chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; Customer reported an AE for MMRII. The caller said she reported this to Merck previously, however original case was not able to be located. Company awareness date marked 7/12/2023. The caller said the patient received a dose of MMRII on 7/10/2023, af; This spontaneous report as received from an other health care professional refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 10-JUL-2023, the patient was vaccinated with improper storage dose of (1 dose) measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin), (M-M-R II) lot #w039699, expiration date: 25-MAY-2024, (exact dose, route of administration and anatomical location were not reported) for prophylaxis. On the same day, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis.  Administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin), (M-M-R II) was exposed to the temperature excursion of 48.8 degrees Fahrenheit for 7 hours and 45 minutes (product storage error). There were no additional adverse events reported (no adverse event).  Lot number w039699 (expiration date: 25-MAY-2024 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with albumin status rHa.
Nausea. BPs 163/115 (pulse 85), 133/101 (pulse 86).
On the afternoon of 01/19/2021 this patient called Health Department to report that she started experiencing "drawing and tightening of the lips" about 9:30pm on 01/18/2021.  Pt stated fear of having a stroke and presented to Emergency Department soon after.  Patient stated was informed by the ED physician that patient possibly had Bell's Palsy related to the COVID-19 vaccine received (01/13/2021).  Pt described that symptoms had "mostly" resolved by time she left the ED after midnight and that was completely resolved when awakened from normal sleep at 7:00am today.    This RN obtained patient's visit note from the 01/18/2021 event.  Summary as follows:  Pt presented to Emergency Department with complaint of perioral paresthesia and earlier in the evening that sides of mouth "drew up."  Pt feared stroke and presented to ED.  Mild paresthesia persisted.  Neurological exam was negative. No unilateral deficits. Speech intact. NIH Stroke scale was 0.  MD's note states patient was advised that the symptoms could be associated with hyperventilation syndrome or could be early manifestation of Bell's palsy with the recent vaccine administration (five days earlier).  Pt was discharged from the ED without finding anything to indicate need for further work up or admission or the presence of an unstable medical condition.  Pt was reminded to take BP med as prescribed due to patient stating had not yet taken evening med dose.
Redness, hard lump 6cm x 9cm, warm, tender to touch and itchy
BLOOD CLOT ON RIGHT CALF; HEMATOMA; BUMP ON SKIN; This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: UNKNOWN) dose, start therapy date were not reported, 1 total administered to right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, first six months post vaccination, the patient experienced a hematoma. The patient had visited the emergency department, where CAT (computerized axial tomography) scan test was done to confirm blood clot in her leg (right calf). The patient's healthcare professional was aware. At the time of this report, the patient experienced a bump coming up on the skin which would come and go and felt anxious. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bump on skin, and the outcome of hematoma and blood clot on right calf was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220513946-covid-19 vaccine ad26.cov2.s- Blood clot on right calf . The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Initial report received from a nurse on 08 Nov 2010: The mother of this child was vaccinated with RABAVERT (batch number 460011A), (dose: 1ml) intramuscularly for pre-exposure prophylactic series on 27 Jul 2010. At the time of vaccination, the mother denied pregnancy. On 03 Aug 2010, the mother presented herself for second-dose of pre-exposure series and it had been found that the mother had not had a menstrual period for seven weeks. Pregnancy test performed on an unspecified date was positive see case (PHHY2010US51547). This child's mother did not use contraceptives and there was no family history reported. The mother had history of normal pregnancy in 2006 following in vitro fertilization procedure and had normal delivery on 13 Jan 2010. The foetus of the current pregnancy died at 4 weeks probably because of genetic reason. A dilation and curettage was used for removal.
Pt received pneumovax on 10/22/09, about 1 hr later her arm started to swell. Today her arm is swollen, has redness from injection site to elbow and is warm to the touch. Treatment: ice, Tylenol or Ibuprofen. If develops fever or redness progresses she is to call.
