. For treatment the patient was on Eliquis, 5mg twice a day, for a total of 90 days. After completion of the 90 days treatment, the patient will receive a new scan and it would be determined if she needed any further treatment. The patient also noted that she traveled before receiving the vaccine but had never experienced a blood clot before. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching, had not recovered from blood clot in left calf, and the outcome of swelling in leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210815176- Covid-19 vaccine ad26.cov2.s- Blood clot in left calf. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
2 mo old 1st set of shots. Screaming inconsolably x3 hrs. No local reaction. Was giving TYLENOL q4H.
1 week ago pt started having lymph node tenderness. Currently progressing to joint pain in both knees. Advised to see physician.
Headache, Chills, Fever, Nausea, Left Hallux Pain for 2 days (Gout)
27SEP95 arthritic pain @ feet, knees, elbows & jaw w/scattered red, raised rash on back & arms appearing 2OCT95 w/itching;
Within seconds of  receiving the 2nd PFizer covid vaccine, the patient slumped over sideways in her chair, losing consciousness.  Next, her arms went straight and locked, both her hands locked in a curled position. I looked up at her face and her eyes had rolled back into her head and her body started jerking.  Shortly after, she sat upright in chair with her eyes open and didn't realize what had happened.  She said a tingling sensation had gone up her arm.  She was extremely pale.  My tech called 911.  I took her blood pressure which was 88/46 with a pulse of 45.  As we were waiting for paramedics, she said she was sweaty and started getting abdominal cramps.  Paramedics arrived and took over her care.
Moderna 2/10/21, 3/17/21, 11/3/21. Positive on 7/30/22
Information has been received from a pharmacist concerning an approximate 10-week-old female who in November 2007 received his first oral dose of Rotateq.  In DEC-2007, "about one month later", the patient developed acid reflux.  The patient sough unspecified medical attention.  At the time of the report the patient's status was not recovered.  A product quality complaint was not involved.  No further information is available.
26 hours after receiving Comirnaty (not listed as option) I suddenly felt shortness of breath, chest pain, achy joints, shaking of arms and legs. I was taken to labor and delivery. Was having regular contractions every 4 minutes and tachycardia (heart rate stayed between 105 and 115 for duration of visit).
Patient has two sites on Left deltoid which appear inflamed with scabs. Referred patient to MD.
Booster dose on 17Nov2021 and Patient had COVID from 18Jan22; Patient previously vaccinated had a very mild case of COVID/ Patient had COVID from 18Jan22 until the end of Jan; This spontaneous case was reported by a consumer and describes the occurrence of DRUG INEFFECTIVE (Booster dose on 17Nov2021 and Patient had COVID from 18Jan22) and COVID-19 (Patient previously vaccinated had a very mild case of COVID/ Patient had COVID from 18Jan22 until the end of Jan) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 039K20A and 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Sulfa drugs) and Thyroid disorder NOS (medication for thyroid).   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Jan-2022, the patient experienced DRUG INEFFECTIVE (Booster dose on 17Nov2021 and Patient had COVID from 18Jan22) and COVID-19 (Patient previously vaccinated had a very mild case of COVID/ Patient had COVID from 18Jan22 until the end of Jan). In January 2022, COVID-19 (Patient previously vaccinated had a very mild case of COVID/ Patient had COVID from 18Jan22 until the end of Jan) had resolved. At the time of the report, DRUG INEFFECTIVE (Booster dose on 17Nov2021 and Patient had COVID from 18Jan22) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. On an unknown date, Blood cholesterol: result not reported Result not reported, talking medication for cholesterol.         It was reported that patient's concomitant medication due to cholesterol and thyroid problem.  No treatment medications were provided.  Company comment- This spontaneous case concerns a 78-year-old female patient with no relevant medical history reported, who experienced the unexpecte COVID-19 approximately 62 days after a booster dose of mRNA-1273 vaccine was administered. Additionally, drug ineffective was also reported. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.  Patient asking for 2nd booster dose.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Follow-up information received contains no new information.; Sender's Comments: This spontaneous case concerns a 78-year-old female patient with no relevant medical history reported, who experienced the unexpected COVID-19 approximately 62 days after a booster dose of mRNA-1273 vaccine was administered. Additionally, drug ineffective was also reported. No further details were provided. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Disseminated rash, nausea, Headache 45-50 minutes following vaccine X 72hrs. 3 hours following - sore throat x 72 hrs. 16 hours following vaccine severe low back pain x 24 hours  TX: Benadryl 50 mg Q 4-6 hours x 4 days.
Headache.  Started within 6 hours.  Has been constant.  Ebbs and flows.  Untouched by Tylenol/advil.
