chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a registered nurse referring to a patient of currently 62 years of age and unspecified gender. The patient's pertinent medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L035283, expiry date: 15-DEC-2016 (dose, route of administration and anatomical location not reported). The doses of ZOSTAVAX underwent temperature excursion: 14.7F for 2 hours and 15 minutes. There were no previous temperature excursions. No symptoms were reported. No product quality complaint (PQC) was involved. No further information was provided. This is one of several reports from the same reporter. Additional information has been requested.
Patient with immediate burning in arm from injection sight down her left arm to all fingers and into neck, chest and left leg.  Burning pain in left chest and neck lasted 1-2 day.  Burning in left arm has been present since 4/8/21 and still present as of today.  in last 2 day now weakness in the left arm.
LINGERING PAIN IN UPPER LEFT ARM; BURNING SENSATION; COULD NOT RAISE ARM/COULD NOT REACH FOR CERTAIN THINGS OR TURN AROUND; SORE ARM; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol, and non smoker, and other pre-existing medical conditions included no known allergies ,no drug abuse. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. The batch/ lot no was not reported and has been requested.  No concomitant medications were reported. On MAR-2021, the subject experienced burning sensation. On MAR-2021, the subject experienced could not raise arm/could not reach for certain things or turn around. On MAR-2021, the subject experienced sore arm. Laboratory data included: X-ray (NR: not provided) no finding was found. On 12-MAR-2021, the subject experienced lingering pain in upper left arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from lingering pain in upper left arm, and the outcome of burning sensation, sore arm and could not raise arm/could not reach for certain things or turn around was not reported. This report was non-serious.
didn´t received second dose of shingrix conisdering the schedule. First dose was given one year ago; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 1 year ago from  the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine which led to incomplete course of vaccination. The reporter consented to follow up
Patient received shingrix/boostrix and Prevnar 13 at approximately 10:40am. She was talking and coherent after receiving the immunizations. Upon getting up out of the chair to leave, she collapsed on the ground She never closed here eyes or seemed unresponsive but she was very disoriented. 911 was called immediately and responded within minutes. Patient stated that she felt ok and was able to answer questions including where she was at and the date. EMS workers checked vitals and cleared her to leave the facility without further treatment.
BREAST LUMP; BOTH BREASTS TENDER; BOTH BREASTS SORE; LEFT ARM MUSCLE SORENESS AT INJECTION SITE; MUSCLE SORENESS IN LEFT ARM; This spontaneous report received from a patient concerned a 66 year old female. The patient's weight was 55.79 kilograms, and height was 155 centimeters. The patient was not ill at the time of vaccination. The patient did not have any vaccination within four weeks prior to the first administration date of the suspect vaccine. The patient was not on any other medications. The patient received covid-19 vaccine ad26.cov2.s (Janssen, Dose number in series 1) (suspension for injection, intramuscular, batch number: 206A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 12-APR-2021 on left upper arm in the muscle for prophylactic vaccination. No concomitant medications were reported. In the afternoon of 12-APR-2021, the patient experienced muscle soreness in left arm. On an unspecified date, patient experienced a breast lump. In MAY-2021 (a month after the J and J COVID vaccine), the patient had the lumpectomy. On an unspecified date in 2021 (last spring/summer), the patient had radiation therapy which completed in JUL-2021 (Dose number in series 1).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from breast lump and recovering from muscle soreness in left arm. On 19-DEC-2021 14:00, the patient received additional non-company suspect vaccine bnt 162 (Dose number in series 2) (form of admin not reported, intramuscular, batch number: FD7218) dose was not reported, administered on left upper arm in the muscle for prophylactic vaccination.  On 19-DEC-2021, right after driving home, the patient experienced muscle was sore in the arm she got injection in. Muscle soreness has improved at injection site, but it was still a little sore (left arm muscle soreness at injection site).  On the morning of 20-DEC-2021, the patient experienced an unusual side effect described as, breasts got sore like a PMS (Premenstrual syndrome symptom) even though she had been through menopause for quite some time. She said both breasts were sore and tender, but the one that she had the lumpectomy and radiation in this past spring/summer was more sore. The patient also had breast tenderness. On 20-DEC-2021 and 21-DEC-2021, it was quite uncomfortable, but on 22-DEC-2021, it was still tender when patient took shower, but a little improved (Dose number in series 2).  The patient was recovering from both breasts tender, both breasts sore and left arm muscle soreness at injection site. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211261375-covid-19 vaccine ad26.cov2.s-Breast lump. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Within a 12-15 hour period post-vaccination patient began to experience pruritis with faint rash under her upper arms, forearms and abdomen.  Patchy, lightly raised rash noted.  No other symptoms noted.
