chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This medically confirmed spontaneous report (initial receipt 01-Sep-2015) concerns a 43-year-old female patient. On 01-Sep-2015, the patient inadvertently received an intramuscular dose of expired AFLURIA (batch number T53909, expiry date: 30-Jun-2015) at dose of 0.5 ml. No adverse reaction occurred after the administration. The outcome was reported as recovered. Reporter's outcome: The reporter assessed the event as non-serious. Additional information was received from the reporter on 01-Dec-2015: The reporter assessed the event as unrelated to AFLURIA.
This spontaneous report was received from a nurse regarding a female patient of unknown age. Approximately on an unknown date in MAY-2014 the patient was vaccinated with GARDASIL dose 2 (dosing regimen unspecified). Approximately on an unknown date in MAY-2014 medication error was reported that the patient received her first dose of GARDASIL on an unknown date in August 2012 and was currently in office to receive her second dose. Nurse handed phone to physician assistant, but the physician assistant did not provide any additional information. No adverse effect reported. There was no product quality complaint involved. The outcome of the medication error unknown. Additional information has been requested.
VASCULITIS; VACCINE WAS INADVERTENTLY ADMINISTERED INTRAVASCULARLY RATHER THAN INTRAMUSCULARLY; HEART RATE INCREASES TO 150-160 WHEN STANDING; INFLAMMATORY ARTHRITIS; MENTAL EXHAUSTION; PHYSICAL EXHAUSTION; SEVERE RINGING IN THE EARS; This spontaneous report received from a consumer concerned a 30 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received Covid-19 vaccine ad26. cov2. s for prophylactic vaccination on an unspecified date in JAN-2021. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intravenous, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination approximately 6 to 8 months after first vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient's vaccine was inadvertently administered intravascularly rather than intramuscularly. It was injected into a blood vessel and it has been a nightmare since. He was confined to home because he has got a heart rate issue, just upon standing his heart rate increased to 150-160. He had inflammatory arthritis, vasculitis, mental exhaustion, physical exhaustion, and severe ringing in the ears. Laboratory data (dates unspecified) included: Heart rate (NR: not provided) (increased) 150-160. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine was inadvertently administered intravascularly rather than intramuscularly, heart rate increases to 150-160 when standing, inflammatory arthritis, vasculitis, severe ringing in the ears, mental exhaustion and physical exhaustion was not reported. This report was non-serious.
patient was administered the pfizer monovalent vaccine and not the bivalent vaccine they were scheduled to receive. patient presented with no symptoms spoke with mom, explained the vaccine was administered incorrectly
Sore arm, brain fog, headache for 2-3 days Blackness and numbness and tingling in third finger on right hand one week after shot and which is forming the basis of this report
10/2: Patient called to report covid pos results from 10/1/21. Sore throat resolved. Patient still has body aches, fatigue, chest heaviness, but no SOB. No cough or fever. Still has taste/smell. States she did not have any unmasked encounters with her coworkers. Discussed quarantine x10 days since s/s first appeared and 24 hrs. without fever reducing meds and improvement/resolution of symptoms. Patient to call hotline when released from quarantine and when s/s resolved for RTW clearance. Patient to update manager. Patient  not part of Quasar. Antibodies testing ordered. VAERS. HX 10/1: Patient  called in reporting chills, body ache, and sore throat that started 9/30. Patient reports she did also get booster 9/30, but also had symptoms. Test scheduled for 10/1/21 at 1210. Patient to quarantine at home at call hotline back with results for further RTW guidelines.
