chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additonal AE; An HCP is reporting an AE on behalf of a patient. The HCP reports that the patient was adminstered an expired dose of GARDASIL 9. No additional clarifying statements or AE details were provided and no additional AE's were reported. No PQC.; This spontaneous report was received from medical assistant, concerning to patient of unknown gender and age. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 25-APR-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter intramuscularly (lot #U007652, has been verified to be a valid lot, expiration date: 14-APR-2023) for prophylaxis (strength was not provided). No additional adverse event were reported (expired product administered) (no adverse event).
Patient complaining of rash that developed approximately 1 week after SPV. Patient now 30 days out from SPV but rash is persistent. Previously evaluated and treated by PCM for arthropod insult with Rx of hydrocortisone. Describes lesions on extremities and trunk to include groin area that are pruritic in nature. Previously also noted to be painful. Lesions are NOT pustules r draining. Otherwise patient is well and non-toxic. He denies any chest pain, shortness of breath, arthralgias, myalgias or other systemic symptoms. He did have a low-grade fever and mild "illness" at peak immune response of vaccine at 7-10 days s/p vaccination. All those symptoms have since resolved.
Flu: greenish/yellow bruise appearance on the entire upper portion of arm (left arm). Prevnar: pain x 1.5 weeks, aches.
12:30 EE state feeling "weird" dizzy and shaky. EE was seated with legs elevated.  Provided juice and cool compress HR 68 RR 16 12:43 feeling "back to normal" Increased sneezing and nasal congestions NKA continue to monitor 13:00 Hr 80 RR 18 SPO2 100% BP 184/89 EE reportedly hypertensive at baseline 13:05 Benadryl 25mg po provided 13:10 Continues to feel "back to normal"  Ambulating well.  Escorted to parking structur by RN.
In first couple of days after MMR shots (also got HEP A, Pevnar 13, and Varivax) she was irritable and cried more often when trying to sleep, but seemed to improve after first couple days. Then woke up around 5 AM (usually sleeps until around 7 AM) crying on July 19, 2011 and rubbing her head. Over the course of the next few hours she continued to rub her head, often violently and a rash began to appear on her forehead, behind her ears, neck, stomach and around her back. Did not appear on legs or arms as far as we could tell. The rash then lasted a few days (possibly up to about a week), although faded after first couple days, especially fading where it had been worst on her head and neck. After the first two days she stopped rubbing her head, however, although it interfered with her sleep most significantly the night of July 19, 2011-July 20, 2011. We did not give her any treatment other than liquid Benadryl as instructed by her doctor for the first day or two for the rubbing the head, which the doctor was not sure was related, although the doctor thought the rash seemed to be an MMR reaction rash.
Information has been received from a registered nurse concerning a female who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown). ON an unspecified date the patient was vaccinated with a second dose of Gardasil (lot# unknown). The nurse reported that the patient had an injection site reaction after receiving the second dose. She developed a "lump" the size of a baseball at the injection site. The patient had no reaction on her first vaccination. No further information is available. Additional information has been requested.
This spontaneous report was received from a certified medical assistant refers to a male patient of unknown age and gender. No concurrent condition and medical history were not reported. On 02-JUL-2015, the patient was inadvertently administered a dose of PNEUMOVAX 23 intramuscular (dose #, strength, and lot # were not provided), which expired on 02-MAY-2015. No adverse effects reported. Additional information has been requested.
The pt experienced a rash on hands and feet following vax. Was told by physician it was hoof and mouth disease. The pt developed a rash on arms, chest, back and legs. The child was seen by the MD and is currently on steroids.
