chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hearing loss; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 25-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequent to the inoculation (date not reported), the patient was treated by a physician for hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; 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 include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event hearing loss was not recovered. The causality assessment was considered as related by the lawyer.  Upon internal review, hearing loss was determined to be medically significant.
In late March 2023, I was feeling "off" for a few days and called the doctor. I was feeling disoriented and thought I was having blood sugar issues. I began to feel really out of it and I went to the emergency department at 2:30AM. I tested positive for COVID-19. I got a prescription for PAXLOVID. I began taking it on Saturday and it began to help. I felt better in about 3 days. I had a severe sore throat that lasted for about 2 days. Several days later, March 29, 2023, I tested negative but then had a rebound case. I tested positive again on April 2, 2023.
Pain in joints and muscles, fatigue, headache, nauseau, fever 101.2, congestion, body aches, chills first 48 hrs. 48 hours after getting the injection i got hives and real bad congestion with headache.  I cake my physician and they have told me to take Claritin and benedryl
Information has been received from a health professional concerning an 11 month old male, with no reported medical history, who on 06/12/2006 was vaccinated with a third dose of hepatitis B virus vaccine rHBsAg (yeast) (thimerosal free). Concomitant vaccine administered on the same day included a fourth dose of diphtheria toxoid(+) Hib conj vaccine (tet toxoid) (+) pertussis acellular 5-component vaccine (+) poliovirus vaccine inactivated (Vero) (+) tetanus Toxoid (Pediacel). At the evening after vaccination he developed some fever. The next days the fever increased until 40c during 2 days. The third day the temperature creased and he developed exanthema on his trunk and back. The general practitioner gave antihistamine, but it was noted that it did not help. Five days after vaccination he was admitted to the hospital because of possible dehydration. No further hospital details were known. Locally, a 10 cm large red swelling was visible, which was painful upon touching. After one week he was recovered. It was thought that he might have suffered from a gastrointestinal disorder. The case is closed. Other business partner numbers include: E2006-03104 and 200600562.
This spontaneous report as received from a nurse practitioner refers to an unspecified number of patients. On unknown dates the patients were vaccinated with dose of RECOMBIVAX HB (lot #, expiration date and dose unspecified) that were exposed to 8/5 degree centigrade to 12 degree centigrade for 158.5 hours, which was an excursion that was not supported by in-house stability data. No adverse effect reported. This is one of several reports received from same source. Additional information has been requested.
I received the vaccine 2/16 at 9:45 am. I woke up at 12:00 am on 2/17 with the chills and a fever. I took Advil and was able to go back to sleep. I began getting the chills again around 10 am and 4 pm  and took more Advil which helped.  I was tired and slept for most of the day on 2/17.  I woke up around 5pm and began experiencing stomach aches which was accompanied with some diarrhea.
Complete loss of hearing in left ear.  Saw PA at 10:30 that a.m. who sent me to Specialist at 1:30 same day who initiated Prednisone treatment 9-day course.
Chills on the night of the vaccination, followed the next day by flu-like symptoms of muscle and joint aches, flushed face, and lethargy accompanied by large red spot on left underarm.  By the morning of the 3rd day, the redness had spread to a 6" x 5" area with tenderness.  I went to the clinic and was told by the nurse that it was cellulitis and to try hot and cold packs to stimulate circulation of the blood to flush out the inflammation.  By bedtime that night the redness with swelling had become 14" long x 5" wide, covering an area from the armpit past the elbow onto the lower arm.  Finally, on the 4th day the redness began to dissipate, eventually disappearing four days later.    When given the vaccination I asked the administering nurse whether or not to expect any side effects.  He said, "Oh, no.  It's not like those flu vaccines."  This was a revaccination for me and I was later told by the Advice Nurse at the clinic that about 20% of patients have this cellulitis allergic reaction!
patient's left arm started to get tingly and she was dizzy 15 minutes after shot. another 20 minutes and the tingly turned painful and included the left ear
Localized rxn with redness, warmth and swelling (about the size of golf ball).  We never saw rxn.  Spoke to mom on phone.  Instructed her to do warm compresses and call in 2 days if not better.  She hasn't called back.
