chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received vaccine at pharmacy at 1:30 PM. By 9:00 PM that evening developed rash with blisters at ankles and legs that progressed to wrists and fingers the next day. There was no rxn at inj site. 3-4 days later developed red rash at wrist line. Pt received mometasone cream and acyclovir from MD which failed to provide relief. Pt went to dermatologist who performed biopsy of blister(s) and stated that it was some type of allergic rxn unrelated to zoster. Pt stated she mowed the yard the day she received the zostavax vaccine at about 3PM. She normally does not do yard work. She stated the dermatologist gave her prednisone which helped to clear up her rash. No  more blisters developed afterward.
slight stomach spasm, racing heart, pins and needle pain in bottom of left foot and right foot, sore arm, nausea
Pt received unnecessary COVID bivalent vaccine today. Pt received J&J on 4/8/2021, Moderna booster 1/14/2022 and 8/5/2022.  Pt received Pfizer Bivalnent on 12/1/2022 then received Moderna Bivalent today, 7/27/2023.
Got big ball on her injeciton site arm; Ball on her injection site arm. was huge & hard; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Got big ball on her injeciton site arm) and VACCINATION SITE INDURATION (Ball on her injection site arm. was huge & hard) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 26-Mar-2021, the patient experienced VACCINATION SITE MASS (Got big ball on her injeciton site arm) and VACCINATION SITE INDURATION (Ball on her injection site arm. was huge & hard). At the time of the report, VACCINATION SITE MASS (Got big ball on her injeciton site arm) and VACCINATION SITE INDURATION (Ball on her injection site arm. was huge & hard) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications provided. No treatment information provided.    This case was linked to MODERNATX, INC.-MOD-2021-090356 (Patient Link).
Patient reported that her upper arm was swollen and red for about the next week after. It also began to itch toward the end of that week.
feeling very energized; pacing the floor, seems to be turned into a robot, walking in circles,; can not sit down not even to eat; In a total fog; Will not be getting the second dose; She won't eat or go to the bathroom unless she was reminded; psychiatric break.; This is a spontaneous report from a contactable consumer (patient's mother) reported. A female patient of 28 years of age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 11Jun2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. The patient medical history includes schizoaffective disorder from 4.5 years ago, went into a coma like state from that was four in a half years ago. The patient's concomitant medications were not reported. It was reported that she took the vaccine on last Friday along with two other family members and one of the family members was her daughter who has schizoaffective disorder. On 11Jun2021, the patient reported that within 15 minutes her daughter said to her how she feels very energized which never happens because her daughter takes Abilify and was never energized. Reporter stated the vaccine turned her daughter into a robot where she was walking in circles, cannot sit down not even to eat, and she was in a total fog for 10 to 15 minutes later she was respond because she was in a fog which makes her not able to comprehend what was being said. She won't eat or go to the bathroom unless she was reminded. Her daughter doesn't know what was going on. The nurse that gave it to her could be a witness. Her aunt was a NP. She felt immediately an energy boost. She doesn't think it was being reported. she found a pod cast that Covid itself has caused mental health issues in people, causing long haul bipolar disorder. The vaccine has a dead virus. It makes sense it would make you worse. she knows it had a dead virus in it. She knows people that work at the health program. Caller says she had a friend whose son was at similar age with the same disorder. "He got a Covid 19 vaccine and went on the deep end too". She wasn't sure which one he got. Referring to her daughter: "She's not going to get the second dose. She can't even do her hair. She can't even walk the dog or go outside by herself. The shot takes you back to where you were."Caller states that violent mental health patients shouldn't take it. Reporter stated this was called a psychiatric break. Treatment includes patient did not get any medicine she was just on regular medicine and not be able to get into the doctor until Friday. Therapeutic measures were taken as a result of events in a total fog, she won't eat or go to the bathroom unless she was reminded, psychiatric break. The events outcome was not recovered.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Injection was given on top of shoulder instead of back of arm.    Shoulder joint and arm started hurting 30 minutes after injection radiating down arm.  Extreme exhaustion and sleepiness but unable to sleep due to pain.  Nausea and stomach upset.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a patient (reported as one of the three patient) who received diluent potion of the vaccine PENTACEL only. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date (date not captured as it was not confirmed which patient received diluent), the patient received a First dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB(PRP/T) VACCINE lot C5545AA expiry date: 06-Oct-2019 via intramuscular route in the right thigh. It was case of actual medication error due to inappropriate reconstitution technique. No adverse event was experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Extreme chills the first evening and progressed to extreme difficulty breathing and chest pains.  I assumed it was the vaccine doing its job to build up my immunity.  So I didn't head to the hospital until my breathing was extremely labored.  At the hospital I was diagnosed with DVT in left leg and multiple pulmonary embolisms in both lungs. I had a very large blood clot in my left lung.
