chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No other Adverse Event reported.; Patient received VAQTA vaccine after expiration date.; This spontaneous report as received from a Registered Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  On 28-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) 0.5 milliliter (strength, route, frequency, and anatomical location, were unknown) with lot # S007769, and expiration date 24-JUL2020 for prophylaxis. No other adverse event reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S007769; expirationdate: 24-JUL-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Hives on face, arms and legs. Acute epistaxis where it has never existed. Swollen R tonsil.
Call from parent; reported mild diarrhea and facial redness/rash on face(cheeks) which started 8/17/2018. Temp 98.6; No recent history of illness or fever; No localized reaction at injection sites.
This spontaneous report as received from a physician via a company representative, refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 17-AUG-2015, the patient was vaccinated with an improperly stored dose of GARDASIL 9 which had a lot number of L001312 and expiration date of 24-FEB-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified dates, the GARDASIL 9 vaccine had four temperature excursions as follows: one 64 hour with a lowest recorded temperature of 31 F (-0.555555556 Celsius), one of 64 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius), one for 8 hours with a lowest recorded temperature of 29 F (-1.666666667) and the other one for 72 hours with a lowest recorded temperature of 33 F (0.555555556 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
accidentally administered an extra booster dose with no reported adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 12 years old female patient who was accidentally administered an extra booster dose of meningococcal A-C-Y-W135 (T conj) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 15-May-2023, the patient accidentally received an extra Booster dose (0.5 mL) of suspect meningococcal A-C-Y-W135 (T conj) vaccine (Strength = Normal), solution for injection (batch number: U7447AC; expiry date: 20-Sep-2024) via intramuscular route in unknown administration site for Immunization with no reported adverse event (Extra dose administered ) (same day latency).  It was reported, She wanted to know if it was safe and what will be the next dosing schedule. The latest schedule of administered vaccine did not populate in their system and that is why she accidentally administered an extra booster dose. Prior to giving the extra dose, the last dose was in 4April2022.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event accidentally administered an extra booster dose with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
The vaccine had an expiration date of 12/31/2069. This cannot be correct?  I am wondering if I am fully covered, this being my 2nd dose.  My 1st dose given on 2/4/2021, lot # EN 5318  had no expiration date.
Developed scratching, redness, swelling, tightness/tautness left arm from elbow to shoulder.  No fever. Gave Benadryl, and Motrin alternating with Tylenol. Next morning swelling, itching, soreness were all diminishing.  Instructed to call Health Dept. if more problems.  We will check with Med Dir re: further immunizations and get back with Mom.
Received call today 10/12/2017 at approx. 1:00 pm. As per patient's spouse, patient experienced injection site pain, up and down arm. Pain started approximately 3 hours after injection. Patient reported no adverse  effect at time of injection. Patient left and began to experience pain approximately 3 hours after injection. Slight fever and some nausea. Received call from patient's spouse asking for guidance as to what to do concerning reaction, I asked if patient was still experiencing pain, he stated yes. Then, I asked if patient had taken tylenol or ibuprofen. Patient's spouse stated she took tylenol # 3. No relief in pain symptoms experienced.
Reported to ER on 8/22 with left side chest pain. A CT scan revealed a condition called myocardial fat pad necrosis
Patient was to receive 2nd dose of moderna vaccine, 0.5 mL. During administration, syringe needle became loose and syringe disconnected from needle while in patient arm. Because of this, more than half of volume of vaccine leaked out and ran down patient arm. Administering nurse estimated that less than half the dose was administered into the arm. Nurse Manager called on-call physician. Physician stated that since less than half of dose was administered to patient, she recommended an additional half dose (0.25 mL) be given to patient. Patient was educated on Dr response, and patient verbalized approval of plan. The additional 0.25 mL dose was then administered to patient.
Shortly after injection was given, patient had a vasovagal reaction.  Patient was helped to the ground and Dr., our on site doctor was called.  Patient was placed supine with legs elevated and monitored by clinical staff.  Patient recovered shortly and stated that she had not eaten yet today.  Patient was given Gatorade and was able to sit in a wheelchair.  Patient was monitored for an additional 30 minutes before being released with accompanying family.  Patient left under her own power in stable condition.
Injection site became red and affected the whole shoulder area. It has been 2 weeks and the redness is still present, sore and itchy. Have used curtain cream, ice and Benadryl. Starting to get a little better but still present.
Fever 103-104ºF, nausea, severe body aches, severe headache, diarrhea, chills and sweats.
This spontaneous report as received from a nurse refers to a 14 patients of unknown ages and genders. On unknown dates, starting from 18-MAY-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot# M011840, expiration date 01-FEB-2018; lot# M026306, expiration date 30-APR-2018; lot# M031557, expiration date 07-APR-2018; lot# K016966, expiration date 10-MAY-2017; lot# K010215, expiration date 05-MAY-2017 for prophylaxis. Additional information has been requested.
