chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt recvd vax & between 2-10 mins later devel marked watery nasal discharge & watering of eyes; did not devel resp obstruction (did cough up some mucous) or distress; resolved over 10-15 mins;
Information has been received from a consumer for VARIVAX (merck), a Pregnancy Registry product, concerning herself with drug allergy to ZITHROMAX and no pertinent medical history. The patient's history of previous pregnancies and live births was not known. The patient was vaccinated with VARIVAX (merck) (dose, route and lot number not provided) on 13-APR-2012. No other co-suspects were reported. There were no concomitant medications. The patient was 5 weeks of pregnancy and approximate LMP of 02-AUG-2012 and an EDD of 09-MAY-2013. Approximately on 23-AUG-2012, two weeks ago the patient did pregnancy test and found she was pregnant after receiving VARIVAX (merck). No treatment information was given. The patient sought medical attention via phone call. Additional information has been requested.
Fever, sore joints, headache, runny nose, throat and cough.  Follow up 06/05/2000: "Patient recovered from adverse event."
administered 0.25ml of the bivalent booster dose to an adult patient.; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.25ml of the bivalent booster dose to an adult patient.) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.25ml of the bivalent booster dose to an adult patient.) and NO ADVERSE EVENT (no adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.25ml of the bivalent booster dose to an adult patient.) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for ACCIDENTAL UNDERDOSE (administered 0.25ml of the bivalent booster dose to an adult patient.).    Concomitant products were not reported.  Treatment medications were not reported.
This case was considered medically important (OMIC). Information was received from a published literature article concerning vaccinating health care workers against smallpox in an isolated primary care facility. The article describes the authors' experience implementing a smallpox vaccination program and its effect on routine operations in an isolated hospital and its nine satellite clinics. Their program included an extensive educational component provided to each person, whether or not they were to receive vaccine. The program was then extended to include non-healthcare workers. One of the vaccinated non-healthcare workers developed perimyocarditis. Relevant medical history was not provided. Indication for smallpox vaccination was immunization. Product was administered on an unspecified date. Dose regimen was not provided. Concomitant medications were not reported. One of the non-healthcare workers who received vaccine developed perimyocarditis. The authors noted that this was the only serious reaction out of approximately 2200 vaccinated non-healthcare workers. The authors concluded that is is as important to address a potential recipient's perception of vaccination, as it is to inform them of scientific fact. They credit an aggressive preliminary education campaign for the compliance in their smallpox vaccination program. No further information was available at the date of this report.
SORENES AT INJECTION SITE.; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included hypertension, pre-diabetic, abstains from alcohol, and non-smoker, and other pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: 25/MAY/2021) dose was not reported, administered on 31-MAR-2021 at 12:00 on right arm for prophylactic vaccination. No concomitant medications were reported.  On 31-MAR-2021, the subject experienced soreness at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site. This report was non-serious.
Patient received under-diluted dose of Pfizer 5-11 vaccine. No signs of adverse side effects noted at this time.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  It was reported that expired vaccine were given as booster shot to patient. The vaccines were stored in freezer and took out one to two vial and placed in fridge each day as needed.
touched the injected arm and said why did that hurt; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) (batch number Z3H93, expiry date 07-JUL-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced pain in arm (Verbatim: touched the injected arm and said why did that hurt).  The outcome of the pain in arm was resolved.   The reporter considered the pain in arm to be related to Shingrix and Shingrix.     The company considered the pain in arm to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt date: 05-SEP-2023 and 07-SEP-2023 The reporter is the patient.  She said she had both of her Shingrix shots and she indicated that she did not had any side effects.  She even indicated that she forgot that had the shot until one time she accidentally touched the injected arm and said why did that hurt and remembered about the injection but patient was not sure if the incident happened after the 1st or 2nd shot. The patient states she did not even know that she had it done then she touched the injected arm and go, why did that hurt, oh it's because she got the Shingrix. The reporter did not consent to follow up. This case was linked with case US2023121053 with same reporter.; Sender's Comments:  US-GSK-US2023121053:Same reporter, different patient
Rash began with small red papules on extremities. Larger red areas today. Red cheeks and ears overnite. tmax 99. sx mild, gradually worsening per mom. Seen by MD 11/20/09. Pink maculopapular rash and blotches on axillae, and thighs, smaller 3mm to 1/2cm papules scattered diffusely, rosey cheeks and external ears. Rash 10 days after MMR/VARIVAX vaccines. Sx tx reviewed, to F/U if sx worsen or persist.
Saturday I didn?t feel right. By the afternoon I had severe chills, a headache and a fever of 101.8. Then I noticed that the site was red, swollen and hot. The fever broke in the middle of the night. The next day the fever was gone but the swelling, pain and heat was bigger. Started feeling much better by Monday. Today, Friday it is swollen again and itchy.
Rash presented on left hand in two small spots. The skin was dry.  Patient washed dishes on 11/10/15 and it caused the spots two blister and dryout/crack.
Patient received severe swelling in her left arm 2 days after second dose.  She treated the adverse reaction with Claritin, Advil, Hydrocortisone for 2 days and it finally went away.  She also received a similar reaction with the first vaccine but not as severe and wide-spread.
Patient had a 103.4 F fever, headache, chills and hives all over her body. This started 24 hours after her vaccine. She took acetaminophen and diphenhydramine to help with the fever and hives.
Vaccine site is red, warm, and itchy 10 days after injection.  Symptoms are similar to symptoms 1-2 days after injections. They had gone away, then came back Feb. 5
By 8 pm I had chills and was visibly shaking. My resting heart rate was 20 bpm higher than usual and my body was so sore it was hard to walk in a normal cadence. I had night sweats soaking the bed and have had diarrhea the next day.
This is a spontaneous report from a contactable health care professional, a medical assistant, through a Pfizer sales representative and follow-up from a contactable physician. A patient of unspecified age and gender received PREVNAR 13 on unspecified date, at 0.5 ml single, intramuscular. Medical history and concomitant medications were not provided. The patient experienced high fever on unknown date which required hospitalization. The facility had ordered around 60 doses of the product. The ordering physician was a part of a 4 site practice. Event outcome was unknown at the time of report. The physician could not confirm the occurrence of the event. Follow-up (18Dec2014): New information received from a contactable physician includes: the physician could not confirm the event. Follow-up attempts completed. No further information expected.
Arm pain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included DULOXETINE, BUPROPION, EMPAGLIFLOZIN (JARDIANCE), LISINOPRIL and EXENATIDE (BYDUREON) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache). On 05-Mar-2021, PAIN IN EXTREMITY (Arm pain) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included Tylenol.   This case was linked to MOD-2021-081682 (E2B Linked Report).; Sender's Comments:  MOD-2021-081682:Dose2
Moderna COVID 19 Vaccine EUA.  Large round raised rash on upper left arm at injection site, hot and slightly itchy.
Severe rash (shingles-like) on the right-side (opposite of arm that I had the shot in) from under my right breast to the center of the back.
rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HEART RATE INCREASED (rapid heartbeat). At the time of the report, HEART RATE INCREASED (rapid heartbeat) outcome was unknown.            the patient received the first dose of vaccination on January 2021 and the second dose was received on February 2021. No concomitant medications and treatment information were reported.
Patient described severe shoulder pain on the vaccinated side. He required steroid injections at the site to reduce inflammation. He described the same symptoms after a previous vaccine.
Breakthrough case admission after three vaccines Pfizer 3/13/21 Lot# EN6200;  Pfizer 4/5/21 Lot# ER2613;  Pfizer 1/7/22 Lot# 33025
1) Slight fever; 2) Left arm red, itchy, sore, warm to touch; 3) Tylenol, ice to site; 4) Benadryl;
Pt was given PPSV23 vaccine instead of Meningococcal B vaccine, with PCV13 vaccine at the same visit.
Nauseous; Felt dizzy; Left arm was catching a cramp/Fingers are also catching cramps/could not hold anything up with left arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), DIZZINESS (Felt dizzy), MUSCLE SPASMS (Left arm was catching a cramp/Fingers are also catching cramps/could not hold anything up with left arm) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced NAUSEA (Nauseous), DIZZINESS (Felt dizzy), MUSCLE SPASMS (Left arm was catching a cramp/Fingers are also catching cramps/could not hold anything up with left arm) and HEADACHE (Headache). At the time of the report, NAUSEA (Nauseous), DIZZINESS (Felt dizzy), MUSCLE SPASMS (Left arm was catching a cramp/Fingers are also catching cramps/could not hold anything up with left arm) and HEADACHE (Headache) 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.   No concomitant medications were taken by the patient. Treatment Medication was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  The patient provided consent to safety for follow up with himself via phone and his doctor but was unable to provide contact phone number for his doctor.
I started with a headache, running nose. For 2 weeks exp congestion to throat,water draining from nose ,no body aches and getting dehydrated. I went to Urgent Care had Covid, Test done results negative.
Narrative: Admitted 4/11 with SOB found to be hypoxic. Received Janssen vaccine x 1 on 6/21/21. Treated with dexamethasone 6mg orally x 4 days while inpatient and discharged on 3/14. She recieved 4 days of dexamethasone 4mg on discharge. Remdesivir was deferred due to AKI.
Progressively worsening difficulty breathing, culminating in collapse and NEAR DEATH, on 14/03/2021.   Results from the E.R.:  extreme hypertension and fluid in lungs.  Intubated (breathing) for a day.   In E.R. for at least 2 days.
She started having a headache about 2 hrs after vaccine. Then she was nauseated and had body aches for two days and was lightheaded for up to a week after the vaccine administration.
the patient literally thought had COVID; the patient literally thought had COVID; got sick; Headache; Nauseas; Fever; throwing up; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Lot number: EW0178) as dose 2, single and (Lot number: EW0186) as dose 1, single for covid-19 immunisation. Relevant medical history included: "gone to the hospital before for injuries" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "the patient literally thought had COVID"; ILLNESS (medically significant), outcome "unknown", described as "got sick"; HEADACHE (medically significant), outcome "unknown", described as "Headache"; NAUSEA (medically significant), outcome "unknown", described as "Nauseas"; PYREXIA (medically significant), outcome "unknown", described as "Fever"; VOMITING (medically significant), outcome "unknown", described as "throwing up". Therapeutic measures were taken as a result of suspected covid-19, illness, headache, nausea, pyrexia, vomiting. The consumer got the Pfizer vaccine for the COVID-19 virus back probably in Mar, may be Apr (further clarification unknown) and 30 days after got it, patient got sick in the middle of night out of nowhere, like the patient have never get sick, patient had gone to the hospital before for injuries but did not ever get sick, patient hardly ever got a cold and then another 30 days were fine and 30 days to that day patient got sick at night again same thing the symptoms were headache, nauseas, fever, throwing up, like patient literally thought had COVID and then went back to sleep, after patient threw up, patient took some Tylenol then felt better the next day, now this has been happening every 30 days almost to the day patient had to begin last night but this time it was not full 30 days, it was like 27-29 days, it is almost every 30 days. Patient got sick in the middle of the night since took that vaccine.
Patient presented to the ER on 7/7/21 with hematuria and was found to have acute kidney injury.  Patient was recently diagnosed with a PE and bilateral DVT 4 weeks PTA and was on Eliquis for these.  Patient also has a history of lung cancer and COPD and is chronically on 4L O2 at home. A foley was placed by Urology in the ER and Eliquis was held due hematuria and changed to heparin drip upon admission.  In the ER, patient was tested for COVID per policy, and was found to be positive on 7/7/21 despite being fully vaccinated (1/24/21 and 2/14/21). Patient was admitted for further work-up and has not been started on COVID treatment due to patient being asymptomatic for COVID.  Pt's chest X-ray was negative for pneumonia.
No adverse effects reported.; a patient received one dose of MMR II on 3/6/2019 and then one dose of VARIVAX on 3/26/2019.; This spontaneous report was received from a nurse referring to a 20 months old patient with unknown gender. Information about medical history and concurrent conditions was not provided. Concomitant therapy included sterile diluent. On 06-MAR-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (recombinant Human albumin (rHA)) (lot # R020831, expiration date 19-JUL-2020, dose and route were not reported) for prophylaxis.  On 26-MAR-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX)(lot # R023735, expiration date 20-AUG-2020, dose and route were not reported) for prophylaxis (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1907USA012991:
Blotchy red rash; Sore arm/finger aching; Weakness; Increased pulse rate; Racy heart; Achy joint; Body ache; Shoulder ache; High Blood Pressure/blood pressure was 200/94; Shivering; Nausea; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd January 2020, less than an hour after receiving Shingrix, the patient experienced pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering and nausea. On 3rd January 2020, the patient experienced red rash. The patient was treated with non-drug therapy (Warm Compress). On an unknown date, the outcome of the pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering, nausea and red rash were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, weakness, heart rate increased, palpitation, joint pain, general body pain, shoulder pain, blood pressure high, shivering, nausea and red rash to be related to Shingrix.  Additional details were provided as follows: Within ten minutes after receiving the Shingrix vaccine, the patient arm was sore. By 4pm she applied warm compress on it.  By 5pm she started feeling weak, racy heart and achy joints. By 5:30 PM her blood pressure was 200/94, and pulse was 85.  Around 6:15 she took medications for her blood pressure.  By 10:30pm her body was aching along with joints, shoulders and her fingers. She was also experienced shivering, nausea and racy heart. On the day of reporting morning she noticed blotchy rash with redness below the injection site covering 4 inches of area. The patient still experiencing all the side effects. No further details were provided. The reporter did not consent to follow up.
Pt developed nephrotic syndrome/minimal chain disease.  Creatinine peaked at 3.12 Pt required hi flow dialysis due to anasarca
STERILE WATER FOR INJECTION MIXED IN AS DILUENT. NO ADVERSE OUTCOMES REPORTED BACK TO PHARMACY AT THE TIME OF THIS REPORT
Got shots but she got them/ suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (had to four sisters) and chickenpox (sister or brother when he or she was a kid).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shots but she got them/ suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she had five sisters and all of them experienced shingles. The reporter stated that his or her one sister experienced shingles so bad as she was suffered terrible. The reporter reported that he or she and his or her younger sister received Shingles vaccine but she experienced shingles but not as bad. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Itchy inflammation Redness warmth hardness at and around injection site lasted 2 -3 days only
Fever, HA, muscle weakness, body aches, confusion, tachycardia, SOB, chest pain, lethargy, dizziness, nausea, decreased appetite, loose stools, blurred vision. Lethargy began shortly after vaccine administration. Other symptoms worsened over next week, and then the employee was evaluated at a urgent care center after 6 days of symptoms. She has also been evaluated by PCP and Ophthalmology.