chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chicken Pox lesions afater immunization with Varivax. Exposed to chicken pox 1/7/02. Varivax 1/9/02. Vesicles consistent with chicken pox and fever 1/20/2002. 20 lesions.
fatigue; falling asleep; Condition aggravated; Night sweat; heavy sweating; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included heart disease, unspecified, fatigue and dizziness.   On 8th July 2019, the patient received the 2nd dose of Shingrix. On 9th July 2019, 1 days after receiving Shingrix, the patient experienced fatigue, sleepiness and condition aggravated. In July 2019, the patient experienced heavy sweating and night sweat. On an unknown date, the outcome of the fatigue, heavy sweating, sleepiness, night sweat and condition aggravated were unknown.   It was unknown if the reporter considered the fatigue, heavy sweating, sleepiness, night sweat and condition aggravated to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received his second injection of Shingrix Monday morning. The patient felt fine within 3 to 4 hours of the shot but that night and next night experienced heavy sweating during the night. It was so bad he had to change his clothes.  The patient Also experienced heavy fatigue. The patient was falling asleep in a golf cart.  The healthcare provider neglected to inform him of the name of the drug and any side effects when they administered the shot. The reporter knew about the brand name when they called the night nurse at local Kaiser-Permanente.  The reporter asked if it was common practice for healthcare providers to not disclose either the name brand and side effects at injection. Also, these side effects pretty normal (as per GSK website) or are these cause for concern considering he already has a heart condition?  The pharmacist reported that the clinical trials, the most common adverse reactions were pain, redness, and swelling at the injection site. The most common general adverse events were myalgia, fatigue, headache, shivering, fever, and gastrointestinal symptoms. The reporter asked do you have guidance as to whether the HCP should have advised him of these events ahead of the injection and provide him the name of the drug.
This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 55-year-old female patient who received Herpes zoster (shingrix) for prophylaxis. Previously administered products included shingrix with an associated reaction of injection site pain (1st dose received in February 2021, for tolerance refer case US2021265856). In April 2021, the patient received the 2nd dose of shingrix. On an unknown date, less than 9 months after receiving shingrix, the patient experienced injected limb mobility decreased, injection site pain and tenderness. On an unknown date, the outcome of the injected limb mobility decreased, injection site pain and tenderness were not recovered/not resolved. It was unknown if the reporter considered the injected limb mobility decreased, injection site pain and tenderness to be related to shingrix. Additional details were provided as follows: The case was reported by the patient's husband. The patient received second dose of shingrix in April 2021 (exact date unknown), into her right arm this time, and again almost immediately began to experience the same type of pain in her right arm, also unresolved. On an unknown date, less than 9 months after receiving the shingrix, the patient experienced injected limb mobility decreased and tenderness. The patient had multiple tests performed and x-rays done for the issue and the doctors had not been able to identify the reason for the pain. The reporter could not provide the lot or expiration date of the shingrix vaccines administered. The reporter gave consent to contact the patient and healthcare professional. The reporter consented to follow up. GSK note- Time to onset for the event pain was provided as 5 min and in narrative it was mentioned as immediately after vaccination, patient began to have pain in her right arm. TTO captured as per structured field. Sender's Comments: US-GLAXOSMITHKLINE-US2021265856:Same reporter.
Woke up with a small red area on 03/08/2005. Area increased in size on 03/09/2005. Red, and warm on 03/10/2005, area 3"x3" red, warm.
I developed Bell's Palsy after receiving covid vaccine.  No history of Bell's Palsy.
Information has been received from a physician and a registered nurse concerning a 37 year old white female registered nurse with hypothyroidism and GERD, who on an unspecified date was exposed to mumps and on 01-MAY-2006 between 08:00 and 17:00 was vaccinated SC with a second dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot # 653128/0515F). Concomitant therapy included levothyroxine sodium (SYNTHROID) and omeprazole (MSD). There was no reported illness at the time of vaccination. It was reported that the patient received the first dose in 1978. On the evening of 14-MAY-2006 (also reported as 16-MAY-2006) the patient reported body aches, chills, being tired, a sore throat and swollen glands in her throat. Medical attention was sought. The physician reported neck pain, a sore jaw, mildly tender parotid swelling, and cervical lymphadenopathy which developed on 18-MAY-2006. A serum mumps immunoglobulin M antibody test performed on 16-MAY-2006 was positive. The patient was diagnosed with mumps. The patient had no reported adverse events following prior vaccination. On 28-MAY-2006 (also reported as 01-JUN-2006) the patient recovered. There was no product quality complaint involved. Additional information is not expected.
Per mom patient complained of arm hurting and being sore post vaccine administration at night around 2000 hours. Mom states that next day area of vaccine administration was red and tender to the touch. MD examination on 06/13/2018: Local reaction to MenB vaccine to left deltoid. 2.5x4cm redness in diameter noted. Provider Rx 20 mg of Prednisone. Instructions of medication: take 2 tabs  by mouth once a day for four days. Patient will return in 5 days for follow up.
Patient developed a quarter-sized red area around injection site. It then progressed to a 3 in by 4 inch red, warm, itchy area around the injection site, per patient. 1 week post-injection patient states it seems to be subsiding.
Severe headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 15:30 (Lot number: FH8027) at the age of 69 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Yogurt" (unspecified if ongoing), notes: Known allergies: Yogurt. Concomitant medication(s) included: LEVOTHYROXINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0158, Location of injection: Arm Left, Vaccine Administration Time: 16:00 PM), administration date: 21Apr2021, when the patient was 68 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734, Location of injection: Arm Left, Vaccine Administration Time: 17:00 PM), administration date: 31Mar2021, when the patient was 68 years old, for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 14Jan2022 13:30, outcome "recovering", described as "Severe headache". The event "severe headache" was evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: The patient was not pregnant during the vaccination. The most recent COVID-19 vaccine was administered in Pharmacy or Drug Store Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had been tested COVID-19. The patient received treatment for the adverse events with Toradal shots, muscle relaxer, gabapentin.  No follow-up attempts are possible. No further information is expected.
I had symptom on May 27, 2022. I had body aches, headaches, joint pain, fever, chills, congestion, chest pain, and a bad cough. On May 28th, 2022, I went to Health clinic and took a COVID-19 test and tested positive. I contact Dr. via health portal and he prescribe me Paxlovid. I have to take the Paxlovid twice a day for five days.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 16-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported. Treatment medications were not provided. It was reported that vial did not undergo any temperature excursions.   This case was linked to MOD21-152032 (Patient Link).
Saturday 10am - fever of 100 degrees Fahrenheit, body aches, chills and fatigue 4pm - took Tylenol (1 tablet , 500 mg) 6pm - fever broke, just fatigued  Sunday Fatigue
Headache, Myalgia, Injection site pain, Fatigue Narrative:  Other Relevant History:
Had dual shot, got Shingles/suspected vaccination failure; I got Shingles on my back; very itchy; nervous; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st Shingles vaccine years ago from reporting, when it was costly and 50 percent effected).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and nervous. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and nervous were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and nervous to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 02-Aug-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient stated that when the more effective, dual shot came out, his/her doctor said he/she should get it. The patient had 2nd and 3rd Shingles vaccine was the current new vaccine in 2021 and the patient experienced shingles on back in spring 2022, which was very itchy and nervous, not pleasant for sure The patient also stated that he/she hate to think what it would had been without the vaccine.  Additional Supportive information: This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting. Follow-up would not possible as no contact details were available.
passed out; convulse; dizziness; This is a spontaneous case from a contactable consumer (patient). A 16-year-old male patient received BNT162B2 (COMIRNATY), dose 1 via unspecified route in arm left on 07Sep2021 at 14:30 PM at patient age of 16-year-old, as single dose for COVID-19 immunisation. Medical history included COVID prior vaccination. No other medical history. The patient had no known allergies. The patient did not receive any medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Sep2021 at 12:30 PM, it started with dizziness, then the patient passed out and when he fell to the ground he began to convulse. The event resulted in doctor or other healthcare professional office/clinic visit. The patient received ibuprofen as treatment. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sore arm for first week 2/9/21- dry eyes, stinging in eyes but mostly left sided 2/10/21 woke up with left eyelid drooped over eye and left side of face droopy with partial numbness 2/11/21 could barely lift open eye and left side of face felt sluggish and looked droopy; went to dr and diagnosed with Bell's Palsy Treated with prednisone (60 mg/7 days) and Valtrex (twice a day for 7 days); Pataday eyedrops Better by Monday 2/15/21; still some droopiness on left jawline and still some dry eye.
Information obtained from chart. Unable to provide further information. Client presented to the emergency department for evaluation of an blood in his stool. He was experiencing increasing fatigue and increasing shortness of breath above his baseline. The patient denied significant chest pain, productive cough, fevers or chills, nausea, vomiting or abdominal pain.
At the beginning of the 7th day the arm got swollen, red and itchy. The area feel hot to the touch. The patient uses alcohol in the area.
Fever; Chills; Nausea; Joint pain; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170), via an unspecified route of administration in the right arm on 30Apr2021 at 15:30 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history included interstitial cystitis. Concomitant medications included vitamin a nos (MANUFACTURER UNKNOWN), vitamin d nos (VITAMIN D) and LDA trace minerals (MANUFAUCTRER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731), via an unspecified route of administration in the right arm on 10Apr2021 at 15:45, as a single dose for COVID-19 immunisation. 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 01May2021 at 08:00, the patient experienced fever, chills, nausea and joint pain. The clinical outcome of the events fever, chills, nausea and joint pain were recovered on an unknown date in May2021.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified were vaccinated with VARIVAX (merck) Injection, (strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 F for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, in house stability data can support those conditions mentioned above that the VARIVAX (merck) was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of the events was unknown. No further adverse event information was available. Follow up information (after previous telephone attempt to obtain follow up information which has been unsuccessful) has been received from a nurse concerning VARIVAX (merck) temperature excursion and one patient of unspecified age and gender who was vaccinated with VARIVAX (merck) (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012384 exp date: 31-OCT-2015 also reported as 03-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of low back pain in a 44-year-old female patient who received BOOSTRIX (batch number TF422, expiry date December 2019). Co-suspect products included TWINRIX (batch number Z75Y2, expiry date March 2020) and Influenza vaccine. Previously administered products included Novartis flu vaccine with an associated reaction of pain (aches and sniffles after receiving the dose in 2009). Concomitant products included iron, Vitamin B 12, vitamin D and Probiotic. On 18th January 2018, the patient received the 1st dose of BOOSTRIX, the 1st dose of TWINRIX and Influenza vaccine. In January 2018, 4 days after receiving BOOSTRIX, TWINRIX and Influenza vaccine, the patient experienced low back pain and bone pain. The patient was treated with ALEVE and Epsom Salt. On an unknown date, the outcome of the low back pain and bone pain were not recovered/not resolved. The reporter considered the low back pain and bone pain to be possibly related to BOOSTRIX and TWINRIX. Additional information was received as follows: The patient received BOOSTRIX and TWINRIX on the left arm, Influenza vaccine received on the right arm. The patient stated that low back pain got better but at the time of reporting it was worse again. The patient reported to her physician but the physician did not believe it to be related to the vaccines. The patient noted she had tried Epsom salt soaks, Aleve, heating pad, stretching and massage but still she was experiencing the issues. The patient was not sure whether she would complete TWINRIX series, she was referred to her physician. The patient stated that the back pain felt like it was not muscular but pain in her bones. The patient did not have the lot number and expiration date of the flu vaccine (non-GSK). The patient had provided contact details of her physician. The reported batch number of TWINRIX (275Y2) did not exist and was updated to Z75Y2, as per sales database.
Large red patch on arm where the booster was administered started on Jan 9, on Jan 10 the patch on arm is larger and hot to touch and itchy.  It's the size of a baseball.   12 hours after administration of the booster, my symptoms felt far worse than those when I received the J&J vaccine in April 2021.  Fever, extreme chills, headache, body aches.
mom brought daughter in mult macular papular lesions, erythema, sl cough, runny nose;no fever mild itchiness;child alert, playful began in diaper area;spread to upper body & face;
Information has been received from a physician concerning a female (age not reported) who on an unspecified date was vaccinated with a first dose of Gardasil (lot# unknown). On an unspecified date the patient was vaccinated with a second dose of Gardasil injection and experienced thrombocytopenia. Medical attention was sought. The physician sent the patient to the hospital. At the time of reporting it was unknown if the patient had recovered. No additional information was provided. Upon internal review thrombocytopenia was considered to be an other important medical event. Additional information has been requested.
patient started having spasms and twitching in left forearm and thumb the morning of 12/8/2021 at approximately 8:15 am while at work. spasms are not continuous but have been occurring periodically over last 3 hours. patient tried to get ahold of his doctor but was not successful. The pharmacist contacted the doctor office but they did not have an appointment available today and suggested he go to emergency room or urgent care. The pharmacist called the patient and recommended that he go to an urgent care or the emergency room and he stated he would.
Patient had previously been diagnoses with COVID 19 in October 2020. She had a fairly serious case that nearly required hospitalization. The night after receiving vaccine, she had a reaction that she described as "Like having COVID again."  She experience fatigue, fever (101.4), aches.  Pain started in neck and worked its way down the body.  Symptoms lasted approximately 16 hours.
itchy red patch devel @ the inj site 2-3wk p/vax this faded by next AM;another patch devel the evening of 29MAR itches & red;dad states there were some white spots which have faded now but a urticarial wheal is still present;
Side effects; Feeling of a strained hamstring; Pain in legs; Pain in knees; General soreness where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects), MUSCLE INJURY (Feeling of a strained hamstring), PAIN IN EXTREMITY (Pain in legs), ARTHRALGIA (Pain in knees) and VACCINATION SITE PAIN (General soreness where the shot was given) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 036B21A and 07A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced MUSCLE INJURY (Feeling of a strained hamstring), PAIN IN EXTREMITY (Pain in legs), ARTHRALGIA (Pain in knees) and VACCINATION SITE PAIN (General soreness where the shot was given). On 31-Dec-2021 at 10:00 AM, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) had not resolved and MUSCLE INJURY (Feeling of a strained hamstring), PAIN IN EXTREMITY (Pain in legs), ARTHRALGIA (Pain in knees) and VACCINATION SITE PAIN (General soreness where the shot was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was on some concomitant medication.  Treatment information was not provided.