chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report from a contactable physician via a sales representative and then from a contactable consumer (medical assistant). An 81-year-old female patient received on 18NOV2014 a single dose of PREVNAR13 in the arm. Relevant medical history included dementia, gerd, osteoporosis, high cholesterol, diabetes, all these conditions were ongoing. Concomitant medications included ARICEPT, BABY ASPIRIN, NAMENDA, lovastatin, escitalopram, multivitamins, metformin, JANUVIA, fluticasone, losartan. On unspecified date in NOV2014, after having received the vaccine, the patient arms were swollen and red (lots of swelling and redness in the entire injection area). The events were persisting at the time of the report. The physician considered there was a reasonable possibility that these events were related to PREVNAR13. Follow-up (25NOV2014): New information reported from a contactable consumer (medical assistant) includes: patient details (age and ethnicity) relevant medical history and concomitant medications, suspect product details (vaccination date, anatomical location of vaccination), reaction data (events verbatim was updated to arms swollen and red, updated onset date and outcome). Follow-up (18MAR2015): Follow-up attempts completed. No further information expected.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose 12/18/20Lot#EK5730 2nd dose 01/06/21,lot#EL3246 Diagnosed covid positive: Symptom onset:08/04/21 Exposure:Travel Symptoms:08/13/21
pt recv vax 24JAN96 & 2FEB96 pt exp 3 grand mal sz between 8AM & 11AM;1 in arms of MD who dx it as grand mal sz;pt t101 R;hosp & had an EEG, CAT scan & spinal tap;mom noted pt adopted but sz not known to be part of pt hx;
Received the vaccine at 1:00 and began feeling ill about an hour later. Began having diarrhea around 5pm which lasted, with slight nausea (no vomiting) through the night until 6am. Felt achy and slight feverish. No painor discomfort at the injection site. States he feels this way when his sugar is low. It was 95 11/7 pm. Ha shad low food but feeling better pm. 11/8/02 no diarrhea or nausea and joint achiness. "Feels pretty good now."
Pt received two of five required vaccines due to lack of records. Pt received Hep A pediatric dose and MCV4 in left deltoid muscle. Pt fainted, fell from seated position onto floor. Pt landed on right shoulder.  Pt turned onto back, awoken with amnonia capsule. BP 100/70, pulse 80. Pt given ice pack, remained supine until felt able to sit up. Given juice and when recovered, Td; IPV; and HPV adm in right arm. Pt reports HX of Fainting related to "taking medication." No further details provided.
Severe Headache x4 days Sinus pressure x3 days Nausea and vomiting x 2 days
Patient was diagnosed with MIS-C at another hospital in February 2022. She was readmitted to our hospital with concerns for refractory MIS-C with HLH/MAS features and treated with anakinra. She is currently followed by our hematologist for cold agglutinin hemolytic anemia and our rheumatologist as well.
2 hrs p/vax became very pale & blue, t104.5, lethargic, shaking, & unresponsive; temp remained 104 x 24 hrs then temp & activity level were nl;
Infant hospitalized for intussusception on 10/21/07-Rotateq given on 7/11/07 and 9/12/07.  10/26/07 Received vax record from reporter which provides RO dose #2 & lot #.  VAERS database updated w/same. Record faxed to CDC.  11/13/07 Linked w/296061. 12/4/07 Reviewed hospital medical records which reveal patient experienced vomiting & bloody stools.  Admitted 10/21-10/23/2007.  BE/air enema diagnosed IS but unable to completely reduce.  Did well post operatively & d/c to home. FINAL DX: Intussusception, surgically reduced & appendectomy.  Records faxed to CDC.
Approx 20 min after injection client c/o soreness at site. Within one hour, c/o being sore all over. Approx 2 hrs after injection, scattered red spots appeared over both lower extremities. By next day spots were all over body. Mother contacted MD and was advised to give BENADRYL. Took child to school further incident. Mother states 02/08/10 S/S of a cold.
