chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This agent reporting this administration as a misuse due to prescribing information age; No additional AE; Nurse calling to report misuse administration of MMR II to a patient over the age of 6 years old.  Nurse reporting that the patient in question is a new patient to their practice and reports that the patient has a history of MMR II being administered; This spontaneous report was received from a nurse referring to a 14-year-old patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.    In approximately 2015, when the patient was 6-year-old, he/she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) for prophylaxis (strength, dose, route of administration, lot # and expiration date were not reported).           On 09-MAR-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 mL/two dose series, for prophylaxis (strength, route of administration, lot # and expiration date were not reported) (product administered to patient of inappropriate). Nurse stated that the patient was not in the care of their practice at the time of the administration of the  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine. Nurse stated that they were unaware of the patient's previous healthcare professional (HCP) information, or if the patient experienced any symptoms related to the off label use of the  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).The nurse reported this as a misuse due to prescribing information age recommendations for first and second dose administration ( product prescribing issue ). No additional adverse event (AE) was reported.
nausia, vomiting unable to either eat or drink without vomiting dehydrtated symptoms lasted 30 hours
sore arm; swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and SWELLING (swelling) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Diagnosed 1.5 years ago). Concomitant products included LENALIDOMIDE (REVLIMID) for an unknown indication.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and SWELLING (swelling). At the time of the report, PAIN IN EXTREMITY (sore arm) and SWELLING (swelling) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided.   This case was linked to MOD-2021-041328 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Information on Medical history received.
The pt developed diffuse interstitial disease of the lungs about 10 days, post vax, Pneumonia. Annual follow up states- I do not believe the pts pneumonia was caused or related to the flu vaccine. The discharge summary states diarrhea, anxiety, hypoglycemia, hyperkalemia and hypoalbuminemia.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was administered with a dose of ZOSTAVAX post supported temperature excursion (0.65ml, subcutaneously, lot # L000450, expiration date: 09-MAR-2016). No adverse effects were reported. Follow up information has been received on 14-MAY-2015 and on 15-MAY-2015, from a pharmacist who was able to provide the patient's initials and dates of vaccinations for the ZOSTAVAX that experienced a temperature excursion; it was stated that the patient of unknown age and gender was vaccinated on 25-APR-2015. The pharmacist had no additional information to provide at the time of the call. This is one of several reports from the same reporter. Additional information has been requested.
Felt nauseous and achy one day after the injection.  That resolved by the next day (two days after injection).   Today (third day after injection) I?m covered in hives, from cheeks (mild) to upper thighs (mild). Neck, chest, upper arms  are covered.
5 days after the booster shot, recieved on 11/12 right arm, Wednesday 11/17 my right lung stayed to really hurt and I noticed I became out of breath easily. By Friday morning I was in a good amount of pain and went to the emergency room.  I have a pulmonary embolism, multiple small ones in my right lung and a free in my left as well as an infarct on my right lung.  There are no signs of any other blood clots in my legs only my lungs.  Multiple doctors conquer it is most likely from the booster. I will now be on blood thinners for at least 6 months and have to see a hematologist.
I did not receive the injection,   I only had a " Poof" of air, there was no needle on the syringe.   No pin prick or spot of blood...  The syringe without a needle was immediately disposed of.  Pharmacist did not believe me.  I reported this to my attending, the  county health dept.  And finally the State health department.  Nobody can tell me what I can do to remedy this.
pt recv 3 doses of vax & lab eval on 24JUL96 revealed a lack of seroconversion for Hep B;
Patient experienced red, warm to the touch, itchy spots on the arm directly below the injection site and on the bicep. She also felt very tired, lethargic, and cold. It started the day after the injection around noon and she took BENADRYL to help with the itching. I spoke with her on Friday and also recommended placing ice on the warm injection site.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No information about medical history, concurrent conditions was reported for the patient. The reporter stated that patient received first dose in the series of with GARDASIL (dose strength, route unspecified) approximately on an unknown date in 2014 (reported as a year ago). The patient's second dose was administered on 23-JUN-2015 (inappropriate schedule of drug administration). No adverse effects reported. The outcome of the events reported is unknown. No product quality complaint was involved. Additional information has been requested.
pt recv vax & devel screaming for 4.5hr, vomiting, high fever p/vax;pt had recovered @ the date of this report, & had recv no further doses of vax;
Narrative:  Pt reporting pain at injection site, lethargy, and nausea after COVID-19 vaccine.
