chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Kinrix administered subcutaneously; This case was reported by a other health professional via call center representative and described the occurrence of intramuscular formulation administered by other route in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th September 2022, the patient received Kinrix (subcutaneous) and Kinrix Pre-Filled Syringe Device. On 16th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route 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: 16-Sept-2022 Reporter's comment:No reactions were reported. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up via email. Additional supportive information: The patient received Kinrix subcutaneously, which led to intramuscular formulation administered by other route.
On 9/5/11 mother not red spot with lump on (R) upper posterior thigh (VARIVAX vaccine site) vaccine administered on 8/26/11 at 4 pm. Pt seen in office on 9/7/11 & doc describes 1-5cm red area on (R) upper posterior thigh, with firm lump underlying red area measuring 1cm. No pustule or pimple. Second red erythematous papule on (L) posterior chest, mid area. Antibx given - KEFLEX though not likely infected.
my brother had the second dose and felt like he was run over by a truck, his muscles hurt so bad; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1 st dose), for COVID-19 immunisation. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "my brother had the second dose and felt like he was run over by a truck, his muscles hurt so bad".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 16-DEC-2015, the patient was vaccinated with an improperly stored dose of VAQTA "25U/0.5ml-SD LLok wCap Ped" which had a lot number of L022259 and expiration date on 06-APR-2017 (route of administration and anatomical location were not reported). There were no concomitant medications provided. No adverse effects reported. No product quality complaint was involved. On an unspecified date, the VAQTA vaccine had two temperature excursions; one of 96 hours and other one of 144 hours. The lowest recorded temperature was 33 F (0.555555556 Celsius) and the highest recorded temperature was not mentioned. 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 several cases from the same reporter. Additional information has been requested.
FEVER, CHILLS, HEADACHE, JOINT ACHES, MUSCLE ACHES, NAUSEA, SKIN HURT ON CHEST
headache; This case was reported by a consumer via call center representative and described the occurrence of headache in a 66-year-old male patient who received HAB (Twinrix) 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 8th May 2022, the patient received the 1st dose of Twinrix (intramuscular) 1 ml and Twinrix Pre-Filled Syringe Device. On 9th May 2022, 1 days after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the headache to be related to Twinrix and Twinrix Pre-Filled Syringe Device. 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: 16-MAY-2022 Reporter's Comment: The patient self-reported this case. The patient received dose of Twinrix vaccine and developed a headache the next day. The event headache was continued. The reporter consented to follow-up. The patient had nothing else to report.
At first, the injection site was a little swollen, red, itchy, warm to the touch, and painful. These symptoms weren't problematic at first and in fact, seemed to go away.  Then exactly 1 week after receiving the vaccine the injection site became significantly inflamed, itchy, warm to the touch, and very warm to the touch. I never ran a fever but have become concerned about infection at the site of injection.  My upper right arm at the largest portion of the muscle is at a circumference of 15 1/4 inches and my left is 16 3/4 inches at it's largest.
My daughter got her MMR and Varicella vaccination on 7/17/09 and started with symptoms on 7/26/09 where she developed a rash with raised bumps without blisters around the injection site. She followed with a fever on or around 7/28/09 and was very agitated and unable to be consoled. She also developed some bumps on other parts of the body. She was seen by her doctor on 7/29/09 and the rash was deemed a reaction to the varicella vaccination and to treat it like a virus and let it run its course and any further problems to return her to the office for more follow up.
PT STATED THAT LYMPH NODES LEFT AXILLA WERE SWOLLEN AND WAS NOT SURE IF THAT HAD ANYTHING TO DO WITH THE TDAP.  ON 2/28/11 SHE RETURNED PHONE CALL AND STATED EVERYTHING WAS FINE.
Patient received 2nd dose COVID vaccine (Pfizer, Lot# EW0182) in the L arm on 06/12/21 at 15:20pm.  reported she was experiencing nausea to EMT observer at 15:30 in the observation area. EMT observer transferred client to zero-gravity chair, offered client water, emesis bag, and EMT observer took client's vitals. Lead RN assessed client. Client was A&O x4, denied SOB, dizziness, chest pain, and changes in vision. At 15:34 client vomited into emesis bag. Emesis appeared clear in color.  Co-lead RN, offered client 50mg Benadryl. Client denied IM route of administration. Client took 50mg Benadryl PO at 15:39. Vitals taken every 5 minutes until EMS arrival. At 1539 client stated she had trouble swallowing "because of thick saliva". EMS #61293 arrived at 15:40 and assumed client care. Client signed AMA paperwork at 1559. Lead RN educated client and her brother on ER precautions, v-safe, and advised client to follow up with PCP. Client left the site with her brother at 1600.
Itchy, erythematous, macular rash on her back, trunk. No fever.
