chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My existing lumbar and thoracic back pain became unbearable (went from a level 4 to level 8 with a 24-48 hour period); I soon required dose-pak steroid orally then multiple level epidural steroid injections (8 weeks later).  These were required for back pain, spine arthritis, disc  bulge and extrusion at multiple levels, with radiculopathies also.  I also had a squamous cell cancer excision from my scalp the day after vaccine, that went on to heal poorly and became infected. Additionally I noted multiple painful joints other than my severe back pathology, occurring within several months of hips, ankles, hands and wrists, and neck. Furthermore I have developed significant fatigue on an ongoing basis and a very concerning 'brain fog' that increases and diminishes daily. This has also caused loss of concentration, some memory difficulties also.  The brain fog began about a month after injection and has worsened since. I am currently being evaluated by a neurologist.
pt claimed had reaction from first dose two hours after receiving it.  had lip swelling and facial swelling but no shortness of breath per doctor's advise took Benadryl and had to take Benadryl for 4 days. She consulted yesterday with Doctor and got an ok to take the second dose and take Benadryl  and Claritin  before the shot. Referred case to supervisor and ok'd to give the shot. after 30 minutes of monitoring pt noted having lip swelling at 1455, gave her Benadryl IM and kept her for another 30 minutes. noted swelling subsided and felt better.
Edema to lt thigh-redness about 120mm in length & fever on 19MAR92; Taken to ER on 18MAR92 & given meds;
Patient was given the four vaccines listed above today. Five minutes after receiving the vaccines, she twice c/o abdominal pain to her father. Patient then told father "I can't see" and collapsed onto the floor but did not lose consciousness or hit her head as she was wearing a backpack. The staff elevated patient's legs and took vital signs. Two MDs were present during patient's reaction. Patient was responsive but crying throughout reaction. After several minutes, patient was assisted to wheelchair and brought back into exam room. Benadryl 25 mg. IM ordered and given to LD. Patient was observed for 30 minutes in exam room. Vital signs were taken after 30 minutes and patient was discharged to home.
Patient states pfizer first dose caused joint pain, tremors and is under the care of a Physician. He requested J&J vaccine for second dose.
Sore muscles starting in left arm and neck. Weakness mostly left arm so far. Has been ongoing and appears to have increased in severity. I purchased deep massager to assist with muscles aches.
Redness at injection site, swelling at injection site, warm to touch, lump under arm.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered after 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 prophylaxis. No Medical History information was reported. On 08-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse reaction). At the time of the report, EXPIRED PRODUCT ADMINISTERED (dose administered after 30 day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine administered on 08-Aug-2022) and NO ADVERSE EVENT (No adverse reaction) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse reaction) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (dose administered after 30 day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 08-Jul-2022 and vaccine administered on 08-Aug-2022). No concomitant medication information was provided. The reporter reported that they administered 1 dose of the Moderna COVID-19 Vaccine from 1 vial to a patient within 6 to 11 years of age after 30 day use by date. It was unknown if this was the first dose for the patient or not. The date when the vial was initially stored in the refrigerator was 08-Jul-2022. It was unknown if the patient experienced any symptoms after getting the vaccine or not. The vial did not undergo any temperature excursions. No treatment information was provided.
Patient was very nervous/ anxious  about vaccine. When it was given , patient seemed to have a seizure and lost consciousness for a few seconds. We called 911. They checked vitals and everything was ok .They told the parent to watch him . They said this happens fairly often when patients get really nervous about vaccines.
Redness of arm a week after the injection.  Dr reported that it did not appear to be a reaction to the shot but that it looked like a skin infection.
12/23/20- mild arm soreness  12/24-12/25- (worse) very tender arm at injection site 12/24-12/25- extreme fatigue (literally no energy) 12/24- for a couple to several days- restless sleep/insomnia 12/24- (off an on for a few days) headache and runny nose  All symptoms resolved within a week. Only took Tylenol or ibuprofen for headache/arm soreness. Massaged arm to help soreness and applied a cold compress.
