chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Series of successive challenging symptoms began ~11 hours after injection: bad chills (~ 1 day);  bad body aches in upper  back and ribs (2-3 days); night sweats (2 nights); intermittent headache (2-3 days); severe constipation (began 4 days after injection, for 2 days); bad calf and shin cramps in bed at night that interfered with sleep (every night for > 1 week); severe painful abdominal muscle cramps-- 4 of 8 abdominal muscles went into spasm at same time-- making breathing difficult(~ 11 hours); cold symptoms that got worse over time, with 'fits' of loud forceful sneezing and continual 'running' nose (2-3 days); extreme fatigue (> 1 week) followed by mild fatigue (2+ weeks and currently).  Still don't have energy to exercise intensely, at level I had before injection.
I received the Moderna Bivalent COVID-19 booster and a flu shot on 10/5/2022. On 12/14/2022, I started to have cold-like symptoms that included a slight sore throat, a slight cough, headache, and body aches. On 12/15/2022, I took 2 home antigen tests, and they both yielded positive results. I began having chest discomfort, so I went to the ER on 12/15/2022. At the ER, I was tested for COVID-19, RSV, and the flu. They also took chest X-rays. I tested positive for COVID-19 and also had acute bronchitis, but I tested negative for the flu and RSV. At the ER, I was given acetaminophen and a saline solution intravenously, because I was also dehydrated. I was then prescribed MUCINEX for the cough and cold symptoms. I was also prescribed benzonatate to treat the cough, prescription strength TYLENOL, an albuterol inhaler for the bronchitis, and a 6-day supply of MEDROL 4mg tablets. My symptoms improved within a day. I tested again 5 days later and still got a positive result. I tested again on 12/25/2022 and got another positive result. On 12/26/2022, I finally got a negative test result. I took another test on 12/28/2022, I took another home test and got another negative result; after that, I felt that it was safe to be around my family. At the time of this writing, I still have some fatigue, but I otherwise feel fine.
Patient was given the GARDASIL # 1 vaccination in her right deltoid muscle. Pt. was advice to sit for the injection but refused.  Very shortly after the injection pt. fell to the floor, loss of consciousness approx 6 second with rolling up of eyes and body shaking.  taking to extended care dept. for evaluation
Information has been received from a nurse practitioner concerning a female who was vaccinated with Gardasil. Subsequently the patient experienced flu-like symptoms such as a high fever and chills which lasted for a few hours. Subsequently, the patient recovered from flu-like symptoms. No further details were provided. Additional information has been requested.
I was pregnant and my husband and I found out our baby did not have a heartbeat on 11/8/10.  At out 10 week ultrasound, the baby measured 6 weeks.  The doctor said it had shrunk.  I got the flu shot 10/25, two weeks before the ultrasound 11/8.  I had a natural miscarriage and passed the baby 11/29.
I experienced a burning sensation in my arm with the injection at the injection site.  It went away after a few minutes.  I contacted my doctor after about three months with the pain not subsiding, and was told by the nurse that they have had simular reports of this reaction from other patients and that it should clear up within a few months.  Has not cleared so far.  My movement/mobility with my left arm is limited due to the pain.
Patient fainted immediately after receiving the vaccination.  He was still seated, and was gently lowered to the floor with his legs elevated.  He came around in about 30 seconds and was able to answer questions without difficulty.  He had perspiration on his forehead and face was drained of color.  BP was 115/79 and pulse 70 immediately after waking.  Patient was monitored for the next 15 minutes while hydrating, and no signs or symptoms were evident after that time.
The spontaneous report was received a pharmacist, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 07-JUN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (which had the lot # L006392, expiration date 26-MAY-2016) (dose and route were not provided) subcutaneously. Information regarding concomitant medication was not provided. No adverse effects reported and there was not product quality complaint involved. Additional information has been requested.
2nd Moderna dose at day 20; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna dose at day 20) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna dose at day 20). On 18-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd Moderna dose at day 20) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that we need to know how to proceed because her occupational health doctor wants her to get a 3rd dose immediately. The patient was not experiencing any adverse reactions.   No treatment medications were reported. This is a spontaneous case concerning a 46-year-old, female patient with no relevant medical history, who experienced the unexpected, non serious event of inappropriate schedule of product administration. The event inappropriate schedule of product administration occurred the same day with the second dose of mRNA-1273 vaccine administration, the patient received her second dose with dosage interval of 20 days from the first dose of vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 46-year-old, female patient with no relevant medical history, who experienced the unexpected, non serious event of inappropriate schedule of product administration. The event inappropriate schedule of product administration occurred the same day with the second dose of mRNA-1273 vaccine administration, the patient received her second dose with dosage interval of 20 days from the first dose of vaccine administration. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Vaccinated with Varivax. Should have been vaccinated with Shingrix. Instructed by Team to vaccinate with Shingrix in 8 weeks and 2nd dose in 2 to 6 months
Had some local pain for 10 days after vaccine. Had erythema, warmth to area 10cmx8cm at site of injection lasting about 72 hours. Have a residual lump in triceps at site of injection; still present now at day 15.
This was after Dose 1 at 16 weeks of my pregnancy blood drawn on 1/12 slightly elevated ASP.There was nothing just wanted to check my anatomy scan. I had a preterm pregnancy before on week 19  On week 21 cervix was good had a spontaneous choroidal membrane separation. The baby dropped 21 weeks dropped in size 10th percentile less than size severe IGR.By week 23 problems exp problems cord dopplers blood flow to the baby.(estimated due date was 6/20/2021)
Information received on 25OCT2013 from a consumer. A 32 year old female experienced a possible allergic reaction. On 23OCT2013; 11:30 AM the female received dose 3 of BIOTHRAX (FAV429) intramuscularly in the left deltoid. That evening, her left arm felt tender and hard at injection site. No redness, itching, or decreased range of motion was noted. On 25 Oct 2013 she awoke with irritation and puffiness around right eye; no redness or sclera was noted. That evening, she felt exhausted and went to bed at 8:00 pm. She awoke at 1:00 am. with increased swelling around eyes and ears; right side greater than left. Additionally her scalp felt itchy, and she noticed hives / itching on lower abdomen, right wrist and left arm. No pain was noted, but the swollen areas felt warm to touch.  She went to the local Emergency Department and her temperature was noted to be 99.8. She was told that she had "a reaction to something: possibly vaccine". It is noted that there were no identifiable cause of her symptoms. She had no prior vaccine allergy history, but was noted to have had a possible past penicillin allergy. She was treated with BENADRYL and prednisone. By 26OCT2013 the swelling had decreased. On 27OCT2013, all symptoms had resolved.
Pain Arm, muscle pain, joint pain, headache, nausea, diarrhea, dizziness, muscle spasms, stomach aches, weakness, fatigue.
Sneezing, vomited, eyes darting back and forth, red eyes (then swelling), itchy feet, red cheeks, some redness (spots on abdomen - rash already present on arms turned red). BENADRYL, ZOFRAN, dexamethasone. No redness or swelling at injection site. No wheezing.
1st set of immunes 4-22-13 bilateral leg swelling 2 cm temp 101 for 1 day; 2nd set 6/24/13 temp 103 3 days inconsolable bilateral leg swelling and erythremia 3 cm.
Chest pain to left side 5days ago.  Started having some headache and feeling like passing out yesterday. Some shortness of breaths and nausea present. Patient presents to ED with 3 days of headache, chest pain and nausea. She had the J&J vaccine 5 days ago. She felt like she was going to pass out.
Arm ache; Patient received 3/4 of the dose; A spontaneous report was received from a consumer concerning a 72-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), received 3/4 of the vaccine and the rest went to the floor and the patient experienced arm ache.  The patient's medical history was not provided. Concomitant medications included Eliquis, unspecified blood pressure medicine and low dose aspirin.  On 20 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273(Batch Number 043L20A), unknown route for prophylaxis of COVID-19 infection.  On 20 Feb 2021, the patient received 3/4 of the vaccine and the rest went to the floor. On an unknown date, the patient experienced arm ache.  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event received 3/4 of the vaccine and the rest went to the floor was considered recovered. The outcome of the event arm ache was not reported.; Reporter's Comments: This report refers to a case of accidental underdose for mRNA-1273, lot # 043L20A, with associated adverse event. 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.
Patient went to MD and diagnosed with cellulitis. Very red, warm to touch, burning pain. Patient also had diarrhea and itchy palms. Patient went to doctor on 6/4/14.
pt recv vax 27OCT97 & the next day pt exp fever 101 & severe frontal h/a;labs showed that sed rate was increased;pt was treated w/Medrol. From follow-up of December 5, 1997 it was reported, "Four days later, headaches subsided then reoccurred six days after onset and last dose of MEDROL (4 mg) - Prednisone 40mg/day - then dose of Prednisone increased to 60 mg - Headache stopped. Prednisone has been decreased in dosage and now off entirely. Headache has not reoccurred. Patient will probably have Temporal Artery biopsy soon." Reportedly the patient recovered from this experience.
Information has been received from a physician, concerning a 17 year old female patient who toward the end of 2007 was vaccinated with the first dose of GARDASIL (Lot#not reported). There were no concomitant medication. The patient fainted within few minutes after her first dose. No injuries were sustained. Additional information has been requested.
Pt displayed a bumpy rash around the immunization site within a few minutes of receiving vaccination. Pt took 50 mg of diphenhydramine around 15 minutes after dose. At around 30 minutes, the pt reported that rash was not getting worse and decided to leave. Pharmacist suggested contacting physician. Pt was contacted again about 2:45 pm. She reported that the rash had spread, up and down arm, and medical consult was encouraged. Primary care physician was notified of reaction.
Patient reports at 4:00 pm she developed a fever of 101 degrees, chills, sever joint and muscle aches, and a head ache. She slept for 12 hours and symptoms have fully resolved a this time.
Patient called saying that his left arm has been hurting since receiving his flu shot 1 month ago. He also states that he cannot raise his arm without pain. Patient's doctor was contacted via voicemail this morning (12/22/17), and a methylprednisolone dosepak prescription was escribed to our location shortly after. Dr. returned our call stating that the patient had been seen by him in his office today and that his pain appears to be localized based on physical exam. Patient picked up prescription for methylprednisolone today, and was instructed by Dr. and the pharmacist to contact his doctor within 1 week if his symptoms have not resolved.
Vaccination failure; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 73 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6200), in left arm, on 18Mar2021 as dose 2, single (Lot number: ER8727), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301358a), in left arm and on 27Apr2022 as dose 4 (booster), single (Lot number: FK9893), in left arm for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "High Cholesterol" (unspecified if ongoing); "BPH" (unspecified if ongoing); "Hereditary Hemochromatosis" (unspecified if ongoing). Concomitant medication(s) included: LOVASTATIN; ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]; LISINOPRIL LUPIN; TAMSULOSIN. The following information was reported: VACCINATION FAILURE (medically significant), outcome "not recovered"; COVID-19 (medically significant), outcome "not recovered", described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Anti viral details reported product=COVID 19 Treatment, brand=Paxlovid, treatment start date=11Feb2023, treatment stop date=13Feb2023. Patient did not have known allergies.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300079607 Same patient/product, different dose/events;
Patient said that the arm became swollen, red, and warm to the touch at the site of the injection.  She also complained that it was painful and had difficulty raising her arm.  She could not lay on it when she slept due to the discomfort.  She took some ibuprofen and the pain, swelling, and redness has subsided since the initial event.
102° fever, unable to stay awake, hallucinations, drowsy, 1 night, 1 day, another night and day
Red warm spot around the injection site; Red warm spot around the injection site; Injection site a little itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Red warm spot around the injection site), VACCINATION SITE PRURITUS (Injection site a little itchy) and VACCINATION SITE ERYTHEMA (Red warm spot around the injection site) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site a little itchy). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Red warm spot around the injection site) and VACCINATION SITE ERYTHEMA (Red warm spot around the injection site). At the time of the report, VACCINATION SITE WARMTH (Red warm spot around the injection site), VACCINATION SITE PRURITUS (Injection site a little itchy) and VACCINATION SITE ERYTHEMA (Red warm spot around the injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications included- Vitamins. No treatment 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 events, a causal relationship cannot be excluded.
ice edge going through her skull; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (ice edge going through her skull) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-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 HEADACHE (ice edge going through her skull). At the time of the report, HEADACHE (ice edge going through her skull) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Small itchy pimple type hives initially on 2/25/21 on head and groin area only.  Spontaneously comes and goes quickly within 30 minutes minor discomfort.  Second vaccine  large chives anywhere from 2 inches to an area of 4 x 6?.  Started 3/17/21. - 3 /26/21.  No rash last 24 hours on medication Claritin and Benadryl . Randomly coming with warm feeling first itchy in areas neck chest abdomen arms back groin and head area. Hives would slowly disappear approximately over 30 minutes. Recurring  several times during the day tapering off.  Extremely annoying but not life-threatening.  Also increase in reflux.   Coincidently had spontaneous posterior vitreous detachment. On 3/19/2021.
Dx: Hemolytic anemia Jaundice Secondary Hypertension Cholestasis - Acute Kidney Injury Encephalopathy Treatment: Methylprednisone INTUBATION IVIG Blood Transfusions IV Fluids NG feeds Rituximab Phenobarbital
Administered MMRV and a varicella vaccine, mistake was not notified until the next morning: 8/26/14. Called patient, spoke with grandmother, who was with the patient. Grandmother stated patient is sore but doing fine, eating pizza and watching TV.
Upon vaccination client's arm instantly went tingly and cold. Radiating quickly to her finger tips.
No additional AE information; 2 months old patient was administered a dose of VAQTA; This spontaneous report was received a medical assistant and refers to a 2-month-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-MAR-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) injection, 1 dose (strength, frequency, route of administration, lot # and expiration date were not reported) for prophylaxis. No additional adverse event was reported. The outcome of product administered to patient of inappropriate age was not provided.
Pt described of dizziness shortly after vaccine was given and the next AM.  Exacerbated by standing/getting up quickly. Asso. symptoms included ear fullness, tinnitus, and visual changes. Recommended rest, fluids, and regular meals.
Red Dots over my body, and groin area in my eyes,  infection in my eye lids, palipatation's, vision, more than usual pain in legs, urinating every 2 minutes, eye twitches,  dizziness,  rashes in groin and under eyes   since a couple days after second vaccine  still ongoing ,  Doctor gave me antibiotics thinking a bacteria infection   on  05/11/2021 no difference  as of yet  anxiety bad a sometimes  went to urgent care 05/22/2021 because of Eye  Doctor said warm compresses and if not better in 48 hrs see an eye doctor  so far it's worse.  Sweating alot in groin area and rash in and around that area
A 64-year-old male patient was admitted to the hospital after becoming unresponsive. The family reported a 2-day history of bleeding from the patient's rectum prior to admission. He had no recent changes in medical conditions or medication regimen, which included Warfarin for stroke prophylaxis secondary to atrial fibrillation. The patient had received an inactivated influenza vaccine 4.5 weeks prior to presentation, at which time his international normalized ratio (INR) was 2.0. During the 6 months prior to presentation, no medications were changed and no significant changes in the patient's health were noted. Upon admission, the patient's international normalized ratio was greater than 15; INR values over the previous 6 months had been relatively stable (range 1.4 to 4.7). A noncontrast computed tomography scan of the head showed a large parenchymal hemorrhagic infarction involving the left temporal, parietal, and occipital lobes. In the emergency department, the patient received a nitroglycerin infusion to maintain systolic blood pressure in the range of 140-160 mm Hg as well as an infusion of 4 units of fresh frozen plasma and 10 mg of vitamin K. Following a neurosurgery evaluation, it was determined that nothing meaningful could be done to alter the patient's outcome positively, and he died approximately 17 hours after admission. The patient's significant INR elevation, after being relatively stable for at least 6 months, was thought to be due to an interaction between warfarin and the influenza vaccination. The Horn Drug Interaction Probability Scale indicated a possible interaction between warfarin and the influenza vaccination. The authors also stated that the possibility of an unknown contributor to the INR elevation could not be totally excluded. Seriousness criterion: death. Causality: possible. Causality cannot be excluded as the pathomechanism remains unclear and therefore the temporal relationship cannot be assessed. Expectedness assessment according to agency label: The reported symptoms are expected after vaccination with BEGRIVAC, FLUAD, FLUVIRIN or AGRIPPAL. No change in benefit-risk-ratio. No measures necessary.  4/21/09 Per FDA COD: Intracranial hemorrhage./pc
On 02/11/2002 pt received routine varicella vaccine. Pt was seen in ER on 02/17/2002 for rash . On 02/22/2002 pt was re-evaluated and vesicles were noted on right leg.
Sensorineural hearing loss   Right side : moderate to severe confirmed by an audiogram February 4,2021  Left side: NOT noticed subjectively - but audiogram done on February 4,2021 confirmed mild to moderate   Seen by ENT 2.4.2021: started on prednisone 60mg daily for 2 weeks with the plan to taper. Received first intratympanic steroid injection by ENT
I started getting symptoms of an outbreak of eczema with an itchy rash on my legs and arms. I went to my doctor and dermatologist and was diagnosed with eczema and was placed on prednisone. The prednisone did clear up the eczema. The eczema came back about 1 week later. I went back to the dermatologist and was placed back on prednisone. This time the eczema was worse. After the second round of prednisone, it got better but did not clear up. I received my 3rd dose of Pfizer and my eczema got worse. I was referred to another dermatologist which is a specialist and was placed on methotrexate. I have been battling this for a year and I am now seeing it clear up somewhat. The eczema is not completely cleared but about 80% clear.
102.3 degree fever, restless, congested. Children's Ibuprofen 5ml.