chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My injection site is magnetic, a magnet stuck to my arm; My arm is swollen and has soreness; My arm is swollen and has soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (My injection site is magnetic, a magnet stuck to my arm), PERIPHERAL SWELLING (My arm is swollen and has soreness) and MYALGIA (My arm is swollen and has soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (My injection site is magnetic, a magnet stuck to my arm), PERIPHERAL SWELLING (My arm is swollen and has soreness) and MYALGIA (My arm is swollen and has soreness). At the time of the report, VACCINATION SITE REACTION (My injection site is magnetic, a magnet stuck to my arm) outcome was unknown and PERIPHERAL SWELLING (My arm is swollen and has soreness) and MYALGIA (My arm is swollen and has soreness) had not resolved.            Reportedly, The patient went to her nail salon and was told that the Moderna COVID-19 vaccine makes the patient magnetic, and at the nail salon a paperclip had stuck to her injection site. The patient did not provide concern for safety to follow up.   Treatment product information was not provided. Concomitant product use was not provided.   Reporter did not allow further contact
Shortly after getting the first vaccine and into the next day, I had sharp 'pins and needles' feeling in my lower abdomen, huge shortage of breath (Barley being able to breathe), extremely bad 'vertigo-like' symptoms. Very dizzy, blurry eyesight, not being able to stand up or hold my balance, my heart felt like it was doing weird things.
Throat, mouth, and tongue swelled.  Took 2 Benadryl 50 mg total.
Received dose from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   This case was linked to MOD-2021-350866, MOD-2021-350960, MOD-2021-350771 (Patient Link).
Still rheumatoid arthritis flare ups; Flu-like symptoms; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4192264-00 (Agency).  A 58 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 13Apr2021 (Batch/Lot number: unknown) at the age of 58 years as dose 2, single and intramuscular, administration date 23Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at cf for rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RHEUMATOID ARTHRITIS (medically significant) with onset 2021, outcome "not recovered", described as "Still rheumatoid arthritis flare ups"; INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu-like symptoms". The action taken for adalimumab was unknown.  Clinical course: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Causality for HUMIRA (ADALIMUMAB): The reporter's causality for the event(s) of still rheumatoid arthritis flare ups was not provided. The reporter's causality for the event(s) of flu-like symptoms with Humira (adalimumab) was no reasonable possibility. Causality for PFIZER BIONTECH COVID-19 VACCINE: The reporter's causality for the event(s) of still rheumatoid arthritis flare ups was not provided. The reporter's causality for the event(s) of flu-like symptoms was Possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be established.
Next morning had a rash at the base of neck, injection site is really sore, itchy
Chest tightening in the 15 minute observation window after Moderna Covid 19 vaccine given.  Gave 50mg of benadryl and monitored for another 15 minutes, and episode improved.
Sneezing after the 1st dose; Chills after the 1st dose; Fever after the 1st dose; Muscle pain after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing after the 1st dose), CHILLS (Chills after the 1st dose), PYREXIA (Fever after the 1st dose) and MYALGIA (Muscle pain after the 1st dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SNEEZING (Sneezing after the 1st dose), CHILLS (Chills after the 1st dose), PYREXIA (Fever after the 1st dose) and MYALGIA (Muscle pain after the 1st dose). At the time of the report, SNEEZING (Sneezing after the 1st dose), CHILLS (Chills after the 1st dose), PYREXIA (Fever after the 1st dose) and MYALGIA (Muscle pain after the 1st dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported.  No treatment information was reported.
This spontaneous report was received from a healthcare worker concerning a patient of unknown gender and age. On 27-MAY-2015 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck) (Lot # K018144; expiration date: 10-APR-2016). No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a healthcare worker (also reported as Healthcare Prof-other) refers to a patient of unknown age and gender. On 04-JUN-2015 the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # K008878, expiry date 23-MAR-2017) (route, dosing regimen and frequency unknown) for an unknown indication. No concomitant medications were reported. No adverse events were reported. There was no product quality complaint reported. The action taken with the therapy with LIQUID PEDVAXHIB was unknown. The outcome of the events was unknown. The relatedness of the events of the therapy with LIQUID PEDVAXHIB was unknown. This is one of the many reports from the same source. Additional information has been requested.
patient was administered the diluent only, with no reported adverse event; only gave the diluent of PENTACEL, with no reported adverse event; Initial information received on 31-Jan-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 17 months old female "patient who was administered with the diluent only, with no reported adverse event" and "only gave the diluent of pentacel, with no reported adverse event" after receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR VACCIN) for Immunization.  On 16-Nov-2022, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot U7311AA) via unknown route in the left thigh (expiry date, strength, form: unknown) for prophylactic vaccination.  On an unknown date the patient was administered the diluent only, with no reported adverse event (single component of a two-component product administered) and only gave the diluent of pentacel, with no reported adverse event(product preparation error)  (latency: same day) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for both the events.   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 guidelines. 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.
