chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a nurse on 08 August 2016. This case involves a 17-year-old female patient who was vaccinated with a dose of MENACTRA intramuscularly (batch number: U5410AA, expiry date: 21 Sep 2017) (dose, dose in series not reported) in right deltoid on 28 July 2016. Patient's illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions are reported as none. Concomitant medications were not reported. On 04 Aug 2016, seven days following the vaccination, the patient experienced widespread rash over her body. On an unspecified date, following vaccination, rash was initially red but has now changed to purple in some areas, rash is raised and itchy, hives are of various sizes, sore throat, joint pain, and nausea. Patient required ER/doctor visit. Blood test had been done by patient. Other relevant diagnostic tests/laboratory data was reported as none. Patient had been treated with Benadryl. The patient was recovering from events pain and itch. The patient was not recovered from other events. Documents held by sender: none.
Pt recvd MMR vax on 19FEB91 & on 24FEB91 pt devel a fever of 105 & taken to ER & recovered;
3-4 hours after injection, extreme fatigue, explosive diarrhea,pharyngitis & L otitis all resolved overnight
Narrative: Patient was diagnosed with COVID-19 on 8/15/2021. He was admitted to the Medical COVID Unit on 8/15/2021 and transferred to COVID ICU on 8/18/2021. He was treated with dexamethasone 6mg IVP daily x 10 days and remdesivir 200mg IV x 1 day, then 100mg IV daily x 9 days. He also received tocilizumab on 8/20/2021. Patient developed severe ARDS and was intubated on 9/2/2021. Prone positioning was initiated on 9/2/2021. Patient continued to clinically decline - developed shock requiring vasopressors and AKI. Family requested withdrawal of care on 9/3/2021. Patient was terminally extubated at 1301 and passed away at 1350.
only sore arm; feeling tired; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (reporting for herself). A 76-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration (at the age of 76) single dose on 02Feb2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced only sore arm and feeling tired both on an unspecified date. She has had to take a nap everyday since. The outcome was unknown.    Information on the lot/batch number has been requested.
I have been having arm stiffness and pain in the injection site and some swelling in my arm pit
Information has been received from a consumer concerning her 15 year old daughter with no medical history and drug allergies, who in July 2008 was intramuscularly vaccinated with the third 0.5 ml dose of GARDASIL. There was no concomitant medication. Several weeks ago the patient experienced vaginal discharge and it was not itchy, painful or "smell". The patient's vaginal discharge came and went. At the time of reporting, the patient did not recover. The patient did not seek medical attention. Additional information has been requested.
Inappropriate age at vaccine administration; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number 3JD32, expiry date 6th April 2021) for an unknown indication.   On 24th January 2020, the patient received Engerix B pediatric. On 24th January 2020, unknown after receiving Engerix B pediatric, the patient experienced inappropriate age at vaccine administration. The action taken with Engerix B pediatric was unknown. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were received as follows: The 20 year old patient who received a third pediatric dose of Engerix-B because the first two doses were administered when the patient was 19 but turn 20 before the third dose, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Left arm ached neck to elbow, temp of 101.4, fatigue, brain fog, nausea, swollen lymph node left arm pit
Information has been received from a registered nurse concerning a 2 month old male patient with no illness at time of vaccination who on 11-DEC-2008 was vaccinated with the first dose of ROTATEQ, orally. The nurse reported that the patient was breast fed prior to administering ROTATEQ, infant immediately regurgitated and vomited all of vaccine with large amount of breast milk. "No adverse reaction" followed. The patient did not seek medical attention. No additional information is expected.
sometimes get pain in the area of the heart, which was short in duration; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER8792), via an unspecified route of administration, administered in left arm on 13Apr2021 13:00 (at the age of 62-year-old), as 2nd dose, single dose for COVID-19 immunisation in pharmacy. The patient had no have other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613) administered in left arm on 23Mar2021 14:00 as single dose for COVID-19 immunisation. After the second dose on 14May2021, the patient sometimes got pain in the area of the heart, which was short in duration. The patient had it for a couple days about a month after the second dose, but it went away. Now (at the time of report), again patient had it for the past two days. It seems to go away if the patient did not exercise (exercise routine is very mild). The patient did not receive treatment for the event. The outcome of the event was resolving.   Information on Lot/Batch number was available. Additional information has been requested.
nasal congestion, intermittent cough. No SOB. Feeling better today. No meds for these symptoms starting 12/2/21
This patient died unexpectedly in her sleep on the night of November 1st, 2 days after she received her flu vaccine and COVID booster in our clinic.