scabbing; shingles; marking that showed up on the face/sore dried up on his face; allergic reaction; swelling on neck and cheek; swelling on neck and cheek; tooth ache; stuffiness in ear; pain right side of the face; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6207), via an unspecified route of administration, administered in arm on 19Mar2021 10:00 (at the age of 63 years old) as 1st dose, single "to get myself vaccinated". Medical history was reported as none. There were no concomitant medications. The patient called about the COVID 19 vaccine, stated that he had side effects that he felt he needed to report and questioned if he needed to know anything before getting the second dose. He stated that he received the first dose on 19Mar2021 and on Sunday (21Mar2021) he began to have symptoms. He stated on Sunday 21Mar2021, he had swelling on his neck and cheek and stuffiness in his ear which he thought might had been a tooth ache or an allergic reaction. He stated that a few days after those symptoms developed he had pain on the right side of his face on 21Mar2021 and markings that showed up on his face on 22Mar2021. Further stated that he went to the urgent care as there was no need to go to the emergency room on 25Mar2021 and was diagnosed with shingles. He began treatment that day for shingles on his right side of his face and it was a seven day course of medication and his last treatment will be finished at the end of that day of the report. He reported that the markings were better and he did not have nerve pain and the sore dried up on his face which was consistent. He went to the doctor on 29Mar2021 just to be on the safe side and the symptoms seemed to be better. He received the next vaccine on 09Apr2021. Further stated he thought it would be good to report his symptoms and see if there was anything Pfizer could tell him. Further stated that the scabbing on unspecified date was getting better. Treatment was valacyclovir. Therapeutic measures were taken as a result of all of the events. The outcome of the event tooth ache and allergic reaction were unknown; pain right side of the face was resolved on 29Mar2021; stuffiness in ear, swelling on neck and cheek were recovered on 31Mar2021; shingles and marking that showed up on the face were recovering.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022; No adverse event; Administered the vaccine to patient after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022) and NO ADVERSE EVENT (No adverse event) in a 76-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 20-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to patient after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 20Jul2022).    No concomitant medications were provided by the reporter.  The patient received half dose.  The number of doses/vials administered were 35 vials. Date the vial was initially stored in the refrigerator was 04-Jun-2022. The vaccines were administered from the 04-Jun-2022 until the 26-Jul-2022. The vial did not undergo any temperature excursions.  No treatment medications were provided by the reporter
This spontaneous report was received from a nurse practitioner and refers to an unspecified patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 28-JAN-2017, the patient was vaccinated with the improperly stored dose of VARIVAX, subcutaneously (dose was not reported) (lot # M036292, expiration date 17-AUG-2017) for prophylaxis. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion greater than 5 degrees Fahrenheit and less than 14 degrees Fahrenheit (6.1 degrees Fahrenheit) for 41 hours and 20 minutes. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA001032: US-009507513-1702USA004127: US-009507513-1702USA004124: US-009507513-1702USA004125: US-009507513-1702USA004126: US-009507513-1702USA004121: US-009507513-1702USA004123: US-009507513-1702USA004176.
Pt reported adverse effects after 1st Moderna vaccine (administered on 9/12/21). Pt said he does not have a headache. However, he developed a sore arm for 1 week which has resolved. In addition, pt felt like his throat was closing up/felt swollen 1 day after vaccine (symptoms have improved per pt), and right ear feels plugged up. Pt said he has been using Nascort and OTC antihistamine that helps with sinus headache (pt does not know the name of the product). I recommended pt to continued using those products, since pt thinks it has been helping improve his symptoms. I left a message with pt's PCP to inform of pt's adverse reaction after 1st Moderna vaccine. Pt said he thinks his symptoms are improving, but wasn't sure if should get the 2nd Moderna dose. 2nd dose should be okay, since pt did not have anaphylaxis. However, informed pt to follow-up with PCP if symptoms do not improve and see what the provider recommends for the pt. In addition, recommended pt to go the ER if pt's throat closed up or if he felt like he couldn't breath.
Information has been received from a health professional concerning an approximately 12 month old male who on 20-JAN-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot#649817/0728R). Following vaccination the patient experienced a fever as high as 103F that persisted for 3-4 days. It was reported that the child also had a rash. It was reported that the patient recovered from fever but the rash persisted. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
6 mo patient was supposed to get a PEDIARIX shot but instead got a KINRIX GSK PY3DZ (R) thigh IM vaccine. Mom reported some fussiness later in the day. Gave single dose of TYLENOL. No more treatment needed.
Began itching all over during the night.  Woke up the next morning with small bumps all over her body (legs, arms, chest, stomach, back).  Bumps were the same color as her skin, not red.  This child has NO allergies but exhibited what appeared to be an allergic reaction.  These itchy bumps remained for 5 days at which time they subsided and the itchiness stopped.  However, she began to complain about her "heart feels funny, like it feels heavy" on Sept 6, continuing through today.  She has never before complained of heart issues, and no abnormalities have ever been detected. We ruled out all possible allergens such as food and drinks, lotions, shower gel, etc.  There was absolutely nothing we could identify that was out of her ordinary day-to-day consumption and application.  The only "incident" that was not part of her normal ordinary daily activities, ingestion or exposure was a Meningococcal vaccination she received two weeks prior ("Menactra" by Sanofi Pasteur).