VACCINE CONSENT FORM SHOWS NO ADR, NO SEIZURES OR NEUROLOGICAL CONDITIONS , NO SERIOUS REACTION TO VACCINE IN PAST, PT HAS BEEN EXAMINED BY PROVIDER IN PAST YEAR. AS VACCINE WAS BEING ADMINISTERED THE FATHER WHO ACCOMPANIED HIS SON THE PT SAID THAT THE PT WOULD PASS OUT.  THE PT DID NOT CONFIRM NOR DENY THIS, UPON ADMINISTRATION OF VACCINE PT BECAME QUIET, GLASSY EYED AND BEGAN TO GO LIMP. HE RESPONDED TO QUESTIONS UNCLEARLY. THE FATHER RESTRAINED PT FROM BEHIND CHAIR AND I IN FRONT OF HIS KNEES TO PREVENT HIM FROM FALLING TO FLOOR. AFTER APPROXIMATELY 3-4 MINUTES, HIS UPPER BODY MUSCLES SHOOK AND THEN THE LOWER BODY, MAYBE 10 SEC?, THEN HE OPENED HIS EYES AND SEEMED RECOVERED. HE WAS ASKED TO REMAIN IN THAT CHAIR UNTIL HE HAD TOTALLY RECOVERED, WHICH HE ASSERTED APPROX 15 MIN LATER. I REQUESTED THE PT AND HIS FATHER REMAIN ANOTHER 15 TO 20 MIN IN WAITING AREA AND TO CHECK OUT WITH ME BEFORE LEAVING. PT WALKED OUT WITHOUT ASSISTANCE, WITHOUT FALTERING OR DIZZINESS.
I received the DTP vac on 7-14-11 at 7:17 pm after giving birth to my son. The national vac for DTP said on national TV & publicized in my doctor's office on a video loop that my baby to be can die without having this vac. I had a severe allergic reaction that was life-threatening after a dose of DTP that made me think and feel like I was going to die. Resulted in disability.
muscle pain; lot of pain; stiffness in muscles; difficult to walk; This is a spontaneous report from a contactable consumer (patient reported herself). A 76-year-old female patient received second dose of BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: Solution for injection) via an unspecified route of administration on 04Feb2021 at single dose for Covid-19 immunization. The patient's medical history included arthritis (history of arthritis/joint pain to begin). She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021. Concomitant medications were not reported. Call back made on 11Feb2021 at 11:51 AM and reached for discussion. She reported that "she thought she was having side effects from the second Pfizer-BioNTech Covid-19 shot". Patient stated she already reported it to Safety and was transferred to Medical Information. She got her first dose of the Pfizer-BioNTech Covid-19 on 15Jan2021 and second dose was on 04Feb2021. She was 76-year-old with a history of arthritis so she had joint pain to begin with but now she developed muscle pain, specifically after the second dose. She did not have it with the first dose. She currently had a lot of pain and stiffness in muscles, it was difficult to walk and she could not raise arms above shoulders without pain. It started about Sunday (07Feb2021), when this became more noticeable". She planned to discuss this further with her physician. No additional details. Outcome of the events was unknown. No PQC Present.  Information on the lot/batch number has been requested.
Pt vaccinated Meruvax II developed arthritic pain & subsequently frank arthritis. Blood test including arthritis serology had been negative.
Initial unsolicited report received from a consumer via other company (Pfizer) on 7 March 2016. Manufacture number: 2016120074 This case involves a 69-year-old patient (gender not reported) who was vaccinated with a dose of INFLUENZA VACCINE (Flu shot) (batch number, expiry date, dose, dose number, route and site of administration were not reported.) on an unspecified date. Patient's medical history and concomitant medication was not reported. On an unspecified date post vaccination, the patient woke up very congested early in the morning and the phlegm was very thick. Lab data and corrective treatment was not reported. The outcome of the events were not reported. List of documents held by sender: none.
MUSCLE DISCOMFORT IN CALF; MASSIVE PAIN IN HEAD; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (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 and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced muscle discomfort in calf, and massive pain in head. The action taken with covid-19 vaccine  was not applicable. The outcome of the muscle discomfort in calf and massive pain in head was not reported. This report was non-serious.
Pt recvd MMR vax approx NOV90; On approx 16NOV90 pt exp bilateral painless swelling of the parotid glands, rt greater than lt gland;
spasms on her shoulder on the same side where she got the shot; Malaise; flu-like symptoms; severe pain in her shoulder on same side of arm where she got the vaccine; low grade fever of 99.3 - 99.7F; A spontaneous report was received from a consumer regarding his 30-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced not being able to move her arm, spasms on her shoulder, severe pain on her shoulder, low grade fever 99.3  99.7 degrees Fahrenheit, Flu-like symptoms, and malaise.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 07 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 08 Jan 2021, after receiving the mRNA-1273 vaccine, the patient experienced not being able to move her arm, spasms on her shoulder, severe pain on her shoulder, low grade fever 99.3  99.7 degrees Fahrenheit, Flu-like symptoms, and malaise. Consent to contact obtained.  Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, not being able to move her arm, spasms on her shoulder, severe pain on her shoulder, low grade fever 99.3  99.7 degrees Fahrenheit, Flu-like symptoms, and malaise, was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Twenty-four hours later... 101 degree fever, screamed inconsolably for three nights and could not be comforted or helped to sleep. Then developed very bad diarrhea. Still woke screaming every 2 hours but could be consoled to sleep. Now a week later, waking more frequently at night, less consolable, and constipated.
Acute dizziness s/p MMR and was prescribed antivert by ER MD and told to follow-up with primary medical provider
Shingles on left arm (from shoulder to fingertips). Only 6 areas.
Swelling and itching worsens at night 3 inch diameter slightly raised circle surrounding injection site.
Patient possibly inadvertently received 1cc of  Moderna COVID vaccine instead of 0.5cc. Patient was notified. State notified
vasovagal syncope episode. Occurred only once. About 10-15mins after giving immunizations. Patient improved with sitting and water intake. Patient was feeling better within 5-10 mins.
Soreness / tenderness in left arm (injection arm)when parallel to ground,; Achiness; Increased nausea; Soreness at the injection site; Increased fatigue throughout the day.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 32-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 10Apr2021 at 10:30 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included GERD, herpes simplex 1, 2, allergy to dust mites and mold (spores). Concomitant medications included omeprazole (MANUFACTURER UNKNOWN) 20mg daily for unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 13Mar2021 at 10:30 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Apr2021 the day of dose 2 at 14:00, the patient experienced soreness at the injection site with increased fatigue throughout the day and took 1,000mg of tylenol extra strength before bed. On the day after dose 2, on 11Mar2021, the patient experienced soreness/tenderness in left arm the injection arm when parallel to ground, increased fatigue/achiness and increased nausea and took 1,000 mg of tylenol extra strength when woke up, and another 1,000mg of tylenol in the afternoon. By day two on 12Apr2021, all symptoms resolved. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included treatment with acetaminophen (TYLENOL) extra strength 1000mg on 10Apr2021 and 11Apr2021. The clinical outcome of the event soreness at the injection site, increased fatigue, Soreness /tenderness in left arm (injection arm) when parallel to ground, increased fatigue / achiness and increased nausea were recovered on 12Apr2021.   No follow-up attempts are needed. No further information is expected.
Chills throughout the night, headache, weakness, frequent urination, soreness at the injection site.
Awakened 8/18/12 by severe itching of shingles vaccination site. Raised welt 2 inches in diameter, sore joints, muscles, lymph notes under arm were swollen - 8/19 rash on arm, raised, welt at vaccination site increased to 5" x 2 1/2" 5/23, welt gone rash still on arm and itching has subsided. Denies any fever during this time.
(L) thigh injection site with erythema, slight swelling, bruising & warmth. Pt is crying & inconsolable irritability. TYLENOL given 80mg & bfeeding in office. Pt did calm after this.
This spontaneous report was received from a registered nurse via company representative concerning an unknown number of patients (No patient's demographics provided). On unspecified dates, the patients were vaccinated with 2 doses of MMR II, dose 0.5 ml, subcutaneous route (frequency and lot numbers not provided). Co-suspect or concomitant therapies were not reported. On unspecified dates, the patients have had negative antibody titers after administration of 2 doses of MMR II. Antibody titers tests were performed. Patients sought medical attention through office visits.At the time of the report, the outcome of the event was unknown. The causal relationship between doses of MMR II and the event was unknown. Additional information has been requested.
Fever 104, severe body aches, chills, headache, nausea, weakness, dizziness
Dizziness/vertigo started as she was walking down to post vaccination monitoring station.   Rested in chair for 30".  Continued to feel a little dizzy, so sat in chair another 30-45" until felt better. Stated 1st episode vertigo in October 2020.   Diagnosed w/Covid 19 in Jan 2021.
anorexia, neutropenia, elevated ammonia;hyperanemenia?;loose stools which tested rotozyme positive;apnea;tx clear liquids, monitor, cleared p/24hr;
Constant bilat. eye blinking lasting 5 days. Happened 3 days after his H1N1 vaccine.
This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (brain fog), abnormal coordination (lack of coordination), fatigue and chills in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 029A21A) for COVID-19 vaccination. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Apr 3, 2021, patient experienced feeling abnormal (brain fog), abnormal coordination (lack of coordination), fatigue and chills). At the time of the report, feeling abnormal (brain fog), abnormal coordination (lack of coordination), fatigue and chills outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.
Severe shaking and cold feeling all over. Uncontrollable movement in both hand especially in left hand. Tightening in throat area. Extreme coldness and could not get warm. Extreme shaking.  Extreme shaking part lasted 20 minutes. Throat tightening lessened after a few minutes.
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.  A 32-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 03Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures included Paxlovid from 14Sep2023 to 19Sep2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
blood pressure increased to 200s; heart palpitations; sick / ill; Body was buzzing inside and then had the shakes, was shaky; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 2022NVX-US-000003869 (Novavax).  A 78-year-old male patient received BNT162b2 (BNT162B2), on 04Apr2022 as dose 2, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose:1, patient started treatment on 14Mar2022 with Pfizer BioNTech COVID-19 Vaccine at dose 1 and reported that everything was fine with the patient.), administration date: 14Mar2022, when the patient was 78-year-old, for COVID-19 Immunization, reaction(s): "no adverse effect".  The following information was reported: TREMOR (non-serious) with onset 2022, outcome "unknown", described as "Body was buzzing inside and then had the shakes, was shaky"; BLOOD PRESSURE INCREASED (medically significant) with onset 2022, outcome "unknown", described as "blood pressure increased to 200s"; PALPITATIONS (non-serious) with onset 2022, outcome "unknown", described as "heart palpitations"; ILLNESS (non-serious) with onset 2022, outcome "unknown", described as "sick / ill". The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (2022) blood pressure increased to 200s, notes: Blood pressure increased to 200s.  Clinical course: On 14Oct2022, it was reported that a patient started treatment on 14Mar2022 with Pfizer BioNTech COVID-19 Vaccine at dose 1 and reported that everything was fine with the patient. The patient had the second dose on 04Apr2022. It was reported, the patient then had heart palpitations and blood pressure increased to 200s. It made the patient sick. Body was buzzing inside and then had the shakes, was shaky and ill. It was also reported that Pfizer had a bad batch of the COVID-19 vaccine which was never recalled.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
HYPOXEMIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY HYPOXEMIA
Delayed skin reaction. Red slightly pruritic about 4x4 inch area of injection. Otherwise feel fine. Fading with triamcinolone cream. OK for second injection ? I am an MD Thanks
9/7/2010 Mother reports to travel nurse, patient seen in ER 9/2/2010 9:30 PM with rash and fever.  9/3/2010 patient taken to another ER with rash, fever and swelling of hands, feet, face neck and ears. Patient seen in clinic by PCP 9/7/2010, symptoms resolved.
I experienced increased heart rate that would not lower even after medications, which has been occurring daily. I went to the ER the following Monday after my dose, and was diagnosed with a heart flutter. The cardiologist confirmed my diagnosis of a heart flutter, and performed electrical cardioversion to treat the heart flutter on 07/25/2022 while today 07/26/2022 is my follow up appointment. I have not recovered, and the treatment has not been successful.
Had rash prior to vaccination. After vaccination she though rash got worse. Appearance of rash erythema nodulent.
Information has been received from a registered nurse concerning three patients who on approximately 18-SEP-2006 was vaccinated with 2 ml PO first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). It was reported that they were vaccinated at 16 weeks of age. There were no problems with the administration of the vaccine. Medical attention was sought. There was no product quality complaint involved. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested. This is in follow-up to report (s) previously submitted on 10/10/2006.  Information has been received from a registered nurse concerning a patient who on approximately 18-SEP-2006 was vaccinated with 2 mL PO first dose of ROTATEQ.  It was reported that the patient was vaccinated at 16 weeks of age.  There were no problems with the administration of the vaccine.  Medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
After vaccination administration client returned to the waiting area for prescribed 15 minute observation.  After 5 minutes client had complaint of feeling faint,, sweating and tingling in hands, feet and lips.  Client walked into clinic exam room to lay down for 15 minutes.  BP initially was 106/67, HR 67.  After 15 minutes and dringking water the client felt better and left the building.
Pains, redness swelling and itching at site given. Also pains increased arm 90 degrees angler warm to touch.
Patient states arm which vaccination was given became red and sore 3 days after vaccination. It them became large, softball size, red, hot, swollen, and itchy. She states it lasted 10 days and is now resolving with bactroban ointment.
Pt got J&J COVID vaccine around 5:15pm, a few minutes into observation time, he told RX tech that he wasn't feeling so well so she suggested he move into the counseling room to lie down. As he got up to move he became lightheaded and had to squad down. We then instructed him to lie down and elevated his feet. We gave him some apple juice and water and he said he felt better after drinking the beverages. He was responsive and alert the entire time, and pharmacist continue to converse with pt until he no longer lightheaded. Pharmacist then asked pt to transition to sitting, continued that observation for 5 more minutes. At around 5:35pm the pt. was able to stand without issue and the pharmacist walked him to  his car without further issue.
10:00 - Shot, felt like I was given a  drink of metal, instant headache.   11:30  Felt Nauseous and very tired, got home around 2:30. Had pain in left hip, left hand fingers cramped up, feet especially toes cramped up, felt sweaty and had cold sweats - started around 1:00. Continued all evening.  Woke up with headache, which still had on 1/6 when reporting of reaction. Small amount of tin taste, pain in left arm, especially in back of shoulder, diarrhea when woke up.