chrisvoncsefalvay/vaers-outcomes huggingface dataset:
It felt like a summer cold. And then I did eventually lose my sense of taste and smell. That was it. It lasted about 12 -14 days. I am back to normal now. I was tired. One day I had a fever of 100.2. I think I took ibuprofen that day. No other treatment. I monitored my temperature and oxygen every day. My oxygen was never abnormal. I have all my energy back. I have my sense of taste and smell back. This was during peach season. I never lost the taste of the peach.
Per the patient's husband, on 03/26/2021, the day after vaccination, the decedent complained of nausea with vomiting, and had difficulty driving. On 03/27/2021, her nausea continued and she complained of shortness of breath while walking. On 03/28/2021, she was short of breath before vomiting a small amount. She then became unresponsive. Death was pronounced a short time later.  Per her treating physician who signed the death certificate, the cause of death is felt to be probable myocardial infarction due to electrolyte abnormalities due to complications of her diabetes mellitus.
cold sores; This case was reported by a consumer via call center representative and described the occurrence of cold sore mouth in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 20th March 2019, 2 days after receiving Shingrix, the patient experienced cold sore mouth. On an unknown date, the outcome of the cold sore mouth was recovered/resolved.   It was unknown if the reporter considered the cold sore mouth to be related to Shingrix.  Additional case details were provided as follows: The  patient reported that she developed cold sores all over her mouth 2 days after getting the dose of Shingrix. The patient ended up with 8 cold sores. It took 3 weeks for them to resolve completely. The patient consented to follow up and provided contact details of the physician related to her.
Information has been received from a physician concerning a 17 week old female with no medical history or allergies, who on 24-JUN-2008 was vaccinated with the first dose of ROTATEQ. There was no concomitant therapy. It was reported that on 25-JUN-2008 the patient developed a tonic clonic seizure, and was foaming at the mouth. The patient was seen in the emergency room and treated with ATIVAN and phenobarbital. The patient was later admitted to the hospital, intubated and placed on a ventilator, the ventilator has since been removed (date unspecified). The patient was also placed on antibiotics because the patient may have aspirated vomit. The patient has four siblings who all have upper respiratory infections. The following lab diagnostic studies were done complete blood count, electrolyte count, blood and urine cultures and CT of the head (date and results unspecified). The patient is reported as not recovered. The reporter felt that the patient's tonic clonic seizure was considered to be immediately life-threatening and an other important medical event. Additional information has been requested.
Got all vaccinations, gone within a year...cardiac arrest; This case was reported by a consumer via interactive digital media and described the occurrence of cardiac arrest in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year after receiving Shingles vaccine, the patient experienced cardiac arrest (serious criteria death and GSK medically significant). On an unknown date, the outcome of the cardiac arrest was fatal. The reported cause of death was cardiac arrest.   It was unknown if the reporter considered the cardiac arrest to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 06-NOV-2022 Reporter's Comments: This case was reported by a consumer via interactive digital media. The patient was the reporter's husband. The reporter said she was not an anti-vaxxer. The reporter mentioned as she received all her vaccinations.  Her husband, who had no heart issues received his as well.  Within a year he was gone due to cardiac arrest.  The reporter was just concerned, not radical. Additional supportive information:  This is one of 2 link cases reported by same reporter. Follow up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR163337:Same reporter. Reporter's case.; Reported Cause(s) of Death: Cardiac arrest
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 14-JUN-2016, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster. The patient was prescribed valacyclovir (VALTREX) and pregabalin (LYRICA) for management of her painful symptoms and excruciating pain. As a direct and proximate result of the 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. Additional information has been requested.
Fever 104.  stiff neck at the base of the skull with pain to move in all directions, foggy, fatigued
Information has been received from a licensed practical nurse (LPN) concerning a 7 month old male with a penicillin allergy and a history of otitis media who on 27-APR-2002 was vaccinated with a dose of Varivax. There was no concomitant therapy. The LPN reported that on 21-MAR-2006, the patient developed a chickenpox rash. Unspecified medical attention was sought, but no treatment was ordered.  No laboratory or diagnostic testing was performed. Subsequently, the patient recovered from the chickenpox rash. No additional information is expected.
This case was reported by a healthcare professional and described the occurrence of injection site dermatitis in a female subject aged between 40 and 49 years old who was vaccinated with FLULAVAL (GlaxoSmithKline). On 30 September 2010 at 15:00 the subject received a dose of FLULAVAL (.5 cc, unknown route, left arm). On 1 October 2010, 1 day after vaccination with FLULAVAL, the subject experienced injection site dermatitis. The subject treated the dermatitis at home (details not specified). At the time of reporting the event was improved. The healthcare professional considered the event was possibly related to vaccination with FLULAVAL. Follow-up received on 20 October 2010 from the healthcare professional: The subject was 48 years-old. FLULAVAL was administered intramuscularly in the left deltoid. The reporter indicated that the subject took action with TYLENOL. The events resolved on 06 October 2010. The subject had received flu shots in the last with no reactions.
