chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I developed an itchy rash/hives on both arms, both legs, and my abdomen.
14 yr old fe here today with Aunt (who has legal custody of child.) to show nurse Rt arm - Local reaction back of Rt arm red, raised, swollen area measures 10" x 11" has a red raised center approx 2" sore to touch - Arm started to swelling some that night after the injection - Had VARIVAX AND GARDASIL #1 same arm - MENINGITIS vaccine
PATIENT STATED HE HAD IMMEDIATE PAIN WITH THE INJECTION, JUST FIGURED THIS PARTICULAR ONE HURT BUT PAIN GOT WORSE AS DAY WENT ON, COULD NOT TURN STEERING WHEEL ON TRACTOR, COULD NOT SLEEP, COULD NOT PERFORM ANY EXERCISED FOR HIS POST ROTATOR CUFF SURGERY. CALLED DOCTOR AFTER 6 DAYS AND RECEIVED A STEROID SHOT IN THE SHOULDER TO RELIEVE THE PAIN. REPORTED TO THE PHARMACY 9/7/19 AND PAIN WAS JUST ABOUT GONE AFTER 16 DAYS
Pt developed Nephrotic Syndrome 4 days after administration of vaccine. Patient may have been in early stages of nephrotic syndrome at time of vaccination, as she had gained some weight since previous visit.  However this is unclear.
dizziness; body aches in almost all joints of body; body aches in almost all joints of body; earache; lethargy; heart palpitations/flutterings; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 05Jan2022 19:15 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing). Concomitant medication(s) included: METHENAMINE. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, prev dose product: COVID 19, prev dose brand: Phizer , prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose administration date: 25May2021, prev dose vaccine location: Left arm), administration date: 25May2021, when the patient was 40 years old, for COVID-19 Immunization; Bnt162b2 (DOSE 1, SINGLE, prev dose product: COVID 19, prev dose brand: Phizer , prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose administration date: 04May2021), administration date: 04May2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious) with onset 06Jan2022, outcome "not recovered", described as "dizziness"; PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 06Jan2022, outcome "not recovered" and all described as "body aches in almost all joints of body"; EAR PAIN (non-serious) with onset 06Jan2022, outcome "not recovered", described as "earache"; LETHARGY (non-serious) with onset 06Jan2022, outcome "not recovered", described as "lethargy"; PALPITATIONS (non-serious) with onset 06Jan2022, outcome "not recovered", described as "heart palpitations/flutterings". Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of dizziness, pain, arthralgia, ear pain, lethargy, palpitations.  Additional information: The patient had no other vaccine in four weeks. No covid prior vaccination. The patient covid tested post vaccination. Covid test post vaccination: covid test type post vaccination: Nasal Swab, covid test name post vaccination: Rapid Test, covid test date: 05Jan2022, covid test result: Negative. Known allergies: No.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Fatigue several hours after shot.  Muscle soreness the day after the shot lasting for about 2 days. The fatigue would come and go for up to 5 days after the shot. I felt fine for a while then suddenly felt completely exhausted and had to lay down. The fatigue was the worst symptom. I did not seek treatment but rested. After five days, all symptoms were gone, and I returned to feeling well and normal function.
Staff inadvertently administered expired dose to a patient, no AE; Initial information received on 15-Jul-2020 regarding an unsolicited valid non-serious case received from a non-healthcare professional.  This case involves a patient (with unknown demographics) who was inadvertently administered an expired dose of vaccine IPV (VERO) [IPOL] (lot number and Expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   It was an actual medication error case due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sore arm at the injection sight that moved down the wrist about 6 hours after the injection then into the shoulder area about 12 hours after.  10 hours after injection a sever headache started like my head was put into a vice grip followed by a temperature of 101 and hot and cold sweats for the follow 18 hours accompanied by not being able to keep down water or a sip of 7-up - anytime a tried to eat or drink during the 28 hours I experienced symptoms it came back up with periods of dry heaving.
At 3:20pm, pt stated she felt "dizzy, especially when she turned her head side to side." Assessed pt, pushfed fluids, offered graham crackers.  Educated to stay, 30 more minutes.  Pt agreed, felt better at 3:30pm, not in distress, stated, 'no longer dizzy".  Reassessed at 3:50pm, pt stated, "felt better".  BP 137/83, 94, 20, O2 stat-98%.
