chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got my two shots, have had shingles twice/Suspected vaccination failure; have had shingles twiceseveral years ago; Excessive amount of pain; Skin is on fire. Clothes bushing against is excruciating; 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.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain and burning sensation. On an unknown date, the outcome of the vaccination failure, pain and burning sensation were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain and burning sensation to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 30-Oct-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got his/her shots and have had shingles twice several years ago. The patient stated that the shingles cause an excessive amount of pain, like the skin was on fire and any clothes bushing against them was excruciating. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Began having tight throat and anxiety after vaccine. no wheezing, lungs clear billaterally. Vitals stable, waited 30 minutes and then discharged to home.
right and left side  body pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (right and left side  body pain) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis.    On 09-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced PAIN (right and left side  body pain). The patient was treated with CYCLOBENZAPRINE at an unspecified dose and frequency. At the time of the report, PAIN (right and left side  body pain) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Fever to 102-103F for 48 hrs after shot. Emesis for 5 days after shot. It took 2-3 weeks for appetite, energy and disposition to recover.
Information has been received from a physician, via a company representative, concerning a 21 year old female patient who was vaccinated (date not specified) with a dose of Gardasil vaccine (yeast). Right after the shot was administered, the patient experienced "more than moderate itching" at the injection site. At the time of this report, the physician reported that the patient was recovering. The patient sought unspecified medical attention. The patient's two sisters also experienced the event as described above after vaccination with Gardasil vaccine (yeast) (WAES0703USA04922, 0703USA05417). Additional information has been requested.
2 day history of rash prior to presentation. On exam, 12cm x 15 cm around erythematous rash lat/post. (L) arm warm to touch, multiple bullae laterally -> given prednisone, KEFLEX pt also presented with torticollis 2 weeks later -> given MOTRIN, BENADRYL
This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma since 2016, COPD since 2013, Peripheral vascular disorder since 2016, Penicillin allergy (Rash as child) and Osteoporosis since 2019. Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 2020 to an unknown date for Asthma, IPRATROPIUM BROMIDE, SALBUTAMOL SULFATE (IPRATROPIUM/ALBUTEROL) from 2012 to an unknown date for COPD, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) for Dry eye syndrome, ABALOPARATIDE from 09-Jan-2020 to an unknown date and ABALOPARATIDE (TYMLOS) from 01-Sep-2020 to an unknown date for Osteoporosis, GLUCOSAMINE & CHONDORITIN for Prophylaxis, VITAMIN D NOS for Vitamin D decreased, LEVOTHYROXINE from 08-Sep-1986 to an unknown date and LEVOTHYROXINE SODIUM (SYNTHYROID) from 09-Aug-1986 to an unknown date for an unknown indication. On 12-Jan-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Jan-2021 at 4:00 PM, the patient experienced DIZZINESS (Dizzy). On 12-Jan-2021 at 6:30 PM, DIZZINESS (Dizzy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, Heart rate: unknown (normal) Okay. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant medications also included Doctor dry eye formula Bid PO for Dry eye syndrome. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Mar-2021: Follow-up received updated patient details, medical history, concomitant medications, second dose information. On 14-Apr-2021: Follow-up received updated past medical history start dates and additional concomitant medications.
Pfizer-BioNTech COVID-19 EUA Significant swelling of the face, neck, and extremities for >18 hours starting 20 minutes after injection. Fever of 101 degrees and chills 18 hours after injection. Significant muscle pain and injection site swelling and redness lasting >3 days. Loss of appetite, nausea, and diarrhea lasting >3 days.
Pt stating arm is very sore, difficulty moving it. Pt is taking Motrin and using hot pack. Reaction lasting >2 days.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2012, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the intended purpose of long-term prevention of shingles and zoster related injuries (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 15-AUG-2016, the patient was treated by a physician for herpes zoster or shingles.  As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
None:  Gave expired covid 19  shot. expired 10/25/2022. Given 1-9-2023
swollen lymph glands under right arm, breast, collar bone , neck pain lasting >11 days
Started with fever of 101.3, aching all over-hurt to touch skin, extreme fatigue, headache all that started about 12 to 15 hours after injection was given and lasted about 12 hours. I'm not sure if this next part has anything to do with the vaccine but I have an IUD(birth control) and I have not had a mensal cycle in over 4 years and about 48 hours after my injection I started with a lite mensal cycle. It's just very strange that I have not had anything in over 4 years and started this after the vaccine and that's the only thing I have done or changed.
