chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Onset of leg pain, 2 days after influenza vaccine on 11/11/2006, weakness with walking on about 11/13/06, increased difficulty walking starting about 11/24/06. Hospitalized 1/27/06 and diagnosed with Guillian Barre Syndrome.  12/12/06 Received medical records from hosptial which reveal patient admitted 11/27/06 after developing acute progressive distal to proximal weakness over a 2 wk period prior to admit.  Difficulty climbing stairs & walking funny, complaining that whole body hurt.  Symptoms began 2 days s/p flu vax.  Also had URI symptoms with low grade fever & was seen in ER approx 2 wks prior to admit & was placed on antibiotics & inhaler for wheezing.  Tx w/IVIG & responded very well.  Consults by Neuro & ID.  Noted to have tremors of upper extremities. DTRs absent in LEs.  Gait was wide based & slow.  Continued to improve & was d/c to home on 12/1/06. Final DX: Guillain Barre syndrome.
I woke up approximately 5:00a.m. on 10/08/2021 with chills, fever of 99.3 and headache with sore throat. This continued for approximately 16 hours with my fever climaxing at 101.9.  I started taking Tylenol around 8:00a.m.
Mom reported hives 2 hrs after appointment. Patient was observed by mom at home and the following she reported hives were gone. Pt was not seen in our office for this.
Imogam and Imovax both administered in the buttocks, no AE; Initial information received on 19-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 28 years old male patient who received RABIES (HDC) VACCINE [IMOVAX RABIES] and while treated with HUMAN RABIES IMMUNOGLOBULIN [IMOGAM RABIES-HT](lot number and expiry date not reported) via unknown route in the buttock nos on 30 Aug 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient had potential exposure to rabies on 27 Aug 2019 due to possible bat bite on left hand.  It was a case of actual medication error due to Product administered at inappropriate site.  It was reported that the possible bat bite on left hand. Imogam and Imovax both administered in the buttocks but Imovax 3 days late. Patient received 6 doses Imovax were recommended.Imovax series received in the deltoid, 5th dose administered since initial dose given in the buttocks.  At the time of reporting, 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 holders 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.
Injection site: red, sensitive and swollen.  10pm- present  Body soreness: (04/07/2021) 11am- present  Nausea: (04/07/2021) 9am- present  Lightheaded/fatigue: (04/06/2021) 6pm -  present.
Symptoms woke patient in the night, day after receiving injection. Redness spans 9 cm by 7 cm and is warm to the touch. Swollen as well. Painful to move the arm. Treated for cellulitis with KEFLEX 500mg BID x 10 days.
19 y/o M AD USMC with Hx G6PD Def was brought in by ambulance with complaints of abdomen discomfort, chills, fever, dysphagia/dysphasia, nausea and  headaches following administration of Janssen vaccine 7-8 hours prior.   Evaluation significant for edema/inflammation of the oropharynx, abdomen tenderness, down-trending BP, fever (>102 F), tachycardia (>115), despite the fluid resuscitation IV, Epinephrine, steriods, Antipyretic and diphenhydramine.   Vital signs and symptoms significantly improved 2.5 hours into the treatment.   Over the evening care, member had a unremarkable observation.  Vital signs maintained stable in the morning and he was discharged with appropriate therapies and follow up instructions.
Pt. was given Hep A vaccine #1 on 6/24/08, which was 1 month prior to her first birthday.  No adverse reactions were reported.
Presented to ER on 8/7 with SOB , chest tightness, palpitations. CT confirmed bilateral PE. patient started on heparin infusion and admitted to the hospital.
Extreme shoulder pain with any movement. Inability to lift are overhead.  Treated with lidocaine patch, anti inflammatories, Tylenol with codeine. Minor symptom relief.
Information has been received from a physician concerning a patient who on 23-Jul-2008 was vaccinated with VARIVAX (Oka/Merck). The physician reported that someone in the office gave a patient VARIVAX (Oka/Merck) instead of ZOSTAVAX (Oka/Merck) by mistake. No adverse reaction reported and this was not product confusion. There was no product quality complaint. Follow-up information was received from a medical assistant who reported that the patient is a 66 year old male. She reported that patient was given the wrong vaccine because it was a case of human error and not product confusion and she felt the labeling was clear and sufficient. Additional information has been requested. This is a consolidation of two reports concerning the same patient.
