chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TINNITUS; INSOMNIA; CHILLS; ACHINESS DOWN LEFT LEG; NAUSEA; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's past medical history included degenerative disc, and concurrent conditions included osteoarthritis, non alcoholic, and non-smoker, and other pre-existing medical conditions included patient had no drug abuse or illicit drug usage. The patient experienced drug allergy when treated with ceclor. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805025, expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 19:20 to left arm for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. On 11-MAR-2021, the subject experienced achiness down left leg. On 11-MAR-2021, the subject experienced nausea. On 11-MAR-2021, the subject experienced headache. On 11-MAR-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) 100.1 F. On 12-MAR-2021, the subject experienced tinnitus. On 12-MAR-2021, the subject experienced insomnia. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, achiness down left leg, nausea, and fever on 11-MAR-2021, and had not recovered from tinnitus, headache, and insomnia. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious.
Severe heartburn; Injection site also itched like crazy; Her injection site also turned puffy; Injection site also turned red; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Severe heartburn), VACCINATION SITE PRURITUS (Injection site also itched like crazy), VACCINATION SITE SWELLING (Her injection site also turned puffy) and VACCINATION SITE ERYTHEMA (Injection site also turned red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (unspecified).   On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced DYSPEPSIA (Severe heartburn), VACCINATION SITE PRURITUS (Injection site also itched like crazy), VACCINATION SITE SWELLING (Her injection site also turned puffy) and VACCINATION SITE ERYTHEMA (Injection site also turned red). At the time of the report, DYSPEPSIA (Severe heartburn), VACCINATION SITE PRURITUS (Injection site also itched like crazy), VACCINATION SITE SWELLING (Her injection site also turned puffy) and VACCINATION SITE ERYTHEMA (Injection site also turned red) was resolving.            The patient reported that she also woke up in the middle of the night with heartburn again. No relevant concomitant medications were reported.  No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable.
pt vaxed on 2OCT92 & 5OCT mom called MD c/o pt pale, stomach ache, rapid pulse rate; to ER in supra ventricular tachycardia;
3/23-0800-palms latching/1600-itching armpits//0700-fine red rash front and back torso, raised red lesions buttocks,groin chest. Severe painful itching. Took OTC Benadryl and Allegra w/o much relief
Patient complained of the pain at the injection site but no swelling, redness, bleeding or hard to touch or fever.
Approximately 18 hours post-vaccine administration, patient was afebrile but with complaint of mild joint pain and body aches.  Approx 24 hours post-vaccine administration, patient became febrile with a temperature of 100.5 F.  Fever, complaint of moderate joint pain and moderate headache, which continued for an additional 14 hours.  By 42 hours post-vaccine, patient had complete resolution of all symptoms.
Injection site bruised after 2nd dose; Red spots on opposite arm after 2nd dose; Bruises on opposite arm after 2nd dose; Burning feeling in arm after 2nd dose; Injection site red after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Injection site bruised after 2nd dose), ERYTHEMA (Red spots on opposite arm after 2nd dose), CONTUSION (Bruises on opposite arm after 2nd dose), BURNING SENSATION (Burning feeling in arm after 2nd dose) and VACCINATION SITE ERYTHEMA (Injection site red after 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 001A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (Injection site bruised after 2nd dose), ERYTHEMA (Red spots on opposite arm after 2nd dose), CONTUSION (Bruises on opposite arm after 2nd dose), BURNING SENSATION (Burning feeling in arm after 2nd dose) and VACCINATION SITE ERYTHEMA (Injection site red after 2nd dose). The patient was treated with CORTISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE BRUISING (Injection site bruised after 2nd dose), ERYTHEMA (Red spots on opposite arm after 2nd dose), CONTUSION (Bruises on opposite arm after 2nd dose), BURNING SENSATION (Burning feeling in arm after 2nd dose) and VACCINATION SITE ERYTHEMA (Injection site red after 2nd dose) outcome was unknown.            This case was linked to MODERNATX, INC.-MOD-2021-078182 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-078182:cross linked to Dose 1
report several side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION. At the time of the report, VACCINATION COMPLICATION outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       No concomitant medications were reported.  Treatment information was not provided.
not feeling right; Puffy vision; difficulties to focus; low grade fever; headache; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (not feeling right), PERIORBITAL SWELLING (Puffy vision), VISION BLURRED (difficulties to focus), HEADACHE (headache) and PYREXIA (low grade fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027c21a) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included VIT D [VITAMIN D NOS], CYANOCOBALAMIN (VIT B12), ATORVASTATIN CALCIUM (LIPITOR) and SALBUTAMOL (PROVENTIL [SALBUTAMOL]) for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEADACHE (headache). On 31-Jul-2021, the patient experienced PYREXIA (low grade fever). On 02-Aug-2021, the patient experienced FEELING ABNORMAL (not feeling right), PERIORBITAL SWELLING (Puffy vision) and VISION BLURRED (difficulties to focus). On 01-Aug-2021, HEADACHE (headache) had resolved. At the time of the report, FEELING ABNORMAL (not feeling right), PERIORBITAL SWELLING (Puffy vision), VISION BLURRED (difficulties to focus) and PYREXIA (low grade fever) had not resolved.        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.   The patient had a severe reaction (unspecified) to a flu shot in the past (date unknown).  Treatment information was not provided by the reporter.