Administered vaccine at 0810 on 1-25-10 at doctors. This was 2nd dose. Child had no adverse reactions with 1st dose 11/16/10. Left deltoid had red rash at injection site blotchy 2 inches in diameter, no edema or whelping. Denied any pain itching SOB or any problems. Vitals : Applied pulse 82, resp 20, B/P 100/108 8:32. Applied pulse 88, resp 16, B/P 100/60, 8:42. Administered 2 tsp Benadryl PO.
Slightly itchy; Rash on the arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Mar-2021 and was forwarded to Moderna on 19-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Slightly itchy) and RASH (Rash on the arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced RASH PRURITIC (Slightly itchy) and RASH (Rash on the arm). At the time of the report, RASH PRURITIC (Slightly itchy) and RASH (Rash on the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information was reported.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: follow up received: second dose added
Abd pain, bloating, gas, jaw pain, body aches. Sx began the day following Tdap vaccine. Sx have improved and almost resolved over last 10 days. No pharmaceutical medications at this time.
I started a period. I have not had a period in a long time due to having a Mirena IUD. I also know when I'm cycling because I get a cyst on an ovary each month. This was not a scheduled period and started about a day after receiving the vaccine.
Information had been received on 20-FEB-2017 from a nurse practitioner regarding an unspecified male patient (age unknown) with hypertension, diabetes, hyperlipidemia, morbid obesity, asthma and allergy to erythromycin. Nurse practitioner reported that she administered PNEUMOVAX 23 (lot# M041394, expiration 23-MAY-2018) (dose and route of administration not reported) to the patient on 17-FEB-2017. Concomitant medications included GLUCOPHAGE, lisinopril, NORVASC, ALLEGRA, albuterol and LIPITOR. Nurse practitioner reported that the patient was seen in the office today with complaints of headaches, flushing, chills, shaking, sweating, and temperature of 102.6 on 17-FEB-2017. The patient treated self with ibuprofen. On 18-FEB-2017, patient stated that he continued with a temperature, dizziness and flu like symptoms. Nurse practitioner performed flu test and strep test that were both negative. Patient's left arm was red at injection site. Patient's present status was reported as recovering. Patient was given unspecified treatment for his adverse events. No further information was provided. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's pertinent medical history and drug reactions/allergies were unspecified by the reporter. On 24-FEB-2014 the patient was vaccinated with PNEUMOVAX23 injection 25/0.5 Y lot # J009723, expire date: 30-JAN-2015 (dosage, route, frequency not reported). No concomitant medications were reported. It was reported that on 25-FEB-2014, patient developed cellulitis, was hospitalized and had surgery (medically significant) for cellulitis after receiving PNEUMOVAX23 (hospitalization). The pharmacist stated that the patient initially had pain at the injection site and then the patient developed cellulitis at the injection site. The reporter stated the patient was hospitalized in the for an unknown period of time and was treated with an unspecified antibiotic after having surgery. The patient sought medical attention (reported as contacted nurse). The pharmacist stated he has 50 vials of the same lot the patient received and also inquired whether the lot # still safe to administer to patients. He also requested a lot check on this lot#/expire date of PNEUMOVAX23. The outcome of the event had surgery for cellulitis after receiving PNEUMOVAX was unknown. The outcome of pain at the injection site and cellulitis after receiving PNEUMOVAX23 was reported as recovering/resolving. The reporter considered the event as serious due to hospitalization. Upon internal review the event surgery considered as serious due to medically significant. Additional information has been requested.
Patient is a 31 y.o  female G9P1 approx 31w4d with EDC of 4/5/20. Patient has a past medical h/o abnormal pap smear, migraines, ectopic pregnancy, and chlamydia. This pregnancy has been healthy. She does has a positive antibody screen for Anti-Leb which is relatively insignificant. She was seen at the office for a prenatal visit on 2/4/20 and was given a 3rd trimester TDAP injection in (L) deltoid. Injection was tolerated well but patient reported increased swelling in arm and around injection site the next day and increased shoulder and upper back pain. She was instructed to come into the office today, 2/6/20, for evaluation. Upon assessing her arm, writer noticed (L) upper arm was swollen with a circumference measuring 39.5cm (right arm which is dominant measured 38.2cm) with a 2cmx4cm raised, red hive. Writer also noted that patient's (L) upper arm, shoulder and scapula were very tender to touch and patient reported pain with any arm movement. Midwife, CNM came and evaluated patient as well.  No numbness, tingling, or weakness noted but swelling, hives and shoulder pain are concerning for brachial neuritis. Patient was instructed to take Benadryl and Tylenol and to monitor symptoms. Since swelling and pain were slightly improved from the day before, midwife was hopeful that patient is recovering from reaction. She was instructed to call her PCP immediately if pain or swelling worsens.
About two weeks after recieving the second dose of the Pzifer COVID19 Vaccine, I started noticing a "chemical-like" smell when I went outside. Over time, I noticed that I started tasting that same "chemical-like" smell in my food and it was become stronger. Certain foods such as meats, cucumbers and sodas, all have that same strong "chemical-like" taste/smell to me.  I had COVID19 in December of 2020 and lost my taste/smell for about 3 weeks.