Administered first of six-series Anthrax immunization course on 10 DEC 2003.  Also given #1 Hep A, #1 Hep B, Typhoid and Smallpox (smallpox not documented, but Patient describes process and procedures accurately).  Approx. 4 weeks later, had sx of coldness, numbness, twitching L side of face.  Lost expression on L side of face.  Within six months, dx w/Bell's Palsy at local facility and hospitalized.  Given 2 gm Rocephin IV x approx. 6 weeks, during and post hospitalization. Sx gradually subsided, but still has occasional coldness, twitching of L side of face.  Despite dx of Bell's Palsy w/possible relationship to vaccines, was given second Anthrax immunization on 15 Sep 2004, along with #2 Hep B and #2 Hep A.  Deployed in Oct. 2004.  Beginning Oct/Nov 2004, began to experience stiffness, pain and swelling of ankles, feet, knees, hands, shoulders, elbows, lower back (sacrum).  Symptoms ebb and flow but pain and swelling in knees, wrist, hands has gradually increased in intensity to average 7/10 pain level.  Able to function fairly well with pain at 5-6/10 level, but not higher.
NEUROPATHY ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/24/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 9:45 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:45 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 25.35.  Concomitant products were not provided.  On 27 Mar 2021, Excursion time was 09 AM and temperature was 35, Excursion time was 10 AM and temperature was 35 total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23 Mar 2021, vial was moved to clinic on 27 Mar 2021. 20 vials were sent to clinic. Vaccine BUD date was 22 Apr 2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.   This case was linked to MOD22-013597 (Patient Link).
Itchy red papules on arms and trunk.  Plaques on legs.  Mom states previous fever has resolved.  She says he is refusing to eat and seems to have more difficulty breathing (he is non-verbal).  He was seen in ER and prescribed prednisone and cetirizine lotion, but mom says he is not improved and is bringing back for re-evaluation.
No known adverse side effects occurred. Patient given a 0.5mL dose for their booster shot, but should have received a 0.25mL dose.
Felt like I had the flu. My back (kidney area) ached, I felt feverous, headache, tired - went to bed early woke up feeling better - took an aspirin during the night. My husband also had the shot at the same time - and had difficulty sleeping - restless.
Pt recv vax on 7/29/98; subsequently pt lymph nodes enlarged of left side of elbow, underarm &groin.
Information has been received from a health professional concerning a 22 year old female with hypertension and "an interstitial problem" NOS who on 09-Oct-2006 was vaccinated intramuscularly with HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Concomitant therapy included unspecified therapy.  On 16-Oct-2006 the patient developed a "quarter size knot at the injection site that was warm to touch". Medical attention was sought and the patient was treated with diphenhydramine hydrochloride (BENADRYL). It was reported that the patient will discontinue the vaccination series. At the time of this report the patient had not recovered from the event. Additional information has been requested.
This case was reported by a nurse and described the occurrence of digestive upset in female patient who received hepatitis B vaccine recombinant for prophylaxis. On 6/10/03 the patient received the 1st dose of Engerix B. On 6/11/03, one day post immunization, the patient experienced digestive upset, severe myalgias, fever greater than 102 degrees F, and anorexia. The subject had to leave work on 6/12/03. The subject was seen by the physician. The events were unresolved as of 6/12/03. The nurse considered the events were probably related to vaccination with Engerix B.
shoulder felt sore; severe headache; cough; thinks it might be COVID; sinus problems; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), COVID-19 (thinks it might be COVID), SINUS DISORDER (sinus problems), ARTHRALGIA (shoulder felt sore) and HEADACHE (severe headache) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure increased.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced COUGH (cough), COVID-19 (thinks it might be COVID) and SINUS DISORDER (sinus problems). On an unknown date, the patient experienced ARTHRALGIA (shoulder felt sore) and HEADACHE (severe headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, COUGH (cough), COVID-19 (thinks it might be COVID), SINUS DISORDER (sinus problems), ARTHRALGIA (shoulder felt sore) and HEADACHE (severe headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant product use was reported
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # L023936 and expiration date 15-MAR-2017, lot # L007559 and expiration date 01-JUN-2017, exact doses and route of administration were not reported). No adverse events were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
PATIENT REPORTED HAVING KNOT LIKE BUMPS UNDER SKIN ON HER RIGHT SIDE 5 DAYS AFTER GETTING VACCINE. THEY WERE UP HER COLLARBONE, INTO HER NECK, AND IN THE ARMPITS. THE PAIN WAS HELPED WITH TYLENOL BUT THE BUMPS WERE STILL PRESENT AT TIME OF SECOND VACCINE APPOINTMENT.
