chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Indicate at which point in the process the medication error occurred: Storage in clinical Practice; No additional adverse events reported/ What was the patient's response? None/ No adverse reaction reported; administration of expired PROQUAD/ expired product inadvertently given/ vaccine was administered 5 days after the expiration date/ Error; This spontaneous report was received from a pharmacist (conflicting information, also reported as from a consumer) regarding an 11-year-old male patient.  According to the pharmacist, the patient did not have any pre-existing physician-diagnosed allergies, birth defects, medical conditions, or illness at the time of vaccination; there was not any other vaccine within four weeks before the Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) administration. Concomitant medication included sterile diluent for vaccines.  The pharmacist reported storage in clinical practice medication error (product storage error) (unspecified date).  Subsequent administration error occurred on 30-MAR-2021, when the patient was inadvertently vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (rHA) (PROQUAD) injection (reported as "# of previous doses 0") (1 dose), subcutaneously in the left deltoid, as prophylaxis, five days after the expiration date (lot number S030215, expiration date 25-MAR-2021).   No adverse reactions were reported (no adverse event).
Localized erythema/edema and pain with, urticaria without itching that initially was localized to the L upper arm then spread to the torso within an hour of noticing. No shortness of breath, chest pain or signs of anaphylactic reaction noted. I took OTC Benadryl 50 mg Q8H PRN , Pepcid 40mg Q12H PRN, and Ibuprofen 600mg Q8-12H for 3 days. I took 2 total doses of Benadryl, 2 doses of Pepcid, and IBU for 3 days (for pain/discomfort in arm). The "Hives" resolved in a little over 24 hours from the time I noticed them at 1600 the day of vaccination. I never felt the need to notify my PCP, or the Pharmacy administering the vaccination.
Large red spot at site of injection, headache, severe pain in the right side of face and jaw, stuffy nose.
32-year-old female no pertinent past medical history and surgical history of C-section presents with complaint of sudden onset of midsternal chest pain that began about 15 minutes prior to arrival. Patient states that the pain started while she was at rest and there are no significant exacerbating or alleviating factors. She received her 2nd Pfizer Covid vaccine yesterday and started experiencing arthralgia, myalgia, fatigue, headache and fevers last night. The fevers have subsided but the patient continues to have some body aches. The patient denies any cough, nausea/vomiting/diarrhea, abdominal pain. Patient denies any leg swelling or calf tenderness.
3/14 felt funny tired, 3/15 am passed out BP dropped arm red and swollen to ER, 3/16 back to ER c/o chest pain, weakness, headache, put on heart monitor. A follow up report received 1/8/2003 adds: It was reported that a pt (3 of 5) received an Imovax Rabies ID vaccination on 03/14/2001. Reportedly the pt developed a headache, sore muscles, and a local reaction. Further info is requested. From telephone conversation on 04/06/2001, it was reported that the pt recovered from this experience. From additional correspondence received on 04/18/2001, it was reported that the pt did not experience nightmares or insomnia. On 03/14/2001, the pt felt "funny" in the evening. During the morning of 03/15/2001, the pt passed out at home. 911 was called and pt was taken to the ER. The pt's BP was decreased and developed an injection site reaction. The pt left from the ER feeling weak and her was red and swollen at the site. On 03/16/2001, the pt went back to the ER, stayed for 8 hours: pt was put on heart monitor, complained of chest pain, weakness and headache. From additional correspondence received on 05/21/2001, the required ER/doctor visit was marked in box 8 of the VAERS form. "Reviewed 05/14/2001. Emergency Room Visit Summary can be secured. Follow-up #1 - No further info was provided from mailed correspondence received on 06/25/2001. This case is closed.
Expired 2nd dose administered after 30-day Use By Date; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered after 30-day Use By Date) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007J21-2A and 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered after 30-day Use By Date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired 2nd dose administered after 30-day Use By Date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication reported  The vial was initially stored in the refrigerator on 27JAN2022 and first removed from the Freezer on 27JAN2022. The 30 day use by date expiration was reached on 27FEB2022. No Treatment medication reported
Cold sore; Developed cold sore above lip after receiving vaccine.; This is a spontaneous report from a contactable consumer (patient, self-reported). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 13Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that she received her first dose on 13Mar2021 and was scheduled on 04Apr2021 for the second dose. As per the patient, the cold sore started a few days ago, around the 24Mar2021. The patient developed cold sore above lip after receiving vaccine. The patient asked she had a cold sore, could she get the second dose. The patient calling about the Pfizer COVID-19 vaccine who says she had a question about getting her second shot that she was supposed to get Saturday because she had a cold sore, and she was wondering if that means she could not get her second dose of the vaccine. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt recv vax;approx 6 hr post vax, he began high-pitched crying that lasted approx 3 hr. pt calmed momentarily w/ rocking w/ recurrence; no fever
Patient received a pfizer vaccine at a mass clinic.  When the nurse went to give her the vaccine she accidentally used a sterile needle that had not been drawn up with vaccine yet and inserted it into the patient arm before realizing the plunger was completely depressed and nothing was in the syringe.  She then proceeded and vaccinated the patient with the correct product.