The same evening of the afternoon that I received the vaccine I began experiencing severe muscle and nerve pain in my body from my feet, up to my limbs and head. It happened often throughout the night, keeping me up as it was so painful. It felt like electric shots shooting up in my body. My muscles were very sore and I felt numb all over my body. The next morning I started walking despite the numbness and pain but experienced intermittent partial paralysis as my right leg could not move and this continued on and off for several days. It was painful because it was involuntary and I could not predict when it would happen so I experienced pain when I went to move it to walk as I normally do and it would not move. I was able to begin biopuncture and acupuncture treatments that upcoming week and continue to get these treatments, regularly, at least monthly. It helped with my mobility and extreme pain but the pain continued mildly and moderately and would increase, as would the numbness, if I walked too much or did mildly strenuous activity. I've also experienced internal vibrations since the vaccine. I've had several relapses, including one for which I went to the ER on June 20, 2021 with overall muscle pain, numbness mostly in the right arm and leg. They labeled it "paresthesia." Modified Myers Infusions beginning in December 2021 further helped with the pain.
POTENTIAL ADMINISTRATION OF AN EXPIRED VACCINE; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. 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 not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced potential administration of an expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential administration of an expired vaccine was not reported. This report was non-serious.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  HYPOXIA  7/14/2022 -- RECURRENCE OF SAME SYMPTOMS
Noted swollen lymph node to "r arm pit." The next day at "around 1:00 in afternoon." "Already getting smaller." Not doing anything for it.
severe body aches, swollen and painful lymph nodes in both armpits and bilateral neck, achy joints and muscles, headache, achy eyes, extreme tiredness, itchy all over and swollen, painful and itchy injection site.
received the first dose of Havrix on 17Jan2018 / has not received the second dose yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 4-year-old female patient who received HAV (Havrix) for an unknown indication.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received on 17th January 2018, batch number 77D5K, expiry date 26th March 2020).   On an unknown date, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was 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 provided as follow: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Havrix, which led to incomplete course of vaccination. The reporter consented to follow up. Reported VARES details pertains to 1st Havrix administration.
After a couple of days my head felt strange, like the beginning of a cold. The third day I started coughing, then for three days just totally miserable, coughing uncontrollably and sinuses filled. I was able to blow my nose and was coughing up phlegm, lots of it. I drank lots of water, took guaifenesin cough syrup and phenylephrine HCl sinus tablets. After a week it lessened, to where  now 2 1/2 weeks after it started I have coughing spells just three or four times a day. I also have a very small sore spot on my right side where the front and back ribs meet, which I believe is a pulled muscle from coughing. I did not take my temperature but I don?t believe I had a fever. I felt it was a severe cold, but I was encouraged to report it since it was right after the second vaccination.
administered the Adjuvant only of the Shingrix vaccine; administered the Adjuvant only,then administered the complete vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix (intramuscular). In November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received shingrix vaccine in an unknown arm. The patient received only adjuvant of shingrix approximately 6 weeks ago from the date of reporting, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter then administered the complete Shingrix vaccine the same day. The reporter did not consent to follow up.
Her arm hurts and states cannot move above shoulder x 3 wks. Has been taking ibuprofen 80, was told to work it to get soreness out. Will call in a couple of days if not better will refer to physician. She contacted physician who told her to continue ibuprofen and previously prescribed muscle relaxant
blood sugar skyrocketed to 480 something; This is a spontaneous report from a contactable consumer (patient's friend). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number was not reported), via an unspecified route of administration on an unspecified date (at an unspecified age) at single dose for COVID-19 immunization. The patient medical history included ongoing diabetes. The patient's concomitant medication included unspecified insulin for diabetes. The patient experienced blood sugar skyrocketed to 480 something on an unspecified date, and he takes insulin. The outcome of the event was unknown.   No follow-up attempts are possible, information about batch/lot number cannot be obtained.
Got zoster inj 10/17 - redness swelling at site that day then 2d later swelling 20 cm round with redness warm to touch could be latex allergy did not inform staff x 2.
