chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The report was first received from a practice manager on 07-SEP-2018, and it was recognized as non-valid because report did not obtain any patient identify. Follow-up information has been received from the practice manager on 18-SEP-2018. This spontaneous report refers to a patient of unknown age and gender. Information of concurrent condition, medical history and concomitant therapy was not provided. On 30-NOV-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 (strength and route were unknown) (lot# N021475 and expiration date 03-JAN-2020) for prophylaxis (Incorrect product storage). No adverse event was reported. The excursion temperature on 08-NOV-2017, 16-NOV-2017, 23-JAN-2018, 06-JUN-2018, 03-JUL-2018 and 14-AUG-2018   was 47 degree Celsius for maximize 15 hours. The excursion temperature on 07-DEC-2017 was 50 degree Celsius for maximize 8.75 hours. The call was not because of data logger. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1810USA001951: US-009507513-1810USA001952: US-009507513-1810USA001953: US-009507513-1810USA001954: US-009507513-1810USA001955: US-009507513-1810USA001957: US-009507513-1810USA001958: US-009507513-1810USA001959: US-009507513-1809USA003709:
CLEARED SINUSES; UNEXPECTED THERAPEUTIC BENEFIT; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy of sinuses problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, one total, administered on 21-MAR-2021 in left arm for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the subject experienced cleared sinuses. On 21-MAR-2021, the subject experienced unexpected therapeutic benefit. Treatment medications (dates unspecified) included: loratadine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cleared sinuses and unexpected therapeutic benefit was not reported. This report was non-serious.
Member described having whole body aches, headache, blurred vision and faint. See was sent to local ER.  10/20/09:  ED records received for date of service 10/18/09.  Dx:  Reaction to smallpox and anthrax vaccines. Assessment:  Presents with c/o severe generalized pain, dizziness, whole body burning (especially joints), double vision, weakness and numb hands.  Given IV hydration, Maalox and Motrin.  Much improved after first liter of fluid.  Discharged to home.
No addtional AEs reported; on 07-OCT-2021, VARIVAX was administered that expired on 26-SEP-2021; This spontaneous report has been received from a nurse concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 07-OCT-2021, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) at a dose of 0.5 milliliter, as prophylaxis (strength, route of administration, and anatomical location of administration were not provided; lot number S030227 has been verified to be valid, expiration date 26-SEP-2021) (expired product administered). The vaccine had not had a temperature excursion. No additional adverse events were reported.
No other issues or concerns noted; Improperly sorted PNUEMOV AX 23 administered 2/8/2022; This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about pertinent medical history, concurrent condition, concomitant medication and drug reaction/allergy was not provided.  On 08-FEB-2022, the patient was vaccinated with improperly sorted (previous temperature excursion was 15.7 degrees Celsius for 8 hours, 10 degrees Celsius for 6 hours) pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # U018309 with expiration date 08-JAN-2023; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). No other issues or concerns noted. The outcome of product storage error was unknown.
1 or 2 days p/vax pt devel a fever & an inj site rxn characterized by redness & swelling the size of a fifty cent piece;
Had MMR and Varicella sq. in Right Arm: area is raised, inflammed and warm to the touch. (About 3 and 1/2 inches length and width). Pt. also says she has some pain and itching at the site. Pt says that she did take some Benadryl and has been applying ice.
Information has been received from a licensed practical nurse concerning a 6 year old female with leukemia and an allergy to Sulfa who on 07/03/1996 and 08/03/1999 was vaccinated with a first and second dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (second generation) (lot # not given). On 05/24/2002 the pt had a mumps titer drawn, which was "less than 10; she was not protected." Unspecified medical attention was sought. Follow-up info indicated that the pt had been vaccinated at another facility and that there were no immunization records available. It was also reported that the pt had similar experiences with hepatitis B vaccine recombinant (yeast) (manufacturer unknown) (WAES #0208USA02265) and hepatitis A virus vaccine inactivated (manufacturer unknown) (WAES #0208USA02264). Additional info is not expected.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GH9693) at the age of 48 years, in right arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 13Mar2021 as dose 1, single (Lot number: EN6208), in right arm, on 03Apr2021 as dose 2, single (Lot number: ER8737), in right arm and on 08Oct2021 as dose 3 (booster), single (Lot number: FF8839), in right arm for covid-19 immunisation. The patient's relevant medical history included: "High bp" (unspecified if ongoing); "morbid obesity" (unspecified if ongoing). Concomitant medication(s) included: NYSTATIN, start date: Oct2022; ASHWAGANDHA, start date: Oct2022; ALIVE! ONCE DAILY WOMEN'S ULTRA POTENCY, start date: Sep2022. Past drug history included: Beta blockers, reaction(s): "known allergies/Beta Blockers"; Nifedipine, start date: Sep2016; Asprin, start date: Jul2019; Xyzal, start date: May2020; Sumatriptan, start date: Jan2021; Flonaze, start date: Jan2013. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19 which included Paxlovid (Treatment start date: 23Mar2023, Treatment stop date: 27Mar2023).  No follow-up attempts are possible. No further information is expected.