Dizziness and Weakness for about 30 hrs diminishing as time passed. Dizziness lessened during this time frame. Weakness also diminished during this timeframe but lasted on and off for a couple more weeks occasionally. Both Completely gone now.
Pt. says that a few days after the immunizations, he sneezed about a hundred times in a row and soon had to be hospitalized. He said that he was having trouble breathing and it felt like someone had their hands around his throat. He said the Dr's. determined that it must be a latex reaction.
This spontaneous report as received from a healthcare worker refers to four patients of unknown age and gender. On an unknown date in 2015 (also reported as in the months of September 2015 and October 2015), the patients were vaccinated with PNEUMOVAX 23 (route, dose and frequency not reported, the patients received lot # 1022795 and one patient received lot # 1002310). On an unknown date in 2015 (also reported as two days after vaccination), the patients called the physician's office to report severe pain, swelling and redness at the injection site. The outcome of the events was unknown. The relatedness between the events and PNEUNOVAX 233 was not reported. This is one of several reports from the same source. Additional information has been requested.
Took medication Saturday 9/26/15 night. Woke up Sunday morning with severe hives and swollen throat. Went to urgent care received EPIPEN and prednisone therapy and discontinued therapy.
Hot flushes at night; I am feeling nervousness; I have high Blood pressure. Ranging from 145-160 to 90-98; headache, it is dull headache; fever; chills; ringing of ear, it is like something buzzing in ear in ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (ringing of ear, it is like something buzzing in ear in ear), HOT FLUSH (Hot flushes at night), FEELING ABNORMAL (I am feeling nervousness), HYPERTENSION (I have high Blood pressure. Ranging from 145-160 to 90-98) and HEADACHE (headache, it is dull headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced TINNITUS (ringing of ear, it is like something buzzing in ear in ear), HEADACHE (headache, it is dull headache), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced HOT FLUSH (Hot flushes at night), FEELING ABNORMAL (I am feeling nervousness) and HYPERTENSION (I have high Blood pressure. Ranging from 145-160 to 90-98). On 02-Mar-2021, PYREXIA (fever) and CHILLS (chills) had resolved. At the time of the report, TINNITUS (ringing of ear, it is like something buzzing in ear in ear), HOT FLUSH (Hot flushes at night), FEELING ABNORMAL (I am feeling nervousness), HYPERTENSION (I have high Blood pressure. Ranging from 145-160 to 90-98) and HEADACHE (headache, it is dull headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Feb-2021, Blood pressure measurement: 145-160/90-98 (Inconclusive) 145-160 Systolic 90-98 Diastolic. On 27-Feb-2021, Body temperature: 103.4 (Inconclusive) 103.4.         Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. No concomitant medications were reported. No treatment was reported.  Symptoms: Patient reported that she had hot flushes in night which got worst and kept her awake at night Action taken with mRNA-1273 in response to the event was not applicable.
Arm pain starting evening after patient received dose. Worsens within 2 days. Received antibiotics from MD for arm pain, swelling, redness, fever, pain that radiated from left arm to left foot and discoloration of left foot. Symptoms persisted > 1 wk.
Chest pain, elevated troponin, cardiology evaluation including echocardiogram. Diagnosis of Myopericarditis
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 06-NOV-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L030587, expiry date: 10-FEB-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from an office manager refers to a 14 years old female patient with asthma. The patient was vaccinated with 3 doses of GARDASIL (lot# not reported) on 16-JUN-2009, 19-AUG-2009 and 18-DEC-2009, respectively. Concomitant medications included ZYRTEC, SINGULAIR, PULMICORT, SYMBICORT, VERAMYST and doxycycline. Since receiving GARDASIL, the patient had experienced migraines, fainting spells and could not sleep. The patient was hospitalized at some point but there was no information about the hospitalization or the name of the hospital. The patient contacted the physician. The outcome of migraines, fainting spells and could not sleep was reported as not recovered. The relatedness for migraines, fainting spells and could not sleep was unknown for GARDASIL. Additional information has been requested.
