chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hot; tired; weakness; difficulty sleeping; bilateral nerve pain legs; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In May 2019, less than a day after receiving Shingrix, the patient experienced nerve pain, feeling hot, tiredness, weakness and difficulty sleeping. The patient was treated with ibuprofen (Advil). In May 2019, the outcome of the nerve pain, feeling hot, tiredness, weakness and difficulty sleeping were recovered/resolved.   It was unknown if the reporter considered the nerve pain, feeling hot, tiredness, weakness and difficulty sleeping to be related to Shingrix.  Additional details were provided as follows: In the 1st week of May 2019, the patinet received Shingrix on left arm. The patient stated she felt hot and tired within a few hours of receiving the vaccine and then woke up in the night with feeling nerve pain running up and down the sides of both legs. The patient had trouble in sleeping, took some Advil and went back to bed. The patient all symptoms lasted no longer than 24 hours and resolved. The reporter did not consent to follow-up. The patient declines healthcare professional (HCP) follow up, does not had vaccine information for this adverse event (AE).
This spontaneous report as received from a 70 year old male consumer refers to himself. The patient had no drug allergies. On 29-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). Concomitant therapies included ALEVE, 81 mg aspirin (reported as "aspirin"), omeprazole, multi vitamin, CRESTOR, sotalol 75 mg and finasteride (manufacturer unknown) (reported as "Finesteribe"). Approximately "6 days" after the shot was given, on 06-JUN-2013, he started to feel discomfort on his joints. The discomfort started with toe joints, progressively moved to his knees both left and right and finger joints. When the patient turned his neck looking back and forth felt discomfort. The patient sought for unspecified medical attention. Unspecified treatment was given. The patient felt it was getting better. Additional information has been requested.
Seizure where eyes rolled back and body became stiff for a minute. On around 8/01/09 I noted some righ arm twitching I wanted to inform the doctor about following the vaccine, then it became more of her whole body becoming jerky and then her first seizure. Admitted into the hospital the seizure were uncontrollable and changing and they  turned into ideopathic infantile spams. She was developing age appropriately prior to her first seizure, and now is delayed with loss of contol of her right side.
3/20/02 Hep B #1 c/o not feeling good 1 wk post shot; 4/25/02 Hep B #2, 1-2 wks Nausea, run down, muscle ache; 5/21/02 Lymph nodes enlarges decreased platelet, blood work; 6/02 Lupus Dx
Patient reports severe nerve and joint pain following Pneumovax and flu vaccines. Advised to seek urgent medical care.
Pt/s mom called & reported pt had sz Sun AM, tx outpt @ ER-Mon AM had another sz mom does not return calls so did not get a complete description;
patient fainted upon receipt of vaccine (within 1 minute of receiving) - pt remained febrile and had cognitive delay for several minutes after coming to (came to on own - no resuscitation or intervention necessary)
POTENTIAL DOSE ADMINISTRATION ERROR; PAIN AT SITE OF INJECTION DURING ADMINISTRATION; This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnic origin.  The patient's height and weight were not reported. No past medical history or concurrent conditions were reported.  On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (manufacturer not specified) (suspension for injection, route of admin not reported, batch number and expiry were unknown) dose was not reported for prophylactic vaccination (dose number series 1).  The patient had no event following covid-19 vaccine ad26.cov2.s (manufacturer not specified)  (dose number in series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2128218 expiry: unknown) dose, start therapy date were not reported for prophylactic vaccination (dose number in series was 2).  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s (dose number in series was 2) booster dose, the patient experienced a potential dose administration error. The patient reported she thought that she got 6 cubic centimeter (cc) dose and that  "it hurt this time" (pain at site of injection during administration) ( dose series 2).   The action taken with covid-19 vaccine ad26.cov2.s (dose number in series 2) was not applicable.  The outcome of the pain at site of injection during administration and potential dose administration error was unknown.   This report was non-serious.
Broke out in blotches and pimples all over my body. Itching was terrible. Went to primary doctor, dermatologist. Allergist and heart doctor. All conclude because of the different sites on my body that it was in my blood stream. Have been dealing with this problem for over a year. The itching was so bad it caused and infection in my left leg ( twice) ending with cellulitis.