Woke up this morning with fevers, headache, body aches, nausea, general weakness and fatigue.
large swollen, hot, red area on arm. Ran fever since 9/9/2020
I got the first Moderna Covid  vaccine on 03/18/2021 and 7 days later I was in the hospital with my first attack of AFib. and was inpatient for several days.  On  04/19/2021 I had my second Moderna Covid vaccine and  exactly 7 days later I had my second attack of AFib. and was again in the hospital and had to have my heart shocked twice.  I had never had a heart problem before taking the Covid vaccine.
Patient received H1N1 nasal mist vaccine on 10/26/09. On 11/5/09, pt. hospitalized for 1 week history of fever, abdominal pain diarrhea and vomiting. Appendicitis was ruled out, pt. discharged 11/7/09 - The same day 11/7, pt developed purpuric rash with bloody stools; readmitted to hospital with presumed diagnosis of HSP (vasculitis). Discharged home = 11/10/09. 12/07/09 DC summary and hospital records received for DOS 11/05/09-11/10/09.  Pt. presented intially with abdominal pain, diarrhea, vomiting. Appendicitis ruled out by surgery and discharged home with presumptive diagnosis of HSP.  Later developed purpuric rash on buttocks, thighs ears, neck and feet bilaterally and grossly grossly bloody stools. Readmitted, treated with prednisone which helped abd. pain. GI consult obtained. Stools became negative for blood.  DC home to f/u with PCP.
Arexvy administered to 57 y.o. Not indicated until age 60.  No known outcomes or adverse effect
I had a severe headache for several hours, a fever of 100.8 at the highest, chills and tired for several days.
5-year-old child received adult dose of Pfizer (batch/lot# FL3197) as first dose.
7 days following the injection - injection site began to itch, become painful, swell, red  at site and a hard lump began to form
Developed itchy, red spots on 12/02/2003.  No known exposure to chicken pox.  Confirmed diagnosis of chicken pox by MD on 12/04/2003.
Hot red swollen cellutltis upper arm. Itchy. Spreading in arm. Given at pharmacy, went to see my physician the next day.
Covid-19 breakthrough cases and that all but one of those patients who were hospitalized had received the Pfizer vaccine. Only one had received Moderna; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Covid-19 breakthrough cases and that all but one of those patients who were hospitalized had received the Pfizer vaccine. Only one had received Moderna) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid-19 breakthrough cases and that all but one of those patients who were hospitalized had received the Pfizer vaccine. Only one had received Moderna) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Covid-19 breakthrough cases and that all but one of those patients who were hospitalized had received the Pfizer vaccine. Only one had received Moderna) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who was hospitalized due to the unexpected, serious adverse event of special interest of COVID-19, after receiving a dose of mRNA-1273 vaccine. Exact date of vaccination, onset date of the event, clinical course, diagnostic tests and treatment details were not provided in the case. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
After the second vaccination in the right arm on 2/4/2021, the site of the first vaccination in the left arm on 1/14/2021, bagan to hurt, and has continued to hurt.
24 hours after vaccine pt became fatigued, febrile, nauseated, had vomiting and vertigo along with muscle aches. Was admitted to hospital on 10/30 and received IV fluids and empiric antibiotics of ceftriaxone IV 1g/50mL every 12 hours. On 10/30 pt started having ringing in right ear and congestion. 10/31 - hard of hearing bilateral ears. Started on FLONASE and CLARITIN. 11/1 pt just now able to tolerate sitting up on edge of bed and 1 short walk of about 25 ft.
pharmacist "ramped" it into her arm, that made her scream; having pain at the injection site; cannot play her piano or do any house work; scream.; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th October 2020, the patient received the 1st dose of Shingrix. On 12th October 2020, unknown after receiving Shingrix, the patient experienced wrong injection technique. In October 2020, the patient experienced injection site pain, activities of daily living impaired and screaming. The patient was treated with hydrocodone and paracetamol (Acetaminophen). On an unknown date, the outcome of the injection site pain, activities of daily living impaired, screaming and wrong injection technique were unknown.   It was unknown if the reporter considered the injection site pain, activities of daily living impaired and screaming to be related to Shingrix.  Additional details were provided as follows: The patient received the first dose of the Shingrix vaccine in her left arm and she stated the pharmacist ramped it into her arm, that made her scream. Since then the patient experienced pain at the injection site and was taking hydrocodone and acetaminiphen to control the pain.  The patient could not play her piano or not able to do any house work.  The patient would be seing the doctor on 2nd November 2020. The reporter did not consent to follow-up.
