chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse concerning an 8 weeks old patient of unknown gender. There was no information about the patient's medical history, concurrent conditions and concomitant therapies. On 16-JAN-2017, the patient was vaccinated with improperly stored dose of ROTATEQ orally from lot number M031650 with expiration date of 16-MAR-2018 (dose and anatomical location not provided) for prophylaxis. The administered dose was exposed to a temperature higher than 8°C but lower than 25°C for 1 hour and 20 minutes determined using digital data logger. The vaccine had no previous temperature excursion. The nurse reported that a possible cause for the temperature excursions was the action of the auto defrost cycle of the refrigerator. They had ordered a commercial unit to eliminate this issue. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA009503: US-009507513-1701USA009504: US-009507513-1701USA008111:
Felt "out of sorts" following vaccination - tired, arm weakness, injection site soreness and body aches experienced on Sunday following vaccination.
Went to give the child the flumist (nasal), and child jolted head back as spraying - small amount of flumist sprayed into child's eye.  We immediatelty flushed with water.  Patient did not have any effects.
had t105.9 fever 1 wk p/MMR; was given; temp x 3 days & generalized rash on 8th day;
Pt stated that within 10 minutes of receiving the vaccine, her L side went numb- pins/needles, could not bear weight on L leg, it buckled beneath her.  The vaccination site had her stay 45 minutes, she stated that they checked her bp and it was wnl.   They had her call someone to drive her home and she was told to seek care if symptoms did not improve.  She called the Covid hotline and reported these symptoms to me.  The Left sided numbness is improving but she also is c/o swelling in her L wrist and ankle and a feeling of dehydration, not being able to get enough water.  These are new symptoms to her. She states no h/o DM.  She is not having any other symptoms of CVA,  no speech issues; no symptoms of anaphylaxis- no tongue/throat swelling, no difficulty breathing. I told her to take 50 mg of Benadryl and have someone bring her to the hospital ED.  I told her to call 911 if symptoms worsen or become severe.  She was in agreement.
Admission Date: 5/4/2022 Discharge Date: 5/6/2022  Condition on discharge: Improved  DETAILS OF HOSPITAL STAY: Patient is a 85 y.o. male with PMH of panhypopituitarism, adrenal insufficiency, OSA, CAD, who presented to Hospital Emergency Department on 5/4/22 with weakness. In the last 24 hours, he has become more weak and confused with cough and SOB. He had fever of up to 103 at home. Wife attempted to improve weakness with stress dose steroids, but patient could not ambulate. He took a home COVID test and was positive. Wife activated EMS as patient could not ambulate. Patient is noted to be awake but poor historian. Wife did not feel she could safely take him home. Will admit observation for continued monitoring.              COVID-19 did not require any O2, decadron or remdesivir. He was vaccinated and boosted in the past. Should stay isolated for 7 more days. He was evaluated by PT/OT who recommended SAR, but there were no available bed. After subsequent evaluation he significantly improved and was discharged home with home PT/OT. He was given stress dose of Florinef on 5/4-6, he will resume standard dose of Florinef tomorrow. Continue DDAVP as before.  Continue other meds as before.  Follow up with PCP if necessary.
The patient received two doses of fluzone in the same season, no AE; Initial information was received on 06-Oct-2020 regarding an unsolicited valid non-serious case from a pharmacist.  This case involves female patient who received two doses of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] in the same season (extra dose administered)  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On 03-Sep-2020, the patient received a 0.5 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination  On 02-Oct-2020, the patient received a 0.5 ml second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7041LA, expiry: 30-Jun-2021, form: prefilled syringe) via unknown route in the left arm for prophylactic vaccination. The patient had no other vaccine on same day  It was a case of an actual medication error due to extra dose administered on 02-Oct-2020 (latency same day).  The patient was given a second dose of fluzone in error and was concerned about having received two doses in the same season. She was not having any ill effects other than the worry of having received an extra dose. The vaccine was administered both times in the pharmacy  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 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
within half-hour of Pentacel injection, patient returned to office inconsolable, copious thick secretions, trouble breathing, worsening of his eczema.  gave one dose of epinephrine IM, within 10 minutes significant improvement in sx, within 30-45 minutes had complete resolution of symptoms.  consistent with anaphylactic reaction to vaccine.  6/08/09 Received PCP office records which consisted of Allergy Consult done 5/28/2009. FINAL DX: vaccine reaction, anaphylaxis; and atopic dermatitis Records reveal patient experienced coughing, screaming, difficulty breathing, excess mucous production, rash on legs, throat swelling following Pentacel vaccination.  Tx in office w/epi, benadryl & tylenol & sent home w/tapering steroids & continued benadryl.  No sequelae & family carries epi-pen.  Continued w/rash on ankles, face & back.  Only initial page of consult sent, remainder requested.  6/10/09 Received vaccine & PCP office records for 4/3/09. Records reveal approx 15 min s/p vaccination, returned to office w/increased rash, increased secretions, inconsolable crying & screaming.  Tx w/epi IM, Tylenol & Benadryl both PO.  6/16/09 Received remainder of Allergy Consult done 5/28/09. FINAL DX: vaccine reaction, anaphylaxis; atopic dermatitis Records reveal pt referred for additional labs tests for allergies prior to next set of vaccinations.