This spontaneous report has been received from a nurse practitioner (N.P) who was also the consumer reporting on her partner, a female patient of an unknown age. The patient's pertinent medical history, drug allergies/reactions, or concomitant therapies were not reported. On 29-DEC-2016, the patient's partner was vaccinated with ZOSTAVAX for the prevention of Herpez zoster (lot #, expiration date, dose, and route of administration were not reported). The patient's partner reported that on 03-JAN-2017, the patient developed shingles (Herpes zoster). It was reported that on that day, the patient started with pain. On 05-JAN-2017, the patient went to an emergency room (ER) due to her pain. On 08-JAN-2017, she developed a rash and then sought medical attention from her primary care physician on an unknown date. The physician prescribed valacyclovir hydrochloride (VALTREX) and gabapentin (also reported as no treatment was given). The patient's partner was thinking she might have transmitted the Herpes zoster to the patient. On an unknown date, the reporter accepted the varicella Zoster virus (VZV) packet. No product quality complaint was involved. The outcome of Herpes zoster was not reported. The causality assessment between Herpes zoster and vaccination with ZOSTAVAX was unknown. Additional information has been requested.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced injection site pain and product supply issue. On an unknown date, the outcome of the injection site pain and product supply issue were unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. In 2018, after 1st dose of SHINGRIX vaccination the patient experienced sore. It was reported that, the patient's 6 months window for 2nd inoculation of SHINGRIX was quickly closed. The patient's physician office continued saying to the patient, they could not get more vaccine. The patient wanted to know the 1st inoculation would be credited and the patient assumed that he needed to start all over.
1. Neck & Rt shoulder pain 9/30 -> pain increased. Went to doctor. Trigger point inj. of lidocaine did not help pain. 2. MRI ordered. No nerve compression. 3. Neurologist consulted because fingers had partial paralysis. 4. Medical center performed nerve conduction electro diagnostic studies and found severe Rt sided axonal post interosseous neuropathy. Neurologist who performed tests asked patient if she had a recent (within last 2 weeks) vaccine & determined this to be the cause of the neuropathy as other causes had been R/O.
A 37-year-old male patient receives a booster dose of Moderna on 01/14/2022. The patient reports that on the third day after its administration, he presented inflammation of the nodules in the area of ??the left armpit. He reports presenting secondary symptoms such as fever, chills, weakness and pain in the left armpit area due to the presence of the nodule. He reports that the measurement of the nodule was the size of his fist. The patient is considered afebrile, with no redness in the area and no pain to the touch.
patient had complaints of right-sided weakness at home on 4/22 and then on 4/23 had right facial drooping and admitted to the hospital  Imaging showed that she had a stroke- Acute lacunar stroke in the left lentiform nucleus.
itchiness on my neck, on my face, on my scalp; This is a spontaneous report from a contactable Consumer (patient). A patient of unspecified age and gender received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced itchiness and stated "I got the Pfizer vaccine, my first shot. And I just had a itchiness on my neck, on my face, on my scalp. I took an anti-histamine and it helped me out. But I was going to ask you is it safe to continue on the second vaccine if I have those types of side effects." The outcome for the events was unknown.  No follow-up attempts are possible. Lot/batch number cannot be obtained. No further information is expected.
First symptom nausea, then extreme fatigue, then extreme pain in nose and eyes. Extreme sensitivity to light. Fever on and off for 5 days up to 102.2. Dry hacking cough, runny nose. Incessent crying and  indescribable pain all over for 5 days. Finally back to normal after 8 days.
This non-serious medically confirmed report (initial receipt 13-Oct-2014) concerns a 50 year old female patient who had a medical history of chronic sinus disorder and allergies. Her concomitant medications included an unknown sinus/congestion medications and an unknown medication for hot flashes. The patient had the flu vaccine in the past. On the 08-Oct-2014 during the school day (mid-day), the patient received AFLURIA (batch number T59607) 0.5 mL annually via the intramuscular route for the prevention of influenza. AFLURIA was stored correctly. On the 08-Oct-2014, later that evening when the patient arrived home from work, the patient broke out in hives. On Friday 10-Oct-2014, the patient developed hoarseness. Later on Friday, the patient sought medical treatment from her primary care provided. Treatment included a steroid shot. The doctor told the patient that it may had been a potential drug interaction because this is the first time the patient was on the unknown sinus/congestion medication and unknown medication for hot flashes (it was unknown when the patient commenced these medications). After the injection, the hives and hoarseness resolved. The patient was fine on the 13-Oct-2014. Outcome was recovered on 10-Oct-2014.
Is it normal to have a reaction a week after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Is it normal to have a reaction a week after getting the vaccine) in a patient of an unknown age and gender 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) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Is it normal to have a reaction a week after getting the vaccine). At the time of the report, VACCINATION COMPLICATION (Is it normal to have a reaction a week after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product was provided.  No treatment information was provided.
