chrisvoncsefalvay/vaers-outcomes huggingface dataset:
HIB and Prevnar was given LAT 11/2/04. Positive erythema 3-4cm. Hydrocortisone cream 1% applied TID; Benadryl 1 1/4 teaspoon every 6 hours.
injection site was warm; injection site was itching; injection site was red; injection site was swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site was warm), VACCINATION SITE PRURITUS (injection site was itching), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE SWELLING (injection site was swollen) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 11-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE WARMTH (injection site was warm), VACCINATION SITE PRURITUS (injection site was itching), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE SWELLING (injection site was swollen). At the time of the report, VACCINATION SITE WARMTH (injection site was warm), VACCINATION SITE PRURITUS (injection site was itching), VACCINATION SITE ERYTHEMA (injection site was red) and VACCINATION SITE SWELLING (injection site was swollen) had not resolved.            No concomitant medications reported by investigator o No treatment medications provided by the reporter.
Fever (101.6) and muscle aches and headache starting around 8 or 9 pm. Lasted through the night, took naproxen at 1 am, fever was lower (100) at 2 am. Fever gone in the morning at 6:30 am
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On 29-JUN-2015, the patient was vaccinated with an expired dose of ROTATEQ, orally, (lot # unspecified, expiration date: April 2015). There was no known adverse effects. Additional information has been requested.
High fever, leg muscular lump, very weak, did want to eat, lie down floor, lost walk ability, always fall down, lost eye contact, stop to talk, no reaction with calling, and no more interaction with others.Did fever relief.
The patient did not go back for the second dose because they were scared.; felt a little short of breath; chest discomfort; chest discomfort and pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): 2023NVX-US-000001461.  A 43-year-old male patient received bnt162b2 (BNT162B2), in Aug2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCOMPLETE COURSE OF VACCINATION (non-serious), outcome "unknown", described as "The patient did not go back for the second dose because they were scared."; DYSPNOEA (non-serious), outcome "unknown", described as "felt a little short of breath"; CHEST DISCOMFORT (non-serious), outcome "unknown"; CHEST PAIN (non-serious), outcome "unknown", described as "chest discomfort and pain". The events "felt a little short of breath", "chest discomfort" and "chest discomfort and pain" required emergency room visit.  Additional information: On 02-NOV-2023, it was reported that a patient started treatment on an unreported day in AUG-2021 with Pfizer BioNTech COVID-19 dose 1 for COVID-19 vaccination. It was reported the patient didn't handle the first dose of his primary series very well. On an unreported date, a couple weeks after receiving the vaccine, the patient felt a little short of breath with chest discomfort and pain. The patient reported going to the ER and seeing their doctor as well as a cardiologist for additional testing. The patient mentioned they were checked for myocarditis, and it was determined he did not have myocarditis. The patient also stated that his heart or lungs were not affected. The patient did not go back for the second dose because they were scared. No further follow-up is anticipated.
Pt Dx 2007 with Grade 5 Arteriovenous Malformation (RF Lobe); causes Simple Partial Seizures; three (3) anti-seizure medications to control seizures. Adverse Event, Symptoms, Duration: Within 12 hours after the injection, my 20 y/o son had an very serious adverse reaction to the flu shot. Awoke from sleep with massive headache, sharp, shooting pain "like a knife" in both ears and in both earlobes; sharp shooting pain in lower back of neck; "pins and needles" sensation in his torso (chest and back); arm pain; dry mouth; body temperatures was normal, but he felt cold, was shivering, teeth chattering, and needed to wrap himself up in a blanket. Be advised that these symptoms mimic the symptoms experienced by my son to the onset of a seizure. Pt did not, however, experience a seizure. Pt was not well enough to go to work, and lost a full day of pay; my husband came home from work to stay with patient. I reported the symptoms and the adverse event to both patient's neurologist and the pharmacy.
Recv DTP 10AM slep all way home, woke around 12 for bottle then back to sleep. Could be aroused but would take very strong stimulus to get him awake. Pale & clammy unitl 6PM, color returned but continued to be drowsy until 9AM next morning.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021 at 1:24 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Feb-2021 at 1:24 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 77.83 for dose administered on 28-Feb-2021.  No concomitant medications were reported.  Batch number 014M20A underwent temperature excursion on 28-Feb-2021 with temperature 27  degrees Fahrenheit from 12:00 PM to 01:00 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 27-Feb-2021. Product moved to clinic on 26-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  No treatment medications were reported.
Left upper eye lid swelling Right cheek swelling Developed allergy from Peanuts after for Covid vaccine shot - Upper lip swelling stayed over 24 hrs.
