chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a health professional refers to six unspecified patients of unknown demographics. Pertinent medical history and drug reactions/ allergies were not reported. On an unspecified date, all these patients received improperly stored VARIVAX (Merck) which were exposed to -3 degree Celsius (C) for 12 hours (dose/ frequency, lot #, expiry date unspecified). Concomitant medications were unspecified. No adverse effects were reported. Additional information has been requested.
Pfizer vial was reconstituted with 0.18 ml diluent, then  0.3ml of diluted vaccine was administered IM to patient  Resident was monitored for several days at place of employment with follow up calls for approximately 3 days His only complaint was sore arm and fatigue
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant medication and drug reactions/allergies were not provided. On unknown date, the patient was administered a dose of improperly stored VAQTA (strength, dose, route, lot# and expiration date were unknown) for prophylaxis (product storage error).  Temperature was reported as below 36 degrees Fahrenheit (35 degrees Fahrenheit). Time frame was reported as 14 hours. There was previous temperature excursion involved. Total time and lowest temperature below 36 degrees Fahrenheit (35 degrees Fahrenheit) for 14 hours. Total time and highest temperature above 47 degrees Fahrenheit (47 degrees Fahrenheit) for 12 hours. The call was because of a data logger. No adverse reaction reported.
Information has been received from a vaccine technician concerning an adult female who in approximately April 1999, 4 years ago, was vaccinated with a 2 dose series of varicella virus vaccine live. The reporter indicated that "ELISA test titer negative". No additional information is available at this time. Unspecified medical attention was sought. Additional information has been requested.
03/3/2021, 03/31/2021 headaches, fever like, fatigued, no energy. Feb. 2021 no lab test. Break out on arm and decided that she was allergic. Tylenol and Benadryl cream took 5 days for rash to go away. Prior to Dose 2, advised to take medication to protect from rash, vitamin, Excedrin and allergy medication .
About eleven hours after receiving the vaccine I was awakened during the night with itching on my back. I used calamine lotion on it and it helped. But each day (I am writing this on day six after the vaccine, the itchiness has spread to my chest and neck and expanded into a larger area on my back. I have been using topical calamine and steroid cream to reduce the itching, and oral Benadryl tablets to reduce the itching and hives.
I started breaking out in hives in different areas of my body a couple weeks after the booster shot.  The hives are worse in the evening but I do feel itchy at different times throughout the day.  Benadryl and Zyrtec do help but the hives are still appearing on a daily basis.
My neck and chest have red splotches on them. I don?t know when they necessarily appeared, but noticed them 2 days after the vaccine. It has not gone away and I am getting concerned.
Patient received under diluted dose of Pfizer 5-11 covid vaccine. No adverse events reported.
Pt recd Engerix-B vax & DPT Polio; immed local rxn; p/4 days recd TB test & exp urticaria & pruritus, giant urticaria & Quincke's edema w/respiratory disorder; allergic rxn; pt hospitalized; rx: corticosteroids IM & antiallergics; see WORM;
THROBBING; ARM SORE AT INJECTION SITE; This spontaneous report received from a patient concerned a 65 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609 expiry: UNKNOWN) dose was not reported, administered on 23-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-MAR-2021, the subject experienced arm sore at injection site. On 21-MAY-2021, the subject experienced throbbing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm sore at injection site, and the outcome of throbbing was not reported. This report was non-serious.
Came home after vaccine, and felt bump in her arm where the injection was.  Didn't think too much of it.  The next morning her cousin came over and compared notes, and verified she had the bump.  She kept rubbing it and massaging it to break it down, and got a little sore, but nothing severe.  No sickness, a little pain over her eye.  Then on Friday 1/29/21, noticed a small spot on her arm, by Saturday got bigger, and today it has started moving to the bottom side of her upper arm.  Is applying ice and it's getting better.   Has been exercising it and stretching it as literature she found to do that.
fever, chills, pain at site of injection, joint pain, loos of appetite, general malaise, insomnia
Swollen eye; Itchy eye; itching in the eye lashes; Arm discomfort; This spontaneous case was reported by an other caregiver and describes the occurrence of EYE SWELLING (Swollen eye), EYE PRURITUS (itching in the eye lashes), LIMB DISCOMFORT (Arm discomfort) and EYE PRURITUS (Itchy eye) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced EYE PRURITUS (itching in the eye lashes) and LIMB DISCOMFORT (Arm discomfort). On 15-May-2021, the patient experienced EYE SWELLING (Swollen eye) and EYE PRURITUS (Itchy eye). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at a dose of 1 dosage form. At the time of the report, EYE SWELLING (Swollen eye), EYE PRURITUS (itching in the eye lashes), LIMB DISCOMFORT (Arm discomfort) and EYE PRURITUS (Itchy eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported.