1:00 AM4/3/21 began having severe cold chills, extreme headache, total weakness, body aches/pains everywhere a surgery had been performed or I had an existing pain the pain was amplified. Could  barely get out of bed. Thankfully slept a lot. This all existed until 2:00 AM 4/4/21
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Medical history was not reported. The nurse informed that on 29-AUG-2014 the patient was vaccinated with MMR II (strength, dosage and route were not reported) lot number: K001231, expiration date: 27-JAN-2016. That may had been improperly stored since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the MMR II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was an any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
arm was a little sore; pain has now moved to under armpit; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced arm was a little sore, pain had now moved to under armpit, both in Apr2021 with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This initial spontaneous case, was received on 02-Oct-2017 from a pharmacist, concerning a 62-year-old adult male patient. The patient's current condition included diabetes and HTN (hypertension) since an unspecified date. Concomitant medications included LANTUS SOLOSTAR pen, quinapril hydrochloride, metformin hydrochloride, amlodipine besilate, HCTZ, and pravastatin sodium for an unknown indication. On 30-Sep-2017, the patient was administered with FLUAD (TIV) (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: 178901 (as reported), expiry date: May-2018), explicitly coded as inappropriate age at vaccine administration. It was reported that, no adverse effects were noted. The outcome of the events was not reported. The reporter assessed the events as non-serious. Follow-up received on 13-Oct-2017: Batch no. and expiry date of the vaccine was added. Concomitant medications were added and hypertension was added as current condition. Narrative amended accordingly.
Vaccine administered inadvertently after temperature excursion. Vaccine given after vial punctured and sitting at room temperature for 28 hours. Vial was first punctured on 6/26/23 at 1040. Vaccine was administered on 6/27/23 at 1500. Vial had been stored at room temperature post puncture and prior to vaccination. Patient was notified on 6/28/23 and reported no adverse effects from the vaccine administration. She again reported no adverse effects at her appointment with her PCP on 7/14/23.
Local erythema - 3 cm, with large area of swelling surrounding. Recommended ice compresses; Benadryl
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. Information on medical history, past drugs and concurrent conditions were not provided. The medical assistant reported that on 16-JUN-2017, the patient was vaccinated with an expired dose of VAQTA (lot # M034893, expiry date: 26-MAY-2017) for prophylaxis. No adverse effects were provided and no further information was provided. Additional information has been requested.
nonstop crying for 3 hrs, not high pitched, but never stopped crying; APAP p/about 3 hrs & pt settled down to sleep;
TDAP and MCV4 and varicella given. About one minute after varicella given, patient stated he felt nauseated. I asked him to lie down and he crumpled up, I laid him down and he started to shake, got pale, lasted about 45 seconds.
On-going lethargy, low-grade fever, chills, edema of injection site, poor appetite for five (5) weeks.
2 days after receiving vaccine began experiencing muscle weakness in the affected arm and has not resolved in the last 3 weeks.  There is no hx of any injury  prior to or since vaccination.  Weakness is isolated to injection extremity.
Shot 2 03/04/2021.  Felt tired mid-evening, went to bed early.  During night woke up several times with  chills and aches all over my body, put extra blanket over me.  Checked temperature = no temp. Chills  continued for a short time, finally warmed up & fell asleep.  About 2 hours later woke up, in my sleep I  had thrown the 2nd blanket aside & was sweating so much I had to change my top and still achy and  now  felt sick to my stomach.  Checked, no temp.  Took two Extra Strength Tylenol tablets, went back to  sleep. When I woke up late Friday 03/05/2021 morning, chills & sweats & upset stomach feeling were  gone. I felt tired & "cloudy" , so slept most the day. was much better Saturday 03/06/2021. On  Saturday I noticed a big "blotch" around my injection sight.  I mention this because since Saturday the red "blotch" has grown and has enlarged to include an area from the upper shoulder down and towards the inside of my elbow.  I have been putting cold wash clothes over the area and it seems to be improving.  The red area only hurts when I push on it, it feels very hot to the touch and at times itches like crazy.  I make sure I don't scratch, just lightly rub to ease the itch.