Patient came in with back pain that was worsening. Tested for C19 - POSITIVE; Discharged
None - pt was administered monovalent when bivalent vaccine was indicated, no adverse reaction or symptoms.
Information has been received from a health professional concerning an approximately 39 year old white female with pcn allergy who "about five years ago," in approximately 1997 was vaccinated with one dose of hep B vaccine recombinant. Following vaccination, the pt experienced generalized illness with aching and chills. The outcome of these events was not reported. She did not complete the dose series. The pt subsequently developed arthralgia, swelling and effusion of the right knee, flu-like symptoms, hives, neck stiffness, and rash following vaccination with MMR II (WAES0205USA00787). Follow up info received, from a registered nurse, on 9/6/02 indicated that she did not know any of the details of the adverse events following vaccination with hep B vaccine recombinant. She stated that it occurred five years ago and that the pt was a new employee as of March 2002. She further stated that there was no documentation of this vaccination or the events in the employee's chart. Unspecified medical attention was sought. No further info is available.
Epileptic Encephalopathy. Severe increase in seizures (number and intensity). Some of the worse ones she has ever had. Started within 3 hours of receiving her vaccine. For 4 days she had some other weird odd side effects besides  significant increase in seizures. Weird reactions and increase in seizures with movement of any kind (in wheelchair, in car, carrying her from chair to bed, etc). Never had this before. Looked odd in her face, glassy eyes for a few days, weird movements. Her doctor called it a cytokoline storm type reaction at first but then she never went back down to her baseline for her seizures as they kept getting worse and worse. Finally on March 24th we did a medication infusion via IV to try to break the cycle and then on April 1st we started her on another seizure medication. On April 28 we increased the new seizure medication trying to get her back down to her baseline. She has never gone back down to her baseline, she is still dealing with an increase in seizures. She has days where she is just seizing all day long off and on for no other reason. Her team of doctors and I are 110% (yes 110%) sure this is a reaction to the vaccine. They called off the second dose, considered J&J vaccine but then with the risk of clots and her not 100% stable due to the first vaccine reaction we decided to hold off. This is horrible because for the last year I lived for the day to get her vaccinated to be protected from COVID and now she can't be. I am devastated and so afraid for her life because as you see in her dx she is very high risk for COVID death. We love to travel and just started cruising as she loves it and now we can't because she isn't vaccinated. She can't go back to her life the way she knew it before the pandemic because of the vaccine not being safe for her. :(
E87.1 - Hypo-osmolality and hyponatremia DIZZINESS ABDOMINAL PAIN
This spontaneous report as received from a medical assistant refers to a 3 month old patient of unknown gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions and allergies were not reported. On 12-SEP-2018, the patient was vaccinated with improperly stored dose of ROTATEQ 2 ml tube, orally (lot # N022015, expiry date: 10-MAR-2019) for prophylaxis. The vaccine was exposed to the temperature of 32.21 degree Fahrenheit (°F) (32F to 35 F) and time frame was 3.5 hours from 06-SEP-2018. Previous excursion was 50.37 °F for 4.5 hours as recorded by a data logger. No adverse effect was reported. No product quality complaint was involved. This is one of the several reports received from the same reporter source.; Sender's Comments: US-009507513-1809USA002868: Original Case : 1809USA002868 US-009507513-1902USA009324: Original Case : 1902USA009323 US-009507513-1902USA009323: Original Case : 1902USA009323 US-009507513-1902USA009326: Original Case : 1902USA009323.
Today 10 days post vaccination around 12pm Two spots in left arm formed, are one is slowly growing in size. One spot is red and warm to the touch (this is the one growing) it is slightly itchy. The other spot is a bruise with a red circular spot surrounding it.
pt recvd vax; pt devel in eve mottling & blotching proximal to inject site;
The patient developed a rash on the left arm initially and then it appeared on the right arm. It began to itch and it continues to itch. The patient has been taking prednisone and triamcinolone but the rash and itching are still present.
This spontaneous report as received from a pharmacist refers to a 71 years old female patient with hypertension, depression who was allergic to cephalosporins and penicillins. The patient was vaccinated subcutaneously with ZOSTAVAX (lot number H012521, expiration date 09-OCT-2013) on 20-OCT-2012. No other co-suspects were reported. Concomitant medications included butalbital, aspirin, caffeine, HCTZ, VIIBRYD, amlodipine, benazepril, TOPROL and hydroxyzine. Sometime before 22-OCT-2012 the patient developed a warm, red, hard area on the back of the arm. This is the arm where the ZOSTAVAX was given. The patient came into the pharmacy for medical attention. No treatment or laboratory diagnostics studies were given. The outcome of the events was given was reported as recovering/resolving. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history concurrent conditions or concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with multiple doses of improperly stored doses of ROTATEQ (dose, frequency and route of administration were unspecified) for prophylaxis, following a prior temperature excursion that was supported. The temperature and time frame was: 0 to 1 Celsius degrees for 2 hours and 53 minutes and there was a previous temperature excursion to 1 Celsius degree for 1 hour and 30 minutes. The excursion was found because of a digital data logger. The lot numbers involved were: M042179 (expiration date 22-JUN-2018), and M044397 (expiration date: 20-JUN-2018). No adverse event was reported. No product quality complaint was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA004047: US-009507513-1709USA004345: US-009507513-1709USA004343: US-009507513-1709USA004344.