Fever, chills, headache, vomiting, diarrhea, lethargic and SOB
This non-serious spontaneous case, initially received from other non-health professional on 13-Nov-2018, concerns an 88-year-old, elderly patient of an unspecified gender. It was reported that, FLUAD (TIV) vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 05-Nov-2018, the patient was administered FLUAD (TIV), [batch number: 250802, dose, route of administration, anatomical location and expiry date: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805541 was crossed linked to original case 201804863 due to same reporter.
had 1st dose, now have shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 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 Information: GSK Receipt Date: 31-Oct-2022 Reporter's Comment: Reporter stated that the patient had 1st dose of Shingrix six weeks ago. But now patient had active case of shingles. Patient asked that if he/she need to go forward with the 2nd dose of Shingrix or  he/she should wait until shingles clears up before taking the 2nd dose.
About 4.5 hours after vaccination I started to see small hives popping up on my arms. Over the next hour it spread to my shoulders, neck, chest, upper and middle back, blotches on my thighs and tops of my feet, behind my ears and on my left temple. The small bumps turned into welts. Cold shower and benadryl helped and no other issues arose.
Red oval shaped, 2 inch rash on right arm below injection site. Warm to touch. Patient saw physician 09/04/14 in evening.
On 8/3/07 right upper arm swollen, red and at injection site hard. Next day she awoke with a racing heart rate of 124, dizziness and fever of 101.0. Seen in Urgent Care and below tests done. Sent home on a Medrol dose pack and by 8/13 symptoms resolved and by end of week arm swelling/ redness gone.
Pt states that after reading the VIS more extently when she got home she started to experience the side effects as listed on the paper as fatigue/soreness/fever. Instructed pt that she should take TYLENOL for the pain and that we would follow up with her pcp and also give them that information.
My shot was Saturday at 2 PM.    Monday night I developed a VERY tender, sore achilles tendon.  I could barely walk Tuesday.  I kept working it up and down and I do not excercise,   so it's certainly NOT from overuse.   I have never had this problem before   I can remember at one time taking some meds that the warnings said they could cause problems with tendons. . so , I'm wondering if this could be because of my shot on Monday.   Hence, the report.
SWELLING, REDNISS, MILD PAIN, ITCHING. TREATMENT: TOPICAL STEROIDS. Symptoms started 1 day after injection' Had similar episode after first vaccination, but onset was in 2-3 days, discomfort was less; first event lasted between 2 and 3 weeks duration.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 23-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose, route and site of administration were not reported) to obtain permanent prevention and protection against shingles and zoster-related injuries. On an unknown date, after and despite being inoculated with the ZOSTAVAX, the patient was diagnosed with shingles and/or other zoster-related injuries and suffered serious physical, emotional and economic damages as a result of patient's injuries. On or about 20-DEC-2016, the patient was treated for shingles. The reporter considered adverse events to be related to ZOSTAVAX. As a direct and proximate result of the ZOSTAVAX, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care - for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. By the time of the report, the patient did not recover from shingles as the patient suffer for ongoing injuries. The outcome of vaccination failure was unknown. The events were considered to be related to ZOSTAVAX.
woke up  on March 9th, 2021 at 5Am  with body aches took 2 tylenols went back to bed  when i woke felt no better had oatmeal for breakfast, laid on couch all day had egg salad for lunch right after lunch could not get warm had 2 blankets on me,  headache, did not have fever at that time went to lay in bed at 5:30PM then about an hour later felt warm but not hot enough to remove blankets, felt feverish took temperture and  it was 100.5 at 8:00PM, grandaughter took me to hospital. temp was still 100, i was very dehydrated got intervenous fluid, took blood and chest x-ray, and covaid test, tested negative, Doctor just said I had a bad reaction to the  Moderna Shot.   Just starting to feel better on this day 3/2-18/2021. Blisters inside  mouth  on  upper lip. they are still there. still do not feel 100%
Extremely sore arm, can not move it at all without people in pain; Extremely sore arm, can not move it at all without people in pain; This is a spontaneous report from a contactable consumer (patient).  A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number was unknown and expiration date was not reported), via an unspecified route of administration, in Left Arm on 17May2021 at 19:00 (at the age of 22-years old) at first dose, single for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  Patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The most recent COVID-19 vaccine was administered at Pharmacy or Drug Store. The patient experienced extremely sore arm, can not move it at all without people in pain on 18May2021 after the first dose and did not had any other side effects. The event was reported as non serious. No treatment was received for the event. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
CELLULITIS OF ARM; SWOLLEN AND PAINFUL LYMPH NODES; SEVERE MUSCLE ACHES; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 55 year old female. The patient's weight was 160 pounds, and height was 64 inches.  The patient's past medical history included left arm cellulitis, and concurrent conditions included penicillin, alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug usage.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, once total administered on 01-APR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On APR-2021,patient Body temperature (NR: not provided) 103.4 f and 100 f.  Patient called and reported that, received Janssen covid 19 vaccine on April 1, 2021 after 2 weeks later still have a 5 cm lump on left arm ( it was hot, red and painful), swollen and painful lymph nodes, 103.4 fever for 24 hours after the vaccine.a low grade fever for 2 additional days under 100. patient also experienced severe muscle aches to lower body and a severe headache for 24 hours.Patient visited to physician on April 12, 2021 and they prescribed antibiotics. Patient was diagnosed with left arm cellulitis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable The patient recovered from severe muscle aches on 03-APR-2021, and severe headache on 02-APR-2021, had not recovered from swollen and painful lymph nodes, and the outcome of cellulitis of arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210431961-covid-19 vaccine ad26.cov2.s-cellulitis of the arm. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Acute renal failure. Altered mental status. Decreased appetite for 2+ days, involuntary jerk/twitch of body and admitted.
