chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events.; Caller is medical assistant requesting four doses administered of improperly stored MMR II. No additional information available. No additional adverse events. No product quality complaints.   See related AEs for other patients:  02220156, 02220157, 0; This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unspecified gender. The patient's concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 27-JUL-2022, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) subcutaneous injection, 1 dose, lot #U023829, expiration date: 30-JUL-2023 (exact dose, vaccination schedule, site and route of administration were not provided) for prophylaxis. The vaccine underwent excursion in 10.1 Celsius degrees (C) in a time frame of 15 minutes. No additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA003406: US-009507513-2208USA003578: US-009507513-2208USA003711:
Patient experienced sore arm following COVID vaccine; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2, via an unspecified route of administration in 2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced sore arm following COVID vaccine in 2020. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
A consumer report has been received. The report concerns an 11 year old female consumer, who had been receiving FLUMIST Quadrivalent started on an unknown date. The patient experience my daughter received FLUMIST Quadrivalent yesterday and has a stuffy nose today which started on 16-OCT-2014. The patient recovered from the even of my daughter received FLUMIST yesterday and has a stuffy nose today. The report was considered to be non-serious.  Summary of follow-up information received on 18-NOV-2014 from a consumer via spontaneous source: Updated event outcome to recovered and updated the narrative.
After patient completed 15 minute waiting period post vaccination, she had almost left the clinic and noted that her nose was "running".  She proceeded to have a gushing nosebleed that lasted approximately 1 hour.  When we noted that the bleeding was continuing, we called her grandson to pick her up and take  her to the ER.  Called the ER at 6:15 pm and pt still there being evaluated.
the following morning after receving the vaccination at around 0300 the patient developed Fv TMax 101.8 F along with chils, body aches, nausea and diarrhea. These symptoms lasted around 36 hours with the patient taking acetaminophen regularly.
This spontaneous report was received from a 31year old female referring to her approximately 1 year old son. The patient's pertinent medical history and concurrent conditions were not reported. In October 2012, the patient's mother was vaccinated with an unidentified Merck HPV vaccine intramuscularly (name, strength, dose, lot number and expiration date were not provided). The patient's mother concomitant medications were not reported (Mother's case reported in MARRS #1610USA002292). On an unknown date, since the patient was 1 year old, he had not been able to function in a "normal child setting". He used to bang his head against the wall and had severe behavioral issues. The patient's mother stated, that her son was very intelligent and had a high intelligence quotient (IQ). Also autism tests were performed on unknown dates and he passed them all. He had not been diagnosed with autisms. At the time of the report, the outcome of abnormal behaviour was reported as not recovered and the outcome of head banging was unknown. The outcome of foetal exposure during pregnancy was reported as recovered. The reporter did not provide for a causality between the adverse events and therapy with the unidentified Merck HPV vaccine. Additional information has been requested.
June 24th - Reported to the ER with headache pain (10/10) and fever (max 102.8). Admitted to hospital for 6 days (discharged 30 June 2009). During his illness, the patient reported neck pain and photophobia. Will send follow-up after pt contacted and/or records obtained. 10/8/09 Received hospital medical records for 6/27-6/30/2009 FINAL DX: aseptic meningitis Records reveal paient experienced HA, neck pain, photophobia, left axillary & supraclavicular nodule, fever x 2 days.  Tx w/IV antibiotics & pain meds.  Multiple LPs done.  ID consult done.  Improved & d/c to home on pain meds for expected continued HA. ICD9 codes: 99709; 3218;E8796; 3051.
Pruritic swollen erythematous area left upper posterior arm consistent with allergic type reaction.
MMR administered on 11/15/06 at 15 month PE. Documented febrile seizure on 11/21/06.
Within 1 hour of administration patient became nauseous and started vomiting. Symptoms resolved by next day.
