chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10/1/2014 8:15 am vaccine given, patient immediately felt severe burn, sting from vaccine. 8:00 pm legs very weak, felt like jelly. 8:30 pm legs gave way and stumbled. 10/2/2014 6:00 am Next morn unable to walk without hyper-extending knees. 2:00 pm Doctor visit with prognosis of Guillain Barre, referred to Neurologist. 10/3/2014 12:45 pm Neurology appt. 3:00 pm neurologist admitted to Medical Center for prognosis of Guillain Barre. 10/4/14 Lumbar puncture showed high protein in spinal fluid. Diagnosed with Guillain Barre and critically low magnesium level. MRI of head and neck: showed bulging disc in neck only, affecting left side of body only, dismissed. 10/5/14 IVIG started for 5 days of treatment. Released on 10/9/14. Returned to hospital ER on 10/11/14 and admitted with returning symptoms of weakness in legs, loss of sensation on right side of body, and labored breathing. 10/13/14 MRI of spine: no findings. Diagnosis: Flare up, observation only, no treatment. 10/14/14 discharged from hospital. 10/15/14 referral to physical therapy due to weakness and short endurance. Visits will be two times per week until stronger and then three times per week until goals met. Residual twitches in upper body, extreme weakness in lower extremities, unable to balance, residual numbness in right side from hips upward, then both sides residual numbness from hips down, headaches.
WATER LEAKING FROM SWOLLEN ARM; SWOLLEN ARM; ACHEY OF PRIVATE PARTS; SWELLING OF PRIVATE PARTS; This spontaneous report received from a consumer concerned a 77 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: 25-MAY-2021) dose was not reported, administered on 31-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 31-MAR-2021, the subject experienced swollen arm. On 31-MAR-2021, the subject experienced achey of private parts. On 31-MAR-2021, the subject experienced swelling of private parts. On 11-APR-2021, the subject experienced water leaking from swollen arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from swollen arm, achey of private parts, swelling of private parts, and water leaking from swollen arm. This report was non-serious.
I had a fever, chills, body aches, head ache, cough that kept me awake through out the night after I woke up from the symptoms roughly around 1 am. These persisted for roughly 18 hours and were extreme compared to any flu or cold symptoms I have had in the past.
Vomiting; Vertigo; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW01J1) via an unspecified route of administration in the left arm on 13Apr2021 at 10:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included psoriasis and sulfonamide allergy (Sulfa). Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included ustekinumab (STELARA) for unknown indication, on an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 23Mar2021 at 10:15 (at the age of 57-yeasr-old) as a single dose for COVID-19 immunisation. On 16Apr2021 at 23:30 the patient experienced vomiting and vertigo. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of reported events and included treatment with Antivert. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vomiting and vertigo was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
blood in stool; upset stomach; rash; muscle pain and aches all over body; muscle pain and aches all over body; This is a spontaneous report from a contactable consumer (patient). A 50-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 27Mar2021 10:00 (Batch/Lot number was not reported) as single dose for covid-19 immunization; acetylsalicylic acid (BABY ASPIRIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Lot unknown reason: Not available/provided to reporter at the time of report completion. Prior to vaccination, the patient was diagnosed with COVID-19. No Known allergies. No other medical history. The patient's concomitant medications included Baby Aspirin. No other vaccine in four weeks.  2 weeks after 1st vaccine on 08Apr2021 3:30 PM a rash started to appear with muscle pain and aches all over body. On 17Apr2021 started with upset stomach. On 21Apr2021 started to notice blood in stool and its been like that ever since. Adverse event started on 08Apr2021 3:30 PM. No treatment received for the events. The patient was taking the following medications; baby aspirin, tylenol, goli gummies, benadryl, melatonin, oesto plex for 3 days only. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19. Information on the lot/batch number has been requested.
FEELING DIZZY AND FELT LIKE SHE WAS DEHYDRATED AND WAS GOING TO PASS OUT.  PT'S FINGERS ON BOTH HANDS WERE RED AND PT STATED THEY WERE DIFFICULT TO BEND.  PT KEPT STATING THAT SHE FELT DEHYDRATED.  PT ALSO SAID HER HANDS FELT COLD, BUT WAS SWEATING.  PT WAS GIVEN ICE FOR HER NECK AND A COLD COMPRESS FOR HER FACE.  PT WAS DRINKING HER WATER WITH A LIQUID IV OTC HYDRATION PRODUCT.  SYMPTOMS LASTED ABOUT 15 MINUTES.  PT RETURNED TO WORK AFTER ISSUES SUBSIDED.  TOUCHED BASE WITH PT BEFORE SHE LEFT FOR THE DAY AND SHE STATED THAT SHE FELT ALOT BETTER AND DID NOT FEEL DEHYDRATED
Hoarseness; Fever 102.4; Runny nose; Not eating; Whiny.
Information has been received from a company representative who heard from her friends that a probably 15 year old female patient who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, on an unknown date the patient got very weak and depressed within several weeks of the shot. Lot number was not available. It was unknown if the patient sought medical attention. At the time of the report, the patient's status was unknown. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, recovery status, healthcare provider name and contact information. Attempts to verify the existence of an identifiable patient have been unsuccessful. No further information is available.
Numbness and tingling to right side of face began 20 minutes after vaccine. The next day had tingling in muscles of right arm and leg.
Days 1-4 - low grade fever (100.8) swollen lymph nodes and extreme sore throat and lethargic. Day 5 no fever but swollen lymph nodes and sore throat. Day 6 congestion, no taste or smell.
Sudden sensorineural hearing loss on the right ear. Symptoms started 1 week after the 2nd dose of the COVID-19 vaccine on Monday 5/17. The hearing loss was accompanied by continuous buzzing sound, static noise, sensation of ear fullness, local discomfort, headache. It progressed over the first week. On saturday 5/22, I performed an online hearing test that confirmed the hearing loss (see section 19 for results). I went to urgent care to get the ear checked and cleaned, with no noticeable improvement in symptoms. On Sunday 5/23 I was started on 30 mg predinsone po. On Monday 5/24, I went to specialist care, she increased dose to 60 mg of prednisone and order additional tests.
First day, 7th, had fever of 101.3 and was sore all over and was having hot flashes.. Next day, 8th, was a little sore and still having g hot flashes. On the 13th, I started getting the hot flashes so bad I had to keep my heat at 66. No more than that. After I would get a hot flash, it was followed by chills. That has been flip flipping until today. Two days ago, 14th, had migraine that wouldn't go away all the way until today, 16th, where I still have migraine and I still have hot flashes/ chills.
Patient administered moderna covid vaccine while temperature excursion was ongoing; Patient administered moderna covid vaccine while temperature excursion was ongoing; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Patient administered moderna covid vaccine while temperature excursion was ongoing) and POOR QUALITY PRODUCT ADMINISTERED (Patient administered moderna covid vaccine while temperature excursion was ongoing) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.    It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the Healthcare professional reiterated that because her facility was unable to download the digital data logger, they would need to treat the issue as a temperature excursion. The data logger was unable to download for the months of Dec-2021, Jan-2022, and Feb-2022. They were filling out a temperature excursion assessment at that time. It was reported that no adverse reactions were reported by any patient. Reporter confirmed that patients had administered doses while the temperature excursion assessment was ongoing.   This case was linked to MOD-2022-501575 (Patient Link).
Itchy raised patches initially like bug bites but multiple little bumps in rings of sorts. First flare up on backs of thighs and outer hips/butt, semi symmetrical. Like granuloma anulare but itchy. Lasted about a month. Then another round of it began January 26, 2022. Same presentation though this time on back of right thigh near knee, upper outer hips and waist, and low back near the spine and a few inches up the spine. Still ongoing at this time.
