chrisvoncsefalvay/vaers-outcomes huggingface dataset:
23Feb2022: Approximately (5) hours post vaccination administration, member noticed 3.81cmWx3.81cmLx0.6cmH subcutaneous mass at the head of his RT Bicep. The edema was hard to the touch, localized, non-pain inducing, nor was colder or warmer to the touch then the surrounding tissue. Pt. reached out to his medical department and was told to monitor for (1) week for any changes. 14Apr2022: Pt. reported to sick and injured, complaining and in-addition to the still present edema at the head of his RT bicep; pain and ecchymosis. Pain characteristics are sharp stabbing in quality, with a subjective scale of 3/10.
Systemic: patient mentioned her tongue was funny. she denied any tingling sensation-Mild, Additional Details: Patient reported her tongue felt funny and wasn't going away. she requested benadryl. Even after dose dispensed she still felt that way. No other symptoms progressed. she waited for about 1 hr and was told to watch out for signs of sever reaction and continue monitoring.
1 wk full body rash started arms-legs; 3 days fever 104 11MAY92; 1/2 hr convuls 11MAY92; jerking 1/2 hr delirium;
Mother noted increase in irritability, crying and screaming soon after Hib/Heo vaccine given. No fever, no difficulty of breathing. Caretaker feels child irritable up to this morning
first shot in July 2018, did not get a second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (patient had his/her first Shingrix shot in July 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-OCT-2022 Reporter's comment: The patient reported that he/she had his/her first Shingrix shot in July 2018 and did not got the second shot yet. The reporter had also asked a question whether he/she should get the second shot asap or do he/she needed to restart the series. The reporter had consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Pt called and complained of weakness and soreness after flu shot. Initially thought she had a virus, but then she said her arm had been swollen from injection site to elbow. Referred to MD. Allergy?? Following up w/ MD in one week.
Pt. came to pharmacy 8/26 stating arm was hurting, swollen, red at injection site, warm to touch. Pt is pregnant so called her OB/GYN.
an extra dose of FLUZONE QUADRIVALENT was accidently administer with no reported adverse event; Initial information received on 28-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 4 years old male patient had an extra dose of fluzone quadrivalent accidently administered with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) for Immunisation.  On 03-Oct-2022, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation and strength not reported; lot UT7681LA) via intramuscular route in unknown administration site for prophylactic vaccination.   On 22-Oct-2022 he also received 0.5 mL dose of the same vaccine (formulation and strength not reported; lot UT7695MA) via intramuscular route in unknown administration site for prophylactic vaccination.  On 22-Oct-2022, the patient had an extra dose of fluzone quadrivalent was accidently administered with no reported adverse event (extra dose administered) (latency: same day of dose 2) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported, a patient who received 2 doses of FLUZONE QIV syringe. 1st dose received on 03-Oct-2022 and 2nd dose was received on 22-Oct-2022. An extra dose of FLUZONE QUADRIVALENT was accidently administer to a patient. This situation is reported as a medication error due to the patient receiving 2 doses of the vaccine.   Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 the 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.
Headache & Myalgia Narrative: missed work following 2nd dose due to above
Case number PHEH2044US003613 in an initial spontaneous report received from a consumer on 21 FEB 2014. This report refers to a 09-year-old child of unknown gender. The medical history and concomitant medication of the child was not reported. On an unknown date the child was vaccinated with FLUCELVAX (batch number not reported). No adverse event was reported following this administration error (inappropriate age at vaccine administration).  Following an internal review on 18 AUG 2014, a significant correction was done for the information received on 21 FEB 2014: The BPI labeling of the event "inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "adult product administered to child".
Patient experienced a progressively worse headache that became a migraine. Patient was incapacitated and unable to work. Patient did not require medical care. Condition was treated with bedrest.
A non-serious spontaneous report of received expired FLUMIST has been received from a registered nurse concerning a 30-month-old female patient. The patient's medical history and concomitant medication details were not provided. The product expired on 02-Jan-2011. The patient received the expired FLUMIST on 03-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information received on 08-Apr-2011 and incorporated into case: no late occurring adverse events.
Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Knee replacement (At the age of 10) and Nervous system neoplasm surgery (Had two months ago). Concurrent medical conditions included Osteoarthritis, Arthritis and Disability (Since 33 years old).    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.            It was reported that the patient had their vocal cord snip during spine cord surgery performed according to the MRI (Magnetic Resonance Imaging).  No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-389026 (Patient Link).
patient received vaccine and was sitting down watching and talking with her mother and technician while her mother was receiving the vaccine then patient started to slowly fall over and blacked out completely.  She was caught by the technician and mom on her way to the ground and did not hit her head; she awoke within minutes to her mom's voice calling her name and had no recollection of falling; says she completely blacked out; she said she was feeling a little nauseous; she wears a continuous glucose pump (blood sugar was reading 111); 911 was called and store manager notified; patient stayed in the immunization room until paramedics arrived and did evaluation and she was feeling better by that point; patient left home with mom and dad
Redness, red red area approx. 2" x 1 1/2" no SOB, fever.
COVID followed by pneumonia For COVID, was prescribed PAXLOVID tablets , outcome, COVID resolved Pneumonia following COVID onset July 1st, 2022, prescribed Anti-biotic medications and am currently still recovering
Developed a large lump at injection site 30 minutes post injection.  After 24 hours, the large lump became inflamed , hot and a large red patch has appeared to circle the injection area.  severe pain in left arm pit (Arm with injection)
patient woke up on 9/10/2020 with a red ring around her upper arm at the site of injection and a rash on her back
Pt w/onset of generalized itching, erythema 1hr p/inject of IPV; had OPV in past; tx w/DPH;
secondary multiple sclerosis.; have shingles, had the shingles vaccine/Suspected vaccination failure; shingles; sharp pain in neck; This case was reported by a consumer via  interactive digital media and described the occurrence of multiple sclerosis in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced multiple sclerosis (serious criteria GSK medically significant), vaccination failure (serious criteria GSK medically significant), shingles and neck pain. The patient was treated with antibiotics nos (Antibiotic (Active Ingredient Unknown)). On an unknown date, the outcome of the multiple sclerosis, shingles and neck pain were not recovered/not resolved and the outcome of the vaccination failure was unknown.   It was unknown if the reporter considered the multiple sclerosis, vaccination failure, shingles and neck pain to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the shingles vaccine 4 years ago from the date of reporting. At the time of reporting, the patient had shingles. The patient also had secondary multiple sclerosis. The patient was having a pretty regular sharp pain in neck. The patient was prescribed antibiotic. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report from a contactable consumer (patient). An adult male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via intramuscular, administered in left arm on 16Feb2021 as DOSE 2, SINGLE, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via intramuscular, administered in left arm on 26Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The medical history included hypertension. The concomitant medication(s) included losartan (LOSARTAN) and modafinil (PROVIGIL [MODAFINIL]) taken for an unspecified indication. The patient had known allergies to amitriptyline and flagyl. On 12Sep2021, the patient experienced breakthrough covid infection. Patient was not tested for covid prior to vaccination. The patient underwent lab tests and procedures which included qRT-PCR COVID-19 test nasal swab on 22Dec2020 with result negative, qRT-PCR COVID-19 test nasal swab on 27Jul2021 with result negative, antigen COVID-19 test nasal swab on 31Jul2021 with result negative, antigen COVID-19 test nasal swab on 06Aug2021 with result negative, qRT-PCR COVID-19 nasal swab on 01Sep2021 with result negative, antigen COVID-19test nasal swab on 11Sep2021 with result negative, and qRT-PCR COVID-19 test nasal swab on 15Sep2021 with result positive. Patient did not receive treatment for the event. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (22Sep2021): Follow-up attempts are completed. No further information is expected.