Later that night he started whizzing, sweating, shortness of breathe and a rapid heartbeat. Blood pressure came high and his wife took him to ER which he was in there for 7hr. They informed him that he was allergic to the vaccine. He also another episode on Sept 9th where he was taken back to the ER and became hospitalize
Patient reports mild headache but that is not unusual, "funky" a little nauseated, foggy. Also there is redness and bumpy and itchy and a little warm or irritation.
weekend after vaccine started having flu like symptoms, started getting a rash that got worse, went to the doctor and was dx with Shingles
FAST HEART BEAT; FEVER; NAUSEA; CHILLS; HEADACHE; RIGHT SIDED CHEST PAIN; FLUSHED FACE; This spontaneous report received from a patient concerned a male. 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: 1805025, and batch number: 1805025 expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced flushed face. On 11-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 deg, and Heart rate increased (NR: not provided) 100 bpm. On 11-MAR-2021 01:30:00, the subject experienced right sided chest pain. On 11-MAR-2021 01:30:00, the subject experienced chills. On 11-MAR-2021 01:30:00, the subject experienced headache. On 11-MAR-2021 02:00:00, the subject experienced nausea. On 11-MAR-2021 05:00:00, the subject experienced fever. On 11-MAR-2021 05:30:00, the subject experienced fast heart beat. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from flushed face on 10-MAR-2021, chills on 11-MAR-2021 02:00:00, nausea on 11-MAR-2021, and fever on 11-MAR-2021 05:30:00, had not recovered from headache, and the outcome of right sided chest pain and fast heart beat was not reported. This report was non-serious.
Pt. received the COVID 19 vaccine on 1-15-21. On 1-21-2021 the pt. called to report that on the Saturday following her vaccine she had chest pain, pain in her jaw, chills, fever, her BP went up, and grinding of her teeth for just that one day and then it went away.
Complained of pain radiating down right arm and up to neck. Began sweating and shaking and feeling like her throat was itching.
For reference only-no adverse events reported by patient. During extremely busy period, forgot to remove blue collar from PREVNAR syringe prior to administering the vaccination. As collar had removed from other syringes in past without difficulty, I attempted to remove the collar while stabilizing the syringe. When the collar came off the syringe, it felt like the syringe shifted. I administered the PREVNAR. There was not reaction from the patient. I called the patient 9/15/16 2:29 PM to follow-up. She denied having any soreness and said she was not having any adverse events.
blood pressure went up to 180/96; fatigue; headache; cough; This is a spontaneous report from a non-contactable consumer (patient). An 81-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: EM9809), via an unspecified route of administration on 08Mar2021 11:30 (at 81-year-old) as single dose for COVID-19 immunization. Medical history included Stage 4 kidney failure, Frequent premature ventricular contractions, allergy (Allergies to medications, food, or other products:Yes), COVID-19 (Prior to vaccination, the patient diagnosed with COVID-19). The patient's concomitant medications were not reported. The patient had the expected side effects of fatigue, headache and cough from 08Mar2021 16:00 for 48 hours. But what he did not expect was that his blood pressure went up to 180/96 and stayed that way from 08Mar2021 16:00 for two days. He was not on blood pressure medication and his blood pressure has never been that high. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the event blood pressure went up to 180/96 recovered on an unspecified date (duration 2 days); while for other events was recovered on 10Mar2021 16:00.  No follow-up attempts are possible. No further information expected.
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age and gender. On 31-AUG-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (0.65ml, lot number L016283, expiration date 07-AUG-2016). No adverse effects reported. Additional information has been requested.
Starting day 3 morning: Extreme stiffness of area from bottom of chest up to below neck encircled body both sides, migraine 2 days, hot flashes lasting 2 days day and night unable to sleep. Day 4 or 5, intermittent chest pains rated 4 on scale 1-10 on right side. Within a week later, pains included center of chest then eventually included left side.
No AE reported at this time; Temperature excursion on MMR II; This spontaneous report as received from a Bachelor of Science in Nursing referring to a 12 month old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On 26-APR-2021 (also reported as "26-APR-2022", discrepant information), the patient was vaccinated with an improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin)(M-M-R II) lot # S039316 with an expiration date on 04-DEC-2021, for prophylaxis (dose, route of administration, and anatomical location).    The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin)(M-M-R II) was exposed to a temperature excursion of -50 degrees Celsius (°C) to +8 °C (10 °C) during a time frame of 0 hours 11 minutes 0 seconds, which was detected by the data logger. There was no prior temperature excursion and no adverse events were reported.  This is one of the two reports received from the same source.; Sender's Comments:  US-009507513-2104USA008253:
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2022 at 11:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 26-Feb-2022 at 4:49 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Information has been received from a registered nurse regarding a patient of an unknown age and gender. On 14-DEC-2012 at 07:45, ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 13.25 hours. Last temperature recorded -17. (It was also reported that on 18-DEC-2012 at 18:30 the ZOSTAVAX lot # H016765 was exposed to -14 for an estimated total time out of range of 12.75 hours). Last temperature recorded -16. On 12-DEC-2012, the patient was vaccinated with an out of temperature range dose of ZOSTAVAX (dose and route administration were not provided) (lot # H016765) (dose number was not provided). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Pt waited her 15 minutes and left, feeling fine. She walked to the elevator and feel light headed. She sat on a bench and a staff member brought her back to the clinic in a wheel chair. She reports she has had lots of stress lately, so wonders if it was a stress response. Pt was pale but no diaphoresis, SOB, angioedema, or other worrisome sx. Drank 8 oz juice and recovered well.
flu; Initial information regarding an unsolicited valid non-serious case received from a consumer (patient) via social media and transmitted to Sanofi on 30-Oct-2020.  This case is linked to cases 2020SA307387, 2020SA307451, 2020SA307452, 2020SA307939, 2020SA307940, 2020SA307941, 2020SA308034, 2020SA306301 and 2020SA302198.  This case involves an unknown age patient who experienced flu (Influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.   On an unknown date, patient reported that every time he/she got INFLUENZA VACCINE (produced by unknown manufacturer) (lot number unknown) via unknown route in unknown administration site for prophylactic vaccination and experienced flu (Influenza).   No relevant laboratory tests were reported.  It was not reported if the patient received a corrective treatment.  Event outcome was reported as Unknown for Influenza.  There will be no information regarding batch number for the case.
29-year-old female received a flu shot on 09/15/2021 at the mass vaccination clinic.  She reports that the shot may have been administered higher than usual and felt the injection in her upper arm. She had pain after the injection which has worsened since. She tells me that she had not any previous reactions or difficulties previously. She tells me that she has been using Advil which helps a little.  She denies any fevers, numbness or tingling. On presentation she reports that she had constant pain rated 1-2/10 while sitting the waxes and wanes, is throbbing and made worse with increased activity of the RUE.  She denies PMH, allergic to medications.  She uses Ocella, Spironolactone for acne and Zyrtec for seasonal allergies. She denies any recent illnesses. She denies possibility of pregnancy.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, Chills, sore throat Narrative:
pt recvd vax & had gen erythema & swelling @ inj site;pt was sent to ped clinic & given 1/2 tsp of DPh;rxn last for several days;
Diagnosis: Hives.  Beginning on October 8 or 9, 2003.  Located first on both arms, migrating to legs, lower and upper stomach, chest, breasts, neck and face.  Self adminsered anti-histminies and topical anti-itch creams for eight days.  Doctor visit on Oct. 16 or 17, 2003.  Doctor rx for Allerga and Benadryl not provide relief by Oct. 19, 2003.  Self administered Zeryec (1x daily) and Pepicid (2x daily) and topical anti-ich cream Oct. 19 - 22, 2003.  90% resolved on 10-22-03.
6 yo male developed temp to 104. 2; arm swelling, erythematous tenderness at vaccine site within 24 hours of injection. Temp persisted x 72 hours. Treated for possible cellulitis with BACTRIM. Also received ibuprofen, TYLENOL, BENADRYL.
About 5 minutes after Pfizer dose #2, patient complained of inability to move left UE, then had trouble responding to questions, follow commands, seemed almost aphasic.  BP was high, up to 240/140, but HR, O2 sat were normal.  After a few minutes, she was able to talk and move left UE, stated that everything had gone black or dark for a bit. She was monitored, sent via ambulance to ED.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 29Nov2021 13:15 (Lot number: 330308D) at the age of 25 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: MELOXICAM, start date: 18Nov2021 (ongoing). Vaccination history included: Bnt162b2 (first dose of the Pfizer Covid vaccine was on 14Mar2021 with lot EN6208,), administration date: 14Mar2021, when the patient was 25 years old, for COVID-19 immunization; Bnt162b2 (2nd dose was on 04Apr2021 which was three weeks apart and has lot , ER8737), administration date: 04Apr2021, when the patient was 25 years old, for COVID-19 immunization.The following information was reported: HYPOAESTHESIA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "felt numbness in his fingers, specifically his pinky finger"; TINNITUS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "started hearing ringing in his ears"; DIZZINESS (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "was getting dizzy like he was almost blacking out"; NAUSEA (non-serious) with onset 29Nov2021, outcome "recovered" (29Nov2021), described as "felt nauseous"; FEELING HOT (non-serious) with onset 29Nov2021, outcome "unknown", described as "was just overheated"; IMMUNISATION (non-serious) with onset 29Nov2021, outcome "unknown", described as "booster".  Additional information: Patient stated that he was calling because his doctor said he should report his symptoms and about 10 minutes after the shot he felt numbness in his fingers, specifically his pinky finger and then started hearing ringing in his ears and was getting dizzy like he was almost blacking out and he felt nauseous too; stated he was just overheated and he had no problem breathing or problems breathing. Numbness was not ongoing and resolved after 30 minutes; the ringing in his ears was not ongoing and has resolved and lasted probably about 20 seconds; symptoms of getting dizzy like he was almost blacking out and feeling nauseous probably lasted 10 minutes and resolved at 20 minutes. Patient did not received any additional Vaccines administered on same Date of the Pfizer Suspect and patient did not received any prior Vaccinations (within 4 weeks). Patient did not visited any physician office or emergency room for the events. Patient did not have family medical history Relevant to AE. No relevant tests was reported. Stated that he had been taking Meloxicam for the last two weeks and it is like a strong NSAID and an anti-inflammatory medication and states he had no lot, expiry date or NDC to provide as it is in an orange pharmacy bottle.   Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.
There was no adverse event.  The first dose was administered on 01/06/2021.  Patient was notified by the Chief of EMS that their second doses were due on 01/20/2021.  Patient was not able to attend the first dose clinic held on 12/23/2020.  Patient answered question on registration form as NOT having a vaccine in the past 2 weeks, and reported at that time only a sore arm after the first dose, received second dose and waited for 15 minutes without issues, then left the clinic.  This error in administration was discovered later in the afternoon when entering injections into Impact.  Medical Director notified of error.  Patient reports no problems, only a sore arm like the first dose.  Instructed to contact with any further side effects. Informed he would not need another dose of Covid Vaccine.
This spontaneous report as received from the Healthcare worker refers to a patient of unknown age and gender. On 07-MAY-2013 the patient was vaccinated with ZOSTAVAX (lot # unspecified, expiration date March 2013) (dose, route and anatomical location unspecified). The Healthcare worker reported that was administered an expired dose of ZOSTAVAX. At the time of the report the patient's outcome was unknown. Additional information has been requested.
This spontaneous report was received from a medical assistant refers to multiple unspecified patients of unknown gender and age. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients started the HPV vaccine series with GARDASIL and finished the series with GARDASIL 9 (inappropriate schedule of drug administration). No adverse effects were reported. Follow up information was received on 30-NOV-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Sender's Comments:  MERCK 1610USA004961:Mfr number.
This spontaneous report as received from a pharmacist refers to a patient of an unknown age.  First dose of ZOSTAVAX was administered to the patient in approximately 2016. On 23-AUG-2017, the patient was vaccinated with ZOSTAVAX dose 2, subcutaneous for prophylaxis. Concomitant therapies included sterile diluent. On 23-AUG-2017, the patient experienced extra dose administered. No adverse effects were reported. The outcome of extra dose administered and no adverse event was unknown.
Became diaphoretic a few minutes after receiving the vaccine. Said his throat was 'scratchy' and was dizzy when he stood up.  Sent to ED for evaluation.  Discharged from ED without incident.