A report was received from a physician via a medical representative concerning a 3 year old female. Her medical history, concurrent diseases, and concomitant medications were not reported. On an unknown date, she received nasal FLUMIST. The medical doctor mentioned that two to three years ago a previously healthy 3 year old female died within three days of receiving FLUMIST in her office. The medical representative was uncertain whether symptoms began shortly after dose or three days later. At an unspecified time period after FLUMIST, the patient started vomiting and collapsed. She was taken to hospital three days after receiving FLUMIST and died. The physician stated that all the tests were negative, and the child was afebrile. The medical representative was uncertain whether an autopsy was performed. She also stated that the doctor thought the death was related to FLUMIST. The official cause of death was cardiac arrest. On an unspecified date, the patient died from the event of cardiac arrest, and at the time of reporting the outcome of the event of collapse and vomiting was unknown. According to the reporter the adverse event of cardiac arrest was considered to be serious with the serious criteria of death and the adverse event of vomiting was considered to be non-serious. According to the company physician the adverse event of collapse was considered to be serious with the serious criteria of important medical event. According to the reporter the adverse events were causally related to the suspect drug of FLUMIST.
LOCAL REACTION:  ITCHING, ERYTHEMA, INDURATION AT SITE AND SURROUNDING TISSUE.  EVALUATED IN ER ON 7/15/17:  WAS GIVEN ORAL BENADRYL, 25MG. AND KENALOG CREAM TOPICAL.  STILL HAS ERYTHEMA/INDURATION AT SITE, SIZE IS DECREASING.
Starting 06/28/2022, she had a fever, body aches, chest congestion and runny nose. It mimicked allergies but with a high fever and body aches. We did at an at home test the same day and it was positive. We called the doctor the same day and they advised me how to treat symptoms at home and advised me to seek care if it progresses. Within 48 hours, she woke up completely normal.
Pt came in for 2 1/2 year physical and let father know that pt was eligible for bivalent booster vaccine. Dad did not disclose that pt had the bivalent vaccine approximately 6months earlier. Bivalent shot was administered to pt. Mom later called to state that she had sent in the pt's vaccine card electronically earlier and it confirmed pt had bivalent vaccine previously. The record was scanned into the chart without the vaccine record updated. Pt did not exhibit symptoms and has not had side effects.
Patient received first shjingles vaccine on wednesday, On Thurday around 10am you noticed about 2 inches orf redness and swelling around where the cvaccine was given. The redeness  increased an inch every day until Sunday  when it went away but the swelling remained unchaged. On Tuesday 06/28 she noticed the same redness had returned. She denies pain, numbness, tingling.
Patient states pain in left arm and swelling. Fever over 100 degrees. States pain started on ride home.
Pt w/ Syncope and dizziness.  BP 115/71, HR 65, RR 12 -- > 115/68, 73. Pt stable and released from the vaccination site.
Patient became very faint and almost collapsed minutes after being vaccinated. Her partner caught her and we ran to her and asked her if she felt like her throat was closing and if she wanted an epipen injection, she said no.  she said she felt very tired, we asked her if she wanted an ice pack, and she said yes, so we gave her a cold compress,  we also gave her a graham cracker and room temperature water per her request and called the paramedics
Injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).  On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). At the time of the report, VACCINATION SITE PAIN (Injection site soreness) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Large volume of vaccine ran down arm during the shot; Large volume of vaccine ran down her arm; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and a large volume of vaccine ran down her arm during the shot.    The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection. During the administration, a large volume of vaccine ran down the patient's arm during her shot. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, large volume of vaccine ran down her arm during the shot, was resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a female patient of unknown age who received her first of two planned doses of mRNA-1273 (Lot number 028L20A) intramuscularly for prophylaxis of COVID-19 infection and during the vaccine administration, a large volume of vaccine ran down the patient's arm. There were no reported adverse events after the vaccine was administered in this case of underdose and exposure via skin contact.
Pt received the PNEUMOVAX in her lt deltoid on 6/19/18. She came back to the office on 6/20/18 because her left bicept developed redness, swelling, pain and itch. The affected area was the medial half (inner aspect of the bicept), not the the deltoid. Redness and swelling was noted along the inner arm from just below the axillary area to just above the elbow. Pt's PCP was notified that morning. Pt was instructed to apply ice packs, Benadryl cream, Hydrocortisone cream. She was also told to notify the office if these interventions do not relieve the symptoms. This writer had to call the pt with lab results the next day and when asked about the rash pt stated that the redness and swelling had move behind the elbow (onto the lower tricept). I advised the pt to elevate the affected arm as much as possible (in addition to applying ice and hydrocortisone cream which helped the itch).
extreme soreness started again; arms were sore; arm where the vaccine was received is extremely sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (extreme soreness started again), PAIN IN EXTREMITY (arms were sore) and VACCINATION SITE PAIN (arm where the vaccine was received is extremely sore) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arms were sore) and VACCINATION SITE PAIN (arm where the vaccine was received is extremely sore). On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (extreme soreness started again). On 11-Mar-2021, PAIN IN EXTREMITY (arms were sore) had resolved. At the time of the report, PAIN IN EXTREMITY (extreme soreness started again) and VACCINATION SITE PAIN (arm where the vaccine was received is extremely sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Doses were administered after 24 hs of the first puncture of the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered after 24 hs of the first puncture of the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Narrative:  No adverse drug reaction involved in this report. This report is for reporting multiple vaccinations given to patient. Patient received 4 COVID-19 vaccines: Dose #1 (Pfizer) received on 1/13/21 at agency #1 Dose #2 (Pfizer) received on 2/5/21 at agency#1 Dose #3 (Moderna) received in error on 2/15/21 at agency#2. This immunization note has been addended to document error. Dose #4 (Moderna) received in error on 3/17/21 at agency#2. This immunization note has been addended to document error. Risk factors: h/o of schizophrenia. Patient came into agency#1 COVID19 Vaccine clinic on 4/22/21 08:59 to get his "3rd vaccine." RN there explained he has received the recommended 2 doses with agency#1; no documentation regarding 2 Moderna doses received from agency#2 in conversation. Pt stated that "his doctor told him to come and get it." RN explained that a 3rd dose is not indicated at this time and notified PCP regarding this matter. No ER visits or hospitalizations since additional doses. Charting and vaccine scheduler system involved in error.