The patient) had 1 ml of Restalyne Kysse dermal fillers placed in my lips on March 13th, 2021. I got the first dose of the Moderna vaccine at around 9:15 AM on 3/17/21 and although the swelling from the initial filler procedure had reduced significantly before the time of vaccination, I found in the early morning of 3/18/21 that I had experienced a rebound in swelling around my lips. The additional swelling is still relatively mild and I don't have any other unusual symptoms (just arm pain, headache, insomnia, and a low-grade fever/chills the night of 3/17).
I read an article about COVID-19 Vaccine and how they can cause different skin reactions and I also sent the article to my doctor. I was taking the cream that I asked for prior and it helps but it takes at least 14 days. It reduces some of the irritation but doesn?t eliminate the reaction in total.  Aug 20 Annual appointment  Told me to use itch cream because he thought the irritation, I was having was fungal. This cream did help some but still didn?t eliminate the irritation in total. In the doctor?s documentation he acknowledges that my belief is that its an reaction to the vaccine he then gives me clotrimazole. To the description he classified in his notes that Skin, mild eczematous pluteus right side
Reported to health department 10/7/02 that after Hepatitis B (#3) vaccine on 10/3/02 became very weak, trembling; had joint pain approximately 2-3 hours after shot. Later that night, had temperature of 103-104 and diarrhea. Went to ER 10/4/02. Received IV fluid due to diarrhea.
Patient developed an ascending sensory neuropathy, possibly a sensory variant of Guillain Barre. This started about 7 weeks after the vaccination and symptoms have started to improve after about 6-7 weeks. Symptoms started in the feet and ascended over a couple of weeks to the knees and is now improving. NO motor involvement.
A report was received from a health care professional on 10/29/2003 concerning 3 vaccinees of unknown demography who inadvertently received expired Fluvirin on an unspecified date. On an unspecified date 3 vaccinees were administered a dos of 2002-2003 Fluvirin. It was not reported if the vaccinees had experienced any adverse reaction at the time of report. There was insufficient information to determine the reporter's causality assessment. Update 1, 02/24/04: Follow up information received from a health care professional indicated that an 18 year old female vaccinee inadvertently received expired Fluvirin on an unspecified date in September 2003. No adverse events were reported. Follow up pending. Cross reference to PJP200400146, PJP200400147 and PJP200400148.
Fever and  vomiting just about 12 hours after vaccine. Lasted about 11-12 hours. Fatigue for another 48 hours.
Lightheaded, Dizziness, Tachypnea, Tachycardia, Diaphoresis
40 minutes after the vaccine I had itchy throat & I had trouble breathing. I had to go to the Emergency room & they gave me an IV with Benadryl & a steroid I was there for about 2 hours then I was cleared to go home.
Vaccine given after 48 hours of a punctured vial; Vaccine given after 48 hours of a punctured vial; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine given after 48 hours of a punctured vial) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006821A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine given after 48 hours of a punctured vial). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial). At the time of the report, PRODUCT STORAGE ERROR (Vaccine given after 48 hours of a punctured vial) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine given after 48 hours of a punctured vial) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to US-MODERNATX, INC.-MOD-2021-077668, US-MODERNATX, INC.-MOD-2021-078047, US-MODERNATX, INC.-MOD-2021-077928 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Non Significant follow up received on 21 JUL 2021, no new information; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-077668: US-MODERNATX, INC.-MOD-2021-078047: US-MODERNATX, INC.-MOD-2021-077928:
Erythema, induration, pain at area of vaccinations. Mild fever, tachycardia. Treatment with ibuprofen, ice to area, Benadryl, and narcotic pain medication.
2 weeks after the 2nd shot (6-24-21) rash on torso and extremities. treated with oral antihistamine and oral steroids per the pedatric doctor. After 2 days of the oral medication it got worse. went back to pediatric doctor and was referred to dermatologist who prescribed a topical steroid and 10 mg of zyrtec and after a week and a half the rash is not better. This is still ongoing and very frustrating. Called my local health department and was advised to contact an allergist-immology doctor and report to CDC. will be calling today. It has now been over a month since this started.