Reported that 17yr old client received the Moderna vaccine against current authorized use based on age regulations; s/w parent/ mom who reports post vaccination, client experienced elevated temperature (103.6) and localized site soreness; denies any present symptoms or additional complaints at this time.
On December 27, 2022 I was tested for Covid 19.  The result was positive.  I was prescribed Paxlovid and took it for the whole 5 days.
Myalgia, Fever, intermittent chest pain, fatigue, left arm pain Narrative:
This spontaneous report as received from a health care worker refers to a 4 years old male patient. The patient was vaccinated with a 0.5 ml dose of ZOSTAVAX (lot # 671775/0466AE expiration date 28-FEB-2013) SQ, a dose of MMR II (lot # not reported), a dose of PEDIARIX and a dose of Hep A vaccine (manufacturer unknown) on 25-SEP-2012. Concomitant therapy included FLUZONE. No adverse events were experienced. Additional information has been requested.
Morning: infant became stiff, red in the face, and eyes rolled back in his head. mother believed he was choking. Afternoon: similar episode occurred, however this time infant also turned blue, 911 was called and infant was transported to ER. Evening: infant was admitted to peds unit at hospital and event occurred again. confirmed as seizure.
Information has been received from an unspecified reporter via a company representative referring to a female patient of unknown age.  The patient's concurrent condition, medical history and concomitant therapy were not provided. On an unknown date, the patient was vaccinated with a dose of  ZOSTAVAX 19400 plaque-forming units (PFU)(dose, lot# and expiration date were unknown)intravenously (incorrect route of drug administration)for prophylaxis. On an unknown date, the patient experienced injection site swelling, a fever, chills and "achy" pains. The patient sought medical attention. (details unknown)The outcome of the events was unknown. Causality was not provided.      Additional information is not expected as it is not permitted to be contacted.
Red, hot sore injection site - checked with pt at 9am on 4-24-14 getting better.
nausea; Puked once; Blisters; This case was reported by a consumer via call center representative and described the occurrence of nausea in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced nausea, vomiting and blister. On an unknown date, the outcome of the nausea, vomiting and blister were unknown.   It was unknown if the reporter considered the nausea, vomiting and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that the unspecified number of patients experienced nausea, vomiting and blister after vaccination. This case has been linked with case US2020053253, reported for same reporter.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On unspecified dates, the patients were vaccinated with improperly stored RECOMBIVAX HB (2.5/0.5, lot # M044032 / expiration date 03-JUL-2019, lot # N006321 / expiration date 08-NOV-2019, lot # N005996 / expiration date 07-JUL-2019, dose and route were not reported) for prophylaxis. The vaccine was exposed to temperature excursion between 0 degrees Celsius to 1 degrees Celsius for 2 hours and 41 minutes. There was no previous temperature excursion nor data logger. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA003854: US-009507513-1709USA003852: US-009507513-1709USA003853:
I can't move my neck; very bad pain in the left side of my neck and armpit/ Sensitive to the touch; very bad pain in the left side of my neck and armpit/ Sensitive to the touch; moderate arm pain from top of arm to about middle of my hand; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received BNT162B2 (BNT162B2),solution for injection, administered in arm left, administration date 10Dec2021 at 12:30 (Lot number: FJ3757) at the age of 39 years as dose3(booster), single for covid-19 immunisation. The patient belonged to the age group Adult (18-64 Years). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 31Mar2021, when the patient was 38 years old, for COVID-19 immunization; BNT162B2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left), administration date: 11Mar2021, when the patient was 38 years old, for COVID-19 immunization. Patient did not receive any other vaccine in 4 weeks. The patient did not have covid prior vaccination and did not test for covid post vaccination.  The patient experienced IMMUNISATION (medically significant) with onset 10Dec2021, outcome "unknown", described as "booster"; NECK PAIN (medically significant), AXILLARY PAIN (medically significant) all with onset 12Dec2021, outcome "not recovered" and all described as "very bad pain in the left side of my neck and armpit/ Sensitive to the touch"; PAIN IN EXTREMITY (non-serious), with onset 11Dec2021, outcome "not recovered" and  described as "moderate arm pain from top of arm to about middle of my hand"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Dec2021, outcome "not recovered", described as "I can't move my neck". First day and half moderate arm pain from top of arm to about middle of her hand. Day 2: Sunday she woke up with very bad pain in the left side of her neck and armpit. Sensitive to the touch. It was Monday and it was still just as painful, very sensitive to the touch and she could not move her neck. Therapeutic measures were not taken as a result of neck pain, axillary pain, pain in extremity, pain in extremity, musculoskeletal stiffness.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a healthcare worker and a registered nurse refers to a patient of unknown age. The patient received expired GARDASIL (lot# 1130X exp date 13-MAR-2011, dose and route unspecified) on 20-SEP-2012. No adverse event reported. At the time of reporting, the outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
States that on Monday, he had his 2019-2020 Influenza Vaccine (flu shot) from Employee Health. States that on Thursday, he started to feel itchiness at his arms and noted to have welchesThen on Friday, the welshes and itchiness scattered to the neck and torso. On Saturday around 0100 early dawn, he woke up with welches and itchiness at his arms, neck, abdomen, underarms and legs. States that he went to the Emergency Room because he thought he has scabies. He was treated for urticarial with Solumedrol. States that he is on his last pill. States that the moment he started the steroids, most of the welches and itchiness disappeared. States that the only bad experience he had with the steroids is that he does not like the weird feeling he has when he takes the medication. States he will finish the medication as prescribed
RASH ON ARM, PAIN ACROSS SHOULDERS, COULD NOT LIFT RIGHT ARM ABOVE SHOULDER
PT c/o s/s allergic Rxn c/o metalic taste, tingling, & enlarged tongue. Prior Hxn allergic Rxn & Bees. Self admin Benedryl 25 mg PO. No effect. EMS called for continueing s/s. Care transferred to hospital. VS 152/96 99% Room Air, Lungs clear, 0 drooling. PT continued with normal conversation during episode.