adverse event: dizzy, lightheaded treatment: observation outcome: released by ems after 30 min
Notified on 09/01/22 at 2:50pm that we are to no longer administer monovalent vaccine
Soreness at injection site and all of arm - within 6 hours through about 36 hours Fatigue - 6-8 hours   Body aches, headache, chills, fever - one week after for about 48 hours
Arm pain that never goes away; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain that never goes away) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20a) for COVID-19 vaccination.     The patient's past medical history included Foot fracture (patient as a history of a fractured foot on Christmas,).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced PAIN IN EXTREMITY (Arm pain that never goes away). The patient was treated with IBUPROFEN ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm pain that never goes away) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment included also heat and ice to help with the pain.   Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: No specific follow-up information recorded. On 31-Mar-2021: NNI; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received and experienced fever, freezing and had teeth chattering shivers refer linked case US2018GSK140957). On 13th July 2018, the patient received the 2nd dose of SHINGRIX. On 13th July 2018, several hours after receiving SHINGRIX, the patient experienced shivers and feeling cold. On 14th July 2018, the patient experienced injection site pain and fever. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, shivers, fever and feeling cold were recovered/resolved. It was unknown if the reporter considered the injection site pain, shivers, fever and feeling cold to be related to SHINGRIX. Additional details were provided as follows: This case was reported for reporter's sister-in-law. The age at vaccination was not reported. At 13:00 hours, the patient received SHINGRIX and at bedtime she experienced freezing and had teeth chattering shivers while she was trying to get to sleep. On the next day morning, 1 day after receiving SHINGRIX, the patient experienced fever (the patient's body temperature was recorded as 101.6 degrees F). The patient took an Ibuprofen and started to feel better by 7 pm. The patient adds that all symptoms were fully resolved. Master of doctorate (MD) contact information not obtained.
Rash shoulders, back. Mildly pruritic. BENADRYL advised. As of 11-10-09 rash resolving. Per pt, PCP thought it was contact dermatitis possibly related to soap or detergent.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown demographics. The concurrent condition, medical history and concomitant medication was not reported. On unknown dates, the patients were vaccinated with improperly stored doses ROTATEQ orally (lot # L025598, Expiry: 13-JAN-2017). No adverse effects were reported. Additional information has been requested.
Pt states that she developed a chest rash the evening of immunization. She developed a large red, hard lump at the injection site accompanied with pain. She developed a sore throat as well. The chest rash resolved in 1 week and the red lump on the arm resolved in 11 days.
Headache, blistery rash, fatigue, out-of-sorts, heart racing.  Walk-in clinic on Sunday gave a steroid shot and Benadryl.
PRETTY SEVERE VACCINE INJURY; LOSS OF COORDINATION; LOSS OF FINE MOTOR SKILLS; DOUBLE VISION; LOSS OF STRENGTH; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced pretty severe vaccine injury, loss of coordination, loss of fine motor skills, double vision, and loss of strength. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pretty severe vaccine injury, loss of strength, loss of coordination, loss of fine motor skills and double vision was not reported. This report was non-serious. This case, from the same reporter is linked to 20211212714.
Fever for 24 hours- 102 degrees, malaise, myalgia 4-5 inches of erythema at site. Improved over next few days. Mother refused childhood immunizations.
Pfizer COVID vaccines received on 7/16/2021 and 8/6/2021 Hospitalization at local Hospital on 10/20/2021. No diagnosis or treatment information available at this time  Pfizer Booster received on 2/19/2022 which is after the adverse event of 10/20/2021
Patient got the shot & got up from her chair & sat on another chair. I was giving vaccine to her sister, & when done we turned around she started to role up her eyes & head started falling then she threw up (vomited) Called 911 & hollered Per MD SYNCOPE
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Nov-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The nurse said that when the lot number of Moderna Covid-19 vaccine of 010A21A was entered into the expiration date lot number look up finder the expiration date was 14-Aug-2021. The nurse said that she had a screenshot of the above lot number 010A21A entered into the lot number expiration date check program that shows the expiration date as 14-Oct-2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Appx 5 minutes after receiving vaccine patient became short of breath, felt light headed, developed urticaria over arms and chest, and itchy throat.  BP stable initially, no wheezing, however appx 2 minutes later began wheezing/coughing and appearing drowsy. Epinephrine 0.3 mg IM given as well as 50 mg Benedryl IV, 02 by nasal cannula. Patient remained conversant and responsive throughout but drowsy and coughing. BP  and SPO2 remained stable until EMS arrived to take to emergency room.
