chrisvoncsefalvay/vaers-outcomes huggingface dataset:
delayed interval between 1st and 2nd dose; sore arm right arm; chills; fever of 101.7 degrees Fahrenheit; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (delayed interval between 1st and 2nd dose), PAIN IN EXTREMITY (sore arm right arm), CHILLS (chills) and PYREXIA (fever of 101.7 degrees Fahrenheit) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 047C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (The patient reported it had resolved.) from 14-Sep-2021 to 2021. Concurrent medical conditions included Kidney failure (He has a history of stage 4 kidney failure). Concomitant products included ATORVASTATIN, GLIPIZIDE, ALLOPURINOL, CHLORTALIDONE (CHLORTHALIDONE), SODIUM BICARBONATE and IXEKIZUMAB (TALTZ) for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm right arm), CHILLS (chills) and PYREXIA (fever of 101.7 degrees Fahrenheit). On 16-Dec-2021, the patient experienced OFF LABEL USE (delayed interval between 1st and 2nd dose). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. On 16-Dec-2021, OFF LABEL USE (delayed interval between 1st and 2nd dose) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm right arm), CHILLS (chills) and PYREXIA (fever of 101.7 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.7 degrees fahrenheit (High) 101.7 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient had a history of stage 4 kidney failure and was advised 90 days to get his second dose of the Moderna COVID-19 vaccine. Patient suffered a sore arm at the injection site and received second dose greater than 35 days after first dose.   This case was linked to MOD-2021-416102 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 16-Dec-2021: Follow-up received on 16-Dec-2021 included updated start date of suspect product, dose 2 information along with treatment drug information.
Positive Covid test; I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive Covid test) and DRUG INEFFECTIVE (I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Positive Covid test) and DRUG INEFFECTIVE (I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars). At the time of the report, COVID-19 (Positive Covid test) and DRUG INEFFECTIVE (I am fully vaccinated, both dose of modern a, yet I got infected wit h covid-sars) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     No Concomitant medications were reported.  No Treatment medications were reported.  Company Comment: Very limited information regarding the events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Few months after receiving the second dose, I started to have random joint pain in knees', lower back, hips, and elbows. I reported to my Dr. and was referred to Rheumatology. Also began to have heavier than normal periods.
On May 17th, 2023 patient came into the clinic for her 6 month well child visit and received multiple vaccines one of which was an Expired vaccine, was given in the right thigh. There was no treatment needed for this, no injury occured.
Extreme tired, ringing in ears, sick to stomach, congestion, extreme headache, eyes aching and swollen, swollen knees, sore hips and ankles.  Lasted until day 5
pt recv vax & upon returning home from the MD ofc, pt was placed on a monitor & mom noted a heart rate of 200 beats/min (this pt is monitored because a sibling died of SIDS);pt taken to ER dx w/OM & sent home;
second shot is given 2 months after the first; Missed dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot is given 2 months after the first) and PRODUCT DOSE OMISSION ISSUE (Missed dose) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot is given 2 months after the first) and PRODUCT DOSE OMISSION ISSUE (Missed dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot is given 2 months after the first) and PRODUCT DOSE OMISSION ISSUE (Missed dose) had resolved.            No concomitant medications were provided. No treatment information were provided.   Reporter did not allow further contact
patient came in to let us know that they experienced left shoulder pain and lack movement. she went to her doctor and he prescribed her a steroid pak for her. Patient just wanted to let us know about the adverse reaction.
I had severe itchy hives all over my body. These symptoms are still ongoing. I went to the ER on Dec 19th. They just gave medicine for it and referred me to an allegorist. I went to the allegorist on Dec 23rd. They just looked at my hives and prescribed me other medicine. They also order blood work on the second visit.