dizziness started 4/11 - 11 days after the vaccnine - followed by nausea and headache.   this has gotten worse since then.  was seen in ER on 4/13 at ER  was then seen at my PCP on 4/12 and again yesterday, 4/22 - had full blood workup , and all blood work came out good / normal ranges, including WBC count -  had ultra sound of left leg and normal and ekg as routine, also normal.   went back to Dr. 4/23 because of bad dizziness lasting all day in waves and headache in temple area.    now being treated with augmentin and prednisone for possible sinus infection, but i have never had this with any other sinus infection i ever had in the past.    next step is MRI of the brain, which i really dont want to do.  any help would be appreciated to rule out if this is due to the vaccine.    very nervous.    Thank you
This spontaneous report as received from a register nurse refers to a 6 months infant, of unknown gender. Medical history and concurrent conditions were not reported. On 31-JAN-2014, the patient was vaccinated with dose 1 of ROTATEQ lot #J007283; expiration date: 27-SEP-2014 (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Nurse called and stated that improperly stored ROTATEQ was administered to patient. No adverse effects reported. The nurse reported that vaccine dose received by patient was a vaccine improperly stored as follows: On 13-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 50 degrees F. On 18-JAN-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (2 pm - 4 pm) the temperature recorded was 49.1 degrees F. On 10-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (12 pm - 6 pm) the temperature recorded was 51.8 degrees F. On 16-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 5 hours (12 pm - 5 pm) the temperature recorded was 51.8 degrees F. On 22-FEB-2014, ROTATEQ was stored outside of recommended temperatures for 4 hours (2 pm - 6 pm) the temperature recorded was 52.7 degrees F. On 09-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 2 hours (12 pm - 10 pm) the temperature recorded was 55.4 degrees F. On 15-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 6 hours (8 am - 2 pm) the temperature recorded was 50 degrees F. On 16-MAR-2014, ROTATEQ was stored outside of recommended temperatures for 20 hours (2 am - 10 pm) the temperature recorded was 64.4 degrees F. On 17-MAR-2014, ROTATEQ the temperature reading on the morning was 64.8 degrees F. The total of hours stored outside of recommended temperatures was 55 hours. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 15-AUG-2014 the patient was vaccinated with M-M-R II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not provided. On unknown dates, the patients were vaccinated with doses of PNEUMOVAX23 (route, lot numbers and expiration dates were not provided). On unknown dates, there was incorrect product storage as an unspecified number of patients received doses of PNEUMOVAX23 improperly stored. No adverse effect was reported. It was unknown if the patients sought medical attention. At the time of the report, the patients status was unknown. This is one of several reports received from the same source. Additional information has been requested.
(L) deltoid became vey itchy immediately  (L) deltoid area became swollen area within 1 hour.
Chills, Dizziness, Scratchy sore throat, difficult to swallow, numb tongue, malaise
Adverse rxn including pain, redness, severe swelling at injection site. Arthralgia, myalgia.
onset of severe bronchospasm w/in 2min of MMR, DTAP vax;no hypotension, no angioedema-resolved w/nebulizer albuterol p/10-15min;
The client tested positive for COVID-19, on 2/26/21, after being fully vaccinated.
positive Covid PCR test results; positive Covid PCR test results; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date Jun2021 (Batch/Lot number: unknown) as dose 2, single and administration date May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 18Dec2021, outcome "unknown" and all described as "positive Covid PCR test results". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Dec2021) positive.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101815362 same reporter/drug/event, different pt
headache, upper and lower back pain.  neck pain.  achy all over.  Side affects were same for Vaccination 1 and 2.  Number 2 more severe.  Weird sympton though was that I had to pee every 30 minutes starting about 12 hours after the shot and contiuing for about 10 hours.  All symptons over about 30 hours after the shots
pt recvd vax; exp inject site soreness for less than 1 day; pt discovered she was 5 days pregnant at time of vax;
I've unknowingly been having symptoms of being hyperthyroid without realizing it until I did some routine lab work.
After the injection, I experienced vertigo. I did a telemedicine with Dr. and I also saw another Dr. in her office.
My son received his second dose of the HepA vaccine 3 months too soon. Initially the doctor told us he was not due for shots. We said that's great if he gets off easy but I asked him to verify that since he said this without looking at his records. I also asked if he could tell me when his next shots would be due. He then told me "Oh actually he does need his second dose of the HepA Vaccine. I wll go let the nurse know." We were moved to the immunizations room at which time I verified my son's name, and date of birth as well as the required vaccine. He received the vaccine and we waited in the lobby to be sure there was no immediate reaction. During this time the nurse came out and told me she had made a mistake. She had not looked at his records pror to giving the vaccine and just looked after we left and saw he was not due for this one for another 3 months. As a mother, and as a general supporter of vaccies in a time when so many are choosing not to vaccinate, I am furious that something so easily avoidable happened. I can't believe both the doctor and then nurse had not actually read the dates on his 1st dose before administering the 2nd.
I broke out in large, red hives all over my arms. By the next morning the hives were also all over my upper thighs. They lasted three days. I did not get any hives on my torso.
no adverse effect; Female patient was administered improperly stored ROTATEQ; This spontaneous report as received from a medical assistant to a 8-week-old female patient. No additional information regarding patient's medical history, concomitant medications and concurrent condition was provided. On 29-NOV-2019, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral, lot # R033251, expiration date 29-JUN-2020 (dose and frequency were not reported) for prophylaxis.  Digital Data logger was involved. The vaccine was stored at the temperature that was reported as 1.9 degrees of Celsius (C), the time frame as 5 minutes. Also there were previous temperature excursions reported as: 1.8 degrees of Celsius (C) for 3 minutes and 9.7 degrees of Celsius (C) for 47 minutes. No adverse effect reported.
POWERFUL METAL TASTE IN MOUTH; HAVEN'T BEEN THE SAME; This spontaneous report received from a patient via a company representative concerned a 59 year old female. 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: 1808609 expiry: 07-SEP-2021) dose was not reported, administered on 21-MAR-2021 09:15 for prophylactic vaccination. No concomitant medications were reported. On 21-MAR-2021, the patient experienced haven't been the same. On 26-MAR-2021, the patient experienced powerful metal taste in mouth. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from powerful metal taste in mouth, and the outcome of haven't been the same was not reported. This report was non-serious.
Within several weeks of the injection I started to develop small bumps under the skin mostly on the left side of my jaw and also down the left side of the front of my neck. The bumps last for a few days and disappear. A few have turned red and get a head on them. They do itch somewhat. Then other bumps develop in the same general area. The neck in this area seems to be somewhat sensitive at times. The itching is able to be controlled with Cortisone. This has been going on since January. These have also developed occasionally around the anus. I have never had anything like this in the past.
SEVERE BACK PAIN ON LOWER LEFT SIDE AND WAS UNABLE TO MOVE OR SIT WITHOUT EXPERIENCING IT; This spontaneous report received from a patient concerned a 72 year old male. The patient's height, and weight were not reported. The patient's past medical history included sciatica. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced severe back pain on lower left side and was unable to move or sit without experiencing it. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe back pain on lower left side and was unable to move or sit without experiencing it. This report was non-serious.
Provider hospital summary "The patient is a 81 YO year old male with past medical history of multiple myeloma extensive bone metatasis s/p radiation therapy on Revlimid, HTN, HLD, Hypothyroidism who presented to Hospital ED from assisted living with complaint of fever, cough, altered mental status 2 days. Patient was recently hospitalized 10/24-11/12 due to sterptococcal septicemia with severe sepsis from his back wound. Patient completed 2 weeks ceftriaxone 2g IV daily with a complete resolution. Patient was found to be COVID +. He was admitted to the hospital for further work up with COVID and FTT. Patient and family signed Hospice paperwork, Patient will be transitioned to  Hospice service on Saturday 12/11.  " Patient expired at hospice on 12/16/2021
Patient reported that he he had flu-like symptoms after receiving the vaccine.  He stated that he had body aches and chills to the point that he was unable to get out of bed for 1 week after receiving vaccine.
Fussy, fever, crying for hours, wouldn't sleep last night. Gave Tylenol and it helped somewhat. Rapid heartbeat.
Fever 102.5 with 12hr of vaccine diarrhea within 18hr of vaccine.
Fever, chills, nausea, aching joints and body, headache, burning prickly skin