Fever 105: 9 days after vaccine.  Flat spots trunk: five days after fever and cough. Nasal congestion x 2 days. MMR reaction.
Big, round, swollen, larger than a half dollar, red, hot, and painful/sore on arm where shot was administered. Lasted for 2 weeks. Hurt to touch and move too much.
I had congestion, rhinitis, fatigue, no fever, dry cough, I was not feeling well at all. I used a home COVID-19 test that came back immediately. I called my doctor on Monday as I was traveling at the time. We discussed my symptoms and decided against my taking the Paxlovid, I used Tylenol as needed. It did take me the whole ten days to get over the virus.
flu; Initial information received on 22-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare professional via Social Media.  This case involves a patient of unknown age and gender who had flu after receiving influenza vaccine.  It was unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, lot number and expiry date - not reported) via unknown route in unknown administration site for influenza immunization.  On an unknown date the patient had flu (influenza) (unknown latency) following the administration of influenza vaccine.  It was unknown if there were lab data/results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Pt was given injection on 4/9/02. On 4/12/02, the pt was seen in the office for left arm cellulitis at the injection site.
Patient was fully vaccinated with Pfizer vaccine + booster (unsure of booster date but patient reports ~2 months ago). Initial series 2/25/21 and 3/18/21. Patient had fever and was admitted for COVID 11/21/21
By the day after the shot I could not move my arm at all. Extremely painful. I have an appointment with my primary tomorrow.
Pt reported feeling light headed shortly after his injection. Pt evaluated by EMS, BP 160/80. Pt reported he was feeling very hungry and can often get light headed when hungry. Pt signed refusal for EMS transport. Pt was given ED precautions. Pt reported feeling better when he left after eating a snack and drinking water.
This spontaneous report was received from the patient's mother concerning her 15 year old son. Patient's current conditions included seasonal allergies, and his concomitant medications included unspecified vitamins and ZYRTEC. The consumer reported that her son was vaccinated on 18-SEP-2017 with the first dose of GARDASIL 9 intramuscular route, (strength, dose, lot number and expiration date were not reported) for prophylaxis. On 18-SEP-2017, after vaccination, the patient experienced typical arm pain, it began that evening and lasted for about a day and then the patient got better. The consumer reported also that on 24-SEP-2017, the pain reappeared and the patient presented a lump and he was unable to lift his arm. The consumer stated that the health care provider was informed on an unspecified date and the physician said that it was unusual that the pain reappeared after a week. There were no diagnostic laboratory tests performed. At the time of this report, the outcome of pain in extremity was recovered on 19-SEP-2017 (Reported as "lasted about a day"), and of pain in extremity (24-SEP-2017), limb mass, and injected limb mobility decreased was not reported. The causal relationship between the vaccination with GARDASIL 9 and the events, was not reported. There was no PQC involved.
There was no adverse event.  Only reporting a defective needle.  When giving the client his 2nd COVID vaccine, a few drops of the vaccine leaked from where the shaft of the needle joins the needle hub.  Was using a BD SafetyGlide Needle at the time.
WHOLE BODY ACHINESS (UPPER AND LOWER BODY, WORSE ON THE RIGHT LEG AND WHOLE UPPER BODY); LOSS OF MUSCLE; LOSS OF STRENGTH (RIGHT SIDE IS DETERIORATED AND HIS STRENGTH IS GOING DOWN); FEELING ACHINESS IN RIGHT ARM AT ADMINISTRATION SITE; This spontaneous report received from a patient concerned a 70 year old white 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 (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 04-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On JUN-2021, the patient felt (body and joint soreness and achiness) soreness throughout his body and joints when started to get active and went outside. The patient stated it was a continuous aching and had made working and activities difficult for him. The patient stated whenever he walked or did something it was painful he described the event was not debilitating but something was not right. The patient stated the achiness went on all summer long and subsided in OCT-2021. At first he thought it might be lyme disease but never got tested for lyme disease. (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: UNKNOWN) dose was not reported, 1 total, administered on 15-DEC-2021 at right arm for prophylactic vaccination. No concomitant medications were reported.  On 17-DEC-2021 two days after taking booster, the patient experienced feeling achiness in right arm at administration site which lasted for more than a month. Patient stated that the achiness traveled throughout whole body, upper and lower body and he feel it daily. He stated that he has some good days and sometime it hurts to move. Patient described that it was worse on the right leg and whole upper body. His shoulder, elbows and arms were achy and felt like workout soreness. Patient noticed loss of muscle and strength as if his right side was deteriorated and his strength was going down (dose number in series 2). Patient has not discussed his symptoms with his doctor yet. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling achiness in right arm at administration site, and had not recovered from loss of muscle, loss of strength (right side is deteriorated and his strength is going down), and whole body achiness (upper and lower body, worse on the right leg and whole upper body). This report was non-serious. This case, involving the same patient is linked to 20220306407 (Dose number in series 1).
