chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccinated after the excursion; Product storage error; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error) in a  patient of an unknown age and gender 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 EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) and PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccinated after the excursion) had resolved and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The facility had a 20 minute excursion in the freezer that the Moderna COVID-19 vials were stored in. The excursion was on Sunday.   This case was linked to MOD-2021-404757, MOD-2021-404629, MOD-2021-404754, MOD-2021-404644, MOD-2021-404793, MOD-2021-404722, MOD-2021-404660, MOD-2021-404699 (Patient Link).
Received vaccine on 30AUG2022 from Agency. Was told vaccine expired on 4NOV2022. Patient received vaccine on 13SEP2022. On 16SEP2022 it was discovered that vaccine expired on 31AUG2022.
high temperature (38C and more)/ fever symptoms; headache; strong fatigue; inflamed lymph nodes in the armpits; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot Number: EW0182), via an unspecified route of route of administration, administered at left arm on 08May2021 at 10:00 A.M (at the age of 36-year-old) as dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: EW0189) via an unspecified route of administration, administrated at left arm on 17Apr2021 at 10:00 A.M (at the age of 36-year-old) as dose 1, single for covid-19 immunization. The patient does not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included meloxicam and tamsulosin hydrochloride (TAMSLUSIN); both from an unspecified date for an unspecified indication. On 08May2021 at 17:00, the patient had a high temperature (38C and more) and had it for two days/ fever symptoms, headache, a strong fatigue for two more days already and it did not pass yet and inflamed lymph nodes in the armpits. The patient did not receive any treatment for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Bloody diarrhea started at end of Oct 2021 that did not resolve and eventually diagnosed with ulcerative colitis in 2022
redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area; This is a spontaneous report from a contactable consumer (patient). This 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EM9809) on 24Feb2021, at the age of 71 years, as the second single dose, in right arm, for COVID-19 immunisation. No other vaccine was administered in 4 weeks. Medical history was none. The patient received the first dose of BNT162B2 vaccine on 03Feb2021 (lot EN5318), at the age of 71 years, in right arm. The patient did not have COVID prior vaccination. Concomitant medication included morniflumate (FLOMAX). On 03Mar2021 the patient experienced redness and skin irritation attacking various folds in the body, starting with the eyelids, moving to the ear canals, armpits and folds in the genital area. COVID was not tested after vaccination. The events resulted in Doctor or other healthcare professional office/clinic visit, required treatment (cortisone shot) and had not yet resolved.
Pt developed coughing and SOB within 5 mins with swelling periorbitally. Pt initially hypoxic but pt responded to Albuterol and Benadryl admitted for observation.
13 days post moderna booster got random hives all over my body. they have been happening daily in random spots ever since. went to urgent care on 12/3 put me on prednisone zyrtec pepcid and benadryl for a week. that seemed to help but the symptoms returned once prednisone was stopped and are still ongoing
CHILLS; This spontaneous report received from a health care professional concerned a 39 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol use, and non-smoker, and other pre-existing medical conditions included the patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 11-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chills was not reported. This report was non-serious.
arm pain was not bad; face has been getting very red lately around the area where her face mask is specifically worn / redness around the site where the first Shingrix dose was administered; redness around the site where the first Shingrix dose was administered; small "pimple sore" the size of the head of a pin developing on her right arm / four little dots around the Shingrix injection site; small "pimple sore"; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (Family History) (grandmother has shingles). Concurrent medical conditions included allergic reaction to wasp sting (patient had allergy to wasp sting).   In February 2021, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm, red face, injection site erythema, pimples and pain. On an unknown date, the outcome of the pain in arm, red face, pimples and pain were recovered/resolved and the outcome of the injection site erythema was unknown.   It was unknown if the reporter considered the pain in arm, red face, injection site erythema, pimples and pain to be related to Shingrix.  Additional details were provided as follows: The patient was in early 60s. The age at vaccination was not reported. The patient stated she had a little reaction to the first Shingrix dose. The patient had small pimple sore the size of the head of a pin developing on her right arm a couple of days after receiving the first Shingrix dose. The patient further described the pimple sore as four little dots around the Shingrix injection site. This pimple sore lasted for a few weeks. The patient also reported that her face had been getting very red lately around the area where her face mask was specifically worn. She stated that this had lasted for two to three weeks. The patient also reported that she had arm pain that started the day of or the day after receiving the first Shingrix dose. This arm pain was not bad and only lasted a few days. The patient also described redness around the site where the first Shingrix dose was administered. She stated that this redness started about a week after receiving the first Shingrix dose. The patient also reported a medical history that she could not wear wool. The patient declined to provide any demographic or contact information out of privacy concerns. The patient was unable to provide the dosage and lot number/expiration date of the first Shingrix dose she received. The reporter did not consented to follow up.
