chrisvoncsefalvay/vaers-outcomes huggingface dataset:
SEVERE BACK PAIN IN BETWEEN THE BLADES AND LOWER BACK; EYES HURT; CHILLS; FEVER; NAUSEA; HEADACHE; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included fibromyalgia, lupus, left bundle branch block, alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug use. The patient was not pregnant at the time of reporting. The patient was previously treated with ivermectin for covid-19 infection; and experienced drug allergy when treated with pethidine hydrochloride, morphine, and oxycodone hydrochloride/paracetamol. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 18-MAR-2021, the subject experienced severe back pain in between the blades and lower back. On 18-MAR-2021, the subject experienced eyes hurt. On 18-MAR-2021, the subject experienced chills. On 18-MAR-2021, the subject experienced fever. On 18-MAR-2021, the subject experienced nausea. On 18-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, and nausea, and the outcome of chills, headache, severe back pain in between the blades and lower back and eyes hurt was not reported. This report was non-serious.
Initial and follow-up information has been received from a licensed practical nurse concerning a 77 year old male with an allergy to sulfonamides and IV dye for allergies and no illness at the time of vaccination who on 24-OCT-2007 was vaccinated with PNEUMOVAX 23 (lot# 655501/1035F) 0.5mL in the left arm injection.  On 16-OCT-2007 therapy included influenza virus vaccine (unspecified) (lot# U244AU) in the left arm.  On 25-OCT-2007 the patient experienced soreness in his left arm, red streaks up the arm and redness around the injection site after vaccination with PNEUMOVAX 23.  Medical attention was sought.  Patient was treated with antibiotics (therapy unspecified) with resolution of streaks.  No further information was provided.  At the time of reporting it was unknown if the patient had recovered.  Additional information is not expected.
This spontaneous report as received from an approximately 60 years old male consumer refers to himself. On unspecified date in December 2013 the patient was vaccinated with ZOSTAVAX (does, route of administration, lot # and expiration date were not provided). Concomitant therapies included CRESTOR and metformin. Patient has no drug reactions/allergies. The patient stated that he experienced itchiness, a rash, redness, swelling and a little pain on 09-JUL-2014 (also reported as 6 months after administration of ZOSTAVAX. There was no treatment given for adverse events and no lab diagnostic were performed. The patient did not seek medical attention. The patient also reported that before receiving ZOSTAVAX he had been diagnosed with the shingles in unspecified number of times. The outcome of itchiness, little pain, swelling, redness and rash was reported as not recovered/not resolved. Relatedness between itchiness, little pain, swelling, redness, rash and ZOSTAVAX was not reported. Additional information has been requested.
Pain and weakness arms and legs muscle spasms legs arms heavy don't move right extreme fatigue headaches fell tripped a few times in early days occasionally tongue feels weird kinda nb and in the way
Patient got her first shot 03/25/21 and the next morning she had some shortness of breath, chest tightness and headaches. It got much wore the next day. She also experienced some dizziness and pre-syncope. EMS was dispatched but did not transport her. Her O2 sat, blood pressure, pulse and temperature were all normal. She then went to a walk in clinic later that day and they told her she had a panic attack. She was still having the shortness of breath and chest tightness. She used her Pro-air and it helped somewhat.
nausea; Severe vomiting; This is a spontaneous report received from a contactable reporter a contactable Pfizer colleague reported for an unknown age female patient.  A female patient (not pregnant) received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number: unknown), administration date 30Aug2021 as dose number unknown, single for COVID-19 immunization. The patient had no relevant medical history. Concomitant medication(s) included: TYLENOL. No known allergies. The following information was reported: NAUSEA (non-serious) with onset 31Aug2021 at 01:30, outcome "recovered" (2021), described as "nausea"; VOMITING (non-serious) with onset 31Aug2021 01:30, outcome "recovered" (2021), described as "Severe vomiting". Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of nausea, vomiting.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient said she woke up around 8:00am on 12/23/21 and was feeling weak in her knees after receiving vaccine the previous day.
Got pregnant 2 weeks later and miscarried at 7 weeks due to high glucose levels due to an autoimmune response of type 1 diabetes that was not diagnosed until June 17th, 2022
The injection site pink, warm and not swollen. The pink area that surrounds the injection site is the size of a grapefruit.
