chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Monovalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) in a 30-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 065K21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient).    Concomitant medication was not reported.  Patient ID was reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Reportedly, in this report the patient was eligible for COVID-19 vaccine. Breakdown of doses were reported as 37 doses from lot 059H21, 26 doses from lot 065K21A, and 12 doses from lot 058A22-2A Treatment medication was not reported.
Shortness of breath, coughing, lightheaded, nausea.  Running nose.
NO ADVERSE EFFECT; improperly stored administeerd; This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patients' concurrent condition, pertinent medical history and drug reactions/allergies were unknown. The patients' concomitant therapy included sterile diluent. On 15-APR-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (therapy type digital data logger) (dose and anatomical location were unknown, lot # R020678 and expiration date: 15-JAN-2020) as prophylaxis (product storage error). No adverse effects were reported. The administered dose of the vaccine experienced a temperature excursion of 15-degree Fahrenheit (°F) to 46 (°F) (reported as (32.57 (°F)) for 22 hours, as recorded by a data logger. The vaccine had no previous temperature excursion. There was no product quality complaint associated with this report.
This spontaneous report was received from a back office lead and refers to a 70 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 08-APR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L042846 and expiration date: 15-SEP-2017) 1 ml, intramuscularly, into left deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Patient had a lot of side effects after the 2nd Moderna vaccination; Very sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient had a lot of side effects after the 2nd Moderna vaccination) and ILLNESS (Very sick) in a female patient of an unknown age 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, the patient experienced VACCINATION COMPLICATION (Patient had a lot of side effects after the 2nd Moderna vaccination) and ILLNESS (Very sick). At the time of the report, VACCINATION COMPLICATION (Patient had a lot of side effects after the 2nd Moderna vaccination) and ILLNESS (Very sick) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
Began with fever, chills, sweats and has progressed 10 days later to now swollen glands in neck, swollen roof of mouth, nerve pain in left side of face, nauseous, vomiting, severe congestion and sinus pressure and pain.
Started having nerve issues which I thought needed chiropractor care. Several adjustments over the last couple months with no relief.  Symptoms are tingling left arm and left leg to fingers and toes. Muscle spasms and twitches and cramps in the forearm, wrist, and foot that cause my fingers and toes to pull in
VERY SICK, SICKER THEN A DOG; DOUBLE VISION; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 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 patient experienced very sick, sicker then a dog, and double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very sick, sicker then a dog and double vision was not reported. This report was non-serious.
Client did not receive full dose of vaccination. The vial that the client received the booster dose from was inadvertently diluted a second time with saline after vial was used. Department of Public Health notified and gave recommendation to report VAER, notify client, and give recommendation to client that client received some vaccine, but not full booster dose. Due to receiving a partial dose, no further doses are recommended. 10/20/2021, 1454, client notified and given all information with good understanding verbalized. Note: Client states received the influenza vaccine in early September 2021, does not remember exact date, unable to find in vaccination registry.
Staring spell, formula out of nose, mouth on 9/12/05 in the events. Received vaccine in the afternoon on 9/12/05. Similar episode on 10/8/05.
fever 103 for 3days. Severe headaches. earaches. Dry cough to the point of bruised ribs
patient had previously gotten doses of the pfizer monovalent vaccine for this age group. Giving the moderna booster was not appropriate.   Clinic charting system brings over data incorrectly from the Agency.  Pfizer monovalent doses for this age group get listed as Moderna doses.  You will only know they were really pfizer if you dig farther into the chart.   Mistake was made because you would have to know that a moderna dose really isn't a moderna dose.
5 minutes after the vaccine, while patient was sitting in the waiting area, patient started having a breathing problem and because unconscious. His head was moving forward and backward rapidly, almost like having a seizure reaction. Had a team member call 911 and Immediately injected 0.3mg generic epipen in his left thigh. Patient became conscious in less than a minute after epinephrine shot. Stayed with patient until EMS came. EMS checked his vital and concluded that patient was having a immunization stress response since he did not have any hives or swelling from the first dose. Patient was given an option to follow EMS to the local hospital but he decided to go home with his family.