When I woke up the next morning I suffered from stomach pain .. Rushed to the hospital for an emergency surgery  Diagnosed with Acute pancreatitis and had to have my Gallbladder removed  Gal bladder was 13CM big  Currently on Antibiotics
Migraine/Pain in the left side of the head; Pain in the left side of the body; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine/Pain in the left side of the head) and MYALGIA (Pain in the left side of the body) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stroke (Suffered Ictus in the past that affected the left side of his body.).    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced MIGRAINE (Migraine/Pain in the left side of the head) and MYALGIA (Pain in the left side of the body). At the time of the report, MIGRAINE (Migraine/Pain in the left side of the head) and MYALGIA (Pain in the left side of the body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Getting over second bout of Shingles in 3 yrs/ Suspected vaccination failure; Getting over second bout of Shingles in 3 yrs; Burning; Itching; Pain; Discomfort; Rash starts to blister; Rash starts to blister; 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.   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), shingles, burning sensation, pruritus, pain, discomfort, rash and blister. On an unknown date, the outcome of the vaccination failure, shingles, burning sensation, pruritus, pain and discomfort were unknown and the outcome of the rash and blister were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, burning sensation, pruritus, pain, discomfort, rash and blister to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-APR-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient had the Shingles vaccine and was just getting over second bout of Shingles in 3 years. Burning and itching and pain were the pain discomforts. Once the rash starts to blister it starts getting better. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Rash; Burning; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and BURNING SENSATION (Burning) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced RASH (Rash) and BURNING SENSATION (Burning). At the time of the report, RASH (Rash) and BURNING SENSATION (Burning) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications was  not reported.   Treatment information was not provided.   Reporter did not allow further contact
Right leg thigh medial to distal injection site erythematous, slightly warm, no induration, no tender 3x5 cm.
Mom called office 4/22/10 stated that pt contacted her from school. Had a bad headache but also while sitting at the table with left arm resting on table thumb became numb then each finger then hand became numb. numbness spread up arm. Mom states it resolved in 45 mins completely - Per mom pt had all imms given on 4/21/10 in left arm but per nurse who saw pt they were not.
In the fifth day after my second dose , I got severe chest pain ( stabbing pain in nature) which was localized in the beginning of the pain then started to radiate to all chest specially right side ( anterior and posterior). shortness of the breathing started with the progression of the pain , I was fainting twice because of the pain which now in the whole chest. I cannot sleep at all and even I have difficulty in breathing and even swallowing. I had severe headache since these symptoms started. the pain makes my movements limited. I have elevated temperature 39.2 c. yesterday I started medications like Paracetamol, NSAIDs and Colchicine ( as prescribed by the doctor)
I received my 2nd vaccination on Monday 01/11/21 at 1200 pm in the hospital. on Tuesday 01/12/21 at 0300 I woke up with sever rigors chills and a temperature of 100.4. throughout the rest of that 24 hour period I had severe exhaustion, pain in my upper extremities and weakness in my lower extremities with poor appetite throughout the day. Again on 01/13/21 around 0200, I woke with fever of 101.0. at that time I had to call out of work for my 7 am shift. by Wednesday 01/13 at 1300 my fever had broken, body aches decreased and appetite improved.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of COVID-19; (Dec2022) Positive, notes: positive test day 10; (Dec2022) Negative, notes: tested negative/ resolved symptoms starting at day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
PT CALLED PHARMACY TO REPORT LARGE GOLFBALL SIZE AREA AT INJECTION SITE.  THE AREA IS RED AND SWOLLEN.  PT REPORTS SEVERE ITCHING AND REDNESS BUT NO PAIN.
This spontaneous report was received from a physician and refers to a 28 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 23-MAR-2016, the patient was vaccinated with the improperly stored dose of RECOMBIVAX HB (1 ml, intramuscularly in unspecified deltoid, lot # L042846, expiration date: 15-SEP-2017). There was no adverse effect reported. On an unspecified dates from 03-JAN-2016 to 24-FEB-2016, the vaccine was exposed to 49 Fahrenheit degree (the exact length of time out of range could not be determined). This is one of several reports received from the same reporter. Additional information is not expected as all the correspondence was returned by the post office.
PT REPORTED FEELING FLUSHED AND DIAPHORETIC. NO DIZZINESS, CHEST PAIN, NUMBNESS OF EXTREMITIES, CHEST PAIN, PRURITIS OR DYSPNEA REPORTED.