chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He has passed out from these attacks; burning in feet; his skin becomes very sensitive to the point that he cannot stand for anything to touch it.; numbness in face; his body overheats to the extreme; sensitive to touch; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In APR-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced passed out (Verbatim: He has passed out from these attacks) (serious criteria GSK medically significant), burning foot (Verbatim: burning in feet), sensitive skin (Verbatim: his skin becomes very sensitive to the point that he cannot stand for anything to touch it.), numbness facial (Verbatim: numbness in face), feeling hot (Verbatim: his body overheats to the extreme) and touch sensitivity increased (Verbatim: sensitive to touch). The outcome of the passed out, burning foot, sensitive skin, numbness facial and feeling hot were unknown and the outcome of the touch sensitivity increased was not reported.   It was unknown if the reporter considered the passed out, burning foot, sensitive skin, numbness facial, feeling hot and touch sensitivity increased to be related to Shingrix.     It was unknown if the company considered the passed out, burning foot, sensitive skin, numbness facial, feeling hot and touch sensitivity increased to be related to Shingrix.   Additional Information: GSK Receipt date: 10-NOV-2023 A reporter reported that his brother received 2nd Shingrix dose in April of 2023, Since that time he had been experiencing numbness in his face and his body overheats to the extreme.  When the overheating happens, his skin becomes very sensitive to the point that he cannot stand for anything to touch it.  These attacks seem to be worse when he sleeps or was very relaxed.  She explained that the attacks begin at his feet and radiate upward until it is throughout his whole body and he had passed out from these attacks.  He had seen doctors and had been to multiple Emergency Departments but had not received a diagnosis.  The reporter did not consent to follow-up.
This spontaneous report as received from a Registered Nurse refers to an unspecified patient of unknown age and gender. On an unknown date, the product was improperly stored at -2 C for 2 hours. On 25-JUL-2014, the patients were vaccinated with VARIVAX (dose, route and lot were not reported). No adverse effects reported. This is one report of two reports from the same source. Additional information has been requested.
My should and arm became horribly painful and I could not move my arm at all by the end of the night. Nothing helped. I tool Aleve, Tylenol, used ice packs and heating pads. It took four days for me to be able to move my left arm again, and be able to move my arm above my head, but the pain persisted. Today, two weeks and two days later, I still have pain and problems in my range of motion when putting my left arm above my head. Somehow, my left shoulder or shoulder joint was injured by my receiving the vaccination
Client received a H1N1 influenza vaccination in her left deltoid muscle.  She states that she experienced a "little pain" immediately after the injection.  Within 30 minutes, she had radiating, sharp intermittent pain that extended from her left shoulder to her left wrist.  The pain was described as "shooting and intermittent". Client examined by office physician.  She had no redness, tenderness, swelling, or bruising at the vaccination site.  There was full range of motion in the left arm.  The site was in the superior forearm. Client referred to occupational health, since she was an in-house employee.  The physician there prescribed ibuprofen 800 mg, vicodan, and to apply cold to the site.
Subsequent to receiving varicella virus vaccine live the pt experienced a chickenpox like rash with approximately 30 lesions.
(public health nurse) was administering the vaccines. Client said she needed a break before administering the other vaccines on the other arm. Client passed out and fell out of chair and hit her head fairly hard. Client was going in and out of consciousness for about 3-5 minutes, We called 911 and two EMS paramedics came to assess her. At this time, the client regained consciousness. EMS assessed her head and symptoms. Client was complaining of pain in the head that radiated down her shoulders. No severe neurological problems were identified. EMS helped the client get up onto a chair and decided she did not need transport to the emergency room. She was deemed stable to go home. We gave her juice boxes and sat with the client. Her aunt pulled up the car and both PHN's helped the client walk and ge3t into the car.
Pt recv vax on 4/21/99; approx 20 min post vax pt exp shaking, weak, pounding heart, dry mouth, stroke-like sx; tx=oxygen, Benadryl
About 25 minutes after booster vaccination (moderna) I experienced a sensation of heat and my body flushed bright red accompanied by an increase in heart rate.  This resolved by the time I got home  ~20 minutes. In mid December I stopped taking Zyrtec and within a week started to have episodes of urticaria and dermatographia with occasional episodes of increased heart rate.  Testing for COVID during this time was negative.     Symptoms decreased with Zyrtec but are still occasionally present now -March 2022.
