chrisvoncsefalvay/vaers-outcomes huggingface dataset:
breaking out in Hives/ hivescontinued to return/outbreaks in new locations; Sleeping difficulty; This case was reported by a consumer via call center representative and described the occurrence of hives in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 2022, 3 days after receiving Shingrix, the patient experienced hives. In July 2022, the patient experienced difficulty sleeping. The patient was treated with azithromycin (Z-Pak), prednisone, benadryl (nos) (Benadryl) and steroids nos (Steroids). On an unknown date, the outcome of the hives and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the hives and difficulty sleeping to be related to Shingrix.   Additional Information: GSK Receipt Date: 15-JUL-2022 Reporter's Comment: The case was reported by the patient and a nurse. The patient reported breaking out in hives shortly after receiving Shingrix.  The patient reported that, hives had continued to return, despite two shots of steroids and a Z-pack.  The reporter reported less than 2 weeks after vaccination, continuous outbreaks of hives had caused sleeping difficulty.  The had been treated with steroids, Benadryl, and Prednisone given.  However, he had new outbreaks in new locations, the hives were concentrated on trunk and groin but were all over his body.  The reporter nurse stated the vaccine was not given at their office, so they did not have the lot/expiry date. The reporter consented to follow up.
About an hour after the vaccine was administered the patient began to feel light-headed and dizzy, the pt became cold and started to shiver. Patient was responsive the enitre time, and was able to talk with the staff. EMS was called and the patient was taken to the hospital. Prior to the injection the patient confirmed that they have never had an adverse reaction to the influenza vaccine in the past and they confirmed that they were not allergic to any reagents in the vaccine.
Clot in bladder; little blood in urine; Got third shot 23Apr in a fib and fever; Got third shot 23Apr in a fib and fever; Got third shot 23Apr in a fib and fever; This is a spontaneous report from a contactable other HCP (patient).  A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration at age of 66-year-old on 23Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. Concomitant medication included axitinib (INLYTA) from 29Mar2021 to 2021. The patient previous took fist dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), both at age of 66-year-old as single dose for COVID-19 immunisation and 2nd shot was not viable (as reported). Patient got third shot 23Apr2021 in a fib and fever, CA levels, creatine levels. On 27May2021, patient went to oncologist, little blood in urine. Hospitalized (in 2021) due to clot in bladder and haven't been on Inlyta for last 5 days, doctor wanted to get him back on it. Patient was to be released from the hospital and has an appointment on 03Jun2021 with his oncologist. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported urinary bladder haemorrhage and fibrillation were likely due to intercurrent/concurrent disease, and unlikely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional information become available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.
Client states that itching occurred by 6:00 pm and that she noted that by 10:00 had hives like on lips. During the night she had hive like reaction on neck and rest of body. Had take Tylenol. By 4:00 pm next day states she felt she still had some swelling on lips but not visible to others
My reaction was not severe with the booster but different from the 1st and 2nd vax.  In Mar. 2017 I had shingles, the rash was small but the pain was bad leading up to the rash.  I had the original shingles shot and since have had the newer 2 shots.  The day after my Moderna covid booster I experienced neuropathy pain in the same area as the shingles pain.  Not extreme but it was occasionally there.  It would happen briefly, about a minute 1 or 2 times a day after the injection.  I take 200 mg gabapentin every evening.  If I don't take it I get the neuropathy pain again.  I am reporting because I had not seen mention of this on the side effects list and wondered if others had the same problem and if it is common.  I ask also because I know we will probably have to have another booster in 6 months and want to be sure it is safe.  It was not bad enough to go to the Dr.
Chills throughout night after vaccine, fever and headache for about 4 hours the day after vaccine, fatigue the day after vaccine.
Patient reported feeling tired and nauseous as well as experiencing vomiting and chills the day of and day after vaccine.  One day later the patient developed significant itchy rash and some swelling down the arm of the injection site.  Rash localized to left arm.  Patient has had similar reactions to other vaccines this way.  Patient was instructed to report to the pharmacy and to her primary doctor any worsening of symptoms or if symptoms do not subside within a couple days.  Patient was instructed to use ibuprofen to help with swelling and steroid cream if rash continues.
I began having extreme thirst around 3pm on Tuesday 3/16. I have drank multiple glasses of water and with little to no relief. It seems to have gotten worse as the day went on. I have also been experiencing frequent urination and fatigue.
11/17/21 presents to ED for "acute onset of left lower extremity pain and cold sensation". PMHx "CHF (congestive heart failure), DVT (deep venous thrombosis), Kidney stones"
Severe atm soreness, headache 2 hours after. Watery eyes and fatigue 6 hours later.
