chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of injection site scab in a 70-year-old female patient who received SHINGRIX (batch number 49ST9, expiry date unknown). Concurrent medical conditions included diabetes. On 9th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In April 2018, 7 days after receiving SHINGRIX, the patient experienced injection site scab. On an unknown date, the outcome of the injection site scab was not recovered/not resolved. The reporter considered the injection site scab to be unlikely related to SHINGRIX. Additional details were provided as follows: The nurse reported to a field representative that a patient had a scab, about 1 to 1.5 inches long and the width of a pencil, horizontal across her arm where she received SHINGRIX in right deltoid. The nurse noted that it looked like the patient had scratched the area, but the patient denied doing so. There was no redness, welling or pain that the patient reported. The reporter had followed-up with the patient immediately after the injection and the patient reported no adverse events. The patient was in the office of an unrelated reason in the week of reporting date and that was when the nurse noted the scab.
Administrating a third dose of Shingrix by mistake to the patient; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 18th February 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 26th May 2021, the patient received the 3rd dose of Shingrix. On 26th May 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows:  The Patient's age was reported to be 61 years. The patient received the 3rd dose of Shingrix by mistake, which led to extra dose received. The pharmacist did not consent nor denied follow up.  No further events were reported.
Administered vaccine had been in the refrigerator > 30days and was expired; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jul-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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccine had been in the refrigerator > 30days and was expired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.  Treatment information, if any, was not provided.  Nurse states they realized today that the vaccine was good in the refrigerator for 30 days. No realized the vial in the refrigerator had expired and it was administered to 6 patients. This is the third of the six adverse event reports.
patient complained of mild itching approximately 15 minutes after administration.  patient self administered benadryl and was monitored for 30 minutes.  patient stated that he was feeling fine after observation and left on his own accord.
Threw up, low grade fever on 04/17/2002. Tired, sluggish all day between 5:45-10pm with redness, warmness to touch, hard to touch developed and saw physician on 04/18/2002. Measurement 9x8 remains reddened and hard not painful to touch.
The child developed a fever of 103F and a red, hot and swollen right arm, approx. 48 hours, post vax. One episode of vomiting and fever continued for 3 days. MD evaluated and stated all "tests were normal". It subsided and he is back to normal.
throat irritation; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat irritation) and RHINORRHOEA (runny nose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, the patient experienced THROAT IRRITATION (throat irritation) and RHINORRHOEA (runny nose). At the time of the report, THROAT IRRITATION (throat irritation) and RHINORRHOEA (runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Negative) Negative and unknown (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.
He was complaining of being tired and decided to go to sleep. The next morning, he was very tired/fatigue and asked for some water for hydration. After that, he said he felt very faint and passed out after saying that. He wasn't responsive to me when trying to wake him. I called 911 when he wouldn't respond; he was passed out for about a minute before he woke and was very disoriented after. The paramedics arrived after; they assessed him for a normal heartrate but pretty fast EKG. He was complaining about chest pain as well. They asked did he want to go the hospital, and he opted in. They were no conclusive results from the blood work and EKG testing done at the hospital. The doctor said the chest pain was probably from a muscle injury from prior to the vaccine and was told to take ibuprofen to aid the pain he was feeling. He was suggested to see a cardiologist as well; when they were prepping him for a CT scan, he fainted again for about 30 seconds or so. Fast forward weeks later to now, he's doing pretty better, but he's still being monitored for an upcoming appointment for another heart assessment.
A 1/2 hour after receiving vaccine my fast started to tingle and it lasted almost 24 hours.  I have had Bell's Palsy in the past (30 years ago)
7x5 cm lesion surrounding needle stick on left quadricep area with slightly firm and dusky center, surrounding erythema. Began 1 week post-vaccination, already resolving in 2 days.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 12-MAR-2016, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). On 20-MAY-2016, reported as today, the patient was vaccinated in the pharmacy with the second dose in the series, which was GARDASIL 9 injection (dose, route of administration, lot# and expiry date were not reported). There was no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
patient began to experience incontrollable shivering. stated she was freezing cold. no other symptoms.  given warm packs and blankets. 2 25mg po benadryl ordered and given. patient assessed by the provider for 30 minutes. improved and d/c'd home.
Patient received hep A and hep B vaccines at 10:40 am. 10 minutes post administration patient became pale/grey in color with cool clammy skin and had an episode of syncope. Patient also with heart rate of 45 beats per minute. Syncopal episode lasted about 10 seconds, oxygen was applied and within 2-3 minutes patients heart rate increased and patient's color returned to pink. 911 called, EMS arrived to scene and patient escorted to emergency department for further evaluation.
Erythematous patches on underarms, creases of arms, inguinal folds, behind knees, chest, neck with rash appearing around 4 days after administration of rash.  The rash initially started on creases of arm. The rash is pruritic and with a burning sensation. Treatment included topical steroids , one round of medro dose pack and prednisone 20 mg daily for 10 days. Patient was seen on day 8/10 of prednisone 20 mg course with rash described above.
