chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diarrhea and itching palms on evening of June 1. Some itching during the week, with bad hives on evening of Friday, June 5. Visited urgent care clinic at 9:00 a.m. on Saturday, June 6 with joint pain and swelling of joints, hands and eyes, and was sent to hospital to receive IV fluids and steroids, and discharged a few hours later.  6/10/09 ER records received DOS 6/6/09. Assessment: Simple hives secondary to vaccination. Post vaccination: pruritus of palms, small welts behind ears followed by diffuse urticarial lesions. Joints, especially knee, feeling inflamed and painful. Warmth and swelling of knees.
Arm was sore from time of onset and got progressively worse as time went on. No redness or swelling; only soreness and aching in muscle and continues to this day.
Light and intermittent tinnitus after the first shot. Loud and persistent tinnitus heard 24/7 after the second shot. Severely impacted sleep. Only able to sleep 2 hours a night even with white noise.
Migraine headache, exhaustion, pain at injection site, shortness of breath, body aches, chills. Took ibuprofen at onset of symptoms, headache subsided but the rest lingered for another 24 hours.
stated was exp extreme pain @ inject site, & upper arm towards shoulder; also tenderness on deep palpation onset approx 1 hr p/inject; 2nd day c/o joint pain;
This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 53-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 8th January 2019, the patient received the 1st dose of SHINGRIX. On 26th January 2019, 18 days after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The healthcare professional (HCP) states that the patient with a medical history of shingles received her 1st dose of SHINGRIX and 18 days later had an outbreak of shingles. The HCP declined to provide any further details other than the ones documented for this adverse event at the time of reporting. This call was transferred from the GSK Response Center (GRC) for Adverse event. Consented to follow up was provided.
LIGHTHEADEDNESS; CHILLS; FEVER; DULL HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a 51 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: 201A21A, and batch number: 201A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 to Left Arm for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the subject experienced lightheadedness. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced dull headache. On 08-APR-2021, the subject experienced fatigue. On 09-APR-2021, Laboratory data included: Body temperature (NR: not provided) 101. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lightheadedness on 08-APR-2021, chills, fever, and dull headache on 09-APR-2021, and fatigue on 10-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210425086.
This initial spontaneous report was received on 06-NOV-2017 from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender (The patient's first name could be a male or female name). Medical history, concurrent conditions, and concomitant medications were not provided. On or about 25-JUL-2012, the patient was inoculated (by an unspecified person) at a pharmacy with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). 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-AUG-2016, the patient was treated by an unspecified health care professional at a home health service facility for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles.  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, and pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
little swelling in the arm; tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia) and VACCINATION SITE SWELLING (little swelling in the arm) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Sep-2021, the patient experienced VACCINATION SITE SWELLING (little swelling in the arm). In September 2021, the patient experienced TACHYCARDIA (tachycardia). In September 2021, VACCINATION SITE SWELLING (little swelling in the arm) had resolved. At the time of the report, TACHYCARDIA (tachycardia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   No treatment information was provided. Patient has never experienced something like that in his life, he's very healthy and doesn't have any medical condition nor takes any specific medication.
PATIENT RECEIVED THE MODERNA VACCINE BUT WAS UNDER THE AGE OF 18.  PATIENT IS CURRENTLY 17 YEARS AND 5 MONTHS OLD
I had a sore throat and felt like i have an upper respitory infection. I felt really wore out.
Sharply demarcated pruritic 2.5 x 1.5 inch oval shaped red area of inflammation / erythema  at site of injection.  Symptoms started  2/21/21, 13 days  after the first dose Moderna COVID-19 vaccine series.  Treated with  diphenhydramine for 2 days.  No longer pruritic.  Red area completely resolved by 2/26/21
6-8 hrs.  after immunization pt. states he had generalized hives, swelling of lips, thick feeling in his throat, and some minor chest pain.  Pt. took BENADRYL- symptoms resolved within 24 hrs.
menstrual like cramps; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (menstrual like cramps) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 MUSCLE SPASMS (menstrual like cramps). At the time of the report, MUSCLE SPASMS (menstrual like cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported. No treatment medication was reported.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown demographics. Patients pertinent medical history, concurrent condition and concomitant medication were not reported. No previous drug reactions/ allergies were reported. Since 01-JUN-2017, on unspecified dates, these patients were vaccinated with improperly stored doses of GARDASIL 9 (strength, dosing details, anatomical location, lot# and expiration date were unknown) for prophylaxis (incorrect product storage). The vaccine was exposed to the temperature of 47 F to 77 F, for a time frame of 10 hours and 42 minutes. Data logger was involved. The vaccines had previous temperature excursion. No adverse effects were reported. No PQC was involved. This is one of the several reports reported by the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA003923: US-009507513-1706USA003924: US-009507513-1706USA003927: US-009507513-1706USA003926: US-009507513-1706USA003925.
