chrisvoncsefalvay/vaers-outcomes huggingface dataset:
oval shaped irritation area presented on abdomen; two small blistery spots on belly or trunk area; This case was reported by a physician via sales rep and described the occurrence of blister in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 273BZ, expiry date unknown) for prophylaxis.   On 2nd January 2019, the patient received the 1st dose of Shingrix. On 2nd January 2019, immediately after receiving Shingrix, the patient experienced blister. On 6th January 2019, the patient experienced skin irritation. On an unknown date, the outcome of the blister was recovered/resolved and the outcome of the skin irritation was unknown.   It was unknown if the reporter considered the blister and skin irritation to be related to Shingrix.  Additional details were provided as follows: The physician reported that male patient received first dose of Shingrix and shortly afterward developed two small blistery spots on the belly or trunk area. Follow up report received from physician on 12th July 2019: The patient also reported that 2"x3" oval shaped irritation area presented on abdomen. No Blisters were reported. The case has been linked to the case US2019124742, reported by same reporter for same patient.
Patient started having diarrhea 2 hrs. after vaccine. Got shot - ate pizza - got diarrhea - allergic to eggs (yolk) - had flu vax in past without any problems. Is diabetic (under control).
SAYS SHE FELT VERY BAD AND HAD BEEN SICK FOR 10+ DAYS AND UNABLE TO GET OUT OF BED. MUSCLE ACHES, PAIN, FEVER, MALAISE. TOLD HER TO GO TO ER AND GET CHECKED OUT. HAVE BEEN UNABLE TO REACH HER TO FOLLOW-UP DUE TO NOT HAVING A VALID PHONE NUMBER ON FILE
Rash (mainly on torso), vomit, swelling/redness at injection site
Cried hard for the most part of 48 hrs & remained quite fussy for over a week.
Shingles 2 days after vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles 2 days after vaccine). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 06-Mar-2023 The reporter reported the case via interactive digital media. The patient received shingles shot and got shingles 2 days later.
fainted immed p/vax remainder of day c/o nausea, h/a, dizziness, sweating went to bed 6PM-ok in AM; had vomiting x 3-4x-did not seek medical attention; stated face felt tingly rest of day; had LOC only momentarily w/fainting episode;
Pt given DTaP, IPV, MMR, and Varicella given on 9/18/13 and 7/21/14.
Edema  & induration R thigh, 10 day after Varicella & HIB R thigh.
Later that day after the vaccination I developed a severe migrane headache that lasted 2 weeks.  After a few days I went to see my PCP who prescribed a Medrol dose pack and muscle relaxer to help with the pain but the headache still remained the 2 weeks before it finally went away
received booster dose from  expired vial; sore arm; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (sore arm) and EXPIRED PRODUCT ADMINISTERED (received booster dose from  expired vial) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient has tested for COVID-19 positive on Sep-2021) in September 2021. Concurrent medical conditions included Sulfonamide allergy (allergy to Sulfa drugs), Hypothyroidism, Hypertension, Impaired fasting glucose and Gout. Concomitant products included ALLOPURINOL for Gout, SPIRONOLACTONE for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder.    On 29-Oct-2021 at 2:00 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received booster dose from  expired vial). In 2021, PAIN IN EXTREMITY (sore arm) had resolved. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received booster dose from  expired vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided. The sore arm had resolved within 24 hours.   Most recent FOLLOW-UP information incorporated above includes: On 05-Nov-2021: follow up received contains updated reporter type, patient demographic details, medical history, added concomitant medications and added events
Pt had itching, redness and swelling at vaccine site for 10 days, post vax.
Nausea on 12/24/09. 5 AM 12/25/09 diarrhea, nausea, vomiting and settled down about 10 PM 12/25/09.
Patient experienced tightness in throat, but did not lose conciousness and could breathe. as time passed she felt some tingling in fingers, nausea and headache. Administered Benadryl 50mg waited per patient's request about 30 min them administered Epipen and called 911. Patient taken via EMS to ER.
sick; This case was reported by a consumer via  interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Moderna with an associated reaction of pain (received Moderna on an unknown date).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 3 months after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient got Shingles shot two and half month back of reporting date and felt little sick. The patient said Shingles shot was not as bad as modern.
"covid arm" Area where shot was became red, inflamed, and hot. Also became a solid lump. Itchy the following day.
Initial unsolicited report received from a physician on 28 September 2015. This case involves a female patient (age not reported) who was vaccinated with a dose of FLUZONE QIV (batch number, dose, route and site of administration was not reported) in the morning of 28 September 2015. Patient's medical history and concomitant medications were not reported. On 28 September 2015, same day following the vaccination, the patient's whole arm was tingling and numb to fingers. Lab data and corrective treatments were not reported. The patient was not recovered from the events. List of documents held by sender: none. Follow up information received from a physician on 02 November 2015. Illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as no. Patient had no other vaccine within four weeks of vaccination. It was reported that FLUZONE QIV was administered (lot number UI445AA, expiry date 30 June 2016) intramuscularly in right arm. Patient had no Lab test.
