chrisvoncsefalvay/vaers-outcomes huggingface dataset:
severely ill; Soreness at injection site; Severe chills; Sweating; Diarrhea; Cramping; her whole body would not quit shaking; This case was reported by a consumer via call center representative and described the occurrence of unwell in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 10th September 2020, less than a day after receiving Shingrix, the patient experienced unwell, injection site pain, chills, sweating, diarrhea, cramp and tremor. On 10th September 2020, the outcome of the unwell, chills, sweating, diarrhea, cramp and tremor were recovered/resolved. On 12th September 2020, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the unwell, injection site pain, chills, sweating, diarrhea, cramp and tremor to be related to Shingrix.  Additional details were provided as follows: The patient had reported the events for herself. The reporter mentioned that she received 1st dose back on 10th September 2020, because she received a reminder on 10th November 2020 to get the 2nd dose. The patient believed she received the vaccine in her upper right arm (because she was left-handed). The patient was severely ill after vaccination. The patient experienced soreness at the injection site, severe chills, sweating, some diarrhea and cramping (which she thinks it might be associated with the chills). The reporter mentioned that that her whole body would not quit shaking; she submerged herself into a tub of hot water and used a heating pad but it did not help, she was covered with sweat from head to toe and also stated that she was not sick at all. All the adverse events lasted for about 5 hours, except the soreness, which lasted for about 2 days. The reporter mentioned that all adverse events were resolved. The reporter gave permission to follow-up with her health care professional. This case had been linked with US2020229461, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020229461:same reporter
Burning; her hands and feet started falling asleep/tingling in her hands and feet; low grade fever; Nausea; Headache; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (her hands and feet started falling asleep/tingling in her hands and feet), BURNING SENSATION (Burning), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (low grade fever) in a 78-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 4), Pfizer vaccine (Dose 3) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse event with Pfizer vaccine, Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.    On 17-Oct-2022 at 4:00 PM, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Oct-2022, the patient experienced NAUSEA (Nausea) and HEADACHE (Headache). On 18-Oct-2022 at 3:00 AM, the patient experienced PARAESTHESIA (her hands and feet started falling asleep/tingling in her hands and feet) and PYREXIA (low grade fever). On 18-Oct-2022 at 5:00 AM, the patient experienced BURNING SENSATION (Burning). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIMENHYDRINATE (DRAMAMINE) at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (her hands and feet started falling asleep/tingling in her hands and feet), BURNING SENSATION (Burning), NAUSEA (Nausea) and PYREXIA (low grade fever) outcome was unknown and HEADACHE (Headache) had not resolved.            No concomitant medications was reported. Patient received the dose at 4:00 PM. By 3:00 AM the following morning the hands and feet started falling asleep and had a low grade fever. By 5:00 AM patient started to experience burning where the tingling in the hands and feet had been. Patient also started to have nausea and a headache. Patient had taken Tylenol, Dramamine, and used Sea Bands for the symptoms. Patient went to the ER for the symptoms at 9:00 AM where her headache had increased to a 6/10. Patient received blood work, and was given an IV with Toradol and IV fluids, after which the headache became worse.
Induration/erythema at injection site (L) lateral thigh 2 days after vaccine (likely DTaP site). Resolved with cetirizine.
outbreak of severe, large,red hives appeared all over my body 1 day after receiving 2nd Moderna vaccine. Prior to injection  was 100% healthy with no symptoms of illness. The hives are huge welts,raised and very itchy.
8JUN95 240PM syncopal episode in parking lot; pt recv vax 230PM w/in 5 mins mom reports pt c/o feeling hot & dizzy; pt was pale, clammy, groggy, BP 74/P, P104;
On 11/21/01, the pt stated his arm became very painful and he was unable to raise it up. It remained painful and difficult to lift for the next several days. Pt consulted with MD and was put on cortisone and pain meds on 11/27/01. Message on 11/18/01, indicated 10% to 15% improvement.