Patient most likely had a vasovagal response which resulted in a "fuzzy" feeling and lightheadedness. He laid down and after about 3-4 minutes said he felt as though he was going to vomit but did not. He had some orange juice and an energy bar and felt better after about 10 minutes.
Patient had labs done on 11/8/21 with elevated glucose. Patient with N/V, increased thirst and voiding. Presented to ED on 11/9/21. Some congestion and cough. No fever. Admitted with breakthrough covid-19 case and DKA.
Flu shot: face redness, whites of both eyes bright red, fever, fatigue, body soreness, extreme abdominal pain lasting through the night, nasal congestion, dry itchy eyes, sleepiness, nausea, bright purple red gums, swollen lymph nodes.
Vaccine administered that went under temperature excursion.; Vaccine administered that went under temperature excursion.; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065K21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (Dose 1) on 07-Jan-2021, Pfizer (Dose 2) on 28-Jan-2021 and Pfizer (Dose 3) on 05-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer, Pfizer and Pfizer.    On 15-Jun-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Jun-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered that went under temperature excursion.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered that went under temperature excursion.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. The expiration date was 05-Jul-2022. Two doses/vials were impacted (1 punctured and 1 not punctured).  The vial moved from freezer to refrigerator on 08-Jun-2022 and 1 vial 15-Jun-2022. The vial was first punctured on 15-Jun-2022 at 9.15 AM. The vial was stored in portable fridge post puncture. The vial underwent temperature excursions on plus 1.9C to plus 6.4 C. Excursion duration was 15 min. Vial was stored in the refrigerator at the time of the excursion. The vial was thawed. Proposed desired use by date was 15-Jun-2022 afternoon. All the vials were in the fridge quarantined. Treatment information was not provided.
Client received a Moderna booster vaccine that was pre-drawn up for 4-5 days prior to vaccination. Unknown symptoms.
Child received DTaP and Varicella 3-7-08 in right thigh.  Child seen in office 3-10-08 due to 2-3 inch erythema to right thigh.  Bruising and itching noted to site.
Patient presented with shortness of breath, chest pain, and weakness. Patient tested positive for COVID and is fully vaccinated with booster.
Patient developed a rash that looks similar to chicken pox 10 days after receiving these vaccines.
Pt reports immediately after receiving her second dose, she felt the injection go straight to her heart. Approximately 15 min after the injection she complained of chest pain, as if being ?punched in the heart?.  The pain was rated as an 8 on scale of 0-10. The pain never subsided during clinic visit prior to emergent transport to EC.
Pt recv vax on 3/29/99; on 3/30/99 pt exp swollen right leg
pt passed out for 10 seconds after received vaccine  for 10 minutes.  EMS came and pt went home
Report received from parent  Raised erythema about 4 inches large on rt arm, not itching, no pain per report of a parent. Parent denies any other adverse symptoms. Advised to have cold compresses for arm, and to give child antihistamine Benardyl and follow up in the clinic in am on 10/24/2019. Parent reported via phone on 10/24 that the swelling is down, erythema persistent, Ibuprofen given, no other signs and symptoms noted. Parent did not bring the child into the office.