A few hours after the injection, I developed pain and then numbness and tingling in my right arm and hand. For a couple of hours, I lost most of the sensation/feeling in my right hand, and had continued pain, tingling, and numbness in my right arm. I did not seek medical treatment. The feeling in my hand slowly came back over the next few hours, but the pain and tingling sensation continued to be severe for another 24 hours. Now, 48 hours later, the tingling is still present, but is more mild. During the first 24 hours, I also experienced brief, intense pain sensations in my head that I can only describe as ?brain zaps.? These seem to have stopped 48 hours later.
Patient was sent from her residential facility by EMS to the ED on 1/27/23 for evaluation of vomiting, cough, and jaundice. Patient reports six days of nausea and vomiting, and additionally notes rhinorrhea and intermittent shortness of breath. COVID-19 PCR test performed in the ED resulted positive. She was admitted 1/27/23 - 1/31/23 for acute hypoxic respiratory failure due to COVID-19 infection and UTI. Patient was started on dexamethasone 6mg IV daily and changed to p.o. to complete a 10-day course. During her admission, she was placed on supplemental O2 to keep saturations greater than 90 %, and was able to wean off. Her most recent COVID booster was administered 12/7/22.
Expired Twinrix Administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 21-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2023, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 19th January 2023, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 26-Jan-2023 Reporter's comment:  The case was reported by the nurse. The Nurse calls to report an expired dose of Twinrix was administered to a patient. The consent to follow up via email agreed. Additional supportive information: As patient received expired vaccine which led to expired vaccine used. This case is linked with US2023011699 same reporter.; Sender's Comments:  US-GSK-US2023011699:same reporter
SORE ARM; INJECTION SITE STINGING; MILD HEMIPLEGIA; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805020, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced mild hemiplegia. On 08-MAR-2021, the subject experienced sore arm. On 08-MAR-2021, the subject experienced injection site stinging. The patient had mild hemiplegic on side where got the shot of the vaccine was given in Right Deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and injection site stinging on 11-MAR-2021, and the outcome of mild hemiplegia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210328827-COVID-19 VACCINE AD26.COV2.S-Mild Hemiplegia. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
After leaving the immunization room, the patient fainted while walking through the store. She hit her head on the floor when she fell. While waiting for the paramedics, she was lightheaded, clammy, pale and sweating.  Paramedics took her to the hospital after initial evaluation in the store.
Beginning about 2-3 hrs after shots were administered the baby cried and was inconsolable for approx. 3 hrs. Mother spoke with medical through Hospital during this time (three different times). Mom stated that at some point during the crying she was extremely concerned about his breathing. Took him to hospital in which he was diagnosed with "fussy infant". His crying resolved during the ED visit. No further intervention was needed.
Patient developed a rash at injection site, that spread into armpit. The rash was painful, and the patient's axillary lymph nodes were swollen. Patient also developed arthralgia in the elbow below the injection site (left arm). He was treated with a course of azithromycin for possible infection. The rash resolved within days, but arthralgia in the elbow persists to present. Patient complains of soreness and stiffness in the joint, especially when trying to grip or lift with his left hand.
Vaccine administered to patients after 32 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator). On 09-Jun-2021, PRODUCT STORAGE ERROR (Vaccine administered to patients after 32 days in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 31-Jul-2021: Follow up information received on 02-Aug-2021 and included patient details (Initial, age, gender, weight, height, race, ethnicity), medical history and first dose details was added. On 14-Aug-2021: Source document contains NNI.
On day 8 post vaccine: Erythema, edema, warmth, mild tenderness
Swollen lymph node under Left arm and in arm pit. Painful to have arm down.
This spontaneous report was received from a registered nurse and refers to multiple patients of an unknown gender and age. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of improperly stored GARDASIL 9 lot # L014415 expiration date: 25-JUL-2017 (dose and route of administration were not reported). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
RESPIRATORY RESPONSE; THROAT CONGESTED, EYES RUNNY, RASPY VOICE REPORTED. PUT IN CONTACT WITH HER PRIVATE MD. NO TREATMENT GIVEN; WATCHFUL.
Patient became dizzy with prickly sensation on back. No skin changes, no oral swelling, no shortness of breath, no difficulty swallowing. Tolerated PO food and fluids, returned to baseline prior to DC.
Symptoms started a few hours after vaccine administered.   Right upper arm red, swollen, and induration present at some areas far from vaccination site. Redness starts 3 inches below left and distal from deltoid injection site. Area itchy and warm. Injection site area appeared clean and without the symptoms described.  Patient presented to immunization clinic after encounter with family practice doctor who recommended to monitor area; if symptoms worse then visit ED.
Information has been received from a physician, for live VARIVAX (Merck), a Pregnancy Registry product, concerning a fetus his mother received VARIVAX live (Merck) and was pregnant. The mother had a positive unspecified pregnancy test and was 13 weeks into the pregnancy. Physician reported the fetus's right hand was not formed and had a malformed right forearm. Physician also reported there was bleeding from the placenta. The outcome of the events was unknown. The events were considered to be Congenital Anomaly. This report linked to case # 1303USA009381 (same source, mother case). Additional information has been requested.