Malaise,-within 1 day of 1st dose, lightheaded, decreased coordination. Day 3 vaccination (8/25/15)-new onset dysphagia with liquid, headache, and numbness in bilateral lower extremities-> mechanical fall dysphagia resolved within a few days. LE numbness continues.
Approximately 5 hours after shot started getting sharp chest pain in left side of chest. The pain would come and go every few minutes. Felt nauseous as well. After a couple hours went to urgent care. When they took my vitals my blood pressure was very elevated 186/120. Usually it?s low. EKG was normal. Felt lightheaded. They sent me to the ER. The hospital did another EKG, chest X-ray and blood panel. After a while blood pressure went back to normal and all tests came back fine. No explanation of what happened. Arm is extremely painful as well.
Pt passed out about 10-12 min after GARDASIL #1. Also broke out in flat erythematous rash on (L) deltoid and chest, w/c cleared. VS stable. Pt observed x2 hrs due to on and off dizziness and sent home. Call received the day after from grandma (guardian) that she broke her retainer.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191 ; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267223; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193 (same reporter)  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020, via intramuscular route in the left deltoid on an unspecified date which was 8.4 Degree C for more than 24 hrs and patient did received this flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant vaccine included Pneumococcal vaccine.  It was a case of actual medication error due to incorrect product storage.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Documents held by sender: none.
Began spotting five days after my first dose.  This lasted for several days.  My ovulation was a week late, making my whole cycle a week longer.  My period was very heavy.
PHYSICIAN REPORTING THAT WHEN GIVING FLUMIST IN THE PAST PATIENTS HAVE EXPERIENCED IENCED MYALGIA AND NASAL IRRITATION; PHYSICIAN REPORTING THAT WHEN GIVING FLUMIST IN THE PAST PATIENTS HAVE EXPERIENCED IENCED MYALGIA AND NASAL IRRITATION; A spontaneous report has been received from a consumer. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v), via nasal route, on an unknown date.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 15-FEB-2019, the patient experienced not applicable physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation (preferred term: Myalgia) and not applicable physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation (preferred term: Nasal discomfort).     The outcome of the event(s) of physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation and physician reporting that when giving flumist in the past patients have experienced ienced myalgia and nasal irritation was unknown.     The events were considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect
On 3/8/2021 received 1st dose of Pfizer vaccination; 3 days later deep sharp pain from left hip down to left pinkeye toe and ring toe (which toes become numb when pain is severe), from 1st dose in March 2021 the pain has been on & off from mild to severe (assumed due to a pulled muscle from exercise, I work out 5 days a week). As of 4/2/2021 upon receiving the 2nd vaccination, the deep pain in my leg has gotten worse, at times my leg is very tender to the touch, the skin on the upper part of my thigh looks lumpy, feels tender. It's now 24 days since the last shot and my symptoms have not subsided.
PATIENT BECAME DIZZY AND PASSED OUT ABOUT 10 MINUTES AFTER RECEIVING HER VACCINE. WHEN SHE REGAINED CONSCIOUSNESS, SHE SAID THAT SHE COULDN'T HEAR OR SEE ANYTHING AND SHE ALSO WANTED TO VOMIT. WE CALLED EMERGENCY SERVICES. EMERGENCY SERVICES CAME WITHIN 10 MINUTES AND SHE SAID THAT SHE WAS FEELING BETTER; BOTH SIGHT AND HEARING IS NORMAL AGAIN. THEY RECOMMENDED SHE REMAINED SEATED FOR A LITTLE BIT MORE BEFORE LEAVING, BUT DECLARED THAT SHE WAS OK.
Patient was provided with Moderna Booster dose instead of the first initial dose of Moderna vaccine. Patient did not experience any adverse reactions from the vaccines.
Tingling in the body; Numbness in hands and feet, lips, tongue; Pressure and heaviness in the chest; Numbness in hands and feet, lips, tongue; Numbness in hands and feet, lips, tongue; Numbness in hands and feet, lips, tongue; Pressure and heaviness in the chest; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the body), the first episode of HYPOAESTHESIA (Numbness in hands and feet, lips, tongue), the first episode of CHEST DISCOMFORT (Pressure and heaviness in the chest), the second episode of HYPOAESTHESIA (Numbness in hands and feet, lips, tongue) and the first episode of HYPOAESTHESIA ORAL (Numbness in hands and feet, lips, tongue) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced PARAESTHESIA (Tingling in the body), the first episode of HYPOAESTHESIA (Numbness in hands and feet, lips, tongue), the first episode of CHEST DISCOMFORT (Pressure and heaviness in the chest), the second episode of HYPOAESTHESIA (Numbness in hands and feet, lips, tongue), the first episode of HYPOAESTHESIA ORAL (Numbness in hands and feet, lips, tongue), the second episode of HYPOAESTHESIA ORAL (Numbness in hands and feet, lips, tongue) and the second episode of CHEST DISCOMFORT (Pressure and heaviness in the chest). At the time of the report, PARAESTHESIA (Tingling in the body), the last episode of HYPOAESTHESIA (Numbness in hands and feet, lips, tongue), the last episode of HYPOAESTHESIA ORAL (Numbness in hands and feet, lips, tongue) and the last episode of CHEST DISCOMFORT (Pressure and heaviness in the chest) outcome was unknown. Not Provided      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.
he takes while he gets the booster; he takes while he gets the booster; had a urinary tract infection; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included tofacitinib citrate (XELJANZ XR) (11mg). On an unspecified date, the patient experienced "he takes while he gets the booster (off label use), (extra dose administered), had a urinary tract infection. The patient reported about the booster for the Pfizer vaccine and in talking he said something about injections and had a urinary tract infection and he does not know if he needs to stop the medication Xeljanz XR 11mg that he takes while he gets the booster. The patient verified the information provided by the transferring agent and stated he is a little taken aback and thought he was going to get an answer to his questions and declined to complete the report. Outcome of the event urinary tract infection was unknown.   Information about lot/batch number has been requested.
This is a 30-year-old who received his 4th anthrax, in his right upper arm, on 03/08/04. He stated he had had no previous reactions to his previous three (3) anthrax vaccinations. On 03/09/04 he noticed after showering that his right upper arm was red and swollen and painful to touch. He relates that his arm is very itchy. He denies any change in muscle strength or sensation in the affect arm. He presented on 03/10/04 to Medical for evaluation secondary to an increase in the swelling of his arm. The Vaccine Healthcare Center (VHC) was asked to evaluate his adverse reaction to anthrax.
Pt presented to primary counter with red, circum sorted, flat erythema approximately 5-6 inches in diameter on Left posterior arm 2 days following a dose of ZOSTAVAX. The area was warm to touch, painful, an slightly pruritic. MD on call suspects cellulitis. Began course of antibiotics today.
Initial and follow up information has been received from a certified medical assistant concerning a 52 year old male pt with a history of emphysema who on 21Apr05 was vaccinated SC with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot 649695/0512P). Concomitant therapies included sertraline HC1 (Zoloft), fluticasone propionate (+) salmeterol xinafoate (Advair) and albuterol (unspecified). On 22Apr05, the next morning, the pt developed an injection site reaction including swelling, redness, infection and cellulitis below this site, fever and chills. The pt was treated with ibuprofen (Motrin) and warm and cool compresses to site. The pt called back on 25Apr05 saying he was not better and was admitted to the hospital. The medical assistant confirmed that the admitting diagnoses were cellulitis of arm, respiratory failure, and pneumonia. Upon follow up information, the medical assistant could not confirm any concurrent conditions at the time of vaccination, as it was the first time the office had seen the pt. It was reported that the pt had not been seen by the office since the date of vaccination. She believed that pt was discharged from the hospital, but she could not confirm if the pt actually was discharged or if he had recovered. It was reported that the pt had not received pneumococcal 23v polysaccharide vaccine in the past. Additional information has been requested.
the patient is not suffering from any symptoms due to the administration of PROQUAD and VARIVAX/ no additonal adverse events reported; a vial of PROQUAD was confused for MMR II; a vial of PROQUAD was confused for MMR II; patient was inadvertently concomitant administered PROQUAD and VARIVAX; This spontaneous report was received from a nurse practitioner and refers to an 18-month-old female patient.  The patient's concurrent conditions, medical history, drug reaction/allergies and concomitant medications were not reported.  On 23-MAR-2021, the patient went to the facility to receive her 12 month old shots and a vial of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was confused for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (MMR II) and the patient was inadvertently concomitant administered a dose of  Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter (route, frequency and anatomical location not reported) with lot number T027115, expiration date 07-FEB-2022; and a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 milliliter (route, frequency and anatomical location not reported) with lot number T024284, expiration date 15-JUL-2022.  The caller reported that the patient was not experiencing any symptom due to the administration of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD and varicella virus vaccine live (Oka/Merck) (VARIVAX) and that she informed the patients father to monitor for fevers and to administer acetaminophen (TYLENOL) every four hours. She will also stay in contact with the patient parents for monitoring. No adverse events were reported.
Migraine; Migraine; fatigue; nausea; diarrhea; This is a spontaneous report from a contactable consumer reported for herself.  A 36-year-old female patient received the first dose of BNT162B2 (Pfizer product, lot number EH9899) , via an unspecified route of administration on 15Dec2020 13:30 at single dose on left arm for immunisation.  Medical history included migraine.  There were no concomitant medications. No allergies to medications, food, or other products. No other vaccines in four weeks and no other medications in two weeks. The patient experienced migraine, fatigue, nausea, diarrhea starting the following day around 10 am (16Dec2020 10:00). The patient was not pregnant. No Covid prior vaccination, and no Covid tested post vaccination. No treatment was received for the events. The outcome of the events was resolved on an unspecified date in Dec2020. The report was assessed as non-serious.
Patient started with a very sore arm that spread to rest of body. Patient's legs became wobbly and patient became dizzy and got blurry vision. Patient also got chest pains and went to ER but was found no issues with heart. Patient hasn't been able to work and symptoms still continuing as of this report 9/10/16.
Three weeks pregnant; This spontaneous prospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Three weeks pregnant) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 09-Dec-2020 and the estimated date of delivery was 15-Sep-2021. On 23-Dec-2020 at 11:00 AM, the patient experienced EXPOSURE DURING PREGNANCY (Three weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.   On 23-Jan-2021 at 11:00 AM, EXPOSURE DURING PREGNANCY (Three weeks pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Jan-2021, Human chorionic gonadotropin: 144 Abnormal. In January 2021, Pregnancy test urine: positive Positive.     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.   Most recent FOLLOW-UP information incorporated above includes: On 02-Feb-2021: No specific follow-up information recorded. On 02-Feb-2021: No specific follow-up information recorded.  No treatment information was reported; Sender's Comments: This case concerns a 23-year-old female patient who received first dose of mRNA-1273 while pregnant (Vaccine exposure during pregnancy). Last menstrual period was 09-Dec-2020  which was 2 weeks before product administration. Urine pregnancy tests positive test was Jan 2020. Date of conception was not provided but estimated date of delivery is 15-Sep-2021. 19 days post vaccination Human chorionic gonadotropin was abnormal
swollen lymph node in my underarm; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node in my underarm) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node in my underarm). At the time of the report, LYMPHADENOPATHY (swollen lymph node in my underarm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment details were provided.   Reporter did not allow further contact
High fever; Body aches; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (High fever) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced PYREXIA (High fever) and MYALGIA (Body aches). At the time of the report, PYREXIA (High fever) and MYALGIA (Body aches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided. No treatment information provided.