Fever / Required ambulance and ER evaluation; Chills / Required ambulance and ER evaluation; Aches / Required ambulance and ER evaluation; Weakness / Required ambulance and ER evaluation; This case was reported by a nurse and described the occurrence of fever in a 64-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 29th May 2019).   On 18th November 2019, the patient received the 2nd dose of Shingrix. On 20th November 2019, 2 days after receiving Shingrix, the patient experienced fever, chills, pain and weakness. On an unknown date, the outcome of the fever, chills, pain and weakness were unknown.   It was unknown if the reporter considered the fever, chills, pain and weakness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Shingrix and experienced fever, chills, weakness and aches. The reporter did not consent to follow up.
Pt presented on 6/7/00 with local reaction. No redness at injection site, however, swelling noted in axillary area also painful with movement, afebrile.
High fever of 103.9 approximately 27 hours post vaccine.  Fever was hard to treat and bring down.  Finally after about 5 hours was reduced to 100.9.  Woke the next morning with a 100.9 degree fever.
6/26/2023 10:28 am Received call from this patient's mother, stating that she is reporting a reaction the COVID vaccines her son received. Mother stated that patient began showing signs of anxiety 2 week after his first vaccination for COVID-19 and the anxiety was worse after the 2nd vaccine, after the 3rd dose of COVID-19 vaccine he disappeared and was found disoriented and confused 7 hours from home. Patient has since been diagnosed with anxiety disorder, pychosis, and neuroleptic malignant syndrome. He is seeing Dr. Mother stated that patient has had testing to rule out tumors and cerebrovascular accindents. Immunizations Received since the initial COVID-19 vaccine: County Health Department Mass Vax Clinic... Pfizer-BioNTech COVID-19 Vaccine, Lot # ER8733 on  4/02/2021; Pfizer-BioNTech COVID-19 Vaccine, Lot #FF2593 on 11/04/2021 Pharmacy... Fluzone Lot # UJ686AA on 8/22/2021; Flucelvax Lot # 942395 on 8/25/2022 Pharmacy.... Boostrix Lot # 7HS93 on 8/5/2022. No vaccines given on same dates as COVID-19 vaccines and none one month prior.  No written information found for prior reactions from any of the vaccines listed.
Local hypersensitivity reaction to MMR.  Right leg at site of vaccine began with swelling, redness (borders ill - defined) within minutes of administration.
Couldn't sleep all night; arm is swollen; back hurts; Just feels weak; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Couldn't sleep all night), PERIPHERAL SWELLING (arm is swollen), BACK PAIN (back hurts) and ASTHENIA (Just feels weak) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Couldn't sleep all night), PERIPHERAL SWELLING (arm is swollen), BACK PAIN (back hurts) and ASTHENIA (Just feels weak). At the time of the report, INSOMNIA (Couldn't sleep all night), PERIPHERAL SWELLING (arm is swollen), BACK PAIN (back hurts) and ASTHENIA (Just feels weak) outcome was unknown.            No concomitant medications were reported.  The dates and lot number were unknown for dose 1 and 2.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 01-Apr-2022: Follow-up document received includes no new information was added.
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient's medical history, current conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored VARIVAX (dose and route were not reported) lot # M024677 and expiry date: 18-MAY-2018 for prophylaxis. The vaccine was exposed to a temperature of -13.2 degrees centigrade for 10 hours 2330 minutes. Previous temperature excursions included 7.3 degrees centigrade for 10 hours 30 minutes and 23.7 degrees for 2 hours. the call was because of a data logger. No adverse effects were reported. There was no product quality complaint involved. This is one of the two cases reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA004256.
Booster COVID immunization given at 0.5 instead of 0.25ml.  Patient's arm very sore and tired with body aches.  Missed day of work on 1/13/22
Information has been received from a physician concerning a 40 year old female nurse who on 4/29/04 was administered MMR to a pediatric patient and inadvertently injected the vaccine into the distal joint of her own finger. The physician reported that one and a half weeks later, the joint which had been injected became red, swollen, and painful. Subsequently, the swelling extended to the adjacent, more proximal joint on the same finger. The nurse was started on therapy with cephalexin. It was reported that the nurse only had swelling in these two joints. Additional information is not expected.