Moderna vaccine was administered from a vial having been opened for over 12 hours.; Moderna vaccine was administered from a vial having been opened for over 12 hours.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Moderna vaccine was administered from a vial having been opened for over 12 hours.) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from a vial having been opened for over 12 hours.) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     The patient's past medical history included Erectile dysfunction, Hypothyroidism, Colon operation, Wrist fracture and Gastric ulcer (Over 20 years ago.). Concurrent medical conditions included Hypertension, Diabetes, Hyperlipidemia, Obesity, GERD, Insomnia, Lipoma, After-cataract and Diverticulosis.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter once. On 01-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine was administered from a vial having been opened for over 12 hours.) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from a vial having been opened for over 12 hours.). On 01-Nov-2021, PRODUCT STORAGE ERROR (Moderna vaccine was administered from a vial having been opened for over 12 hours.) and EXPIRED PRODUCT ADMINISTERED (Moderna vaccine was administered from a vial having been opened for over 12 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment information provided. Patient age over 65, Immunocompromised
hives on bilateral arms/legs, trunk, hands, feet, and neck; This is a spontaneous report from a contactable other healthcare professional, the patient. A 31-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown) via unspecified route of administration in the left arm on 19Mar2021 at 18:45 (at the age of 31-years-old), as a single dose for COVID-19 immunisation. The patient medical history included polycystic ovarian syndrome from unknown date. The patient had allergy to sulfa drugs and wasps. The patient did not take any concomitant medication. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021 at 00:00, the patient experienced hives on bilateral arms/legs, trunk, hands, feet and neck. The patient did not receive any treatment for the reported event. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event urticaria was not recovered at the time of reporting.    Information about lot/batch number cannot be obtained. No further information is expected.
I had vaccination on 04/15/2022. On 09/27/2022, I was feeling very chilly and shaky. I took an at home COVID-19 and it was Positive. I contacted my PCM who prescribed Paxlovid. I still presently have asthma symptoms in my chest.
Severe ringing in ears, hypersensitivity to sounds, ear pain, feeling of fullnesss, headache.  Still ongoing 3/27/2022
Patient experienced myocarditis after receiving his 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of MYOCARDITIS (Patient experienced myocarditis after receiving his 2nd dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Patient experienced myocarditis after receiving his 2nd dose) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Patient experienced myocarditis after receiving his 2nd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were reported  Patient had taken 2nd dose 3 weeks after 1st dose. Company Comment This case concerns a 41-year-old, male patient with no relevant medical history reported, who experienced the expected event of myocarditis. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No Treatment medications were reported; Sender's Comments: This case concerns a 41-year-old, male patient with no relevant medical history reported, who experienced the expected event of myocarditis. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Pt is from overseas and had received 2 doses of COVID 19 Moderna vaccine.  The other country is using a 4 month timeframe for a 3rd dose, and pt had an app that told him to get his booster.  Pt is a student, and came to a vaccine clinic to get a booster.  Pfizer booster was administered, but it was then discovered that his administration was 1 month early per CDC guidelines.  Pt did not have any allergic or adverse reactions, and is feeling fine.
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022; No adverse event; Patient administered the vaccine after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered the vaccine after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 06-Jul-2022).    No concomitant medication was reported.  Patient received half dose of vaccine.  On 04-Jun-2022 the vials were initially stored in the refrigerator.  The vial did not undergo any temperature excursions.  No treatment information was provided.
Sleepy; Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (Vaccination site pain) in a 62-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 Crohn's disease.  No Medical History information was reported.  In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second 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. In 2021, the patient experienced SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (Vaccination site pain). In 2021, SOMNOLENCE (Sleepy) and VACCINATION SITE PAIN (Vaccination site pain) had resolved.   No concomitant medication information was reported. No treatment medication information was reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
TROUBLE WITH SPOTS ON ARM AND ANKLE; TROUBLE WITH AN INGROWN TOE; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (TROUBLE WITH SPOTS ON ARM AND ANKLE) and PAIN IN EXTREMITY (TROUBLE WITH AN INGROWN TOE) in an elderly female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (MODERATE TO SEVERE CHRONIC PLAQUE PSORIASIS).   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SKIN DISORDER (TROUBLE WITH SPOTS ON ARM AND ANKLE) and PAIN IN EXTREMITY (TROUBLE WITH AN INGROWN TOE). At the time of the report, SKIN DISORDER (TROUBLE WITH SPOTS ON ARM AND ANKLE) and PAIN IN EXTREMITY (TROUBLE WITH AN INGROWN TOE) was resolving. It was unknown if patient was enrolled in a COVID-19 Vaccine trial. No concomitant medication information was provided.  The reporter's causality for the events of trouble with spots on arm and ankle and trouble with an ingrown toe with Humira (adalimumab) was reported as probable. No treatment medication was provided.
approximately 3 weeks after the covid vaccination was received, my daughter began not feeling well.  She was experiencing extreme fatigue, substantially enlarged lymph nodes, a slight sore throat and mild sinus stuffiness.  Depending on the thermometer used, she either had no fever or a very low grade fever (less than 100).
