chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 019B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Feb-2021 at 4:24 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2021 at 4:37 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 20.84. Concomitant products were not provided. On 28-Feb-2021, Excursion time was 09 AM and 1 PM temperature was 27 and 26 respectively, total doses given for the day was 152, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 27-feb-2021. 20 vials were sent to clinic. Vaccine BUD date was 26-Mar-2021. On 28-Mar-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 150, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 15 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021. On 28-Feb-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 27, 10 AM: 40, 11 AM: 44, 12 AM: 46, 1PM: 26, 2 PM: 37, 3 PM: 43 and 4 PM: 45. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.   This case was linked to MOD-2022-566976 (Patient Link).
tremendous arm pain; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The physician states the patient had received Shingrix and reported tremendous arm pain. No further details provided. The reporter consented to follow up. This case has been linked to US2020206890, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020206890:same reporter, different patient
Per mother hives on torso and neck started approximately 4 hours after Covid-19 vaccine. Mother gave oral benadryl. Hives continued off and on for 48 hours. Mother contacted pediatrician 48 hours after the hives started and physician advised to contiune oral benadryl. Hives subsided 72 hours after Covid 19 vaccine.
severe muscle/bone pain (even after taking fiorinal w/codiene), tinnitus, sore eyes ( for a week), teeth hurt (for a week), eruptions on skin (red blood dots, when fully erupted watery like a blister, with a white solid core if squeezed, came in 2s on leg, back, chest, not all over body/just 6 eruption sites), yellow patches of skin on both forearms (like a healing bruise yellow, but no bruise at sites),  regular sore arm - not a big deal, sick/unwell feeling for a week.
Localized swelling/redness, warmth to Left arm.  25mg Benadryl PO, topical hydrocortisone.
He threw up once at 7:00pm and then again at 8:30pm. He had a low grade fever, and has had diarrhea twice once last night and once this morning.
Rash, swollen inguinal nodes, fever. Onset about 5 days after vaccination.
Patient last flu shot 11 years ago and at that time had a golf ball size reaction at site of injection. This time she experienced approximately 1 week to 2 weeks of extreme muscle aches and malaise. Was seen by her internist. Complete blood count, CPK and CMP all normal. Reaction lasted 2 weeks. Dr. states flu shot and not to take in future.
12/5/09, 2:30pm sudden onset chills, fever 101-102 degrees. Took flu medication OTC at night and went to bed at 5pm. Increased chills, fever, shortness of breath during night. Improved by 10:00 AM 12/6/09. Improving but weak at 3pm.
Reactive lymphadenopathy/diagnosed 10/5/2021 10/1/2021-Swelling in neck/ Underarm wasn't notice until doctors visit on 10/5/2021 10/4/2021- swelling of feet that went away the next day 10/8/2021-nipples hurting9Not diagnose or treated
SWOLLEN ARM; TINGLING IN LEG/VACCINATED ARM/HANDS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with influenza vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: UNKNOWN) dose was not reported, administered on 19-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-JUL-2021, the subject experienced swollen arm. On 19-JUL-2021, the subject experienced tingling in leg/vaccinated arm/hands. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tingling in leg/vaccinated arm/hands, and the outcome of swollen arm was not reported. This report was non-serious.
Severe full body aches, headache, low grade fever, nausea, severe fatigue, dizzy, pain in injection ste
11/03/22 presents to ED for "shortness of breath". PMHx of "COPD, metastatic melanoma to the lung"
Information has been received from a physician concerning an 18 week old male who on 10-SEP-2007 at 16:00 was vaccinated PO with his second 2.0 ml dose of Rotateq (lot# 657510/0970U).  On 12-SEP-2007 at 02:00 the patient experienced vomiting which lasted 3 days or longer.  Unspecified medical attention was sought.  On 13-SEP-2007 the patient recovered.  The date of administration for the first dose was not available.  There was no product quality complaint.  Additional information is not expected.