Information has been received from a Registered Nurse concerning a female who was vaccinated with one dose of GARDASIL (lot number not reported) in the gluteal region and 2 doses of GARDASIL (lot number not reported) in her deltoid. The patient said she did not experience pain when it was given in the gluteal region but she did have injection site pain when it was administered in the deltoid. Subsequently, the patient recovered from injection site pain. Follow-up information was received from a Registered Nurse concerning a 22 year old female student who on 30-OCT-2007 was vaccinated with the first dose of GARDASIL (lot number 655154/1210U), intramuscular into left gluteal. The patient had no previous exposure to this or related vaccine. While the patient was in the clinic, she described discomfort of GARDASIL shots, "they were the worst! Except for the first one I got in the butt. I didn't feel that one at all." The patient was informed that injection did not indicate for that site to the nurse's knowledge. The patient stated that she would try to obtain further information on this. Subsequently, the patient recovered. No further information is available. This is one of two reports received from the same source.
Patient reported severe stomach pains a few hours after the vaccination.  She says the pain has gotten progressively worse since the day of vaccination on Monday April 5th 2021. The pain alleviates when she has had something to eat and tends to return when she eats.
States that she felt "tingling in her head, ringing in her ears, and blurred vision and felt really bad" approximately 30 minutes after the vaccine was given.
Patient was feeling fine while leaving the pharmacy. Aches and pains in joints (shoulders, knees, ankles) started approximately two hours after leaving the pharmacy. The back area around kidney and appendix felt tender and inflammed. Patient felt feverish, but when measured resulted in 97.2F. Patient felt exhausted and laid down around 3-4pm. Woke up around 7pm with sugar levels being approximately 300 despite missing dinner, which went down with insulin. Woke up this morning with no aches/pains with sugars normal. Patient followed up with primary care provider via phone and did not need any additional medical support. Patient states did not do anything else that day and did not meet anyone else; he believes its a reaction from the vaccine.
Pt exp burning sensation between the shoulders; p/dose w exp a burning sensation between shoulders, lt arm pain (elbow & below), swollen lt arm & was arthritic in joints;
10/25/02 two days post vaccine developed hives, swelling of face, lip and throat. No difficulty with breathing. Swallowing hurts also had flu-like illness. Treated in ER 10/26/02 Solumedrol, Benadryl and Pepcid IV, Toradol IM for pain. Rx: Lortab prn, discharged post treatment.
Anaphylaxis Chest tightness started @ 6:00pm  following vaccine. Developed wheezing in all lung fields (confirmed by MD.) Developed hives- Albuterol, Benadryl and epinephrine administered @ 700pm. EMS called and transported to Hospital.
This case was reported by a nurse via call center representative and described the occurrence of therapeutic response decreased in a child patient who received Hepatitis B vaccine for prophylaxis.  On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine, the patient experienced therapeutic response decreased. On an unknown date, the outcome of the therapeutic response decreased was unknown. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient received a full series of hepatitis B vaccine with an unknown brand name as a child. Titers were drawn and they were low (therapeutic response decreased). The patient received one booster dose with ENGERIX-B on 17th August 2018. The reporter declined to provide more information. Lab Comments: On an unknown date, the lab test was performed.
flushed, clammy, yellowish skin tone, t103 7 to 10 days;severe h/a 7 to 10 days;lethargic, no appetite, trouble sleeping 1st 2 noc;
Moderna Covid-19 Vaccine EUA.  My reaction was that I had 101 temp, chills, felt nausea, and felt faint.
Patient received moderna vaccine on 3/8/21, 4/6/21 and 12/7/21 (site, and lot number unknown). Presented to ER on 7/6/22 and found to be COVID positive. Patient is a 79-year-old gentleman diagnosed with COVID recently as documented in the H and P and who presented to the emergency department secondary to persistent weakness with falls.  He was isolated appropriately and monitored for hypoxia.  He did end up with slight hypoxia and was placed on O2 per protocol and dexamethasone which resolved by the close of his hospital stay and was on room air.  Physical therapy and occupational therapy were consulted.  Was on Accu-Cheks AC and HS as well as glipizide and long-acting insulin and metformin.  Blood sugars did elevate secondary to steroid.  Was complaining of some coughing as well as sore throat that were persistent so was placed on ceftriaxone and Zithromax for pneumonia.  Pulmonary toilet, Mucinex, incentive spirometer, flutter valve made available.  Those symptoms improved by the close of his hospital stay.  Was felt he would benefit from rehabilitation so arrangements were made for discharge to  He was discharged there in stable condition on 7/13/22
Discharge Diagnosis:  Hypoxia, COVID 19, Type 2 MI, ESBL E.coli bacteremia,    Hospital Course:  The patient was admitted with the above. She was treated with 5 days of remdesevir and steroids. She was on 2 liters oxygen at D/C.She had an elevated Troponin which cardiology felt was a type 2 MI.  Her course was complicated by ESBL E.coli bacteremia. No source was found. She had a negitive 2D echo and blood culture were negitive 48 hours prior to discharge. CT of the abdomen was negitive for abcesses or causes of infection. She was placed in invanz 1G daily for 11 daily at D/C with a midline placed. She was asked to follow up outpatient.
Headache, nausea, body aches, joint pain, lower back pain, fever, sore abdomen, diarrhea, low appetite, extreme thirst, fatigue. Still occurring as of today, three days after administration.
On awakening the following morning client reported having chills, nausea, dizziness, fever and his "bones" felt sore. He went to hospital emergency room were he said his temperature was recorded at 103F and he said the doctor told him it was a reaction to the flu vaccine. He was given IV fluids and antibiotics and told to take Motrin or Tylenol for fever and report to own doctor if he did not feel better.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced a varicella like rash with 5 - 10 lesions on his face and trunk.
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 23-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 23-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
p/vax pt within min fainted for a few seconds, was given o2, vital sign monitored, juice given. recovered.
Patient given Janssen Covid 19 vaccine out of age range. Pt 13 y/o and only approved for 18y/o and up at this time.
At 6am the following day (22 hours later), I felt sick and dizzy, passed out and hit my head on the floor. I arose without consciously remembering and was moved to a bed, where I regained consciousness. My body/hands felt tingly and my dizziness was intense. I was taken to the ER, where they gave me fluid and potassium. I was sent home with a heart monitor to evaluation irregular heart palpitations.  Heart monitor and follow-up cardiology tests and visits determined normal heart function.  For about 5 months after the event, I was dizzy, nauseous, and fatigued almost every day, to the point where I could not function normally.  Cardiology appointments and tests proved normal. Eventually my symptoms faded (seemingly on their own).  I continued to have some gastroenterology tests for the accompanied nausea and weight loss -- even though my symptoms had mostly faded at this point. (weight loss was occurring slowly since 4/2/20 when I gave birth to my son)
Patient reports shocking sensations in limbs for the last 30 days, elevated blood pressure, and a soreness at injection site
numbness in the lower lip; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (numbness in the lower lip) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, the patient experienced HYPOAESTHESIA ORAL (numbness in the lower lip). At the time of the report, HYPOAESTHESIA ORAL (numbness in the lower lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was reported.
Information has been received from an unknown reporter referring to a 6 year old female patient. The patient's medical history and concurrent conditions were not reported. On 30-JUN-2016, at 15:57, the patient was vaccinated with an expired dose of M-M-R II (rHA, lot # K008625, expiration date 16-JUN-2016), 1st dose, subcutaneously in the left deltoid. She was also vaccinated, on the same date, at 15:11 with the 1st dose of INFANRIX, in the left deltoid, intramuscularly. No adverse effects were reported. This is one of four cases from the same reporter source, (linked to MARRS # 1607USA000647, 1609USA005771, AND 1609USA005772). Additional information is expected.
Fever, severe joint pain that night that made me cry. I do have a high pain tolerance. Nausea and severe headache. I was sick the first 3 days I didn't want to go anywhere. I took Theraflu at day 3 and my headache hurt so bad I could not watch tv, or use a computer screen. I did not call a doctor, and did not have any treatment from a doctor. I powered through. The joint pain all over my body still is on and off. I was a former athlete, so I do realize some of this is from wear and tear. It just came on like a freight train though.
This non-serious medically confirmed spontaneous (initial receipt 16-JAN-2015) concerns an unknown demographics patient. On 23-SEP-2014, the patient received intramuscular AFLURIA (batch number T58806) 0.5 ml once. On an unspecified date, the patient began experiencing soreness and swelling at the injection site shortly after receiving the vaccine which persisted at the time of reporting. The outcome was not yet recovered. Reporter comments: The reporter assessed the events as non-serious.
soreness at injection site; Chills; Fatigue; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ALPRAZOLAM for an unknown indication.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (soreness at injection site), CHILLS (Chills), FATIGUE (Fatigue), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment include ice pack
Exactly 14 days after received the booster, I began suffering from spontaneous urticaria that has become chronic. It has been over 6 weeks since symptoms began and it's still continuing. They are only slightly less severe then when they started.