1.) High fever, 2.) measle-like rash, also infected 2 year old brother living in same household with the same measle like rash, 3.) severe hives, 4.) behavior changes, since being vaccinated she will not leave mother's side.  She must be with mother at all time.  If separted from mother, she will cry for hours.  Never exhibited behavior like this prior to vaccination.  She is unable to provide a rational explaination for her behavior.     Adverse symptoms 1, and 2 noted above have resolved.  Adverse symptom 3 noted above does return from time to time.  Adverse symptom 4 as noted above continues to be present and seems to be getting worse.
Extreme pain in right arm, nausea, body aches. Pain spread to neck, shoulder, and armpit. Swelling and redness at injection site, lasting for about a week.
I was fine the day I  received the shot. The next day i was fatigued, but still worked through the day. I also had jaw soreness and the novacaine wore off. I went to bed at 7:30pm and slept 12 hours.  day 2 post vaccine, i woke up with a swollen lymph node on my left side of the neck, felt sore, a little bit of a headache, but i felt rested.
Systemic: Confusion-Mild, Systemic: Dizziness/Lightheadedness-Mild, Systemic: Fainting/Unresponsive-Medium, Systemic: Shakiness-Mild.
?Prized-BioNTech COVID-19 Vaccine EUA?  My symptoms started two days after first vaccine. My right eye started drooping and my smile was drooping as well. The right side of face was like I had a stroke.  I went to urgent care and was diagnosed with Bell?s Palsy.
My bowel habits have permanently changed.  Stools are smaller, way more frequent, and so soft it requires a lot of toilet paper to get clean. This is ongoing and annoying.
PATENT CAME IN ON 12/12/2015 SAID HIS ARM HURTS EVER SINCE THE SHOT BUT ONLY WHEN HE LIFTS THE ARM.
No additional AE details were provied; had been administered to a patient. Per caller the VAQTA experienced a prior excursion on 25JUL2022 of 46.5F for 15 minutes and then experienced excursion today 29JUL2022 of 48.2F for 15 minutes; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 29-JUL-2022, the patient was vaccinated with improperly stored (product storage error) dose of hepatitis a vaccine, inactivated (VAQTA) syringe, 0.5 milliliter, administered intramuscularly (IM), lot #: W002889, expiration date: 06-MAR-2023 (strength and site of administration were not provided) for prophylaxis. Temperature excursion information: on 25-JUL-2022 46.5 degree Fahrenheit and on 29-JUL-2022 48.2 degree Fahrenheit for 15 minutes. There was no additional adverse event reported.
Breakthrough case admission after 4 vaccines MOderna 3/7/21 Lot# 023M20A;  Moderna 4/8/21 Lot# 018B21A;  Moderna 10/26/21 Lot# 024c21A;  Moderna 5/5/22 Lot# 056A22A
Patient received the flu vaccine lot #AFLLA688AA, exp. 6/2012 on 10/17/2011 in the left buttock. The following morning, she noted a reddened area approximately 9 cm in circumference around the injection site. The area is warm to touch and raised approximately 1 mm.
This afternoon started to develop a rash on the right side of the neck that migrated to the right ear.  Mother reports it is about 1-2 inches big.  Denies any pain, itching, irritation.
sore arm; This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovering/resolving.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: The patient experienced sore arm after the 1st dose of Shingrix. The reporter consented to follow up. This case is 1 of the 4 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020189740:same reporter US-GLAXOSMITHKLINE-US2020189738:same reporter US-GLAXOSMITHKLINE-US2020189737:same reporter
Pain and tingling right after injection. Tingling from DVT could have been linked. Body aches, migraine, SOB starting at 3 am 3.26.2021, took advil at that time. 9am legs in excruciating pain sharp stabbing pains 9/10. 11 am 101.6 degrees 1:00 pm 102 fever.   2:00 feverish, pain 8/10. Biggest complaint now is fever, lower extremities, migraine.
Per Workers Comp email-Caregiver stated she received her annual flu vaccine on 10/12/23 at the Medical Office Bldg. She said approximately 1 week later she began to develop numbness in bilateral feet and it slowly crept up her body. It is now numb from the chest down and bilateral hands. She came to ED on 10/29/23 and was subsequently admitted into the hospital. They ran CT, MRI & lumbar puncture ? she was awaiting the results but said the provider said with the symptoms, they were leaning towards it being Guillain-Barre? syndrome. They are treating her with 5 days of IVIG and she will be admitted the entire time.