affected the muscles; affected the muscles and the overall body more than the head or the brain; affected the muscles and the overall body more than the head or the brain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA).  A 37-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid" (unspecified if ongoing), notes: I had very bad long covid. The patient's concomitant medications were not reported. The following information was reported: MUSCLE DISORDER (non-serious), outcome "unknown", described as "affected the muscles"; HEAD DISCOMFORT (non-serious), PAIN (non-serious), outcome "unknown" and all described as "affected the muscles and the overall body more than the head or the brain".  Additional information: It was the only safe vaccine for patient. She had very bad long covid and Pfizer basically saved her. The fact that it affected the muscles and the overall body more than the head or the brain. She really couldn't take moderna.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Right arm hurt at time of shot. States he had difficulty raising arm due to pain. Took Ibuprofen (without food) and it diminished over time but "still feels tightness in the muscle". Denies any numbness or tingling in arm/hand.
Joint pain; chills; headache; nausea; diarrhea; feel so bad; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;  formulation: solution for injection Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 04May2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis, degenerative disc disease and obesity. The patient was allergic to reactive oxygen species (ROS). Concomitant medications were not reported. The patient previously took sage and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04May2021, the patient experienced joint pain, chills, headache, nausea, diarrhea and felt so bad. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events of joint pain, chills, headache, nausea, diarrhea and feel so bad were recovered on an unknown date of May2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
It makes your arm hurt; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 60-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The patient received 1st dose of Shingles vaccine, at the age of 60. After vaccination the patient had pain in arm. The patient stated that, it was better than suffering with shingles. This case is linked with case US2021AMR264878, reported for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR264878:Same reporter.
Refridgeration excursions identified; No adverse event; Bivalent vaccines have undergone several temperature excursions and may have been administered to patients; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2022 at 3:45 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 23-Sep-2022 at 3:45 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and may have been administered to patients).    No concomitant products reported.  It was reported that refrigeration excursions identified, state vaccine was housed in these units. There were excursions noted. Manufactures were notified and the state department and made aware of the situation. The Nurse called for a clinic that she was assisting. The clinic had a similar issue with vaccines stored in their freezer. Vaccines stored in the refrigerator that underwent several temperature excursions going back to August 2022. Date vial moved from freezer to refrigerator was 07 Sep 2022. The vial underwent temperature excursion. The body site was mentioned as deltoid.  No adverse reactions reported for the patient.  No treatment products reported.
Hives began on knees this a.m. and have spread all over her body. Patient is being treated with Epinephrine and Claritin.
PATIENT DEVELOPED A LARGE ERYTHEMATIC AND EDEMATOUS AREA AT THE SITE OF THE INJECTIONS IMMEDIATELY AFTER RECEIVING THE VACCINATIONS.
TC from mother stating that son came home from school c/o extreme tiredness. States went to bed and slept about 4 hours. Brother had same vaccine and had fainted and c/o tiredness when home from school. Both went to school today.
On April 17  I started having a sore throat and coughing  I drank  warm tea , It felt like I had allergies. On Monday I felt really tired and achiness. On Tuesday the 19th  I went to get tested  for COVID-19 and the test came back positive . I drank plenty of water and tea. I  stayed home for 3 days   and I still have a  productive cough .
Severe throbbing headache that sent me to the emergency room a week later. CT Scan and bloodwork looked normal but unbearable headache continued.   Developed small fiber neuropathy in hands and feet. Lost sensation in hands and feet along with a burning feeling.
COVID 19 bivalent booster given as a 2nd dose. No adverse event to report.
pericarditis with pleural effusion and fib rvr. thoracenthesis, beta blocker and calcium channel blocker. NSAID, colchicine
Fever, sore discolored throat&gums, inability to eat cause vomiting& neausia, pains&aches throughout body as if had flu that lasted 4weeks. EXTREME FATIGUE  inability to function
About 3 weeks after the 2nd Moderna COVID19 vaccine, both my knees became effused and quite painful, so that it was difficult to sit and arise from a chair. Although I have mild DJD in both knees, it seldom bothered me, and less than 1 month before the vaccination, I was able to hike 3 miles up & down hills without knee pain. After onset of symptoms, pain was constant, 7/10 on most days, my knees were palpably effused, and I was having trouble getting out of bed and walking to the bathroom. I suspected a vaccine reaction, and consulted Orthopedist, who injected each of my knees with steroid. Now, 2 wks later, I am back to baseline, and am able to walk 2 miles without knee pain.