Menveo administered via  SC; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA724Z, expiry date 30th September 2023) for prophylaxis.   On 11th September 2022, the patient received the 2nd dose of Menveo (subcutaneous). On 11th September 2022, unknown after receiving Menveo, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 12-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The health care professional reported that the menveo was administered via subcutaneous route, which led to intramuscular formulation administered by other route.
A 50 year old male nurse reported that he received an injection of Flu Shield (2001-2002 Formula) on 9 Nov 2001. On 16 Nov 2001, the patient developed optic neuritis of the left eye with symptoms of central vision loss. He was seen by "several eye physicians" who diagnosed an inflamed optic nerve. The patient stated that he is unable to see out of his left eye. An MRI was normal. Analysis of CSF revealed "minimally elevated protein" and no neoplastic cells. Unspecified "blood work" was negative. Testing for Lyme's Disease, HIV, syphilis, and multiple sclerosis were negative. He was treated for Lyme Disease with Ceftriaxone "despite negative test result." The reported stated he is seeing several speciality physicians but none are able to "pinpoint what is going on." He also developed fatigue which the physician feels "may" be related to the antibiotic therapy. Optic neuritis is considered medically important. FOLLOW-UP information received from the physician on 01/11/2002 indicated that the pt also developed weakness, myalgias, and "other viral symptoms". Subsequently, the weakness, fatigue, viral symptoms and myalgias resolved.
3/22--cold all day, by 10 pm almost shivering, 2 hours later aching all over, headache on the morning of 3/23 followed by diarrhea and vomiting. At 8:30 in the evening of 3/23 taken to ER for dehydration, given two iv's and released the morning of 3/24.
Severe Shingles on left side of face affecting, ear, nose, eye, nose & side/top of head. Treated with Acyclovir 800mg 5x, Gabapentine 300mg 3x, Prednisone 20mg 1x for 5 days
felt throat discomfort throughout day p/vax 10PM;pt suddenly had red skin, gen itching & hives/welts, inc sensation of swelling in throat;
After injection a little itching .  The next  day I had what is called 'Covid Arm'.  Rash and itching on the arm.  Had fever, muscle pain, tired and chills
headache (2 days), dizziness, nausea, fatigued (2 days), irritable (3 days), felt "off" like out of body experience or like she was intoxicated but was not.
fever, chills, nausea, vomiting, lower abdomen cramps, arm soreness, weakness Went to emergency room on 4/9/2021
Her arms are sore after the 1st dose; This is a spontaneous report from a Pfizer-sponsored program, received from a non-contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1ST DOSE, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported.  It was reported that patient mentioned that her arms are sore after the 1st dose. The patient wanted to know her schedule for the second dose. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Patient stated that it started out with a  tightness in her arm. Then later that day it turned into numbness of both her ring and pinky finger on her left hand. The numbness is still present 7 days later on 10/26/20 when the patient called in to report the adverse event.
PATIENT CAME IN WANTING PRIMARY PFIZER VACCINE. VACCINES LABELED IN REFRIGERATOR/COMPUTER WERE WITHIN EXPIRATION DATES.  AFTER PATIENT RECEIVED VACCINE, THE REMAINING VACCINE DATES WERE EXAMINED. THE DATES LOGGED IN THE COVID RECEIVING LOG AND THE DATES IN THE COMPUTER WERE LOGGED INCORRECTLY.  AFTER RECEIVING THE PFIZER VACCINE AND ONCE PLACED IN THE REFRIGERATOR, THE EXPIRATION SHOULD HAVE BEEN 10 WEEKS BUT WAS EXPIRATION WAS LOGGED FROM SCANNING THE QR CODE ON VACCINE.  THE VACCINE GIVEN WAS 2 WEEKS AFTER THE CORRECT BUD DATE.
This is not an adverse report. This is a report of suboptimal injection. The nurse reports that some of the vaccine "ran down the subject's arm" after injection. The cause of this is unknown - perhaps a leaky hub or improper injection technique.