Previously my tinnitus was mild and I only heard it occasionally.  After receiving my 2nd Pfizer Covid booster, my tinnitus is much louder and I hear it all the time.  I now have trouble sleeping and concentrating.
smallpox-07/12/02, 07/20/02-4-5" erythematous area surrounding SP site, positive lymph nodes, fever. Treated with T 07/22/02-Reeval-erythema resolving
swollen lymph nodes, pain in arm and under arm, pain in left breast with nerve pain radiating to left nipple
Flu like symptoms for approximately 24 hours. My whole ached from head to feet. Miserable!!
Arm itching; Little fatigue; muscle pain; chills; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Little fatigue), MYALGIA (muscle pain), CHILLS (chills) and PRURITUS (Arm itching) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced FATIGUE (Little fatigue), MYALGIA (muscle pain), CHILLS (chills) and PRURITUS (Arm itching). On 15-Feb-2021, FATIGUE (Little fatigue), MYALGIA (muscle pain) and CHILLS (chills) had resolved. At the time of the report, PRURITUS (Arm itching) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported.
Information has been received from a nurse concerning an approx 60 yr old female who, in the past two weeks, on approx 04Oct04, was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #'s reported as 649696/0490P and 649732/0513P). It was reported that the pt developed red, swollen arm at the injection site after receiving pneumococcal 23v polysaccharide vaccine. It was also reported that the pt was seen in clinic and diagnosed with cellulitis. The pt was treated with antibiotic as an intervention. The reporter indicated that cellulitis was considered to be an other important medical event (OMIC). The nurse reported that 2 other female pt's had similar experiences with pneumococcal 23v polysaccharide vaccine (WAES0410USA02650 and 0410USA03089) in the past two weeks. There was no product quality complaint involved. Additional information has been requested.
I started getting a major headache. That lasted a couple of days. The second day, I started sweating profusely at night. I had to change my shirt three or four times a night. I had a temperature of 103. I had no congestion. I didn't have any phlegm. It was mainly the headache the and profuse sweating and then I started getting a little achy. That lasted about three days. The fourth day, I went to take a COVID test negative result. I called my personal doctor and told him my symptoms. He thought I might have had COVID. I went to retake the test by his request the following day, it came back negative again. After that, I went to see the doctor about two days after the second test. I was feeling crummy still. He looked at me and he sent me for a chest x-ray and gave me antibiotics, not sure what the antibiotic was. And I took the antibiotic for 10 days. And chest x-ray came back and he said he wanted me to take another one before he told me what was wrong. And he did blood tests, too. I took the second chest x-ray about five days into the antibiotic regimen and by then I had started feeling better. Took the second chest x-ray and two days later, he told me I had a minor case of pneumonia. He said my blood test showed a high, it was reading high that I had a real bad infection. I think about a week and 1/2 later after the antibiotic regimen, I started feeling a lot better. My sweats had almost diminished. My temperature came down to 98 degrees. It took about two weeks where I started feeling a lot better but I wasn't 100% still. I went to the doctor about three weeks after it all started. I told him I felt a lot better and everything seemed normal. I went for a third chest x-ray. He said my chest was fine and to go ahead and finish the regimen of antibiotics. I was good about a month later.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tinnitus-Medium, Systemic: Visual Changes/Disturbances-Severe
Information was received from a pharmacist via a company representative referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On an unknown date the patient received a dose of ZOSTAVAX (dose, frequency and route unknown). No concomitant therapy was reported. On an unknown date after receiving the dose of ZOSTAVAX, the patient developed shingles. The outcome of the event was unknown. The causality was unknown. Additional information has been requested.
I felt ill on day 1., 01-02-2022.  That night I had a seizure (after being seizure free for years).  I woke up the next morning exhausted, aching all over.  I could barely function.  I went to work and it was unbearable.  On 01-04-2022 I woke up more exhausted and more in pain from the seizure that the booster shot induced and I could not go into work.  I stayed home.  I had the following issues:  Headache Brainfog Major aches (all over my body) Fever Chills Nausea Feeling as though I had ran a marathon (just like I had in the past when I had history of seizures)  On 01-08-2021 I had another seizure.  Same byproduct of the seizure came from that.   These seizures are directly related from the booster.  Since the booster I have never felt the same.  My seizures are now back after being seizure free for years.
THE INJECTION SITE IS INFECTED - RED SWOLLEN ABOUT SIZE OF DIME, LOOKS LIKE PUS RIGHT UNDER SKIN AND IT HAS A SCAB ON TOP . I RECOMMENDED THAT HE SEE HIS DOCTOR
Broken capillaries (rash-like) under right arm, discoloration of under arm hair Flu-like sx - sore throat, swollen glands, muscle aches, headache, no fever.