Patient reported on 9/25/19 that she had a red bumpy rash around the circumference of her arm that appeared as a stripe
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE OBSTRUCTIVE SLEEP APNEA ACUTE NON ST ELEVATION MI
Death due to underlying condition Narrative:  This was a 65 year old patient diagnosed with colon cancer with a terminal prognosis. Patient was not willing to pursue any further curative treatment and was referred to hospice, where he passed on 2/6/2021. Given 1st dose Pfizer COVID vaccine on 1/13/21.
Very short hot flash; Chills; went for a run and when he returned, he was still feeling hot. He checked his body temperature and it was 95.5; flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HOT FLUSH (Very short hot flash), CHILLS (Chills) and PYREXIA (went for a run and when he returned, he was still feeling hot. He checked his body temperature and it was 95.5) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (Chills) and PYREXIA (went for a run and when he returned, he was still feeling hot. He checked his body temperature and it was 95.5). On 16-Mar-2021, the patient experienced HOT FLUSH (Very short hot flash). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HOT FLUSH (Very short hot flash), CHILLS (Chills) and PYREXIA (went for a run and when he returned, he was still feeling hot. He checked his body temperature and it was 95.5) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.  The patient went for a run and when he returned, he was still feeling hot. He checked his body temperature and it was 95.5, he started having flu like symptoms. He later decided to take a shower, the water did not feel cold (he said normally when he has fever and he takes a shower, the water is usually cold). On 16-Mar-2021, he had a very short hot flash.  The patient did not take anything to alleviate the symptoms or call his healthcare provider. Patient said he is doing better, the previous side effects have resolved.Patient stated he got the 2nd dose on 14Apr2021 and had no side effects from that.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Patient said he is doing better, the previous side effects have resolved.Patient stated he got the 2nd dose on 14Apr2021 and had no side effects from that
Two hours after receiving second Moderna vaccine, he developed a red rash on arms bilaterally- not pruritic rash - lasted for one week.
Green frothy diarrhea started 1 day after administered lasting x 11 days - probiotics & hydration recommended.
Patient was a healthy 16 month old boy when he went in for his 'well baby' visit to his pediatrician on Friday, January 14th, 2011. At 9:30am he was healthy and fever free, so he has his 15 month shots and the flu shot, as recommended by the doctor. 12 hours later he developed a fever of 105.1,had a febrile seizure & was rushed to the ER in an ambulance. His heart rate was over 250 bpm!!!!! The fever was treated with MOTRIN & TYLENOL, and about 2 hours later he was 101f, however his heart rate was still irregular and much too fast -approx 180 - at rest. He was admitted to the hospital, for 2 days. He had many, many test done -urine, blood, 24 and 48 hours cultures, flu test, etc but all tests were negative. We went home on Sunday despite no diagnosis. I saw the doctor on Monday & Wed but no symptoms of illness since the fever and heart rate went down in the hospital. I am very concerned that my son had an adverse reaction to the flu shot.
The patient started experiencing hives on his arms and chest the night the vaccine was received. The patient was directed to go to the emergency room where he received Benadryl and Prednisone.
Day 3 post vaccine, I started to itch on my collarbone. A red round dot had appeared with severe itching. Each day the dot became bigger and protrude from my chest in a raise fashion. There were also smaller dots further down on my chest. By day 7 the dot had gotten bigger and had a circular pattern of raised blisters, consistent with the singles. I also had several  peripheral neutropathy attacks in my feet as well.
Patient received flu vaccine on 10/26 given by staff. Patient came back to clinic on 10/31 with complaints of red swollen arm where injection site was given. Showed provider picture of arm the next day which displayed large area of swelling erythema. Patient has no prior issues with previous flu vaccines. Location of red arm swelling was well beneath deltoid muscle and patient verified site of injection. Picture was taken of arm on 10/31 for training purposes.
Vaccine was given on 4/3/21.  Pt. presented to this facility with chest pain, pneumonia, hypotension on dehydration on 5/28/21
Presented to the hospital for generalized weakness, intermittent confusion,decreased appetite last 2 weeks and found to have covid 19.  Patient does not have any respiratory symptoms do not think and he needs any treatment at present. Tx.  COVID-19 virus infection, may be contributing to weakness/decreased p.o. intake.  No respiratory failure, no steroid or disorder started, supportive care, keep him in airborne precautions.  DuoNebs as needed, supplemental oxygen if needed to keep SpO2 greater than 92%.  discharged home.