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 02-NOV-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLok wTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced two temperature excursions of 48 hours each. For one excursion the lowest recorded temperature was 34 F (1.111111111 Celsius) and for the other excursion the lowest recorded temperature was 32 F. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Body pain; Arm and armpit sore; Arm and armpit sore; Back pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) from a sales representative. A 35-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (COMIRNATY), as dose number unknown (booster), single (Batch/Lot number: Unknown) at the age of 35 years for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete: Unknown manufacturer) for COVID-19 immunisation. The following information was reported: PAIN (non-serious), outcome "recovering", described as "Body pain", PAIN IN EXTREMITY (non-serious), AXILLARY PAIN (non-serious), outcome "recovering" and all described as "Arm and armpit sore", BACK PAIN (non-serious), outcome "not recovered".  Additional information: Patient side effects occurred within first 24 hrs and began to diminish the next day. The next day the body pain was better except for the back. Event took place after use of product.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
6 Days p/vax nausea, stomachache, not eating, h/a w/low grade temp, shaky;
Nausea, vomiting, weight loss, unable to eat, severe stomach pain, back pain, lethargy, dizziness for 12 days.  Lab tests on 3/2/22 showed elevated liver enzymes and elevated alkaline phosphate, diagnosis of hepatitis. Negative for hepatitis A, B and C. Given protonix prescription. Symptoms resolved in about 10 days and blood work on 4/20/22 showed normal lab values
Friday night in the middle of the night I woke up not feeling well. By Saturday afternoon I started spiking fevers. My upper arm, from the shoulder to the elbow was bright red and swollen and itchy. All my muscles were hurting. I kept taking Tylenol. Monday morning it was still red and swollen. I called my PCP and he sent me to urgent care. They did 2 Covid tests and both were negative. They said I did not have any bacterial infection and that it was just an inflammatory response. The nurse who administered the vaccine said a full dose is .5 ml and a booster is .25 ml. They told me they will give me the full dose due to my age and autoimmune condition. Most of the redness is going down. I still have a red circle on my arm.
Tdap IM Right deltoid localized angry red swollen to size of tennis ball. Site extremely sensitive to degree that it hurt to have a sleeve touch it. Had fever of 101 degrees F. for ~12-16 hours with shaking chills. No nausea, vomiting, headache,neuro-type symptoms, shortness of breath, tachycardia. Redness extended down to elbow. Redness/swelling lasted 4-5 days.
passed out; fever; shivers; sore arm; bad headache; nausea; vomiting; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of passed out in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 17th July 2019, less than a day after receiving Shingrix, the patient experienced passed out (serious criteria GSK medically significant), fever, shivers, pain in arm, headache, nausea, vomiting and fatigue. On 17th July 2019, the outcome of the passed out was recovered/resolved. On 18th July 2019, the outcome of the fever, shivers, pain in arm, headache, nausea, vomiting and fatigue were recovered/resolved.   It was unknown if the reporter considered the passed out, fever, shivers, pain in arm, headache, nausea, vomiting and fatigue to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experienced fever, shivering, passed out briefly, sore arm, bad headache, nausea, vomiting, and fatigue within hours of this dose. These symptoms lasted for 24 hours and then resolved. The patient developed a bad headache and fatigue on 29th July 2019 that lasted for 24 hours and resolved on 30th July 2019. The reporter consented to follow up. The c consumer declines HCP follow up, but stated that safety may follow up with her if they wish. She declined to provide her full name. She did not have vaccine information for this case.
Pt noticed increasing redness and swelling on R arm beginning 9-17-09. Warm to touch. Mild soreness noted.
Patient stood up and then felt lightheaded. She felt like she was going to pass out an was dizzy.
Information was received on 06-OCT-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. The patient was inoculated with a dose of ZOSTAVAX vaccine at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 28-JUN-2016, the patient was treated by a physician at an ear nose and throat practice for the onset of a severe vesicular outbreak, accompanied by weakened immune systems, which was diagnosed as herpes zoster, or shingles. The patient experienced persistent symptoms and complications of his condition, and has been prescribed gabapentin (manufacturer unknown), VALTREX and tramadol (manufacturer unknown) in an attempt to manage his outbreaks and pain. As a direct and proximate result of these malfunctions, 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, pain and suffering, and other damages. Additional information has been requested.
The broken glass cut the HCP on a finger and she began bleeding.; The broken glass cut the HCP on a finger and she began bleeding.; The broken glass cut the HCP on a finger and she began bleeding.; syringe was broken; This spontaneous report was received from a nurse referring to a 34-year-old female patient (herself). The patient's pertinent medical history, concomitant medications and drug reactions/allergies were unknown.  On 21-MAR-2023, the nurse reported that she picked a syringe up of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) intramuscular injection (strength: 5 mcg/0.5ml, product quantity: 1, lot #W022795, expiration date: 19-MAY-2025, administered for prophylaxis, dose and route of administration were not provided) from her tray and did not realize the syringe was broken, which had been broken into more than three pieces (syringe issue). The exact location of the breakage on the syringe was finger flange ring. The broken glass cut the nurse on a finger and she began bleeding (injury associated with device; wound haemorrhage; limb injury). The caller said no treatment was provided. On the same day, the patient had recovered from injury associated with device, wound haemorrhage and limb injury. The action taken with hepatitis b vaccine (recombinant) (RECOMBIVAX HB) regarding all events was not applicable. This product was received on 27-MAR-2023.  The causal relationship between all events and hepatitis b vaccine (recombinant) (RECOMBIVAX HB) was not reported.  This is one of the 2 reports from the same nurse. ; Sender's Comments:  US-009507513-2208USA002311:
2:05 pm. 5-10 minutes after receiving bivalent booster patient complaints of having slight dizziness. Wheeled patient to med bay monitored vital signs. orange juice offered.   2:17 Vital Signs stable and patient was able to sit without any further complains of dizziness release from vaccination site.
AFTER INJECTION PATIENT FAINT AND FELL DOWN  . I PULLED HER SIT DOWN ON THE FLOOR . THEN SHE WAKE UP , I ASK SHE  CAN BREATHE . SHE SAID YES  AND EVERYTHING ARE OK. THEN WE CALLED 911,
redness below injection site; Raised area about 2-4 inches below the injection site of the deltoid area; This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th October 2019, the patient received the 1st dose of Shingrix. In October 2019, less than 3 weeks after receiving Shingrix, the patient experienced erythema of extremities and swelling. On an unknown date, the outcome of the erythema of extremities and swelling were unknown.   It was unknown if the reporter considered the erythema of extremities and swelling to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The reporter stated that the patient experienced raised and red area, about 2-4 inches below the injection site of the deltoid area. The reporter consented to follow up.
patient felt body ache; received booster dose 0.5ML instead of 0.25ML; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (patient felt body ache) and ACCIDENTAL OVERDOSE (received booster dose 0.5ML instead of 0.25ML) 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 05-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2022, the patient experienced ACCIDENTAL OVERDOSE (received booster dose 0.5ML instead of 0.25ML). On an unknown date, the patient experienced MYALGIA (patient felt body ache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Myalgia, at an unspecified dose and frequency. On 05-Feb-2022, ACCIDENTAL OVERDOSE (received booster dose 0.5ML instead of 0.25ML) had resolved. At the time of the report, MYALGIA (patient felt body ache) outcome was unknown.            No concomitant medications were provided.  The patient and the wife received the Booster shot of Moderna on 05-Feb-2022. However both of them received 0.5ML instead of 0.25ml.   This case was linked to MOD-2022-474971 (Patient Link).
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, injection site pain, chills, fatigue Narrative: Employee reports injection site pain/discomfort, chills, fever, headache, body aches, fatigue, nausea/vomiting/discomfort, and felt light-headed. Reports took Tylenol (no dose/frequency specified).
#1 Moderna 1/24/2021 1500 #2 Moderna 2/21/2021 1500 #1Moderna lot 029L208 #2Moderna lot 039K208 Side effects started that day after, that include pain to abdomen, chest, pelvic area and chills, felt feverish did not check temp, headache, injection site pain.    Did the adverse event start after the first or second vaccination?  Side effects started after each vaccines the following day, she just now realized this today. Symptoms severity about the same compared to 1st shot. Symptoms started resolving after a week or so.
Pt had swelling nearby site of injection. Swelling on leg substantial in size. Area swollen and hot to the touch. Area red and uncomfortable. Swelling adjacent to injection area.
VOMITING; FEVER; HEADACHE; NAUSEA; FATIGUE; CHILLS; This spontaneous report received from a patient concerned a 29 year old male. 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 was not reported, administered on 25-MAR-2021 at left deltoid muscle for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-MAR-2021, the subject experienced vomiting. On 25-MAR-2021, the subject experienced fever. On 25-MAR-2021, the subject experienced headache. On 25-MAR-2021, the subject experienced nausea. On 25-MAR-2021, the subject experienced fatigue. On 25-MAR-2021, the subject experienced chills. Laboratory data included: Body temperature (NR: not provided) 101-105 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and chills on MAR-2021, and had not recovered from headache, nausea, fever, and fatigue. This report was non-serious.; Sender's Comments: V0:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
This spontaneous report was received from a Nurse Practitioner via company representative refers to a female patient of unknown age who on an unspecified date was vaccinated with GARDASIL (Lot #, dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. The Nurse Practitioner listed in this case heard of a story where a girl who was located somewhere in or near Massachusetts started walking or runny funny after receiving GARDASIL. The Nurse Practitioner may have heard this through a news story or another unspecified source. Patient's outcome is unknown. The relatedness for the event was unknown for GARDASIL. Additional information is not expected.
broke out in a rash; This is a spontaneous report from a contactable Pharmacist. A 66-years-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Lot number: not reported) via an unspecified route of administration on 05Feb2021 as dose 1, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced broke out in a rash. The patient also took an antibiotic and thought that rash was caused by the antibiotic. The patient now wants to get the second dose past the 42 days. The reporter wanted to know if the patient should start over. Outcome of the event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Prior to adverse event, fairly severe symptoms included headache, chills, fever, extreme aches, fatigue, and diarrhea. Adverse events symptoms:  chest and back pain, indigestion below breast bone, shortness of breath, inability to run ( typically 5 miles every other day),  elevated heart rate.
Weakness in arm 12+ hours post injection; instant arm soreness, tenderness and stiffness; extreme arm soreness 12+ hours post injection; Mild sense of dizziness 2+ hours post injection
Incorrect BUD date of 6/25/21 was entered into the vial label and it should have been 6/23/21. Patient was given the dose 2 days after BUD date. No treatment was needed.  Dr.  spoke to the patient on 7/12/21 and explained the events. The patient felt comfortable and did not have any further concerns. Patient is returning for the second dose on 7/16/21. No additional treatment needed
Fevers 101.5; Nausea; Dizziness; Headache; Body aches; This is a spontaneous report from a contactable Other HCP (patient). A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) , intramuscular on 17Jan2021 13:30 at the second single dose (lot number EL0142), intramuscular on 27Dec2020 13:45 at the second single dose (lot number EJ1685) for covid-19 immunisation .  Medical history reported as none.  There were no concomitant medications.  The patient experienced fevers 101.5, nausea, dizziness, headache, body aches on 17Jan2021 22:00. The outcome of events was not recovered.
I received the flu vaccine from my OB/gyn and drove across the street to pick up a prescription at pharmacy. When I was in line to pay, approximately 15 minutes after receiving the vaccine, I felt odd, everything started to get fuzzy and dark and I woke up to the cashier helping me up. The ambulance was called because I was pregnant and my BP and blood sugar levels were checked which came back normal. I was released and notified my OB/Gyn of the reaction.
Headache, Myalgia, Arthralgia, NauseaVomiting, fatigue Narrative: