chrisvoncsefalvay/vaers-outcomes huggingface dataset:
achiness; tiredness; mild headache; general malaise; This case was reported by a consumer via call center representative and described the occurrence of pain in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd September 2020, 1 days after receiving Shingrix, the patient experienced pain, tiredness, headache and general malaise. On 3rd September 2020, the outcome of the pain, tiredness, headache and general malaise were not recovered/not resolved.   The reporter considered the pain, tiredness, headache and general malaise to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experiencing achiness, tiredness, mild headache and general malaise. Reviewed adverse effect section of PI to patient and offered a copy. The reporter did not consent to follow up. The reporter declined to provide HCP information.
Received ROTATEQ vaccine on 8/25/14 and on 10/24/14 mother reported that after vaccine on 8/25 child had diarrhea and spitting up along with fussiness x 12-18 hours.
Injection site is red swollen and is the size of a softball pain under arm when I apply deodorant or move arm pain around breast and upper neck
I received my Vaccine at my Mother-in-law's senior living facility.  I went to urgent care
There were no adverse events. However, the patient inadvertently received the Janssen COVID 19 on April 10, 2021 at the community vaccine event although he is 16 years old.   This  situation was identified on April 29, 2021 during routine quality checks.  Pt.'s  parents were notified and a wellness check was completed on pt. Pt. denies any usual side effects or adverse events from the vaccine , 19 days after being vaccinated.
1 Day after receiving vaccines, developed red, warm swollen area on left anterior thigh. Diagnosed 6/21/07 with cellulitis, treated with Keflex for a 10 day course.
Extreme fatigue, dizziness that resulted in 2 falls and complete loss of hearing. Dizziness started about 10 AM on Saturday morning (2/27) following the vaccination and continued until around 2 AM on Wednesday morning (March 3). Loss of hearing was gradual and started Sunday (2/28), but did result in complete loss of hearing which is slowly returning. She called in to the clinic to have adverse effects addressed.
Patient told his grandmother he "just wanted to go to sleep" then, fell to the ground.  His eyes began to roll up into the back of his head and his limbs began to contract. We called 911. Patient came to about a minute later and complained about a headache.  I spoke to him, asked him questions and he responded correctly but, he complained of headaches.  911 arrived and took him to hospital.
One day post-inoculation with the COVID19 vaccine, I experience a spike in body temperature at 99.9 degrees F and chills. Two days following the vaccine, I began to feel nausea with a bit of stomach cramping and chills. I could only eat a milk shake for a meal.  Later that evening, I began having diarrhea. By Sunday, I was not eating at all, had a slight temperature of 99.8 degrees F, stomach cramping, chills, and diarrhea. On Sunday night, I began to feel achy all over and still could not eat or look at food.  On Monday, February 22nd, I had to stay in bed the whole day as I felt to weak to do anything.  By the next day, I began to feel much better and was able to eat solid food again.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 56-year-old female patient who received SHINGRIX for prophylaxis. On 7th March 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The patient was experiencing mini-flares of shingles, so she did not get the 2nd dose until a day before the date of reporting. For tolerance dose see case ID US2019GSK013815, reported for the same patient.
shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the pt's past medical history, concurrent conditions, or concomitant medication. On or about 08-DEC-2011, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) injection (dose, route of administration, vaccination site, lot # and expiry date were not specified) by a pharmacist for long-term prevention of shingles and zoster-related conditions. On an unknown date, the pt was treated by a healthcare provider for the following injuries resulting from the use of zoster vaccine live (ZOSTAVAX): shingles. The outcome of the event was unknown.    Additional information has been requested.
No additional adverse effects were reported; patient, date of birth 6/29/2019, received the third dose of ROTATEQ on 5/6/2020/after age of 8 months; patient, date of birth 6/29/2019, received the third dose of ROTATEQ on 5/6/2020/after age of 8 months; This spontaneous report has been received from a nurse and refers to a 10-month-old patient. The patient's concurrent conditions, medical history, and concomitant medications were not reported.  On 06-MAY-2020 (after age of 8 months), the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # S005875, expiration date: 30-NOV-2020) dose 3, administered at a dose of 2 milliliters, once, orally as prophylaxis.         No adverse effects were reported.