Day 1 woke to to fatigue and very sore arm. Day 2 still fatigued, sore arm, headache.  Day 3 still very fatigued and headache  Day 4 still very fatigued and woke with vertigo
Vaccine stored in refrigerator on 02Jun2022 and administered on 07Jul2022; Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 02Jun2022 and administered on 07Jul2022) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059M21A, 026A21A and 031M21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergic reaction to antibiotics, Bipolar disorder, Post-traumatic stress disorder, Restless legs syndrome, Hypothyroidism, Osteoporosis, Sleep disorder and Depression. Concomitant products included ESCITALOPRAM from 17-Jun-2021 to an unknown date for Bipolar depression and Depression, LEVOTHYROXINE from 20-Aug-2020 to an unknown date for Hypothyroidism, TRAZODONE from 13-Sep-2021 to an unknown date for Post-traumatic stress disorder and Sleep disorder, ROPINIROLE from 13-Dec-2021 to an unknown date and GABAPENTIN from 16-Jun-2021 to an unknown date for Restless legs syndrome, ACICLOVIR (ZOSTER) for an unknown indication.   On 12-Feb-2021 at 9:28 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 12-Mar-2021 at 1:29 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 07-Jul-2022 at 9:59 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 07-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 02Jun2022 and administered on 07Jul2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID vaccine from a vial that had exceeded its 30 day working expiration.) and PRODUCT STORAGE ERROR (Vaccine stored in refrigerator on 02Jun2022 and administered on 07Jul2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vial was initially stored on refrigerator on 02-Jun-2022. The vial did not undergo any temperature excursion.  No adverse events noted at the time of reporting.  No treatment was reported.
Extremely sore arm intensified 14 hours later when I decided to take Advil. Within a minute I began to weaken, ultimately collapsing on bathroom floor. My husband heard me fall and tended to me. He stated that I was unresponsive for 5-10 seconds. My husband provided me water and allowed me to lie on the floor until I was strong enough for him to assist back to bed. He reported my skin was clammy and moist to the touch. After resting for 15 mins he assisted me to the bathroom to urinate. I returned to bed and slept until 5:30 am when I awoke and went downstairs. I was feeling well enough to go on my weekly 90 minute bike ride at 8:30 am.
Needed Tdap. Was accidentally given Dtap-IPV (Kinrix) instead, as well as MMRV. These 2 vaccines were drawn up for the patient's sibling and they got switched. The mistake was realized prior to administration of MCV4 and the sibling has not been given any vaccines yet at that time. The patient and parent were made aware of the mistake and instructed that the DTAP would take the place of the intended Tdap.
Vax given 24APR91 @ 4PM onset sitffness, eyes rolling , "hot" at approx 7PM-no prior fever noted;
After receiving the 2nd dose of Shingrix, I experienced severe headache, body aches, nausea, chills, fever beginning roughly 6 hours after receiving the vaccine. I was unable to go about daily activities. My symptoms lasted roughly 12 hours, gradually resolving on their own. I experienced this same reaction after receiving the 1st dose of Shingrix (at the same Pharmacy on 9/17/20), but did not report it through VAERS.
Within 5 minutes of administering vaccine, patient reports feeling not good, sweaty, ringing and feels like going to pass out. 911 call activated, checked the BP-80/60, hr-70, O2 sat-100% and RR-18. Denies any SOB, wheezing or chest tightness. EpiPen was ready to administer but patient BP back to 90/60 s and stayed the HR and Sats as above. No syncope. Chest sound clear and patient reports never had vaccine before and have some phobia towards injections. EMS came to the clinic, by the time patient is already start feeling better so patient doesn't want see the EMS. Watched the patient in the clinic for 30 minutes.
When walking from vaccination area to observation area she passed out and hit the back of her head on the floor Her husband, was with her and was able to provide information that she got lightheaded after her first shot, as well, but did not pass out. On initial evaluation, she was not responsive.  BP 180/100, HR ~65 Legs were elevated and she slowly started to regain consciousness.   She complained of pain in the back of her head EMS was called due to head trauma She was placed in a C-collar and taken via ambulance to ED for further evaluation
Child received DTaP/Hib-combination shot in L thigh on 9/3/03. Mom noted nodule in area after shot which developed reddish/purplish color by next day. Last night leg appeared swollen with redness around site nodule much smaller-child still walking on leg without problem. Told to apply cold compress every 1-2hr x 24 hours.