Information has been received from a physician concerning a female friend who apparently had shingles 5 years ago who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient experienced quite a severe reaction to the vaccination by having hives all over, and "had to be treated with corticosteroids (unspecified), etc." At the time of the report the patient's status was unknown. Attempts are being made to obtain additional information. Additional information will be provided if available.
This spontaneous report as received from health care worker refers to a female patient of unknown age (reported as college age). Approximately on an unknown date in 2009 (reported as 4-5 years ago) the patient was vaccinated with GARDASIL (dosing regimen unspecified). Approximately on an unknown date in 2009 (reported as 4-5 years ago), patient experienced anaphylactic reaction (medically significant) and difficulty breathing (medically significant) about 45 minutes after vaccinated with GARDASIL. The patient came back to the clinic, reporting she was having difficulty breathing and was given an injection of epinephrine. The patient sought medical attention and was taken to an unspecified hospital emergency room. The outcome of the events was unknown. The causality of the events with GARDASIL was not reported. Product quality issue was not involved. Upon internal review the events anaphylactic reaction and difficulty breathing was considered as serious (medically significant). The case is linked to #1407USA005962 via same reporter link. Additional information has been requested.
Body aches; Fever upto 101.3; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Fever upto 101.3) and HEADACHE (Headaches) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma since 20-Jul-1990.   On 18-Feb-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN (Body aches), PYREXIA (Fever upto 101.3) and HEADACHE (Headaches). On 21-Mar-2021, PAIN (Body aches), PYREXIA (Fever upto 101.3) and HEADACHE (Headaches) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 °F.         No concomitant medications provided. After the second vaccine, the patient experienced a fever up to 101.3, body aches, and headaches. After 24 hours of the symptoms, he took Tylenol and it was better within another 24 hours.   This case was linked to MOD-2021-018246 (Patient Link).
The pt experienced a drenching fever for 2 days, extreme fatigue (slept all day). Rash onset 10 days post vax. Pink spots, a few blistered; all over body except face.
Moderna vaccine manufacturer expiration date 20-May-2022 was taken out of the freezer on 20-Apr-2022 and administered on 24-May-2022; Patient was given expired (4 days expired) Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 20-May-2022 was taken out of the freezer on 20-Apr-2022 and administered on 24-May-2022) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K21-2A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER (Dose: 1, Lot/Batch number: EL3302, Dose/volume: 0.3 ml, Route and Body site: Intramuscular, left deltoid.) on 25-Jan-2021, PFIZER (Dose: 2, Lot/Batch number: EL9264, Dose/volume: 0.3 ml, Route and Body site: Intramuscular, left deltoid.) on 18-Feb-2021, PFIZER (Dose: 3, Lot/Batch number: FF8841, Dose/volume: 0.3 ml and Route: Intramuscular.) on 14-Oct-2021. Past adverse reactions to the above products included No adverse event with PFIZER, PFIZER and PFIZER.    On 24-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 20-May-2022 was taken out of the freezer on 20-Apr-2022 and administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was given expired (4 days expired) Moderna vaccine) and PRODUCT STORAGE ERROR (Moderna vaccine manufacturer expiration date 20-May-2022 was taken out of the freezer on 20-Apr-2022 and administered on 24-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Moderna vaccine lot 033K21-2A manufacturer expiration date 20-May-2022 was taken out of freezer on 20-Apr-2022. Out of freezer expiration date was 20-May-2022. No treatment information was reported.
Right arm my thumb and 2 of my fingers are numb and still numb to this day, I cannot feel any thing it is like my thumb n fingers are a sleep they tingle, numb and when i sleep my whole hand goes numb
Persisting Redness, pain, and swelling at and around (about 4 inch radius) the inject sight 70 hours after the injection. Thermometer measures this area of the body about 2-3 degrees hotter than the rest of the body.
