chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fell sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the flu vaccine and experienced fell sick. This case has been linked with same patient cases US2020AMR223839 and US2020AMR223838 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR223839:same patiente US-GLAXOSMITHKLINE-US2020AMR223838:same patiente
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On an unknown date in 2014, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On an unknown date in 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Moderna COVID-19 Vaccine EUA. 01/21/21: Patient called to report adverse side effects following receipt of Moderna COVID-19 vaccine on January 13, 2021, 15:15. 01/18/21, evening: Patient reported left under arm pain ("armpit"), and lymph node pain. 01/20/21: Pain continued of the left underarm, vaccination site redness , inflammation, itchy hives and skin hot to touch (vaccination site). 01/21/21: late am-early pm, symptoms continued (01/18, and 01/20/21), and patient noted shooting pain down the left arm and called to report and seek further guidance. Patient advised to call primary care physician for evaluation, and use cool compress 10-15 minutes per hour (vaccination site on the arm).  01/22/21: called patient to obtain follow-up information and status of vaccine side effects. Patient went to Urgent Care on 1/21/21, pm, prescribed Zyrtec, Ibuprofen, and use ice at vaccine site.  Return if symptoms worsen. Patient reported redness and itching have decreased, still has pain under the arm and skin is hot to touch. No additional side effects or adverse events reported. Patient also shared that she has experienced similar symptoms following bee stings.
Narrative: Patient received 1st covid moderna vaccine on 3/19/21 and 2nd dose on 4/16. Patient was found deceased at his home by local PD on 4/28/21. Cause of death has not been determined, no further details available at this time regarding how patient was found. Patient reported no side effects after 1st or 2nd dose of the vaccine. No prior history of COVID infection. Pt has a history of non-ischemic cardiomyopathy, atrial flutter/atrial fibrillation with cardioversion 7/12/2019@hospital, hypertension, OSA using CPAP, GERD, peripheral neuropathy, orthostatic hypotension, prior right DVT, hyperlipidemia, diabetes mellitus, CK-MB stage III and osteomyelitis with multiple amputations wheelchair-bound.
A report has been received from a Health Professional concerning a 10 year old, male subject, who had been receiving FLUMIST (INTRANASAL). FLUMIST (INTRANASAL) started on 30-Dec-2013. It was reported that the patient had been administration expired product on 30-Dec-2013. The outcome of the event of ADMINISTRATION OF EXPIRED PRODUCT is unknown. The report was considered to be non-serious.
Vaccinated 10/28/2021, 3/12/2021, 2/12/2021. Hospitalized with COVID 1/8/22
Information has been received from a physician concerning a 20 year old female with a penicillin allergy and no other reported health history who on 21-DEC-2006 was vaccinated with a first dose of Gardasil (lot # 654389/0961F) (0.5 ml), intramuscularly. Concomitant therapy included birth control pills. Subsequently, she had experienced severe pain in the arm since the vaccination. She was unable to raise her arm more than a 45 degree angle. She had been seen by her family physician who diagnosed her with "Frozen Arm Syndrome". it was reported that she would be seen by an orthopedic surgeon in a few days. It was noted that the patient is "thin build, weighed 119 pounds and was five feet six inches tall. It was noted that there was no previous injury to area or to arm. Unspecified medical attention was sought. At the time of the report, the patient was considered to be not recovered. The patient's experiences were considered to be disabling. Additional information has been requested.
This spontaneous report as received from a healthcare professional refers to unspecified patients of unknown age and gender. The patients' medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with a doses of improperly stored PROQUAD (Merck) (lot #, expiration date, dose and route were not reported). No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected due to no consent to contact Health Care Professional was given.
PT EXP PAIN AND STINGING AT SOI AFTER RECEIPT OF ENGERIX-B.  TREATMENT:  PT COUNSELING.  DOSE #2 PT EXP SIMILAR PAIN AT SOI.
I noticed that after receiving the vaccine, I started getting migraines daily. They have become so severe that my blood pressure was at level 1 hypertension. My menstrual cycles were significantly worse. Consistent headaches that lasted for weeks. I went to urgent care due to a nose bleed that would not stop due to my elevated blood pressure. I still suffer from headaches a year later. I have never had sever headaches like these. Its ongoing like daily. I do cocktails of OTC meds and I was prescribed Sumatriptan. This helps with the issue but the issue is unresolved. My work is affected but my supervisor is aware of the situation and makes accommodations when the headaches are to much to handle. Urgent care took vitals and completed a CAT scan. I was given some medication via IV.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with improperly stored dose of ZOSTAVAX, lot # L015416, expiration date 01-AUG-2016 (dose, route of administration and indication were not reported). Concomitant therapy was not provided. No adverse effects were reported. Additional information has been requested.
