chrisvoncsefalvay/vaers-outcomes huggingface dataset:
There are no more blisters but there are still bumps.; The pain inside his head is still excruciating and it radiates to the right eye and ear.; The pain inside his head is still excruciating and it radiates to the right eye and ear.; severe, severe case of shingles; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HERPES ZOSTER (severe, severe case of shingles), SKIN MASS (There are no more blisters but there are still bumps.), PAIN (The pain inside his head is still excruciating and it radiates to the right eye and ear.) and HEADACHE (The pain inside his head is still excruciating and it radiates to the right eye and ear.) in an 82-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 055F22B) for COVID-19 prophylaxis.     The patient had no medical history/conditions, allergy, concomitant diseases or risk factor.  Previously administered products included for Product used for unknown indication: Flu vaccine on 26-Sep-2022. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 27-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In October 2022, the patient experienced HERPES ZOSTER (severe, severe case of shingles). On an unknown date, the patient experienced SKIN MASS (There are no more blisters but there are still bumps.), PAIN (The pain inside his head is still excruciating and it radiates to the right eye and ear.) and HEADACHE (The pain inside his head is still excruciating and it radiates to the right eye and ear.). At the time of the report, HERPES ZOSTER (severe, severe case of shingles) and HEADACHE (The pain inside his head is still excruciating and it radiates to the right eye and ear.) had not resolved and SKIN MASS (There are no more blisters but there are still bumps.) and PAIN (The pain inside his head is still excruciating and it radiates to the right eye and ear.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.     The patient had received the other vaccines in the 4 weeks prior to COVID-19 vaccine. The patient received the Moderna COVID-19 vaccine 1st dose  on 06-Mar-2021 (lot number - 036A21A), 2nd dose on 03-Apr-2021 (lot number - 026B21A), 3rd dose on 24-Oct2-021 (lot number - 004F21A) and 4th dose on  04-Apr-2022 (lot number - 083J21A). The reporter stated that within2 weeks after getting the bivalent booster dose on 27-Sep-222 her husband had severe shingles. It was on patient's forehead and eye all the was to his head. The patient was given various shingles meds and patient was now on the 3rd pain medication but it was not helping.
Patient received undiluted dose of 5-11yr old Covid Pfizer (orange cap) vaccine.
RASH STARTED FROM THE ABDOMEN THE NEXT DAY AFTER THE VACCINES WERE GIVEN AND AN A FEW DAYS IT WAS ALL AVER THE BODY PER CHILD MOTHER.
Swelling at injection site-right arm. traveled to axillia, and onto chest (right)
Patient experienced excessive bleeding at the site of injection. Blood began to pool under the inject safe barrier bandage, went get another bandage, and blood was coming from around the bandage. Pulled off the bandage and began cleaning around injection site and seen a small whelp. Bleeding  stopped. Applied small amount of pressure at the site, whelp went down.
11 yr old child returned to clinic 1/23/10 with complaint of pain and swelling at injection site after receiving immunizations on 1/21/10.  Patient was seen and evaluated by MD and treated with KEFLEX 250/5ml 500mg PO BIDX 1 week and warm compresses. Follow up information received states, onset was 1/22/10 per pt's mother. Manufacture's - (1) Sanofi Pasteur (2) GlaxoSmithKline.
Pt presented to ER complaining of swelling in hands and lips; Bilateral hand paresthesia, tightness in throat and chest. Treatment: Pepcid, SoluMedrol. Home: Medrol Desepak and Zyrtec.
Information has been received from a pharmacist concerning his granddaughter (14 month old female) who at about age 12 months (approximately August 2008) was vaccinated with a half dose of VARIVAX (Oka/Merck). Pharmacist does not know why she received a half dose. His granddaughter then developed "atypical chickenpox" about 2 weeks age (on about 08-Oct-2008). The patient recovering. The patient sought medical attention and was seen by a doctor. No further information is available.