ONSET OF SXS 3 DAYS P/ VAC: FATIGUE, FEVER, INFLAMED THROAT, HEAD TO TOE ITCHY RASH, CHILLS.  ALL SXS LASTED FOR 5 DAYS. NO TMT GIVEN. OUTCOME: NO INJURY.  PT HAD PAPULAR RASH PER MD ON SCALP, ARMS & ABDO.  IMMUNIZ NOT CONT'D
nonviable after a temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in a female patient who received HAV (Havrix) (batch number ABXB28AA, expiry date 30th June 2022) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient was given a dose of Havrix that was deemed nonviable after a temperature excursion, which led to incorrect storage of drug.  No symptoms were reported. This is one of the several cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021142812:same reporter US-GLAXOSMITHKLINE-US2021142813:same reporter US-GLAXOSMITHKLINE-US2021142815:same reporter US-GLAXOSMITHKLINE-US2021142816:same reporter US-GLAXOSMITHKLINE-US2021142817:same reporter US-GLAXOSMITHKLINE-US2021142818:same reporter US-GLAXOSMITHKLINE-US2021AMR151436:same reporter US-GLAXOSMITHKLINE-US2021AMR151444:same reporter US-GLAXOSMITHKLINE-US2021AMR151445:same reporter US-GLAXOSMITHKLINE-US2021142817:
RAPID HEARTBEAT FOR 90 MINUTES, SHORT OF BREATH, EYES SWOLLEN, DIZZY TO THE POINT WHERE I COULDN'T WALK , WHOLE BODY  MUSCULAR CONTRACTIONS FOR 90 MMINUTES, TREMORS AFTERWARDS, CHILLS FOLLOWED BY FEVER. STARTED AT 1:00 AM , PEAKED AT 2:00 AM, STARTED TO TAPER OFF AT 6:00, HEART RATE RETURNED TO NORMAL AT 9:00 AM
Around 2 hours after receiving the Janssen Covid-19 treatment. Symptoms of headache, body soreness, pain at injection site, fatigue, and "mental fogginess" (as if I were concussed) occurred. On the following morning, 9/11, I awoke with a slighter headache, with the same pain at injection site and continued body soreness. These persisted through the day but once the evening came again around 6 pm - the body soreness increased, and fatigue as well as the mental fog came back. This subsided after a good nights rest and since 9/12 no problems have arisen.
joint pain and extra twist; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient took the first dose of BNT162B2 on an unspecified date for covid-19 immunisation. The patient (consumer's wife) had a few days of joint pain and extra twist. Her b friend weak or so of being very tired, arm joint pain also. The outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Fever 103.3; Pain, swelling & increased reddness x 1 wk; Seen by MD;
Myalgia and fatigue occurred within 3 hours of injection and got progressively worse. Symptoms began to subside after approximately 30 hours. ADVIL helped myalgia.
Information has been received from a physician concerning a female who in December 2006 , was vaccinated with Gardasil 0.5 mL, injection.  In December 2006, the patient experienced muscle aches all over, especially in the legs and arms. The patient's muscle aches all over, especially in the legs and arms persisted for 3 months. The patient sought unspecified medical attention. Additional information has been requested.
Beyond the sore arm, around midnight the same night as the vaccine, I experienced a 10 minute time period of chills with uncontrollable shivering that persisted until I laid under the covers as still as possible and let it pass.  The following day, I felt like I didn't want to do anything and was easily irritable.  All symptoms resolved after 48 hours.
FEELING UNDER THE WEATHER; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced feeling under the weather. it was reported that most of reporter's coworkers experienced a couple of days of feeling under the weather. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of feeling under the weather was not reported. This report was non-serious.
her mom tested positive with Covid-19 vaccine; COVID-19 confirmed by postiive COVID-19 test; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program, Pfizer First Connect. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced a positive COVID-19 test on an unknown date. The clinical outcome of the event COVID-19 was unknown.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
CC: headache, lightheaded 14 minutes after vaccine administration. Treatment: no medicine was given. Water and graham crackers improved the symptoms. Outcome: Patient condition improved and the patient was discharged to POV/Home.
Severe headaches and face tingling. OTC pain reducers do not help. I do NOT think this is related to the vaccine but the lady on phone from Vsafe said to report it. Headaches started in August 2021 and my second vax shot was April 22 2021. Headaches wax and wane from mild to severe and nearly debilitating (shooting pain and tingles down my left arm and making the left side of my face tingle). left side of head only. Headache is constant though, a constant dull ache on left side of head above my ear and near my temple, it fluctuates in severity. Three intense spike in past two months. Intense spikes last  a few minutes to an hour, aprox at best guess.
soreness of the arm; cough; sore throat; lymph nodes on right side of neck have swelled; in pain; A spontaneous report was received from a consumer concerning a female patient of unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness of the arm/injection site pain, cough, sore throat/oropharyngeal pain, swollen lymph nodes/lymphadenopathy and pain.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 02 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot# unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 02 Jan 2021, the patient began to experience soreness of the arm and developed a cough and sore throat that progressively had gotten worse. She reported swollen lymph nodes on the side of her neck with pain radiating from her right side to her ear.    No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, soreness of the arm, cough, sore throat, swollen lymph nodes and pain, were considered unknown.  ; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
pt recv vax & presented to ER @ 0130 w/nausea, h/a, fever 99.9, chills starting 5 hr p/vax;
stroke; Information has been received from a lawyer regarding a case in litigation concerning a 62-year-old male patient. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.  On 25-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) for prophylaxis in a pharmacy. On or about 25-FEB-2018, as a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient was caused to suffer a stroke, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of the event was not reported. The event was considered to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of stroke was considered to be medically significant.