Per MD note on 5/24/13. 66F with h/o HTN p/w swollen, red arm 1 day after receiving pneumococcal vaccine at that site to ED. She is an otherwise healthy woman who had the pneumococcal vaccine administered at noon yesterday. Several hours after receiving the vaccine she developed chills and fever to 101.3. She took ibuprofen which brought it down. She did not have any skin symptoms at that time. The morning of 5/24/13 she began to develop redness at the site of the injection which spread over the course of the day to cover most of her upper arm. The arm also began to swell and feel warm. Her fever also returned this afternoon. She initially presented to her local Urgent Care clinic who recommended she come to the ED. She has no redness or swelling elsewhere, no sick contacts, no history of allergy to vaccines, no CP, SOB, abdominal pain, N/V/D or dysuria and otherwise has been well. Likely cellulitis from recent trauma of injection. No sign of abscess. Will start Bactrim/Keflex and d/c to outpt f/u with PCP on Monday. Pt was instructed to let physician now about injection so that they may tell they vaccination provider and eval for any infected lot of vaccinations.
ADULT OBSTRUCTIVE SLEEP APNEA 1/14/2023,  1/19/2023,  1/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Serious nosebleed following administration of H1N1 LAIV to right nostril. 4 hours after health department administered H1N1 LAIV into right nostril, 16 y/o develop nasal anterior bleed. No previous history of nose bleeds. No blood pressure issues. Bleed was spontaneous, and not the result of blowing nose. No clotting problems or other medical issues in this patient. Lot # 500776P with expiration of 26 JAN 2010.
body aches, fever, edema eyelids & breast tenderness; testing: CXR, breast ultrasound, CBC, SMA, ESR, IGG, IgE, IgM; not completely recovered;
Slight loose cough. Nonproductive. Slightly sore tonsils. Start 0700am this morning.
Breakout on face and scalp of shingles-like; blisters that ooze yellow discharge; ooze yellow discharge; Headache; Fever; Sore arm; swollen glands on right face and throat; This non-serious case was reported by a consumer and described the occurrence of shingles in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension, gastroesophageal reflux disease and hormone replacement therapy. Concomitant products included losartan, pantoprazole, estradiol (Estradiol Patch) and carvedilol.   On 23-MAY-2023, the patient received the 1st dose of Shingrix. In MAY-2023, an unknown time after receiving Shingrix, the patient experienced headache (Verbatim: Headache), fever (Verbatim: Fever), pain in arm (Verbatim: Sore arm) and swollen glands (Verbatim: swollen glands on right face and throat). On 26-MAY-2023, the patient experienced shingles (Verbatim: Breakout on face and scalp of shingles-like), blister (Verbatim: blisters that ooze yellow discharge) and fluid discharge (Verbatim: ooze yellow discharge). The outcome of the shingles, blister, fluid discharge and fever were not resolved and the outcome of the headache, pain in arm and swollen glands were not reported.   It was unknown if the reporter considered the shingles, blister, fluid discharge, headache, fever, pain in arm and swollen glands to be related to Shingrix.     It was unknown if the company considered the shingles, blister, fluid discharge, headache, fever, pain in arm and swollen glands to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-MAY-2023. This report was submitted via the online direct entry reporting system. this report was submitted by site public reporting. The patient was not pregnant at the time of reporting The patient was the reporter. Dates for Breakout on face and scalp of shingles-like blisters that ooze yellow discharge from 26 May 2023 to ongoing. The patient received Losartan, Carvedilol, Pantoprazole and Estradiol patch start date was unknown stop date was ongoing. Patient had expected side effects of headache, fever, sore arm, then the breakout. Still had temperature of 100 and swollen glands on right face and throat that appeared when blisters did. The patient reported that the symptoms were not treated. The reporter consented to follow up.