Big Ole Knot (bigger than a quarter/golf ball size); Can feel the heat from it (the knot); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Big Ole Knot (bigger than a quarter/golf ball size)) and FEELING HOT (Can feel the heat from it (the knot)) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jul-2021, the patient experienced SWELLING (Big Ole Knot (bigger than a quarter/golf ball size)) and FEELING HOT (Can feel the heat from it (the knot)). At the time of the report, SWELLING (Big Ole Knot (bigger than a quarter/golf ball size)) and FEELING HOT (Can feel the heat from it (the knot)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drugs included No concomitant drugs included
9 cm x 15 cm area of non-tender, macular erythema distal to the injection site on the left arm.
Patient was admitted reltated a fall with fem condylar fracture, hyptension and bradycardia. AKI.  pt treated with fluids and electrolyte replacement. Pt asymptomatic for covid tested + upon discharge.
Cellulitis at upper arm. 05/15/07-records received-for DOS 4/11/07 and 4/25/07- Seen in ER on 4/25/07-Assessment:Left arm Cellulitis versus immunization reaction of arm left shoulder and arm swollen rash noted on his extremities. Warmth redness.
shooting pain up my buttocks; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (shooting pain up my buttocks) 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 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL PAIN (shooting pain up my buttocks). At the time of the report, MUSCULOSKELETAL PAIN (shooting pain up my buttocks) outcome was unknown.            No concomitant medication was provided by reporter. No treatment information was provided by reporter.
inadvertently administering expired dose of Adacel to a patient/ No AE; Initial information received on 23-Apr-2019 regarding an unsolicited valid non-serious case received from a nurse by phone.  This case involves a 37 years old female patient who was vaccinated with an expired 0.5 ml once dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Batch number: U5603AA and expiry date: 11-Apr-2019) via intramuscular route in the left deltoid on 23-Apr-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.    It was a case of actual medication error due to expired vaccine used.  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Documents held by the sender: none.
Fever, aches, chills, pain in left arm, red and swollen at injection site (left arm). Patient went to doctor's office Thursday 1/21/10. Given antibiotics and told to take Ibuprofen and antihistamines at Dr. office. 1/25/2010 left arm red at injection site, warm to touch, redness spreading over other parts of upper arm.
high blood pressure reading; had a fever; arm pain in the injected arm site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th November 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 20th November 2020, less than a day after receiving Shingrix, the patient experienced injection site pain. On 21st November 2020, the patient experienced fever. On 24th November 2020, the patient experienced blood pressure high. On an unknown date, the outcome of the injection site pain was not recovered/not resolved and the outcome of the fever was recovered/resolved and the outcome of the blood pressure high was unknown.   It was unknown if the reporter considered the injection site pain, fever and blood pressure high to be related to Shingrix.  Additional details were provided as follows: There are no events reported with 1st dose of Shingrix. The patient received 2nd dose of Shingrix in the right arm and had arm pain in the injected arm site.  The patient reported fever and reporting a high blood pressure reading 167/102. In November 2020, fever resolved. The reporter did not consent to follow up.
Patient self scheduled for COVID 19 Pfizer Vaccine. After receiving the vaccine the patient notified staff they have already received the Moderna vaccine dose 1. Patient states did not realize this was not recommended. Monitored patient for 15 minutes and no adverse symptoms were experienced. Educated on symptom management if develops and advised would be reporting to VARES.
Temperature  of 100.1 with chills. Took  two acetaminophen.  Temperature was my normal 97.7  about 4 hours later.
Mom stated she noticed on Wed. 6/11/03 around 12 Noon swelling, redness of her son's right thigh and also warm to touch. Mom also stated child was limping, and she had to carry him to the pediatrician. Child seen by 2 other pediatricians and one infectious disease doctor. Mom stated child walking now, and swelling and redness has decreased.
A report has been received from a Health Professional concerning, Male subject, who had been receiving Nasal FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 07-Oct-2014. Office manager reported that patient was inadvertently administered by FLUMIST. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST TO A 53 YEAR OLD PATIENT is unknown. The report was considered to be non-serious.