Pain in my shoulder that I had many years ago when I first took cholesterol medication prescribed to me. It is a mild pain all the time. I also have increased blood pressure now and my doctors are trying to figure out the source of it. The CT scan of my shoulder also showed that there was nothing there, so the pain is also unexplained.
pt recvd vax & had R lateral frontal neck & jaw swollen to size of size of fist monday; c/o sl discomfort of side of neck; c/o sore throat w/ palpitation & swallowing; rhinorrhea & congestion;
No additional AE; HCP reporting an inadvertently administered MMR-II that was expired.; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 10-MAR-2023, the patient was vaccinated with an expired dose of measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (rHA) (M-M-R II) injection, (lot number U007684 which has been verified to be valid, expiration date reported and validated and expiration date as 09-MAR-2023) (dose, strength, route of administration, and anatomical sites of injection were unknown by the reporter). in combination with sterile diluent (dose, strength, route of administration, anatomical sites of injection,  lot number and expiration date were unknown by the reporter).  No additional side effects were reported in the patient.
Patient developed discomfort in his left shoulder at the injection site.  At some point during the night he got very diaphoretic and realized that his heart was going very fast.  This morning still rapid so he decided to go to his physician's office to be checked out.  Was found to be in atrial fibrillation and sent here.
I felt sick, I had body aches, chills, sore throat, and swollen lymph nodes on one side. That lasted no longer than a week. Then I was just feeling tired. On 09/01/2021 I could not walk up the stairs. I was dizzy and I had shortness of breath. I went into the ER because I had severe back pain and could not walk. They wanted to send me home but then they noticed my heart rate was really high. They did blood tests, urine test, EKG, and chest CT with contrast. The troponin and D dimer were elevated. Urine test was normal. The EKG and CT scan were abnormal. They said it was Saddle Pulmonary Embolism. They admitted me in the hospital. I was there for 5 days. They prescribed some medications. I also developed a hematoma on my knee.
This case was reported by a nurse via call center representative and described the occurrence of rash in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. The reporter considered the rash to be unrelated to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional stated the patient experienced a large local reaction. The healthcare professional was not sure if reaction was due to SHINGRIX. The healthcare professional was not willing to provide patient demographics or any additional information at the time of the call. The healthcare professional stated she had not actually seen the rash.
injection was given into shoulder joint rather than deltoid muscle. I developed severe shoulder joint pain 3 hour post vaccine administration. the injection site was too high up in the arm and too posterior.
Noticed a couple spots on face on Sept 19, 2008. On Sept 26th he had more red spots on face, legs and one or two on back. Saw Dr. on Sept 29th with diagnosis of chicken pox from immunization. Prescribed Fentanyl still drops and Anaesthesulf Lotion
Feeling very woozy/dizzy while standing and had trouble balancing going down stairs. I thought I was just really tired but it happened all day (even with caffeine) and the next day (after a lot of rest).
About one hour after receiving the vaccine I broke out with hives on my face and chest. Contacted Moderna and was told to contact my healthcare provider. I did a virtual visit and was placed on steroids and an antihistamines. It has been 18 days since my vaccination and still have joint pain that is affecting my walking. I did not have this before and am taking 800mg of motrin every 8 hours.
Sore arm Headache for multiple hours - ibuprofen  Body aches for about 3 days  Diarrhea off and on for 3 days Entire right side of my body was flushed red for about 3 days  Exhaustion
Initial - flu-like symptoms. Ongoing (still present at 14 days) red blotches, bruising & soreness at injection area.
This spontaneous report was received from a pharmacist referring to an unspecified female patient of unknown age. Information about concurrent condition, concomitant medication and medical history was not provided. On an unknown date the patients were vaccinated with PNEUMOVAX 23 (Lot# M020521, Expiry date: 17-NOV-2017, 1 dose) for prophylaxis. The pharmacist reported the patient called the pharmacy "the next day complaining of redness, swelling, pain, and inflammation and was ordered KEFLEX by her physician". The pharmacist requested a lot check for this lot of PNEUMOVAX 23. The outcome of the events was reported as recovered/resolved. This case is one of three "Multiple Patient Reports" (MARRS# 1701USA004988 and 1701USA003778). Additional information has been requested. Sender's Comments: US-009507513-1701USA003778: US-009507513-1701USA004988.
I waited 15 mins after shot, nothing.  At 6 that same evening,  a red spot was around injection site. I felt fatigue the next day, and that was it. The spot faded away. Then on Jan  12, I noticed the spot around the injection site  came back,  with being really itchy.  Now it's spread to a little down my arm, and my hand. Doctor advised me to report it. I did take some Benadryl  due to the itching and it went away a little bit- the itching, but the redness is still there and it feels warm at the site.   ***PLEASE ONLY CONTACT ME VIA EMAIL***
Information has been received from a licensed practical nurse referring to "about 3" patients of unknown age and gender. Information about concurrent condition, medical history and concomitant therapy was not reported. On unknown dates the patients were vaccinated with doses of improperly stored VARIVAX (Merck) (lot # L035126 and expiration date: 14-SEP-2017; data logger; dose and route not reported). There was no previous temperature excursion. No adverse effects were reported. Additional information has been requested.