Day after first vaccine, fainted. Periodic dizziness. Urgent care diagnosed vasovagal syncope. 2nd dose 7/12/21 Immediately after 2nd dose, dizziness, odd noises in ear, nystagmus, later Dr. determined it was vertigo.  September 27 still experiencing vertigo multiple times per day.
second day after the shot injection site had a red rash, itchy and the size of a half dollar, the third day the rash at injection site was the size of a tennis ball, itchy and I had a red rash all over both my arms, on the fourth day the rash on both arms was gone but I had an itchy red rash on both my legs - I have taken Tylenol dual action acetaminophen (two pills twice a day), iced the injection site and used Benadryl
skin has been reacting; This spontaneous case was reported by a consumer and describes the occurrence of SKIN REACTION (skin has been reacting) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN REACTION (skin has been reacting). At the time of the report, SKIN REACTION (skin has been reacting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication reported.   No treatment information provided.
I was nauseous and dizzy within five minutes of receiving the vaccine. Over the first two days the symptoms continue to get worse until I went to the doctor on Friday. When I went to the doctor they prescribe some nausea medication. I was feeling Very unwell and have taken the day off from work. Over this weekend the nausea symptoms have gotten worse and I am weak. I am still very nauseous and weak And have the chills
Patient had 3 doses of Oral Rotavirus vaccine, at 2 mo, 4 mo and 6 mo of age.  Patient was diagnosed with intussusception at 8mo of age. 5/16/07.  06/12/2007 Hospital record received for admission 5/16-18/2007 Intussusception.  Infant presented to ED with persistant vomiting, black stool, decreased po fluids, and not seeming quite himself.  He may have fallen out of bed the morning of admission.  PE: WNL except for tenderness of the abdomen with decreased BS.  Hydrostatic reduction done under general anesthesia. D/C DX: Intussusception.
She reported that a patient received GARDASIL 9 after undergoing an unevaluated temperature excursion.; No further adverse event reported / No additional adverse events.; This spontaneous report was received from a Registered Nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On an unknown date, the patient was vaccinated with an improperly stored hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), at a dose of 0.5 milliliter (ml) (formulation, strength, vaccination scheme frequency, route of administration, and anatomical location were not reported; lot number T007024 has have been verified to be a valid lot number for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, expiration date reported and upon internal validation established as 23-APR-2022) as prophylaxis (product storage error).   The administered dose of the vaccine experienced a temperature excursion of 50.9 degrees Fahrenheit (F) for a time frame of 0 hours and 39 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse events were reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
chest pain; winded easily/ shortness of breath; This case was reported by a consumer and described the occurrence of chest pain in a male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) (batch number 292r2, expiry date unknown) for prophylaxis.   On 7th December 2021, the patient received FluLaval Quadrivalent 2021-2022 season. On 7th December 2021, 30 min after receiving FluLaval Quadrivalent 2021-2022 season, the patient experienced chest pain and shortness of breath. On an unknown date, the outcome of the chest pain and shortness of breath were not recovered/not resolved.   It was unknown if the reporter considered the chest pain and shortness of breath to be related to FluLaval Quadrivalent 2021-2022 season.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of FluLaval Quadrivalent 2021-2022 season and 30 minutes later developed shortness of breath, winded easily and chest pain. The patient went to emergency room immediately and had to go twice. Even after a week his symptoms was persist. The reporter also stated that the patient was given the wrong medication instead of Fluarix (which was intended to be given). The patient believed that the wrong medication was given had a lot number 292r2 which he believed was given to given. The reporter consented to follow-up.
approx 27 hours after dose #2 developed fever which reached 102 F, chills, body aches, lymph node tenderness.  At present, large reddened area at and below injection site and lymph tenderness
Skin warm and flush, body rash covering torso area and legs and parts of neck and face. Mother treated with Motrin, Benadryl, Zantac and Tylenol.