Altered Smell....food smelled rotten or had a metallic smell.  Taste was unaffected
Raised red bumps on back of both arms near elbows and on forearms. Area near right elbow presented with itching. No bumps/itching or irritation near injection site. Employee washed area that itched and stated itching resolved. Nothing warm to the touch. No temperature - current temp was 98.6. No other signs or symptoms. Box 9 marked as no due to bumps remained but itching did resolve.
pt recv vax 11OCT95 & 16NOV97 pt devel a fever of 102 & several lesions;on 17NOV97 pt had 20 lesions & was vesicular;
This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender.  The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date(s), the patients were vaccinated with improperly stored doses of PROQUAD from lot #s M064719 with expiry date: 07-MAY-2018; M037010 with 21-FEB-2018; and M037011 with expiry: 21-FEB-2018, for prophylaxis (dose, route and anatomical location not reported). The vaccine lots had a temperature excursion of -13.6 degree Celsius for 3.5 hours. No adverse effects were reported. The vaccines had no previous temperature excursion. The temperature excursion was identified by data logger. The lot # M064719 has been verified to be not valid for PROQUAD. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA002051: US-009507513-1706USA002056: US-009507513-1706USA002053: US-009507513-1706USA002054: US-009507513-1706USA002055: US-009507513-1706USA002056.
Fever of 103.3F that lasted 24 hours beginning 6pm on April 14th Violent shaking chills that lasted 18 hours beginning 10pm on April 14th Swollen lymph glands and sore throat Nausea beginning 8pm on April 14th, lasted 36 hours  Headache that is ongoing for more than 48 hours beginning within 2 hours of vaccination Feeling unable to warm up beginning 2 hours post vaccination and lasting until 9pm on April 14th Painful aching joints lasted 36 hours beginning 5pm on April 15th Fatigue began within 2 hours of vaccination, is ongoing more than 48 hours post vaccination
After immunizations on 2/20/07 was inconsolable for about 8 hours and had fever about 12 hours. After immunizations on 5/1/07 was inconsolable for about 6-8 hours, vomited several times for about 1 hour and had fever lasting about 24 hours.
Patient presented to The Gym for a COVID vaccination. Prior to the vaccination the employee was asked upon arrival and prior to her vaccination about previous vaccinations and past medical history relevant to the vaccination injection. The patient stated no to all pre injection questions. The patient then received her Moderna Vaccinations, she was escorted to her observation area. While in the observation area, an assistant attempted to make a 2nd vaccination appointment. It was at this time that the patient reported that this was her 2nd vaccination and her 1st vaccination was on 01/15/21 (Pfizer vaccine). This was immediately reported to the Clinic Commander. The patient reported with conversation  that she had active COVID the  week after her 1st vaccination. The patient was observed for 30 minutes. Additional patient information was obtained. The patient was instructed to immediately report to the closest ER if she noted and S/S of adverse  reactions. In addition, during the patient's observation time, she reported that she thought getting 2 different vaccines would be fine due to the recent  article - which she pulled up on her phone (now testing obtaining different vaccines for extenuating circumstances). The patient was called the next day and again this am. She initially did experience fatigue and body aches, mild intermittent fever. This was resolving this am as per patient report via phone call per this NP.
I got one shot/ I got both of those/came down with Shingles yesterday / suspected vaccination failure; came down with Shingles yesterday; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received one dose (possible non gsk vaccine) on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On 7th May 2021, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. A couple of years ago, the patient received both doses of new shingles vaccine and a day before reporting, the patient had shingles. The patient stated that he/she had no rash yet, but never had pain. This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
The patient was given the monovalent booster instead of the bivalent booster.   Patient made aware, no adv.
