chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; Received 1st dose Moderna COVID19 vaccine at 17 years old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st dose Moderna COVID19 vaccine at 17 years old) and PAIN IN EXTREMITY (sore arm) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st dose Moderna COVID19 vaccine at 17 years old). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received 1st dose Moderna COVID19 vaccine at 17 years old) and PAIN IN EXTREMITY (sore arm) 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.   concomitant medications were not provided. Treatment information were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: FU Received. New Event Added
This spontaneous report was received from a healthcare professional referring to multiple unknown patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot # M005972 with expiration date 02-FEB-2018 and lot # M031970 with expiration date 30-JUN-2018, for prophylaxis (dose and route were not reported). It was stated that the vaccines were exposed to a temperature between 6 and 14 Fahrenheit degrees with a time frame of 20 minutes and that the diluent for both vaccines did not experienced any temperature excursion. A previous excursion was reported with a temperature between 6 and 14 Fahrenheit degrees with a time frame of 15 minutes. A data logger was used to control temperature. No adverse events were reported. A product quality complaint was not involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1703USA007367:
2 weeks from the day I received the shot I developed a half dollar sized round rash on the opposite arm that the shot was administered. The rash was red in color, raised skin and was located near my right bicep, inside elbow area. This rash subsided for most part the day after. Also had the chills for over 48 hours, slight headaches on and off and was extremely tired with low energy. It felt like I was in a fog for a couple of days.
Received vaccine in her office by RN. In 35 minutes site had expanding reddness and severe itching. Employee stated by phone that she had already taken a benedryl and was advised to go to the Emergency Department.
2 days after injection, patient presented with a rash just below the injection site. Rash was about 1 inch wide and 2 inches long, raised, warm, and patient said sore but not really itching. I advised patient to keep watch over the rash, and if no improvement in the next few days or worsening, she should contact her Dr.
STROKE; BLOOD CLOTS; This spontaneous report received from a consumer via a social media, by a company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced stroke, blood clots, and was hospitalized (date unspecified) and still in ICU (intensive care unit). It was reported that "Just had 2 coworkers in 3 weeks of each other got strokes and blood clots one is still in ICU (intensive care unit)". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the stroke and blood clots was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, from the same reporter is linked to 20220234166.  Version created to amend previously reported information on 14-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1- Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events  20220234488-covid-19 vaccine ad26.cov2.s-Stroke, Blood clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Subject report that within 10 min. of receiving the vaccine he developed chest pain, headache, sweating, and blacked out. He was seen by a military physician who diagnosed heat stroke. The next day he again sought medical care and was told he had heat exhaustion. Approximately 2 days after immunization the subject had not improved and his wife called the ambulance. By the time the ambulance arrived, the subject was unresponsive and was flown to the hospital, where he reportedly was admitted to ICU with multi-organ failure (heart, kidney, liver with fluid build-up) and remained in a coma for 45 days. During his hospitalization he reportedly underwent exploratory surgery. When he woke up he had tubes in his chest and stomach. Following hospital discharge, the subject received rehab through the civilian system for about 3 weeks. After rehab, he returned home for 3 days, and then returned to work. At this time he still had an open wound and drainage tubes (which remained in for approximately months). After about 1 year he was stationed. He saw numerous physicians and was "in and out of hospitals". Diagnoses included GERD, hypertension, anxiety, hernias, and chronic chest pain. The subject reports that he was finally discharged in August 2003 after obtaining a congressional letter. Residual effects include depression, ventral hernia, PTSD, adhesions of peritoneum residual scar post-nephrotomy, chronic (chest) pain syndrome and bleeding through the rectum. He now takes lisinopril for the hypertension, ranitidine for the GERD, and hydrocodone for the chronic pain. The military has classified him with a 40% disability
prescribed or given GARDASIL 9 um for a patient for secondary prevention of genital warts for a patient who already had genitall warts, prior to vaccination. So the patient, or this person already has had previously been exposed um to HPV. So he was; This spontaneous report was received from a physician and refers to a male patient of unknown age.  The patient's medical history and concomitant therapies were not reported. The patient's concurrent conditions included  genital wart.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). The reporter prescribed or given this vaccine to a patient for secondary prevention of genital warts, but the patient already had genital warts prior to vaccination (Off label use ).