Follow up information was received from the child's mother, who reported that her daughter's high fever was due to roseola. Information regarding Prevnar (pneumococcal 7 valent conjugate vaccine injection) was received from a mother regarding her 9 month old daughter who experienced roseola. The pt received a dose on 28Apr04. Relevant medical history was not provided. Indication for Prevnar was immunization. Product was administered on 28Apr04. Dose regimen was 1 dose. Concomitant medications were not reported. The child's mother reported that on 28Apr04, post immunization, her daughter developed a fever. The fever at its highest was over 104.5 F rectally. On follow up, the mother stated that spots came out several days later, when the fever broke, which she believed to be roseola
COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an 82-year-old female patient 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive for COVID.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
June 9, 2021 was the first time I fainted. I've experienced heart palpitations, dizziness, extreme fatigue, short of breath, and migraines. Ive fainted a total of 10-11 times since June 2021. Prior to this I had no heath conditions and never experienced anything like this.
Small red splotches scattered on both arms, both legs, tops of feet, and stomach. No itching, burning or pain associated with splotches. No other symptoms reported.
Flu-like symptoms for 2 days, Arm and leg pain and tingling for 1 day
Pt recvd MMR vax on 6MAY91 & 3MAR92 lab eval revealed no antibodies to measles or mumps;  No further details were provided;
Rash throughout thigh, abd., little in groin. Minimally raised mostly flat. BENADRYL & cortisone cream prn. Started in Lt leg moved to Rt. leg on B/L at O.V.
Moderna Covid-19 Vaccine EUA Injection site-red, warm at touch, sore, episodes of feeling hot and cold of body. had wierd sensation, Lightheaded, nauseated.
Extreme pain at injection site and entire upper arm. Weakness in arm. Unable to support weight climbing a ladder.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of GARDASIL (dose and route were not reported, lot # K023432 with expiration date: 18-JUN-2016; lot # K009482 with expiration date: 06-MAR-2017) which were exposed to temperatures outside of the recommended range. No adverse experience was reported. This is one of several reports received from the same reporter. Additional information has been requested.
she's been noticing memory loss that is getting worse/having problems remembering; chronic fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Jul2021 (Lot number: FA6780) at the age of 52 years as dose 1, single and administered in arm left, administration date 23Jul2021 (Lot number: FA6780) as dose 2, single for covid-19 immunisation. Relevant medical history included: "ADD" (unspecified if ongoing); "Epstein Barr" (unspecified if ongoing), notes: Epstein Barr: was diagnosed either about 1984 or 1985; "Allergies: Latex" (unspecified if ongoing), notes: Allergies: Latex; "spine surgeries", start date: 2018 (unspecified if ongoing), notes: she had spine surgeries and the last one was in 2018. Concomitant medication(s) included: BACLOFEN; MODAFINIL taken for attention deficit hyperactivity disorder. Past drug history included: Cipro, reaction(s): "Allergies: Cipro", notes: Allergies: Cipro; Steroids, reaction(s): "Allergies: very very vey intolerant to any steroids", notes: Allergies: very very vey intolerant to any steroids. The following information was reported: AMNESIA (non-serious) with onset 2021, outcome "not recovered", described as "she's been noticing memory loss that is getting worse/having problems remembering"; FATIGUE (non-serious) with onset 2021, outcome "recovering", described as "chronic fatigue". Therapeutic measures were taken as a result of fatigue.  Additional Information: Caller states that she is calling in regards to the Pfizer Covid Vaccine. She is athletic, healthy, almost 53 year old woman. She takes good care of her self. Since the final vaccine her memory is very bad and it is starting to scare her. She had Mono as a child, but its like its reactivated. She has not had this in a long time. She is scared, she works in Medical field, she is college educated. Like she didn't know yesterday was Monday, she even overdrawn on her checking account, she is not a wacky person, she has the funds, she has thousands but she is not focused, and her memory is now really bad. She was calling about the side effect, when she had Mono, or more specifically she knows she has Epstein Barr in the blood, her doctor waited a long time for her to get the vaccine, she was afraid that she might have the problem. She has questions if there is other studies that have information about the vaccine and the Epstein Barr or anything similar to that, or that the vaccine may have escalated or reactivated a condition. She wasn't sick for years and she is healthy, thin, eats well, doesn't do drugs. Her Mom's a nurse, her dads a retired doctor, and she herself works in devices.  No follow-up attempts are possible. No further information is expected.
pt received covid19 vaccine, complained of nausea & brain fog (cloudy) pt admited to ER with fever and increase in Blood pressure, midnight complained of tightness in chest (SOB). pt was released fr ER w/tylenol + ibuprofen+ zofran. While at home, pt complained of pain in hip, swollen arm, chill, Dr informed to rest + keep hydrate w/water, call 911 for help if symptoms worst or severe.
Patient phoned pcp office Clinic to inform: receipt of 2nd Moderna vaccination at HD on 2/18/21, patient states on 1st evening felt numbness and tingling in tongue, as well as fatigue, body aches, chills, but took benadryl and no worsening s/s. Typical side effects of body aches, chills, sore joints continued throughout day 2 and day 3. On day 3 patient reports she developed a rash on her neck and swollen eyes.  Reported information to pcp NP for advisement today.
got the shot /nowhave shingles / once there is an outbreak, it never goes away/suspected vaccination failure; got the shot /nowhave shingles / once there is an outbreak, it never goes away.; This case was reported by a consumer and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The age group was not reported but it was selected as an adult as per vaccine indication. The patient never had the shingles shot. The physician convinced patient to get the one and never had shingles before the shot. The patient got the shot and now had shingles. Once there was an outbreak, it never goes away. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, event onset time and laboratory confirmation for shingles were unknown at the time of reporting. The information regarding consent to follow up was not reported. No further information available.
Lips started tingling, then burning about thirty minutes after injection.  I have had no facial fillers previously.  Symptom lasted for several hours.  No treatment.
Initial sore arm at injection site lasting 2 days. Feeling run down for 2 days. Sinus cold symptoms and vomited once on 4th day after injection.
Moderna COVID-19 vaccine EUA Extreme tiredness and weakness day after second dose Complete upper body covered in rash second day after second dose
7 Year old female received second dose of pediatric Pfizer vaccine 9 days after receiving the first dose.
little sore arm(L arm); itchy; little bumps on her legs, thighs, arms and on her back.; face swells up; rash; chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (little sore arm(L arm)), PRURITUS (itchy), VACCINATION COMPLICATION (little bumps on her legs, thighs, arms and on her back.), SWELLING FACE (face swells up) and RASH (rash) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 202A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Depression, Anxiety and Migraine.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little sore arm(L arm)), PRURITUS (itchy), VACCINATION COMPLICATION (little bumps on her legs, thighs, arms and on her back.), SWELLING FACE (face swells up), RASH (rash) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ITCH) for Itch, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (little sore arm(L arm)), PRURITUS (itchy), VACCINATION COMPLICATION (little bumps on her legs, thighs, arms and on her back.), SWELLING FACE (face swells up), RASH (rash) and CHILLS (chills) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified medications to treat depression, anxiety and migraine.  Treatment medication also included alcohol (topic).     Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow Up received on 04-MAY-2021 Contains Updated Event Outcome to Recovered, Reporter declined to Follow Up.
Pt returned a week or so later complaining of large bruise on arm. Advised to go to physician. Pt said had no insurance. I said should still go see.
Headache, fatigue, chills x 4 days.  Headaches and fatigue continue on day 12 post vaccination.
Pain in shoulder & arm where shot was given that day. Pain returned in shoulder & arm on 10/7/2013.