FUSSY, TIRED, YET NOT SLEEPING, HOT TO TOUCH,  9AM PREMEDICATED WITH TYLENOL LIQUID 0.8 ML 2PM HAS NOT NAPPED(USUALLY TAKES 2 ONE HOUR NAPS) 2PM TYLENOL THE SAME DOSE 0330PM TEMP 102.0 F RECTALLY - MOTRIN 0.8 ML 0430PM TEMP 101.7 F RECTALLY 0500PM      100.7 0530PM      101.5
This spontaneous prospective pregnancy report was received from a registered nurse and refers to a 23 year old pregnant female patient with no drug reactions or allergies and no pertinent medical history. The patient's last menstrual period (LMP) was on 06-NOV-2015 and the estimated date of conception was on 20-NOV-2015. On 04-DEC-2015, the patient was inadvertently vaccinated subcutaneously with a dose of VARIVAX lot # L001330, expiration date 13-JAN-2017 (dose and frequency were not reported). The patient was not taking any concomitant medication. On 21-DEC-2015, the patient experienced nausea and increased urinary frequency, which made patient suspect pregnancy. Later, on 23-DEC-2015, the pregnancy was confirmed via urine pregnancy test. The patient was being treated with prenatal vitamins. The estimated date of delivery (EDD) would be on 12-AUG-2016. At the time of the report, the pregnancy outcome was pending. No product quality complaint was involved. Additional information has been requested.
The morning, post vax, pt broke out in "fine" rash on right arm. The rash started just above elbow and continued down arm. Rash itched; itching lasted 3 days. Did not take any medication or use any treatment for the symptoms. Denies having rash/itching elsewhere. Denies any other problems. (Injection given in right deltoid).
I felt like I was getting a cold.  I was tired, no fever, nasal drainage. I didn't have serious symptoms.  I did not suffer greatly.
Very sore left arm the next day after injection. The next day after injection had chills, hot flashes, and low grade temperature of 99. Was restless and unable to sleep on the night of the 13th. Also had lower back pain as well as low energy and overall tired feeling. These symptoms lasted until the later morning of the 14th. Ibprofun was taken.
Left arm slight redness no edema noted, pt has slight edema at the medial epicondyle, good rom of the arm, slight warmth, good grip rom of all left upper joints.
This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on 22Mar2021 (Lot number: EL9266) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced nosebleeds in Mar 2021. The patient was scheduled for the second dose in 4 weeks. The clinical outcome of nosebleeds was unknown.
On 01/16 I started having an itchy scalp and throughout that evening and into the early AM my body started itching all over. My hands started to swell very badly and hives started to appear on my arms, waistline, and neck. I went to ER and was given a RX for Prednisone. The hives persisted and I ended up back at the ER because of how much pain and discomfort I was in. I ended up prescribed hydrolyzed, cetirizine, prednisone, omeprazole, and ketorolac. I was also substituting Benadryl and Claritin with cetirizine to see if one was more effective. The hives started going away after about 2 weeks and now I have a case of Dermatographia that persists. Throughout this I have had occasional throat swelling, continual itching and redness, hives, significant heartburn, swollen lymph nodes, and lung pain.
Throat fullness, voice became hoarse, started coughing, and I became short of breath. Took 50 mg of Benadryl, but symptoms persisted and got worse. Went to the ER (in the same building) per the advice of a colleague that is a former ER doctor. Saw Dr. within the ER and received Epi, solumedrol, and nebulizer treatment and was monitored for about 4 hours to be sure there was no rebound effect. Had some left upper back pain post treatment and chest fullness so a chest xray was done. Voice returned to normal and the throat fullness had gotten better. I was given a script for Prednisone 60 mg for a four day course to complete. The last day to take this will be tomorrow.
TOOK VIVOTIF ON DAY 1, 4, AND 6; This spontaneous case report (PVX2019-1659) was received from a pharmacist on 26-Jun-2019. It describes an adult female consumer who "took Vivotif on day 1, 4, and 6". She was receiving Vivotif for an unknown indication.  Case report: The consumer took Vivotif doses on day 1, 4, and 6. The first and the third dose were taken on 21-Jun-2019 and 26-Jun-2019, respectively.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif on day 1, 4, and 6" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif on day 1, 4, and 6" was considered as not applicable.
FELT PRETTY UNCOMFORTABLE; SKIN FELT REALLY ITCHY; BAD HEADACHE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 23-JUN-2021, the subject experienced felt pretty uncomfortable. On 23-JUN-2021, the subject experienced skin felt really itchy. On 23-JUN-2021, the subject experienced bad headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt pretty uncomfortable, skin felt really itchy and bad headache was not reported. This report was non-serious.
Besides a sore arm (which I always have with vaccines), instead of being more tired, I am incredibly awake. My usually insomnia is much worse and I?ve had incredible trouble napping and sleeping.