VOMITING; NAUSEA; DIZZINESS/LIGHT HEADEDNESS; This spontaneous report received from a health care professional concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced dizziness/light headedness. On 07-APR-2021, the subject experienced nausea. On 08-APR-2021, the subject experienced vomiting. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, dizziness/light headedness and vomiting was not reported. This report was non-serious. This case is a duplicate of 20210417771.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
5 (possibly sooner) months after my vaccines, I noticed my hair falling out in patches. After going to the dermatologist, I was diagnosed with Alopecia Areata, and autoimmune disease on May 30th 2019.  I have never ever noticed my hair falling out before, and highly believe the HPV vaccine kickstarted the autoimmune disease.
This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. No Medical History information was reported. On 13-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-May-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patients received the Moderna Covid 19 vaccine after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patients received the Moderna Covid 19 vaccine after temperature excursion) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. The reporter stated that, in her facility where she works at there had been temperature excursions with her freezer. It has been happening for weeks since April 2022. The storage condition at the time of the excursion was frozen. The vial with lot number affected were 065K21A and 045L21A. The maximum or minimum temperatures reached were as follows maximum 30 Fahrenheit Degrees and minimum 18.9 Fahrenheit Degrees. The vaccines suffered 2 temperature excursions since April, both lasted less than 1 minute. The reporter does not have the information on date vial(s) moved from freezer to refrigerator. The vials currently stored in frozen state. On visual inspection no changes were observed in any vaccine state. The Proposed desired Use by Date was not reported. No treatment medications were reported. This case was linked to MOD-2022-591989 (Patient Link).
RASH AT INJECTION SITE, DOWN LEFT FOREARM STEROID INJECTION TO HELP WITH RASH AND ITCHING
I developed cellulitis at the injection site approximately 1 week after receiving the vaccination.  The arm became red, swollen, itchy and warm to the touch.  Symptoms began on Saturday evening and have gotten progressively worse.  It is now Monday morning and I'm continuing to monitor the symptoms.
Flublok being administered to pediatric patients with no reported adverse event; Initial information received  on 10-Oct-2022 regarding an unsolicited valid non-serious case received from a other health care professional.  This case is linked to cases 2022SA420021, 2022SA419213, 2022SA418226, 2022SA419186 and 2022SA420094.  This case involves a 9 years old male patient and health professional reported flublok being administered to pediatric patients with no reported adverse event. (Influenza quadrivalent recombinant vaccine) [Flublok]   The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On 10-Oct-2022, the pediatric patient received a 0.5 ml dose of suspect Influenza quadrivalent recombinant vaccine (with unknown strength and formulation) (lot: QFAA223, expiration date: 30-Jun-2023) via intramuscular route in the left deltoid for Influenza Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the guidelines. 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.
Allergic reaction with localized swelling and inflammation left arm.  Arthralgia's multiple including both shoulders, neck, hips, ankles, wrists and fingers.  Fatigue and general malaise.