7.5 cm erythematous, indurated area with soft margin and central clearing at site (L) - thigh.
large red area (3 3/4" diam) purple, w/blistered area, nausea for 2 days;
Posterior pain in left scapula that radiates up spine, into left anterior and posterior shoulder down to left deltoid at injection site.  Intermittent numbness and tingling from anterior left deltoid down to left hand.  Intermittent muscle spasms that feels like skin crawling  and moderate to sever pain from left deltoid at injection site down to left hand.
Case was vaccinated and boosted by 10/21/21, then was hospitalized for Covid 21/30/21. Admitted for rib fracture and found to be Covid positive. Required up to 20 litres of oxygen during hospitalization for shortness of breath and hypoxia.  Discharged after 12 day in hospital.
Severe rash over entire body appearing in the evening after the shot.  Initial treatment with antihistamine had little effect. Eventually used triamcinolone cream and that helped to reduce the rash. Still persists 4 weeks later with lingering rash on legs.
pt recv vax 24MAY95 & 5 days later devel a lesion; the next day had scattered papule vesicular lesion; 1JUN95 had widespread varicella lesions & full-blown chickenpox (4+); next day therapy w/Zovirax was initiated for tx;
first dose 20april2021 and the second dose on 14july2021.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 20april2021 and the second dose on 14july2021.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036c4a and 042B21a) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 20april2021 and the second dose on 14july2021.). On 14-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose 20april2021 and the second dose on 14july2021.) had resolved.            No concomitant medications was reported Treatment information was not provided
Information has been received from a physician concerning a 24 year old female with latex allergy who on 10-NOV-2011 in the mid-afternoon was vaccinated with the first dose of GARDASIL (Lot# 669285/0691AA, exp 17-AUG-2013) (route not reported). Concomitant therapy included LO SEASONIQUE from October 2011. On 10-NOV-2011, within several hours after the vaccine, the patient called the physician's office reporting that she was experiencing "itchiness all over." The physician told her to take some BENADRYL when she got home, but her condition progressed to nausea and dry mouth. When the patient developed shortness of breath, she was taken to an Emergency Room where she received IV BENADRYL and unspecified steroid intravenously. The emergency room staff noted that the patient had some hives on her back. She was released that same evening and was prescribed a tapering dose of an unspecified steroid. The physician reported that the patient was recovering and that she had instructed her patient to not received any additional doses of GARDASIL. Therapy with GARDASIL would not be reintroduced. Upon internal review, the patient itchiness all over, nausea and dry mouth, shortness of breath and hives on her back which required IV BENADRYL and unspecified steroid intravenously were considered to be other important medical events. Additional information has been requested.
Abnormal bleeding in pregnancy. I was 8 wks at the time of injection. At 10+4 I had unprovoked moderately brisk vaginal bleeding (bright red) which lasted approximately 2hr followed by approximately 3wks of dark brown spotting. No etiology was ever determined. No other complications in pregnancy, estimated delivery date is 10/24/21.
Patient exp body aches and headaches next day after the Shingles vaccination which lasted 1 week and a half. As a result of the vaccination patient got Shingles.
Anthrax dose number 4 10x10 cm erythema with 3-4 cm nodularity with pruritis and pain.  Treated with Allegra and Triamcinolone 0.1% topically per military protocol.  VAERS filed per protocol for LR4 reaction.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Joint Pain-Medium, Systemic: Nausea-Medium, Additional Details: Patient came to the pharmacy on 9/27/2021 complaining that she was still experiencing a sore arm and hasn't felt right since being vaccinated. States she has a fever as high as 102 F over the past two days, says has a very sore arm which is warm to the touch, experienced body aches, and nauseousness. States she wanted me to report this and was advised to tell a medical professional if symptoms worsened. I followed up with her later that day and she said she felt better but still had a sore arm.
Pt C/O feeling sick after pneumonia vaccine. Arm is also very sore. Pt is sleeping so mom does not know if the area is red and hot. If it is she will take him to Urgent Care. Otherwise she will ice and give TYLENOL or MOTRIN for aches. No fever. If he worsens she will take him to Urgent Care. Will call with update. 07/19/18 (Thr Jul 19) 04:42 PM. 07/19/18 (Thr Jul 19) 05:24 PM, Pts mother calling back states pt has a fever of 102.4. Mother was made aware to take pt to Urgent Care.