chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccination adverse reaction; Inappropriate dose of drug administered; Device issue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4474900-00 (Agency).  An 84-year-old male patient received BNT162b2 (BNT162B2), on 11Jan2021 as dose number unknown, single (Lot number: EL0142) at the age of 84 years intramuscular for covid-19 immunisation; adalimumab (HUMIRA), since Sep2019 (ongoing) (Lot number: 1161756) at 40 mg (40 mg (in 2 wk)), subcutaneous for psoriasis. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Tobacco use/a pack and a half of cigarettes per week", stop date: 1980, notes: Tobacco use/a pack and a half of cigarettes per week (stopped 1980); "Heart murmur" (unspecified if ongoing); "Abstains from alcohol" (unspecified if ongoing); "Unspecified substance allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION REACTION (hospitalization) with onset 12Jan2021, outcome "not recovered", described as "Vaccination adverse reaction"; DEVICE ISSUE (non-serious) with onset 19Jul2022, outcome "not recovered"; INCORRECT DOSE ADMINISTERED (medically significant) with onset 19Jul2022, outcome "not recovered", described as "Inappropriate dose of drug administered". The patient was hospitalized for immunisation reaction (hospitalization duration: 1 day(s)). The action taken for adalimumab was dosage not changed.  Additional information: The patient wife stated that the patient experienced unspecified adverse reactions from PFIZER COVID 19 VACCINE where in he was hospitalized for one day. His wife refused to provide his concomitant medications and other information. It was unknown if he was enrolled in a COVID-19 Vaccine Trial. Took HUMIRA injection but the needle did not go all the way in then HUMIRA ran down at the side of the body/did not get any of HUMIRA/pen was defective   Causality for HUMIRA 40MG/0.4ML(ADALIMUMAB) The reporters causality for the event(s) of adverse reactions to PFIZER COVID 19 VACCINE with HUMIRA 40mg/0.4ml(ADALIMUMAB) was no reasonable possibility. The reporters causality for the event(s) of took HUMIRA injection but the needle did not go all the way in then HUMIRA ran down at the side of the body/did not get any of HUMIRA/pen was defective onset 19Jul2022 and took HUMIRA injection but the needle did not go all the way in then HUMIRA ran down at the side of the body/did not get any of HUMIRA/pen was defective onset 19Jul2022 was not provided.  No follow-up attempts are possible. No further information is expected.
injection site soreness/pain; injection site swelling; injection site warmth; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular). In April 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, injection site swelling and injection site warmth. On an unknown date, the outcome of the injection site pain, injection site swelling and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site pain, injection site swelling and injection site warmth to be related to Shingrix.  Additional details were provided as follows:  The patient reported this case. The age at vaccination was not reported. Approximately two weeks ago (of date of reporting), the patient received the 1st dose of the Shingrix vaccine in left arm.   The patient had soreness, pain, warmth and swelling around the injection site.   These symptoms lasted for almost a week. The patient did not consent to follow-up. Unable to obtain additional information at this time.
Vaccine administration Moderna booster on right arm.Pfizer arm previously with similar sx. Reported to VAERS last time.Had another COVID shot 2 weeks ago on Saturday  Flare up under axillary region of lymph node with significant swelling.  Swelling has since gone down. Patient is noticing increase in body odor since immunization. Has been experiencing ongoing sore throat since booster. Lymph node swelling is no longer occurring per report of patient. Swelling of lymph node occurred a few hours after the vaccine. Treatment: ibuprofen for fever that he also got with the vaccine No other sx occurring.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions and concomitant medications was reported. On 27-FEB-2016, the patient was vaccinated with a dose of VAQTA injection, lot # L023936, expiry date 15-MAR-2017 (dose, route of administration and anatomical location were not specified). The administered dose of VAQTA underwent temperature excursion at minimum 35 Fahrenheit degrees for 7 days. There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several cases received from the same reporter. Additional information has been requested.