36 hours after swelling in bicep area of left arm,( enough to form large wrinkle) red and warm to touch. Achiness in arm.
Patient said his right arm swelled and he got a red rash, and localized pain (allergic reaction).
Left upper extremity with redness and swelling with some tenderness in mid lateral deltoid. Supportive care rendered. 13 yr old here with mother with C/O left arm pain. Child received 4 immunizations at 10am today and later while at school - felt pain in her left arm and called her mother who picked her up - no meds given.
She received a pneumococcal 23 vaccine on 06/21/2022. 2 days later she began to have left arm pain at the injection site and noticed  "band" of redness around the injection site and swelling around lateral upper arm. Pain was a 8 out of 10, aching, with associated tenderness to palpation. Pain improved with Tylenol. No fevers or chills or drainage from the injection site on left upper arm. No inhibition of day to day activities due to pain. 5 days after initial symptoms started, patient had some elbow discomfort which has resolved.  she states her pain is 0 out of 10, but becomes a 3 out of 10 when pressing over the injection site, she states the swelling and redness have significantly gone down. Denies shortness of breath, numbness or tingling of extremities, fatigue, malaise. She denies previous vaccine reaction, she does say she has hereditary angioedema.
Allergies: Swelling; This spontaneous report was received from an other health professional and refers to a currently 58-year-old female patient. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies included mycophenolate mofetil (CELLCEPT), albuterol sulfate, albuterol, alprazolam (XANAX), betamethasone valerate (DEL-BETA), budesonide (+) formoterol fumarate(SYMBICORT), cetirizine hydrochloride (ZYRTEC), cholecalciferol (VIT D3), doxepin hydrochloride (SINEQUAN), filgrastim (NIVESTYM), omeprazole (PRILOSEC), ondansetron hydrochloride (ZOFRAN), thyroid (ARMOUR THYROID), tramadol hydrochloride (ULTRAM), valsartan (DIOVAN), folic acid (FOLVITE), hydroxychloroquine sulfate (PLAQUENIL), levofloxacin (LEVAQUIN), losartan potassium (COZAAR), megestrol acetate (MEGACE), metformin hydrochloride (GLUCOPHAGE), mometasone furoate (NASONEX) and montelukast sodium (SINGULAIR).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (strength, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  On an unknown date, the patient experienced allergies: swelling.  The outcome of the event was unknown.   The relatedness between pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) ant the event was not provided.
Injection site remains hard at 10 days after vaccination.  Rash and persistant itching starting on day 9 after vaccination.  Rash area on left upper arm is about 4" x 3."
Left groin area swollen size of dime-nickel. Bruised on first day post vaccination. It has gone down to the size of a pea/quarter inch, the day of the 2nd vaccination (29 days later)
After injection, I had a  2 inch bruise around the injection site and my arm was sore.  Six days after vaccine, I developed an itchy rash near the injection site.  It spread approximately 4 inches down my arm.  It was hot to the touch, and sometimes it would burn.   I contacted my PCP and she told me to take Benadryl, apply a cold compress, and she called in some antibiotics.
The patient states she woke up the next day with a rash around the outer arm, extending from the injection site.  The rash was about 2 inches wide, and 3-4 inches long.  There was some light swelling, but no bruising or itching.
Information regarding PREVNAR was received from a pediatrician regarding a 4-month-old patient who received a dose on an unspecified date and experienced excessive irritability.  Relevant medical history was not provided.  Product was administered on an unspecified date.  Dose regimen was 1 dose 1 time per day (intramuscular).  Concomitant medications were not reported.  During 25-Nov-2007 to 18-Dec-2007, the patient developed excessive irritability.  Treatment included BENADRYL.  The patient had not recovered from the event.  No additional information was available at the time of this report.
Bilateral arm rash noted. " I notice that it was itchy, but I did not pay attention to it, but now I noticed I have welts reactions on my arm."