Hospitalized 7 days post positive COVID test for fatigue, chest tightness, dyspnea, and cough. Treated with Remdesivir x 3 days with possibility of 5 days if she continues to need supplemental O2, patient feels this is an asthma exacerbation and not related to COVID infection.
PATIENT CAME IN AND GOT THE  COVID 19 UPDATED VACCINE  ON 01/10/2023  AND I WAS TOLD BY THE PATIENT THAT SHE HAS EXPERIENCED MUSCLE PAIN SINCE SHE GOT HER FLU SHOT ON 10/29/2022 AND THAT SHE WOULD LIKE IT REPORTED, I CALLED HER ON 01/13/2023 TO MAKE SURE SHE DID NOT EXPERIENCE THE SAME MUSCLE PAIN WITH THE COVID 19 VACCINE THAT I INJECTED AND SHE SAID NO BUT THAT HER RIGHT SHOULDER WAS STILL PAINFUL AND FEELS LIKE THE IMMUNIZER DID SOMETHING WRONG ON 10/29/2022 WHEN SHE RECEIVED THE FLU VACCINE
Had a large reaction the next day after the first shot - couldn't get up off the couch.  Worse on the second shot.   The first big issue was that my left ankle started aching horribly, as did my neck and toes and knees.  It's continued. The next one I've noticed is that my issues with horrible muscle knots that causes headaches constantly has returned.  Neck aches and my body locks up.  I've had it previously but it's back with a vengeance.  I have also started gaining weight and being tired - feels like my thyroid may be going out of balance again (had been stable at a high Synthroid dose for several years - thought I was on a full replacement dose at this point).  It appears that the vaccine has triggered a number of autoimmune/inflammation flareups.
Vestibular disturbance started on 5/7/2021 and has lasted until current date 7/29/21. Intense sense of spinning, vertigo.  Unable to drive, walk, work.  Unable to focus eyes.  Unable to concentrate.  Unable to look at any screen on a phone, computer or tv.  Unable to get depth perception.  Continuous sense of airy head, detached sense of self.  Incredibly disturbing and unsettling.  Unable to perform daily life activities.
Arms are sore; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (MI) via call-center (Reference number- 00342342) and transmitted to Sanofi on 02-Nov-2020.  This case is linked to cases 2020SA320485 and 2020SA307661 (same reporter).  This case involves a 47-years-old female patient who experienced arms are sore (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled syringe, lot number LUT7007NA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arms are sore (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.
51 yo male pt s/p Pfizer COVID vaccination: dose 1 on 3/4/21 and dose 2 on 3/25/21. PMH of ALL s/p MUD PBSCT 1/15/20 c/b GVHD of the skin and joints for which he is treated with tacrolimus, prednisone, and ruxolitinib at baseline; tacro and rux held on admission. Presented to the ED 8/26 after an assisted fall at home. Of note, he tested positive for COVID on 8/24 at outside institution. He underwent monoclonal antibody infusion and decompensated shortly afterward. Upon arrival to ED, he was found to be hypoxic requiring HHFNC and was admitted to hospital for further care. Received remdesivir and dexamethasone. Hospital course complicated by acute hypoxic respiratory failure in the setting of COVID PNA with superimposed PsA/MSSA/E. Faecalis PNA. Despite prolonged antibiotic treatment and heated high flow oxygen therapy, pt became increasingly tachycardic and acutely decompensated requiring intubation, 3-pressor support, inhaled veletri, proning, and bicarb infusion. His oxygen saturation continued to drop and he was profoundly hypotensive. After discussion with the patient's wife and children, the decision was made to pursue comfort care. Pressor support was decreased and the patient expired shortly after at 10:30AM on 9/17.