Noticed that her left upper arm was red and slightly itchy in two adjoining areas. States she doesn't know if this is from the Tdap vaccine she received on 8/28/13 or possibly from bug bites that she may have received when she spent approximately 2 hours at a fair. She noticed the redness and itching shortly after she returned from the fair that evening. Symptoms have stayed the same since that time. She has used an OTC antiseptic ointment. States this treatment has relieved the itch for a period of time.
Warmness at the injection site; Redness at the injection site, three inches in diameter; Itchiness at the injection site; A spontaneous report was received from a consumer concerning a 76-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness at the injection site, three inches in diameter, warmness at the injection site, itchiness at the injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Detail Batch Number) intramuscularly for prophylaxis of COVID-19 infection.   Redness at the injection site, three inches in diameter, Warmness at the injection site, Itchiness at the injection site.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events were not applicable.  The outcome of event(s), redness at the injection site, three inches in diameter,warmness at the injection site,itchiness at the injection site was unknown.
This solicited report was received from a mother referring to unspecified number of her children, of unknown age and gender, as a part of a market research. There was no information about the patients' concomitant medications, concurrent conditions and medical history reported. On an unknown dates, the patients were vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown) (dose, route of administration, lot# and expiry date were not reported). On an unknown dates, the patients had bad reaction to the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown), therefore their mother reported that her children did not need the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (manufacturer unknown). The outcome of the event was unknown. The reporter considered the event to be related to Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine(manufacturer unknown). Additional information has been requested.
Nausea, vomiting, diarrhea developed a few hours after receiving flu vaccine. Symptoms continued through most of the night. By noon, patient was tolerating fluids and soft food.
I?ve been experiencing extremely bad left shoulder and upper back pain, for more than a year,  I?ve done multiple treatments, muscle relaxers, corticoide shots, nerve block, chiropractor, physical therapy, massages, lifestyle changes, etc. nothing has worked so far. This affects my life lots, working is hard because I?m in pain all day, sleeping is hard as well as when I move it hurts any my back cracks, I have to stretch all day, even when I?m out let?s say in a restaurant, which is embarrassing, I?m uncomfortable all day, i had to stop working out due the pain, now I only do stretches or easy yoga. I feel lost and depressed.
This spontaneous report was received from a healthcare worker refers to a patient of unknown demographics. On 10-MAR-2014 the patient was vaccinated with ROTATEQ orally (dosing regimen unspecified). No concomitant medications were reported. On an unspecified date medication error was reported as the patient received doses on 10-MAR-2014 that were exposed to temperatures outside of the recommended storage range noted in the prescribing information. No adverse effect reported. No product quality compliant involved. The outcome of medications error was unknown. This case is linked to: 1403USA005417, 1403USA011256, 1403USA011262, 1403USA11268, 1403USA011301, 1403USA011335, 1403USA11343, 1403USA011350, 1403USA011353, 1403USA011356, 1403USA011363, 1403USA011380, 1403USA011414, 1403USA011416, 1403USA011418, 1403USA011422, 1403USA011424, 1403USA011425, 1403USA011427. (Same reporter link). Additional information has been requested.
This spontaneous case, initially received on 27-Nov-2017, was reported by other health professional and concerns an adult male patient of unspecified age (51-64 years). On an unspecified date (reported as 6 to 10 years ago), the patient was administered with influenza vaccine, (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, the patient had fever, runny nose, chills and fast heartbeat. At the time of the report, the outcome of the events was not reported.
Clot; big lump/almost like 3 inches diameter round/very hard lump; Pain in both arms at the deltoid/pain in legs; Lower legs and arm were weak/weakness in muscle; Headache in the left side of her head; Patient has not received the second dose; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], VITAMIN D [VITAMIN D NOS], FISH OIL and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Clot) (seriousness criterion medically significant), VACCINATION SITE MASS (big lump/almost like 3 inches diameter round/very hard lump), PAIN IN EXTREMITY (Pain in both arms at the deltoid/pain in legs), ASTHENIA (Lower legs and arm were weak/weakness in muscle), HEADACHE (Headache in the left side of her head) and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Clot), VACCINATION SITE MASS (big lump/almost like 3 inches diameter round/very hard lump), PAIN IN EXTREMITY (Pain in both arms at the deltoid/pain in legs), ASTHENIA (Lower legs and arm were weak/weakness in muscle) and HEADACHE (Headache in the left side of her head) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received the second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing was delayed on an unknown date.       Patient had to shower with hot but tolerated water to make sure the clot doesn't form all over.  Company comment: Very limited information regarding these events have been provided at this time. Further information is requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information is requested.
goose-egg sized area at injection site became hot, hard, red, itchy, with fine, tiny bumps. Pain in inner ears and throat.
Pt c/o redness, itchiness at injection site 1 day after receiving VARIVAX #2, resolved with antihistamine.
15 hours after injection woke up at 1am with fever, chills, migraine, body aches
Raised red circle, surrounded by a another pink circle. Inflammed and hot to the touch.