Dyspnea onset 48-72 hours after FLUMIST. TX with DECADRON 4 mg IM and PREDNISONE pack 5 mg UD X 1 pack.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent conditions or medical history were provided. On an unspecified date in 2016 (reported as "on or after 03-MAR-2016"), the patient was vaccinated with an improperly stored dose of ROTATEQ injection (lot # M002252 with expiry date: 28-FEB-2017, orally; strength and dose were unspecified). There were no concomitant medications provided. The administered vaccine underwent the temperature excursion at 8.3 degrees Celsius for 19 minutes. There was no previous temperature excursion. Data logger was involved. No concomitant medications were reported. No adverse effect was reported. This is one of several reports from the same source. Additional information has been requested.
pt recv vax 15APR96 pt exp swelling of the eyelids;no further details were provided;
Initial unsolicited report received from a nurse on 04-Nov-2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of FLUZONE INTRADERMAL QUADRIVALENT (manufacturer: Sanofi Pasteur, batch number, expiry date, dose details, route and site of administration were not reported) on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date in 2014, patient developed cellulitis of the upper arm. Laboratory investigations and corrective treatment were not provided. The outcome of the event was not reported. Upon internal review this case was considered serious due to important medical event: cellulitis of upper arm. List of documents held by sender: none.
0.03ml dose given from vial diluted with 0.18ml saline instead of 0.3mL dose give from vial diluted with 1.8ml saline. Discovered after administration and patient had left. No 3mL syringes were available at that time.  It appears based on math that correct amount of vaccine was given, but not as diluted as it should have been. No ill effects noted by patients while present 15minutes directly after administration
This is a spontaneous report received from contactable consumer (patient). A 20-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EW0150), at the age of 20, via an unspecified route, left arm, on Apr 8, 2021, at 12:30, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On Apr 8, 2021, at 15:00, patient had a full body rash (red dots covering her whole body). Patient stated the rash and itching was worse today. Patient did not go to emergency room/physician office. The outcome of itching: unknown; full body rash (red dots covering her whole body): not recovered. No follow-up attempts needed. No further information expected.
mom noted redness @ inject site called MD rt leg w/nodule noted @ site (2cm nodule); no redness, no tenderness; MD observed 23MAY94; noduel remained 2cm observe 6JUN94; lt leg DT inject site red, soft, tender; referred to surgeon who perfo;
Swollen lymph node on left side of throat - swollen enough that it hurt to swallow, and neck was tender to the touch. No sign of redness in the throat or on the neck, just very swollen/pulsing lymph node on left side only (opposite side of vaccine injection site). Did not sting or feel like a sore throat - just a strong pressure / feeling of lump that made it painful to swallow. Began approximately 48 hours after vaccine, and started to resolve today (so, total duration of swelling was approximately two days). No other symptoms, no exposure to COVID. Was not concerning enough to report to a doctor, did not obstruct breathing or anything.
No adverse effects reported; An unknown number of unspecified patients may have been administered vaccines improperly stored; This spontaneous report was received from a nurse and an office manager and refers to an unknown number of patients of unknown age and gender. There was no information provided about the patients' concurrent conditions, concomitant therapies, historical drugs, drug reactions or allergies, or medical history.  On multiple unspecified dates, the patients were vaccinated with improperly stored doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) (exact dose, frequency, route and site of administration were not reported); with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) (lot# R000550, expiration date 08-JAN-2020) (exact dose, frequency, route and site of administration were not reported) and with haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB) (lot# R000877, expiration date 24-SEP-2020) (exact dose, frequency, route and site of administration were not reported) all administered for prophylaxis. The administered doses were exposed to a temperature below 36 Fahrenheit degrees (F): 31.6 F for 2 hours and 13 minutes and 25.7 F for 1 hour and 35 minutes, and temperature above 47 F: 50.5 F for 18 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.  Follow-up information was received from a physician's receptionist on 01-AUG-2019. The patient was a 11-year-old female. On 16-JUN-2019, she was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot# R025725, expiration date 25-MAY-2021) 0.5 mg in left deltoid (frequency and route of administration were not reported). It was clarified that no patient received measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (M-M-R II) and haemophilus b conjugate vaccine (meningococcal protein conjugate (LIQUID PEDVAXHIB). The reported temperature excursion occurred from 30-MAY-2019 to 22-JUL-2019. The reporter stated that the temperature probe was misplaced, which resulted in an incorrect reading. No adverse effects were reported.  This is one of 3 reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA003824: US-009507513-1907USA011013:
Chest pain and palpitations for 12 hours leading to admission to hospital. Post-vaccine myocarditis diagnosed.  Treated for several days with motrin and steroids, and IVIG.
Injection likely given subcutaneously. The person administering the injection squeezed my skin prior to injecting and likely did not reach muscle with the needle. One day later, I have a 2-inch red, swollen area.