104 + fever for 48 hours, dizziness, light headedness, severe headache.  Very very miserable itchy rash ALL OVER.  Starting     Day following vaccine  and continuing ten days later. Not treatable with otc creams or meds.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 12-AUG-2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot number not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 07-SEP-2016, the patient was treated for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
This case was reported by a other health professional via call center representative and described the occurrence of shingles in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: This case was reported via webform. The age at vaccination was not reported. The age group was not provided, but was captured adult as per vaccine indication. Apparently the reporter had multiple cases of Shingles in the past and it had been reported to VAERS already. The reporter was asking, did the GlaxoSmithKline (GSK) have a recommendation on such a scenario. The reporter had seen in the studies, most patients did receive the second dose but she wanted to confirm. This case was already reported to VAERS. No additional information was provided. This case has been linked to the US2018146907, reported by the same reporter.
Tinnitus (ringing in ears).  First noticed it the day after the first dose.  Didn't think too much of it until it did not subside.  Saw an ENT who wrote it off and did nothing for me.  It is not loud enough to be debilitating but it is annoying.  It has not ceased, nor has it subsided at all.  It continues to this very minute.
Discomfort at injection site beginning 10/28. Fever evening of 10/29. 10/31 (L) arm with well circumscribed 7cm x 5cm reddened area with fullness and tenderness.
Pt came to the pharmacy on 1/22/2015 and said that her right arm was sore, that it still hurts and she has difficulty raising her arm.
EW0167 might be the number of the lot it's difficult to read. I had the vaccine about 12:00 noon. On the date noted, I had real severe chest pains. It was on the left. It was shocking it made me fall down to the floor to get down on the ground. The pain lasted for a while and then it eased up but was still painful. I went to the doctor because it got better after a bit. The next day, I called the doctor and they told me go to ER. I went to urgent care, and they did an EKG, and it was still kind of hurting. It was like a muscle thing on the outside; costochondritis that she thought it might be. She thought also I might be low on Iron or dehydrated. They gave me a shot of Toradol. I felt better later that day, and I felt fine with it for a while. A month later, I was having the pains again. It was on the right side that time, and it was very difficult to breathe because it was painful to breathe. I went back to the doctor. After three days of not working. I saw doctor. I had fallen before and so thought it was an injury to my ribs that was causing it. They said if it happens a third time, we'll have to talk. They gave me another dose of Toradol. It took a while, but it was getting better by the next day and kept getting better. It took a few days before I was all the way better after that one, but I could breathe more easily after this one and so I could work.
On 1/27/2021, after having received Dose #2 of Pfizer Covid-19 vaccine on 01/07/21, I experienced severe calf pain while playing soccer. Over the next 2 weeks I experienced vascular claudication in that leg and was eventually diagnosed with arterial thrombus in Left tibioperoneal, anterior tibial/dorsalis pedis and posterior tibial  arteries. I do not have any known predisposing conditions for arterial thrombus and no history of thromboembolic disease.
Starting by 5:00pm in the evening, I started feeling faint and very exhausted. I had zero appetite and ate some noodles for dinner. I felt like I couldn't stand up. I started feeling the chills and joint/muscle aches by 8:00pm. I fell asleep at 9:30pm because I was so tired and woke up at 11:00pm feeling incredibly feverish, naseauish and weak. I couldn't stand in the shower I felt so weak. Then around 11:30pm I vomited all of the contents of my stomach. I didn't feel nauseous after I finished vomiting. The next day I still felt feverish and like I didn't have an appetite. I spend around 5 hours of the day sleeping. I felt more like myself by 7:00pm the following day.
Flu shot given 10/03/2013-On 10/4/2013 5:52:27 PM Patient arrived at our clinic with significant redness over the Left ant thigh; there was an annular ring over the ant thigh that was surrounded by lighter colored ring of redness. Patient was examined by Dr. and found to have no fever or chills and Mother stated no tick bites. Patient was given prescription for Cephalexin and advised to seek further treatment if worsening or no improvement of systems. Patient was taken by Mother to Hospital for treatment the next day.
rash on site of vaccine, looked like a sunburn it was about 3" long and 2 1/2" wide, and it felt hot,  lasted about 3 days
tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a patient and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive to Covid virus after 1st shot of the Moderna Covid-19 Vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive positive.         No concomitant medication was reported , No treatment medication was reported .   Reporter did not allow further contact
Period heavy and lasted 3 weeks, arm pain, muscle soreness all over, headache, tired
Initial case received from a consumer, who is also the patient's husband, on 13 August 2010.  The reporter also reported similar events in himself; that information is captured in case number 2010-04381.  A 46-year-old female patient received an intramuscular left deltoid injection of MENACTRA (lot number not reported) on 11 August 2010 for travel purposes.  The patient denied relevant medical history or illness at time of vaccination, and had no known allergies.  One day post-vaccination, on 12 August 2010, the patient complained of a fever, headache, and fatigue.  She also noted redness, swelling, and warmth at the injection site, and complained that her arm was sore.  She was seen by a physician on 14 August 2010 and treated with steroids and antibiotics.  As of 15 August 2010, she reported feeling "better", although her arm was still sore.  Follow-up information was received 31 August 2010 from a health care professional who provided lot numbers for which identified the events experienced by this patient and her husband (captured in case 2010-04381) are in the context of a cluster.  The MENACTRA lot number was U3434AA.  Outcome remained not recovered.  Documents held by sender: none.
Headache; Muscle pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (Headache), MYALGIA (Muscle pain) and ARTHRALGIA (Joint pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took paracetamol but it only gave minimal relief.
palpitations and chest pain beginning after Johnson & Johnson COVID vaccination in November 2021 along with past medical history notable for prior traumatic brain injury in 2020 with complete resolution of symptoms.
This spontaneous report as received from a other health professional refers to a patient of unknown age. In 2017, the patient was vaccinated with ROTATEQ lot # M042172 with expiry date 08-JUN-2018, lot # M044399 with expiry date 25-MAY-2018, oral for prophylaxis. In 2017, the patient experienced incorrect product storage. On an unknown date, the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. Additional information has been requested. Sender's Comments: US-009507513-1708USA009399: US-009507513-1708USA013259: US-009507513-1708USA013257.
Description: polyarthralgia, onset 4 hours following Anthrax vaccine, dose #8; also received Meningococcal vaccine same day, but not documented in DEERS data; within 24 hours, joint pain became severe, also developed generalized muscle aches, fatigue, headache, scalp tenderness, facial swelling, slurred speech, loss of peripheral vision bilaterally, and bilateral hand and foot swelling
On 9/19/2021, I started to develop a pain in y chest. It wasn?t going away so I scheduled a covid test the net day. The covid test was negative. They did chest Xray and they sent me to the ER to do CT Scan. I went and a scan was done. I was diagnosed with a blood infection, embolism in both lungs and pneumonia. I was given antibiotics and blood thinners. The pain in my chest got very bad while I was hospitalized but has gotten better toward Wednesday and Thursday. The hospital discharged me as there was nothing more they could do after the antibiotics. I was sent home with my antibiotic regimen and anticoagulation drugs and am currently using that now.
Redness and pain at site of injection with residual subcutaneous induration (knot) painful; and cutaneous post infl; discoloration (resolving).
Motehr called and reported need to go to ER folllowing immunizations given 12/31/2008. She stated respirations became labored and temperature 102.7.  Tongue and lower lip were swollen.  At ER treated with Benadryl and was fine within 1 hour.
Subject in pneumococcal vaccine trial, with severe COPD hospitalized for COPD exacerbation. Vaccination took place on 11/28/07. According to the physician the relationship is 'none'.
Massive brain aneurysm stroke vasospasms emergency cesarean on October 23rd baby's weight 5 lb regular birthdate December 7th
Patient received Hep A and varicella vaccines approx. 2:30 pm. Within 20 min patient syncopized in the room and struck her mouth on something as she fell. Chipped two teeth with minor lac to lip.
