chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of ringing in ears in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced ringing in ears. On an unknown date, the outcome of the ringing in ears was unchanged. It was unknown if the reporter considered the ringing in ears to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 62 years or 63 years. It was unknown to the reporter if there was a previous medical history of ringing in the ears. The patient received SHINGRIX 2 to 6 months before the date of reporting at another retail pharmacy, and since the first dose had been experiencing ringing in his ears that was still ongoing. The pharmacist did not having any vaccine information from the 1st dose. The previous pharmacy had no record of administration. The patient presented for 2nd dose of SHINGRIX to a retail pharmacy. The date of first dose administration was unknown, onset of ringing in ears was unknown, interventions or MD/ER treatment were unknown. The pharmacist stated she did talk to patient about starting a B Complex to assist with ringing in the ears, unknown if patient followed this intervention recommendation. The pharmacist stated not knowing many adverse event question answers due to her pharmacy was not the administering location. Additionally, the patient only shared limited details.
NEXT DAY AFTER THE VACCINATION SHE HAD REDNESS AROUND THE INJECTION SITE (3 INCH DIAMETER), AND IT WAS ITCHY AT THE INJECTION SITE.
Information has been received from a healthcare worker referring to a patient of unknown age and gender. No relevant medical history or concurrent conditions were reported. On 02-JUN-2016 the patient was vaccinated with a dose of GARDASIL (dose, route, dose number, lot# and expiration date were not reported) that had been mixed with 1 whole vial of sterile diluent prior to administration. No adverse effects were reported. Additional information is not expected as no contact details were available.
NAUSEA, PAIN STARTED ABOUT 6 PM, THEN VOMITING 12/28/09 Discharge summary, ED and Hospital records received for DOS 10/28/09-11/05/09. Pt. presented to ED with LUQ abdominal pain, nausea and vomiting and found to have high lipase and admitted. Ureteric stent placement for ureteric stone. Discharged stable to f/u with PCP. DC DX: Left renal calculi s/p removal and stenting; acute pancreatitis, resolved.
At 12:40 pm 52 years old female, complain of itching all over her left hand. Patient is allergic to Levaquin. Has history of Hypertension. BP 200/110, HR 85, RR 16 and OS 98 %. Patient stated that she took her blood pressure medicine last night. Nurse gave patient some water. Patient stayed for 30 minutes for observation. 13:10 pm BP 180/100, HR 87, OS 98% RR 16. Patient stated that her hand was no longer red and itchy. Patient stated that she was not dizzy and was standing by her chair. Nurse advice patient to check with her MD about her elevated blood pressure. Patient stated that she felt good. Patient was released at 13:25 pm.
I had the 2nd Moderna dose on 4/16.  Two weeks after vaccination (4/30) I got tinnitus.   I hear the heartbeat with an unpleasant echo. It's just happening in my right ear. Mornings are the best moment of the day. I am having problems to fall asleep. My doctor recommended Fluticasone nasal spray and Zirtec.
Hives-onset 2 days later, increased in intensity until office visit 5 days later. Also had cough and vomiting x 3-4 days at time of office visit. Started 1-2 days after hives onset.
Patient came to pharmacy seeking flu vaccine. Vaccination was processed correctly. Vaccinating pharmacy technician administered moderna covid vaccine by mistake.
Received boosters: MMR given in left arm and Varicella vaccine to right arm (tricep) subcutaneously on 6/10/2011 due to negative titers. Approximately 12 hours later she felt tired and "not herself" and felt as if she were coming down with a cold. The next morning she awoke still ill vomiting once a large amount of white frothy gastric juices (did not eat that am) prior to 5K walk/run. During the 5K, she c/o increased fatigue and body aches with last 1/4 mile of walk unrelieved with fluids/gatorade. She returned home and took BENADRYL and TYLENOL taking every 4-6 hours for the next 24 hours. She advised as BENADRYL wore off Sat evening she noted hives to her chest which resolved by taking more BENADRYL. Sunday am her right arm was very painful with 10x6cm erythematous swelling hive like reaction to VAR site. She was seen at hospital being diagnosed with local site reaction and instructed to use VICODIN and KEFLEX if s/s worsen, Monday 6/13/11 continued fine macular redness to face, arms, palms of hands, soles of feet, and legs denying active rash to chest/back/abd. Also c/o: scalp and neck itching itches, no headache, no sinus pain, and no sinus pressure. Nausea vomiting x 3 days (vomited day 1 but nauseated x 2 days) okay 6/14 but little appetite, body aches on 6/11/11 now okay.  Skin symptoms: hives to chest on 6/11 now diffuse small red bumps to arms, legs, face, upper chest, neck that itch. No fever but felt feverish (up to 100F?) over weekend self treating with TYLENOL. No eye symptoms. No otolaryngeal symptoms. No cardiovascular symptoms. No pulmonary symptoms. No genitourinary symptoms. No hematologic symptoms. No neurological symptoms. 6/14/11: actively scratching arms and legs with tenderness and pain to right tricep with redness and hive at vaccine site 2/3 circumference around upper right arm (tricep region). Denied any new clothing, deodorants, detergents, soaps, hair care, foods, exposures to insects, plant life, animals, new medications, or any change in routine over last 4 months. She denied any headaches, chest pain, shortness of breath, edema, or other systemic symptoms.
Chills when I went to bed. Woke up 12:30 am with nausea, chills, rapid heartbeat. Took Tums.
Received vaccine. Acute varicella; > 50 pox in first 24 hours. Positive exposure.
At 2 a.m. on January 10th, I woke up with a high pitched ringing  sound in my head. The sound was constant and disrupts my sleep significantly. It is always present but not as noticeable during the day when there is noise in the surrounding area, however, my job requires a lot of report writing and for that I work in silence. Therefore, the ringing sound is very distracting and makes it hard to focus. I saw my general practitioner, on January 14th at 4:15 p.m.. She cleaned out my right ear and started me on a 6-day steroid. She did not clean out the left ear because it did not appear to have any wax buildup. I began taking the steroid on Saturday January 16th. The ringing is still there but it does seem to be more on my left side than my right now. I went to an ent specialist on January 19th who checked my hearing and said there was no hearing loss. Her recommendations were to call her in a week and if ringing doesn't go away, she will try another steroid. As of today, the ringing is still present and I have finished the course of steroid.
suspected vaccination failure; shingles on face, neck, chest and nose; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's daughter. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got mild shingles on face, neck, chest and nose. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Pt received FLU and PNEUMOVAX vaccine on 10-28-08. On 10-29-08 pt woke up with fever, chills and body aches. No SOB, hives, swelling or itching.
pt recv vax 5APR97 10AM & 6PM 5APR97 feeling blah MN on 5APR97;temp of 102 took APAP;Sunday arm started swelling;8APR97 saw MD;
Fatigue for 2 days Nausea and vomiting occurred 34 hours after injection Fever/chills for 24 hours the day following the injection Sore arm muscle
Stroke symptoms,  double vision,  numbness of lips, tongue , mouth and gums. General weekness,   shaking and confusion. Symptoms began receding after 20 minutes.  As EMS arived
On March 5th I woke up with low grade fever and headache, eyesight was like a veil over my eyes and I could not see well at all.  It was as if cataracts had appeared over both eyes overnight. I slept off and on all day, drank lots of liquids and took Tylenol for the fever. The symptoms cleared up at 7:00 am on March 6th. I did not take any of my medications on March 5th except for my eyedrops, that seemed to help with my vision problems.
This case was reported by a pharmacist and described the occurrence of exacerbation of psoriasis in a subject of unspecified age and gender who was vaccinated with FLUARIX (GlaxoSmithKline). Concurrent medical conditions included psoriasis. In 2011 the subject received unspecified dose of FLUARIX (unknown details). In 2011, less than one year after vaccination with FLUARIX, the subject experienced exacerbation of psoriasis. Per the pharmacist, the subject experienced "aggravation of underlying psoriasis" and also described it as "aggravation of their full-body psoriasis subsequent to their 2011 FLUARIX dose." At the time of reporting the outcome of the event was unspecified.
Day after shot and physical, pt. dev flu like symptoms, severe myalgia and fatigue, then fever and severe cough- went to uc- had fever, abnormal chest xray, and was given Zpack. Was seen at my office and was in resp. distress, hypoxemic, sounds of pneumonia and 15 lb. weight loss, dehydration. Was given Rocephin shot and admitted to hospital.
Bad intestinal side effects; This case was reported by a consumer via interactive digital media and described the occurrence of gastrointestinal disorder in a 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 gastrointestinal disorder. On an unknown date, the outcome of the gastrointestinal disorder was unknown.   The reporter considered the gastrointestinal disorder to be possibly related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media.  The reported had asked that why anyone would not tell us the efficacy of taking just one of the 2 shots. The patient had bad intestinal side effects and thought it to be from the first shot. Additional supportive information: Follow-up would not possible as no contact details were available.
Very ill feeling started on the following morning from the vaccination. Joint and muscle ache, chills, headache, stomach ache and fever. The symptoms were severe on the first day, and they were gradually fainting during the next two days. Was unable to work on the next day following the vaccination.
11/15 Pt was given the Anthrax shot, but on 11/16/03 my menstruation cycle started, it really was too early for my period at this time.
Patient received vaccine in right Deltoid, immediately following administration pt stated to nurse ?I feel like everything is going dark and I'm going to pass out.  Nurses then escorted the vehicle the pt was in to observation where they assisted the  ambulatory pt from the passenger side of the vehicle to the observation tent. Pt was placed on the stretcher in a very mild  trendelenburg position. Skin Vitals, BP, Pulse Rate, Oxygen Saturation, Respiratory Rate/ Quality, pupils were all assessed with unremarkable findings. A BG test was performed with a reading of 110. Water was provided to pt and supportive care was continued for 15 minutes. At which point the pt stated ?I feel much better. Pt was encouraged to stay another 15 minutes for further observation. Pt did remain in observation for an additional 15 minutes but she stayed in her brother vehicle with her brother. Upon completion of the 15mins pt stated I feel fine. Providers then felt comfortable with her leaving the site as she was with her brother and would be with family all day.
This spontaneous report as received from a healthcare professional refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot #, expiration date, dose and route were not reported). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Patient developed wheezing, face tingling all over but mostly on one side, throat tightness, difficulty swallowing but no trouble breathing, 20 minutes after receiving the 1st dose. These symptoms lasted for 10 hours until she used her inhaler.
2/1/21 first , 2/18/21 second first   2/1/21   , fever started 2/19/21 am  103 temp. earlier,      102.7 temp. now ( has taken no meds so far)  Advised to take apap or ibuprofen to keep temp < 101
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 55-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included breast cancer. Concomitant products included Shingrix. On 31st July 2018, the patient received the 2nd dose of Shingrix (intramuscular). In July 2018, less than a month after receiving Shingrix, the patient experienced swelling arm. On 31st July 2018, the patient experienced pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were recovered/resolved. It was unknown if the reporter considered the swelling arm and pain in arm to be related to Shingrix. Additional details were reported as follows: This case was previously reported to the physician. The patient age at vaccination could be 55 or 56 years old. The patient received Shingrix in left arm. The patient received Shingrix in appropriate muscle and immediately experienced soreness at the injection site and at the top of her left arm. The patient also experienced swelling in her left arm. However, it was not as severe as the swelling that occurred after the 1st dose of Shingrix. The swelling and soreness after the 2nd dose only lasted for 2-3 days. This case was previously reported by the patient. This case linked with case US2018147996, reported by same reporter for the same patient.
2 1/2 hours, post vax, I had chills lasting for several hours. The arm, from injection site to elbow, was hot, edematous and red. The MD saw area on Monday. Rx'd Biaxin 500mg BID X 10 days. The arm was very painful for 1 full week.
PT RETURNED DAY FOLLOWING INJECTION WITH LOCALIZED REACTION (REDNESS AND SWELLING) AT INJECTION SITE.  BENADRYL 50 MG IM GIVEN.  RX FOR ORAL BENADRYL GIVEN.  RX FOR AMOXICILLIN ALSO GIVEN.
is a 39 yo M with no significant PMH. He presents for symptoms following Johnson and Johnson vaccine.   PMH: none PSH: Right knee surgery, Lasik   Family Hx: Denies any family history of HTN, clots, heart disease   Patient received the Johnson and Johnson COVID-19 vaccine on 4/11/21, he began feeling tiered, headache and bilateral leg pain on 4/12/21. He had one dose of Tylenol 4/12/21. At around 4pm on 4/14/21 he reports that he had SOB, more bilateral leg pain, and dizziness. He states he went home and slept. Woke up Thursday and all his symptoms had resolved. Denies chest pain, numbness, tingling, swelling in his legs.   Patient does endorse that he does have a stressful job working for airport and he had 3-4 cups of coffee daily. He also endorses that after the new of the side effects of the Johnson and Johnson vaccine appeared, he did notice he had more anxiety.   Occupation: Works at airport, 12 hours shifts, on-call Social: no drinking, no drugs, smokes 1 cigarette per day for past 8 years
Approx 6 hrs after receiving 6mo vaccine had vomiting with associated limp/pale episode. No seizure activity. Returned to baseline within 60-90 min.
Approximately two minutes after patient receiving  the vaccine shot complained of lightheaded and had  self-limited systemic hypotension. Symptom and blood pressures resolved within 15 minutes.  Patient later referred he had a similar episode when he donated blood in the past.  Patient previous leaving the vaccination clinic recover himself completely denied any constitutional symptom including chest pain, headaches, nauseas or vomiting and vital signs were within normal limits.
This spontaneous report as received from a physician assistant via company representative refers to a 73 years old patient. The patient was vaccinated with a dose of ZOSTAVAX (lot number not provided) subcutaneously on an unknown date. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced shingles after receiving ZOSTAVAX. The outcome of shingles was reported as recovered. The patient saw healthcare professional (HCP) for seek medical attention. Additional information has been requested.
Patient reporting severe Chest Pain, Shortness of breath, Lymph node swollen, Significant Heart Inflammation around heart.
tested positive for COVID after getting both shots.; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Apr-2021. The most recent information was received on 09-Apr-2021 and was forwarded to Moderna on an unknown date.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID after getting both shots.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID after getting both shots.). At the time of the report, COVID-19 (tested positive for COVID after getting both shots.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: positive (Positive) positive.         No concomitant medication reported.  No treatment medication reported.  Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Upon internal review on 21-Jul-2021, an event (lack of drug effect) was added. Suspect drug dosing was also updated.; Sender's Comments: Based on the information provided, the natural history of COVID-19, and the established profile of mRNA-1273, a causal association between the event of COVID-19  and mRNA-1273 use is assessed as not applicable.
short lived apillary adenopathy; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 73-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 72 years intramuscular, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Adult onset atopic dermatitis", start date: 01Jan2012 (unspecified if ongoing), notes: Pertinent details: Treated with various beam UVB. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 1st, Date: 11Jan2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 11Jan2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "short lived apillary adenopathy"; BNT162b2 (Dose: 2nd , Date: 04Mar2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: EN6201), administration date: 04Mar2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "short lived apillary adenopathy", "1st dose: 11Jan2021; 2nd dose: 04Mar2021"; BNT162b2 (Dose: 3rd , Date: 28Sep2021, Site and route of injection:, Anatomical site of injection: Left deltoid, Route of administration: Intramuscular, Batch/Lot number: 301558A), administration date: 28Sep2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "short lived apillary adenopathy". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "short lived apillary adenopathy".  Additional information: Reported as, only side effect from vaccine was short lived apillary adenopathy or the side of the injection. Sender's Comments: Linked Report(s): PFIZER INC-202300066370 same patient and event, different dose number;
Fever 102-103, chills, body aches, vertigo(accompanied by nausea), localized reaction at injection site 6 inches by 8 inches with redness, induration and heat, amber colored urine, despite drinking adequate fluids. These symptoms started 23-24 hours post injection and lasted 48+ hours. The localized reaction is still  there, but getting better today, which is 5 days later.
Developed fatigue within 5 hours. Developed severe full body aches, chills, night sweats, headache, fatigue, restlessness, and sore muscles 11 hours after injection. As of 31 hours post-vaccination, side effects continue.
vaccination site pruritis; vaccination site redness; vaccination site swelling; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore arm), VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE SWELLING (vaccination site swelling) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced ARTHRALGIA (sore arm). On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE SWELLING (vaccination site swelling). On 10-Feb-2021, ARTHRALGIA (sore arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (vaccination site pruritis), VACCINATION SITE ERYTHEMA (vaccination site redness) and VACCINATION SITE SWELLING (vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Swelling of both hands and arms. Hives presenting on both arms and wide spread itching and redness. Referred to physician. Outcome unknown at this time.
Will hold DTAP vax until further discussion w/parents; pt exp convulsions & hallucinations p/DT vax;
I went into the hospital 5/7/21 with a blood platelet count of 2 8/21/20 platelet count was 230 9/8/2020 platelet count was 213 4/19/21 platelet count was 161 Since my transfusion in the hospital my platelets have varied from a high of 120 to a low of 55