Hypertension; Unevaluable event; Maternal exposure during pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of HYPERTENSION (Hypertension), UNEVALUABLE EVENT (Unevaluable event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     The patient's past medical history included Caffeine consumption (caffeinated beverages less than 3 per day).    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 24-Jul-2022. On an unknown date, the patient experienced HYPERTENSION (Hypertension), UNEVALUABLE EVENT (Unevaluable event) and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The delivery occurred  on 04-Jul-2022, which was reported as Unknown. For neonate 1, The outcome was reported as Delivered NOS. Delivery was Live birth. No congenital anomalies was reported for neonate. At the time of the report, HYPERTENSION (Hypertension) and UNEVALUABLE EVENT (Unevaluable event) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant and treatment medications were not provided. Pregnancy outcome was reported as Live birth. Company comment-This spontaneous case concerns a pregnant female of unknown age, who experienced the unexpected non serious event of Maternal exposure during pregnancy which occurred in the context of mRNA-1273 vaccination. Hypertension and Unevaluable event (Other significant medical condition) were also reported as non-serious events. Gestation period at exposure and last menstrual period not provided. The outcome of pregnancy was live birth with no congenital anomalies. No further details available for review. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.    This case was linked to US-MODERNATX, INC.-MOD-2022-683376 (Parent-Child Link).   See case US-MODERNATX, INC.-MOD-2022-683376 for details regarding the child case.
presence of poison ivy rash with no itching; off-label benefit from receiving the Moderna COVID-19 Vaccine; felt crappy/dragging; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (off-label benefit from receiving the Moderna COVID-19 Vaccine), DERMATITIS CONTACT (presence of poison ivy rash with no itching) and FEELING ABNORMAL (felt crappy/dragging) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Previously administered products included for an unreported indication: STEROIDS (high dose steroids generally used to treat the allergic reaction to poison ivy). Concurrent medical conditions included Allergy to plants (severe allergic reaction to poison ivy - has occurred off and on for 35 years). Concomitant products included BORAGO OFFICINALIS OIL, FISH OIL, LINUM USITATISSIMUM OIL (3 OMEGAS), ESOMEPRAZOLE, MAGNESIUM, MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (VITAMIN D3), UBIDECARENONE (CO Q10) and ASCORBIC ACID (VIT C) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced FEELING ABNORMAL (felt crappy/dragging). On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (off-label benefit from receiving the Moderna COVID-19 Vaccine) and DERMATITIS CONTACT (presence of poison ivy rash with no itching). On 14-Feb-2021, FEELING ABNORMAL (felt crappy/dragging) had resolved. At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (off-label benefit from receiving the Moderna COVID-19 Vaccine) had resolved and DERMATITIS CONTACT (presence of poison ivy rash with no itching) outcome was unknown.            Treatment information not reported.   This case was linked to MOD-2021-213441 (Patient Link).
Metallic taste in mouth two days post vaccine and now 1 month following. My NP told me to report on this site.
10 minutes, post vax, pt reports tingling feeling in cheeks and up back of neck. BP-L 142/90; R 134/90. Pt reported she had no breakfast prior to IZ. Stayed in clinic until 10:55 and stated she felt better and wanted to get breakfast. Advised to seek medical attention if symptoms persisted. Called at 15:00, pt attending art class per husband.
12/18/2022 I had a runny nose all day, then towards the end of the day I got a sore throat, and 99-degree fever that evening for maybe an hour.  12/21/2022 I went out to eat and couldn?t taste the food.  Took and At Home COVID-19 Test, positive. Loss of taste lasted about 3 days. Reached out to doctor by email and didn?t hear back.  12/23/2022 I had a little bit of a sore throat in the evening.  I stated home for the next 2 weeks and didn?t notice symptoms.   Late January of 2023 I noticed a ringing in my ears.  I got into see an audiologist on March 7.  That doctor advised hearing is fine, ringing not related to hearing loss.  Ringing in ears continues to time of reporting.
Pfizer-BioNTech COVID-19 Vaccine - One day following administration of the Pfizer COVID-19 vaccine, pt repoted chills, body aches, shakiness in his hands and tingling in his feet and hands.  He treated with Tylenol, rest and fluids and opted to also contact his physician to report the symptoms as he is currently being tested for a hereditary immune system disorder.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-AUG-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
She got her vaccine, she put the shot in and didn't feel it go in.  Later on in the afternoon it got sore and had a little bit of fever in it.  The next day it was still sore.  By Friday afternoon or Saturday morning she could tell the difference in her legs.  Her legs felt like muscle pains in her legs, they were real heavy, hardly able to pick them up, felt like they weighed about 50# a piece and has had weakness in her legs.  The left foot is numb.  She did not have these issues prior to the vaccine.  She went to her doctor Tuesday 11/6/23, had blood work, and did muscle testing.  This morning she went to an UC and he also done the same tests, but did not draw any blood.  The UC doctor this morning told her to see a neurologist if her symptoms did not get better.  Her PCP told her to get some magnesium and to try that, which she got today.  They checked her levels and said that everything was OK.  She already started taking the magnesium today.