Heart palpitations , shortness of breath , muscle aches, Headaches Dizziness tingling in my hands and feet.
This spontaneous report was received from a registered nurse concerning a 5 day old patient of an unknown gender. The patient's medical history, concurrent condition and concomitant medications were unknown. On an unknown date, a 5 day old patient was vaccinated with a dose of VAQTA 25/0.5 (units not provided), dose and route of administration were not reported, lot # M009377 with expiration date: 17-JUN-2017). No adverse effects were reported. Follow-up information has been received from the registered nurse on 07-NOV-2016 and 10-NOV-2016. The patient had no pre-existing allergies, birth defects and medical conditions. No adverse events following prior vaccination were reported. On 19-SEP-2016 at 11:30 am, the patient received the first dose of RECOMBIVAX HB lot # reported as M009377 (dose, route of administration and anatomical location were not reported) (not VAQTA as previously reported) and on 18-OCT-2016 at 11:55 am, she received the second dose of RECOMBIVAX HB lot # M010671 (dose, route of administration and anatomical location were not specified). Additional information is not expected as all scheduled follow up information has been received. Sender's Comments: MERCK 1609USA009694:Mfr number.
Gave a rotavirus vaccine to a 5 mth old with no hx of receiving of rotavirus. Child exceeded age limit for first time dose under rotavirus catch-up vaccine schedule.
pt recv vax & devel severe aches & fever for several days;hx included rheumatoid arthritis;pt eventually recovered & also recv addtl med for arthritic flares;this is one of 3 patients from this site who exp above rxn p/lot# 4958106
Patient received Pfizer vaccine with 1st dose on 03/11/2021 and 2nd dose on 03/31/2021.  Patient Covid + on 10/05/2021 and hospitalized. Per H & P: Patient is 75-year-old female she has a past medical history significant for hypertension hyperlipidemia diabetes mellitus chronic kidney disease gastroesophageal reflux disease patient has been complain of generalized weakness fatigue cough for decreased appetite diarrhea and abdominal pain no blood in the stool did not have any dysuria frequency hematuria she has been complain of cough no hemoptysis no dyspnea exertion no orthopnea she become more fatigued and weak she was brought to the hospital was found to have COVID-19 positive patient previously vaccinated for COVID-19 her chest x-ray showed diffuse peripheral lower opacities suggestive of atypical pneumonia CAT scan abdomen pelvis peripheral groundglass opacity lung base consistent with viral pneumonia right lower pole nonobstructing 9 mm renal stone no hydronephrosis cholelithiasis without cholecystitis patient was admitted to hospital for further evaluation treatment    Assessment and plan  1.  Abdominal pain and diarrhea, COVID-19 viral pneumonia  2.  9 mm nonobstructive stone  3.  Cholelithiasis without cholecystitis  4.  Diabetes mellitus type 2 non-insulin-dependent  5.  Acute kidney injury chronic kidney disease stage III monitor BUN/creatinine  6 hypertension uncontrolled continue monitor, hyperlipidemia  7.  Patient was started on IV steroid IV fluid hydration monitor BUN/creatinine monitor inflammatory markers physical therapy occupational therapy DVT GI prophylaxis
Information has been received from a physician concerning a 15 year old female who on approximately 20-MAR-2007, "a couple weeks ago", was vaccinated with a first dose of Gardasil. Subsequently the patient developed swelling. The patient sought unspecified medical attention. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates since 29-OCT-2015, the patients were vaccinated with improperly stored doses of GARDASIL (lot # K007828, expiration date 02-MAR-2017, exact doses and route of administration were not reported). It was reported that since 29-OCT-2015, the vaccines were exposed to temperature of 32.3F during cumulative of 7 hours. No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
3 inch x 7 inch, oval, warm, swollen, raised area on (L) upper arm.
Headache, backache, nausea, joint pains for two days, used Tylenol, Ibuprofen and Benadryl
This medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns a 46 year old male patient. On 26-OCT-2014, AFLURIA underwent temperature excursion at 50 degree Fahrenheit. On 27-OCT-2014, AFLURIA again had temperature excursion at 50 degree Fahrenheit for undetermined amount of time. On 27-OCT-2014, the patient received temperature excursion AFLURIA (batch number: T50507) via intramuscular route at 0.5 ml. Outcome was reported as unknown. Reporter's comments: The reporter assessed the event as non-serious.
