chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; Sore arm; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 79 years as dose 3 (booster), single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Apr2021, when the patient was 78 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details), administration date: Jan2021, when the patient was 78 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021, outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021, outcome "recovered" (Dec2021), described as "Sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: It was reported that, no other vaccine was received with in four weeks. Adverse event: Sore arm that persisted 3 weeks after injection. Patient was not diagnosed with COVID prior vaccination and was not tested with COVID post vaccination. Had no known allergies.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Red rash where shot was given for 2 days..8 days later rash appeared again. Also headache
Information has been received from a physician concerning a 11 year old male patient who on 21-AUG-2008 was vaccinated with a second dose of VARIVAX (Merck) (lot # 660499/0132X). On 09-SEP-2008 the patient was seen in the physician's office with the complaint of chicken pox. The patient's brother also developed chicken pox after vaccination with VARIVAX (Merck) (WAES# 0809USA01837). Additional information has been requested. This is one of several reports from the same source.
4 days after she received her second dose she had hives from head to toe.  She has gone to urgent care and is being treated with Benadryl, prednisone and famotidine and still the hives have not resolved.
This spontaneous report was received from a pharmacist regarding a patient of unknown demographics. There was no information about concurrent condition, concomitant medication and historical medication. On an unknown date the patient was vaccinated with improperly stored ZOSTAVAX lot no. M032141/ expiration date-02-OCT-2017 (incorrect product storage). No adverse event was reported. Temperature and Time of excursion was 17F for 2 hours. There was no previous excursion and call was not because of data logger. The outcome of the event was unknown. No PQC (product quality complaint) was involved. Additional information has been requested.
administration error: gave pt full dose of moderna instead of flu shot. pt already received 3 doses of pfizer
Extremely sore arm starting day after. Extreme dizziness and nausea upon rising. Fever/chills for 48 hours after vaccine. Redness and itching at injection site for 5 days.
Pt. has never had an allergic reaction to eating fresh pomegranates. She has been eating fresh pomegranates since the age of 2. After receiving the vaccine for covid-19, she ate fresh pomegranate 3 days later, within 15 minutes she had an allergic reaction; her lips began to swell to double in size. It was treated immediately with over-the-counter Benadryl at home.
no symptomatic side effects; VAQTA that was inadvertently administered after it's expiration date; This non-valid spontaneous report was received from a certified medical assistant and refers to a patient of unknown age ad gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-MAR-2023, the patient was inadvertently administered with an expired dose of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, lot #W007375, expiration date: 16-JAN-2023 (expired product administered), administered for prophylaxis (dose, and route of administration were not provided). The vaccine had not experienced any temperature excursions and no symptomatic side effects were reported for the patient.  This report is non-valid due to lack of the patient's identifiers.  Follow up information recived on 07-APR-2023:  This spontanous report refers to 15-month-old male patient.The patient identifiers were provided. Vaccine administrator was provided.  Tis is one of the several cases recived from the same reporter.
Patient died; portal vein thrombosis; thrombocytopenia; This is a spontaneous report from a contactable physician. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced portal vein thrombosis and thrombocytopenia 2 weeks after first Pfizer vaccine. Patient died. The patient died on an unspecified date. It was not reported if an autopsy was performed. The outcome of the events portal vein thrombosis and thrombocytopenia was unknown. The outcome of the event unknown cause of death was fatal.  Information on the lot/ batch number has been requested.; Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. Based on temporal association, a causal association between the reported events and BNT162B2 cannot be fully excluded. Case will be reassessed when additional information is available including medical history and concomitant drug information.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate. ; Reported Cause(s) of Death: Patient died
Patient inadvertently was given  vaccine after published  expiration date. Moderna Company did analysis of vaccine vial and determined  lot 007B21A maintained activity necessary to protect against covid 19. Patient did not call office to report adverse event. This is administeration error without adverse event
Day after shot, shooting pain from injection site to my fingertips. Then pain started across left shoulder. Rash/Hives on both forearms, lymph nodes swelling under left arm and left knee swelling. Shooting pain has gone and rash/hives are slowly disappearing, but swelling of lymph nodes and knee are still present 3 days after shot.
pt.recd vax & exp. urticaria,fever & malaise.rash resolved except for 2 red welts.pt. con't. to feel weak & tired.
Symptoms started 2 days after vaccine administration. Started on the right arm (opposite of injection), radiates to the right neck and fingertips. Neuropathic, worse at night. Improves to a 3/10 with ibuprofen. No weakness/sensory loss.
2 to 3 hr p/vax became fussy & vomited large amounts of breast milk; devel fever of 104 a during the noc; mom stated pt became limp & had blank stare; fever diminished p/given APAP & sponge baths; pt had t101A; pt gradually improved;
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age. The patient was vaccinated with the first and second dose of GARDASIL (dose, route and lot number not provided) respectively on 28-SEP-2011 and 16-FEB-2012. No other co-suspects were reported. No concomitant medications were reported. On 23-OCT-2012 "today" the patient was to get the third dose. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
This spontaneous report as received from a pharmacist referring to a patient of unknown age and gender. Information about the patient's medical history, concomitant medications and drug reactions/allergies was not provided. On 06-SEP-2018, the patient was vaccinated with VARIVAX (lot # N035940, expired date 21-DEC-2019) with STERILE DILUENT intramuscularly instead of via the subcutaneous route for prophylaxis(Subcutaneous injection formulation administered by other route). Concomitant therapies included sterile diluent. No adverse event was reported.
On 15Nov2021, he reported having a Light fever which lasted for 24-36 hours.; Receive 0.5ml Booster Dose; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (On 15Nov2021, he reported having a Light fever which lasted for 24-36 hours.) and ACCIDENTAL OVERDOSE (Receive 0.5ml Booster Dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A, 020B21A and 029A21A) for COVID-19 vaccination.     Patient had no known allergies. Patient never had COVID positive  test or diagnosis. Patient was not given other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 15-Nov-2021, the patient experienced PYREXIA (On 15Nov2021, he reported having a Light fever which lasted for 24-36 hours.) and ACCIDENTAL OVERDOSE (Receive 0.5ml Booster Dose). In November 2021, PYREXIA (On 15Nov2021, he reported having a Light fever which lasted for 24-36 hours.) had resolved. At the time of the report, ACCIDENTAL OVERDOSE (Receive 0.5ml Booster Dose) outcome was unknown.            No concomitant medications were reported. No treatment details were reported. It was reported that the Symptom was lasted for 24-36 hours.   This case was linked to MOD-2022-648152, MOD-2022-648106, MOD-2022-648157, MOD-2022-648275 (Patient Link).
Site of vaccination is sore, swollen, red (about 2 inches diameter circle), feels a little warm, and is firmer than surrounding tissue.  I received the shot 2 days ago and at this time I have not had any treatment.  I am keeping an eye on the situation and will reevaluate, on a daily basis, treatment options if they become necessary.
Patient complaining of arm soreness, especially at injection site. Problem started in December (vaccine was given in October) and is still continuing. Says occurs up to shoulder. She is unsure if it is caused by vaccine but she believes it might be.
Patient was observed with red cheeks was given prn Benadryl. Patient then stated his throat was hurting and having difficulty swallowing after receiving half dose of Benadryl. He was assessed by nursing team, 911 was called immediately. Vitals HR-88, B/P-100/68 R-22. EMS ARRIVED WAS TAKEN TO NEAREST HOSPITAL WITH MOM. Patient was alert and orient when he left with EMS.
Patient was unable to walk and was taken to the ER. The diagnose was Guillain-Barre as per patient's wife.
After receiving a Tdap injection, my arm became very sore, and I was unable to lift weights. I remained in this condition for almost a week. Therefore the Tdap caused sarcopenia. Also, I felt my social skills decreasing, and I fear that this injection has caused me to have autism.
Patient came to office on 12/17/2009 and complained of persistant muscle ache at the injection site that is worse when she lays on that arm at night and when she raised her arm above the horizontal plane.
Patient was given a COVID Vaccine during a vaccine clinic that was for healthcare workers. The patient is 16 years of age and that wasn't realized during screening. I caught it when entering vaccines into MCIR.
Patient received vaccine 10 days after the beyond  use date. Beyond use date was on 11/20/2021. will not re-vaccinate at this time.
Per father - child c/o lips hurting. Father noted swollen lips and child with throat swelling, eyes red and hives.  12/15/09 ED records received (DOD ED Discharge Sheet) service date 11/23/09. Assessment: Face swollen, difficulty breathing.
Patient called office 7-9-08 complained of having severe pain left deltoid after injection at site 7-7-08 lump and redness. Took Tylenol. Pain less but has redness going into outer side of arm warm to touch. Seen in office today; Diagnosed allergic reaction to vaccine; Cellulitis
Patient called pharmacy and reported itching on face and neck, around 1 hours and 45 minutes after vaccination. Patient stated she would seek medical attention at place of employment ( Hospital/ Clinic)
This case was reported by a consumer and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. The patient had a Family History of shingles (Patient's wife and father). Previously administered products included SHINGRIX with an associated reaction of pyrexia (received 1st dose on 9th March 2018, refer case US2018042240 for more information) and Shingles vaccine (received couple of years ago and it was about 50 percent effective). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, chills, lower extremities weakness of, sickness, tiredness, influenza-like symptoms, feeling bad and drug dose administration interval too long. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the fever, chills, lower extremities weakness of, sickness, tiredness, feeling bad and drug dose administration interval too long were unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the fever, chills, lower extremities weakness of, sickness, tiredness, influenza-like symptoms and feeling bad to be related to SHINGRIX. Additional details were provided as follow: The age at vaccination was not reported. The patient completed his two dose vaccine series. The patient had to wait to wait slightly past the 6 month window to get his second dose because demand was high due to vaccine effectiveness, which led drug dose administration interval too long. The reporter suggested that a lot of doctors did not recommend people to get vaccinated against shingles. The patient experienced fever, chills, legs were weak, tiredness and talks about how sick he felt the whole weekend for most of the segment, repeating some of the symptoms he indicated after receiving his first dose. The patient felt lousy and reaction which were flu like it was only a day or two and then it went away, but said it was better than getting Shingles. The reporter said that they want to not get Shingles, the disease shingles, which was supposedly the most painful thing, which feels like lightening going through your body, so the manufacturer had developed a shingles vaccine. The patient asked if they could do anything to decrease the reaction and was suggested aspirin. The patient encouraged anyone who was had chickenpox to get vaccinated.
shivering, general body pain, extreme weakness, severe sleepiness ( sleeping 24 hours ), nausea (unable to drink water or eat) , no fever
Vertigo, shingles, Bells palsy. 2 weeks in currently and still experiencing all symptoms associated with.
Was given varicella 8/9/13 broke out in shingle looking rash 2 days later on (L) lower leg.
100-101F fever and chills  started on 12/27 @ 945pm 100-103.0F fever, nausea, vomiting, chills and diarrhea on 12/28 @0900am  103.5F  on 12/28 @ 0640pm.  Advil and Tylenol have been taken
heart attack; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "heart attack".  Clinical information: I just wanted to let you know I have never taken any of these jabs, by the fake president and I never will and I will live to see my 62nd birthday. I wouldn't be a bit surprised if that jab isn't what killed and knocked down this football player that had a heart attack right on the field and he lived but she didn't. STOP PUSHING THE JAB".Agent asked if caller had any medical information questions that they would be able to assist with today, in which caller stated, "Nope" "STOP PUSHING THE JAB" Caller was thanked and wished a wonderful day, in which they responded back with "STOP PUSHING THE JAB" agent warned caller of disconnection and disconnected.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A few months after I received my 2nd Pfizer vaccine, I started noticing an irregular heartbeat in the form of palpitations only when resting.  I had never experienced this before so I am wondering if this could have been a side effect of the vaccine(s).  My primary doc sent me to a cardiologist where additional diagnostics were done.  I had an EKG, echo-doppler, stress test (treadmill), and 48-hr heart monitor.  The results of these were that I had some rare extra beats in the form of PACs and PVCs.   The only treatment prescribed so far is magnesium oxide 400 mg to "settle them down".  However, I have already been taking 400 mg magnesium, so following up with my cardiologist now.  However in the meantime, the palpitations have subsided and I hardly notice them this week.
Tested positive on 12/29/2022 after my daughter had tested positive. Began having extreme diarrhea on 12/29. That only last 10 hours. I then began having cough, congestion, sore throat, and low grade fever. Symptoms persisted and I called PCP. PCP prescribed PAXLOVID. Symptoms persisted for 3 weeks resolving slowly.
Light headed, cold clammy skin, pale, cold sweats and numbness to left arm where she received vaccine.
10yr old & 11mo old needed Td d/t dog bite;RN mistakenly gave DT & pt devel hives the next day that was medically tx w/o sequela;
No diluent used, pt given full concentration of vaccine. No adverse reaction was noted at time of departure from clinic. Called to notify parent of vaccine medication error aprox 1 hour after vaccine was given. No adverse reactions noted at this time.
This is a spontaneous case, initially received on 10-Jan-2018 from other health professional (nurse), concerning 35-year-old, adult, female patient. The patient's medical history and concomitant medications were not reported. On 08-Jan-2018, the patient was administered with AFLURIA QUARDIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: XF33208, expiry date: 30-Jun-2018). On 09-Jan-2018, after 1 day of vaccination, the patient experienced general itchiness but more specific to the ankle. In addition, she complained of painful and swollen ankle. It was reported that, 6 hours later, both the ankles of the patient were still swollen, and it was tender which made her uncomfortable. The patient took BENADRYL to ease the symptoms and to sleep. The patient had not yet recovered from the events swollen ankles, pain in ankle, tenderness, generalized itching and discomfort (reported as still experiencing the symptoms). The reporter considered the events as non-serious. Follow up received on 06-Mar-2018: The AE follow up information had not received in 30 days, hence this report was considered the events as non-serious. Follow up received on 06-Mar-2018: The AE follow up information had not retrieved in 30 days, hence this report was considered as lost to follow up. No amendment was done in the narrative.
2 minutes after receiving the first dose of the Pfizer/BioNTech covid vaccine, patient stated, "I feel chest burning and my head." On site physician assistant was notified. PA asked the  patient to further describe symptoms. Patient stated, "I feel nauseated and dizzy. I feel chest burning." Vital signs were assessed at 2:49pm. Blood pressure was 114/72, heart rate was 54 beats per minute, 99% oxygen on room air. Heart and lung sounds were clear. After being assessed, the patient was kept on site for further evaluation, but displayed no signs. Patient stated, "I feel fine" after surveillance.  An interpreter was used for the entire interaction.
Took flu shot Monday, Oct. 20, 2014-Several hours later, felt sick at stomach, diarrhea for four days-arm where shot was given very red and swollen for days-ached all over-even my toes-I do not want this again-felt bad for about a week.
Ringing in ears, ranging from high-pitched to loud persistent hissing, pulsating sound; ears plugged; symptom on-going three days after initial dose of Moderna vaccine (3/26/21); appointments with PCP and consultation with ENT scheduled for tomorrow (3/30/21)
Received her 2nd dose of Pfizer approximately 12:15 PM. A couple of minutes later while sitting in observation the pt started to c/o dry cough, itchy throat, and difficulty swallowing. The pt appeared flushed. Pt was laid down and assessed  by staff. 911 called and  asked for lights and sirens, 911  was called at 12:19 PM. Initial VS: 107/63 HR 106, O2sat 93%, pt began to c/o worsening difficulty swallowing, pt appeared flushed, O2sat dropped to 88%. Epi Pen autoinjector administered IM in the left thigh at 12:20 PM. About a minute after the Epi pen was administered the pt?s pulse ox came back up to 96%  and the pt reported a strong relief of the difficulty swallowing and the itching in her throat. BP immediately post Epi was 103/78, HR 76 O2 Sat 96% Repeat BP; 109/79 HR 89 O2Sat 99% RR 16  Repeat BP 12:27 PM 106/63 HR 114 O2Sat 98%  Staff continued to monitor pt?s O2sat and HR. At one point during observation while waiting for EMS the pt reported the difficulty swallowing seemed to be returning, pulse ox remained above 90%.  Pt transported to ED.  Pt has no medical history or allergies per mom. Pt is not taking any medications. Mom reports when the pt received her first dose she did experience flushing, dizziness, and a cough. The pt?s pediatrician happened to be present at clinic and told the pt she was fine and was cleared to get the 2nd dose per mom.  RN followed up with mom later that day, pt was home and doing well.
patient lost consciousness for approximately 45 seconds. I applied ice pack to her neck and she regained consciousness within a few seconds.
Severe body aches, chills, joint pain, neck pain, pain at injection site, headache, nausea, weakness, fever 100.4
33 year old female with no significant past medical history presents to the ED with syncope s/p receiving first COVID-19 vaccination this evening at 1758. The patient states that she completed her 15 minutes of observation when she suddenly felt dizziness after standing and had a syncopal episode, waking up on the ground. Per the nurse at the scene, the patient hit the back of her head. The patient does not remember hitting the back of her head as she lost consciousness prior to falling. Since then, the patient has been experiencing symptoms of generalized weakness and intermittent nausea, but denies symptoms of headache, visual changes, vomiting, neck pain, back pain, shortness of breath, chest pain, or abdominal pain. The patient has had normal PO intake today. She reports that she has had three separate syncopal episodes s/p getting her blood drawn in the past, but denies syncopal episode s/p receiving vaccinations in the past. The patient is an otherwise healthy individual with no known drug allergies, taking no daily medications, and denies the use of alcohol, tobacco, or drugs. Her last normal menstrual period was completed recently and she denies any chance of pregnancy, recent pregnancies, or currently nursing.