Moderna COVID 19 Vaccine: Patient started with symptoms of covid 5 days after first vaccine.  She was hospitalized and passed due to COVID 19 on 2/6/21.  Patients family informed us when she was due for the second dose.
Patient reported shoulder pain and trouble moving her arm. She did not seek medical attention and said she will follow up with me in a few days. The condition has improved slightly over the last 10 days. The photo she provided showed that the injection may have been high on the shoulder.
This spontaneous report was received from a health care student refers to a patient (age and gender unknown). On unknown dates, the patient received 2 doses of live (Merck) VARIVAX. No other co-suspects were reported. No concomitant medications were reported. It was reported that the patient had negative VZV antibody titers for varicella zoster virus. Laboratory titer of varicella was performed. The outcome of negative titers for varicella zoster virus was unknown. Negative titers for varicella zoster virus was unknown related to live (Merck) VARIVAX. Additional information has been requested.
Skin redness and rash, non-localized, itchy, painful, warm to the touch and swollen/ irritated. Loratidine 10mg, soaking  in oatmeal bath, topical hydrocortisone
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 15-FEB-2017  at 15:05 , the patient was vaccinated with improperly stored VARIVAX injection (lot # M018436) (expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441:  US-009507513-1704USA000389:  US-009507513-1704USA000390:  US-009507513-1704USA000391:  US-009507513-1704USA000392:  US-009507513-1704USA000393:  US-009507513-1704USA000394:  US-009507513-1704USA000395:  US-009507513-1704USA000396:  US-009507513-1704USA000397:  US-009507513-1704USA000398:  US-009507513-1704USA000399:  US-009507513-1704USA000400:  US-009507513-1704USA000401:  US-009507513-1704USA000402:  US-009507513-1704USA000403:  US-009507513-1704USA000404:  US-009507513-1704USA000405:  US-009507513-1704USA000406:  US-009507513-1704USA000407:  US-009507513-1704USA000408:  US-009507513-1704USA000409:  US-009507513-1704USA000410:  US-009507513-1704USA000411:  US-009507513-1704USA000412:  US-009507513-1704USA000413:  US-009507513-1704USA000414:  US-009507513-1704USA000415:  US-009507513-1704USA000416:  US-009507513-1704USA000417:  US-009507513-1704USA000418:  US-009507513-1704USA000419:  US-009507513-1704USA000420:  US-009507513-1704USA000421:  US-009507513-1704USA000422:  US-009507513-1704USA000423:  US-009507513-1704USA000424:  US-009507513-1704USA000425:  US-009507513-1704USA000426:  US-009507513-1704USA000427:  US-009507513-1704USA000429:  US-009507513-1704USA000430:  US-009507513-1704USA000431:  US-009507513-1704USA000432:  US-009507513-1704USA000433:  US-009507513-1704USA000434:  US-009507513-1704USA000435:  US-009507513-1704USA000436:  US-009507513-1704USA000437:  US-009507513-1704USA000438:  US-009507513-1704USA000439:  US-009507513-1704USA000440:  US-009507513-1704USA000441:  US-009507513-1704USA000442:  US-009507513-1704USA000443:  US-009507513-1704USA000444:  US-009507513-1704USA000445:  US-009507513-1704USA000446:  US-009507513-1704USA000447:  US-009507513-1704USA000448:  US-009507513-1704USA000449:  US-009507513-1704USA000450:  US-009507513-1704USA000451:  US-009507513-1704USA000452:  US-009507513-1704USA000453:  US-009507513-1704USA000454:  US-009507513-1704U.
Right upper arm, two red warm areas- approx. 6 cm, circular, and 4 cm circular. Temp 97 degrees. No treatment.
Left arm pain and swelling in wrist and fingers. Tendonitis systems in wrist and gout like systems in fingers. Then bursitis systems in left elbow