Loss of taste in the left side of the mouth; Shakiness only the left side; Fast heartbeat; Shortness of Breath; Weakness; Lungs felt heavy; Pain in the lungs; Headache; Join pain; Body Ache; Nausea; This spontaneous case was reported by a dental assistant and describes the occurrence of AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath) and ASTHENIA (Weakness) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath), ASTHENIA (Weakness), PULMONARY FUNCTION TEST (Lungs felt heavy), PULMONARY PAIN (Pain in the lungs), HEADACHE (Headache), ARTHRALGIA (Join pain), MYALGIA (Body Ache) and NAUSEA (Nausea). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, AGEUSIA (Loss of taste in the left side of the mouth), TREMOR (Shakiness only the left side), HEART RATE INCREASED (Fast heartbeat), DYSPNOEA (Shortness of Breath), ASTHENIA (Weakness), PULMONARY FUNCTION TEST (Lungs felt heavy), PULMONARY PAIN (Pain in the lungs), HEADACHE (Headache), ARTHRALGIA (Join pain), MYALGIA (Body Ache) and NAUSEA (Nausea) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
RED AND ITCHY SPOTS ON BODY/ARMS/LEG/FACE/BUTTOCKS; MORE AND MORE STAINS EVERYDAY; This spontaneous report received from a patient 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, and batch number were not reported) dose was not reported, administered on 11-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On NOV-2021, the patient experienced more and more stains everyday. On 12-NOV-2021, the patient experienced red and itchy spots on body/arms/leg/face/buttocks. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from red and itchy spots on body/arms/leg/face/buttocks, and more and more stains everyday. This report was non-serious.
This patient reported swelling, itching, and pain at and around the injection site.  She sought evaluation at the ER due to the late hour of onset of symptoms.  She presented at the pharmacy late 9/8 to inform us of the event, and she exhibited an area of redness and swelling approximately 5" in diameter on her left arm, extending from the center of the deltoid.
Information has been received from a 55 year old female consumer with a history of colon cancer and an immunocompromised status, who on an unspecified date was vaccinated with the second dose of pneumococcal 23v polysaccharide vaccine. Subsequently, the patient experienced swelling in her arm. It was unknown whether medical attention was sought. Subsequently, the patient recovered from swelling in her arm. No product quality complaint was involved. Additional information is requested.
Defective retractable syringe. Syringe retracted before dose was fully administered and over half of the dose did not make it into the patient's arm. Administered another full dose to the patient with no issue.
This spontaneous report was received from a Medical Assistant regarding unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On an unknown date, the patient was vaccinated with improperly stored (Oka/Merck) VARIVAX (dose strength, route and lot number was unknown). No concomitant medication was reported. No adverse event was reported. The outcome of the event was unknown. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Red, inflamed area measuring 50 mm in length and 30 mm in width. The site is warm to touch. No c/o of pain in the site.
Hives began about two weeks after a 11-22-21 Pfizer booster which was shot #3.  Hives continue to now in July 2022.  I have never before had hives.  First Pfizer vaccines on 4-1-21 and 4-22-21 did not produce adverse reactions.  Hives began as slightly raised skin rashes on buttocks and lower stomach.  In subsequent weeks, they involved trunk and legs.  About six weeks after the #3 booster, rashes increased, and soon tongue, lips, chin, cheeks began to swell, but no redness.  This continued in about 5 to 7 day cycles.  On 4-2-22, acute swelling of tongue and air passages in early morning hours woke me.  I could not swallow.  Air passages were slowly constricting.  I went to emergency.  Hives recently [cont. at #19]
~72 hours after vaccination I started feeling general body aches, tiredness & weakness. & headache which got worse into the evening. Peak temperature was 100.7 F. Overnight experienced alternating chills & hotness, dizziness increasing headache, weakness & body aches almost to the point of delirium. Symptoms started subsiding during today.