This spontaneous report was received from a physician regarding to a 74-year-old female patient. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On an unknown date in 2003, the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, route, lot# and expiration date were unknown) for prophylaxis. On an unknown date in 2003, the patient experienced rash. The outcome of rash was unknown. The causality of event was not reported.; Sender's Comments: US-PFIZER INC-2018004088:
30 minutes after itching tongue- self resolved  8 days later super edematous arm with a 6 inch weld that was approximately 1 inch raised off the arm- got bigger over 5 days then went away- Arm would not fit in shirt sleeve
pt recv vax & exp pain @ the inj site which progressed to the whole arm & hand;this occurred on 8AUG97;pt hand is sore & sx have currently not resolved;
Information has been received from a health professional concerning a white female who on 02-APR-1996 was vaccinated with a dose of Varivax. It was noted that the patient developed a generalized rash with less than 50 lesions. The patient was not hospitalized and it was unknown if the case was documented by a physician. Additional information has been requested.
Pain increased; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Pain increased) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) solution for injection for Psoriasis.    Concurrent medical conditions included Psoriasis.   On an unknown date, 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 and RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) 150 milligram. On an unknown date, the patient experienced PAIN (Pain increased). At the time of the report, PAIN (Pain increased) had not resolved.            No concomitant medications were reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The patient reported after taking COVID vaccines pain increased from mild to severe.  The reporter causality for the event of pain increased with Risankizumab was not provided.  No treatment medications were reported.
Severre migraines started happening daily about 2 weeks after vaccination, causing vomiting and light headedness. Pressure in head and behind right eye, attempted to treat with pain meds such as morphine which did not work, MRI scan showed a subdural empyema on the frontal lobe of brain which needed immediate surgery, broad spectrum antibiotics were given which did not help as the infection spread whilst I waited for surgery, outcome of the infection caused me to have a seizure resulting in loss of speech and movement before the emergency surgery, and also a seizure after the surgery. The second surgery was successful and I was put on the correct antibiotics, alot of morphine and anti-epileptic medication. Had multiple therapists to help recover and regain my movement and speech. These events(subdural empyema induced by vaccination) has heavily effected my memory & mental health (depression, anxiety, bpd), left me on permemant medication, changed my personality and has crippled my confidence & trust.
t102-103 x 5 days; red papular rash x 7 days;
August; with my breathing it's not quite a wheeze, but it's not normal. It's a little tighter, even at rest I would notice it.  At first, I didn't know if it was from stress or what it was from. I thought it was odd. After that started, I noticed soreness in my chest, even at rest. When lying down, if I went to get up, I would notice a strange a soreness in the middle to left side of chest when I tried to get up. I went to the doctor. She thought it might be something called Costochondritis. It seems like my chest tightness as abated some at this time. The breathing thing as persisted. It's not a wheeze, but it's in the middle between what a wheeze is and what normal breathing is. It's intermittent.
Nauseous, chest tightness, blurred vision.  Pt. verbalized that she passed out.  BP #176/36, P 60, Ox 98%, RR 36,  BP #2 81/40.  Water given as per pt. request.  Pt. instructed to take small sips.   Pt. verbalized that she is feeling better.  f/u BP 90/60, at 2:05pm, BP 81/47@2:07pm.  f/u BP 100/50 @2:12pm.  Pt. verbalized that she still feels nauseous, having chest tightness and blurry vision.  Pt. transported to stretcher by EMS.  Pt. legs elevated BG assessed @91. BP 92/48.  Pt. states she is feeling better, not feeling nauseous anymore, does have a little chest tightness.  f/u BP 98/57@2:31pm.  Pt. reports that she has a history of anxiety.  At 2:50pm pt. left with father.  Pt. instructed to f/u with primary doctor and call 911 is symptoms persist.
pt recvd vax; cough inc, SOB & fever (100-101), got worse w/ 4th shot;very fatigued, under MD's care; fourth dose of rabies not given;
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 14Jul2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 48 years, in left arm 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 included: "Shellfish allergy" (unspecified if ongoing); "Peanuts allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Naproxen, reaction(s): "known allergy: Naproxen", notes: known allergy: Naproxen. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: Tested positive for COVID after a negative rapid AND PCR test; (04Nov2022) Positive, notes: Tested positive for COVID after a negative rapid AND PCR test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was given Paxlovid for Covid-19 treatment.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201280013 Same patient/reporter; different drug/AE;
Patients mom contacted pharmacy on 03/24/2022 reporting that the patient has had a rash. She reports that the patient has had a rash on the nerve ending that mimic tiger stripes. The rash has not gotten better. The rash began a few days post vaccine. She also reported that the patient had two different treatments but the rash has not improved.