(date of birth: 08/23/1988) received the 1st COVID vaccine (Pfizer, Lot #: EW0171, expiration date: 08/2021) at 12:37 PM. Patient was sitting in the observation area when he flagged medical. At 12:44 PM, Medic  made contact with the patient who stated he felt ?lightheaded.? Patient was conscious, alert, and oriented to person, time, place, and event (COAx4) and appeared to be in mild distress. Respirations were at a rate of 18 breaths per minute and skin was palm, warm, and dry. Pupils were dilated to about 4 mm and were equal and reactive to light. Nurse  then attended to Medic with patient. Patient denied any other complaints or any pertinent medical history and claimed last oral intake was at 10:30 AM, with minimal fluid intake. Patient stated symptoms began about 5 minutes status post vaccine. Patient denied headache, nausea, blurry vision, chest pain, or shortness of breath. Medic instructed the patient to stay in the observation area for an additional 15 minutes and gave the patient a water bottle to drink. At 1:05 PM, patient stated he was ?feeling 100% better.? Patient was conscious, alert, and oriented to person, time, place, and event (COAx4). Respirations were at a rate of 16 breaths per minute and skin was normal for ethnicity. Pupils were equal and reactive to light. Medic advised the patient to stay hydrated, eat well, and to have a person drive for him at his second dose appointment. Patient was able to stand, walk without assistance and with a steady gait when he departed.
First dose - swelling and redness around the knees. Soreness in the knee joints.  Went to  see the nurse and she wasn't sure what was causing the redness and swelling. Second dose -swelling and redness around knees again.  Soreness in knee joints. Did not go to the doctor. Booster - swelling around knees, swelling and redness on forearms, swelling and itching on back,  a treated ganglion cyst on wrist was huge and swollen.  Had difficulty breathing but could have been due to anxiety about my body swelling up all over.  Went to the emergency room and was given benedryl.  The ganglion cyst immediately went down and back to normal. Have been taking Zyrtec which seems to help.  Still have occasional soreness in the joints of my knees and right elbow.
LEFT ARM ONLY:  HOT TO TOUCH, SWELLING, PAIN GENERAL NAUSEA HIVES ITCHING
Pt had high fever for first couple days, then fever went down. For the next couple weeks, patient said she felt very tired and sickly.
01/16/22 presents to EC ED for "generalized weakness, fatigue, cough, and shortness of breath". PMHx of "CVA, DM type II, HTN"
The patient had his second Moderna vaccine on 2/18/2021.  Around the same time he actually mechanically injured his knee.  On 3/8/2021 he went to a care clinic for knee pain but had also developed severe bilateral shoulder, bilateral hand and hip girdle pain with stiffness a few days after receiving the vaccine.  At the time he was told that this pain was likely related to compensating for his knee pain.  He then presented to see me (primary care provider) in my office after having the knee repaired on 4/5/2021.  Reported he was able to bear weight and walk as usual on his knee but was not seeing any improvement in his shoulder, hand and hip girdle pain and stiffness.  Ultimately was diagnosed with polymyalgia rheumatica, started on prednisone and referred to rheumatology.
Severe headache; This is a spontaneous report from a contactable pharmacist, who is also the patient. This 37-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK 5730; expiration date Mar2021) intramuscular in the left arm on 21Dec2020 at 17:30 at the age of 37 years at single dose for COVID-19 immunisation. Vaccination facility type was hospital. Relevant medical history included Major Depressive Disorder (MDD), anxiety and foramen ovale patent. Concomitant medications were not reported. Past drug history included allergy with sulfamethoxazole/trimethoprim (BACTRIM) and aripiprazole (ABILIFY). On 22Dec2020 at 06:00, the patient experienced severe headache resistant to butalbital/caffeine/paracetamol (FIORICET) and ibuprofen, which were taken as treatments. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, she had not been tested for COVID-19. The patient was recovering from the event.
This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender that were vaccinated with a dose of ROTATEQ (dose, dose number, lot number and expiration date were not reported), oral, that was improperly stored. No adverse effect reported. Medical history and concurrent conditions were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of eight (8) reports from the same reporter. Additional information has been requested.
Initial misuse report received from a non-healthcare professional on 22 July 2013. A female patient was administered two doses of ActHIB. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
pain in neck and spine within first few minutes; pain in neck and spine within first few minutes; itchy throat; slightly difficult to breathe; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (pain in neck and spine within first few minutes), SPINAL PAIN (pain in neck and spine within first few minutes), THROAT IRRITATION (itchy throat), DYSPNOEA (slightly difficult to breathe) and DIZZINESS (dizziness) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced NECK PAIN (pain in neck and spine within first few minutes), SPINAL PAIN (pain in neck and spine within first few minutes), THROAT IRRITATION (itchy throat), DYSPNOEA (slightly difficult to breathe) and DIZZINESS (dizziness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 29-Mar-2021 at an unspecified dose and frequency. At the time of the report, NECK PAIN (pain in neck and spine within first few minutes), SPINAL PAIN (pain in neck and spine within first few minutes), THROAT IRRITATION (itchy throat), DYSPNOEA (slightly difficult to breathe) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported.