pain in the arm; mild headache; low fever of 99 degree F; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient had no medical history related to mentioned adverse event and both acute and chronic illnesses at the time of vaccination. Patient did not receive other vaccines given within 1 month prior to Moderna COVID-19 vaccine. Concurrent medical conditions included Glaucoma and Seasonal allergy (season allergies). Concomitant products included NAPHAZOLINE HYDROCHLORIDE (EYE DROPS [NAPHAZOLINE HYDROCHLORIDE]) for Glaucoma, CALCIUM and PRAVASTATIN for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F). On 27-Feb-2021, PAIN IN EXTREMITY (pain in the arm), HEADACHE (mild headache) and PYREXIA (low fever of 99 degree F) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications also included medications for allergies.  It was reported that patient received first dose of Moderna COVID-19 Vaccine on 25 Feb 2021 and second  dose on 25 Mar 2021.   On 25-Mar-2021, the patient again experienced mild headache, pain in the arm and low fever of 99 degree F.  On 27-Mar-2021, the patient recovered from the events.  No treatment medications were provided.   This case was linked to MOD-2022-654644 (Patient Link).
Itching at the injection site; side effects after vaccination; Light headedness; Weakness in all the body; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT (side effects after vaccination), DIZZINESS (Light headedness), ASTHENIA (Weakness in all the body) and PRURITUS (Itching at the injection site) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Drug allergy (hypersensitive to aspirin.). Concomitant products included ATENOLOL for Blood pressure high, DILTIAZEM, CITALOPRAM, COLECALCIFEROL, UBIDECARENONE (COQ10 + D3), VITAMINS NOS, CALCIUM, MAGNESIUM and ZINC for an unknown indication.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced ADVERSE EVENT (side effects after vaccination), DIZZINESS (Light headedness) and ASTHENIA (Weakness in all the body). On 25-Jan-2021, the patient experienced PRURITUS (Itching at the injection site). On 23-Jan-2021, ADVERSE EVENT (side effects after vaccination), DIZZINESS (Light headedness) and ASTHENIA (Weakness in all the body) had resolved. At the time of the report, PRURITUS (Itching at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.
FluLaval administered after temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2022-2023 season) (batch number GF9PM, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   In October 2022, the patient received FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Oct-2022 Reporter's comment: A pharmacist called to ask for information about the administration of Flulaval to 7 staff members.  The Flulaval vaccines that were administered were exposed to room temperature for a few weeks.  The reporter did not provide exact data about time and temperature of the excursion, but mentioned that vaccines were out of refrigeration approximately from 15th September 2022 to 10th October 2022 and then vaccines were administered to the staff members. The reporter did not provide either the exact date of administration nor the identifiers of the 7 people that received this vaccine.  The reporter asked about the stability of Flulaval when exposed to temperatures higher than recommended and asked if the staff members had to be re-vaccinated. The reporter consented to follow-up. This case was for 1 of 7 linked patients reported by same reporter. Additional supportive information: The patient was administered Flulaval after temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2022156225:Same reporter US-GSK-US2022AMR157001:Same reporter US-GSK-US2022AMR157003:Same reporter US-GSK-US2022AMR157005:Same reporter US-GSK-US2022AMR157006:Same reporter US-GSK-US2022AMR157008:Same reporter
Mild nausea and body ache; Mild nausea and body ache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Mild nausea and body ache".  Additional information: The patient had mild nausea and body ache one day after vaccination.Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Chills, sweating, fatigue, muscle soreness across body, ?COVID arm? redness and firmness underneath injection site (not at injection site, about 2 inches down the arm)
Patient stated she started feeling more dizzy after administration. Paramedics were called and patient refused to go to hospital. The next morning patient reported still being dizzy, having a headache and shortness of breath. She stated she went to the ER, was admitted to the hospital for 2 days then released. She states that now she is no longer short of breath. She states she didn't talk to the doctor so she doesn't know why she was admitted.
The patient experienced facial redness and swelling with hives on his face, neck, chest, back and arms. The patient was treated with Benadryl.
After not having a sinus infection for over 6 years 2 days after the vaccine I started getting a sinus infection which turned severe and let into bronchitis. I'm on my second round of antibiotics now. I was treated in the emergency room and I went to the Urgent Care. I was visiting my son and not at home so it's not able to go to my family physician
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" Provider contacted an individual in regards to an individual who received the Covid-19 Vaccine on 12/19/2020. The individual reported sand paper face rash and full swollen face that started 3 days after receiving the vaccine (1/1/2021). Individual reported that she had Botox and facial fillers on 12/15/2020. This event was an unwitnessed by the staff at Health Department. The event was reported to Epidemiologist.
Daughter started feeling bad 2 weeks after taking vaccine. She started to complain about her ankles and back hurting. As weeks went by she keeping feeling bad, she started having trouble breathing, her hands had started to swell, headaches and weak.  She went to the ER for her breathing issues, and she could barely move.
Reaction to first SHINGRIX vaccine shot. Temperature of 102.1, nauseous but not throwing up, shot location very hot about one hour after receiving and then entire body was hot all over, body shivering and cold all night with covers on, tired and slept two night and a day. Received vaccine from pharmacy. I originally had the shingles vaccine in 2007 and thought I should follow-up with the new 2-shot vaccine as it had better coverage but I will not take the second follow-up shot. This reaction had not occurred to me with an other vaccines.
Non-itchy rash over torso, abdomen, arms & amp; legs; I broke out in red / solid red across her abdomen; This case was reported by a consumer via call center representative and described the occurrence of rash in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th August 2020, the patient received the 1st dose of SHINGRIX (intramuscular). In August 2020, 2 days after receiving SHINGRIX and an unknown time after starting ZYRTEC, the patient experienced rash and erythema. The patient was treated with cetirizine hydrochloride (ZYRTEC). On an unknown date, the outcome of the rash and erythema were unknown.   It was unknown if the reporter considered the rash and erythema to be related to SHINGRIX.  Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in left arm intramuscularly and two days later she broke out in red, non-itchy rash over torso, abdomen, arms and legs. It was solid red across her abdomen. The patient had an online chat with her provider who said it was an allergic reaction. The patient had no itching or difficulty breathing and took ZYRTEC for 2 days and the red rash resolved.
Mom states shots were given @ 1PM & pt started crying 115PM & cried continuously & inconsolably until 3AM 11JAN92 then slept fitfully; mom states pt recvd APAP when got home; fussiness & sore leg lasted x 3 days then pt was fine;
how long side effects last; patient pregnant received the vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (how long side effects last) and MATERNAL EXPOSURE DURING PREGNANCY (patient pregnant received the vaccine) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced VACCINATION COMPLICATION (how long side effects last) and MATERNAL EXPOSURE DURING PREGNANCY (patient pregnant received the vaccine). At the time of the report, VACCINATION COMPLICATION (how long side effects last) outcome was unknown and MATERNAL EXPOSURE DURING PREGNANCY (patient pregnant received the vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication list was not provided. Treatment information was not provided.  This prospective pregnancy spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced unexpected event of maternal exposure during pregnancy with associated unexpected event of vaccination complication, described as side effects. The associated event occurred after Spikevax however, the exact time to onset was unknown since there is lack of information regarding number of doses and dates of administration. Rechallenge was unknown due to lack of key information regarding Spikevax administration (number of doses and exact dates of administration). The benefit-risk relationship of drug is not affected by this report   Reporter did not allow further contact; Sender's Comments: This prospective pregnancy spontaneous case concerns a female patient of unknown age with no relevant medical history reported, who experienced unexpected event of maternal exposure during pregnancy with associated unexpected event of vaccination complication, described as side effects. The associated event occurred after Spikevax however, the exact time to onset was unknown since there is lack of information regarding number of doses and dates of administration. Rechallenge was unknown due to lack of key information regarding Spikevax administration (number of doses and exact dates of administration). The benefit-risk relationship of drug is not affected by this report
CLIENT STATED STARTED FEELING ILL FRI. EVENING 03/11/11.  SAT. 03/12/11 HAD ON SET OF FLU LIKE SYMPTOMS, STATING NO FEVER. SUN. 03/13/11 NIGHT PAIN IN LEFT SHOULDER, REDNESS BELOW INJECTION SITE, TENDER TO TOUCH. MONDAY 03/14/11 CLIENT CALLED AND STATED WAS GOING TO ER.
Fever 102 for about 10 hours. I slept most of the day. My wife finally made me take 2 acetaminophen and the fever is gone and I was able to eat a small amount of food around 7 pm. Even room temperature water upset my stomach. I wore a tee shirt, a wool shirt, and a light parka to go to a meeting this morning. When we got home I slept with all my clothes on under a heavy blanket. I'm starting to feel better now. I had a similar reaction to the first dose on 3/16/2018, which I didn't report. I am a healthy, active person who rides my bicycle 30-50 miles at least 3 times a week. In March I tried to ride through the symptoms, but I had to quit after 22 miles. That's unusual for me.
Sepsis, inflammation of gallbladder, GI infection, agitation, delirium
PROBLEMS WITH HIP AREA; GOT SICK WITH COVID VACCINE; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (PROBLEMS WITH HIP AREA) and ILLNESS (GOT SICK WITH COVID VACCINE) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On 29-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (PROBLEMS WITH HIP AREA) and ILLNESS (GOT SICK WITH COVID VACCINE). At the time of the report, MUSCULOSKELETAL DISCOMFORT (PROBLEMS WITH HIP AREA) had not resolved and ILLNESS (GOT SICK WITH COVID VACCINE) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 103, Concomitant medications details were not reported. The reporter causality for the events was not provided with respect to HUMIRA (ADALIMUMAB). It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Treatment information was not provided by the reporter.
Pt was driving home and had overwhelming need to fall asleep. She called a family member who told her she wasn't making sense and was concerned that she was drunk or drugged. Pt went directly home and had taken no meds that day. She felt feverish and took her temp which peaked at 101 at 6pm. When she woke up at 7mp she was in and unusual position and believed that the health care provider she had seen earlier in the day was in her home and had been interviewing her at her home. When she woke up at 7 pm the fever was gone and she felt totally normal again.
First dose Moderna given 3/18/2021 at 0925.  Patient was in waiting area and complained of feeling very fatigued with nausea and heaviness to arms and legs.  Patient taken to the Emergency Department via wheelchair at 0950 for evaluation.
This spontaneous report was received from a registered nurse and refers to a 12 months old patient of unknown gender. No medical history, concurrent conditions and concomitant therapies were reported. On 05-MAY-2015, the patient was vaccinated with an improperly stored dose of (Oka/Merck) VARIVAX (lot # K021933, expiration date 10-NOV-2016, dose 0.5 ml., subcutaneously) (anatomical location was not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, as all required information has been received.
24 hours post vax, pt experienced a local reaction characterized by redness, soreness and rash to right upper arm with fever, myalgia and arthralgias, mostly hip joints. Pt advised to use cold compress to injection site and to take Motrin or Tylenol.
Right arm slightly swollen at injection site that day. Next morning it was much more swollen (I joked that it looked like Popeye arm) and it was painful to the touch but not painful during arm movement. That severe swelling lasted for several days. As swelling started to subside, it began to intensely itch.  The intensity lasted for several days. Today, nine days after the injection, there is still a lump on my arm and it still itches. I am considering contacting my doctor to see if he needs to assess it.
09/21/2013 Moderate Other. Mother reports pt had a fever of 103 Fahrenheit on 9/21 and diarrhea 4x on 9/22. The fever was 101 Fahrenheit on 9/23. He developed a pink, papular rash all over his body that started 9/26, and was seen by a physician on 9/30. Pt did not have a fever or a cough. Mother said the rash lasted 4-5 days. Physician did not say it was chicken pox.
Pt recv vax on 1/5/98; on 1/8/98 pt exp fever (105), rash over entire body, febrile seizure
12:48 PM: Shot 11:00 PM: Woke up with chills and aches/pains.  No fever. ~5:00 AM: In and out of sleep.  Chills, aches/pains, sleeping hallucinations, crushing headache and fever. 5AM-5PM: Chills, fever (99.1-100.5) and crushing headache.  Aches and pains stopped in this time frame.  Lots of mini-naps but I could not stay asleep because of the headache. 5PM: Took 2 Tylenol.   Headache became a dull roar and fever reduced to about 99 8PM: Fell asleep. ~2AM: Woke up sweating, no fever. 6AM: Woke up with no symptoms and feeling good.  Lots of brain fog which lifted throughout the day
Patient described brain fog. Tinnitus progressing to hearing crickets and then hearing the ocean. Patient broke out in shingles, this time affecting the eye and losing partial eye sight (had visit with eye doctor recently). Has follow up regarding tinnitus with healthcare provider soon. First Shingrix dose was November 13, 2020.