Couldn't sleep on left side where shot was given. Problem raising arm above shoulder height. Problems still occuring 10 days later.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 08-APR-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # S006050, has been verified to be a valid lot number; expiration date 12-DEC-2020) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Patient reported to have seizure episode for 10 minutes. Seen at ED and then transferred to hospital and had CT, LP , labs and EEG completed. Required versed to resolve seizure episode. Since then has been evaluated in ED and hospital due to multiple episodes of seizure activity.
Red, warm, and raised to Rt. thigh injection sites. On 11/19/2014 Dr. ordered antibiotic with office visit.
First dose received Pfizer, no ASE as per client.   Received Moderna vaccine today, tolerated well, no ASE.
red swollen area with pain and cant raise arm much behind her and cant reach behind you and pain is radiating
While patient was sitting after the vaccination about couple hours, pt fell on the ground with her face down. pt was quickly laid on the ground with legs up on the chair. pt resumed alert and oriented after falling on the floor. After 15 minutes, pt felt better and started sitting on the chair and had some juice and coke. Then, pt still felt dizzy and nausea and decided to lay down again. After another 15 minutes, pt felt better and mom took her home.  She was told to follow up if needed and watch for concussion.
This spontaneous report as received from a pharmacist refers to a 13 year old male patient. On an unspecified date in 2002 the patient was vaccinated with first dose of (Oka/Merck) VARIVAX (dose, route and lot # unknown). The patient was never administered a second dose of (Oka/Merck) VARIVAX. No adverse events were reported. Additional information has been requested.
Started with multiple red papules on 12/01/07.  Examined 12/04/07.  Physician noted multiple red papules with vesicles all over.  Dx: chicken pox.  Plan: Benadryl, Motrin/Tylenol prn.
Constant pain on the bone area on top of the left eye and makes the left eye watery. This symptoms is soothed by taking one tablet of a Regular Strength Tylenol a day in the morning. With this I can sleep well at night and ok when I wake up but the pain start like an hour after I got up from bed.
Large local erythema (L) deltoid 2 d prior. Vomiting.
Pt has eczema. Ten days after he was given PROQUAD vaccine, he developed a vesicular rash, with much worse rash in areas of skin affected by eczema, appearing like eczema herpeticum.
About 9 days after receiving the vaccine, I began experiencing itching, redness and swelling at the injection site - they symptoms have worsened over the span of 3 days so far. Currently using hydrocortisone, Benadryl Spray, and ice to treat symptoms.
This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (couldn't sleep last night), MUSCLE STRAIN (feels as if she pulled a muscle), BONE PAIN (collarbone on the left side, it was a lot of pain.), PAIN (Aches) and MASS (Bump/lump) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 048B21A and 025B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.No Medical History information was reported.On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced MUSCLE STRAIN (feels as if she pulled a muscle), PAIN (has pain in the front and the back/It's hurting all this top part/ She has pain in the front) and ARTHRALGIA (hurting on the same side on the back of the shoulder). On 17-Jan-2022, the patient experienced INSOMNIA (couldn't sleep last night), PAIN (Aches), VACCINATION SITE PAIN (especially pain on the side that they put the shot), HEADACHE (headache), PYREXIA (fever) and MYALGIA (Had body aches but it's more on the left side). On 18-Jan-2022, the patient experienced BONE PAIN (collarbone on the left side, it was a lot of pain.), MASS (Bump/lump) and BACK PAIN (has pain in the front and the back). At the time of the report, INSOMNIA (couldn't sleep last night), BONE PAIN (collarbone on the left side, it was a lot of pain.), PAIN (Aches), VACCINATION SITE PAIN (especially pain on the side that they put the shot), HEADACHE (headache), PYREXIA (fever), ARTHRALGIA (hurting on the same side on the back of the shoulder) and MYALGIA (Had body aches but it's more on the left side) outcome was unknown and MUSCLE STRAIN (feels as if she pulled a muscle), MASS (Bump/lump), BACK PAIN (has pain in the front and the back) and PAIN (has pain in the front and the back/It's hurting all this top part/ She has pain in the front) had not resolved. No Concomitant product use was reported. The patient stated they received the Moderna booster on 17-Jan-2022 and had headache, fever, aches, and especially pain on the side that they put the shot. The patient couldn't sleep last night. The patient had body aches, but it was more on the left side. Reportedly, on 18-Jan-2022 by the collarbone on the left side, it was a lot of pain. The patient touched it, and there was a bump. It was a lump, and it was hurting. If the patient pressed the lump, it hurts. Also, it was hurting on the same side on the back of the shoulder. The patient reported that it was hurting all this top part. The patient had pain in the front and the back, and the patient felt as if the patient pulled a muscle.No treatment information was provided.