INJECTION SITE SWELLING SORENESS FACE RED AND FLUSHED ARM FROZEN - COULD NOT LIFT PROPERLY FOR 3 DAYS CONSTANT PAIN IN ARM HAND SWOLLEN AND "PALE"
AFTER ADMINISTERING VACCINES TO THE PATIENT, THE PATIENT STOOD UP AND FELT LIGHT HEADED.  I ASKED IF SHE WAS OK, SHE SAID NO AND SAT BACK DOWN.  SHE WAS DIZZY AND FELT AS THOUGH SHE WAS GOING TO FAINT, BUT NEVER DID. AFTER 15 MINUTES AND SOME PO FLUIDS, SHE WAS WELL.
Could not lift my left arm over head to remove my sweater that same evening.  I had acute shoulder pain on side where the shot was given.  The shot was given high in my left deltoid.  I continue to have the pain in my left upper arm and shoulder.  Should becomes stiff during the night.   This is chronically painful but not disabling or an emergency.
sore arm; swollen arm; Pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), PAIN (Pain) and CHILLS (chills) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), PAIN (Pain) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (sore arm), PERIPHERAL SWELLING (swollen arm), PAIN (Pain) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
pt noted to be lethargic in morning following immun; fever 99.8 ax; pt had 4 cc emesis;
more than 36 days after the first dose without receiving the second dose; temporary depression; (rash) itches; bad rash all over my body/ rash look like welts; Fever; Body aches; Chills; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days after the first dose without receiving the second dose), DEPRESSION (temporary depression), RASH PRURITIC ((rash) itches), RASH (bad rash all over my body/ rash look like welts) and PYREXIA (Fever) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 091D21A and 033C21A.) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included FLUOXETINE, LAMOTRIGINE and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.   On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced RASH (bad rash all over my body/ rash look like welts), PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days after the first dose without receiving the second dose), DEPRESSION (temporary depression) and RASH PRURITIC ((rash) itches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. On 01-Aug-2021, PYREXIA (Fever), MYALGIA (Body aches), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 36 days after the first dose without receiving the second dose) had resolved, DEPRESSION (temporary depression) outcome was unknown and RASH PRURITIC ((rash) itches) and RASH (bad rash all over my body/ rash look like welts) had not resolved.            This case was linked to MOD-2021-272984 (Patient Link).
ACHE; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced ache. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of ache was not reported. This report was non-serious.
received a dose of the Moderna COVID-19 Vaccine that expired on July 25th; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th). On 26-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID-19 Vaccine that expired on July 25th) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information was not reported..   This case was linked to MOD21-124492, MOD21-124485, MOD21-124297, MOD21-124406, MOD21-124409, MOD21-124481, MOD21-124417, MOD21-124423, MOD21-124424, MOD21-124434, MOD21-124447, MOD21-124492 (Patient Link).
Positive Covid test 05Nov2021; Positive Covid test 05Nov2021; This is a spontaneous report from a contactable other hcp (Patient). A 30-years-old Non Pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0191, Expiry date was not reported), via intramuscular route of administration on 15Jun2021 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization and patient received dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735, Expiry date was not reported), via intramuscular route of administration on 23May2021 (at the age of 30-years-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history and concomitant medications was not reported. The Patient had no known allergies. Patient had not received other vaccine in four weeks. The patient was not diagnosed with COVID-19 prior vaccination and had tested COVID-19 post vaccination. On 05Nov2021, the patient experienced positive COVID and vaccination failure. The Patient did not received treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test (Coronavirus AG IA) positive on 05Nov2021 Nasal Swab. The outcome for the events was recovering. Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events VF, Covid 19, and suspect drug BNT162B2 cannot be excluded The impact of this report on the benefit/risk profile of the product is evaluated as part of 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, as appropriate.
Fever for 48 hours along with body aches and fatigue Swelling, redness and itch at injection site which lasted for a week Large, painful, swollen lymph nodes in armpit of injection arm which  lasted for around 9 days
Information has been received from a physician concerning a 10-year-old male with no pertinent medical history and no allergies, who on 21-JUN-2000 was vaccinated subcutaneously with a first dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# "17185"). There was no concomitant medication. On an unspecified date, the patient was vaccinated with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot# 632765/1405J). On 27-JUN-2006 the patient developed mumps. Unspecified medical attention was sought and blood work was done (no results were reported). Subsequently, the patient recovered on 30-JUN-2006. No product quality complaint was involved. Additional information has been requested.
Patient had syncopal episode within a couple of minutes of vaccination.  Felt better after resting and drinking juice; was released to home.
the lump on her left arm had developed some rash, swelling and itching; the lump looked like a teenager skin blemish; redness rash and itchy at injection site after second dose; She also noticed that on the exterior of the skin, there is still minute reddish purplish discoloration; redness rash and itchy at injection site after second dose; the lump on her left arm had develop some rash, swelling and itching; redness rash and itchy at injection site after second dose; the lump on her left arm had develop some rash, swelling and itching; the lump on her left arm had develop some rash, swelling and itching; This is a spontaneous report from a contactable consumer reported for herself. A 77-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EN6208; Expiration date: Jun2021; NDC and dosages unknown), via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at the age of 77-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications included none. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection) on an unspecified date for covid-19 immunisation and experienced lump surrounded by black and blue discolorations on the injection site of her left arm. On an unspecified date, the patient experienced redness rash and itchy at injection site after second dose, after her second dose (date not captured/stated), the lump on her left arm had developed some rash, swelling and itching and just went away after a week. On the day of this report, the lump looked like a teenager skin blemish that looked close to a large pimple. She also noticed that on the exterior of the skin, there was still minute reddish purplish discoloration and that the little lump was still there. She mentioned that she did not feel alerted and concerned because initially when she asked a nurse in the vaccination center, they mentioned that they have already seen side effects that looks like this. Now, consumer was just wondering if there were any reported events about this. Referred to physician or HCP for proper clinical diagnosis and clinical recommendation. Investigation assessment included none. The events were not serious. Clinical outcome of event the lump on her left arm had develop some rash, swelling and itching was recovered on an unspecified date and outcome of other events was unknown.  No follow-up attempts are needed. No further information is expected.
Swollen red, feverish slightly painful with itching. It's is hard to the touch and the skin is so tight that it feels like an orange peel. I have taken Benadryl every night with Zyrtec. Applied hydrocortisone ointment QID. With little results of decreased reaction.
Extreme dizziness, chest pain, shortness of breath and fatigue.  These lasted for 6 hours, but the dizziness lasted throughout the next day making it impossible for me to drive or walk much. I had to stay in bed.
Sore arm started about 6 hours later and lasted about 24 hours Dizziness started within half an hour intermittent for 48 hours Extreme sensitivity to normal noises and lights started 20 hours after, lasted 4 hours Shooting, intermittent pain in upper left quadrant of chest, started 6 hours after, ongoing, 30 hours out also occasionally in right shoulder/chest, and left side of neck Partial  PARALYSIS of left arm starting about 3 hours after, significant worsening 40 hours after and ongoing
Very heavy bleeding on period.  Abnormal amounts of blood.  Typically, my period lasts no longer than 5 days, however, I'm on day 6 and I'm still bleeding very heavily.
Severe leg pain around injection site and throughout leg (could not walk without pain for approximately 12 hours).  Red, raised rash on abdomen lasting for approximately 10 days.
A 3rd dose of MMR was given by mistake. The patient had requested a menactra for school however the appointment was made for an MMR. Per vaccination site the patient did not have a 2nd dose of MMR so the dose was given. However, when the patient came back with a vaccination card a 2nd dose was given 4/3/2015 at another location. So the patient got 3 total doses of MMR. The patient is ok no side effects or concerns.
Passed away after getting a 3rd vaccine shot; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Passed away after getting a 3rd vaccine shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Passed away after getting a 3rd vaccine shot) (seriousness criteria death and medically significant) and PYREXIA (Fever). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PYREXIA (Fever) outcome was unknown.            Concomitant product use was not provided by the reporter.  No treatment information was provided.  Company Comment: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected event of Death. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring an unknown date. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected event of Death. The event occurred on an unknown date after receiving the third dose number of mRNA-1273 (Moderna COVID-19 Vaccine) and had a fatal outcome, with death occurring an unknown date. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
Patient complained of muscle and joint pain with increased intensity, and vomiting, no fever, muscle pains have subsided since yesterday but patient still has aches and pains and fatigue.
taking live oral typhoid took 3 doses as prescribed exp stomach cramps & vomiting p/3rd dose;a rash appeared on trunk 24hr p/3rd dose;rash disappeared w/in 48hr;
Patient complained of tingling pain in the arm about 20 minutes after vaccination. She then complained of chest pain and trouble breathing in the next next hour. Patient was recommended to visit the ER. She received care at the hospital and was given Nitroglycerin, IV Bendaryl, Zofran and Pepcid. EKG was run. ER said it was probably a reaction to the vaccine and discharged her with instructions to stay hydrated.
Terrible symptoms right after the shot, headache, dizzy, pain in arms, pain in armpits and across breast, wanted to throw up if lifted stuff, my arms felt swollen down to palms, Fever, Chills and nausious. Then a month later bilsters on hands and feet. Terrible pain, blistering, crack, peeling, couldn't use regular shampoo burns, couldn't use hand gel sanitizer.
bud 1/7/23, administered 1/12/23 - moderna anaylsis found lot still active against covid-19 on date given
The patient given immunization with an expired Pfizer COVID-19 vaccine. This was the third dose (booster) for the patient. The label for this vaccine indicated the multi-dose vial must be discarded 12 hours after first puncture when stored at room temperature. The pharmacist thought the vial had been opened at 10:35 am on 2/23/2022. It had actually been opened at 10:35 am on 2/22/2022. The administration was at 5:30 pm on 2/23/2022.