chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RASH ON IMMUNIZATION SITE - NOT SURE WHEN IT STARTED BUT PATIENT CAME IN ON 8/30/19 COMPLAINING OF RASH AT INJECTION SITE. 2 IN BY 2 INCH
On 11/26/99, the pt developed injection site itching which intensified for the past week.
warm, red, indurated 2x2 cm ar4ea on LVE (left upper extremity).
at the injection site, burning at insertion site radiating down the arm, then extreme fatigue with blurry vision and my face started burning at this time took claritin ready tabs x2 . mild sob they took my BP it was over 170/90 hr was over 90 they took it every 15 min until it started lowering and the reddness and burning in my face got better and my vison cleared up and was allowed to go home. 3 hours after the shot started feeling short of breath , was on the phone with the allergist and was told to take my inhaler , albuterol 2 puffs and allegra 180mg. and had extreme fatigue and chills and body aches, took 2 tylenol and took a nap. 7hours after the shot all symptoms had resolved except for the arm site pain and a mild headache.
The injected vaccine burned when it was going in. Her eyes teared up and had a runny nose all day. The initial injection did not hurt, but the arm still hurts today (12/3/09), but not at the injection site. The muscle of the arm hurts, when she presses on it.
Very mild headache; This is a spontaneous report from a contactable consumer (the patient). A 37-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 16Feb2021 15:30 (at the age of 37-years-old) as a single dose for COVID-19 immunization. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3247), via an unspecified route of administration in the left arm on 27Jan2021 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunization. On 17Feb2021 13:00, the patient experienced a very mild headache. The patient was still able to focus at work. He had not needed to take any headache medicine yet. The clinical outcome of very mild headache was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Numbness in wrist and arm that was vaccinated after running and then while using a computer (this has never happened to me before). Also, I had digestive pain.
Round, erythematous lesion 7x5cm  on right thigh, mildly warm to touch non tender. Blanches with pressure.
I have waited to send this in case I had further complications. After taking shot one day I had a stroke the next, I spent 3 days in hospital after all the tests they could give me they said it was definitely a stroke a small one on the right side of brain no large damage. For several weeks after experiencing the stroke I had numbness on the right side of my face and continual headache. The top of my left arm and hand up to my elbow was numb and tingling to the touch. I have had headaches off and on for at least a month or more. I need to know what the ingredients of the shot are, there is something in the shot that obviously affected me.
I gave Tdap/Boostrix, when I should've given the patient Pediarix.
I did not have an adverse reaction to the vaccine. I tested positive for COVID-19 on 10/08/2022. I had a dry cough, sore throat, I felt off and really tired. I contacted my doctor and got a prescription for Paxlovid. I took one dose, and I got really sick with vomiting from 03:00 to 11:00PM ET. I had a red, itchy rash on my chest too. I went to the emergency for observation, and I was given IV- fluids. I stopped taking Paxlovid. One week later, I was outside doing yardwork and I got very weak and shaky. I went back to the emergency room as I had a racing heart and palpitations. It took about a month before I started feeling better. As of today, I have not had any more symptoms.
This case was reported by a nurse via sales rep and described the occurrence of injection site rash in a patient who received PEDIARIX. On an unknown date, the patient received PEDIARIX. On an unknown date, an unknown time after receiving PEDIARIX, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was unknown. It was unknown if the reporter considered the injection site rash to be related to PEDIARIX. Additional details were provided as follows: This case was not previously reported to anyone. The age at vaccination was not reported. The patient had denied permission to contact their physician. The nurse had not requested any follow up and declined to provide details for the report. The details of injection site and patient name were not available. This case has been linked to case US2016073723 and US2016073731, reported by the same reporter.
Expired Havrix administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix pediatric) (batch number KY35X, expiry date 16th February 2023) for prophylaxis.   On 27th February 2023, the patient received Havrix pediatric. On 27th February 2023, unknown after receiving Havrix pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023  Reporter's comment: The healthcare professional (HCP) reported that nurse administered an expired dose of Havrix on the day of reporting. No patient details were available. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient was administered with expired Havrix vaccine, which led to expired vaccine used.
Heart palpitations and heart arrhythmia beginning 3 days after vaccination and lasting over 24 hours straight.
Varivax given on 12/13/01 in right thigh. Mom reported fever and chills, post vax, lasting the day. Mom noted red, tender "lump" on right thigh on 12/23/01 and took him to the ER. On 12/24/01, dx'd with cellulitis of thigh. Mom was told "staph infection secondary to injection". Rx'd with cephalexin. Follow-up appt with doctor on 1/8/02 and cellulitis resolved. (Pt had a fever with 6 month DTAP, Comvax and PCV-7 #3).
Systemic: Patient complained of swelling around the eyes, She presented with increased blood pressure and pulse. Patient was given two doses of benadryl with no response. 911 was called due to high BP
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. No medical history and concurrent conditions reported. On 14-AUG-2015, the patient was vaccinated with LIQUID PEDVAXHIB (dose, route, lot# were not reported) and PENTACEL on the same day (overdose). No concomitant medications reported. No adverse effect reported. Additional information has been requested.
Headache Narrative: Reported recent visit to primary care providers office. Headache present for 4 days following vaccine
Pt adm 3/26/03 with 1 d h/o fever, confusion, loss of appetite.
Patient said she had no heart issues prior to getting the vaccine and pt stated she had a heart attack 3 days after her booster shot.  Wanted this reported.
Extremely sore at injection site. Chills for the last 3 hours. Slight dizziness while in bed.
Mom phoned me to relate child's recent illness-concerned it could be linked to Prevnar vaccine he received. Approximately twenty days post vaccination, the child developed fever, vomiting and wheezing. Treated with Erythromycin and Albuterol/saline nebulizer. He is now recovering.
The pt immediately received Td-98 on 9/24/2004, and her arm was sore immediately. For the first two weeks after immunization, she could hardly move her arm, as it was sore. The pt has no redness or swelling, it just hurts when she moves her arm. The pt reported that the is not getting worse. The pt was seen by an MD on 10/29/2004, and the pt's arm was improving, but it was still throbbing. There were no physical findings upon examination. Her throbbing arm keeps her up at night. The pt's arm has not affected her ability to work. The pt is able to move her arm, and exercise makes it better. It is when the pt lies still that arm is problem. The pt is very sensitive to medication. The doctor has suggested MSN cream, but the pt has not tried it yet.
Developed a rash around the mouth and tongue after receiving first vaccine. Was treated with diflucan.
Received shot 1040AM about 45min later had elevated heart rate, chest discomfort, then chills, body aches, tiredness, sinus congestion, went home got into bed and over the next 30 hrs. Had previous symptoms along with fever 101.5, sinus congestion, diaphoretic, nausea, diarrhea, headache, scalp tenderness, sob, pain on R side of chest with inhalation.
Pain in mouth, allergic reaction. Swelling gone after 48 hours without any form of medication.
A non-serious spontaneous report of administration to individual over 49 years of age was received from a registered nurse concerning a  66-year-old female subsequent to FLUMIST. Relevant medical history and concomitant medications were not reported. On 11-Sep-2009, the patient received FLUMIST. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable and the event is considered to be resolved. On 20-Oct-2009, it was confirmed that the patient did not experience any adverse events.
On 11/02/06 pt wife called to say pt running fever and c/o sore arm at site and injection and aching all over body. Pt taking Advil for pain and fever, Presented to clinic at 11/03/06. Temp 99.4 with pain and swelling in left arm.
Brief diaphoresis, dizziness post vaccination Vitals: HR 67, O2 Sat RA 98, BP 110/81, RR 18
One day following administration of vaccinations the left thigh became swollen with an urticarial rash. The left thigh was the site of the DTaP.
She received H1N1 vaccine Thursday 1/28/2010 started "feeling bad" on Friday 1/29/2010 in the afternoon. She had bodyaches all over her body that were "really bad".  She also states she had a sore throat and  headache but no fever. She stated when she "received the seasonal flu vaccine she had a similar reaction but did not have body aches this severe."  She stated she felt much better by 2/1/2010.  Yesterday she developed laryngitis but does not have a sore throat or fever.  She stated she does not plan to see a physician nor did she see a physcian for the other symptoms.  She did not give the name of her physcian stating "I do not like to go to doctors"
This spontaneous report has been received from a pharmacist referring to a 71 year old female patient. The did not have pertinent medical history or concomitant medications. The patient's drug reactions or allergies included cephalosporin and hydrocodone, acetaminophen (VICODIN). On 21-SEP-2017, the patient was vaccinated with PNEUMOVAX 23  (strength, dose, route, anatomical and location were not reported) lot # N000508, expiration date 19-OCT-2018, for prophylaxis. On 22-SEP-2017, the patient went to the pharmacy because "her upper arm was swollen, splotchy, red and warm to the touch " (peripheral swelling, pigmentation disorder, skin warm and erythema). No treatment was provided and none laboratory studies were performed.  At the reporting time, The outcome of peripheral swelling, pigmentation disorder, skin warm and erythema was reported as not resolved. The causality assessment between therapy with PNEUMOVAX 23 and the events was not reported.
Patient received second Shingrix dose on 4/25/22 at 4:36pm (first dose given 01/04/22). According to daughter that night patient complained of muscle ache, pain and fever. The next day 4/26/22 patient felt worse and was taken to the hospital. This morning (4/27/22), daughter called and reported that patient is in critical care. I spoke with the patient's hospital doctor who gave the following symptoms/conditions: fever, rigors, chills, multi organ failure, ischemic hepatitis, acute renal failure, DIC (disseminated intravascular coagulation). I asked provider if he felt it was due to the vaccine or could there be any other underlying conditions. He said it is difficult to pinpoint the cause and if it could be the vaccine or a combination of events. Patient is currently patient is still in the hospital. Pharmacy has quarantined the Shingrix Lot numbers until further clarification from the manufacturers.  Please note many patients have been administered Shingrix from this lot with no issues.
body aches and pain; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included central core disease.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was recovered/resolved.   It was unknown if the reporter considered the general body pain to be related to Shingrix.     Additional details were provided as follows: The patient self-reported the case. The age at vaccination was unknown. The patient stated that for the type of MS he had more prone to pain than the average population, and he experienced more than average muscle pain for average activity. The reporter stated that he had his first dose of Shingrix approximately 2 years ago and he only recalled experiencing body aches and pain  after received his first dose of Shingrix. The patient provided limited information (unknown lot and expiration date). The reporter consented to follow-up with health care professional (Pharmacy). For the tolerance of the 2nd dose, refer case US2022044832, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022044832:Same patient, same reporter
Red dots on stomach and back, started 5/23/2014, had diarrhea for 2 days, Temp of 99.
This case was reported by a pharmacist and described the occurrence of back pain in an adult female subject who was vaccinated with DTaP (manufacturer unspecified). On an unspecified date, the subject received unspecified dose of DTaP vaccine (details unknown) and experienced wrong vaccine administered (DTaP is not indicated in adults). Two days after vaccination with DTaP vaccine, the subject experienced back pain. The subject's daughter called the pharmacy and stated that her mother began experiencing back pain approximately two days after receiving the vaccination. At the time of reporting, there were no further details available for this report. At the time of reporting the outcome of the event was unspecified.
shingles; including any and all of its sequelae; Information has been received regarding a case in litigation from a lawyer and referred to a 68 years old male patient (pt). His age at vaccination was 66 years old (also reported as 67 years old). No information was provided regarding the pt's medical history, allergies, drug reactions, concurrent conditions or concomitant medications. In March 2013, the pt was administered zoster vaccine live (ZOSTAVAX) by the physician (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. As a result of his receipt of zoster vaccine live (ZOSTAVAX), in October 2014, the pt was caused to suffer shingles, including any and all of its sequelae. As a result of his receipt of zoster vaccine live (ZOSTAVAX), the pt had been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the pt required and/or will require more health care and services and did incur medical, health, incidental and related expenses. The pt was informed and believed and further alleges that he would in the future be required to obtain further medical and/or hospital care, attention, and services. The outcome of the events was considered as not recovered. The reporter considered the events was related to the suspect vaccine.  The reporter considered the events to be disability.
After the vaccine, I had a severe headache like a migraine, fever 102. I took Tylenol and Ibuprofen for a few days while this lasted. Within a week I had an awful, dry headache, which leaded to my vision to change. The migraine medication didn't help. I had extreme restless legs. Maybe a week later, I noticed my vision was not great. I was closing one eye to look at things on my phone. I was diagnosed with a stigmatism, and given contacts by my doctor. A few weeks later, I was told again at another eye exam that it was much worse and needed corrective lenses for both eyes.
went on a hunting trip and said had leg cramps, too.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (went on a hunting trip and said had leg cramps, too.) in a male patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Dec-2021, the patient experienced MUSCLE SPASMS (went on a hunting trip and said had leg cramps, too.). At the time of the report, MUSCLE SPASMS (went on a hunting trip and said had leg cramps, too.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.   No treatment information was provided by the reporter.  The patient got the Moderna COVID-19 Vaccines. Patient went on a hunting trip and had leg cramps.   Reporter did not allow further contact
hearing loss in left ear; tinnitus; This is a spontaneous report from a contactable consumer (patient). A 82-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: unknown), on 24Feb2021 (at the age of 82 years old) as a single dose in the left arm for COVID-19 immunization. Relevant medical history included known allergies: Keflex. Historical vaccine included: first dose of BNT162B2 lot number=en9581, administration date=03Feb2021 at 02:00 PM, Right arm.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included warfarin sodium (WARFIN), Spironolactone, Torsemide. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26Feb2021at 14:00 AM, the patient experienced Hearing loss in left ear, and tinnitus. No treatment was received for the events hearing loss in left ear and tinnitus. The outcome of the events hearing loss in left ear and tinnitus was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Large rash/swelling at injection site like an enormous bug bite. Noticed itching immediately following injection and some swelling/hardness a few hours later, didn't notice full rash until the following day. Had soreness and swelling/hardness with first injection in a smaller area with no rash.
Client received Hep B injection on Thur 8/1/02. in the evening of the same day her mother noticed red, pruritic, rash on her neck and back. On Friday 8/2/02 the rash her arms, legs, stomach. On Sat 8/3/02 muscle aches , heaches, general swelling. Referred to physician client went to Dr who facts that the rash was d/t vaccine .Gave Benadryl inj. Dr questioning of client has mononucleosis.
This spontaneous report as received from a 71 years old female consumer refers to herself. The patient had none pertinent medical history. The patient had none drug allergies. On 12-OCT-2012 the patient was vaccinated with ZOSTAVAX (lot # reported as H012521, expiration date reported as 09-OCT-2013). Concomitant medications included calcium, vitamin D and unspecified organic treatments. It was reported that the patient believed that she might be coming down with a case of shingles. The patient explained that "2 days ago", on 16-OCT-2012 she had a little break out at the corner of her mouth, and "yesterday", on 17-OCT-2012 she developed 3 very itchy dots in 3 inch areas on her chest. "This morning", on 18-OCT-2012, on her left upper arm she developed an itchy patch in about a 3x3 inch patch that was pink, and has turned red at the time of reporting. It was subsequently reported that the patient also explained that she had additional symptoms including chest pain and pain that went down her left arm that had occurred in the last few days as well as tiredness and weakness inside her thighs that began "today", on 19-OCT-2012. The patient did not seek medical attention. She took a couple of aspirin to treat these symptoms. The patient also mentioned that she was taking BENADRYL to stop her initial reaction with the itchy patches on her chest. After taking BENADRYL the itching has stopped. Treatment given for the adverse events also included: lavender essential oil and OLUX FOAM. Lab diagnostics studies performed were reported as none. The adverse events did not improve. The outcome was reported as not recovered. Additional information has been requested.
Patient was administered Fluzone Quad and Shingrix on same day 11/18/2019. Patient presented with rash and redness on upper arm 1/11/2020. Went to physician and received medrol dose pack. Pain increased and went to physician 1/20/2020 and diagnosed with shingles.
experiencing shoulder problems / had shoulder pain; had sore arm for 2-3 days; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included arthritis.   On 18th April 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th April 2021, less than a day after receiving Shingrix, the patient experienced shoulder pain and pain in arm. On 21st April 2021, the outcome of the pain in arm was recovered/resolved. On an unknown date, the outcome of the shoulder pain was not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received her 1st dose of Shingrix in unknown arm and experienced sore arm for 2 to 3 days and recovered. The patient also had shoulder pain that had not recovered. The patient had already consulted with her healthcare professional regarding the shoulder pain and her healthcare professional said it was her arthritis. The patient did not consent to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021139680:same reporter - same patient - (FU1)
Pfizer-BioNTech COVID-19 Vaccine EUA Neck pain on left side of neck (same side I got the needle in). Mild pain began on Saturday night, went away and returned on Sunday night (still mild), went away and returned on Monday night. Beginning Monday night, the pain was severe and severe pain lasted until the following Saturday (5 days). Neck was stiff, hot to touch, and in pain even when not moving it. Advil helped but did not fully resolve. On Saturday afternoon, the pain decreased suddenly and pain completely subsided by around Tuesday.