3RD DOSE OF MODERNA COVID VACCINE GIVEN 11/10/21, LOT #077C21B. 4TH DOSE OF MODERNA COVID VACCINE GIVEN 5/24/2022, LOT #056M21A pt had a positive COVID test in SNF on 8/1/22 (locally); transferred to a local hospice facility with dx of NSTEMI and GIP for pain/dyspnea; bed bound, on O2; pt passed away in the hospice facility
Rash around injection site (upper left arm) about 3 inches diameter. Itchy and not red, starting to blister on 6/18 AM.
Itching, hives within 15-20 minutes after administrartion, Benadryl 25mg given orally x 1 dose. Employee went to ER on 06/29/2016 with hives and was evaluated by MD.
soreness to injection site for two days, fatigue, headache, elevated temperature,  sore throat, muscle aches
Injection site pain. Cellulits at the injection site. 103.4 F temparature. Treatment: Levofloxacin 500 mg iv x 3 days Vancomycin 1 gram q12n x 2 days Patient was positive for Staph/-Coag Neg
patient received moderna dose  #1 - 9/21/22 at another location and then given pfizer as their second dose in the series  on 1/21/22
The pt experienced a fever of 101, myalgia, arthralgias, sore arm at injection site, lasting 24 hours.
Ever since she got flu shot left arm is painful and red while exercises (school gym class). Otherwise she feels normal.
fever to 103.8 6-8hr post vax;persisting x 3 days;irritability;adm to hosp to r/o sepsis/meningitis-hyponatremia;recv IV ATB & fluids; Annual follow-up states the pt has recovered.
No adverse event; patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 27-Oct-2022, the patient experienced UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (patient was administered a lower than authorized dose of the Moderna COVID-19 bivalent vaccine).    No concomitant drug was reported. The patient received 0.25 mL dose instead of 0.5 mL dose (Lot #: 061F22A, Expiration date: 16MAY2023) of  the Moderna COVID-19 bivalent vaccine The patient had not reported any adverse reactions at that time. No treatment drug was reported. This case contains information for the 17th of 18 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-666284 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-666284:
About 5pm on 3/18 headaches started and continued. By 10pm chills started and all over aches in muscles and joints especially in legs. Midday on 3/19 I experienced severe a headache. I spent all of 3/19 resting and sleeping with little energy to do more.  This continued until overnight on 3/19. By Saturday morning 3/20, I feel much better. I have a minor  headache and body aches are almost gone.
PRESSURE PAIN FROM THE LEFT CROWN OF THE HEAD; SWELLING NEAR THE LEFT EYE; PRESSURE IN THE LEFT EAR CANNEL; SOFT TISSUE SWELLING AROUND THE CROWN/SOFT TISSUE LUMPS OR SWELLING/NEW BUMPS ON HEAD; PRESSURE PAIN IN THE LEFT EYE NEAR THE BROW; SINUS PRESSURE; SORENESS IN HEAD; SORENESS IN BACK OF NECK; SORENESS IN INJECTION SIRE; SORENESS IN THE LEFT ARM; This spontaneous report received from a patient concerned a 33 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. takes blood pressure medications when necessary. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-JUN-2021, the subject experienced soreness in the left arm. On 14-JUN-2021, the subject experienced soreness in injection sire. On 15-JUN-2021, the subject experienced soreness in back of neck. On 15-JUN-2021, the subject experienced soreness in head. On 17-JUN-2021, the subject experienced pressure pain from the left crown of the head. On 17-JUN-2021, the subject experienced swelling near the left eye. On 17-JUN-2021, the subject experienced pressure in the left ear cannel. On 17-JUN-2021, the subject experienced soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head. On 17-JUN-2021, the subject experienced pressure pain in the left eye near the brow. On 17-JUN-2021, the subject experienced sinus pressure. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from soreness in the left arm, and soreness in injection sire on 16-JUN-2021, and had not recovered from soreness in back of neck, pressure pain from the left crown of the head, swelling near the left eye, pressure in the left ear cannel, soft tissue swelling around the crown/soft tissue lumps or swelling/new bumps on head, pressure pain in the left eye near the brow, soreness in head, and sinus pressure. This report was non-serious.
Fever, chills, headache, back ache, tiredness. The fever and chills lasted about 12 hours, the headache, backache and tiredness lasted 36 hours and were relieved with Ibuprofen.