Within 5-10 minutes of the shot I started to get a metallic taste in my mouth. Then my legs started to feel heavy and numb, then my face felt numb and then my arms. I could barely pick something up and I could not stand. Then my jaw started to shake and so did my legs. I went to the ER and they said I was having a shock/panic attack response to the vaccine. On Monday 1/25 I woke up in extreme stomach pain and went back to the ER and they said I needed to have my appendix out. I went to a hospital where they tried to just give me antibiotics, but still had to have my appendix out on Wednesday 1/27.
he administered one of PROQUAD at 12 months of age, then the dose two two of PROQUAD at 2 years of age. this can be considered alternate dosing; This spontaneous report was received from a physician regarding to 4 children, who were 2-year-old and their gender was unknown. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On an unknown date, patients at 12 months of age were vaccinated with first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, frequency, route, therapy type, lot# and expiry date were unknown) for prophylaxis. At 2 years of age, the patients were vaccinated with second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, frequency, route, therapy type, lot# and expiry date were unknown) for prophylaxis (inappropriate schedule of product administration).
received dose on April 11th 2022, expired on April 6th 2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-week-old male patient who received HBV (Engerix B) (batch number 722KC, expiry date 6th April 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th April 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 11th April 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-APR-2022 Reporter's Comments:  Clinic administrator reported patient received a dose of Engerix B that was already  expired on 6th April 2022.  The reporter consented to follow up.
Patient experienced numbing of the left jaw area (described as similar to being at the dentist) for 2 hours after his first dose.
When dose was reconstituted it was reconstituted with NS instead of the liquid provided  in the vaccine.  So juvenile only received partial dose of this vaccination.
Patient got 2 vaccine on 8/7  around 5pm. On 8/8 patient experienced redness of the injection area and keep spreading on patient's arm. She also stated that the area is warm to touch. Patient call us on 8/9 to report the symptoms and was recommended by to attend urgent care due to potential allergy symptoms.
Information has been received from a nurse manager concerning a 77 year old female patient who on 03-MAY-2010 was vaccinated intramuscularly with the first dose of PNEUMOVAX 23 (lot# 664964/1338Y). Subsequently the patient felt weak and ill the next day (on 04-MAY-2010) as well as the patient's arm was slightly pink at the injection site. The patient sought unspecified medical attention and was advised to use ibuprofen and TYLENOL (manufacturers unspecified) as needed. On an unknown date, the patient had recovered. Follow-up information has been received from the nurse manager concerning the 77 year old retired female with no definite allergies but "some antibiotics caused dizziness and nausea" who was vaccinated IM with the first dose of PNEUMOVAX 23 into her right deltoid at approximately 4:00 PM on 03-MAY-2010. On 4-MAY-2010, the patient complained of general ill feeling and felt weak at 10:35 AM. The patient was advised to use TYLENOL, ibuprofen, or phenergan (25mg, PO) as needed. On 05-MAY-2010, the patient complained of warmth and swelling of injection site. On 05-MAY-2010, the patient, who had refused to be seen on 04-MAY-2010, was seen by a physician. The patient was to use ibuprofen, TYLENOL and ice to the injection site and to follow-up for problems per doctor's instruction. The physician reported that the patient was diagnosed with of pulmonary embolism/infarction on 10-MAY-2010 and the pulmonary embolism/infarction was not related to PNEUMOVAX 23. The symptoms of warmth and swelling of the site noted on 05-MAY-2010 at the time of an office were addressed. No further follow-up occurred related to the complaint of ill feeling or symptoms of localized reactions. Upon internal review, "pulmonary embolism" was determined to be an other important medical event. Additional information has been requested.
Hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset 19Nov2022, outcome "unknown", described as "Hives". The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient recieved vaccination, within 5 minutes she reported not feeling well.  She was seated and briefly passed out.  She was shaky and sweating.  Paramedics were called. Patient was evaluated in ambulance.  Within 30 min of initial reaction patient returned to pharmacy feeling well as her reaction had passed.
Increased heart rate approximately 12 hours after injection rising to a sustained 100+ bps (up to 120+ bps) during sleep
Information has been received from a physician concerning a patient who on third week of December 2008 was vaccinated with the first dose of ROTATEQ (LOT# not reported). 24-28 hours after dose was given, the patient experienced blood in stools. The outcome of adverse event was unknown. The patient did not plan on administering any further doses. It was reported that the patient sought unspecified medical attention. The blood in stools was considered as important medical event. Additional information has been requested.