Major itching/ horrific itching -left arm, feet and arm pit - worse on her head; Scabs on her head because of the itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Major itching/ horrific itching -left arm, feet and arm pit - worse on her head) and SCAB (Scabs on her head because of the itching) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 018A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 24-Feb-2021, the patient experienced PRURITUS (Major itching/ horrific itching -left arm, feet and arm pit - worse on her head) and SCAB (Scabs on her head because of the itching). At the time of the report, PRURITUS (Major itching/ horrific itching -left arm, feet and arm pit - worse on her head) and SCAB (Scabs on her head because of the itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
2nd dose received greater than 36 days from 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received greater than 36 days from 1st dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 028L20A) for COVID-19 vaccination.     The patient did not have any allergy. The patient had not tested positive covid test or diagnosis. .    On 28-Aug-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received greater than 36 days from 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received greater than 36 days from 1st dose) outcome was unknown.            Concomitant medications was not provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2022-568025 (Patient Link).
Booster shot received at pharmacy on 8/15/21. By 8/20/21, I had a severe vasculitis episode with hemorrhages on right and left legs. By 8/25/21, I now have shingles rash that appeared suddenly and is speeding on rifht side of face and arms. Vomiting and fever.
pt recvd vax in 1989 & exp redness & induration @ the inj site; reporter expressed a concern w/the lot# involved in the report;f/u JAN95 indicated that the pt was doing fine
postherpetic neuralgia; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently approximately 72-year-old patient of an unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 22-SEP-2017, the patient was administered the zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiration date were not specified) at physician's office for the long-term prevention of shingles and zoster-related conditions. Subsequently, on an unspecified date, the patient was treated by a providers for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster and post herpetic neuralgia. The outcome of the events herpes zoster and post herpetic neuralgia was not reported. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).
Pain at site of injection, shoulder area, lower arm area. Rash at site of injection; outer arm, inner arm, at wrist, inside of left thumb. Injection was on the left arm. I went to the pharmacy where I received the Flu vaccine on 11/2/15. I reported to the pharmacist about the pain (sometimes extreme) and showed her the rash. She, I was told, reported it to the manufacturer. I was told to take Ibuprofen for the pain and BENADRYL for the rash, as directed. My only concern at this time is for the pain and rash to go away and not have any adverse effect on my health.
Headache at base of skull on right hand side (opposite of where the injection was given) from 30 m after vaccine to 1 hr after vaccine. Then, mild rash on right side back and arm from 1 hr after to 1hr 40 minutes after
fever; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2), administration date 29Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LENVIMA taken for endometrial cancer, start date: 01Jun2021; AMLODIPINE BESILATE taken for blood pressure management, start date: Aug2021. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for covid-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 29Aug2021, outcome "recovered" (2021), described as "fever"; HEADACHE (non-serious) with onset 29Aug2021, outcome "recovered" (2021), described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: EAP enrollment form states patient's diagnosis is endometrial cancer, ICD C54.1. Prescribed Lenvima 12mg daily, start 6/1/2021. Patient reports her blood pressure is "fairly stable" now that she's taking Amlodipine 2.5mg daily. start 8/2021-unknown end date Patient had the second COVID booster on Sunday, 8/29 (Pfizer), and she hasn't felt good since, with a fever and headache lasting a couple days. start 8/29/2021-unknown end date. Patient's healthcare provider. no relevant history.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022; 82 patients administered expired moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 035C21A, 038B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (82 patients administered expired moderna vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 11-Jan-2022 and was administered on 20-Apr-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Date the vial was initially stored in the refrigerator on 11-Jan-2022. The vial did not undergo any temperature excursions. No patient has reported adverse reaction. No treatment medications were reported.
SkinRash, Rash, bilateral forearms had rash for about 6 hours