blood pressure spike so high and so quickly; Initial information was received on 16-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 71 years old female patient who experienced blood pressure spike so high and so quickly while receiving vaccine influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 04-Nov-2022, the patient received a unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, expiry date, lot number not reported) via unknown route in unknown administration site for prophylactic vaccination(immunization).  On 05-Nov-2022 the patient developed a non-serious event of blood pressure spike so high and so quickly (blood pressure increased) (latency: 1 day) following the administration of influenza vaccine.  It was reported that "She did receive medication at the ER that brought her blood pressure back down down, however two days later it shot up again and she went back to the ER. Her PCP doubled her blood pressure medications and it now controlled. Caller also stated her cardiologist wants her to take some tests, but she is not sure she needs them now. Patient did say she was on blood pressure medications prior to receiving the shot, but has never had her blood pressure spike so high and so quickly".   Relevant laboratory test results included: Blood pressure measurement - On an unknown date: [shot up to 208/111]; on an unknown date: [was at 230/144]; on an unknown date: [back down down]; on an unknown date: [it shot up again]  Action taken with influenza vaccine was not applicable.  It was not reported if the patient received a corrective treatment for the event (blood pressure spike so high and so quickly).  At time of reporting, the outcome was Recovered on an unknown date for the event blood pressure spike so high and so quickly.; Sender's Comments:  US-SA-2022SA514521:
At around 11pm on 9/19/2022 there was a sudden onset of hives on the upper back, inner arms (between elbow and shoulder on the side touching the torso), hives beneath the armpit on both sides, and on the posterior side of the thighs between the knee and glutes.   Within 3 hours the hives expanded rapidly with the entire back being covered in hives. Hives spread to the tops of the shoulders (deltoid area), and in spots all over the front of the torso. Consistent and strong feelings of itchiness were felt.  There were no respiratory issues. A hot bath, 2 doses of diphenhydramine 25mg (Benadryl), and one does of cetirizine (HCI)10mg (Zyrtec) was taken. I then went to sleep and 6 hours later all of the hives were gone.   On 9/21/2022 I went to my primary care doctor; I showed him photos I had taken of the hives (which are available upon request; he advised me to fill out this report. His examination resulted in finding no hives or symptoms during his physical examination.   On 9/21/2022 itchiness of the face with slight hives was felt. Anti-itch cream was applied and 8 hours later all itchiness ceased.   In the days before and after the vaccination, there were no changes in diet, vitamins, medication, or activity. I had not been in a pool or hot tub, nor exposed to any chemicals or allergens.
Dose/charting discrepancy on patients Covid booster. The signed paper work is noted that patient received his booster shot which is a half dose, but the documentation in chart states regular full dose. Can not guarantee or verify what dose received but it is possible that instead of a half dose booster it was a full dose.  Did reach out to Patient and advised her that no further actions are needed at this time and she denies any adverse reactions or side effects.
Patient stated that she noticed that evening that her arm ached [the same day she received the vaccine].  She stated that she noticed on 10-5 that it was swollen the size of a half dollar and red.  On 10-8 she stated that it was still red, hard as a rock, and swollen but less red than 10-5.
Next day the injection site became red, itchy, warm to the touch, and circular in appearance. It got better after a few days. While the injection site improved, I had bilateral rashes on my forearms. This became better, then 1 week after the shot, which is today, the injection site became inflamed again, felt like a hard lump, became itchy. Appears to be "covid arm" as I've researched.
Case number PHEH2012US015558 is an initial spontaneous report received from a pharmacist on 03 Aug 2012: This report refers to a patient of unknown age group and gender. This patient was given only the CYQ-135 liquid component of MENVEO vaccine (batch number: unknown) intramuscularly on an unspecified date, because the pharmacy discovered an extra MenA lyophilized conjugate vaccine component of MENVEO. No other adverse reaction was reported following this administration error.
About 12 hours after vaccination experienced chills, body aches, intermittent headache and general discomfort. This lasted about 5-6 hours after which there was less aching but could tell that fever persisted, felt sluggish and warm.  Temp was 99.9 at the highest over a 2-3 hour period. Ibuprofen was taken about 5  hours after the symptoms started, but only once. Late morning of 01/12 symptoms subsided and felt normal.
Patient stated she "felt bad" and all her joints were aching and stated she was going to bed at 9 pm (usual bedtime is 1 am).  When she laid down she had uncontrollable chills, then complained of shortness of breath (9:30 pm).  Husband took to ER where she was vomiting, dry heaving, & had diarrhea.  They gave Zofran & had her on oxygen (O2 levels were 87-92 with out oxygen).  Dr. came in at 2:00 am and told patient & husband that he felt like this was a uncommon reaction to the flu shot. They did all blood work, chest xrays, urine, etc... (all this information was given by husband to PharmD).
bad effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (bad effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event and Tinnitus.   On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (bad effects). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (bad effects) outcome was unknown. Not Provided          She stated that she is not the only person experiencing bad effects after the 2nd dose, that a lot of other people have had bad effects. Consent to follow up denied 30MAR2021   Reporter did not allow further contact
Vaccine given 9/25/07. Sx started 9/26/07 with local pain and HA. Sx - increased fatigue - local pain, redness and HA. 5 x 7 cms. Temp 99.5.
Walk from sight of shot to where my husband sat and started to fall dizzy.  Then my head started to swarm, by this I mean(nose is the middle) Left side of my brain was turning clockwise and the right side of my brain was turning counterclockwise. Then the right side of my tongue started to tingle. They came and gave me Benadryl.  After 1 hour from the time they gave me the shot I thought I could walk to my car without falling. Next day, just felt like something foreign was in my body--didn't feel right. 4/17/2021-I still get confuse on what day it is, and my hands itch off and on. Continuation page won't let me type there.  Need to add Medications--#9
Information has been received from a health professional concerning a 44 year old Caucasian female with no known drug allergies and with asthma and migraines. On 10-JUL-2000, 11-Aug-2000 and 11-JAN-2001, the patient was vaccinated with a first (632392/1378J), second 1632392/1378J) and third (635178/0473K) dose of hepatitis vaccine recombinant (yeast), respectively, in the left deltoid intramuscularly. Concomitant medications include atorvastatin calcium (Lipitor), conjugated estrogens (Premarin), budesonide (Pulmicort), salmetrol xinafoate (Serevent), and gemfibrozil. On 11-Aug-2000, after the second dose was administered, the patient experienced body aches and headaches, but felt better the next day. On 11-Jan-2001 after the third dose, the patient developed a headache, bodyache, dizziness and fatigue in the evening and went to bed. The following day 12-Jan-2001, the patient still felt sick and had nausea with diarrhea that lasted  for one day. The third day after vaccination the patient still felt sick. The reporter stated on 17-JAN-2001 that it is now five days later, and symptoms persist. On 20-Jan-2001, the patient stated that she felt "nauseated and dizzy, but the body aches have gone and the headaches are no longer with me". On 26-Jan-2001, the patient described symptoms as: "my head feels as if it is going to explode. I am dizzy, nauseated , and tried to remember my phone number, but had look it up" On 31-JAN-2001, the patient was "feeling much better" and felt that the symptoms were a "combination of Hep shot, the flu and migraine. The patient sought unspecified medical attention.  No further information is expected
Sharp pain in left arm, Dizziness, room spinning, nauseated, Trouble breathing, Heart beating fast.
Adverse reaction to Hepatitis B vaccination. Within one week, was feeling weak and experiencing many MS like symptoms. Continued for many months. Was hospitalized at beginning of October for IGG treatment and continuing to receive on a monthly basis. Have now been diagnosed with Multiple Sclerosis.
Patient developed watery eyes later in the afternoon of receiving her COVID.  The following day she had flu like symptoms and this morning she has bilateral swollen lymph nodes in the axilla area.
pt recvd Engerix-B & it was determined that pt did not respond; A booster dose of Engerix-B was administered 9APR92; titer result was neg;
Pt received the H1N1 mist at our office on 10-15-09. 2 days later had a red bump then spread into a rash that hurt and itched. Mom waited until 10-23-09 to report to us. Told pt to use BENADRYL q 8 hrs. Mom answered no to all questions.
Subacromial-subdeltoid bursitis. My shoulder joint has been hurting ever since I took the shot.
I have had large hives - urticaria -- since my January 11, 2022 booster.  I thought I would wait to report them until they subsided, and now,  more than a year later,  they are almost gone.   At first I had them all over the the back of my shoulders and neck,  and my upper arms,  with a few on my chest,  and a few on my thighs.  Now I have just a few on my shoulders,  two on my right thigh,  and one on my right upper arm.  They manifest first as large hard lumps,  then become very itchy,  then the tops open and bleed,  then scab over and take a very long time to go away,  often leaving hard scar tissue behind.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 29-SEP-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 with lot # L007720 Expiration date: 08-JUL-2016, 0.5 ml (route and anatomical location of administration were not reported). The vaccine had three temperature excursions one of 328 hours with a lowest recorded temperature of 29 Fahrenheit (F) (-1.666666667 Celsius (C)), the other one of 264 hours with a lowest recorded temperature of 33 F (0.555555556 C) and the third one of 64 hours with a highest recorded temperature of 48 F (8.888888889 C). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor Product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Patient was administered COVID-19  0.25mL Moderna booster when they had requested the Pfizer 0.3 mL booster originally. Pt originally had the 2 dose Pfizer series beforehand previously. There was no adverse reactions reported at the time or after the shot.
My son's arm is sore since the shot.  He has a temperature of 100.8 since 5:25pm today.  I have given him tylenol and plenty of fluids.
fatigue; muscle ache; rash on all of their face and neck; rash looked like the points of a needle; flu like symptoms; chills; fever 101.5; soreness in their arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (soreness in their arm), INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills), PYREXIA (fever 101.5) and RASH (rash on all of their face and neck) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included BUPROPION and PROPRANOLOL for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness in their arm). On 23-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever 101.5). On 27-Feb-2021, the patient experienced RASH (rash on all of their face and neck) and INJECTION SITE RASH (rash looked like the points of a needle). On an unknown date, the patient experienced FATIGUE (fatigue) and MYALGIA (muscle ache). The patient was treated with PREDNISONE for Rash, at an unspecified dose and frequency; SERTRALINE HYDROCHLORIDE (SERTAC) for Rash, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at an unspecified dose and frequency. On 25-Feb-2021, INFLUENZA LIKE ILLNESS (flu like symptoms), CHILLS (chills) and PYREXIA (fever 101.5) had resolved. On 02-Mar-2021, RASH (rash on all of their face and neck) and INJECTION SITE RASH (rash looked like the points of a needle) had resolved. At the time of the report, PAIN IN EXTREMITY (soreness in their arm), FATIGUE (fatigue) and MYALGIA (muscle ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Pyrexia (high-high): 101.5 (High) 101.5.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: No specific follow-up information recorded.
Vaccine administration error.  The vaccine expired on 8/18/13.  The vaccine was given on 8/19/13.