PUNCTURED VIAL OF VACCINE KEPT IN REFRIGERATOR FOR A DAY; PUNCTURED VIAL VACCINE GIVEN AFTER A DAY; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 23-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-JUN-2021, the subject experienced punctured vial of vaccine kept in refrigerator for a day. On 23-JUN-2021, the subject experienced punctured vial vaccine given after a day. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the punctured vial of vaccine kept in refrigerator for a day and punctured vial vaccine given after a day was not reported. This report was non-serious. This case, from the same reporter is linked to 20210651118.
daily episodes of rapid heart rate, elevated blood pressure, chills, sweating, shaking, dizziness, light-headedness, brain fog
Large red, raised lump on (R) leg. Increased in size since yesterday. Hot to the touch & streaking up leg.
Respiratory Distress; Initial information received on 08-Oct-2019 regarding an unsolicited valid serious case received from a physician.  This case involves unknown demographic patient who experienced respiratory distress (respiratory distress), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient ongoing medical condition: severe Food allergy. The patient's past medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date maybe(wasn't sure of the date) last year, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and Expiry date unknown) via unknown route in unknown administration site.  On an unknown date, the patient developed a serious respiratory distress (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  (Other relevant tests included no lab data.) Final diagnosis was respiratory distress.  It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for respiratory distress.  Information on the batch number was requested.  List of documents held by sender: none.; Sender's Comments: This case involves a patient of unknown demographics who experienced respiratory distress (after vaccination with vaccine FLUZONE QUADRIVALENT. Time to onset is unknown. Moreover, further information including concomitant medications and lab tests excluding other etiology would be needed to fully assess this case. Based on available information, the role of the vaccine cannot be assessed.
Pt presented with cough/wheezing. The next day post receiving flu vaccine was treated with Albuterol neb/prednisone.
Patient received Moderna COVID-19 vaccine #1 on 02/09/2021.  Patient received Moderna COVID-19 vaccine #2 on 03/09/2021.    Patient admitted to hospital 03/10/2021 through 03/11/2021 due to syncope on 3/110/2021.  Patient had gotten up out of bed to go to the bathroom, called out to her husband then had syncopal episode and fell to the floor.  According to husband, she had loss of consciousness for 5 minutes.  Per husband and EMS, she then had another syncopal episode after taking a few steps and then collapsed.  No urinary incontinence.  Syncope occurred day after receiving 2nd dose of COVID-19 vaccination.  CT brain as well as CT cervical spine negative for acute abnormality or cervical fracture.  Hemodynamically stable.  Cardiac enzyme negative x 2.  EKG negative for acute abnormality or arrhythmia but with baseline abnormalities.  Suspicion was that symptom was due to vasovagal reaction to 2nd dose of COVID19 vaccine.   Notably husband also reported that on 02/23/2021 patient was showering, and he then heard her calling out.  He found her undressed and wet in the living room area confused.  She did not know where she was.  Patient  also with history of TIA in 05/2020.   patient with history of mild dementia.
Sharp chest pain, feeling of a lump in my throat, hypotension, elevated heart rate.