started running temp 17JAN97-103 no other s/s;19JAN97 temp 105 MD instructed mom to alternate Ibuprofen & APAP;20JAN97 MD visit-pt broke out in moderate amount of red rash (face-neck-trunk) runny nose, cough & was dx otitis;
Presented to Emergency Department on 4/11/03 with a rash on chest, accompanied by another smallpox vaccinee with same signs/symptoms No other signs or symptoms; no other complaints.  Vital signs within normal limits.   (Referred reporter to military smallpox program, but reporter was not successful in submitting a report).
On 6/21/2021 right before I went to bed, I experienced the worst case of chills ever. I paid it no mind, put several comforters on my bed and went to sleep. At approximately 2 AM I awoke with a maximum migraine, dizziness, diarrhea, stomach ache and throwing up. That lasted three days. Although the throwing up has subsided yesterday evening, I?m still experiencing the stomach aches, dizziness and diarrhea. I?m hoping it?s not the vaccine, being that it?s my first dose and it?s scaring me to take the second dose. I have yet to see any other side effects other than what I?ve seen so far
Next day - overwhelming fatigue. 2nd day - full body hives and chills and fever.
Vaginal infection - currently seeking medical care, 2/12 had general low grade fever/malaise and noticed infection on 2/13; unsure if related or not
Pt returned 2 days after receiving high dose and PREVNAR w/itching and swelling of lips and hands.
THIS VACCINE HAD A STRANGE OCCURENCE WHEN I GAVE IT TO THIS PT-----UPON PUSHING THE NEEDLE INTO THE PTS ARM THE MEDICATION WOULDNT PUSH OUT OF THE BARRELL, I PUSHED FOR A LITTLE BIT AND THEN REALIZED THAT IT WASNT GOING TO WORK SO I PULLED THE NEEDLE BACK A LITTLE AND THEN A SUCTION SOUND OCCURED (THE SYRINGE WAS SUCTIONED TO PTS ARM) AFTER PULLING BACK THE MEDICATION DID GO IN BUT ONCE FINISHED AND I PULLED THE NEEDLE OUT OF HIS ARM IT WAS BENT!!?? HE WAS SUPER SWEET AND STATED THAT IT DIDNT HURT AND ALSO HE DIDNT BLEED---I BANDAGED HIS ARM AND TOLD HIM TO PLEASE LET ME KNOW IF HE HAS ANY ISSUES AND APOLOGIZED PROFUSELY!!------Patient called back today (7/10/23) stating that his arm is still sore and prevents him from doing his daily activities.  He has used Ibuprofen for pain and iced the area and is going to continue this care for a few more days before following up with his family practice provider.
Discomfort in swallowing; pain in the left breast; left arm pain/discomfort; headache; chills; swollen lymph nodes in my left neck. area  and left breast; This spontaneous case was reported by a nurse and describes the occurrence of DYSPHAGIA (Discomfort in swallowing), BREAST PAIN (pain in the left breast), PAIN IN EXTREMITY (left arm pain/discomfort), HEADACHE (headache) and CHILLS (chills) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concurrent medical conditions included Latex allergy, Allergy to antibiotic (Bacitrin), Drug allergy (Tegaderm patch), Allergy to antibiotic (Biaxin), Drug allergy (Codeine), Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Penicillin allergy, Allergy to antibiotic, Allergy to antibiotic, Allergy to antibiotic, Allergy to antibiotic, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy, Drug allergy and Hypothyroidism since 29-Mar-2015. Concomitant products included LEVOTHYROXINE from 29-Mar-2015 to an unknown date, CLOPIDOGREL, KETOROLAC TROMETHAMINE (TORADOL), SERTRALINE HYDROCHLORIDE (RESTRALINE), LORAZEPAM (LORAZEPAN), LEVOFLOXACIN (LEVAQUIN), CIPROFLOXACIN HYDROCHLORIDE (CIPRO 1A PHARMA), HYDROXYZINE, HYDROXYZINE EMBONATE (VISTARIL [HYDROXYZINE EMBONATE]), MIDAZOLAM HYDROCHLORIDE (VERSED), ONDANSETRON, LEVOFLOXACIN, KETOROLAC, FAMOTIDINE, CLINDAMYCIN, DEXAMETHASONE, MUPIROCIN, CEFIXIME (FLEXERIL [CEFIXIME]), METHYLPREDNISOLONE ACEPONATE and AZITHROMYCIN for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DYSPHAGIA (Discomfort in swallowing), BREAST PAIN (pain in the left breast), PAIN IN EXTREMITY (left arm pain/discomfort), HEADACHE (headache), CHILLS (chills) and LYMPHADENOPATHY (swollen lymph nodes in my left neck. area  and left breast). On 24-Jan-2021, DYSPHAGIA (Discomfort in swallowing), BREAST PAIN (pain in the left breast), PAIN IN EXTREMITY (left arm pain/discomfort), CHILLS (chills) and LYMPHADENOPATHY (swollen lymph nodes in my left neck. area  and left breast) had resolved and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-024374 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: On 27-MAY-2021, Non significant follow up was received. On 01-Jun-2021: On 01-JUN-2021, Non significant follow up was received On 22-Jun-2021: Follow-up information received on 22-JUN-2021 contains significant information-Concomitant medications added, Events And outcome of event added. Medical history added
Lump at injection site, pain from shoulder blade , down arm to fingertips. Extreme pain in shoulder and elbow 10 days post injection
Heart PVC's (arrythmia) symptoms happening 200-300 times a day.
