chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a physician and described the occurrence of incorrect storage of drug in a 52-year-old male subject who was vaccinated with FLULAVAL. The reporter is the subject. The subject received no other vaccines on the date of receipt of FLULAVAL. There were no concurrent medication. On an unspecified date, the subject received unspecified dose of Influenza vaccine (unknown). At an unspecified time following the receipt of INFLUEZA vaccine (unknown), the subject experienced a sore arm. The outcome of the sore arm was not reported. On 19 October 2008 at 1:00 pm, the subject received 1st dose of FLULAVAL (.5ml, unknown, left arm), and experienced incorrect storage of drug. The physician reported that, on 19 October 2008, the subject was administered FLULAVAL that had possibly been stored below recommended temperatures for about 2 hours. The physician reported that one other subject received FLULAVAL that had possibly been stored below recommended temperatures for about 2 hours. Please see case A0754351A.
patient bled a lot more than usual after getting the Pfizer COVID Vaccine/the site was bandaged but, it was still bleeding pretty good; This is a spontaneous report from a contactable pharmacist. A 14-year-old male patient received first dose of BNT162B2 (BNT162B2) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reports patient bled a lot more than usual after getting the pfizer covid vaccine/the site was bandaged but, it was still bleeding pretty good on an unspecified date. Pharmacist reports that the patient received first dose of the Pfizer COVID Vaccine and it bleed a lot more than usual. Reports using a 1 inch needle giving the shot and the site was bandaged but, it was still bleeding pretty good. The outcome of the event was unknown.  Additional information has been requested.
No adverse effects reported; Multiple patients were vaccinated with improperly stored ROTATEQ on multiple dates; Information has been received from a medical assistant concerning a patient of unknown age, gender and race. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On 17-OCT-2018, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) orally for prophylaxis (lot number N034400 with expiration date in 10-MAY-2019) (strength and anatomical location were not provided).  The Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was stored at an unknown temperature for an unknown time frame. There was a previous temperature excursion and the call was because of a data logger.  No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1907USA001848: US-009507513-1907USA001849: US-009507513-1907USA001847: US-009507513-1907USA001793: US-009507513-1907USA001794: US-009507513-1907USA001795: US-009507513-1907USA001796: US-009507513-1907USA001797: US-009507513-1907USA001798: US-009507513-1907USA001799: US-009507513-1907USA001800: US-009507513-1907USA001801: US-009507513-1907USA001802: US-009507513-1907USA001803: US-009507513-1907USA001804: US-009507513-1907USA001805: US-009507513-1907USA001806: US-009507513-1907USA001807: US-009507513-1907USA001808: US-009507513-1907USA001809: US-009507513-1907USA001810: US-009507513-1907USA001811: US-009507513-1907USA001812: US-009507513-1907USA001813: US-009507513-1907USA001814: US-009507513-1907USA001815: US-009507513-1907USA001816: US-009507513-1907USA001817: US-009507513-1907USA001818: US-009507513-1907USA001819: US-009507513-1907USA001820: US-009507513-1907USA001821: US-009507513-1907USA001822: US-009507513-1907USA001823: US-009507513-1907USA001824: US-009507513-1907USA001825: US-009507513-1907USA001826: US-009507513-1907USA001827: US-009507513-1907USA001828: US-009507513-1907USA001829: US-009507513-1907USA001830: US-009507513-1907USA001831: US-009507513-1907USA001832: US-009507513-1907USA001833: US-009507513-1907USA001834: US-009507513-1907USA001835: US-009507513-1907USA001836: US-009507513-1907USA001837: US-009507513-1907USA001838: US-009507513-1907USA001839: US-009507513-1907USA001840: US-009507513-1907USA001841: US-009507513-1907USA001842: US-009507513-1907USA001843: US-009507513-1907USA001844: US-009507513-1907USA001845: US-009507513-1907USA001846: US-009507513-1907USA000952: US-009507513-1907USA000953: US-009507513-1907USA000954: US-009507513-1907USA000959: US-009507513-1907USA000962: US-009507513-1907USA000963: US-009507513-1907USA000964: US-009507513-1907USA000965: US-009507513-1907USA000966: US-009507513-1907USA000967: US-009507513-1907USA000968: US-009507513-1907USA000969: US-009507513-1907USA000970: US-009507513-1907USA000988: US-009507513-1907USA000989:
Several hours after injection, patient felt a pulling or straining muscle feeling. After several weeks, symptoms got worse with tenderness, numbness, pain, inflammation and immobility occurred. Progressive range of motion deterioration. Patient on numerous occasions received analgesics and anti inflammatories from her physician.
slight fatigue and achiness dry eyes acute pain in lymph nodes on the right side of the neck around 11 pm. lasting only 10 minutes.