After vaccine administration, patient told the medical staff administering the vaccination that he felt a rush "going through his head" and that he was going to faint.  Patient slowly placed himself to the ground.  Medical staff on site told NP that the patient was turning pale and that they laid him down.  Patient stated that he felt some numbness in his legs that went away after 10 minutes.  Patient's vital signs were WNL.  Patient remained in lying position with legs elevated for around 10 minutes.  Patient then spent an additional 10 minutes sitting with water intake.  Vitals were taken again and were again WNL.  Patient did not lose consciousness or hit his head.  Patient denies any past medical history and denies taking any medications.  Patient stated that he had a small breakfast in the morning and was a little anxious prior to his vaccine administration.
Fussiness, Pupils dilated, arching back , funny breathing, turned pale.  This episode lasted for few seconds. History of Constipation and spitting frequently, therefore baby was on Hypoallergic formula Nutramigen.  Mom called EMS and baby was taken to ER where the baby was diagnosed at BRUE
very sick; diarrhea; She was having bile coming out of her and her body kept pushing out; couldn't eat; lost 13 lbs; didn't receive the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (very sick), DIARRHOEA (diarrhea), BILE ACID MALABSORPTION (She was having bile coming out of her and her body kept pushing out), FEEDING DISORDER (couldn't eat) and WEIGHT DECREASED (lost 13 lbs) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anal cancer.    In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (very sick), DIARRHOEA (diarrhea), BILE ACID MALABSORPTION (She was having bile coming out of her and her body kept pushing out), FEEDING DISORDER (couldn't eat), WEIGHT DECREASED (lost 13 lbs) and PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose). At the time of the report, ILLNESS (very sick), DIARRHOEA (diarrhea), BILE ACID MALABSORPTION (She was having bile coming out of her and her body kept pushing out) and WEIGHT DECREASED (lost 13 lbs) outcome was unknown, FEEDING DISORDER (couldn't eat) was resolving and PRODUCT DOSE OMISSION ISSUE (didn't receive the 2nd dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: positive (Positive) antibody test that shows positive and says 60.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medication was not provided.
Red, raised, itchy, rash covering thighs, arms, chest, buttocks.  Absent on Face, soles of hands and feet.
An hr after TDap was received patient states difficulty breathing, throat feels like closing up, face turned bright red and swollen, swollen eyes, BP increased. Rapid response called, IV started, Benadryl 50mg IM given, O2 10 liters via mask, Solumedrol 125 mg IV push given. Transferred to ICU due to still complaining of weakness and difficulty breathing.
Contracted COViD 12 days after Pfizer vaccine booster; Contracted COVID 12 days after Pfizer vaccine booster; booster; This is a spontaneous report received from non-contactable reporter from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome unknown; IMMUNISATION (medically significant), outcome unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache (3:30 PM day of booster) Chills (6:00 PM day of booster) Body Aches (4:00 AM day after booster)
fever; chills; fatigue; headache; stomach upset; aches; illness; This is a spontaneous report from a contactable pharmacist (patient herself). A 59-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL1283) intramuscularly on 21Jan2021 08:15 PM at single dose in right arm for COVID-19 immunization at Hospital. Medical history included hypertension. Known allergies included walnuts and penicillin. It was unknown if covid prior vaccination. Concomitant medications in two weeks included lisinopril, colecalciferol (VITAMIN D) and multivitamin. The patient previously took first dose (at 59-year-old) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685) intramuscularly on 31Dec2020 06:45 AM in right arm for COVID-19 immunization. It was reported that 12 hours post vaccination symptoms started, fever, chills, fatigue, headache, stomach upset, aches and 48 hours of illness on 22Jan2021 08:30 AM. Treatment for adverse events included Tylenol and Motrin. No covid tested post vaccination. The outcome of events was recovered on unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Patient experienced a rash on his hands a few minutes after receiving the flu shot. Mom indicated that patient has sensitive skin. Patient stayed around the pharmacy for a few minutes. The patient did not have any shortness of breath. After a few minutes at the pharmacy the parents felt comfortable taking the patient home and monitoring him from there. I spoke to the parents 30 minutes and 2 hours after the report, the parents stated the patient is okay and the rash has gone away.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult male patient received bnt162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: Patient was treated with COVID 19 anti viral treatment with Paxlovid from 22Sep2023 to 27Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9:00 pm I had chills after retiring for the evening.  Next day I have "hazy eye sight. (9:00am) ful listless.
aches; but with excruciating leg cramps in the night; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (aches), MUSCLE SPASMS (but with excruciating leg cramps in the night), PYREXIA (fever) and CHILLS (chills) in a 70-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 3030478) for COVID-19 prophylaxis.     No Medical History information was reported.  On 23-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 24-Oct-2023, the patient experienced PAIN (aches), MUSCLE SPASMS (but with excruciating leg cramps in the night), PYREXIA (fever) and CHILLS (chills). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, PAIN (aches), MUSCLE SPASMS (but with excruciating leg cramps in the night), PYREXIA (fever) and CHILLS (chills) was resolving.      The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.  Concomitant product use was not provided by the reporter.  The patient experienced fever, chills, aches, but with excruciating leg cramps in the night. Came on 10 hours after vaccine was given. The patient took Aleve with minimal response. She expected local pain and swelling at the injection site, but not this. Improved over the next days, but not gone yet it was unknown if the patient experienced any additional symptoms/events.
2/15/09 Night of injection L arm became sore.  2/6/09 Severe pain to L arm.  2/7/09 increase temp, felt bad.  2/8-9/09 redness noted to L arm below site of injection.   Felt very bad + pain continued to worsen.  2/10/09 to health dept + with severe pain L arm, some swelling -> 2 areas of redness noted each approximately 2 to 3 inches in size and below injection site x 3-4 inches Temp 98.8, BP=146/92 (denies hx increase B/P) Referred to Dr (PCP).  2-11-09 CP called to report Dr.  Starting antibiotics and arm feels some better this AM, continues to have headache.
The first thing in the morning I felt a slight fever and when I took my temperature it was one hundred point something so I took a home COVID-19  test and it was positive so I called my Doctor and he had me come to the parking lot of his office and gave me a nasal swap and that COVID-19 test resulted in positive.  Dr suggested Paxlovid and it was prescribed by the Pharmacy and I did use the prescription with no side effects.
My daughter got her last GARDASIL vaccine yesterday. Woke up with shakes through the night and it very dizzy today. Feels feverish.
(2) pulmonary embolisms, heart attack 3 days after vaccine. Medications to break up clots, plus 2 stents.
PT WAS GIVEN MMR V AND VARICELLA ON THE SAME DAY IN EACH ARM.  SHE WAS MEANT TO GET MMR AND VARICELLA SEPARATELY BUT ACTUALLY RECEIVED TWO DOSES OF VARICELLA.   PT MOTHER WAS NOTIFIED OF ERROR.   I ASKED PT MOTHER IF PT WAS SHOWING IN SIDE EFFECTS AND SHE STATED PATIENT WAS ENERGETIC WITH NO EVIDENCE OF RASH, FEVER OR  MALAISE.  I ADVISED HER TO WATCH PATIENT FOR 7-14 DAYS PER CDC RECCOMENDATION.  IF SHE STARTS SHOWING SIGNS OF SEVERE REACTION LISTED IN VIS SHE WAS ADVISED TO CALL 911 OR GO TO ER IMMEDIATELY.   I ALSO TOLD PT MOTHER TO CALL OUR CLINIC WITH ANY QUESTIONS SHE MIGHT HAVE.  MOTHER STATED PATIENT WAS ENERGETI C AND EVEN WENT TO STORE AND PLAYED AND ATE LIKE NORMAL.  I ADVISED PT PER CDC TO ADMINISTER ANTIPYRETICS AS NEED PER INSTRUCTIONS FOR FEVER OR PAIN. MOTHER SEEMED TO UNDERSTAND INSTRUCTIONS THAT WERE GIVEN.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On an unknown date, the unspecified number of patients were vaccinated with GARDASIL (lot #, dose, route not reported), which were improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
A report was received from a health care professional on 12/12/03 concerning a 3 year old male vaccinee who inadvertently received Fluvirin on 12/11/03. On 12/11/03 the vaccinee inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
09/21/2005 8pm mother gave child Tylenol for temp of 102.7. 8:45 pm mother of child states, he was lying on the floor and started jerking all over. He was staring and his fingertips and mouth started turning blue. I picked him up and he quit jerking but acted cold and teeth were chattering. We went to ER, they put in an IV But gave no medication. They drew blood for lab. They kept him for two hours and we went home.
Patient came in on Friday. She has a big red mark on her Right arm. Since she got the PNEUMOVAX on the right arm, She is suspecting she is having an allergic reaction. Other than that, patient seems ok. Told her to use Ice pack and take Benadryl.
Within 5 minutes fingers started tingling and then toes. Face was getting flush but I thought I was okay. Left vaccine site after 15 minutes. Got in car and started to have face swell up and get red all over. Went back into vaccine site and told them I was having a reaction. They observed my red face and puffiness and gave me 2 benadryl . My neck was feeling tight and red as well. I stayed there another 30 minutes, and it didn't get worse and stayed the same. They told me to keep taking benadryl for 2 days plus an over the counter 24 hour allergy pill. Also they directed me to go to the hospital if it got worse.  I took the benadryl  as directed and it stayed about the same for a day. Then slowly got better with a few flare ups within the first week.
Information has been received from a registered pharmacist concerning a female patient who on 15-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (lot number 667610/1355Z). The registered pharmacist reported that on 15-APR-2011 the patient experienced shoulder pain. The shoulder pain was in the same arm that the ZOSTAVAX was administered. The patient sought unspecified medical attention. It was unspecified if any treatment was given for the adverse event or any lab diagnostic studies were performed. At the time of the report, the patient's outcome was unknown. No further information is available.
Pt present to ED c/o SOB. Hx COPD and pulmonary fibrosis. Wears 2L O2 prn. Several weeks of solid use with wheezing, cough and SOB. Took Zithromax and prednisone 40mg and Urgent care provided Rocephin and steroid shot with medrol, levaquin and mucinex. Admitted 1/13/21. Positive COVID-19 pcr on 1/19/21.
Patient is 11 and inadvertently give pfizer 12+ adult vaccine instead of age 5-11 pediatric pfizer vaccine. After notifying the child's mother, she said he had no adverse events, just a sore arm from the vaccine
Patient did report latex allergy which was review prior to giving shot - patient was advised of the minute amount from plunger, but the amount ws not documented as high enough to be contraindicated for a latex allergy. Patient was ok with getting the vaccine, and was assured that we did have benadryl and epipen available. After vaccine was administered, patient was directed to the waiting area, within 10  minutes the pt reported itching and was given a dose of benadryl. The patient did have a moment where her voice was hoarse, and the pharmacist asked if she was in need of more assitance and a dose of epipen with any difficulty breathing. Patient denied the need of epipen dose and only requested a second dose of benadryl. She was able to speak freely and said that this is a typical reaction for her allergy that she manages with benadryl. The patient was kept in the clinical service room under surveilance and checked on every 5 min for 30 min. Pt breathing ws unchanged, and cont to deny the need of the epipen, and stated that they were fine to leave. Pt husand present and breifed on situation. Patient denied additional aid , but I did not feel comfortable letting patient leave with still what sounded like strained breathing, I offered her an epipen in case symptoms got worse, and advised pt to urgent care or ER for follow up.
On 03/05/2023, I woke up feeling achy and extra tired even though I had just woken up. I also had a little congestion and cough. I assumed it was allergies and wasn't concerned about exposure since I work from home. As the week progressed my symptoms got worse. By Wednesday, my nose was running constantly, so I took a COVID-19 test and it was positive. I did a telehealth visit and began taking Paxlovid on 03/08/2023. After beginning the Paxlovid, my runny nose began decreasing rapidly. The rest of the symptoms gradually got better. I still have a bit of achiness and soreness but am otherwise feeling pretty normal.
Nausea, vomiting, diarrhea, fever beginning early morning the day after receiving the vaccine. Fever and flu-like symptoms persisted through the next day