Pt in clinic for Hep B #2. Parent asked if any other immunizations were needed before college. Meningococcal was offered and discussed. Immunization was requested and given on 8/08/06 it was discovered he had received meningococcal on 7/25/06.
left eye has blurry vision; A very large floater in the middle of the eye.; Throbbing migraine; Arm soreness; This is a spontaneous report from a contactable other healthcare professional, the patient. A 51-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955), via an unspecified route of administration in the left arm on 29Mar2021 at 10:15 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included a heart attack 11 years ago due to Kawasaki virus. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medication. The patient previously received aspirin-based products and experienced sensitivity (but not bad as reported).  The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID -19 vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 30Mar2021, the patient experienced throbbing migraine and arm soreness a day after he received the vaccine. On 31Mar2021 at 06:00, the patient experienced blurry vision in left eye and a very large floater in the middle of his eye, two days after he received the vaccine. The events resulted in a doctor or other health care professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of the event throbbing migraine, arm soreness, floaters in eye and blurry vision was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
A few hours after injection, patient's arm began to swell and she felt as though her throat was closing.
Loss of consciousness, throwing up, pounding headache, diarrhea, stomach bloating and cramping, and body chills within 30 minutes of first dose.
Systemic: swelling in both feet, burning sensation in both feet-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient reported that 48 hours following first dose she experienced swelling in both feet and a burning sensation in both feet.  These symptoms have persisted for greater than 24 hours and have not subsided when reported at 4:42 pm 5/24/21
Pt presented for covid booster shot when she was offered the flu shot by reception, she accepted. Flu questionnaire was reviewed with pt, VIS was given and flu vaccine was administered. When attempting to document the flu administration a red alert appeared stating the pt already received the flu shot this season. I confirmed the information with pt and pt stated that she had "forgotten." And added that she didn't remember if she had gotten the flu vaccine this year or last year.
Sore arm; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and PAIN IN EXTREMITY (Sore arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Lung disease.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath). On 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Mar-2021, DYSPNOEA (Shortness of breath) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.
The patient (self) felt a soreness around the site of the injection begin immediately and grow throughout the day. The soreness continued to at least April 12 (at the time of this report). The soreness was immediate unlike a tetanus shot but the pain the following days was 2-3 times less that of a tetanus shot. By 4pm the same day, the patient felt fatigue and tired and had difficulty staying awake. Around 6pm the patient took 200 mg of ibuprofen by mouth because of a strong headache. At 7pm the patient was experiencing the following: headache, warm head to the touch, shivering/shaking,  fatigue, mild aching. The patients pulse was consistent 100-104 bpm. The patients temperature at 8:30pm was 100.4 F. The patient then went to bed at 9pm. Patient had trouble falling asleep due to fever, shaking, aching. The patient slept intermittently until midnight. At midnight, the patient noticed the fever and shaking had ceased but the headache and aching were still strong. The aching was all over the body. The patients eyes hurt to move. The aching was constant and at times was throbbing. At 3am the patient could still not sleep well so he took 650 mg of Acetaminophen by mouth. The patient began to notice some relief approximately 30-60 min after. The patient fell asleep after the relief began and slept soundly til 9:15 am, April 11th. The patient awoke feeling much better. All side effects had stopped with the exception of a feeling of weakness and slight dizziness. The patient was able to carry on normally and took no more medications.
Redness, warmth, swelling to site on (R) arm where vaccine administered. Temp 98.2. Diagnosed with cellulitis; given 7 day course of KEFLEX PO with resolution.
pt recv vax 24JUL95 & APR96 exposed to chicken pox;30APR96 pt devel a t104 according to f/u afeb;2MAY96 3wk p/exposure to chicken pox pt devel full blown chicken pox w/22 vesicular lesions (10 typical lesions & 10-20 pap;itching,discomfort;
Baby developed lethargy, sudden fever (101 degrees), irritability within 2-4 hours of vaccines. No associated signs or symptoms to localize what infectious agent may be causing symptoms. Symptoms persisted 11/8 pm (day of vaccination) through today 11/10 pm 48 hours, though fever <100 today and not as listless. Still cranky. No localized reaction to any inoculation site. Normal PE today.
Patient describes pain/discomfort (sometimes a sharp pain) when moving her right arm in certain ways. When raising arm above her head, try to push or pull or bear weight with that arm. States pain is worse the more active she is. Will see MD for evaluation 1/31/17.
Menstrual spotting and flow after 2 days of vaccination. Not suppose to occur until 2 weeks from this date.