Information has been received from a physician concerning a 15 year old female who on approximately 09-APR-2007 was vaccinated with Gardasil. In April 2007, the patient experienced a crescent shaped burn-like area, over a small hematoma about 1 centimeter in diameter at the injection site. No pain was noted. It was reported that the patient sought unspecified medical attention. It was also reported that the patient is recovering at this time. Additional information has been requested.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 55-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 10-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-APR-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Noticed a small red bump on her back along her spine. The next morning (6AM) she had hives all over her stomach, back and on the upper thigh of one leg.
Initial report received from a patient on 17 January 2014. A female adult patient (date of birth not reported) was vaccinated 8 - 9 years ago with ADACEL; lot number, route, site and date of administration were not reported. On unreported date, the patient developed syncope, a "terrible" migraine and the arm she received the vaccine was swelled, red and tender to the touch. She was unable to work for 2 -3 days. The patient denied being sick at the time of vaccination. Concomitant medications and medical history were reported as none. Laboratory tests were not reported. The patient had recovered on an unreported date. No further details were available at the time of this report. Documents held by sender: None.
Follow-up information had been received on 19-APR-2017 from a lawyer regarding a case in litigation concerning a male patient (age not reported) who was inoculated with ZOSTAVAX (dosage and lot#/expiration not reported) on or about 21-JAN-2011 at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended but rather caused patient to contract a persistent strain of herpes zoster. On or about 12-DEC-2015, patient was treated by physician at a community hospital for a painful rash that was diagnosed as shingles. On or about 13-DEC-2015, patient was evaluated for severe shingles and was diagnosed to have profound post herpetic neuralgia, a painful and chronic condition caused by the residual nerve damage after contracting shingles. While shingles and post herpetic neuralgia are chronic and incurable conditions, patient had been prescribed antivirals and morphine, as needed, to manage his symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Redness and large area of edema at injection site - first noted 3-4 hours post injection and lasting 3 days. C/O nausea after receiving injection. C/O chest tightness about 4-6 hours post injection; this was relieved by 4 puffs of albuterol inhaler.
2nd dose not received yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1 and half year ago from reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose not received yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 05-SEP-2023 The healthcare professional wanted to confirm if they could administer the second dose to this patient.  Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
This child has regression in acquired skills (from in home ABA program), screaming, crying, tantrums, noncompliance, and irritability.
I was exposed to covid on 09/26/2022.  I was exposed to someone around 09/22/2022 because this person tested positive on this day.  I experienced headaches, and the following day I had a rapid test and it was positive, had low grade fever, stuffy nose and head, just general achiness.  I did a PCR test on 09/25/2022 but this rest came back negative. On the Antigen test when I took it was positive. The doctor I saw did another PCR test which came back positive. The doctor also prescribed Paxlovid which helped my symptoms.  I have no symptoms today.
Patient did not have any adverse reactions to the vaccine, this was given at age 14 and was not approved at that time for age group. He has done well with vaccine and has now received both doses.
Patient's Parent called HD on 8-8-08 at 1305.  She stated her daughter received a Hep A, Dtap, Prevnar on 8-7-08.  She stated about 30 minutes ago the child developed hives on her face.  She was instructed to contact her pediatrician ASAP.  The child was treated with Benadryl per phone instructions from the pediatrician, and the hives resolved without further problems.
This spontaneous report as received from a physician via company representative refers to a 13 year old female patient with unspecified multiple allergies and AUGMENTIN allergy. On 09-AUG-2013, the patient was vaccinated with a dose of GARDASIL (lot # J003727, expiry date was 07-NOV-2015) intramuscular and Tdap. Concomitant therapies included ZYRTEC, SINGULAIR, NASONEX, ADVAIR and PROAIR. On 15-OCT-2013, the patient experienced fever, rash and upper respiratory infection for which she went to the physician's office and the emergency room on 15-OCT-2013 and sought medical attention. Also the physician reported that the patient went for a second emergency room visit at an unspecified time. On 21-OCT-2013, the patient came to the physician's office for cold symptoms and possible pneumonia. Again on 22-NOV-2013, the patient came to the physician's office for vomiting and stomach pain and was prescribed ZOFRAN. The patient was treated with PEPCID, prednisone and BENADRYL. As of 02-DEC-2013, the patient was still vomiting. At the time of this report, the outcome of rash, vomiting, fever, stomach pain, cold symptoms, upper respiratory infection and possible pneumonia was unknown. Additional information has been requested.