Attestation signed by (M.D.) at 9/30/2023  3:48 PM   I saw and examined the patient.  I agree with the findings and the plan of care as documented in the note.      EMERGENCY GENERAL SURGERY PROGRESS NOTE Initiated:  9/30/2023 by  DO   Hospital Day(s): 8     Operations & Procedures: ? none   Summary / Hospital Course: Patient is a 80 Y female presents to the ED with N/V and LLQ pain admitted for obs for non-strangulated herniation 2/2 resection with colostomy for colon cancer done in 1998 with reversal. Hx of chemo and radiation. Asymptomatic, Covid positive. Improved on bowel rest with NGT and placed on clear liquids after NGT was removed.  ______________________________________________________________________   SUBJECTIVE and 24 hour events:   Denies N/V with intake, Denies ab pain, reports passing gas, reports BM   Latest Vitals: BP 123/69  | Pulse 72  | Temp 97.8 °F (36.6 °C)  | Resp 18  | Wt 81.6 kg (180 lb)  | SpO2 92%  | Breastfeeding No  | BMI 32.92 kg/m²
pt child recv vax & pt went to bed w/chills, body aches, bad back pain & had one spot on side under arm;red & painful;broke out w/less than 100 spots vesicles;sore throat, chest pain;itching;could not sleep @ noc;dx chickenpox; 02/11/2010 Information has been received concerning an otherwise health 35 year old male patient who was exposed to his son (vaccinated on 06-FEEB-1998 with one dose of VARIVAX). On 13-MAR-1998 the patient "went to bed with chills, body aches, bad back pain and had on spot on his side, under his arm". The spot was described as bein "like his son's first spot (WAES 98032271) in that it was "worse, red and painful". On 14-MAR-1998 the patient "continued to feel beat up and when he went ot shave, he noticed that he had broken out with less than 100 spots all over his chest, back, nec, face, and scalp". He also experienced sore throat and chest pain. THe patietn was seen by a physician. A chest x-ray was obtained and the patient was prescribed acyclovir 800 mg. On the after noon of 15-MAR-1998, " the aches began to subside, itching began and he could not sleep at night". On 16-MAR-1998 the patient was "very itchy and was totally covered with spots that looked clearly like chickenpox", He was seen again by a physician who agreed with the diagnosis of chickenpos. On 11-MAR-1998 preliminary results of PCR analysis revealed Oka/Merck vaccine strain ant that a throat swab was negative VZV. It was also reported that the patient's skin lesions were healing, however, "he has developed oral lesions which the physican has diagnosed as varicella lesions". The physician also stated, as fas he knew, "the patient has no evidence of an alterd immune system and an HIV test was pending". Further additional information indicated that the treating physician " did not thing that this was a severe case of adult chickenpos, but the equivalent of a typical childhood case of chickenpox". Subsequently the patient's experiences were reported in a published literature article. It was noted that the patient developed varicella after exposure to his vaccinated child. No further information is available.
GREEN/YELLOW PHLEGM; COUGH; This spontaneous report received from a patient concerned a 31 year old of unspecified sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 to Left Deltoid for prophylactic vaccination.  No concomitant medications were reported. On 08-APR-2021, the subject experienced cough. On 09-APR-2021, the subject experienced green/yellow phlegm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cough, and green/yellow phlegm. This report was non-serious.
strong headaches, nosebleeds, chills, sore throat, nose pain and flu; strong headaches, nosebleeds, chills, sore throat, nose pain and flu; strong headaches, nosebleeds, chills, sore throat, nose pain and flu; strong headaches, nosebleeds, chills, sore throat, nose pain and flu; strong headaches, nosebleeds, chills, sore throat, nose pain and flu; strong headaches, nosebleeds, chills, sore throat, nose pain and flu; This is spontaneous report from contactable consumer (patient) via Medical information team. A 31-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 12Apr2021 (at the age of 31-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient got the first dose of the Pfizer covid vaccine on April 12th and she got an appointment to get the second dose on 3May. Patient comments that since she had the first dose, she has been having strong headaches, nosebleeds, chills, sore throat, nose pain and flu on an unspecified date in 2021. She would like to know if these are normal symptoms after vaccination. The outcome of the events was unknown.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Fell down; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell down) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Prostate cancer.   On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (Fell down). At the time of the report, FALL (Fell down) outcome was unknown.            No relevant concomitant medications were reported. Treatment information was unknown.
always get the flu after the shot, once H1N1; I always get the flu after the shot; Initial information regarding this unsolicited valid non-serious social media case was received from a consumer (patient) and transmitted to Sanofi on 27-Oct-2020.  This case was linked to cases 2020SA305170, 2020SA305222, 2020SA305230, 2020SA305270, 2020SA305371, 2020SA305401, 2020SA305420, 2020SA305444, 2020SA305474, 2020SA305488, 2020SA305527, 2020SA305545, 2020SA305591, 2020SA305629, 2020SA305651 and 2020SA305230.  This case involves a patient with unknown demographics who always get the flu (influenza), once H1N1 (H1N1 influenza), after the shot of vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided   On an unknown date, the patients received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) and once H1N1 (H1N1 influenza) unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was nor reported. Final diagnosis was the patient always get the flu after the shot and always get the flu after the shot, once H1N1.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported events.  There will be no information available on batch number for this case.