Syncopal episode, hypoglycemia & vasovagal syncope noted on ER notes. Collapsed, was revived & attended to by medical provider. Given PO water & glucose. Transferred to ER, was cleared & released.
Fever, red, warm, itchy arm- BENADRYL and hydrocortisone cream for tx.
the last vial in the box was opened/booster doses administered from vial that had not been properly disposed; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (the last vial in the box was opened/booster doses administered from vial that had not been properly disposed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (the last vial in the box was opened/booster doses administered from vial that had not been properly disposed). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (the last vial in the box was opened/booster doses administered from vial that had not been properly disposed) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details was reported.  No treatment medication details was reported.  The last vial in the box was opened on 02-Nov-2021.   The last vial in the box was opened on 19-Nov-2021. On 30-Nov-2021, it was found that a vial that had not been properly disposed of, thought it was a current viable vial, and gave booster doses from that vial.
I had gout that flared up in May and was very painful. I went to see my doctor and she prescribed colchicine to help alleviate the pain and clear the gout. She also prescribed potassium citrate for me to start taking as a preventative. The gout has cleared up and I am feeling much better.
Information has been received from a registered nurse concerning a 67 year old female with high blood pressure who on Nov 21 2005 was vaccinated IM into the right arm with a dose of pneumococcal 23v polysaccharide vaccine (lot 651330/1048P). On Nov 21 2005, the patient was also vaccinated in the left arm with a dose of influenza virus vaccine (unspecified). Concomitant therapy included sertraline HCL (Zoloft), hydrochlorothiazide (+) valsartan (Diovan HCT) and verapamil HCL (Veralan). On Nov 21 2005 the patient developed shortness of breath, shooting pain in her right arm, shaking of her head and body, dryness of mucus membranes, nausea, diarrhea, fatigue, cellulitis and she felt flushed. From her right deltoid to her elbow she developed cellulitis with swelling, tenderness and axillary pain. The patient was treated with cephalexin (Keflex) and acetaminophen (+) hydrocodone bitartrate (Vicodin). The patient was reported as recovered. Shortness of breath, shooting pain in her right arm, shaking of her head and body, feeling flushed, dryness of mucus membranes, nausea, diarrhea, fatigue and cellulitis were considered to be disabling and other important medical events by the reporting nurse (OMIC). There was no product quality complaint involved. Additional information has been requested.
A non-serious spontaneous report of gave 1/2 dose of H1N1 was received from a consumer concerning a 36-year-old female. On 27-Oct-2009 the patient received 1/2 dose (0.1 ml) of H1N1, Intranasal in a single nostril. The other half dose was discarded by the person administering the vaccine. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
I experienced a disruption in my menstrual cycle. My period arrived almost three weeks early and was exceptionally heavy. This is something I have experienced after my second Pfizer dose, first booster, and this most recent booster shot.
arm soreness at injection site for 3 days; felt tired since getting the vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 16Jul2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19. Patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included herbal tea (MANUFACTURER UNKNOWN), hydration and beauty drops (MANUFACTURER UNKNOWN) from an unknown date for an unspecified indication. On 17Jul2021, the patient experienced arm soreness at injection site for 3 days, felt tired since getting the vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event arm soreness at injection site for 3 days was recovered on 20Jul2021. Whereas, that of felt tired since getting the vaccine was unknown.  No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date the patients were vaccinated with VAQTA. dose, route, lot number and expiration date were not reported. No co-suspect and concomitant therapies were reported. The physician reported that unspecified patients may have received improperly stored VAQTA exposed to maximum 10C for multiple time frames (on an unknown date). No adverse effects were reported. This is one of several reports from the same source. Additional information is not expected.