This spontaneous report as received from a physician refers to a 86 years old female patient. The patient was vaccinated with a dose of pneumococcal vaccine (unknown name, manufacture unknown) (dose, route and lot number not provided) on an unknown date, "many years ago". No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient developed sinusitis with streptococcus pneumoniae. The patient also developed fever and bacteremia. The patient was hospitalized. The patient was given vancomycin as treatment for the adverse events. The outcome of sinusitis with streptococcus pneumoniae, bacteremia and fever was reported as recovering/resolving. The reporter considered bacteremia as life threatening. Additional information has been requested.
Onset of urticaria within about an hour of the vaccine.  No wheezing or other problems noted.  Given Benadryl, injectable epinephrine, Decadron IM and PO Prelone.
Fever of 102.9 per ear w/in 45 minutes of receiving shots. Continued w/intermittent fever up to 102.9 off and on for the next 40 hours. Gave ibuprofen and monitored.
No Adverse Event; 1st dose administered on 06Apr2021; 2nd dose administered on 24May2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 06Apr2021; 2nd dose administered on 24May2021) and NO ADVERSE EVENT (No Adverse Event) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 06Apr2021; 2nd dose administered on 24May2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose administered on 06Apr2021; 2nd dose administered on 24May2021) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Patient did not have allergies to medications, food and other products. Patient did not have acute illnesses at the time of vaccination and up to one month before vaccine.  No treatment details were provided   This case was linked to MOD-2022-643584, MOD-2022-643751 (Patient Link).
hypothermia; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot ER8737, second dose) solution for injection intramuscular in the arm on 02Apr2021 at 11:00 (at the age of 38-years-old) as a single dose for COVID-19 vaccination. Medical history included ongoing Hashimotos from 03Jan2014 and ongoing hypothyroidism from 03Jan2014. Concomitant medications included ongoing levothyroxine for hypothyroidism from 2014 and ongoing liothyronine for Hashimotos from 2019. Historical vaccine included BNT162B2 (first dose, lot EN6199) for COVID-19 vaccination on 12Mar2021 with no adverse effect reported. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 02Apr2021, the patient experienced hypothermia, the patient temperature dropped to 94.79 degree F. Seriousness criteria was important medical event. The patient almost went to ER (emergency room). There was no treatment for the event hypothermia. The outcome of the event hypothermia was recovered in Apr2021.  Information on Lot/Batch number was available. Additional information has been requested.
Information has been received from a physician concerning a patient with fibromyalgia who on an unknown date was vaccinated in the arm with a dose of ZOSTAVAX (Merck) (Lot # and expiration not reported). Physician reported that after vaccination with ZOSTAVAX the patient continued to complain of fibromyalgia (date unspecified). It was reported that the adverse event did not improved. The patient sought unspecified medical attention. At the time of reporting the patient's outcome was unknown. Additional information has been requested.
ACUTE NON ST ELEVATION MI 3/24/2023 ASTHMA, UNSPECIFIED
Per the patient's mother the patient had swelling in the arm that the immunization was administered in, along with itchy and a very hot arm. The patient's mother contacted the patient's doctor and treated the adverse event with high dose benadryl every 4 hours as needed. The symptoms did resolve after 4 days and the arm has since returned to normal with no continuous adverse events reported.