Shot in upper right arm near shoulder. 3 hrs later, 12:30 or so, arm " hurt" when I move. Swollen and bright red color, and put cold compress and later heat till about 6:00 pm. Sat. and Sun. still hurt, and Mon. better and light red.
This case was reported by a nurse via sales rep and described the occurrence of rash in a 72-year-old male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced rash and itchy upper limbs. On an unknown date, the outcome of the rash and itchy upper limbs were recovered/resolved. It was unknown if the reporter considered the rash and itchy upper limbs to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, however it could be 71 or 72 years old. The patient developed rash on lower right abdomen and had severe itching on left arm and chest. The symptoms resolved by own. The patient did not receive the 2nd dose till the time of reporting.
Extreme swelling in "my" arm all the way up into "my" neck.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an unspecified route of administration in the right arm on 02Aug2021 at 13:45(at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 02Aug2021 at 14:30, the patient experienced extreme swelling in arm all the way into her neck and went urgent and was prescribed 3 antibiotics. That was something had to pay for due to the reaction. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and included treatment with antibiotics(unspecified). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event extreme swelling in arm all the way into her neck and went urgent and was prescribed 3 antibiotics. That was something had to pay for due to the reaction was not recovered at the time of this report.
Participant reporting breakthrough case of COVID-19. I had a little chill on Friday April 22nd and I thought that it was cold out but it was not. I woke up Saturday morning feeling like I had the flu like symptoms. I ached and felt terrible. I had nasal and phlegm like congestion. I was tired and did not feel like doing anything. My son contacted me on Sunday and advised that my grand daughter tested positive for COVID-19 so tested myself and it was positive also. I took Zicam to help with the symptoms. I spoke with my doctors nurse and he prescribed some medications for me. I am on a Prednisone pack for 6 days and I am now on azithromycin. Outside of the coughing I feel great.
MODERNA COVID-19 VACCINE EUA today is January 20, 2021 - ONE week after the injection this is the first reaction to the shot (other than soreness at injection site for 2 days after injection.   At approximagtely 6:35 this evening I experienced a  REACTION-A ROUND HARD CIRCLE AT INJECTION SITE APPPROX. 1 1/4 inches in diameter. with some redness surrounding the hard circle. I applied ice and called primary care physician- Dr, assured me to keep applying ice and perhaps take a Claritin- or a Benadryl as I do not have Claritin in the house.
Moderna COVID?19 Vaccine   Swollen lymph node in the neck, right side, size of a pea, no pain or discomfort
mild shaking of extremities twice lasting 20 to 30 seconds w/in 24 hrs of vax;
pt recv vax 22MAR96 & 29MAR96 devel congestive heart failure which required a MD visit;has hematocrit dropped from 37% to 32% over four days;alk phos was elevated 540;lft were nl;
While waiting the 15 minutes recommended after vaccination, the patient became very lethargic, started sweating profusely, and had muscle weakness.  911 was called, and the patient was given Benadryl 25mg by mouth.  Paramedics also administered Epinephrine 0.3mg IM, and the patient was transported to the hospital.
Pt said his shoulder sore, tingling of face, bruises, when vaccinated he was bleeding. He said he took TYLENOL but did not help.
Localized reaction. Redness approx 3" diameter lasting through 11/01/2010. Itchy through 11/02/2010. Headache on 10/30, 10/31, 11/01 & 11/02.
Severe muscle pain 4 hours after injection; radiates to hand and backward to left shoulder blade
Pt came into the store on 8/11/21 reporting a reaction to her second dose of her covid vaccine. She did not have a reaction on her first dose nor after the 15-20 minute wait period after the shot on 8/10/21.  She had a swollen upper lip and believes it is due to the vaccine. We recommended her Benadryl to help with the swelling and advised her to see a doctor to make sure if it was due to the vaccine or if it was something else.
Information has been received from a female immunization coordinator who "about 2 months ago" in approximately January 2008, was vaccine with .65mL of zoster vaccine live (Oka/Merck). Subsequently, the patient experienced severe injection site swelling, fever of 100.6, aches and headaches for 4 days after receiving the vaccine. It was unspecified if medical attention was sought. At the time of the report the patient had recovered. There was no product quality complaint involved. Additional information has been requested.