chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I am looking in the mirror and its little bit kind of swollen in that area; Pain; almost like a deep bruise in my shoulder where the shot was; Pain; almost like a deep bruise in my shoulder where the shot was; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm on 14Aug2021 as dose 1, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 14Aug2021 early, the patient got the Pfizer first shot (Covid-19 Vaccine) and patient got some pain, felt almost like a deep bruise in shoulder where the shot was. So, moved arm around and when woke up (15Aug2021) and arm was still sores feels like it got a little worse but looking in the mirror and its little bit kind of swollen in that area and the patient was calling to see if had any tips, advice or anything like that. The patient's outcome of the event vaccination site pain was not recovered and other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2015, the patient was inoculated with the ZOSTAVAX vaccine at a pharmacy as recommended for routine adult health maintenance for the long term prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 26-JUL-2016, the patient was treated for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown.  Causality assessment was related. Additional information has been requested.
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 21-NOV-2012 was vaccinated with an improperly stored dose of PROQUAD (merck) (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Back stiffness; Vaccination site pain; Pain sacroiliac; Muscle pain; Fatigue; Spinal pain; Stiffness joints; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Back stiffness), VACCINATION SITE PAIN (Vaccination site pain), SACRAL PAIN (Pain sacroiliac), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Ankylosing spondylitis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Back stiffness), VACCINATION SITE PAIN (Vaccination site pain), SACRAL PAIN (Pain sacroiliac), MYALGIA (Muscle pain), FATIGUE (Fatigue), SPINAL PAIN (Spinal pain) and JOINT STIFFNESS (Stiffness joints). At the time of the report, MUSCULOSKELETAL STIFFNESS (Back stiffness), SACRAL PAIN (Pain sacroiliac), SPINAL PAIN (Spinal pain) and JOINT STIFFNESS (Stiffness joints) had not resolved and VACCINATION SITE PAIN (Vaccination site pain), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had resolved. Not Provided          This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant or treatment medication provided
red itchy rash on anterloposterior torso, upper inner arms, neck groin, all apparent in a.m.; This spontaneous report was received from healthcare professional and refers to a male patient of an unknown age. The patient had no known allergy, no other illness at the time of vaccination and no chronic or long-standing health conditions. At the time of vaccination, the patient was taken unspecified herbal remedies. There was no information about the patient's medical history provided.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (reported as HPV vaccine of Merck & Co but lot # S008154 has been verified to be valid for hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), expiration date was not provided but upon internal validation established as 20-NOV-2021), in the deltoid, intramuscularly for prophylaxis (exact dose was not provided) and influenza virus split virion 3v vaccine inactivated (FLUARIX) lot number: TAR35, intramuscularly in the deltoid, for prophylaxis (exact dose and expiration date were not provided) (age at vaccination was provided as 15years and 11 months).  On 01-OCT-2019 at 07:00 am, the patient awoke with red itchy rash on anterioposterior torso, upper inner arms, neck groin, all apparent in the morning. As treatment prednisone and methylprednisolon (MEDROL) dose pack were given. The patient had to follow prednisone dosing and cetirizine (ZYRTEC).  The outcome of the event was not recovered. The causality assessement was not provided.  Follow-up information was received from a medical assisstant on 04-JAN-2021. Additional information has been requested. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S008154; expirationdate: 20-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
LOT OF SYMPTOMS; This spontaneous report received from a consumer concerned a male of unspecified age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers No concomitant medications were reported. On an unspecified date, the subject experienced lot of symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lot of symptoms was not reported. This report was non-serious.
1. sore left arm - started after 10 hrs; lasted 2 days 2. fever (37.4 C), started after 12 hrs; lasted 8 hrs 3. enlarged and painful lymph nodes in armpit, started after 4 days, ongoing  No treatments administered for any symptom.
Patient falsified DOB when registering for vaccination, stating the minor was 2005. Guardian consented to the vaccination. Department of Health verified with statistical records that the patients actual DOB is 2006 which made the vaccine a contraindication.  No known adverse reactions noted.
This spontaneous report as received from a physician refers to a 35 year old male patient (who is also a pharmacist). The patient's concurrent conditions included asthma, rhinitis allergic and allergy to penicillin (reported as 'penicillin gave him a rash'). On 22-MAY-2015, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K019561, expiration date: 20-APR-2016) dose unspecified, intramuscularly in the left deltoid. Concomitant therapies included albuterol sulfate (manufacturer unknown) as needed. On 22-MAY-2015, the patient developed soreness at the injection site. The next day, he experienced pain and local swelling in his left arm, which then progressed to encompass most of his upper left arm. The following day, these symptoms became severe and he presented to the emergency room, was diagnosed with cellulitis, and was treated with antibiotics (unspecified). His white blood cell count was elevated with a left shift. The pain and swelling did not improve and he was admitted to the hospital on an unspecified date in 2015. His symptoms then spread down to his left elbow. While hospitalized, the patient also experienced headache, chills, a flat red rash along with the pain and swelling. He was treated with intravenous steroids and vancomycin. The patient was discharged from the hospital on an unspecified date in 2015. The patient was seen in the office on 24-JUN-2015 (reported as "today") and his symptoms had completely resolved (on an unknown date in 2015). The relatedness between the events and PNEUMOVAX 23 was not provided. Upon internal review, the events were considered to be medically significant, as they were treated with intravenous steroids. Additional information has been requested.
This was reported by patient's daughter to me at the pharmacy. She went to urgent care: fever, chills, nausea, vomiting, fatigue, muscle aches.
This is a spontaneous report from a physician referring to a male in his thirties who received his first dose of Lymerix on 7/29/99 and subsequently, he felt achy. This symptom resolved. The pt received his 2nd dose of Lymerix on 8/4/99. Seven days later, on 8/11/99, he experienced flu-like symptoms, vomiting and nausea. A doctor visit was required. The most recent information, received on 9/1/99, reports the condition of the patient is ongoing.
Muscle ache; Spasms/buttock spasms/ muscle cramps; Injection site hurt; walking difficulty; walking painful; both legs are hurting; This is a spontaneous report from a contactable consumer, the patient. An 80-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3242), via an unspecified route of administration in the left arm on 06Feb2021 (at the age of 80 years-old) as a single dose for COVID-19 immunization.  Ongoing relevant medical history included myopathy, neuropathy, neurological issues, and chronic pain. Additional medical history included the patient also had spinal cord surgery several years ago and sensation issues for a lot of years. The patient's concomitant medications were not reported.  On an unknown date the patient experienced muscle ache, muscle spasms, injection site hurt bit, walking difficulty and walking painful.  On 10Feb2021 the patient experienced both legs are hurting. The patient reported that they had the first vaccine on the 06Feb2021 and the injection site hurt a little bit and a couple of days went by and then the patient had the muscle aches and all of a sudden it was severe with muscle cramps and spasms from the buttocks down the leg on the left side.  The patient stated that now both legs are hurting a lot from about 10Feb2021. The patient stated that he could barely walk and it was very painful to walk. The patient stated he was using a walker, cane, and holding onto objects when walking. The patient said it is a little better, but the patient still has to take baby steps and the patient is currently having a buttock spasms.  The patient stated they have the second appointment 27Feb2021 and the patient is leery of taking the second dose as the patient has not been able to function for the last 2.5 weeks and is not sure about getting the second dose. The clinical outcome of the muscle ache, injection site hurt, walking difficulty, walking painful and both legs are hurting was unknown. The outcome of the event muscle spasms/buttock spasms/ muscle cramps was not recovered.
pt recv vax 3NOV97 & 19NOV97 pt devel 5-6 skin lesions;21NOV97 lesions became more pustular;
PATIENT HAD BLUE LIPS WHILE SITTING IN THE CAR ON DAY AFTER 2ND SHOT. HE HAD BODY ACHES AND FEVER STARTING THE DAY AFTER HIS 2ND SHOT. HE FELT HIS HEART WAS DIFFERENT AND 'HEAVY' AND INFLAMMED. HIS BOWEL PATTERN  WAS ALSO DIFFERENT.
Redness to site & warm to touch.  Doctor advised for cool compress to be applied and give TYLENOL PRN.
Prolonged swelling under left arm from date of shot in 9/2021 to present (roughly nine months) and still present. Lymph nodes were confirmed normal via ultrasound in June, but swelling persists. Not nearly as prominent as the date of the initial inject but obviously visible when examined.
This Non valid spontaneous report was received from a registered nurse and refers to an unspecified number of unspecified patients of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On dates on or after 21-SEP-2017, the patients were vaccinated with improperly stored dose of PEDVAXHIB for prophylaxis, lot# N000238 with expiration date of 25-OCT-2019, lot# N003701 with expiration date of 01-NOV-2019, lot# N008079 with expiration date of 02-DEC-2019, lot# N012920 with expiration date of 07-FEB-2020 (strength, dose, route and frequency were not reported); or with improperly stored dose of RECOMBIVAX HB for prophylaxis, lot# N020613 with expiration date of 05-MAY-2020, lot# N002202 with expiration date of 04-NOV-2019, lot# N011851 with expiration date of 19-DEC-2019; or with improperly stored dose of ROTATEQ orally, for prophylaxis, lot# N000175 with expiration date of 20-SEP-2018, lot# N005618 with expiration date of 04-OCT-2018, lot# N005078 with expiration date of 22-NOV-2018; or with improperly stored dose of VAQTA for prophylaxis, reported lot# M019924 with expiration date of 02-SEP-2018, lot# N008823 with expiration date of 26-MAY-2018. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32°F (degrees Fahrenheit) to 35°F for 40 minutes; No previous temperature excursion was done. The call was because of a "data logger". This is a non-valid case due to lack of patient identifier. Follow up information was received from the registered nurse 30-APR-2018. The nurse stated the temperature excursion was stable and they had two refrigerators that held the related vaccines. The nurse was not able to provide patients' names or initials, or ages, but was able to provide number of patients, gender information, and vaccination dates. This report referred to a female patient vaccinated with improperly stored ROTATEQ (oral; lot# N005078 with expiration date 22-NOV-2018) on 27-SEP-2017. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. This is one of several reports received form the same reporter(link reports: 1710USA004069, 1805USA001661, 1805USA004617, 1805USA004618, 1805USA004590, 1805USA004591, 1805USA004592, 1805USA004593, 1805USA004674, 1805USA004675, 1805USA004676, 1805USA004677, 1805USA004678, 1805USA004680, 1805USA004681, 1805USA004682, 1805USA004683, 1805USA004967, 1805USA004968, 1805USA004969, 1805USA004970, 1805USA004971, 1805USA004972, 1805USA004973, 1805USA004974, 1805USA004975, 1805USA004976, 1805USA004977, 1805USA004978, 1805USA004979, 1805USA004980, 1805USA004981, 1805USA004982).
Dose administered after manufacturer date of expiry; Received expired first booster dose after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J COVID-19 Vaccine (First Dose) on 28-Oct-2021. Past adverse reactions to the above products included No adverse event with J&J COVID-19 Vaccine.    On 17-Jun-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired first booster dose after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Dose administered after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.    No treatment information was reported.  On 17-Jun-2022, patient received expired first booster dose of Moderna COVID-19 vaccine. Vial was removed from freezer at 10AM on 17-Jun-2022. 1 dose / 1 dose administered after manufacturer date of expiry. The vial did not undergo any temperature excursions. Patient was on way back to the vaccination site to be re-vaccinated. Re-vaccination was kept on hold, until Tier 2 team reaches out for regarding the urgent case.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 26-AUG-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K010215, expiry date: 05-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose12/2020 2nd dose01/10/21 Diagnosed covid positive:08/16/21 Symptom onset:08/16/21 Exposure:work Symptoms:loss of smell/taste, runny nose,congestion
tingling on left side of face, numbness in left arm, blurry vision. Evaluated by EMS-Refusal to transport.
Patient received first dose of Moderna vaccine on 01/06/21. On 01/15/2021 she developed a rash that is approximately 3 inches across and 2 inches down on the arm that received the injection. The rash begins approximately 3 inches down from the injection site. She describes it as slightly itchy and warm to the touch. She has not used anything to treat the rash.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 23-FEB-2019, the patient was vaccinated with improperly stored dose of VARIVAX subcutaneously, lot # N035941, expiry date: 18-DEC-2019 (dose and anatomical location were not provided) for prophylaxis. The dose of VARIVAX was stored out of recommended range (temperature: 12 Fahrenheit degrees) for 2 hours and 3 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported.
I'm normally pretty careful about masking up indoors, but the weekend before I got sick, I went to brunch, and I think that's where I picked it up. I woke up on 2/7/2023 with a sore throat. I took a home antigen test, and the result was negative. The sore throat lasted for most of the day, and I felt tired. On 2/8/2023, I woke up feeling worse. I had congestion, sore throat, and a headache. I also felt really fatigued. I fully isolated myself and stayed around an air purifier. I took SUDAFED, but it didn't help. On 2/9/2023, I took a home test and got a positive result. I worked half a day remotely and then took the rest of the day off, because I was so fatigued and felt so sick that it affected my concentration. I slept for most of the day. I took DAYQUIL and NYQUIL that day and night, but they weren't as effective as I wanted them to be. After the first hour or two, they were effective, but they quickly wore off. They were better than nothing, though. On 2/10/2023, I still felt fatigued and sick. I again took DAYQUIL and NYQUIL. I slept all day. On 2/11/2023 and 2/12/2023, I felt better, but I had a little bit of a headache, plus runny nose and postnasal drip. On 2/13/2023, I still had a little bit of a runny nose and an annoying cough in which I felt the need to clear my throat. By 2/15/2023, I felt fine otherwise, but I was still testing positive. I stayed home, though, and I took precautions to not infect my husband. I finally tested negative on 2/18/2023. When I tested again on 2/19/2023, I was still negative. I had a telehealth appointment on 2/9/2023, and the doctor told me about PAXLOVID, and I ultimately decided not to take it.
Rash & itching to bilat. arms and face with sensation of hard to swallow within 30 min. of injections of TDAP, HPV, MCV-4, HEP A, & VARICELLA.
I noticed a lingering sore throat that seemed to not go away. It was persistent for several days. After 3 or 4 days I completed an at home COVID-19 home test on Monday January 09, 2023. By this time, I had developed fever, achiness in feet, cough, and tiredness. I chose not to take the recommended medications. I treated my symptoms with acetaminophen. At night I took NYQUIL for stuffiness. I started to feel improvement 3 or 4 days later. I also lost my taste and smell. This symptom took the longest to return. There are still sometimes when it returns but for the most part it is gone.
Patient stated that she noticed her arm getting sore and swollen in a couple of days and 6 of her lymph nodes were swollen and went to her PCP Dr. to get it checked. They checked her and performed some scans to ensure everything was okay  and the vaccine didn't affect her adversely.  They found the scan and results to be normal per Pt.
hives started on arm where vax given (w/in 30min of vax) & spread to back quickly;taken to ER DPH given;vomiting @ ER;14MAY98 still itching & has hives still;28MAY98 some itching & hives still;
SEVERE REPEATED VOMITING. HARD, UNCONTROLLABLE CHILLS AND FLU-LIKE ACHINESS UNTIL THE NEXT MORNING.  TOOK PHENERGAN SUPPOSITORY AND TYLENOL DOSES.  GENERAL MALAISE AND SORENESS UNTIL MORNING OF 10/17/2010. LEFT ARM STILL SORE WITH QUARTER-SIZED RED AREA AT PRESENT (10/20/2010.) THE VACCINATIONS WERE GIVEN AT TWO SITES L ARM AND ONE SITE R ARM. IM INJECTION R ARM GIVEN HIGH ON DELTOID APPROX. ONE INCH OR LESS FROM TOP OF MUSCLE WAS VERY PAINFUL FROM THE TIME OF INJECTION UNTIL 3 DAYS LATER. THE NIGHT AFTER THE INJECTION IT WAS NECESSARY TO KEEP THE ARM IMMOBILE TO PREVENT EXCRICIATING PAIN. THE ONE THAT REMAINS RED IS THE INJECTION FOUR + INCHES DOWN (SUB Q.) IT WAS MORE ITCH AND SORE THAN PAINFUL. IF IT IS IMPORTANT, I ASSUME YOU WILL CONTACT THE HEALTH DEPARTMENT TO DETERMINE WHICH VACCINE WAS GIVEN IN EACH SITE.