Approx 15 min p/inject edematous eyelids-nearly swollen shut. Hives & respiration - negative finding. w/in 5 min urticaria rash noted cervically & facially, eyes remained edematous child irritable.
Chills & body aches Chills lasted about 8 hours Aches lasted 3 days
About a week after getting the second dose, the following symptoms started. I've had these symptoms for two months straight: vibrations, neuropathy (painful at time), brain fog, noise + sound sensitivity, balance issues, fatigue.
Nausea and headache then vomiting. All began approximately 40 hours after vaccination. Treatment was rest and bland foods for 36 hours. Nausea subsided after vomiting for about 2 hours. Occasional nausea but no more vomiting for next 24 hours. Light headache continued for 36 hours.
Within 24 hrs of administration Dtap and IPV to L thigh redness, swelling, warmth began. In office 48 hrs after immunization left thigh with 16cm x 26cm erythema, hot.
Jynneos administered intramuscularly; Case reference number US-BN-2022-001693 is a spontaneous case report initially received on 27-Jul-2022 from other health care professional via Communication (reference number: USBAV22-0690) and concerns a *51-year-old female patient.*  The patient's medical history and concomitant medication details were not reported.  On *13-Jul-2022*, the patient was vaccinated with the first dose of Jynneos (Smallpox and Monkeypox Vaccine, Live, Nonreplicating, batch number: FDP00002), at dose of 0.5 mL, administered intramuscularly (IM) in the *right deltoid region*, for pre-exposure prophylaxis (PrEP) (explicitly coded as 'Inappropriate route of vaccination'). As reported, the patient worked in a lab that handled monkeypox samples.  At the time of this report it was known that the patient did not experience any adverse event due to Jynneos vaccination.  This case is linked with cases no. US-BN-2022-001673, US-BN-2022-001687, US-BN-2022-001688, US-BN-2022-001689, US-BN-2022-001690, US-BN-2022-001691, US-BN-2022-001692, US-BN-2022-001694, US-BN-2022-001695, US-BN-2022-001696, US-BN-2022-001697, US-BN-2022-001698, US-BN-2022-001699, US-BN-2022-001700, US-BN-2022-001701, concerning the same reporter.  Non-significant case correction received from on 29-Jul-2022 included an additional reference number.  All follow-up information is blended into the case narrative above, with the latest information presented between asterisks (*).  Follow-up information received from a health care professional via on 09-Aug-2022 included patient details and additional information about the administrated dose of Jynneos.; Reporter's Comments: A 51-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A 51-year-old female patient was vaccinated with the first dose of Jynneos, intramuscularly, at dose of 0.5 mL, in the right deltoid region, for pre-exposure prophylaxis which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was known that the patient did not experience any adverse event due to Jynneos vaccination. The patient's medical history and concomitant medication details were not reported. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
The vaccine was administered on the following date: 12/18/20 and at approximately the following time: 1pm   She reports that she didn't feel great after vaccine but thought just normal post-vaccine symptoms.  She felt itchy and wheezing that evening.  She took benadryl and felt better.   She woke up the next morning and her face was flushed and she felt palpitations.  Went to work and checked her vitals, tachycardic to 120s-130s.  About 11am felt lightheaded and was taken down to ER.  HR was 150s. Has history of bee sting allergy and this felt like that.  No Epinephrine but was given 25mg IV bendaryl and IV fluids (1L NS).  Took another 75mg of benadryl last night and Allegra this morning feels fine.   From ED visit note:  Vitals at triage BP 106/73, HR 95, RR 18, O2 100% EKG HR 104.  Vitals with HR 77-95 No labs, COVID negative   The symptoms began the following morning after administration of the vaccine.  The symptoms were: tachycardia, lightheadedness, flushing, itching, wheezing The treatment of the reaction was:   o Antihistamines: IV and PO benadryl   Other medications taken on day of reaction:  Tylenol
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 25-JUN-2008, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. During 2016, the patient was treated at a medical center, for the onset of a vesicular rash, which was diagnosed as herpes zoster, or shingles. Later in 2016, the patient sought further treatment at a medical facility for ongoing and worsening symptoms of shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
big heart blood clot; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 66 years). Medical history was reported as none. There were no concomitant medications. The patient experienced big heart blood clot on 23Mar2021 14:00. Therapeutic measures were taken as a result of big heart blood clot. Outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Diarrhea cha,cha,cha,abdominal discomfort,4:45-5:15.
A little tired/intense extreme fatigue; A little headachy; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (A little tired/intense extreme fatigue) and HEADACHE (A little headachy) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FATIGUE (A little tired/intense extreme fatigue). 03-Apr-2021, the patient experienced HEADACHE (A little headachy). At the time of the report, FATIGUE (A little tired/intense extreme fatigue) and HEADACHE (A little headachy) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable.
Warm, redness and tenderness 6x13cm. Seen on 4/17/09, Cephalexin 500 mg PO given. Pt to f/u with provider next week.
Flu-like symptoms (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms (1st dose)) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms (1st dose)). On 16-Feb-2021, INFLUENZA LIKE ILLNESS (Flu-like symptoms (1st dose)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medication information was not reported Treatment information was not reported   This case was linked to MOD-2021-307667 (Patient Link).
got the shot, had shingles 1 time/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's son/daughter. The age at vaccination was not reported. The patient received the Shingles shot and still got shingles one time. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case is linked to case US2021AMR190632 reported by same reporter for another patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190632:same reporter
She is having some allergy reaction. It is not severe. It is just like you know, not severe allergy reaction; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 10 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 17Nov2021 (Lot number: FBC5127) at the age of 10 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Nov2021, outcome "not recovered", described as "She is having some allergy reaction. It is not severe. It is just like you know, not severe allergy reaction". Therapeutic measures were taken as a result of hypersensitivity.  Additional information: Any prior vaccinations (within 4 weeks) was reported as no.second shot date was 08Dec2021.Patient was took Benadryl ( dose like 5mg) for the adverse event.  No follow-up attempts are possible. No further information is expected.
Right arm began hurting 6 hours later, began to swell at this time. Pt reports night sweats during evening 1 night. Right deltoid swollen: erythema 5 inch diameter 24 hours later.
Temp of 102.F, backache, severe joint aches, fatigue, headache, and "beet red" face.
Patient diagnosed with extrapulmonary tuberculosis; Positive Quantiferon gold (thought to be secondary to BCG vaccine); Information has been received from the authors in the published literature article entitled as stated below, referring to a 48-year-old male with a history of type 1 diabetes complicated by end-stage renal disease status post kidney and pancreas transplants (performed on an unspecified date reported as 5 years ago). The patient's concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with bcg live (manufacturer unknown) administered for tuberculosis bladder (strength, lot #, expiry date, and route of administration were not provided).  On an unspecified date, the patient had taken a Quantiferon gold test that resulted positive and was thought to be secondary to bcg live (manufacturer unknown) vaccine. Afterwards, on an unspecified date (reported as for the past 7 months), the patient experienced chronic diarrhea, abdominal pain, and weight loss, so he was admitted to hospital. Initial infectious work-up was positive for norovirus and entamoeba histolytica. On an unknown date (reported as hospital day 3), he developed fevers and hemorrhagic shock, and an urgent colonoscopy revealed multi-focal large ulcers throughout the colon evidencing pan-colitis. Additional biopsies showed granulomas, positive acid-fast bacilli (AFB) stain for AFB, and positive mycobacterium bovis on AFB culture. Finally, the patient was diagnosed with extrapulmonary tuberculosis (TB) and started anti-TB therapy with rifabutin, isoniazid, pyrazinamide, and ethambutol. He initially improved, but subsequently had multiple complications including transaminitis concerning for hepatoxicity and worsening renal function from hemorrhagic shock caused by a bleeding mesenteric artery; therefore, the anti-TB regimen was held. The reproted complications significantly impacted drug levels as well as the dosing of anti-TB medications and immunosuppressants. After clinical stabilization, improvement in renal function and transaminitis, he was re-started on anti-TB medications in a step-wise approach. According to the authors, the patient improved with anti-TB treatment. Pulmonary TB was ruled out with AFB sputum and mycobacterium tuberculosis (MTB) polymerase chain reaction (PCR). The patient was eventually discharged on anti-TB medications and close follow-up.  The reporting authors of the article described extrapulmonary tuberculosis diagnosis in the context of a previous bcg live (manufacturer unknown) vaccine administration.  Upon internal review, extrapulmonary tuberculosis was determined to be medically significant.  A copy of the published article is attached as further documentation of the patient's experience.  Literature report:
A nurse reported that a female received an injection of DT Toxoids Adsorbed, Purogenated on 8/18/00. On 9/05/00, she developed "extreme soreness" at the injection site. This is 1 of 4 pts from this facility who had an adverse experience following receipt of this vaccine, lot 471038.
A patient came in wanting a booster dose for Pfizer. She received Pfizer before as her primary dose series. She was administered the booster dose from the purple cap.  At checkout it was discovered she was 17 instead of 18 at the time of administration. She was also administered the dose sooner than 6 months after her primary series. Her last dose was administered on 6/6/2021 and the booster dose was administered on 11/30/2021. I have already reached out to Pfizer's Medical and Safety Team to report the incident.
Shingles long after second shot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles long after second shot) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039N20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR [ACICLOVIR SODIUM]) for Antiviral treatment.   On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced HERPES ZOSTER (Shingles long after second shot). The patient was treated with ACRIVASTINE (BENADRYL OTC) at an unspecified dose and frequency. At the time of the report, HERPES ZOSTER (Shingles long after second shot) outcome was unknown.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
About 3 days after the shot I developed a fever of 100.4, severe diarrhea, fatigue and body aches and all this lasted for at least 2 weeks. I also lost my taste.   The doctor said that it was possible that I contracted covid about the same time that I was vacinated so my body may have had a covid contamination and Moderna shot battle all going on at the same time.
Pt receive varicella vaccine in her left arm on 2/8/11. Today (2/10/11) she reports that her left arm is red, has a lump the size of a baseball that is hard & it is hot to touch. She states that there is no drainage at site.
Pt said she noticed a red mark on her arm on 1218/21.  She did not feel ill except she had a "headache."  12/20/21  area on Right arm at the deltoid site measures 6 cm long by  7 cm wide.  There is an induration in reddened area measures 2 cm Long by 4 cm wide.   area is warm to the touch and red.  Pt said it was much worse on 12/18/21.
Fever, chills, body aches, shortness of breath, fatigue, nausea, dizziness, sore arm, runny nose, food tasted funny/off by 8pm on 3/6. Fever lasted almost 3 days.  Shortness of breath was gone on the second day, chills and body aches lasted until the fever was gone.  Nausea and dizziness lasted a week.  Red, raised, blotchy, itchy patch on arm around injection site arrived within a day.  On the evening of 3/16/21 a red, raised, blotchy, itchy rash began on my legs and by 3/17/21 had spread up my legs, buttocks, back and small blotches began forming on my arms before I took Benedryl which calmed down the reaction.  It is 3/18/21 and I am still fatigued, especially at the end of the day.
A patient, now 50 years of age, reported that she received an injection of Tetanus Toxoid 10 years ago and subsequently developed shaking and tremors. She also developed a runny nose, cough, grey tongue, sore throat, anorexia, insomnia, weakness, right temple pain, "extreme" anxiety, headache, "cracking and popping" in her head and ears, palpitations, and her right ear had "sensitive hearing". She recovered.
Sz lasting about 1 min w/temp of 102F; Onset 8 hrs post inject; Seen in ER; Exam negative; Sent home;
PATIENT VACCINATED AT 1130; MOM RETURNED AT 1345 C/O HIVES AND COUGH.  MOM STATED SHE GAVE BENADRYL RIGHT BEFORE RETURNING TO CLINIC. SPO2: 95% DR. SPOKE W/ PARENTS AND OBSERVED PT, LISTENED TO LUNGS AND HEART.  PT STATED HE'S NO LONGER COUGHING AND DOES NOT HAVE ANY SOB OR DIFFICULTY BREATHING.  WILL CONTINUE TO MONITOR.