Breathing difficulties; allergy; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty breathing in a 82-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season at an unknown dose. On an unknown date, 2 hrs after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced difficulty breathing and allergy. On an unknown date, the outcome of the difficulty breathing and allergy were unknown.   It was unknown if the reporter considered the difficulty breathing and allergy to be related to Influenza vaccine Quadrivalent 2018-2019 season.  Additional details were provided as follows: The reporter had no information on the manufacturer of the vaccine or when the adverse events occurred. The case was filed for FluLaval and Fluarix Quadrivalent 2018-2019 season, however, no information was provided which vaccine caused the adverse events. Two to four hours after receiving Flu vaccine, the patient had to visit the emergency room with breathing difficulties. The reporter had no specific details about the agent that caused allergy to the patient, but the patient could eat eggs. The reporter consented to follow up.
A vial of Pfizer covid vaccine was drawn up incorrectly by mistake by one of the nurses in our practice, RN. In turn, this patient was mistakenly given the incorrect dose of the Pfizer covid vaccine by RN. Patient was administered 0.25ml instead of appropriate 0.3ml dose. After discussing this with the manufacturer, gave patient repeat full dose as soon as possible, as recommended. Patient was notified of error and agreed to receiving additional full dose, given on 1/25/21 at 4:54pm.
9/21-missed period for the month. 3 weeks after receiving the shot I began feeling a tightness in my chest and abdomen this has continued ever since. 10/30/08- possible seizure.  The following symptoms I have experienced since 10/24/08- My digestive tract does not seem to be working properly.  I am not hungry and when I eat food does not get digested properly.  My stomach feels like it is in a knot. My heart is beating irregularly, at times very fast, and there is a tightness around my chest and heart. It is difficult to breath.  11/03/08 Spoke with office MA. Seen 10/27/08 for amenorrhea and pelvic pain. 11/24/08 MR received from PCP for several OVs beginning 10/29/08 with c/o abdominal discomfort, ill feeling, and fatigue. PE (+) for tearfulness, poor eye contact.  Assessment:  Pain, abdominal, generalized, acute.  Nausea w/ vomiting.  Dizziness/vertigo NOS, acute.  Depressive d/o. Returned 10/31/08 with c/o dizziness and feeling unwell x 5 days. Missed last period but currently menstuating. Feels dizzy after eating with slow digestion.  Feeling cold, some nausea. Assessment:  nausea, alone with dizziness.  Etiology unclear. Returned 11/3/08 with for f/u with c/o feeling unwell x 2 months since HPV vax. Currently bilateral flank pain and bilateral lower abd pain.  Feeling heartrate changes, slower then faster. HR = 110bpm. One episode last week of body shaking, no LOC. Tx by EMS with O2. Upon PE pt is anxious.  Asessment:  Pain, abdominal, generalized.  Palpitations, acute.
Night of 3/06/21    -headache    -severe chills    -high fever    -body aches    -fatigue Above symptoms disappeared on 3/09/21  3/09/21    -began tasting/smelling a very strange taste, almost like dog food, when eating most foods    -taste either completely masked over the normal taste of the food or mixed with it    -taste made it unbearable to eat certain foods that were my favorite foods before    -foods that are affected       -meats       -flour based foods(tortillas, pancakes, cookies, etc.)       -fried foods    -foods that aren't affected       -fruits       -sweets/sugars       -liquids(that I've tested such as tea, coffee, milk, water, flavored water, etc.)    -this taste severely limits the foods that I can eat and is still present as of 3/16/21
At 12 hours post-vaccine administration, woke with a sharp headache pain in center of head (felt like corpus callosum). Then became aware of chills. First, chills felt like running down my nerves (like when you get scared), then changed to body shaking chills. Dressed warmer, took Tylenol, returned to sleep within 30 minutes. Woke again 3 hours after that with more chills and body aches. Fell asleep 1-2 hours after, awoke at 7am experienced chills, body and joint aches, nausea, and headache. Continued these symptoms with the addition of heat flashes for the next approx 16 hours. Lingering headache, grogginess, and chills/hot flashes for the next 12 hours. Symptoms fully resolved within 36 hours post-administration.
R deltoid erythema/swelling surrounding injection site approximately 1 inch diameter with extension towards axilla, axillary lymphadenopathy, tender/mobile.
Pt received both Flu and Pfizer covid vaccines. About 20 minutes later pt stated she began to feel "itchiness" and "swelling in mouth and throat area".  Stated it felt similar to when she has an "allergic reaction to shellfish". Her O2 was 97% and HR was 71. RN gave patient 10 mg of PO Zyrtec and water. Pt waited the full 30 minute observation period and stated she felt safe to leave. RN advised patient to call MD if symptoms worsen
First day after receiving vaccine- tired. Second day - malaise, fever. Third day - headache, muscle aches, runny nose, chest congestion, ear pain, anorexia, insomnia.
BREAKTHROUGH HOSPITALIZATION FOR COVID-19. VACCINATED 3/10/21. UNABLE TO GET DATE FOR 2ND VACCINE.  BOOSTER GIVEN 11/16/21. Information from case report form says he was admitted to ICU.  He was in contact with a known case of Covid-19.  He was symptomatic with only weakness listed.
Approximately 3 hrs. after shot, I had extreme tiredness and slept for approximately 6 hours. I had a headache before and after sleep.  The day after shot, I was still tired, had a headache, chills and a 100 degree fever. By evening, I was feeling fine. No headache, chills, or fever.  2 days after shot, I had a headache only. 3 days after shot, in the evening, I was very tired, had a headache, felt nauseous and dizzy. This did not last long. I went to bed and slept fine. Woke up feeling fine.
This spontaneous report as received from a physician refers to a unspecified number of patients of unknown age and gender. On an unknown dates between 05-JAN-2016 and 15-JAN-2016, the patients were vaccinated with incorrectly stored doses of GARDASIL (dose, frequency, route of administration and indication were not reported, lot # K010215 with expiration date: 05-MAY-2017). This is one of several reports received from the same reporter. Additional information has been requested.
Slight dizziness and lightheaded.  Abdominal pain and nausea.  Later complained of plugged nose.  States she had a bad Headache, chills during the night. C/O arm soreness following day.
Given DTAP on 8-18-11 in left leg. Mother states some mild inflammation and redness noted pt had some itching, soon after the itching stopped Mom states pt had fever 100.3 max on yesterday, after giving TYLENOL fever went away. Pt has had redness for 2-3 days at injection site, edema, warm to touch and with induration and increasing in size.
Patient was accidentally given a higher dose of covid vaccine for his age group, patient has been asymptomatic, no other issues noted.
Symptoms rash, pruritus, scratchy throat, cough approximately 20 minutes after administration of Hepatitis B Vacccine. Treatment - Prednisone, Bendaryl, Zyrtec, Zantac.
Painful arm / lump at injection site within 1-2 hrs. Pain moved to elbow and joint stiffened in approximately 72 hrs. By 5 days, elbow joint locked and pain increased. Pt received IM steroid in office and PO steroid Rx -> improvement w/in hours.
PATIENT EXPERIENCED TINGLING SENSATION TO TIP OF TONGUE AND HANDS S/P VACCINATION
Had flu shot at 2pm 10/28/2014. Went home took a nap then at 5pm when individual woke up notice itching, looked at legs noticed hives. Took BENADRYL. Symptoms are resolving.
Pt seen the day after MMR/varicella vaccines were given for new onset bruising of torso and lower extremities/face. No known trauma. Pt. had a few days of red spots on body previously, before vaccines, thought to be heat rash. The pt. was afebrile and acting like himself.
Developed slight tingle/numbness in right cheek area, like a very mild Bells Palsey
Patient received 2nd dose of COVID19 vaccine on 1/26/2021 and was diagnosed with a positive COVID19 test on 4/2/2021. Asymptomatic infection.
This spontaneous case, initially received on 22-Nov-2016, was reported by a health professional and concerns a(n) 62-year-old female patient. Weight: not provided; Height: not provided. Past medical history included Soy allergy. Drug history included Penicillin (Reaction: Penicillin allergy). Concomitant medication: Not reported. Administration of company suspect drug(s): The patient received AFLURIA from 18-NOV-2016 at 2:30 pm to 18-NOV-2016. Dose regimen: 0.5 ml, Route of administration: Intramuscular. Batch number: WT57008. No additional suspect drugs. Adverse reactions/events and outcomes: On 18-Nov-2016, 3 to 4 hours after receiving AFLURIA, the patient had a reaction. About 5pm, the patient developed headache (Medically Significant, outcome: Recovered/Resolved). About 8 pm, her mouth/face began swelling (Medically Significant, outcome: Recovered/Resolved). The reaction progressed and the patient went to emergency room and received prednisone and EPIPEN. The patient had recovered from the anaphylactic reaction. Reporter's comments: The pharmacist reported the case as serious as it required intervention to prevent permanent impairment/damage.
The patient described symptoms of brachial neuritis; a deep, steady and severe itching pain in her upper arm which radiated down to her fingers. This was followed by a sudden weakness all over. She got the chills, stomach ache and delirium at the ER, her BP & HR were low and she had a high fever.
PATIENT BROUGHT TO ED IMMEDIATELY AFTER RECEIVING COVID VACCINE;  PATIENT HAD 2 MINUTES OF LOSS OF CONSCIENTIOUSNESS AS PER FATHER; FATHER CAUGHT PATIENT; PATIENT DID NOT HIT HEAD; PATIENT STABLE
I am unsure of the day in June of 2015 that I first received the rabies vaccine but the day after I received my first shot I developed symptoms of increased depression, uncontrollable crying, shooting electricity shock like pains all over my body, suicidal thoughts, generalized body aches, bone aches, and increased forgetfulness. I had begun taking Pristiq 50 mg by mouth daily on March 27, 2015 and I took my first of three rabies vaccinations in June of 2015. These symptoms lasted until approximately 2 and 1/2 to 3 weeks after the last vaccination was given.
Attendee received first dose Pfizer vaccine at 09:20 am in the left arm.  Lot# FA7484. Attendee was directed to observation area.   At 09:25 voiced complaints of dizziness.  Attendee's skin was warm and dry.  Attendee's respirations were not tachypneic or dyspneic. Attendee assisted to the cot to lie down.  Water given. 09:27  Lying on the cot. HR:  52   BP:  98/70   O2Sat%:  98      09:37 - Attendee stated he felt better and wanted to go home   HR:  75   BP:  100/80   O2Sat%:  96  09:40 Sat up in the cot without dizziness.  Then to standing position without dizziness.    09:45 - Care Practitioner educated on home discharge/adverse reaction instructions and attendee was discharged to home with their mother.
Initial and follow-up information has been received through the Merck pregnancy registry from a consumer concerning her 19 year old daughter with no pertinent medical history who on approximately 15-OCT-2006 was vaccinated with a first dose of GARDASIL.  There were no concomitant medications.  On 18-DEC-2006, the patient was vaccinated with a second dose of GARDASIL.  On 30-DEC-2006, the patient found out she was pregnant.  Unspecified medical attention was sought.  In September 2007, the patient gave birth to a healthy female via primary cesarean section because she "just couldn't push that baby out."  The baby weighed 9 pounds and 1 ounce.  At the time of the report, both mother and baby were well without any problems.  Upon internal review, "just couldn't push that baby out" was considered to be an other important medical event.  Additional information is not expected.
Pt came back to pharmacy 2 days after receiving a vaccine, stating she had very strong metallic taste/smell as soon as she received the vaccine. Burst in month that went to nose that lasted for few seconds and went away. Pt spoke with her Dr about this symptom and Dr told pt to have pharmacy report to VAERS for possible vaccine effect associated with her symptoms. She said she was feeling under the weather for past couple days but all better now, but wants to report her experience. She did not mention anything to pharmacy staff at the time of vaccination.