Information has been received from a health care worker concerning a 11 year old female with latex allergy, allergic reaction to amoxicillin (+) clavulanate potassium and diphenhydramine hydrochloride, and no pertinent medical history, who on 17-APR-2007 was vaccinated intramuscularly with varicella virus vaccine live (Oka/Merck) (lot # 656290/0113U). There was no concomitant medication. On 17-APR-2007 the patient experienced increased swelling of the upper right arm with warmth and tenderness noted at the injection site. Unspecified medical attention was sought. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information has been requested.
Within 2 hours, patient started developing raised bumps on face, arms, trunk and legs. Also had a daily headache, temp around 100 degrees and backache for the following 5 days.
low grade fever for over 12 hours fatigue and exhaustion for over 12 hours miscarriage - fetus measured at 7 weeks - calculated that fetus was 4 weeks at time of injection
WHEN PHARMACIST ATTEMPTED TO INJECT PNEUMOVAX THE NEEDLE DETACHED OR SOME OTHER DEFECT OCCURRED AND THE DOSE WAS NOT ADMINISTERED. THE PHARMACIST THEN ADMINISTERED A PNEUMOVAX FROM A NEW PREFILLED SYRINGE. THE PATIENT STATES THAT STARTING THE EVENING AFTER THE VACCINATION, SHE EXPERIENCED EXTREME TIREDNESS THAT SHE DESCRIBES AS WORSE THAN A FATIGUE. SHE STATES THAT SHE WAS SO TIRED THAT SHE ALMOST FELL ASLEEP DRIVING AND HAD TO CALL HER HUSBAND TO PICK HER UP. WHEN SHE GOT HOME, SHE STATES THAT SHE SLEPT FOR 26 HOURS STRAIGHT. THE INJECTION SITE IS STILL INFLAMED TODAY (10/18/17). THE INFLAMED AREA IS VERY RED AND COVERS AN AREA OF CLOSE TO 5 INCHES IN DIAMETER. THE PATIENT HAS BEEN PUTTING ICE ON THE INJECTION SITE AND TAKING ALEVE. SHE WAS ADVISED TO WATCH IT AND MAKE SURE IT DOES NOT WORSEN AND CONTACT HER DOCTOR IF HER CONDITION WORSENS.
"Tingly feeling all over, feels like pins and needles all through my body"  within 5 minutes of receiving vaccine.   Staff member with constant observation, no further adverse event.  Approximately 15 minutes post vaccine, symptoms were gone.  Staff member observed for full 30 minutes.
103.7 degree Fever High Pitch Screaming Could not calm or settle baby for hours Splotchy looking skin on abdomin Baby could/would not sleep Baby could/would not sit steady like he  typically does (almost like he was "floopy" like a noodle. We pages the emergency docotr on call she advised to give advil, we did. A few hours later Patient fell asleep and calmed Since this eppisode Patient has not been eating or sleeping like he typically does and his daycare reported him not as happy go lucky,
Swollen Lymph Nodes in neck/the swelling had grown from a pearl size to the size of medium size marble; extreme fatigue; This is a spontaneous report from a contactable consumer via Pfizer. A female patient of an unspecified age received first dose of BNT162B2 (BNT162B2, formulation: solution for injection, lot number: Unknown) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swollen lymph nodes in neck and extreme fatigue 10 days post her first vaccination. She mentions the swelling had grown from a pearl size to the size of medium size marble. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information was expected.
Received VARIVAX #2 on 7/27/09 - erythema, pruritis, sl. tenderness, 4-5cm diameter elevated area.
An expired PROQUAD (lot S017265 exp 12/1/2020) was administered to one patient on 12/10/2020; No additional adverse events reported; This spontaneous report was received from a registered nurse and refers to a 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-DEC-2020, the patient was vaccinated with dose of expired measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) injection, subcutaneously, lot # S017265, expiration date 01-DEC-2020 (strength and dose were not reported) reconstituted in properly stored and not expired sterile diluent for prophylaxis. No additional adverse events reported.
Information has been received regarding a case in litigation from a lawyer, a 74 year old female patient, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 17-OCT-2013, the patient was administered the ZOSTAVAX (lot number, dosage and route of administration not provided) by a pharmacist at a pharmacy. On or about 27-JUL-2015, the patient was treated by a physician's assistant for the following injury resulting from her ZOSTAVAX use: Herpes zoster. The outcome of the herpes zoster is unknown. The patient claims damages as a result of: injury to themselves, loss of consortium, loss of services, and economic losses. Additional information has been requested.