Patient started experiencing increased in tachypnea, increased work of breathing requiring Xopenex and Prelone right after receiving Pediarix and Haemophilus vaccines.
Shingles - tingling and numbness - left side of face, neck, shoulder and arm - 36 hrs. after injection - flu like symptoms. Treatment - 5 courses of VALTREX - still prescribed 3 mos. post injection.
Developed extreme gastro intestinal issues. Explosive diarrhea up to 30 minutes after eating and fecal incontinence. Tried food diary, OTC medicine. nothing worked. Called GI doctor and got appointment. Doctor told me to stop taking BP medication, prescribed Lomotil to use as necessary, and scheduled upper and lower GI. PCP changed BP medication from Lisinopril to HCTZ and Amlodipine. No difference. Still experienced the same issues. Had Upper and lower GI on April 22, 2021. Results from biopsy showed Lymphocytic Colitis.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A - 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. List of concomitant medication were not given.
The patient reported that upon leaving the building after receiving the first dose of the moderna vaccine, she experienced facial tingling.  She returned to the facility and was assessed by the nurse and it was determined that no oral swelling had occurred. The physician ordered 50mg of Benadryl . The patient was reassessed and stated that no additional tingling was felt after about 18 minutes. The patient was discharged after an additional 24 minutes to her mother picking her up.
Hives below injection site, severe pain in arm and under arm radiating to shoulder blade at 48 hours, couldn't raise arm. Nausea, severe headache, fever for 24 hours, had to stay in bed. Right arm affected.
Shortly after vaccine given, patient c/o dizziness, light headedness and being "hot". Patient was diaphoretic and nervous before shot. Cool compress applied. Mother in room. Patient observed x 20 minutes with no further issues. Denied issues upon leaving. Declined H2O.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 69-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EL9269), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6202), in left arm, on 09Sep2021 as dose 3 (booster), single (Lot number: FC3183) and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9895) at the age of 68 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 diabetes" (unspecified if ongoing); "peripheral neuropathy" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "squamous cell carcinoma of skin" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; METFORMIN; LISINOPRIL/HCTZ; ROPINIROLE; NEXIUM [ESOMEPRAZOLE SODIUM]; ASPIRIN [ACETYLSALICYLIC ACID]; ROSUVASTIN; FISH OIL. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Presented with increase coughing and muscle aches with Positive antigen test. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Patient has no known allergies. Patient received Multivitamin medication in 2weeks.  No follow-up attempts are possible. No further information is expected.
Fever around 4PM on 12/25 with chills and feelings of being feverish. Was as high as 103.1. Body aches starting 12/25 and lasting until 12/30 that were severe for 24 hours. Nausea and headache starting 12/26 and lasting until at least 12/31.
Patient now has chicken pox per school nurse. VAERS filled out per request of RN.
pt recv vax 1APR97 & during the noc, 2APR97 pt exp h/a, fever & nausea;by 2APR97 pt recovered;
Patient Reports transient muscle spasms in arm where Shingrix was administered. Reports that it only happens when his arm is at Rest and there may be a lump in arm there.
Myalgia JOINT STIFFNESS, SHOULDER SWOLLEN, FATIGUE, HOT/COLD FLASHES, SKIN SENSITIVE Narrative:  Other Relevant History:
i am having shortness of breath, ear ringing, nausea, feeling faint, dizziness, weakness, heart pounding and what feels like anxiety but unusual.  if these persist ill need to go to the hospital
Incident related to early administration of vaccine, first dose received on 5/19/21, pt instructed by clinic incorrectly to return on 6/09/21 for second dose, pt returned on 6/10/21 for 2nd dose, dose was given to pt on 6/10/21 which is 6 days ahead of the 28 day separation for the Moderna vaccine. This was reported to the Visit NP, float RN, and pt was called to make aware, incident reports and VAERS filled out.
A report has been received from a Pharmacist concerning a 55 year old, Female subject, who had been receiving Nasal FLUMIST. FLUMIST started on 01-Oct-2012. The patient experienced administration to patient over 49 YO which started on 03-Oct-2012 and upset stomach which started on 02-Oct-2012. The outcome of the event of administration to patient over 49 YO is unknown and the patient recovered from the event of upset stomach on an unspecified date. The report was considered to be non-serious by company physician. Summary of follow-up information received by AstraZeneca/MedImmune on 18-Oct-2012 from pharmacist: new event as upset stomach added, outcome as recovered added, reporter information updated, event start date added.