I have been experiencing extreme shoulder and SI joint pain without obvious cause for a month. Extreme pain and limited range of motion in right shoulder. Thinking back, I realized the pain started about the time I got my "over 55" flu vaccine.
After receiving COVID booster vaccine reports 10 minutes after administration developed sever itching.  States she took a Benadryl prior to Booster due to itching after second vaccine of COVID.  Reports after she went home, the itching continued.  Patient states she went to Urgent Care Saturday evening on 10/09/21 and was prescribed a Medrol dose Pak.  Reports itching did not improve and she returned to Urgent Care on Wednesday 10/11/2021 for ongoing itching, and development of sore throat, and flu like symptoms was given Steroid IM injection, prescribed Pepcid, and instructed to continue to take Benadryl. Reports she was also tested for strep throat and COVID- both tests were negative.  Patient states sore throat and flu like symptoms improved, but she continues to have itching.  States she continues to take Benadryl and Pepcid as instructed by Urgent Care.
ARM PAIN, SWELLING, REDNESS, PUSTULE/PURULENT DISCHARGE.
013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (013H22A Exp 5/24/23 was put in the refrigerator on 12/5/22. Vaccine was given today 1/9/23).    No concomitant medication was provided by reporter.  Unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No treatment medication was provided by reporter.
Very weak, and dizzy, and then I stood up to walk to the sink and I collapsed onto the counter partially blacking out for a second.
Received 2nd MMR. Developed large area >10cm redness at vaccine site then febrile illness 4-5 days later.
Pt. in cardiac arrest on 04/13/2021.  Pt.  was pronounced dead at  Hospital on 04/13/2021.
Pt. states arm hurt when she got the injection. States she can't raise or lift her (L) arm. The pain is in her (L) shoulder. States she has to take two ALEVE q 12 hrs. Pt. denies any external redness, swelling or warmth.
Pt stated injection site and area around turned blue and a big knot formed where injection was given.
Injection site reaction (heat, redness, itching) ongoing, with my first shot it started a week later and lasted a week. This started 36 hrs after the shot. Soreness and inflammation in trapezius on my right side.  Fever (highest temp was 101.1), body aches, and fatigue all started at 15 hrs and lasted about 12.
PFIZER COVID VACCINE #3 GIVEN 11/5/21, LOT #FF8841; pt had a positive COVID test in the nursing home on 2/5/22; 2/7/22 pt to hospital with increasing SOB, cough; acute renal failure, anemia; EKG showed Atrial Fib with RVR, medications given to treat; DNR/DNI; ABX given; family decided to transition to comfort; given Decadron and nebulizer treatments; 2/10/22 pt returned to nursing home where she passed away
This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 13-FEB-2018, the patient received improperly stored dose of VARIVAX (lot # N017394, expiration date 07-JUN-2019) subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of VARIVAX was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA001826; US-009507513-1903USA002595; US-009507513-1903USA002596; US-009507513-1903USA002598; US-009507513-1903USA002599; US-009507513-1903USA002600.
no adverse event; HCP called to report administration of ROTATEQ after unreported temperature excursion; This spontaneous report was received from a medical assistant and refers to an unspecified number of patients of unknown age and gender.  The patients' medical history, concurrent conditions, and concomitant therapies were not reported.  On approximately 18-JUL-2022 (also reported as "the week of 18-JUL-2022"), 2 vials, 2 ml 3 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) underwent a temperature excursion for an unspecified amount of time and temperature.  On an unspecified date in July 2022, the patients were vaccinated with doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, dosage regimen, route of administration, lot #, and expiry date were not provided) as prophylaxis (improper storage of product in use). There were no adverse events reported.  This is a non-valid case due to lack of patients' identifiers.
Information has been received from a physician concerning a 6 month old male who in June 2007, was vaccinated with a 2ml oral dose of ROTATEQ (Lot# not provided). In June 2007, the patient developed fine papules a few days after the second dose. Unspecified medical attention was sought. There was no information when the first dose of ROTATEQ was given. Subsequently the patient was noted to be recovering. There was no product quality complaint. Additional information has been requested. This is in follow-up to report (s) previously submitted on 9/17/2007. Information has been received from a physician concerning a 7 month old male who on 12-JUL-2007 (previously reported as June 2007) was vaccinated PO with a 2.0 ml dose of ROTATEQ (lot# 656705/0241U). Concomitant vaccinations administered that day included an IM dose of poliovirus vaccine inactivated (unspecified) (lot# 205482), an IM dose of hepatitis B virus vaccine (unspecified) (Lot# "AHB40206"), an IM dose of Tdap (lot# U19858A), an IM dose of Hib conj vaccine (unspecified carrier) (lot# UF104A) and an IM dose of PNEUMOVAX 23 (lot# 808692B). On the same day, the patient developed a fever lasting " a few days." On 16-JUL-2007 the patient also developed fine papules described as a generalized rash. The patient was seen in the clinic on 18-JUL-2007 for the rash. No medication was given, observation and follow-up phone call were made. Patient returned to clinic two weeks later for daycare forms. Subsequently, the patient recovered. There was no information when the first dose of ROTATEQ given. There was no product quality complaint. Additional information is not expected.