PATIENT CAME IN TODAY AND REPORTED THAT AFTER SHE GOT HER VACCINATION ON 09/07/18 (FOR FLUARIX AND PNEUMOVAX 23) SHE WENT HOME AND LATER IN THE EVENING AROUND 7PM  STARTED ITCHING AND NOTICED RASHES ALL OVER HER BODY. SHE ALSO DEVELOPED SWELLINGS THAT WERE RED. ACCORDING TO HER  THE ITCHING AND RASHES WERE VERY BAD BUT SHE DID NOT REPORT TO ANY MEDICAL FACILITY, INSTEAD SHE PURCHASED ANTI-ITCH MEDICATION FROM A STORE IN TOWN (THIS COULD HAVE BEEN (DIPHENHYDRAMINE). SHE HAD THIS REACTION FOR UP TO 2 DAYS BUT THEN SHE BEGAN TO HAVE SOME RELIEVE AFTER THE 2 DAYS. SHE SHOWED ME HER SKIN AND IT LOOKED RED BUT ALL THE SWELLING HAD GONE DOWN AND SHE SAID SHE WAS FEELING OK. WHEN ASKED IF SHE HAD ANY REACTION TO VACCINES IN THE PAST SHE SAID NO. SHE HAD FLU SHOTS IN THE PAST WITH NO REACTION. THE PNEUMOVAX, SHE GUESSED COULD BE THE CULPRIT. I INFORMED HER THAT I WOULD REPORT TO THE VAERS AND TO HER DOCTOR.
Patient states he received J&J vaccine on 4/1; on 4/10 he had nonradiating persistent low back pain. A few days after that (on 4/13) he felt numbness and pain in his legs, in addition to ?decreased sensation in his inner thighs. These sensations were migratory and intermittent. Also noted in his upper extremities as well. He also had issues with temperature sensation in his lower extremities. On 4/14 he had slight haziness in vision while driving which resolved after 30-60min and has not recurred. He also had slight difficulty walking. On 4/15 he had an appointment with his PMD; had L-spine XR which revealed moderate lower lumbar facet arthritis, and was thought that change in sensation was likely d/t radiculopathy - was prescribed ibuprofen, muscle relaxant, oxycodone (took oxy x1, ibuprofen for a few days). Since then he has also had intermittent stabbing pains in various parts of his body which resolved spontaneously. On 4/17-4/18 his back pain resolved. On 4/18 at 4:30am he woke up with R-sided facial weakness. He has not had focal weakness aside from the face.  Was seen in ED that morning for this R-sided facial droop involving the forehead, diagnosed with Bell's palsy and given prednisone/valacyclovir. Yesterday 4/19 around mid-day he started having L-sided facial weakness and slurred speech. This has progressed since yesterday. Reports ability to swallow, though a little difficult d/t cheek weakness. Low back pain has returned as well. Does report constipation and possible poor bladder emptying for the last few days.  He was seen by a Doctor and referred to ED to rule out AIDP and other diseases after J&J vaccine.
left upper chest pain that began after vaccination but worsened over 4 days, prompting a visit to our , where there were concerns for myocarditis. He was ultimately transferred to a local hospital for further care.
I got a horrible headache within 2 hours of getting the vaccine that made me throw up multiple times when I even moved , for the first 24 hours. I started feeling numbness in my left arm and left leg within 3 hours of my shot. I formed a lump on my left hand the size of a larger marble 4 hours after shot . My heart started feeling like it was beating very slow within 4 hours. By day 2 the headache went away but the lump and numbness continued for at least 4 weeks post vaccine. I started getting heart palpatations by day 2 that have not stopped and are getting more pronounced and more often , 3 months post vaccine.
Information has been received from a pharmacist referring to a female patient of unknown age. On 10-OCT-2015 the patient was vaccinated with a dose of ZOSTAVAX (dose, lot# and route were not reported) for vaccination. On 20-OCT-2015, for an unknown reason, the patient had a prescription that she was filling for a tapering dose of prednisone. Pharmacist did not know if the prednisone was for a preexisting condition or a new condition. The outcome of adverse event was reported as not recovered/not resolved. Causality was not reported. Additional information is not expected because the pharmacist would not like to be contacted.
Pt presented to clinic with localized swelling on the left deltoid. Pt stated that he received the vaccine and a day later woke up with swelling and itching. Technician asked pt if pt is experiencing any other symptoms such as blurry vision, chest tightening/pain, etc. and pt declined additional symptoms. Allergy extender examined pt and said it was a local reaction not concerning for anaphylaxis and prescribed pt Benadryl and Zyrtec. Informed pt to follow up with pcp as needed