I have been experiencing a mild fever (100 degrees F) for more than five days since the day (11.21.2020) after I received the shot.
Pediatric patient ordered for Fluzone - received Flublok.  Mfg contacted . No adverse events noted.
This spontaneous report as received from a medical assistant refers to a 16-month-old patient of unknown gender. No information on the patient's concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On 11-OCT-2016, the patient was vaccinated with improperly stored dose of VARIVAX injection (lot # M025867 with expiry date on 24-MAY-2018; dose and route of administration were not reported) for prophylaxis. The administered dose experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received. Sender's Comments: US-009507513-1610USA010748: US-009507513-1610USA004609: US-009507513-1701USA000676: US-009507513-1701USA000677: US-009507513-1701USA000678: US-009507513-1701USA000679: US-009507513-1701USA000680: US-009507513-1701USA000681: US-009507513-1701USA000682: US-009507513-1701USA000683: US-009507513-1701USA000684: US-009507513-1701USA000685: US-009507513-1701USA000686: US-009507513-1701USA000687: US-009507513-1701USA000688: US-009507513-1701USA000689: US-009507513-1701USA000690: US-009507513-1701USA000691: US-009507513-1701USA000692: US-009507513-1701USA000693: US-009507513-1701USA000694: US-009507513-1701USA000695: US-009507513-1701USA000696: US-009507513-1701USA000697: US-009507513-1701USA000698: US-009507513-1701USA000699: US-009507513-1701USA000700.
cellulitis from Right shoulder to Right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis.; Fevers to 102 F; chills x 48 hours; severe Right arm swelling; This is a spontaneous report from a contactable physician (patient).  A 44-year-old female patient received first dose of bnt162b2 (BNT162B2, lot number 4121 EL 1283) , via an unspecified route of administration from 19Jan2021 13:15 at single dose on right arm for covid-19 immunization.  Medical history was none.  The patient's concomitant medications were not reported.  The patient experienced cellulitis from right shoulder to right elbow within 48 hours of shot, necessitating antibiotic therapy for cellulitis. The patient experienced fevers to 102 f, chills x 48 hours, severe right arm swelling on 20Jan2021 02:00.  The patient underwent lab tests and procedures which included body temperature: 102 fahrenheit on 20Jan2021. Therapeutic measures taken as a result of the events included Keflex times 10 days. No covid prior vaccination, no covid tested post vaccination, no other vaccine in four weeks. The outcome of the events was recovering.; Sender's Comments: Based on temporal association, a possible contributory role of BNT162B2 cannot be completely excluded for reported events cellulitis, fever, chills and swelling arm. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
24 hours after kindergarten shots given, patient returned to our office with left arm red/hot/swollen x 2 in x 2 in.
Covid-19 vaccine (orange top) given after BUD date of 5-3-22.   Expiration date 5/31/22.   Letter being sent to parents to re-vaccinate patient.
Pt was given both ZOSTAVAX and PNEUMOVAX 6-20-11. Approx 5 hrs later, developed generalized achiness, and right arm where ZOSTAVAX was given was sore and reddened. He had fever next day at 100.4 - 6/21 - seen by MD, Rx'ed anti-inflam, pt contacted 6/22 said improving.