HARD TIME CONCENTRATING; SHORTNESS OF BREATH.; SEVERE SHAKING; FATIGUE; HARD TIME MOVING; HEADACHE; EYE PAIN; FACE BRIGHT RED; FEELING LIKE BOTOX ON FACE; SEVERE BODY ACHE; ARM HEAVY; NAUSEA; This spontaneous report received from a parent concerned an 18 year old female. 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 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 07-APR-2021, the subject experienced face bright red. On 07-APR-2021, the subject experienced feeling like botox on face. On 07-APR-2021, the subject experienced severe body ache. On 07-APR-2021, the subject experienced eye pain. On 07-APR-2021, the subject experienced arm heavy. On 07-APR-2021, the subject experienced nausea. On 07-APR-2021, the subject experienced headache. On 08-APR-2021, the subject experienced severe shaking. On 08-APR-2021, the subject experienced hard time moving. On 08-APR-2021, the subject experienced fatigue. On 10-APR-2021, the subject experienced shortness of breath. On 12-APR-2021, the subject experienced hard time concentrating. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from face bright red, and feeling like botox on face on 08-APR-2021, and nausea on 09-APR-2021, was recovering from arm heavy, headache, severe body ache, and shortness of breath., and had not recovered from severe shaking, fatigue, eye pain, hard time moving, and hard time concentrating. This report was non-serious.
Swollen and painful left armpit and side of chest area for 2 days and continuing. Swollen lymph nodes on the neck for 2 days and continuing. Taking ibuprofen 400 mg 1-2 times daily.
Severe Muscle Aches; activities of daily living impaired; Felt as if she had the flu; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, 1 day after receiving Shingrix, the patient experienced muscle pain, activities of daily living impaired and influenza-like symptoms. On an unknown date, the outcome of the muscle pain was not recovered/not resolved and the outcome of the activities of daily living impaired and influenza-like symptoms were unknown.   The reporter considered the muscle pain to be related to Shingrix. It was unknown if the reporter considered the activities of daily living impaired and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, but was selected adult as per vaccine indication. The patient received dose of shingrix in 2019 and experienced muscle pain, she couldn't get out of bed the next day. Patient stated that she felt as if she had the flu. The reporter did not consent to follow-up. All information was not available. This case is linked to the case US2021054417, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021054417:Same reporter
Patient presented with tightness in chest after 1st dose of COVID vaccine. Patient has history of severe allergic reactions to vaccinations. Administered 50mg of Benadryl PO.  Patient condition worsened rapidly with hives and anxiety. 911 contacted for transport. 0.3mg Epi administered in right deltoid. Epi began working quickly. Care transferred to EMS and transferred to Hospital.
Patient began to have projectile vomiting and un-well sick feeling for 3 days following vaccination.
Patient had HA, fatigue, sense of heaviness, fever, and local arm swelling and redness at injection site after HPV #3 vaccine and Hep A vaccine.  Persistent erythema at injection site 2wk after immunizations. Clinical course most c/w HPV vaccine reaction.
On 11/1/00, post vax, pt had immediate arm discomfort and it continued all day. Approx. 14 hours later, had muscle and joint aches then through the night had an increased in aches and chills, which continued much of next day. She took ibuprofen and antihistamines. The following morning, she woke up with hives on neck and she continued to take Benadryl and ibuprofen and reported to Employee Health on 11/6/00.
A non-serious spontaneous report of hives has been received from a physician concerning a 32-month-old female, subsequently to FLUMIST. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST. No past medical history nor concomitant medications were reported. The patient received the first FLUMIST dose on 27-Oct-2008 and the second FLUMIST dose on 30-Dec-2008. On 31-Dec-2008, the patient reported to the physicians office because she got hives all over. The patient was given diphenhydramine and sent home from the physicians office. The outcome was not reported.
Sore area of injection for two days.  Tolerable no meds taken.  The entire day after very tired, just wanted to lay down.  Day after that woke up a 100% better, albeit arm area a little sore.
Information has been received from a nurse referring to unspecified number of patients of unknown age and gender. During the time period of 30-OCT-2015 through 04-NOV-2015, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # K018183, expiration date 04-MAY-2016) (dose and route were not reported). No symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Symptoms- lightheaded Pt was diaphoretic and alert. reclined pt and he responded quickly.  Water was given.
Soreness/Pain in the injection site and not able to lift the arm for almost 75 hours.