This case involves an adult patient with an unknown gender who felt sick (malaise) after receiving INFLUENZA VACCINE. The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination. On an unknown date the patient became so sick (malaise) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported "Used to get mine at the hospital. The last one was at drug store. May not be another. Made me so sick brother." It was unknown if the patient experienced any additional symptoms/events. It was unknown if there were lab data/results available. It was not reported if the patient received a corrective treatment for the event. At time of reporting, the outcome of event was reported as unknown. There will be no information on lot number for this case.
swelling, redness of inj site (lt thigh)-local rxn; irritability;rx w/APAP, hot compresses;resolved 14JUN 10AM
This spontaneous report as received from a registered nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 ZOSTAVAX on 29-JUL-2011. Route of administration was unknown. No other co-suspects were reported. No concomitant medications were reported. On 26-SEP-2012 the patient received the second dose of ZOSTAVAX. The patient was not experiencing any known symptoms. Additional information is expected.
Information has been received from a pharmacist via a company representative referring to a female patient of unknown age. Patient's concurrent conditions, concomitant medication and medical history were not provided. On an unspecified date in 2010 the patient was vaccinated with one single shot of ZOSTAVAX (lot#, expiry date and route were not provided). On an unspecified date after receiving ZOSTAVAX the patient developed shingles. The patient spoke with the pharmacist for medical attention and received antiviral medication (name/dosage/frequency/manufacturer unknown) as treatment. The outcome of the event was reported as not recovered. Additional information has been requested.
Started menstruating 14 days earlier; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 59267-1000-01) via an unspecified route of administration in the left arm on 20Apr2021 at 12:00 (at the age of 43-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included propranolol (MANUFACTURER UNKNOWN), taken for an unknown indication from an unknown date and unknown if ongoing. On 22Apr2021 at 00:00, 2 days after the shot, the patient started menstruating 14 days earlier. The event 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 event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event started menstruating 14 days earlier was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient received both vaccinations on 14 DEC, after the vaccination she noticed some discomfort over the area, on 15 DEC in the morning she noticed redness, swelling, and increased discomfort.  On 16 DEC she called the clinic, area over left triceps demonstrated a 5x6 cm area of mild edema/redness.  Suspect local reaction, treated with warm/cold compresses, Tylenol for discomfort.  discussed return precautions.  Note is in database
Information has been received from a nurse concerning a 16 year old female who on an unspecified date "couple of weeks ago" was vaccinated with Gardasil (lot# unknown) injection.  The patient experienced syncope "5 minutes" after receiving the Gardasil vaccination.  Medical attention was sought.  The nurse had given the patient a Popsicle.  The patient had fully recovered after a couple of minutes and walked out of the office the same day as the vaccination.  Additional information has been requested.
On 4/7/21 patient administered Janssen vaccine. On 4/8/21 at 7:00 am patient had stroke symptoms and advised to call 911 after conversation with AARP nurse hotline. Patient had difficult speaking and right side weakness. Transported via ambulance and admitted to hospital until discharge on 4/11 at 1:00 pm. Per patient diagnosis was Hypertensive Crisis, Acute Stroke with High suspicion for cardioembolic stroke.
After the shot I had flu like symptoms and stayed in bed for 48 hours. The first day I didn't take any medication, but I did take medication on the second day. I slept through it the first day. Then around 11/15/2022, I started getting sick with what seemed like an upper respiratory infection. Then it turned into chest congestion with head congestion. Then it turned into a sinus infection and all these symptoms occurred at the same time. I never had a fever. I tested twice for COVID-19 and both were negative. During this time, I had also taken 2 weeks worth of MUCINEX to try and combat this before calling the doctor. When I went to see my doctor, I went to get a chest x-ray and I realized I needed something to combat this. I was given a steroid, 8 day course of prednisone. I was also given doxycycline for 20 days. I felt well for exactly 2 days, 48 hours. That was around 01/01 and 01/02 where I felt well. I had no chest congestion, no wheezing, no post nasal drip. Around 01/03/2023, the symptoms started again and it's progressively getting worse up to today. Today, I have wheezing, coughing, a possible sinus infection/congestion and post nasal drip. I'm coughing so bad that it's in the upper bronchial tract. There's thick mucus that has been choking me. When I wheeze bad, I start coughing really badly and I can only force something to come up a couple times a day. According to my tests, no COVID-19 and no fever.