This is in follow-up to report (s) previously submitted on 8/14/2008. Information has been received from an office secretary concerning a 23 year old female neighbor who on approximately 08-JUN-2008, was vaccinated with the first dose of GARDASIL vaccine (yeast). The office secretary stated that on approximately 09-JUN-2008, the patient experienced tingling in her hands and toes, the day after receiving her first dose of HPV vaccine, postpartum 3 weeks ago. The patient's tingling in her hands and feet persisted. Additional information has been requested. In follow-up the office secretary stated that she had not seen her neighbor since the initial report but knew that her neighor did follow up with her physician and was doing well. No further information was provided.
Later that night after the vaccine I was really tired. My arm was really sore. I woke up later that night with a pounding headache causing me to sleep all day. Later during the night I got up to use the restroom and noticed a rash going down my stomach about 4-5 inches wide but it wasnt itchy or anything at that time. I went back to bed and sleep all day the next day and night. 8/21, I noticed eczema had covered most of my right side and it got really itchy on the various places down the right side of my body. This progressed over the next couple of weeks. I felt ok for the next few days but by Wed I was back down and feeling really bad and severely nauseous.   By that Thursday I beginning feeling a little better, but the itchiness and eczema continued to get worse.   On 9/2 I reached out to my PCP and was advised the COVID shot had triggered an immune reaction and caused a lot of inflammation in my body and prescribed a steroid to help.   I was really tired and couldn't sleep.  Was really sweaty at night, but  I take my last dose of the steroid today so hopefully all symptoms will resolves soon, but I am feeling better and no itchiness just left with a lot of scars from the eczema.
Breakthrough case admission after 3 vaccines Moderna 4/29/21 Lot# 017C21A; Moderna 5/27/21 No lot# AVAILABLE Moderna 12/22/21 Lot# 032H21A;
A 67-yo female received a Pneumovax injection 0.5ml IM in the left deltoid and 2 days later presented to the Emergency Department with complaints of erythema, warmth, edema, and pain in the left upper extremity.  The symptoms were moving down the extremity and were not relieved with Benadryl.  The patient had a history of hyperlipidemia, osteoarthritis of the knee, and osteopenia and was seen in the Geriatric Clinic on 20 Jan 2011 where she received the Pneumovax injection.  Concomitant medications included Actonel 150mg monthly, aspirin 81mg daily, Niaspan 500mg daily, Vytorin 10/80mg daily, and Zolpidem 10mg at bedtime as needed for sleep.  The patient also reported taking alpha lipoic acid tablets, Citracal+D, CoQ10, fish oil 1200mg, glucosamine chondroitin complex, vitamin B complex, and vitamin C.  On 22 Jan 2011 when presenting to the Emergency Department, the patient's blood pressure was 157/84, heart rate 84, respirations 18, temperature 36.8ºC, and pulse oximetry 98% on room air.  The patient reported pain of 7 on a scale of 0 to 10.  The patient was diagnosed with cellulitis and was admitted to the hospital on 23 Jan 2011.  History and physical showed "swelling, redness, and tenderness in the upper left limb extending to the wrist with marked pain, associated tenderness".  There was no fever or chills. On 23 Jan 2011, a duplex of the left upper extremity showed no evidence of deep venous thrombosis, CBC was normal, EKG normal, and blood culture was negative.  C-Reactive protein was high at 5.9 (normal <0.6mg/dL).  The patient was treated with IV clindamycin with significant improvement. On 24 Jan 2011 the CBC was normal.  The patient was discharged home on oral clindamycin 300mg every six hours for 6 days.  On 31 Jan 2011 the patient was seen in the Geriatric Clinic for follow-up.  She was still having some paresthesia along the inner proximal left arm and minimal pain when lifting objects.  The swelling had subsided and there was some residual mild pink discoloration.
Both vaccines on 9/16/2021. Flu shot didn't hurt, Pneumovax was very painful - mentioned to administering pharmacist. Only moderately sore arm and slept well that night. By about 8:30pm on 9/17/2021, arm started to itch intensely. Upon inspection, flu shot site had healed, but Pneumovax injection site was swelling dramatically - about 2 inches wide, spanning 1/4 of my arm.  Site was bright pink, hot, and very painful to the touch. Couldn't sleep that night. Had to use Flovent inhaler (a rare thing), but kept having asthma breathing difficulty. By 8:00am on 9/18/2021, swelling was larger - about 3 inches wide and circling half of my arm. Went to Urgent Care sometime around 10:30am.  PA examined and prescribed meds for swelling and possible skin infection.
C/O pain LUQ and some in (L) axillary area and felt warm. Did not take temp. Started approximately 2 hrs following inj on 5/19. Continued 5/20, but lesser degree. Did not miss work.