Patient had severe shaking after her first booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of TREMOR (Patient had severe shaking after her first booster dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 013A21A and 013A21A) for COVID-19 prophylaxis.     Patient had no allergies to medications, food and other products.  Concurrent medical conditions included Asthma (Mild asthma).   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TREMOR (Patient had severe shaking after her first booster dose). At the time of the report, TREMOR (Patient had severe shaking after her first booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter was unaware if the patient was taking medications.   Reporter did not allow further contact
The patient was given the influenza vaccine subcutaneously instead of intramuscularly. The patient experienced a localized swelling (up to golf ball sized), redness, and tenderness to touch. This condition self-resolved over the next 48 hours. The patient did not require any hospitalization or further interventions.
Tiredness; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Tiredness) and MYALGIA (Soreness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Hypertension, Chronic kidney disease and Arthritis. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), ACETYLSALICYLIC ACID (ASPIRIN LOW), METFORMIN, ATENOLOL, LISINOPRIL, MAGNESIUM OXIDE, AMLODIPINE, ATORVASTATIN and CLONIDINE for an unknown indication.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Tiredness) and MYALGIA (Soreness). At the time of the report, FATIGUE (Tiredness) and MYALGIA (Soreness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment details were reported.   This case was linked to MOD-2021-391840 (Patient Link).
Intense headache, sweats, chills, join ache, nausea, exhaustion lasting about 2 1/2 days
Within 3 minutes of vaccines given, both injection sites broke out with rash. Mom got Benadryl and 1/2 tsp po. Rash continued mainly around front of neck and down with smaller amounts to stomach, back, arms and lower legs. Rash was blotchy. Has never reacted to injections before this. At 18:25, rechecked and rash is clearing up. Only rash noted at this time is at injection site and it's fading. Family left at 18:45. No further problems. On 2/21/01, at 07:41 called and parent stated no rash or problems throughout the night. Continued to give Motrin and Benadryl every 4 hours. States only marks on child is where shots were given. States has knot at one injection site on (RL). (To be expected from DTAP vaccine).
11-5-05:  Flu vaccine at flu clinic and worked in yard. 11-7-05:  Complained of aches, pains, tingling, numbness and heat all over  - down spine and down to right major toe, right thumb, left shoulder, but mainly in her neck and spine. 11-17-05: Saw family doctor and was referred for MRI of neck and had blood test.  Put on anti-inflammatory meds and Aciphex 11-23-05: Referred for MRi of thoracic region. 12-01-05: Family doctor referred patient to neurologist for evaluation of arachnoid cyst and disc problem in neck. 12-05-05: Saw neurologist who told her about cyst on spine and that the flu shot or any shot can cause neuralgia. Referred her to a neurosurgeon and placed on muscle relaxant. 12-13-05: Saw neurosurgeon.  He told her the cyst may have been there since birth or from an accident and they would just monitor it.  The neuralagia was from inflammation and he felt that it was from the flu vaccine.  Patient is concerned and does this mean that she should not get anymore flu shots in the future? and she wants to know if anyone else has ever had this happen to them?
Had given Vaxelis and had also given a dose on HIB that did not need to be given; This non-serious case was received during the Reporting System monitoring on 12-OCT-2022 with the following Primary ID 2359757-1. The original narrative from the sender is the following:  When I was documenting the vaccines given I then realize that I had given Vaxelis and had also given a dose on HIB that did not need to be given.  The reporter did not provide an assessment of causal relationship between Vaxelis and the reported events "Had given Vaxelis and had also given a dose on HIB that did not need to be given".  No further information is expected.
3-4 DAYS POST VACCINE I NOTICED A FACIAL RASH X24HRS  ALONMG WITH THAT I HAD SOME CHEST TIGHTNESS, SORE THROAT, NECK PAIN.
Headache, Aches, Chills, Fever, Lethargic, Exhaustion - Lasted 40 hours Sore Arm - Lasted 54 hours