Multiple pulmonary embolisms in bilateral lungs with lung infart, superficial blood clot in the right groin area, significant right abdominal pain, shortness of breath, low oxygen saturation levels admitted 3 days in the hospital. 36 hours of Lovanox  injections followed by transition to Eliquis 10 mg twice per day, respiratory exercises, oxycodone given for pain Pain has diminished in lower right lung area, clotting appears to be under control
Second vaccination was on Wednesday April 14 at 12:34. The following morning at 5:00am I began to have extreme chills, muscle pain all day. When I would get warm from the chills then I would get overheated. This was on Thursday. Thursday night I sweated so bad that I went through four t-shirts and 4 pillow cases. This morning (Friday) the muscle pain has gone as has the chills. I woke up congested, still getting got easily and extremely tired.
Pt. states that after receiving the 3rd dose of Phizer 12/16/2021, started experiencing symptoms shortly after of dizziness (Vertigo). Periodically throughout the day x 3. No noted Primary visit/communications. Pt. still experiencing symptoms.
Around 7:00 AM he became despondent, crying inconsolably.  This has never happened in his life.
Headache, Myalgia, Arthralgia, Fever, Fatigue, Chills Narrative:  Other Relevant History:
Burning upon injection; pain and swelling times 12 days;  01/04/2021-large red and swollen hive type appearance around injection site, approximately 4" long x 3" wide and warm to touch, palpation is hard to touch
Started developing rash on 2/1/14. Rash got worse on 2/2/14 so mother brought child to be evaluated - diagnosed with erythema multiforme. Advised to stop use of amoxicillin (which had been prescribed on 1/27/14).  Unsure if rash due to amoxicillin, underlying viral/bacterial infection or due to varicella vaccine that was administered on 1/20/14.
Strong tingling that traveled up my leg on the side of my body that I received the shot. Later tingling up my arm started. This continued for several days, then calmed down. I then felt mild tingling for about six weeks before it disappeared.
Kidney stone; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney stone) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Kidney stones (She's gotten a kidney stone after taking a medication a long time ago. After she stopped taking the medication, the kidney stone went away.).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (Kidney stone) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (Kidney stone) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was reported as acidity medication. Treatment information was not provided.  Patient reported that she had gotten a kidney stone after taking a medication a long time ago. After she stopped taking the medication, the kidney stone went away. They said it was because of the acidity of the medication. They did not confirm that the kidney stones was from the Moderna COVID19 Vaccine.  This spontaneous case concerns a 54-year-old female patient with a relevant medical history of Nephrolithiasis, who experienced the unexpected serious (medically significant) event of Nephrolithiasis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the first dose of mRNA- 1273 vaccine. Very limited information was provided regarding clinical course and treatment. The rechallenge is not applicable, since it is unknown if the event had resolved prior to the second dose. Previous episode of nephrolithiasis remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.   This case was linked to MOD-2021-396187 (Patient Link).; Sender's Comments: This spontaneous case concerns a 54-year-old female patient with a relevant medical history of Nephrolithiasis, who experienced the unexpected serious (medically significant) event of Nephrolithiasis after mRNA- 1273 Moderna vaccine. The event occurred at an unknown date after the first dose of mRNA- 1273 vaccine. Very limited information was provided regarding clinical course and treatment. The rechallenge is not applicable, since it is unknown if the event had resolved prior to the second dose. Previous episode of nephrolithiasis remains a confounder. The benefit-risk relationship of mRNA- 1273 vaccine is not affected by this report.
Patient received 1st dose Moderna covid vaccine at 1343 and monitored for 15 minutes At approx 1402 patient c/o dizziness, HA, chest tightness & feeling as she was going to pass out Patient started hyperventilating & her eyes rolled back. Code Blue called & she was lowered to the floor, difficult to arouse, following simple commands & breathing/had pulse. Was jerking, Code team arrived, placed on NRB & IV placed for IVF, transported to ED via stretcher.   States also got fatigued after vaccine