Convuls x 1 epi, fever & local rxn; 2 prior DTP; no previous hx of convuls in pt or family;
got sick as a dog with the flu I'm never getting the flu shot again; Initial information received on 02-Jan-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves an unknown age and unknown gender patient who experienced got sick as a dog with the flu i'm never getting the flu shot again while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer at unknown (formulation, strength, dose, expiry date, lot number, route, administration site)  for prophylactic vaccination.  On an unknown date the patient developed a non-serious got sick as a dog with the flu i'm never getting the flu shot again (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got sick as a dog with the flu I'm never getting the flu shot again).  At time of reporting, the outcome was Unknown for the event got sick as a dog with the flu i'm never getting the flu shot again.
fever on Sat 101, Mon 103, Wed 100.8, taking motrin reg since tues Q4 hrs x2 pils every 4 hours if not fever  goes rt back up.  Has been going on for 3 days
Normal soreness and swelling at injection site. Within  4 days  developed a hard mass about 3" x 2" with soreness and itching at site.
Varicella breakthrough in a previously immunized child. Febrile; approximately 20 lesions.
Confusion, Headache, Myalgia, ErythemaMultiform, Lymph nodes swelling Narrative:
Post vax the patient became weak and pale. Was still weak the following day. On 11/09/2001 the patient was back to normal.
2 MINUTES APPROXIMATELY AFTER RECEIVING DOSE SAID I DON'T FEEL RIGHT, THE INJECTION SITE DOESN'T FEEL RIGHT, I FEEL DIFFERENTLY, I FEEL LIKE I'M GOING TO PASS OUT" STATES HIS PUPILS DILATED, EYES ROLLED BACK, COLOR IN THE FACE CHANGED (PALOR) AND THEN HE FAINTED AND PRVENTED HIM FROM FALLING.   HE DESCRIBES FEELING THAT THE VISION HAD CHANGED, LOOKED BLACK AND SPOTTY, AND THE HUMIDITY, THE GROUND LOOKED SPOTTY TO HIM.  IN LESS THAN A MINUTE HE CAME TO CONSCIOUSNESS BEFORE WE COULD ADMINISTER AMMONIUM SALTS.  PULSE RATE WAS STEADY AND POUNDING, FELT NORMAL.  TOOK VITAL SIGNS, PULSE OX 98%, WITH PULSE OF 55 ON THAT DEVICE AND THEN WITH WRIST B/P READ B/P OF 174/75 AND HR UP TO 66BPM, PATIENT KEPT FOR ADDITIONAL 25 MINUTES FOR OBSERVATION AND DOING JUST FINE NOW.
No additional AEs; a 65 year old male patient was administered GARDASIL 9 on today; This spontaneous report has been received from a pharmacist referring to a 65-year-old male patient. No information regarding the patient's medical history, previous drug reactions or allergies, concurrent conditions or concomitant medications was provided.  On 07-DEC-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (product administered to patient of inappropriate age) dose and frequency reported as 1 time dose (dose, route of administration and anatomical site of vaccination were not reported; lot number T036442 has been verified to be valid, expiration date reported and established as 09-APR-2023) as prophylaxis.   No additional adverse events were reported (no adverse event).
Pt did not bring her vaccination card with her to clinic, looked her up in medical database and was found to have 2 different ID accounts. LVN given prior vaccination history. Patient sent to vaccination able with LVN.  Patient given booster dose of Pfizer lot # FJ1620 to left deltoid by LVN.  Patient then came into clinic with husband on 12/9/21 for his booster dose and he was noted to be too early for booster. She then said that she got her booster a week or so ago on 11/30/21.  Reviewed chart and found pt to have received booster dose early and 1st and 2nd doses not charted.  Reviewed info and educated LVNs  about reviewing prior vaccination status.
Swelling left leg. Femoral vein DVT identified on ultrasound on April 5, 2021 (partially occluded clot). hematologist switched me from Eliquis to starter pack of Xarelto.
loss of conscious  / Joint Pain / Headache / Muscle  Aches/ Nausea / Fatigue / chills / Fever / Swelling of arm with pain still recovering at home
Itch rash all over the body  that started with a big one in the back. Dermatologist diagnosed Pityriasis rosea
Headache and back pain, itching in the vaccine area, flu, bone and joint pain, temperature of 38.7
Information has been received from a registered nurse with pneumonia in the past, who 7 years ago received a dose of PNEUMOVAX and her unspecified arm was sore the next day for 2 weeks. The patient took ADVIL. Subsequently, the patient recovered. No further information is available.
Received shingles shot 4-20-12, per email, pt has "itchy blistering rash at injection site, plus headache."
Experienced Hives/Rash on arms and legs on day 2 and day 8 after the vaccine. Treated at home with Benadryl. Severe Headache Day 1, 2, and 3 after the vaccine. Treated at home with Advil.