This is a spontaneous report from a Pfizer sponsored program, received from a non-contactable male consumer reporting for himself. A male patient of an unspecified age and ethnicity started to receive PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient had a bad rash on an unspecified date with outcome of unknown. The patient thought it was an allergic reaction. Consumer wanted to know if another medication would also give him the same side effects. No follow up attempts are possible. No further information is expected.
Legal report of a male patient who experienced neurodevelopmental injuries coincident with Certiva. On an unreported date, the patient received Certiva vaccination. On an unreported date, the patient experienced severe neurodevelopmental injuries, which was considered medically significant (OMIC). Pertinent laboratory test, diagnostic procedures, medical history or concomitant medication information was not provided. The patient was a child.
Headache, Myalgia, Fever, chills, runny nose Narrative:
When patient arrived for 2nd dose moderna shot on 5/28/21, she reported a mild rash on her arm that appeared about 12 hours after her first dose. Patient described the rash as looking like she had been bit by a dog and reported it being located on the inside of her elbow area (not where the IM deltoid shot had been administered). Rash resolved after about a day.  Patient denied any symptoms such as chest tightness/SOB.  Rash was a little bit itchy per patient.
Within 1 to 2 minutes began feeling a tightness in throat and chest.  Felt a huge lump in my throat. Elevated blood pressure and pulse.
30 y/o M with hx of pulmonary embolism presents to discuss referral potnetially to pulmonology as he was seeing one in country this past fall when he was diagnosed with an acute sub-massive 'unprovoked' PE. Diagnosed with submassive pulmonary embolism in July with evidence of R heart strain, although he states that he had been having L lower calf pain for a few days prior.  Ultrasound showed potential sequelea of DVT however without confirmation or presence at that time. Hypercoagulable workup sent which did show elevated lupus anti- coagulant but in the setting of already initiated anticoagulation, it was non diagnostic at that time for underlying hypercoagulability.   endorses that he continues to have mild chest pain and cough, and wants a renewal of his profile.  2 months after his PE, he did have an echo that showed: Adequate study with NSR RA/RV: Normal LA: Normal LV: Chamber size & wall thickness: Normal Systolic function: Normal with EF of 65 % Diastolic function: Normal RWMA: None Mitral Valve: Minimal MR. No MS Aortic Valve: Normal Tri-leaflet AV. No AS or AR Tricuspid Valve: Minimal TR with normal est RVSP (28 mm Hg). No TS Pulmonic Valve: Minimal PR. No PSFull Echo report will be in the system  a repeat CTPA which showed bilateral subsegmental and segmental pulmonary emboli, although with decreased clot burden from prior.  He continues to have mild chest pain, but notes that it is improving.    he spent 3 days in the ICU on a drip, and was initiated on anticoagulation at the time of diagnosis.  He has continued on apixiban for anticoagulation.
No adverse events.  mis administration because of age (splenectomy) (Menactra Not Licensed for >55 years of age)
Felt hot and cold; Ear ache; Neck ache; knot at the injection site; weakness; Red at injection site; Injection site soreness; Tiredness; Joint pain in leg and hand; Headache; chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site) and ASTHENIA (weakness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (had Covid over a month prior to this report and was treated with Regeneron then) in 2021.    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Aug-2021 at 1:00 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (chills). On 15-Aug-2021 at 4:00 PM, the patient experienced FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site), ASTHENIA (weakness), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE PAIN (Injection site soreness), FATIGUE (Tiredness), ARTHRALGIA (Joint pain in leg and hand) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) 15-Aug-2021 for Adverse event, at a dose of 2 dosage form. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Felt hot and cold), EAR PAIN (Ear ache), NECK PAIN (Neck ache), VACCINATION SITE NODULE (knot at the injection site), ASTHENIA (weakness), INJECTION SITE ERYTHEMA (Red at injection site), INJECTION SITE PAIN (Injection site soreness), FATIGUE (Tiredness), ARTHRALGIA (Joint pain in leg and hand), HEADACHE (Headache) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  It was reported that the patient waited until she was Covid negative for 2 weeks before getting the vaccine like her physician recommended. Moreover, the patient reported that her symptoms were very similar to when she had Covid-19.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Patient received Paxlovid treatment from 30Aug2023 to 01Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293526 Same patient, different event/drug (Paxlovid Case);
A report has been received from a Health Professional concerning a 12 year old, male subject, who had been receiving Nasal FLUMIST. FLUMIST started on 27-Oct-2012. The patient experienced tested positive for influenza A which started on 11-Dec-2012. The outcome of the event of tested positive for influenza A is unknown. The report was considered to be non-serious. Follow-up of significant information received AstraZeneca/MedImmune 09-Jan-2013: patient identifiers, drug and adverse event start date added. Lot numbers added. Initial and follow-up information processed together.
Painful lump, 3-4 cm in diameter, under left axilla similar in texture to a lipoma. appears non fluid filled, no erythema. pain to touch.
Raised, Red, and sore to touch. Redness moved up left leg several inches. Patient refused to walk on leg after taking nap.