chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vertigo/ room is spinning; Dizziness; Slight head pressure; little bit of a headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo/ room is spinning), DIZZINESS (Dizziness), HEAD DISCOMFORT (Slight head pressure) and HEADACHE (little bit of a headache) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo/ room is spinning), DIZZINESS (Dizziness), HEAD DISCOMFORT (Slight head pressure) and HEADACHE (little bit of a headache). At the time of the report, VERTIGO (Vertigo/ room is spinning), DIZZINESS (Dizziness) and HEAD DISCOMFORT (Slight head pressure) had resolved and HEADACHE (little bit of a headache) 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. Treatment information was not provided. Patient reported that the events resolved after 5-6 days.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: Event head pressure updated. Outcome of events reported earlier updated to resolved. On 07-May-2021: Reporter's contact information updated .; Sender'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.
Initial information received on 01-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an unknown gender six months old patient who was vaccinated with a 0.25 ml dose of FLUZONE QUADRIVALENT (Batch number: UT6259OA, expiration date: 30-Jun-2019, site of administration: left thigh and route was not reported) on an unknown date. Concomitant medications included was 0.5 ml dose of FLULAVAL QUADRIVALENT 2015/2016 lot number: B4J3H via unknown route on an unknown date. The patient's medical history were not reported. It was an actual medication error due to extra dose administered (two dose of FLUZONE QUADRIVALENT given too soon). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Patient's right leg became swollen with a lump and a 3 x 6 cm area of erythema.
Cold; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient's husband) reported a female patient of an unspecified age received first dose bnt162b2 (Solution for injection) via an unspecified route of administration from unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that he and his wife are scheduled for their second dose tomorrow morning. Stated that his wife has a cold but no temperature. Clarified that this is for Pfizer Covid.
This spontaneous report as received from a registered nurse refers to an unspecified number of adult patients of unknown age and gender. No information regarding the patients' medical history or concurrent conditions was provided. On unknown dates, each of the patients was vaccinated with two pediatric doses of VAQTA injection (dose, route of administration, lot# and expiry date were not reported) together, to equal an adult dose of VAQTA at the same office visit. There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Bumpy rash on thighs began developing the day after the vaccine.  It turned red  and spread to my arms the next day, and has since spread to my lower legs, feet, and partially up sides of my torso.  One week out, I still have it, though it might be starting to resolve some.  It has not itched.
Axillary lymphadenopathy & mild tenderness/pain on same side as injection (left); currently unresolved
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 02-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Reporter stated that no treatment was given to the patients.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Mom said she felt very hot when she got up that morning so she checked her temp. It was 103. Other than the fever she did fine. Mom gave her Tylenol and temperature went down. She said when I called to check on her today that it never went back up. She said she had been 10 hours after Tylenol when she checked her temp that morning.
he cant get out of bed and he is going crazy; fatigue and joint pain; fatigue and joint pain; he cant get out of bed and he is going crazy; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received first dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), both via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. In Feb2021 patient experienced fatigue and joint pain, he could not get out of bed and he was going crazy. It was reported that the patient had received both vaccines and has had side effects starting in February. The patient had fatigue and joint pain and they were 99.9 percent sure they would rather have that then death. She states that he is a strong hardworking man and he could not get out of bed and he was going crazy. They had been to the doctors and he has had every test known to man and have all come back normal. The caller wanted to know if there is any information on how to help get rid of the side effects. Caller wanted to know how she can get her husband involved with the clinical trials. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Developed whole body hives 4 hrs after the vaccine. No wheezing or breathing problems. Parents are Benadryl and the hives resolved by the next day. This is his first time getting the MenQuadFi, his first meningococcal vaccine was Menactra in 2018.
Weakness in arms, legs and hands. Could not stand or walk without assistance, pain, numbness. Diagnosis: GBS (Guillain-Barre syndrome) CIDP (chronic inflammatory demyelinating polyneuropathy). (IVIG infusion).
rt arm started swelling by time pt got home form clinic; took a nap thereafter (unusual for pt); arm more swollen & red, sl nausea; 6JAN93 arm swollen rom shouder-elbow & tender, bleeding @ inject site required bandaid;
Vaccine received at about 0900 on 01/04/2021 at her place of work, Medical Center, where she was employed as a housekeeper. About one hour after receiving the vaccine she experienced a hot flash, nausea, and feeling like she was going to pass out after she had bent down. Later at about 1500 hours she appeared tired and lethargic, then a short time later, at about 1600 hours, upon arrival to a friends home she complained of feeling hot and having difficulty breathing. She then collapsed, then when medics arrived, she was still breathing slowly then went into cardiac arrest and was unable to be revived.
Patient had syncopal episode and vomiting  within a couple of minutes after receiving COVID vaccine.
This started in the morning of the 12/21/2022, with a real sore throat. It felt like I had a golf ball in my throat. Severe cold symptoms: running nose, coughing, lethargy, fatigue, sneezing, headache, and body aches. sleeplessness. I tested 3 times for COVID-19 and they all came back negative every time.  I tested for RSV, the results were negative. I tested for the Flu A and B and the results were negative.  I tested at the Hospital for the RSV and the Flu A and B because I am in a study. December 26, 2022, I had a telehealth visit on January 16, 2023 because I was not feeling better. The first visit. I was prescribed Doxycycline for 7 days. I did not get better. January 16, 2023, I had an in person visit, they did a chest X-ray, and they gave me methylprednisolone tablet.  I never fully recovered. On March 27, 2023, I got sick again. It regrouped and I went through the same symptoms again.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL 9 lot # L043213 for prophylaxis. On an unknown date the patient experienced incorrect product storage and no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to GARDASIL 9. Additional information has been requested.
Pt reported to clinic in on 10 June with 102.9 degree fever, sore throat, and chest pain (5 out of 10).  He received the vaccinia virus 11 days prior.  Given the probable viremia and chest pain the pt was medevaced to a medical center.  He was placed in the ICU under observation by Cardiology.  Serologic markers indicated that he had a myo-pericarditis presumably from the vaccinia he received.  He stayed in the ICU for 4 days, and on the ward for 2 days.  When his troponin levels returned to normal he was released.  He was sent home on convalescent leave for 6 weeks. He is to receive follow-up Cardiology care.  We hope to have him back to full duty in 2-3 months.
Received Flu vaccine at 0945, one hour after vaccine mom noted patient rolling tongue back and forth inside lower lip.  Became fussy ate a little at 1030.  Refused lunch, fell asleep on way to medical doctor office. Vomited x 2 in office, lethargic but arousable in medical doctor office for 1 hour, then alert and active.  Later at home temperature 100 degrees axillary and fussy. Seemed fine in am 11/7.
This case was reported by a healthcare professional and described the occurrence of injection site bleeding spot in a 4-year-old female subject who was vaccinated with HAVRIX, (GlaxoSmithKline).  Concurrent vaccination included MMR II (Merck) and VARIVAX (Merck) both given on 25 March 2009.  There were no concurrent medications.  On 25 March 2009 at 14:00 the subject inadvertently received an adult dose of HAVRIX in the left arm for the 2nd dose.  On 25 March 2009, at an unspecified time after vaccination with HAVRIX, the subject experienced injection site bleeding spot and an unintentional overdose.  She should have received a pediatric dose of HAVRIX.  At the time of reporting the events were resolved.  Follow-up information was received on 13 April 2009 from the reporting medical assistant.  The events resolved.  The medical assistant considered the events were related to vaccination with HAVRIX.  The medical assistant considered that the events could have been associated with erroneous administration: wrong dose.
Soreness at location of injection, during both vaccines on 12/22 and 01/11. Rash located on both arms, chest and back, rash occurred 01/10 and is ongoing as of 1/13/21. Swelling of face, hands, arms and ankles. Ongoing. Doctor advised these may be delayed reactions from the initial dose on 12/22.
needle or syringe popped off; splashed into my face/it got in my eyes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (needle or syringe popped off) and OCCUPATIONAL EXPOSURE TO PRODUCT (splashed into my face/it got in my eyes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (needle or syringe popped off) and OCCUPATIONAL EXPOSURE TO PRODUCT (splashed into my face/it got in my eyes). At the time of the report, DEVICE CONNECTION ISSUE (needle or syringe popped off) and OCCUPATIONAL EXPOSURE TO PRODUCT (splashed into my face/it got in my eyes) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment information was provided
Patient came into the hospital for second dose Pfizer. Patient was told to check in with lead RN's to have BP checked due to high BP at last second dose appointment. RN took patients BP at 1320. BP: 160/118. RN retook patients BP at 1327. BP: 150/120. RN called 911 at 1329. Paramedics arrived on scene at 1340. EMS took patients BP at 1342. BP: 142/122. Patient was recommended to go to emergency room. Patient denied going to emergency room and signed AMA form. Patient was educated by RN on worsening signs and symptoms of a hypertensive crisis. RN recommended that patient go see PCP regarding high BP readings. Patient verbalized understanding of education and reason to go to PCP. Patient was denied second dose Pfizer due to high BP. Patient verbalized that he would go see PCP soon. Patient was told to see Lead RN's before coming back for second dose appointment so BP could be checked before vaccination. Patient verbalized understanding of instructions.    Patient received second dose Pfizer on 7/20/21 (LOT#: EW0183) at 1415. RN stated to another RN that she had seen patient in the observation area at 1416. RN's went up to patient and confirmed that it was the correct patient. Patient stated that he had gone into another hospital on 7/08/21 at 1800 to get BP checked. BP reading at clinic was 125/82. Patient stated that all tests came back normal. Patient was not given any new medications during visit. Patient was discharged from clinic. Patient stated that he feels good. Patient left vaccination site unassisted with a steady gait at 1430.
A day or two after the vaccine was administered I had flu symptoms and it was difficult to raise my right arm. I was given TAMIFLU at an urgent care clinic and my symptoms got better, but I was still unable to move my right shoulder. Today, almost 2.5 years later I am still unable to move my right arm. I believe the flu shot caused an RA flare that attacked and severely damaged my right shoulder joint and the nerves in that area making it paralyzed.
Pt came back in the next day after getting new Pfizer Bi-Valent booster.  Pt states tolerated prior doses fine. This dose arm started aching noticeably by bedtime (9pm'ish).  Woke up the morning of 9/10/22 and had a red slightly raised area oblong 2" wide aby 1" tall roughly. Warm to touch, some pain/tenderness, with a tight knot like feel.    Pt advised these are listed side effects of original vaccine and would apply to new booster.  Pt to try OTC pain relievers, antihistamine, ice pack. Was advised to notify Dr through exchange/after hours portal and follow up with them monday especially if hasn't subsided. If get's worse go to Urgent Care Clinic/ER.   Report any long term issues if any later through MD follow up.
Pt fainted after injection was given twice in the office. Pt hit head on counter. No tx ness. Pt was reclined and observed in office for over 20 min. Given cold packs and released to mother.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 02-NOV-2011, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 24-APR-2015, the patient was treated by a physician for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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 unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a registered nurse concerning an 8 year old male who on 24-SEP-1999 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). There was no concomitant medication. On 21-JUN-2007, the patient experienced rash on abdomen and chest- erythematous small papules. There was an outbreak in the patient's classroom. The parent called to report on 23-Jun-2007, definitely varicella. Subsequently, the patient recovered from rash on abdomen and chest - erythematous small papules on an unknown date. Additional information is not expected.
"yesterday my arem was sore. More sore than usual with a shot to the point it was difficult to move. Last night, I had the chills and was very achyespecially in my joints. This morning, I checked my temperature and do not have a fever. I feel better, but I am groggy from lack of sleep".
It starts out like a slotting pain in my heart. The inside of my chest in the center, it hurt to touch it. The past 3 weeks, I been having stomachache. I was getting body aches. I contact the virtual doctor; they think it might be an ulcer. They gave me medicine for it. I also had a headache for 2 weeks. If my heartburn and stomach pain do not go away, they are planning on doing a Colonoscopy.
This spontaneous report was received from a registered nurse regarding to multiple unspecified patients of unknown age and gender. No concurrent conditions or pertinent medical history were reported. The registered nurse reported that on unspecified dates between 01-AUG-2016 and 23-AUG-2016, multiple unspecified patients received improperly stored doses of VARIVAX, lot number M015735, expiration date 30-MAR-2018, lot number M004663, expiration date 27-JAN-2018 and lot number M008173, expiration date 16-FEB-2018, (dose, frequency and route not reported). No adverse effects were reported. The registered nurse confirmed that the excursion temperature was 8F for a time frame of 552 hours. The temperature went back in range and there were no previous excursions. It was unknown if the report was part of a data logger, and no product quality complaint was involved. This is one of two reports from the same reporter. Additional information has been requested.
Raised are on left on left anterior thigh, red base and some tenderness. Consistent with varicella vaccine site.
Information has been received from a pharmacist concerning an approximately 82 year old patient who was vaccinated with a dose of PNEUMOVAX (lot# 661831/0310Y). Subsequently the patient experienced cellulitis at the injection site. At the time of reporting, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Patient stated experiencing pain in the arm on which she was administered flu vaccine. The patient is still experiencing pain. The pain started 3 days after the immunization.
At birth, child had an apgar of a 9 and 23 hours (shortly after Hepatitis B) his heart stopped. Child was blue from SIDS. At 3 weeks, few days after Hepatitis B, child had viral meningitis and brain damage.
Received MMR and Varivax on 8/18/99.  On 11/12/99 pt developed red papule vesicular rash on r/buttocks, spreading to r/leg to shin in Dermatome pattern.  Culture of vesicules confirms Varicella-zoster.  Diagnosis of shingles.
A report was received from a consumer concerning a female patient who was participating in the mRNA-1273 Emergency Use Program and experienced fever.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received a planned dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  The patient reported they were running a fever on an unknown date. No additional details were provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, fever, was unknown.; Reporter's Comments: This case concerns a female of unknown age who had a nonserious expected event of pyrexia.  Event onset occurred with unknown latency after a planned dose of mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the pyrexia, a causal relationship cannot be excluded.
symptoms. pins and needles sensation on face and arms ongoing since 9/10/21( Shot on 9/9/21)