Localized hives approximately 2 hours post vaccination. OTC hydrocortisone used to treat symptoms. Reaction subsided by next day.
Fever of 100.4.  Ibuprofen used. Went to bed/slept.  Temperature normal (97.3) in am.
Report 2001016368-1 described red and swollen injection site in four nineteen month old vaccinees of unspecified gender who received Infanrix. On an unspecified date, four vaccinees received a dose of Infanrix; it was not known whether or not, they had received previous doses of Infanrix. Subsequently, they experienced "very red, swollen thighs." As of 06/28/01, the outcome of the events was unknown. This case is considered not reportable as a pt has not been identified. Follow-up request is being done.
Vaccine lowered immune system resulted in shingles; Developed small blisters on cheek, itching me; Feel swollen glands on the left side of the same arm of the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Apr-2021 and was forwarded to Moderna on 26-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Vaccine lowered immune system resulted in shingles), BLISTER (Developed small blisters on cheek, itching me) and LYMPHADENOPATHY (Feel swollen glands on the left side of the same arm of the injection site) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, the patient experienced HERPES ZOSTER (Vaccine lowered immune system resulted in shingles), BLISTER (Developed small blisters on cheek, itching me) and LYMPHADENOPATHY (Feel swollen glands on the left side of the same arm of the injection site). At the time of the report, HERPES ZOSTER (Vaccine lowered immune system resulted in shingles), BLISTER (Developed small blisters on cheek, itching me) and LYMPHADENOPATHY (Feel swollen glands on the left side of the same arm of the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient mentioned they were on a lot of other medications as well.  Treatment medication included Valtrex prescribed by Nurse Practitioner.
This initial spontaneous report was received from a physician referring to a 6 month old male infant. There was no pertinent medical history, concomitant medication, concurrent conditions or drug allergies/drug reactions described. On 01-SEP-2015 at 11:18 hours, the patient was vaccinated with a dose of improperly stored ROTATEQ oral solution (lot # K023157 with expiration date 23-JUL-2016, second dose; dose was not reported), that was exposed to out of normal storage temperature range. No adverse event was reported. Lab diagnostics test were not performed. It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information is not expected as all correspondence was received.
Felt Feverish, headache, muscle aches, stomach pain, fatigued. Next day developed a fine rash on lower chest and back. Took Motrin for the headache and muscle pain. Took Zertec 24 hr for the rash. Called nurse advice line.
Gray dot on thigh; This case was reported by a nurse and described the occurrence of skin discoloration in a 6-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, less than 4 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR171230, US2022AMR171264   Additional Information: GSK Receipt Date: 16-NOV-2022 Reporter's Comments:  The patient experienced gray dots noted on legs (left thigh) after receiving 1st dose of Pediarix, 2nd dose of Pediarix and Hiberix. The reporter was consented to follow up. Additional supportive information: This case linked with US2022AMR171230, US2022AMR171264 as same patient. This was 1 of several linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR171025:Same reporter US-GSK-US2022AMR171007:Same reporter US-GSK-US2022AMR171034:Same reporter US-GSK-US2022AMR171044:Same reporter US-GSK-US2022AMR171042:Same reporter US-GSK-US2022AMR171039:Same reporter US-GSK-US2022AMR171028:Same reporter US-GSK-US2022AMR149561:Same reporter US-GSK-US2022AMR149560:Same reporter US-GSK-US2022AMR149551:Same reporter US-GSK-US2022AMR148962:Same reporter US-GSK-US2022AMR148961:Same reporter US-GSK-US2022AMR148919:Same reporter US-GSK-US2022AMR171056:Same reporter US-GSK-US2022AMR171052:Same reporter US-GSK-US2022AMR171062:Same reporter US-GSK-US2022AMR171050:Same reporter US-GSK-US2022AMR171048:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR171230:Same reporter US-GSK-US2022AMR171264:Same reporter US-GSK-US2022AMR171083:Same reporter US-GSK-US2022AMR171088:Same reporter US-GSK-US2022AMR171154:Same reporter US-GSK-US2022AMR171095:Same reporter US-GSK-US2022AMR171047:Same reporter US-GSK-US2022AMR171174:Same reporter US-GSK-US2022AMR171169:Same reporter US-GSK-US2022AMR149560: US-GSK-US2022AMR149561: US-GSK-US2022AMR148961: