chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 4 month old male patient who was vaccinated with his first dose of ROTATEQ orally. After receiving the vaccine the patient experienced severe diarrhea that lasted for thirty days. The patient had seen physician for medical attention. The physician reported that the patient's weight was back up and on an unspecified date the patient had recovered. Follow up information was received from the physician concerning the patient who was vaccinated with the first dose of ROTATEQ on 18-MAR-2009. On 19-MAR-2009, 1 day after vaccination, the patient developed severe, persistent diarrhea. The patient experienced 6 watery stools per day. The patient responded to cereal added to diet and the diarrhea resolved in 30 days, on approximately 18-APR-2009. The patient was able to gain weight in spite of the diarrhea. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. No information about concomitant medications, pertinent medical history and drug allergies was provided. On unknown dates, an unspecified number of patients had been administered improperly stored (since 22-APR-2015) doses of VARIVAX (Merck) (dose, frequency, route of administration not reported), (lot # K002928, expiration date 26-FEB-2016). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
States Saturday 11/21 had headache, rt arm red, swollen, painful. Today arm feels better but had one episode of diarrhea and dizzy when swimming. Feels ok now.
This spontaneous report as received from a nurse refers to a 16 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 11-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 2, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
DTaP and PCV 7 given on 12/5/07 Both in Rt thigh (HIB in Lt Leg)- Developed swelling/induration at site-favoring leg-appears painful to touch- no known fevers- parents used heat and cold-pt. seen 12/14- no longer favoring leg-still with some 1cm by 1 cm induration
redness & swelling of rt arm. swelling area just over 2" in dia. soreness and itching were also experienced.
FEEL A LITTLE PRESSURE IN THE CHEST LEFT SIDE; WHOLE HEAD FEELS HEAVY; TERRIBLE HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and 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: Unk) dose was not reported, administered on 12-MAR-2021 at 14:22 (PST) for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the subject experienced feel a little pressure in the chest left side. On MAR-2021, the subject experienced whole head feels heavy. On MAR-2021, the subject experienced terrible headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the terrible headache, feel a little pressure in the chest left side and whole head feels heavy was not reported. This report was non-serious.
It was reported that a 74 year old female received a Fluzone SV '99-'00 vaccination on 11/3/99. Reportedly, on 11/9/99, the pt experienced diplopia.
1 month after getting COVID vaccines (2nd dose 3/25/21 lot 039A2IA) pt developed  eczematoid lesions throughout legs that has persisted to this point. No prior history of eczema, allergies or asthma.  This is my 4th or 5th patient with similar and no prior history.
Could not move left arm an hour after vaccine.  Joints and muscles started hurting 4 hours after vaccine.  Runny nose, headache, exhausted 6 hours after vaccine.  Next morning every joint and muscle hurt to the point that I could not even walk without hurting.  Hip joints felt broken, ran fever 101, fingers swollen and in pain.  I didn't even feel this bad when I had Covid over a year ago( I was just tired for a few weeks with a slight sore throat when I got Covid).  I was in major pain for 2 days with swelling in my left cheek and my left ear hurt.  I was told to take tylenol and benadryl.  I don't want to take the 2nd shot now, because of the pain I felt  for 2 days.  I would rather just get Covid again.
Bivalent booster was given as 1st dose. Patient has never received primary series. No adverse medical complications reported or hospitalizations since vaccine administration.
Swollen lymph node under left arm; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 26Mar2021 at 11:45 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. The patient had no allergies to medications, food, or other product. Concomitant medication included unspecified medications within two weeks of vaccination for unknown indication. 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 31Mar2021 at 05:00, five days after the vaccination, the patient experienced swollen lymph node under left arm, the arm that got the shot in. The patient did not receive any treatment for the event. 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 event swollen lymph node under left arm was not recovered at the time of this report. No follow-up attempts are needed. No further information is expected.
pt recvd vax; exp unk type of rxn; pt is seeing neurologist for sxs;
pt recv vax 21OCT96 & 4FEB97 pt exp an inc temp of 100, confusion & malaise;4FEB97 resp viral cult was positive for influenza A;tx included Flumadine on 3FEB97 for 21 days;pt recovered;this is 1 of 28 cases;
Patient says that everything tastes like metal.  She can't raise either arm above her head.  She is sore under her breasts up to the shoulders.  She has swelling in the antecubital crease.  She also has shortness of breath.
got a shingles shot n got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a month after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional details were reported as follows: The age at vaccination was not reported. The reporter knew a women who got a shingles shot and got shingles within 1 month. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
25 minutes after receiving 2nd dose Moderena, Patient began complaining of nausea and vomited 5 times. she then began of complaining of epigastric pain, radiating left arm pain, and pain in left armpit. Dose placed in left arm. Patient then began complaining of feeling itchy. EMS was called and patient was transported to hospital.
Reported to PHN that child was seen at ER on 12/11 (2 days after receiving vaccination) for reddnes/rash on right arm. Reddness/rash extended approx. 6 inches around vaccination site down arm and also on posterior side of arm. Arm was warm to touch, but child had no systemic fevers. No other sx's noted. MD prescribed IV antibiotic that was admin. in ER (MOC did not know name of antibiotic). Child dc'd from ER/observation only tx prescribed. On 12/12, MOC noted reddness/rash on arm was gone and child had no sx's of distress. F/u with MD is scheduled for week of 12/15.
Maculo-Papular rash over entire body, fever 102. Started 9/19 on face and by morning had spread to extremities and trunk. Resolved after a few days.
NO ADVERSE AFFECTS MODERNA BIVALENT NOT AVAILABLE AT THIS TIME , ON BACK ORDER.
Approx 1 min p/last inject became limp, LOC x approx 1 min; Did  not fall; mom held onto him; Alert p/approx 1 min & oriented; Walked out w/mom; Taken by mom for exam w/pvt MD;
Injection site itching; Injection site tender/Delayed injection site tenderness; Arm was very sore; Chills/Fever (101.5)/Fever all day; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Arm was very sore), VACCINATION SITE PRURITUS (Injection site itching), VACCINATION SITE PAIN (Injection site tender/Delayed injection site tenderness) and PYREXIA (Chills/Fever (101.5)/Fever all day) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021 at 7:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021 at 6:00 PM, the patient experienced PYREXIA (Chills/Fever (101.5)/Fever all day). On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was very sore). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Injection site tender/Delayed injection site tenderness). On 10-Jan-2021, PAIN IN EXTREMITY (Arm was very sore) and PYREXIA (Chills/Fever (101.5)/Fever all day) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Injection site tender/Delayed injection site tenderness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment included antihistamines.  Concomitant medication was not reported.
A non-serious report of fever, sore throat and nasal congestion was received from a pharmacist concerning her son, an eight year-old male. No medical history and concomitant medications were reported. The patient received one dose of FluMist vaccine on 13-Dec-2007. One week later on 20-Dec-2007, the patient developed fever of up to 102 degrees, sore throat and nasal congestion. The outcome of the adverse events was not reported. Rechallenge is not applicable. The reporter did not provide a statement of causality for the events. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
I had a low grade feverstarting around 2-3 hours after mysecond vaccine, which quickly rose toaround 103 about 14 hours after myvaccination; Full body chills; Muscle weakness; Headache; This is a spontaneous report from a contactable consumer, the patient. A 37-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0179) via an unspecified route of administration in the left arm on 04May2021 at 10:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The had no known allergies. Concomitant medications included colecalciferol (VITAMIN D3) (MANUFACTURER UNKNOWN), fish oil (MANUFACTURER UNKNOWN) and ibuprofen (MANUFACTURER UNKNOWN) all for unknown indication, from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 13Apr2021 at 16:00 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 04May2021 at 23:30 the patient experienced high fever (103 degree Fahrenheit), full body chills, muscle weakness, sore arm, headache. He had a low-grade fever starting around 2-3 hours after his second vaccine, which quickly rose to around 103 about 14 hours after his vaccination, where it stayed for around 3 hours. He took 500 milligrams of acetaminophen when his fever rose but it did not reduce it below 103.The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of high fever, full body chills, muscle weakness, sore arm, headache and included treatment with acetaminophen 500 milligrams from unspecified start date to unspecified stop date. On 04May2021, patient underwent lab tests and procedures, which included, body temperature and the result was 103 Degrees Fahrenheit. The clinical outcome of the events fever, full body chills, muscle weakness, sore arm and headache was not recovered.  No follow-up attempts are needed. No further information is expected.
Fever/Rash for 1-2 days. Aveno/Motrin.
complained of burning and tingling sensation down left leg 1 hour after receiving vaccination. Had not resolved. Sent home, antihistamine benadryl.  Told to consult with PCP.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, concomitant medication and medical history were not provided. On 17-SEP-2015 the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # K009745, expiry date 17-FEB-2016, dose and dose number were unspecified) orally. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Per parent, the day after vaccines, patient developed high fever and seizures.  Taken to ER where she was informed it was due to the flu.
Red, swollen, painful, down to 2 days, (same arm that pt was recently treated for cancer in his elbow), took APAP, symptoms reduced, currently gone.
I am unsure if this is related but thought I should report it because it was highly unusual, but: My menstrual cycle began at around 12:30am on 03-19-2021. There was some bad cramping as is usual for me in the first 24 hours. I was able to function normally enough until about 9P (on 03-19-2021),  at which time I began experiencing debilitating cramps and muscle spasms that made it difficult to walk or move. I felt lightheaded and like I was going to pass out (which has never happened related to my period before). I got in bed and this persisted until moving at all brought me to tears. I have not been in this much pain from cramps and muscle spasms in over a decade.  And never this prolonged and intense. I was unable to sleep until about 4:30am, managed to sleep for a few hours, had to see, and now I'm here filling this out before I attempt to go back to sleep.  My pain at the moment is high, but similar to what a normal "first day of cycle and it's bad" day would be for me.  Before this, though, was 8 hours straight of some of the worst pain I've ever felt in my life.  I felt it important for me to make a formal report in the event that adverse effects surrounding menstruation were common for others and in case this does not subside. I am thinking it will like the initial muscle aches after receiving the shot.
I forgot to take my Allegra and woke up with a big red rash on my left arm in the area I received the shot. My left arm was sore also.  I took my Allegra the following day and the rash seemed to lesson. It started up again on 3/10/21 even though I have been taking my Allegra daily.  I have had to urinate often since the rash. The clinic checked my urine and said it was clear.
Experienced multiple health issues after receiving SHINGRIX 50MCG INJ. Nausea, fever, weakness, chills, joint pain, headache, stomach irritation, swelling and rash at injection site. As of today 5/4 symptoms are slowly dissipating.
Same here/ shingles; itch; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received old shingles vaccine, 7 years ago and was fine).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, several days after receiving Shingles vaccine, the patient experienced shingles, pruritus and pain. On an unknown date, the outcome of the shingles, pruritus and pain were unknown.   It was unknown if the reporter considered the shingles, pruritus and pain to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient received Shingles vaccine and got shingles a couple of days later after the new vaccine with itch and pain. The reporter asked if he/she went back for the second dose. The follow up would not be possible as no contact details were available. The case was linked with case US2021AMR170346 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR170346:Same reporter
lt arm pain @ site of inj;next day or two devel rotator cuff injury in lt shoulder;eventually treated w/NSAID & physical therapy;8mo p/shot 90% mobility restored but still pain @ inj site on stretching the arm;
BREAKTHOUGH COVID: 78 YR OLD FEMALE FULLY VACCINATED AND BOOSTED with MODERNA. Ed admit with Severe HA. Upon arriving to the ED pt was found to have a BP of 215/97 HR 82 w/ low grade fever. Pt states that she is compliant w/ her BP medications . Reported SOB and anxious. Neurology PDx with hypertensive crisis and COVID-19 infection,Intracranial atherosclerosis of posterior circulation.  Denied symptoms of Dizziness, visual changes, weakness, paresthesia or dysphagia, CP or Palpitations, n/v/d abd pain, cough or fever.
I63.9 ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY 4/19/2023 CONFUSION
Patient received the 1st dose 4 years ago and didn't get the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 4 years before the date of reporting).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 17-May-2022 Reporter's comments: The pharmacist called in to inquire if the patient need to start series all over. The patient did not get the second dose. The pharmacist was unable to provide vaccine details. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Jan and Feb I got the 1st 2 shots in my left shoulder, within a month I begin to get extreme weakness in my both shoulders; Jan and Feb I got the 1st 2 shots in my left shoulder, within a month I begin to get extreme weakness in my both shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 25Jan2021 (Lot number: EH9899) at the age of 73 years as dose 1, single and administered in deltoid left, administration date 15Feb2021 (Lot number: EN9581) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Graves disease", start date: 1970 (unspecified if ongoing), notes: Stop date: Only took meds one year for Graves. Concomitant medication(s) included: SYNTHROID taken for hypothyroidism (ongoing). The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), ASTHENIA (non-serious) all with onset 2021, outcome "unknown" and all described as "Jan and Feb I got the 1st 2 shots in my left shoulder, within a month I begin to get extreme weakness in my both shoulders". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: consumer stated, "You have the dates out of order, Jan and Feb I got the 1st 2 shots in my left shoulder, within a month I begin to get extreme weakness in my both shoulders.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200038441 same reporter/SD, different patient
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-JUN-2016, the patient was vaccinated with a dose of improperly stored VAQTA "10Pk 50U/1ml SD Llok w Caps Adult" with lot number L031196 and expiration date of 15-FEB-2017 (dose, route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 34 (1.111111111 Celsius degrees) for 216 hours, at the lowest recorded temperature of 32 (0 Celsius degrees) for the sum of 256 hours, at the lowest recorded temperature of 31 (-0.555555556 Celsius degrees) for 224 hours at the lowest recorded temperature of 30 (-1.111111111 Celsius degrees) for 136 hours, at the lowest recorded temperature of 29 (-1.666666667 Celsius degrees) for 72 hours and at the lowest recorded temperature of 33 (0.555555556 Celsius degrees) for 104 hours. . The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Nurse administered the Pfizer 12+ Bivalent vaccine on 03/13/2023; however, the vaccine technically expired on 03/08/2023 due to being removed from ultra cold storage 10 weeks prior.