This spontaneous report was received from a medical assistant concerning 2 unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reporter. On an unknown date, the patients were vaccinated with PNEUMOVAX 23 injection, lot # L018503, expiration date: 15-MAR-2017 (dose, route and anatomical location of administration were not reported), which were improperly stored. The lowest temperature excursion reported was 33.3 F for 2 hours and the highest temperature was 46.6 F for 30 minutes. The temperature excursion was detected by a digital data logger. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reported. Additional information has been requested.
Pfizer Dose 1 3/23/21 (ER8727 Pfizer Dose 2 4/21/21 (ER8731) Pfizer Dose 3 10/25/21 (FF2593) COVID Positive 1/25/22  1/25/22: This is a 67 y.o. female with multiple comorbidities who presented to the ED via EMS due to generalized weakness.  Duration about 2 weeks, worsening in the last 24 hours. Reports being fatigued and not being able to walk.  Associated symptoms include feeling feverish, chills, and chest pain.  She also reports increasing right buttock pain.  Notable PMH include severe COPD on home oxygen at 2-3 liters per minute, and chronic pilonidal cyst/infection of the right buttock.  Referral for evaluation per general surgery had been placed at her annual exam.  She had not recently been on antibiotics. Endorses possible COVID exposure.  Endorses COVID vaccination status + booster.  1/30/22: Patient is a pleasant 67 yo F who presented with worsening generalized weakness with associated fever//chils, chest pain, and right buttock pain. Pertinent history of chronic pilonidal cyst/infection of right buttock. Not on recent antibiotics. Patient noted to be satting in the 80's, normotensive, 100.4 F. Placed on oxygen supplementation. Labs showed low Mg2+, no leukocytosis, mild thrombocytopenia. Lactate normal. Troponin negative. UA + leuk est. COVID rapid antigen was positive. CXR showed cardiomegaly and pulmonary vascular congestion. CT Abdomen/Pelvis notable for perianal cellulitis/abscess. Patient was given Mag rider and vancomycin in the ED. Of note, D-dimer was elevated and thus prompted CTA that showed new PE on right side. Heparin gtt started. Of note, patient was already on Xarelto for Afib. Thus, pulmonology consulted, but pulmonology then consulted heme/onc given new PE on anticoagulation. Heme/Onc recommended transition from heparin to Lovenox and to continue x 4 weeks, ordered APL workup, with plan to transition to warfarin if positive. General Surgery was consulted for perianal abscess. On 1/27, right perirectal abscess spontaneously drained with improvement in patient's pain. Given the PE on anticoagulation and perirectal area improving, surgery decided to hold off on any type of surgical intervention. Doxycycline 100 mg IV BID was started 1/27. Patient was treated with remdesivir, dexamethasone and Lovenox for COVID-19 treatment. Patient's oxygen was weaned down from 6 to 4 L with saturations in 90's. On 1/30/22, patient was deemed stable for discharge home with close follow-up with PCP, and surgery and heme/onc.
Respiratory distress (SOB), chest pain 3/10 intermittent sternal.  VS stabilized back to baseline and D/C'd to home.  Documented allergy in HL.
The patient described 6 hours post vaccine, symptoms starting as a rash(with itching) on one side of face that woke her from a sleep at 0100  on April 29th.  She received the vaccine at 1700  on April 28th. She reported no other symptoms prior to that point, post vaccination. She woke again at 0900, where her face was described as swelling- She took 1 capsule of diphenhydramine. Symptoms worsened, as described by patient for her make an emergency room visit under her own accord. She reports in the emergency room a treatment of IV diphenhydramine, famotidine, and oral prednisone daily for 7 days. The Diphenhydramine was repeated in 3 hours. She discharged at that time without being admitted. It was recommended to her to not get the Moderna Vacccine 2 nd dose.
Expired Drug Used; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number unknown, expiry date 31st January 2022) for prophylaxis.   On 1st February 2022, the patient received Menveo. On 1st February 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The patient received expired dose of Menveo, which led to expired vaccine used. The reporter did not have further information about the patient or the vaccine. The reporter did not consent to follow up.
No adverse event. We picked up what was supposed to be COVID-19 Moderna vaccine. Lot numbers and expiration date matched tracking sheet given to us by National Guard. Color of medication also matched what was stated on Fact Sheet for Healthcare Providers and CDC website for the Moderna vaccine. Instead, the medication in the vial was actually COVID -19 antibodies meant for hospital use. After administration for 44 individuals, we received call from National Guard that the medications had been mixed up. The vials and box that medication came in had no identifying factors to indicate it was not the Moderna vaccine.
Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 01-Feb-2021, PAIN IN EXTREMITY (Arm soreness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.    Most recent FOLLOW-UP information incorporated above includes: On 21-Feb-2021: NNI added.
Severe itching and dermatographia all over body, and diagnosed by doctor. Symptoms showed up 13 days after vaccination with booster. Has never had these symptoms before. Still present but treated with daily Zyrtec and Pepcid AC.
Right arm (inside bicep) was slightly swollen and red, approx 2 inches in diameter. No itching. Patient could not move arm past shoulder height. Painful to touch. Occurred 1 day after vaccination (on 9/10/09). Pharmacist gave diphenhydramine and acetaminophen when notified on 9/11/09.
Eyes become puffy. Pain started from the bottom of her feet and moved all the way through her body.
Sensitive to temperature, chills , fever, sweats, headache,  tx with tylenol, with no relief,  01/07/2021 faint headache only
Pt. recieved vaccine past 12 hours expiration. No adverse event. MD notified pt. Pt. declined revaccination.
HISTORY OF PRESENT ILLNESS:  This 83-year-old male with a past medical history of coronary artery disease, a history of CVA with residual right-sided weakness, iron-deficiency anemia comes in for complaint of ongoing shortness of breath and worsening malaise, fatigue, weakness.  Patient stated that, over the past 3 days, he has begun to experience symptoms of increasing progressive shortness of breath where he was unable to ambulate.  He also stated that he was coughing with dark brown sputum. He is admitted for coronavirus 2019 pneumonitis.
Pt exp nausea & chills; Seen in ER t37.5, 2.3 induration w/mild to moderate tenderness over the inject site; Hospitalized for 3 days; t38.5 while in Hosp; pt had previous rxn to Td in 1985;
This case was reported by a pharmacist via sales rep and described the occurrence of headache in a 59-year-old female patient who received SHINGRIX. On 17th May 2018, the patient received SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced headache, chills, muscle pain and influenza-like symptoms. The patient was treated with ibuprofen. In May 2018, the outcome of the headache, chills, muscle pain and influenza-like symptoms were recovered/resolved. It was unknown if the reporter considered the headache, chills, muscle pain and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she had a headache, chills, muscle aches, like she had the flu, so she took an ibuprofen and felt fine at the reporting date. The details of the treating physician were also provided.
STARTED ON 08/03/21 - 1 DAY POST VACCINATION - EARS RINGING, HEADACHE FROM FRONT HAIRLINE TO BACK OF NECK, PAIN IN SHOULDER BLADE, FOGGY, ANXIOUS. TYLENOL NOT HELPING.  08/25/21 - CHRONIC EARS RINGING AND HEADACHE.  PATIENT TOLD TO CALL COVID HOTLINE.  I TOLD HER TO SEE A DR OR NP ON 8/25/2021.  I CALLED AT 11:30 AM 8/26/21 - PATIENT DID NOT SEE NP/DR.  SHE IS FEELING BETTER TODAY.
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 19-OCT-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) lot # L002213, expiry date 21-JUL-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sore arm, inflamed axillary lymph nodes, headache, chills, night sweats, body aches all of which started about 9-10 hours after vaccination and persisted for at least 12 hours
Breakthrough case admission after two vaccines Pfizer x2; Pfizer 8/23/21 Lot# FC3181;  Pfizer 10/21/21 Lot# FF2593
Patient stated about 15 mins after 2nd pfizer vaccine noticed left hand felt cold compared to right.  Then felt the cold feeling radiating up into arm towards shoulder into neck area.  Patient sat for 1 hour with improvment in the hand but c/o discomfort to left neck area.   Left radial pulse noted.  Patient has sensory, motor sensation
pt recvd vax;weakness,tingling,throbbing & hot pain in arm;to MD;tx:large doses of ibuprofen;devel GI-distresss from med;
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age. The patients medical histories were not reported. On an unknown date the unspecified number of patients were vaccinated with GARDASIL which were improperly stored. Concomitant medications were not reported. No symptoms reported. The outcome of improperly stored vaccine administered was unknown. Additional information has been requested.
Redness and itch on injection site. There is a bump on the back of patient's neck. Treatment: Patient will visit MD today (10/19/2010).
Covid 19 test taken on 1/14/21 results came back on 1/17/21 positive
Severe headache and 24hrs later growing eye pain and noticeable redness in right eye (first time experience)
Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. This occurred on 4/10/21 and on 5/12/21.
I had cold-like symptoms on March 17, 2023. On the 20th I had burning runny eyes and body aches. I went to the doctor on the 21st. I got lightheaded in the shower and was nauseous. At the doctor I tested negative for COVID-19, strep and the flu. I was diagnosed with something in the RSV family. I was not prescribed any medication.
High fever (102), extreme headache, severe body chills,  body aches, swollen lymph nodes in neck and groin. Onset at 2:00 pm, kept developing rapidly until I took 800 mg of ibuprofen  around 6 pm and symptoms lessened within an hour. Symptoms still present but mild with the pain meds. Injection site pain as well.
pt recv vax 28JUN95 & on 31OCT97 pt was dx w/chickenpox;nurse said pt was not sure if the case was more mild than usual;
This spontaneous report as received from two healthcare workers refers to unspecified patients of unknown age. On 05-MAY-2014 between 8:50 a.m and 9:10 a.m, unspecified patients were vaccinated with VAQTA (strength, dose, route unknown, lot# J01135, expiration date 10-MAR-2016). It was reported that the patients received improperly stored VAQTA, it was exposed to 26.2F for 5.5 hours. One reporter reported that they believed the VAQTA was in recommended storage temperature when removed from refrigerator and administered, but they were not 100% certain so they included the products in the excursion information. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:41 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Nov-2021 at 2:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) 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 62.79.  Concomitant products were not provided.  On 03-Nov-2021, Excursion time was 10 AM, temperature was 35, total doses given for the day was 117, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Oct-2021, vial was moved to clinic on 03-Nov-2021. 6 vials were sent to clinic. Vaccine BUD date was 05-Nov-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  Treatment medications were not reported.
Extreme pain in left arm  which lasted 12 hours - from 3 am to 3 pm on March 20, 17 days after injection.  Pain disappeared as quickly as it started.  I did not seek treatment.
Around a month after 2nd vaccine, I started experiencing pain in my pelvic. Then, I was diagnosed with cyst. my period was not regular since I got second dose.  I was not feeling good in general all this time. On November 19, I got heart palpitation and high pulse. It didn't stop until next day. I was very weak, feeling nauseaus and dizzy. I was admitted to the cardiology department for the night. Doctors could not find any issues with the heart. I was discharged, but didn't feel any better. I had the same symptoms every day or every other day for another month. I was to ER 5 times total until they said they can not help me because they can not diagnose me with anything. The only new event that has happened to me was Pfizer vaccine. I was completely healthy person until that time. I don't feel as terrible as felt for the last months, but my heart still bothers me. I am waiting for my doctor to schedule me with allergist and hormone specialist. Also, I have a follow up visit with cardiologist next week.
eye pain; headache; Pressure in the eyes; This is a spontaneous report from a contactable consumer (patient).  A 30-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via an unspecified route of administration, in left arm on 19Feb2021 at 12:15 PM (age at vaccination: 30-Year-old), as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included ibuprofen (ADVIL), taken for an unspecified indication, start and stop date were not reported. The patient did not receive any vaccine within four weeks prior to covid-19 vaccine. The patient was not diagnosed with covid-19 prior vaccination and not tested for covid-19 post vaccination. The patient was not allergic to any of the medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL3247 and expiry date was not reported), via an unspecified route of administration, in left arm on 29Jan2021 at 12:15 PM (age at vaccination: 30-Year-old), as DOSE 1, SINGLE for COVID-19 immunisation and experienced headache. On 20Feb2021 at 13:00, the patient experienced headache, pressure in the eyes and eyes felt sore. It started with a headache that reached the eye area after about 24 hrs of taking the vaccine. The headache was present after the first dose, but without the eye pain. Events persisted for 2.5 days. The patient did not receive any treatment for the events. Outcome of the events was recovered on an unspecified date in Feb2021.