My lower lip and chin swelled up at 8:30 pm, about 8 hours after the vaccine injection. I discussed over the phone the reaction with my doctor.  And emailed her photos of my chin and lip. She advised me to take Benadryl and ordered an Epi pen for me if needed.  I took oral Benadryl at 11 pm. The following morning the swelling had gone down, but my left cheek felt slightly numb & tingly. I did not take any other medication.  And all the symptoms seemed to resolve by noon the following day, which was 24 hours after the vaccine injection.  I was concerned about taking the 2nd dose of the vaccine and having another adverse reaction. My family practice doctor sent me to an allergist  for consult. I discussed my reaction with her, showing her the photos.  She felt that I had a bradykinin reaction and it would be ok to have the 2nd dose of the vaccine.  I did get the 2nd dose of the Moderna vaccine and did not have any adverse reaction as I had had with the 1st dose.
Neck pain and in back of head, twitching hands, dizzy, nauseous, cold feeling, fever, feeling very weak. Patient was admitted for meningitis symptoms. All tests came back negative.
Mother states approximately one hour after receiving immunizations, child stated his "ears were burning." Mother looked to find child covered in hives from head to toe. Mother called physician, who advised Benadryl. After giving one dose mother stated child greatly improved, mother gave another dose six hours later and hives completely went away.
Patient waited in office for 15 minutes and denied reactions when checking out. Upon exiting building she felt nauseated and vomited. Mother brought her back into building to report reaction.
Within an hour, I felt like I had been hit by a tank; difficulty breathing, dysequilibrium, problems with balance that induced dizziness and vertigo, wobbly gait, extreme weakness, continual tiredness--not refreshed by sleep, difficulty sleeping, insomnia, injection site pain, severe headaches for weeks, eyeball pain, chills, fever, inflammation, joint pain, muscle pain, activity-induced or cognitive exertion muscle fatigue, nausea, swollen lymph nodes, especially in neck, sore throat, difficulty swallowing, cognitive problems -- difficulty with memory, focus, concentration, problems with wordfinding ability, misspeaking; short-term blurry vision; extreme difficulty with body temperature control leading to shaking
under arm started swelling with burning sensation; under arm started swelling with burning sensation; headache; chills; feels tired; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (under arm started swelling with burning sensation), PERIPHERAL SWELLING (under arm started swelling with burning sensation), HEADACHE (headache), CHILLS (chills) and FATIGUE (feels tired) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced BURNING SENSATION (under arm started swelling with burning sensation), PERIPHERAL SWELLING (under arm started swelling with burning sensation), HEADACHE (headache), CHILLS (chills) and FATIGUE (feels tired). At the time of the report, BURNING SENSATION (under arm started swelling with burning sensation), PERIPHERAL SWELLING (under arm started swelling with burning sensation), HEADACHE (headache), CHILLS (chills) and FATIGUE (feels tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
10.19.11 P.C. from patient had "knot" on left arm, 102 degree temp (10.14.11) nausea/vomiting, went to clinic Sat. PM. MD gave rx. MD said was a 4 hr virus. Mom stated "blotchy" arm began Sat. Pt n/v & sleepiness all wkend. Returned to school to school nurse PM. U arm continues blotchy. Spoke with someone in office (spoke to dr) Pt to go to infirmary.
Case number PHEH2013US025552 is an initial spontaneous report received from a health care professional on 05 Dec 2013. This report refers to an 11-year-old female patient. Past medical history and concomitant medication were not reported. She was vaccinated with MENVEO, (batch number: M12094 and expiry date: 31 Aug 2014) at a dose of 0.5 ml intramuscularly on 28 Oct 2013, which was stored at 0 C for 250 minutes over a period of 63 days. No adverse event was reported following this administration error.
No additional AEs; Caller reported VARIVAX administered after temperature excursion.; This spontaneous report has been received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 19-MAY-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, 0.5 milliliter (ml), intramuscular (IM) (valid lot number W034708 [expiration date 01-NOV-2024]) (dose number, frequency, vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion of 6.4 degrees Fahrenheit with a time frame of 42 minutes (product storage error). No previous temperature excursion.  No additional adverse events (AEs).
allergy was activated more severe and began to spread to the upper lip; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 28-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW01620), via an unspecified route of administration, administered in Arm Left on 22Apr2021 11:00 (Age at vaccination: 28-years-old) as Single dose for covid-19 immunization. (Vaccination facility: Other). Medical history was reported as no.  Concomitant medication included lisinopril dihydrate (LISINOPRIL [LISINOPRIL DIHYDRATE]) taken for an unspecified indication, start and stop date were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 Prior to vaccination. It was reported that patient already had an allergy in her hands which had already been controlled by a soothing eczema cream but a few hours after the application of the Pfizer vaccine, on 23Apr2021 14:45 the allergy was activated more severe and began to spread to the upper lip. Patient received treatment for the event with Fexofenadine. The outcome for the events was reported as not resolved at the time of this report.   Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.
Information has been received from a healthcare professional concerning a 19 year old female who on 24-JUN-2009 was vaccinated with a dose of GARDASIL. ON 28-JUN-2009 the patient experienced itchy with hives. The patient's itchy with hives persisted. The patient sought medical attention via telephone. Additional information has been requested.