swollen lymph nodes in both armpits; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes in both armpits) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) 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 23-Mar-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes in both armpits). At the time of the report, LYMPHADENOPATHY (swollen lymph nodes in both armpits) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
t105, cried cont 4-6hr called & called office & told about fever prevention;
Summary from patient: On 13. March 2021, I had to be taken with an ambulance to the Emergency Department, due to uncontrolled vomiting (vomiting by each head movement) and severe headaches. I was unable to move any longer and experienced severe dehydration. Since childhood I pass out, when I need to vomit, which made the situation extremely serious. A MRI done in the evening was normal. Diagnosis: Severe Migraine Attack Low Platelet count noticed by attending Physician (mild, rebounded) I had to stay in the hospital overnight. For the following two weeks, I experienced constant nausea and irritation of both eyes, dizziness on and off, headaches at the back of my head on and off. ?Feeling the eyes?, eyes easily strained (phone + computer), light sensitivity.  On 27. March 2021, I was referred to a Neurologist, due to my ongoing symptoms, who confirmed diagnosis, Severe Migraine Attack. Neuro Exam: normal. He stated that it is extremely unusual to get such a severe event at my age, particularly, since I had never experienced anything like this before. He gave me an intravenous injection of Solu Medrol 500 mg, which resolved most of my symptoms, except the issue with my eyes. In addition, he prescribed some Migraine prophylaxis, which made me drowsy and therefore I stopped the medication after two days.  On 3. April 2021, I went for a follow up visit with the Neurologist. He said, he gave me these strong medications, as I had a Status Migrainosus. My eyes continue to bother me, getting strained on screens and they are still light sensitive. My head is more sensitive, for example to abrupt movements and heat.
This spontaneous report as received from a licensed practical nurse via a company representative refers to a female patient of unknown age. The nurse heard of this adverse event from the patient's mother. In approximately May 2013 (reported as 2 years ago), the patient was vaccinated with a dose (reported as one dose) of GARDASIL (route of administration, lot # and expiration date unknown). Afterwards, on an unknown date, the patient experienced an inability to walk right and was hearing voices in her head. The patient's mother saw an article which discussed similar effects related to GARDASIL use (reported in MARRS # 1505USA003630) and correlated the symptoms discussed in that article to the patient's experience. The patient sought an unspecified medical attention. The outcome of the adverse events was unknown. The relatedness between the adverse events and the vaccination with GARDASIL was not reported. Additional information has been requested.
Patient should have received adult dose of Engerix-B however got the pediatric dose of Engerix-B
Booster dose, selected dose #2 in series because primary doe was Janssen.  Vaccine administered came from vial that was kept in fridge longer than manufacture recommended storage date. The manufacture informed us via written statement that patients "maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration." Revaccination was not advised. We called the patient to inform them of the situation and the information we received from the manufacture. No adverse reactions were reported by the patient.
received Moderna vaccines on 1/17, 2/12, 10/27/21 COVID-19 positive by PCR on  1/14/22 admitted to hospital on 1/15/22 d/t SOB, COVID 19 pneumonia underlying COPD , CHF
Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 18 years old female patient who received a booster dose of MENACTRA lot U6151AA Expiry date 16-MAR-2020 via unknown route in the right arm on 15-Oct-2018 but she had already had her booster dose in 2017. The patient's past medical history, medical treatments, vaccinations and family history were not provided. It was a case of actual medication error due to extra dose administered. After dose had been given the Nurse realized on review of the health record that the patient had already received a booster of MENACTRA at age 16 in 2017. The patient was not aware of the prior dose. The nurse will notify her that she has had 2 boosters of MENACTRA in 2017 and 2018. It was not reported if any adverse event occurred or not. 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. List of documents held by sender: none.
This spontaneous report was received from a physician who referred to 13 months old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 12-JUN-2017, the patient was vaccinated with improperly stored dose of VAQTA lot #N005274, expiration date 03-APR-2018 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 54 degrees Fahrenheit for 70 hours. Data logger was not involved. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA012767: US-009507513-1709USA007325: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1709USA012768:
15JUL94 papular rash noted @ hepatitis & TB site; site cleansed prior to administration of above w/alcohol prep pad
Fever/Chills, Chest Pain with Dizziness (on and off for multiple days) Severe Headache lasting 3 days.
SEVERE PAIN IN THE ARM, SEVERE HEADACHE, MUSCLE, JOIN PAIN AND HIGH HEVER FOR 3 DAYS (38.8 - 39.3 C)
Had a fever ranging from 101 to 104F as measured by temporal scan for a period of around 30 hours.  Sweats, dehydration and drowsiness as would be common with such a fever.  Recovered on own at home.
1st Dose of COVID Vaccine on 3/25/21 2nd Dose COVID Vaccine on 04/13/21 Vaccines was Given too soon.  Patient stated She is Doing fine.  Patient Denies any aDveRse reaction