extremely sick from shingles shots; This case was reported by a consumer and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of illness (received 1st dose on an unknown date, for tolerance refer case US2021AMR230973).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was unknown.   The reporter considered the sickness to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received 2nd dose of Shingles vaccine and got extremely sick from the shingles vaccine but he/she was glad to received them. The case was linked with case US2021AMR230973, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR230973:1st dose, same reporter
Full blown migraine for 5 days, extremely dizzy, fever of 104 for 4 days
rt/leg swelling. Patient presents with lateral right leg swelling, numbness, and tingling that travels up to hip x 8 hours. Also reporting L foot tingling. COVAX dose 1 yesterday. Denies fever, cough, N/V/D, sick contacts, or injury/trauma, clotting disorder.  History:  pt had 1st dose of Moderna vaccine yesterday and did some BLE work-out today and since morning pt has noticed intermittent right lower leg tingling that became more pronounced this afternoon, with sensation of swelling of right lower leg and upper leg and tingling in whole leg, except foot, but later says pt also has tingling in sole of right foot pt thinks.  Pt also just noticed some tingling in left sole.  Denies back pain, leg pain, recent travel,
Pt recvd 3 Hepatitis B doses on 3AUG89, 31AUG89, & 23JAN90 following these titer was neg;
*injection site pain and stiffness *persistent headache *muscle and joint pain and stiffness *(3) hours of chills and shivering that started 10 hours after injection *fatigue -all symptoms resolved 36 hours after injection
31JUL92 recvd 1st dose of Engerix-B & 4AUG92 devel nausea, vomiting, diarrhea, myalgia & chills; treated w/rest & APAP;
administration after temperature August excursion; administration after temperature August excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature August excursion) and POOR QUALITY PRODUCT ADMINISTERED (administration after temperature August excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature August excursion) and POOR QUALITY PRODUCT ADMINISTERED (administration after temperature August excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (administration after temperature August excursion) and POOR QUALITY PRODUCT ADMINISTERED (administration after temperature August excursion) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The minimum temperature reached in this excursion was -14 °F. The maximum temperature reached in this excursion was 23 °F. The duration of the excursion was 365 Days. Treatment medication was not reported.  Basically the provider never downloaded their reports and only looked at the temperatures once a day. This starts in December 2020 and had gone on until now. They have a new now and kept their frozen vaccine in the freezer of their fridge/freezer combo unit and only stored in the fridge the day they used the vials.
Headache, Arthralgia, Fever, CoughWheeze, fatigue, injection site pain, chills, runny nose, lymph node swelling
PATIENT STATED THAT AFTER LEAVING HERE ON 04/03/2018 SHE BEGAN TO ITCH ALL OVER HER BODY AND FELT LIKE HER THROAT WAS CLOSING UP. THE REACTION WAS SO SEVERE THAT SHE CALLED 9-1-1.  SHE SAID THE PARAMEDICS GAVE HER BENADRYL AND AFTER A WHILE SHE WAS OK.
Patient had no unexpected adverse effects. Only experienced sore arm from injection in the 24-48 hours following injection. Felt slightly achey and feverish with no elevated temp documented.
Complaint of shortness of breath/difficulty breathing, cough, chills, elevated temperature (max 103), sore/scratchy throat, headache, runny nose/congestion, loss of taste/smell, myalgia, and malaise.
The patient is an unaccompanied minor and received a first dose Pfizer Covid-19 immunization on route 9/12/2021.  There was no vaccine record accompanying the child. Upon arrival the child shared he had received vaccines prior, but thought he had "measle and chickenpox vaccines". Even with the aid of an interpreter he did not mention Covid or polio.   MMR, Varicella and Covid vaccines are required to be administered within 48 hours of arrival.  Child arrived on 9/22/2021 and was vaccinated (with all catchup ACIP vaccines including Covida and Polio) on 9/24/2021 (12 days after 1st Covid dose) less than the 21 day requirement for Covid 2nd doses. We are adhering to the CDC Deviations and Errors guidelines and will not administer a 2nd dose. The child had MMR/Varicella /Polio/Covid on 9/12/2021 and the vaccination record was not received until 10/13/2021.  No MMR or Varicella were given on 2/24/2021 as we had been informed that MMR/Varicella had been administered.   No adverse reactions at this time.
Pt developed a lump in right where shot was given immediately after receiving shot. Also pt bleed a lot after receiving shot but stated he was on a blood thinner but not sure the name of it and that he did not get the blood thinner at our facility.
Patient received booster Covid 19 vaccine 3/11 and on 3/12 experienced muscle aches and chills.  Starting 3/13 in morning, patient noticed arm pain and lymph node swelling on the left arm.  3/14 patient still complains of tenderness under the arm. Pt took over the counter motrin for discomfort
BODY ACHES; FEELING LOW; HEADACHE; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, feeling low, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from headache, body aches, and feeling low. This report was non-serious.