chrisvoncsefalvay/vaers-outcomes huggingface dataset:
high pitched persistant crying, fever, loss of appetite, throwing up, listlessness, loss of muscle control, diarrhea, shaking, death
headache; tiredness; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches). At the time of the report, HEADACHE (headache), FATIGUE (tiredness) and MYALGIA (body aches) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Apr-2021, Blood pressure measurement: 170/90 (High) high 170/90.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported.. Treatment: Blood pressure medication
No additional adverse effect reported; the patient received a dose of improperly stored ROTATEQ; This spontaneous report was received from a registered nurse concerning to patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided.   On 03-MAR-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 1 dose (unspecified), orally, (frequency not provided; lot # 1660942, expiration date 06-FEB-2021), for prophylaxis. There was a data logger issue involved. There were multiple temperature excursions below 2 degrees Celsius (1.28 degrees Celsius) for a time frame of 2 hours and 30 minutes (reported as hours). No previous temperature excursion were reported. No additional adverse effects were reported.  This was one of several reports received from the same source.; Sender's Comments:  US-009507513-2003USA005842: US-009507513-2003USA005917: US-009507513-2003USA005962:
redness, swelling, itching ,soreness, lasted about 10 days. took one benadryl capsule. resolved
p/vax pt found to be preg via home preg test; last menstrual period 4/16/99;estimated delivery date was1/25/00; during 1st wk july/99 approx 6wks p/recv 2nd dose vax pt had miscarriage; MD visit required;
crying, described by mom as high pitched as if in pain; duration 14hrs from the time of receiving immun; examined in ER & @ MD office; during the 24 hrs p/exam no focal exam; irritable;
Hive on left cheek, flushed skin, anterior neck and chest and anterior upper shoulder. Slightly lightheaded - symptoms occurred 3 min after shots. Patient was given 25 mg of BENADRYL and appeared stable one hour later when she came to my clinic.
Mom states she was here 11-2-12 for well visit. Received HIB and PREVNAR. Noted a rash behind ears and face itchy, when pt. got home Tuesday.
Injection site soreness for 3 days, extreme tiredness, severe headaches, and red rash around armpit area, not itchy but under both arms.
Per provider to administer 6 vaccines to patient today, IPV, MMR, VARICELLA, TDAP, HEP B and MCV4.  Administered IPV, MMR & VARICELLA to patient. After administering all 3, patient began to complain of nausea and dizziness. I let him know we can wait for a few minutes for him to feel better to administer the last 3 vaccines. Patient agrees with plan. Patient then asked for a water bottle. I gave him a bottle of water and asked MA to accompany me to make sure patient is okay. Upon going back to the room, patient's symptoms got worse, stating he still felt bad. We then checked his pulse and 02 which was 40 and 98%. I was concerned that pulse was too low and had provider come in with patient. Patient then had an emesis episode, provided him with emesis bag. Upon check up, provider advised to hold off on giving the last 3 vaccines due to patient's symptoms. He let provider know of this, which she agreed to. She advised to let patient's mom know that due to his symptoms to hold off on vaccines and have him return to administer the remaining ones. I let patient and his mother know of this. Mom proceeded to explain that she prefers if all vaccines are given now, stated that their ride is here now and is being inpatient, that if they do not hurry up they will leave, and mom explained she does not have another ride to take them home. She also stated she is unable to return since she has no one available to bring them back another day. I repeated that unfortunately per provider, she still does not recommend giving remaining vaccines because of symptoms. I went ahead and let my mananger know of this situation. She let me know to waste remaining vaccines and she went in to speak with patient's mother. Patient was scheduled for vaccines at another location.
Face felt tight; Face felt tight, possibly slightly swollen; Slight redness in face; Was exhausted, fatigue; fever; This is a spontaneous report from a contactable consumer (patient, self-reported). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6198 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 27Feb2021 at 11:00 AM, as a single dose for COVID-19 immunization. The patient's medical history included allergies to pollen, grass, trees, mild allergy to wheat. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 27Feb2021 at 11:00 AM, the patient experienced face felt tight, possibly slightly swollen, slight redness in face, was exhausted, fatigue and possibly slight fever for 3 days following vaccination. All symptoms subsided after 72 hours. The patient received on sight EMT administered Benadryl as treatment for the events. Outcome of the events was recovered on 02Mar2021 at 11:00.  No follow-up attempts are possible; information about lot/batch number cannot be obtaine.
fasting blood sugar sky rocketed to 400, but it is still 300; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (fasting blood sugar sky rocketed to 400, but it is still 300) and PAIN IN EXTREMITY (sore arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0260L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic, Asthma, Hypertension and Cholesterol total abnormal NOS.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced BLOOD GLUCOSE INCREASED (fasting blood sugar sky rocketed to 400, but it is still 300) and PAIN IN EXTREMITY (sore arm). At the time of the report, BLOOD GLUCOSE INCREASED (fasting blood sugar sky rocketed to 400, but it is still 300) had not resolved and PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitantly, patient was taking medications for asthma, hypertension, cholesterol and diabetes. No treatment related information has been reported.
Kidney pain started. 1/16/2021 and is continuing through 1/192021
Slight sore arm, 1st day achy, chills, 1st day day 2 - day 5:  Enlarged lymph node in right armpit with swelling and 2 small bruised spots day 3 - aching in both calves of legs; feels like a muscle cramp day 4- day 5 - aching in only left calf of leg day 1-5: slight numbness in tip of tongue
had the shot and shingles twice/Suspected vaccination failure; shingles, feeling of hot electric wires wrapped around waist; pain; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had the Shingle shot and shingles twice and described it as a feeling of hot electric wires wrapped around waist. The patient reported it was like anything else the shot helps but once get it, the pain could last almost a year with flare ups. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
No additional AE details; a patient was inadvertently administered an expired VAQTA; This spontaneous report was received from an office manager and referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-MAR-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection 25U/0.5 mL, 0.5 mL, lot #W006214, expiration date: 04-MAR-2023, administered for prophylaxis (route of administration and anatomical location were not provided) (expired product administered). No additional adverse event details were reported (no adverse event).
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was vaccinated with a 0.5 ml third dose of PENTACEL (lot number: C5541AA and expiry date not reported) via intramuscular route in the right thigh on 13-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ENGERIX B, FLUZONE QUADRIVALENT, PREVENAR 13 and ROTATEQ for Immunisation on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique because only the TDaP-IPV portion of PENTACEL was given and not the ACTHIB. It was unknown if any adverse event was occurred or not following the vaccination. 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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. Documents held by the sender: none.
6/30/10. Pt seen at Health Center with redness and swelling at injection site and erythema around site.
extreme diahrea  weakness  anto diahrea med  dicyclomine still have diaerhea
the Moderna  vial was taken out of the fridge and left at room temperature for about 25 hours and got injected to patient by accident. Patient has not experienced any side effect yet
Swelling and pain in hands, feet and knees began approximately two weeks after second vaccine and is still continuing. Have been to ER, twice to PCP, second appointment with Rheumatologist on 4/1/21. No abnormal results to 23 lab tests/bloodwork, ECG/EKG, X-rays.
if an allergic reaction concerning arteries is a side effect from the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Lot number: GL0446) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for Covid-19 immunization. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "if an allergic reaction concerning arteries is a side effect from the vaccine".  Additional information: Reporter in regard to Pfizer biontech covid vaccine bivalent for adults, if an allergic reaction concerning arteries is a side effect from the vaccine. Reporter states that his reaction seems to be moving around the body. He has some kind of reaction going on and wants to know if it's related to the vaccine. Reporter clarified reaction that occurred to be similar to an allergic reaction, it's not a normal allergic reaction as it seems to concern the arteries. Reporter commented it is not easy being sick.
Patient reported injection site reaction of swelling, redness, and soreness. Patient's provider deemed it as cellulitis and treated with antibiotic.
A solicited report has been received from health professional via Regulatory Authority concerning a 2 year old, male patient, enrolled in study. Concomitant medications of the patient were not reported. Patient had no recent history of respiratory or gastrointestinal infection. The patient received FLUMIST QUADRIVALENT (intranasal), on an unknown date. The patient experienced Guillain-Barre syndrome. Action taken with FLUMIST was unknown. The outcome of the event of Guillain-Barre syndrome was unknown. The company physician considered the event of Guillain-Barre syndrome as serious due to criteria of Important Medical Event. Based on the information in the report, and awaiting the reporter's assessment, the company physician considered the events of Guillain-Barre Syndrome to be related to FLUMIST.
Pins and needles feeling in arm for about 2 hours after injection.  Temperature of 99.3 remainder of day and random bands of pain around skull the rest of the day and night.  Pain at injection site.  Second day,  temperature of 100.3 with flu like symptoms including muscle aches, nausea, and chills. Pain at injection site.
Female caller stated she reccieved the vaccine  on 1/25/2021 @ 4:10 pm in her left arm and has expereinced itching to the injection site since she was injected. But yesterday she not a 2 inch circular red spot at injection site, still no pain only experiencing itching. RN recommended a 1% OTC cortisone cream to be applied direcly to affected area. If the itching should persist to contact her PCP. Caller verbalized understanding.
This spontaneous report as received from a nurse refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided. Concomitant therapies included sterile diluent. On 29-NOV-2017, the patient was inadvertently vaccinated with a dose of VARIVAX 0.5 ml, lot # 1141AA, expiration date 14-JUL-2013 (route of administration was not reported). No adverse effects were reported.
Patient received a J&J COVID-19 vaccination. 3 hours post immunization patient began to have cramps/hot feet. 3 days later he took some APAP because he wasn't getting better. 1 week later he began to experience congestion (pt suspected pneumonia). 1 week later- hurt all over and couldn't sit or lay down. Proceeded to go to ER. The ER admitted the patient for observation. He states they performed 4 X-rays & 2 lumbar punctures. States he had protein in his lumbar. Patient states his nerves are burnt in his legs. Doctor told him he would be in a wheelchair. States Sept. 1 st he will lose insurance because he is unable to work and needs disability.
Intense pain and restricted movement in arm. Saw doctor and taking Advil. Will have MRI tomorrow.
Mother states child woke up in the middle of the night hallucinating.  Screaming saw a monster continued to see it for about 2 hours and tried to swat it away.  Denies fever- ADVISED MOTHER TO CALL HER PHYSICIAN States she was continuing to pull at her hands when mother went to work this am.
Pt received Varivax vaccine on 3/7/00. Pt was presented to MD's office on 3/15/00 covered entire body.
Janssen COVID EUA 2021: During post vaccine observations the patient stated feeling locolized itching. Patient did not showsigns of anaphylaxis, no rash or uticaria, no angeodema and had clear lumgs with no complaint of SOB, Difficulty breathing or chest pain. Patient signed AMA via Hospital.
patient received a booster covid 19 moderna vaccination on 12/30/21 after her scheduled apt with her PCP. After administration it was brought to the MA's attention that the immunization was administered after 12 hours of the bottle puncture time but before 24 hours.  contacted the CDC who recommended i contact moderna. Moderna informed me there is no recommendations at this time.
Patient received 0.5 ml of Moderna 6mo-5 yr vaccine instead of 0.25 ml No Side effects reported
I have had a feeling of "Pins and Needles" in both my upper arms and upper legs everytime I go to move either limb  after it has been resting. The pins and needles could also be described as a burning sensation. I am also experiencing muscle soreness at night,  The feeling has not gone away and does not appear to be getting better after 3+ weeks.
Severe sensory integration issues/defensiveness leading to patient manually removing his orthodontia/braces, and sharp exacerbation in neuro-motor tics.  Patient subsequently developed a persistent sore throat with negative strep culture by throat swab.  12/2013 patient's neuromotor tics continued and vocal tics began.   He experienced knee and finger joint swelling.  His strep titre was positive (>800) and he was treated with antibiotics.  His sharply increased neurological symptoms persisted for several months, and the joint swelling recurred several times.  His strep titre subsequently dropped to "normal".
pt recvd vax;11 days later started URI sx which later devel into a pertussis like illness requiring numerous MD visits & hosp;pertussis culture neg;still w/ spasmodic cough;CXR - inc perihilar markings on 3nov95;
What I believe to be ?Covid Arm? started about day 8-10 post shot.   No symptoms initially, then noticed redness, swelling hardness, warmth to touch, mild to moderate pain and itching on right arm.   Over several days, took 2 Tylenol at bedtime to ease symptoms.   I scheduled a visit with PCP on 1/27/21 but cancelled it because arm felt somewhat better.   However, even today, I feel a mild tenderness in the arm and down to the right wrist.   Redness is faint,: itchy if I scratch or irritate it.   I have not contacted my PCP about this yet.
This spontaneous report as received from a physician via company representative refers to a male patient of unknown age. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (Lot number, expiry date and dose was not reported), subcutaneously. On an unknown date, 2 days after injection, the patient had a rash all over the body. The outcome of rash all over the body was unknown. Additional information is not expected.
2nd dose pizer 2/11; 2/12 fatigue, body aches,  2/16 rash noticed 5PM (bra line, breast, back, legs, down thighs at bedtime, under arms), rash was spreading, pt put calamine lotion on rash, woke up 2/17/21 and rash is gone.
I started to develop like little pimples; I have rash down the back of neck, along the bridge of my nose, eyebrows and eyelids, on my chin, around my mouth and down my chest; more of pustule but like a rash; allergies; This is a spontaneous report from a contactable consume.  A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EH9899) the first dose on 22Dec2020 at single dose for covid-19 immunisation. Medical history was none. There were no concomitant medications.  Patient reported for primary/prescribing healthcare professional details included that actually did it through her county, her county health department so it wasn't specifically a doctor. She was priorities due to her job duty. She was a social worker. Due to the environment where she worked, she had high risk of exposure. She believed that 20Jan2021 was the second dose. Patient received the COVID 19 vaccine on 22December2020 early in the morning around 9 AM and around 6 hours later she started to develop like little pimples which she thought were associated with wearing a mask an N95 however it progressively the rash progressively got worse and now she had rash down the back of neck, along the bridge of her nose, eyebrows and eyelids, on her chin, around her mouth and nose and down her chest. What she saw was were worse pimple that was actually it was more of pustule but like a rash. Patient did try topical for allergies, Cortisol cream and it did not help and she just spoke to a doctor telephonically. She was going to take oral Benadryl but she recommended that should first contact or see a medical Professional in person to them to asses so just the topical. Outcome of events was not resolved.
Pt at clinic with mom for imm. Pt was to receive 7 vaccines and became upset and anxious. Mom tried to comfort pt , but he was visible stressed and crying. I asked another nurse to help as stand-by. I was able to administer the first three vaccines in pt's right arm. Pt stopped crying and laughed saying  "it didn't hurt." The the pt's face got pale and he stopped laughing. He appeared close to fainting. Pt stated he felt dizzy and his tongue felt tingly or numb. Pt was not short of breath and his airway was open upon inspection. Pt appeared tired, but never lost consciousness. After giving him 5 - 10 minutes and a drink of water, he stated he was ok. After discussing the incident with pt's mom, we decided to defer the rest of the vaccines until the next week. Reviewed with mom the s x s of allergies, and that she should take him to the ER if they develop. Mom verbalized understanding.
Narrative:  Pt was a 92 YO male with PMH of afib, anemia, HTN, HLD, COPD, aortic stenosis, depression, and congenital Factor IX disorder who passed away on 10/28/21. No details available about cause of death; no evidence that death was caused by COVID-19 vaccine.
Increase stooling onset 3/23/2020 several times a day initially fever after vaccines now with diaper rash
Adverse reaction to the shot; A spontaneous report was received from a consumer, concerning a female patient of unspecified age, who received Moderna's COVID-19 vaccine and experienced an adverse reaction to the shot.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unspecified date, prior to the onset of events, the patient received their first dose of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.   No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the event, an adverse reaction was considered to be unknown at the time of this report.
Fatigue, slight fever, chills same day and next. Itchy arm starting around 5 days after with on and off pain.
Client states that Sat. 09/11/2010 her arm began to itch. She got nauseous, and nearly passed out. This am she woke up with the left side of her face swollen below her ear. Tender and hot to touch. Afebrile. Advised to hold cold cloth to area and take Benadryl prn.
Heart palpitations, rapid heartbeat, lightheadedness, atypical chest pain, shaky hands started to occur two days after the vaccine was administered. This was not normal. It would not stop by drinking water nor by eating bananas. Went to the ER where in triage my heart rate was 160 - again not normal. After 2 hours the heart racing stopped that day . The  next 3  mornings had slight tremors and it has since gone away.