redness on left arm; swelling of left arm; hives on left arm; my arm feels like it is on fire; headache; pain at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (she has had 12 to 18 outbreaks of shingles before receiving the Shingrix vaccine). Previously administered products included Zostavax (received Zostavax in 2012). Concurrent medical conditions included cyst (had a cyst on her back may be before the Shingles vaccine was unresolved) and pain (had cyst sore was unresolved). Concomitant products included paracetamol (Tylenol).   On 8th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 8th July 2021, 2 hrs after receiving Shingrix, the patient experienced injection site pain, erythema of extremities, swelling arm, headache, hives and burning sensation. On an unknown date, the outcome of the injection site pain, swelling arm and headache were recovered/resolved and the outcome of the erythema of extremities, hives and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, erythema of extremities, swelling arm, headache, hives and burning sensation to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient for herself. The patient also had the Zostavax vaccine in 2012.  The patient has had 12  to 18 outbreaks of shingles before receiving the Shingrix vaccine on 8th July 2021.  The patient has a cyst on her back, she did not know when the cyst started, it may be before the Shingles vaccine on , the cyst was sore and unresolved. The patient was going to the doctor at the time of reporting for treatment for the cyst.  The took a Tylenol 2 hours before receiving her Shingles vaccine in her left deltoid. The patient received Shingrix vaccine and within 2 hours after the vaccine she experienced pain at the injection site (resolved after 5 days), redness on left arm (unresolved), swelling of left arm (unresolved),headache (resolved after 4 days), hives on left arm (unresolved), her arm felt like it was on fire (burning sensation left arm, unresolved). The patient consented to follow up with her doctor. The case had been linked with US2021151565, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021151565:same reporter
Information has been received from a physician concerning a 13 year old female with no relevant medical history or allergies who on 12-APR-2007 was vaccinated with a first dose of GARDASIL (lot number 1926F) (injection site and route not reported). On 12-JUN-2007 the patient was vaccinated with a second dose of GARDASIL (lot number 655324/0089U) (injection site and route not reported). On 12-OCT-2007 the patient was vaccinated with a third dose of GARDASIL (lot number 658222/0927U) (injection site and route not reported). On 16-JUL-2008, the patient was vaccinated with a fourth 0.5 ml dose of GARDASIL (lot number 0063A) intramuscularly (injection site not reported). Secondary suspect therapy included a dose of VARIVAX (Oka/Merck) (lot number, injection site and route not reported). On 17-JUL-2008 the patient experienced numbness, soreness and pain at the injection site. There is no redness or induration. The patient went to see the physician. The patient's events persisted. Additional information has been requested.
Patient presented to HD on 10/25/10 & reports that 2-3 days ago her left upper arm felt feverish. RN noted area of erythema with puss-filled center, similar looking as a pimple. Patient also had an area on the left side of her forehead, left side of neck & right jawline that had pimple-like sores. Patient c/o neck itching.
Pt with c/o itching to her upper back s/p 3rd Pfizer vaccine. Pt noted to have a 2 inch raised, red rash to the upper, middle back and pt had been scratching the area since her vaccine. Pt was able to ambulate to monitoring area and did receive Zyrtec 10m po with some relief of her itching. After monitoring x30 mins pt's overall symptoms resolving and she was able to ambulate out of the Covid Vaccine Clinic with her children, and husband to drive pt home.
Tinnintus. Increase over usual tinnitus, beginning about 28 hours after injection, continuing. No treatment sought.
Arm weakness, back ache, lethargy, myalgias, arm redness and swelling.
Vomiting; Diarrhea; Fever; Night sweats; Severe weakness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 24Sep2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included lupus, degenerative disc disease, fibromyalgia, post-traumatic stress disorder (PTSD) and anxiety. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the right arm on 03Sep2021 at 12:30 (at the age of 33-years-old) as a single dose for COVID-19 immunisation and received bupropion hydrochloride (WELLBUTRIN), metoclopramide (REGLAN) and prochlorperazine maleate (COMPAZINE); all for unknown indication on unknown date and experienced drug allergy. On 25Sep2021 at 14:00, the patient experienced vomiting, diarrhea, fever, night sweats and severe weakness. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vomiting, diarrhea, fever, night sweats and severe weakness was resolving at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Patient came in on 02/03/21 for her COVID vaccine. When she was questioned about which arm she wanted it administered in, she stated she wanted it in her right arm as she still experiences soreness in her left arm due to her second Shingrix vaccine administered over a year ago. She stated it doesn't hurt all the time, but if she "bumps it or lifts her arm above her head," it is somewhat tender. She is a retired pharmacist, and she stated she did some research on her own. She stated she thought the needle may have caused a bursitis like condition. The patient is incredibly thin and thought maybe the needle went too far.
Felt really bad after the third one; adverse reaction; Felt like hit by a truck; extremely bad flu; trouble getting out of bed; 99.8 fever - running a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt really bad after the third one), VACCINATION COMPLICATION (adverse reaction), FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (extremely bad flu) and BEDRIDDEN (trouble getting out of bed) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002F21A., 029K20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Lung cancer (Patient reported she has hardly any lungs.Never had chemo, no radiation.) in 2009 and Lung cancer (Patient reported she has hardly any lungs. Never had chemo, no radiation.) in 2012. Concomitant products included DENOSUMAB (PROLIA) and OMEPRAZOLE for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt really bad after the third one), VACCINATION COMPLICATION (adverse reaction), FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (extremely bad flu), BEDRIDDEN (trouble getting out of bed) and PYREXIA (99.8 fever - running a low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Felt really bad after the third one), VACCINATION COMPLICATION (adverse reaction), FEELING ABNORMAL (Felt like hit by a truck), INFLUENZA (extremely bad flu), BEDRIDDEN (trouble getting out of bed) and PYREXIA (99.8 fever - running a low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.8 (High) 99.8 fever.         It was reported that patient did not take antibody test before third shot.  The adverse reaction that she had in her my mind was because  she had antibodies and it was fighting it.   This case was linked to MOD-2021-359456 (Patient Link).
This spontaneous report as received from a nurse refers to a 7 months 28 days old male patient. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours), oral, ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
17JAN93 c/o mild pruritus arms & trunk; no rash; afebrile; 18JAN93 pruritus worse but over same areas; seen by MD dx dry skin, pruritis w/no rash; given Eucerin lotion & DPH; 21JAN93 devel rash over arms & trunk; afebrile; dx allergic derm
11/14/2021 Driving and all of a sudden, I felt like my ears were blocked and I could not clear them. I thought I had wax and so I used Debrox. It did not clear it. I had ringing in the ears and was lightheaded. I went to the doctor 11/23/2021 and he flushed my ears and they were clear. A week later they were not any better. I used Flonase and decongestants to see if that would clear the feeling of fullness. After this, my doctor tried low dose of prednisone, no change. I made an appointment with an ENT Dr. locally, and they did a hearing test. My left ear was mild to moderate hearing loss. My right ear was moderate to severe. He put me on high doses of prednisone for 2 weeks and did an MRI. I still had no change in hearing loss or other symptoms. He said there was nothing more he could do. He referred me to another doctor and he agreed there was nothing more to do without doing any tests. It is very distracting and even effects my emotions. I was not ready to give up. I made an appointment with a different ENT on 4/18/2022. 4/20/22 She did a steroid injection directly into no right ear. As of today, there is no change, maybe even worse.
After receiving SHINGRIX vaccines on 2/19/18 and 5/23/18, he developed patchy erythematous, itchy, urticarial rash on chest and arms. After the first immunization, the rash lasted for several weeks, then gradually resolved. The rash reappeared within a day of receiving second vaccine in the series. No accompanying systemic symptoms, including no respiratory symptoms, angioedema, faintness or GI symptoms.
Patient called doctor on 1/21/22 and stated that when looking at her account she noticed her second dose of the Moderna covid vaccine given on 1/20/22 was the 50 mcg dose. Patient thought both doses 1 and 2 were supposed to be 100 mcg. RN called to urgent care to verify, and it was found that patient was correct, she should have been given 100 mcg dose. Patient was made aware that error occurred.
Shingles:  Mild case Onset - 06 April 2021 Medication given:  Famciclovir 500mg Tablets - 1 tab 3 times each day by mouth for 10 days Resolved 14 April 2021
Pt developed a local reaction after vaccination. Additional information has been requested. pt was being treated with hydrochlorothiazide and other drugs and developed discoloration on her teeth.
06052009@9:16am MOC t.c. c/o mild dizziness 1 hours post vaccinations then severed ha, lbp and dizziness with falling this morning on ambulation.  had previous HPV vaccinations w/o issue, suspect menactra but referred to pmd for evaluation of any possible underlying medical conditions prior to this conclusion for patient safety and care.  MOC stated verbal understanding of instruction and will call pmd immediately.  per MOC pt is not suffering any breathing or chest pain currently but is aware to take to ER immediately if it occurs, MOC stated verbal understanding.
EXTREME ABDOMINAL PAIN; VOMIT SEVERAL TIMES; 12 HOURS OF DISTRESS; NAUSEA; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included menopause. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 29-APR-2021, the subject experienced extreme abdominal pain. On 29-APR-2021, the subject experienced vomit several times. On 29-APR-2021, the subject experienced 12 hours of distress. On 29-APR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nausea, extreme abdominal pain, vomit several times and 12 hours of distress was not reported. This report was non-serious.
Severe spinning, nausea, vomiting, occurred at 2:15 a.m. while on duty, was transported to ER and diagnosed with Peripheral Vertigo. Follow ups with ENT, Neuro and PCP have continued with Vestibular Rehabilitation. While in ER, the MRI, MRA, CT, CT with Contrast was done, showed no signs of anything that could have caused this. Ironically tracking back, I received my 2nd Dose of the Pfyzer Vaccine on January 6, 2021 at 8:45 a.m. and this occurred on February 13th at 2:15 a.m. I have not had any other issues before this nor any signs of damage to the nerve or ear that regularly affects Vertigo Patients per my Neuro and ENT. The incident took place 4 weeks and 2 days after the 2nd vaccine. 2 days after the 2nd dose, I experienced Low grade fever, chills, and body aches that lasted only 12 hours, but nothing with the 1st vaccine nor anything after the 2nd dose issue until the Vertigo.  I am unable to drive, conduct my job, which requires me to go to emergency calls and carry a Taser (CEW). I have been off work since this occurred and still not eligible to go back to work.