My husband and I both received a PNEUMOVAX shot against pneumonia and we both got sick right away. Headache, body aches and pains, fatigue, he had stomach pain and indigestion and I have a runny nose and cough. We were both very healthy prior to the shot! We both still feel sick after 9 days and plan to take some time off work.
At the injection site, red circle a little larger than a dollar coin; Swelling; Intermittent itchy feeling; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 31Mar2021 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient did not have any allergies to medications, food or other products. Concomitant medications included estradiol (MANUFACTURER UNKNOWN), citalopram (MANUFACTURER UNKNOWN) and phendimetrazine (MANUFACTURER UNKNOWN); all from an unknown date for an unknown indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205), via an unspecified route of administration in the right arm on 09Mar2021 (at the age of 47-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Apr2021, the patient experienced red circle a little larger than a dollar coin at the injection site, swelling and intermittent itchy feeling. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events red circle a little larger than a dollar coin at the injection site, swelling and intermittent itchy feeling were not recovered at the time of reporting.   No follow-up attempts are needed. No further information is expected.
It was reported that a 47 year old female received Fluzone SV '99-'00 vaccination on 10/4/99, at 07:30. "Four hours after she began to experience pain at her left deltoid, which radiated over cap of shoulder and down axilla. It felt like a fractured rib with deep breathing and was difficult to breathe for 72 hours." On 10/8/99, the pt was "feeling 100 % recovered". No treatment was given. No additional information was provided from follow-up correspondence request.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 25-NOV-2013 at 07:45. ZOSTAVAX lot # J008434 was exposed to -12C for an estimated total time out of range of 42.75 hours. On 26-NOV-2013, the patient was vaccinated with an out of range dose of ZOSTAVAX (dose and route administration were not provided) (Lot number J008434, Exp. Date: 11-OCT-2014). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
103.4-104.1°F for two days, nausea, vomiting, muscle pains, dizziness, shivering
Patient called pharmacy 48 hours after administration of VARIVAX to inquire about reaction at injection site.  Patient reports that injection site is swollen, bruised, red/maroon in color, and itching.  The swelling and redness has become progressively worse and is now the size of sand-dollar.  The swelling is described as "hard as a knot."  The rash has no vesicles or bumps.
Pt developed very large red swollen area, chills, temp, breathing problems.  2 weeks later developed terrible pain in the upper left arm muscle and not as severe pain the right upper muscle radiating into shoulder. Dx: torn supraspinatus tendon, degenerative joint disorder, joint effusion, subchondral cysts, mild dysfunction of the median nerve at the carpal ligament, such that occurs in carpal tunnel syndrome.
Awoke @ 2:15 AM on 5/12/21 (first dose vaccine on 5/11/21) in severe pain, unable to roll over or get out bed without assistance and with 103.5 degree fever - lasted for 24 hours (fever varied from 100-103.5).  Unable to ascend up and down stairs to use bathroom, had to use bedside commode.  Unable to eat, consume limited liquids due to nausea and 10/10 full body joint, muscle pain.  Chills.   5/13/21 - drenched in sweat upon wakening.  Vision is blurry and eye muscles are very painful to move - still occurring.  Fever controlled to 98-99.0 thru day with fever reducers.  Fever at bedtime with sweating, ringing in ears at bedtime and black spots in vision.  5/14/21 - Call into primary care physician
After the second shot I had bruises and sores all over my body and sores in my mouth. I went to a walk in clinic where they did some blood work and my blood platelet was at a 2 when it was supposed to be between 140-400. They admitted me and gave me platelets and steroids and it got to a count of 50 and I was released. Then my platelets dropped again and I went then I was prescribed a medication to keep my platelets up and ever since its been fluctuating up and down.