Wiped out, sleeping on and off; Wiped out, sleeping on and off; Fever of 101 F; chills; Nausea; exhaustion; Internal itch or creepy crawly skin; migraine headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 101 F), CHILLS (chills), NAUSEA (Nausea), FATIGUE (exhaustion) and PRURITUS (Internal itch or creepy crawly skin) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no historical condition was reported).    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (Fever of 101 F), CHILLS (chills), NAUSEA (Nausea), FATIGUE (exhaustion), PRURITUS (Internal itch or creepy crawly skin) and MIGRAINE (migraine headache). On 22-Feb-2021, the patient experienced FATIGUE (Wiped out, sleeping on and off) and SLEEP DISORDER (Wiped out, sleeping on and off). On 21-Feb-2021, PRURITUS (Internal itch or creepy crawly skin) had resolved. On 23-Feb-2021, PYREXIA (Fever of 101 F), CHILLS (chills), NAUSEA (Nausea), FATIGUE (exhaustion), MIGRAINE (migraine headache), FATIGUE (Wiped out, sleeping on and off) and SLEEP DISORDER (Wiped out, sleeping on and off) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Flu like symptoms- fever, chills, body ache, fatigue lasted about 20 hours, pain in left shoulder, swollen lymph nodes in left armpit for 3-4 days. Intense headache followed for 5 days after flu like symptoms eased up.
Within 1-2 hours of the shot I began having palpitations and felt as if my heart was racing. I had several dizzy spells and new syncopal episodes throughout the early part of the day. At around 9:30-10:00pm the dizziness worsened with extremity numbness and a lack of feeling in my extremities sort nausea. I went in to my bathroom and sat on the floor. I did not vomit, I did not lose consciousness but my body went in to a state of constant contraction with me being unable to release or move any extremities. I had  high heart rate and respiratory rate. This went on for 15-20 minutes while EMS arrived. My vitals were stable besides heart rate and respiratory rate. I was transported to a local hospital. In route I was given BENADRYL this slightly improved the contractions. At the hospital I was given ATIVAN which also helped release the contractions.
Arm pain from neck to elbow.  Cannot lift arm or lay on it.  Hurts to move it.  Ice/NSAIDS/APAP does not relieve pain.  Slight improvement over time.  Visit to PCP on 11/17/22 and received prednisone.  Will report if prednisone resolves issue.
GRANDPARENTS CALLED TO INQUIRE ABOUT LOCALIZED REDNESS, SWELLING, CHILLS AND HEADACHE.
feet were swollen; This case was reported by a consumer and described the occurrence of swelling of feet in a 76-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2019, the patient received Shingrix. On 30th July 2019, 1 days after receiving Shingrix, the patient experienced swelling of feet. On an unknown date, the outcome of the swelling of feet was not recovered/not resolved.   It was unknown if the reporter considered the swelling of feet to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and feet were swollen and they were, at the time of reporting. The swelling did not go down overnight.
This case was reported by a physician and described the occurrence of paresthesia all over body in a 28-year-old female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). On 26 September 2013 at 15:15 the subject received a dose of FLULAVAL (.5 ml, unknown route, right arm). On 26 September 2013, within minutes of vaccination with FLULAVAL (described as "right after" vaccination), the subject experienced paresthesia all over body, blood pressure is up, heart rate up, numbness (described as "numbness from head to toes"), and tachycardia. Per the physician, the subject reported "feeling numb from head to toes, her blood pressure went up, heart rate went up" and the subject had "tachycardia at around 100." Per the physician the injection site "looks ok" and the subject "did not develop fever nor shortness of breath." The subject had "tingling numbness all over her body, including her hands. The physician described symptoms as having paresthesia." Relevant diagnostic tests included on 26 September 2013, heart rate was measured "at around 100." The physician put the subject "on a monitor" however, he did not provide specific details. Treatment included an unknown medication initiated on 26 September 2013 per the physician. The physician considered the events were clinically significant (or requiring intervention). At the time of reporting the events were unresolved. Per the physician, the subject was "not being hospitalized yet." The physician considered the events were probably related to vaccination with FLULAVAL.
two months old patient received a dose of pneumovax23; no adverse effect; This spontaneous report was received from a registered nurse referring to a 2-month-old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy details were not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (strength, dose, frequency, route of administration, lot# and expiry date were not reported) for prophylaxis (product administered to patient of inappropriate age). No adverse event was reported. No product quality(PQC) complaint was filed.; Sender's Comments:  US-009507513-1909USA002944: