chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Going to the restroom a lot; Nauseated; Shaky; Not feeling too well; Weak; Dizzy spells; A spontaneous report was received from a consumer concerning herself, a 42-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizzy spells, felt weak, Fainting (Syncope), not feeling too well, weak, shaky, and nauseated, going to the restroom a lot.  The patient's medical history was not provided by the reporter. Concomitant medications were also not reported.  On 18Mar2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot/Batch number: 032M20A) intramuscularly in her right deltoid for prophylaxis of COVID-19 infection.   On 18Mar2021, the patient experienced dizzy spells, felt weak and almost Fainted. On19 Mar2021, patient was not feeling too well, weak, shaky, and nauseated. On an unknown patient going to the restroom a lot. The event almost Fainted was considered to be medically significant.  Action taken with mRNA-1273 in response to the events was Unknown.   The outcome of the events, dizzy spells, felt weak and almost Fainted, patient was not feeling too well, weak, shaky, and nauseated, going to the restroom a lot was considered to be unknown at the time of this report.; Reporter's Comments: Based on the current available information which shows a strong temporal association between the use of the mRNA-1273 and the reported events, a causal relationship cannot be excluded. Nausea is consistent with the safety profile of the product.
02/26/2021 Vaccination. I took Benadryl before vaccination. I got an upset stomach, nauseous. My armpit swelled up so much, I couldn't even put my arm down. I had to put ice packs there and a few days later, the rash came back to my arm again like the first vaccine.
HEAD PRESSURE; FATIGUE; This spontaneous report received from a patient concerned a 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: 1808609 expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced head pressure. On 19-MAR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from head pressure, and fatigue on 20-MAR-2021. This report was non-serious.
swelling at injection site 13 days after injection; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (swelling at injection site 13 days after injection) in a female patient of an unknown age exposed to mRNA-1273 (Moderna COVID-19 Vaccine) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     No Medical History information was reported.    On an unknown date, the parent 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,  after exposure to mRNA-1273 (Moderna COVID-19 Vaccine), the patient was diagnosed with INJECTION SITE SWELLING (swelling at injection site 13 days after injection). At the time of the report, INJECTION SITE SWELLING (swelling at injection site 13 days after injection) outcome was unknown. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment was reported.
I had flu like symptoms including extreme exhaustion; achy limbs; and a severe headache for about two days. The symptoms were made better with Tylenol.
Resident reported soreness to left arm and began having diarrhea and chills at approx. 0900 the day after receiving the vaccine. No treatment at this time.
After the patient received his shot and instantly he began to sweat, felt thirsty, looked pale in color, unable to hear clearly and vision was blurred.  He never completely fainted or fell on the ground .  He felt no pain and his temperature was normal at 96.8F.  After 10 minutes the patient symptoms started going away.  When the paramedics arrived they cleared him to leave.
Fever, chills, irregular heart beat, with heart bounding hard and sensation of skipping beats and fluttering. This continued throughout the next day or so and slowly subsided. Pain in chest, feeing like some heavy weighted object on my chest, dizziness and fatigue. Frightening symptoms, it seemed my heartbeat was out of control.  My oxygen meter showing lower than normal rating. Extremely exhausted and fell asleep not long after symptoms started and sleep for hours. I was wrapped in blankets wearing layers of clothes felt freezing cold.
The following day 8.28.21 I began to feel very weak, developed a bad headache all day, felt like I could not wake up and extremely fatigued.  I laid in bed or couch all day long as ai felt weak and light headed.   On 8.29.21 I was feeling better when I woke up at 7am.  Right around 1030am I began to have this sudden urge of anxiousness and numbness down my left side of chest and arm and felt funny inside, almost like I wanted to burst out of my skin.  Then About 15 minutes later I started puking violently.   Now I am back in bed and exhausted
A non-serious, spontaneous report of six month-old received FLUMIST, fever and loss of appetite was received from a nurse concerning a six month-old male patient, subsequent 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. Neither relevant medical history nor concomitant medications have been reported for this patient. The patient received FLUMIST on 11-Oct-2008. As reported on 14-Oct-2008, the child has had symptoms of fever and decreased appetite since vaccination. The outcome for the reported adverse events was not reported.
Kinrix administered to a 12 months old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 23-SEP-2022 Reporter's Comments:  The reporter stated that the Kinrix to a 12 months old patient. Reporter asked how to proceed with patient. The reporter mentioned that actually there were 2 patients who received the Kinrix vaccine, since these patients were twins. Did not consent to follow-up. Additional Supportive Information: The Kinrix to a 12 months old patient, which led to inappropriate age at vaccine administration. Refer case 1 of 2 twin case US2022137222; Sender's Comments:  US-GSK-US2022137222:Same reporter
On the day of the vaccination in the afternoon I felt very tired and at times I felt dizzy.  The next day I woke up with an intermittent headache, little bit fatigue, very very tired, my arm was super heavy and I was in bed all day. The third day I felt dizzy at times, tired, my eyes itched a lot and my body.  I didn't take any medication at any time.
ADMISSION HISTORY AND PHYSICAL: DATE OF ADMISSION:  07/02/11 CHIEF COMPLAINT:  Visual disturbance. HISTORY OF PRESENT ILLNESS:  Patient is a 34-year-old woman with no significant past medical history who reports visual disturbance for the past week.  Initially, the problem was intermittent and characterized by a sensation of the room lurching to the left when she opened her eyes.  This persisted for about 15 to 20 minutes after each time she slept or had a nap, but was not entirely consistent.  Two days ago, the patient noted double vision, but this also was only when trying to look at distant objects.  She denies any monocular vision loss and can correct the double vision by covering one eye or by focusing on something nearby.  She also reports that her eyes feel "stuck shut" when first opening in the morning, although there is no crusting or discharge. Yesterday, the day prior to the admission, she has felt lightheaded all day, but on further examination, she states that she was off balance when walking and could not quite figure out where her body was in space.  She denies any recent travel.  Denies any tick bites.  Her only recent medical procedure was hepatitis B vaccine, the first of her life that she knows of, approximately 2 weeks ago. She has been preparing to be a CNA and this vaccine was given as part of her training and readiness through the home health agency. PAST MEDICAL HISTORY:  Recurrent sinusitis and allergic rhinitis. PAST SURGICAL HISTORY:  C-section x3, tubal ligation on the third one. MEDICATIONS:  Tylenol p.r.n. and allergy medicines over-the-counter. DIAGNOSIS: internuclear ophthalmoplegia
Started spotting 2 days after the vaccine which continued for 5 days. I then got my period which came a few days earlier than it was supposed to. I am usually very regular.
I suffer from chronic low back pain. After recovering the flu shot, my back started stiffening. I have pulsating stabbing pain on left side of my lower back that radiates to my left hip and down to my leg. My back feels heavy and the pain seems to be different than what it usually is. It's day 5 since I received it, and my knees are starting to get stiff, plus my feet are getting tingling sensations.
Suspected Vaccination failure; took the singles shot / still got the singless; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the concerned patient. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided.
Information has been received on 25-JUL-2017 regarding a case in litigation from a lawyer and a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. The patient was inoculated with ZOSTAVAX (lot number and expiration were not reported) subcutaneous on or about 08-FEB-2010, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 08-JUL-2016, the patient was treated by physician for a painful and blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed acyclovir and dermatologic (unspecified)( LIPODERM) for treatment of her painful symptoms. 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, pain and suffering, and other damages. Additional information has been requested.
swelling, pain, erythema at injection site (2" round) and additional reddness noted below and proximal to injection site.
This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received SHINGRIX for prophylaxis. On 1st June 2018, the patient received SHINGRIX. On 1st June 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema and vaccine administered at inappropriate site. In June 2018, the patient experienced sleeplessness. On an unknown date, the outcome of the injection site pain, injection site erythema and sleeplessness were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the injection site pain, injection site erythema and sleeplessness to be related to SHINGRIX. Additional details were provided as follows: The nurse reported the case for herself. The reporting nurse received a dose of SHINGRIX which was reportedly administered too far below the deltoid, which led to vaccine administered at inappropriate site. The patient experienced local injection site pain and redness (3-4 inches in diameter), and it started resolving seven days later. Less than a week after receiving SHINGRIX, the patient could not sleep due to pain. The nurse did not have lot number or expiration of vaccine. It was not known if this had been reported before. The reporter had consented to follow up.
Head spinning; Blacked out; Fever of 102.7F; Chills; Sweating the whole night; Unable to sleep (just rest her eyes); Muscle cramps  and/or muscle convulsions; Felling freezing; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Head spinning), LOSS OF CONSCIOUSNESS (Blacked out), HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)) and MUSCLE SPASMS (Muscle cramps  and/or muscle convulsions) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)), MUSCLE SPASMS (Muscle cramps  and/or muscle convulsions), FEELING COLD (Felling freezing) and CHILLS (Chills). On 18-Sep-2021, the patient experienced VERTIGO (Head spinning), LOSS OF CONSCIOUSNESS (Blacked out) and PYREXIA (Fever of 102.7F). At the time of the report, VERTIGO (Head spinning) had not resolved and LOSS OF CONSCIOUSNESS (Blacked out), HYPERHIDROSIS (Sweating the whole night), INSOMNIA (Unable to sleep (just rest her eyes)), MUSCLE SPASMS (Muscle cramps  and/or muscle convulsions), FEELING COLD (Felling freezing), PYREXIA (Fever of 102.7F) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2021, Body temperature: 102.7 (High) 102.7F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.; Sender's Comments: This case concerns a 32 year old female, with no details on medical history provided, who experienced the unexpected event of LOSS OF CONSCIOUSNESS. The event occurred approximately one day after receiving a dose of Spikevax, which dose number is unknown. Rechallenge is unknown as there is no information about other doses of Spikevax. The benefit-risk relation of Spikevax is not affected by this report. Event of loss of consciousness was automatically upgraded as a serious event as per IME list. However, based on information available and as per medical criteria, it was classified as Non-serious.
Day after vaccination fever 99.1, nausea, dizziness, questionable vasovagal RXN.
Swollen lymph nodes back of neck and scalp; no other sign of infection; within 5 days developed bodily rash on torso, arms, buttocks which is still resolving.  Saw urgent care dr and family doctor; nothing diagnosed.
TDaP to (L) Delt 7/24 and PPD to (L) lower forearm at same visit. Pt in for PPD reading clear induration to (L) lower FA and (L) upper arm noted with erythema, warm to touch and pt with c/o itchiness. PCP eval Rx hydroxyzine.
Break through COVID19 infection: I had sinus infection, then I woke up early in the morning and had severe problems with breathing. So then I went Clinic and got in right away. The symptoms were similar to COVID19 and was positive.  Specifics for me: moderate aching bones, ran low temp, little above normal, severe congestion and breathing issues.  It lasted about 10 days total. I told the Doctor at next visit - if I had not had the vaccine I think I would have died.  I believe the vaccine modified my symptoms.
Two days after vaccination had swelling in both wrists and both hands and fingers. Seeming arthritic condition. Never had any type of arthritis or swelling of hands or wrists. Slight pain in hands and inability to grip or hold items. First took acemetacin for several days with no relief. then tried normal aspirin for several days. After two weeks someone suggested taking ibuprofen. I took 200mg per day and found slight relief. Contacted my PCP on 2/28/2021 to request a video visit that occurred on 3/3/2021 at 8:00 am. Doctor agreed that swelling and arthritic condition was the result of vaccination and advised to take 600 mg of ibuprofen every 8 hours for a week. Have had some relief from this medication. Doctor advised not to take the second vaccination shot.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24-month old male patient who received FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. Notes: The child had 2 pediatric doses of FLUZONE QUAD in 2017 previously. Concomitant medications included Hepatitis A Vaccine second dose (Lot number not provided) on 01-Oct-2018. On 01-Oct-2018, the patient received a 0.5ml dose of suspect Influenza Quadrival A-B Vaccine, lot number UI986AB, expiry date 30-Jun-2018 via intramuscular route in the right thigh. It was an actual medication error due overdose. It was reported that staff gave a 2 yr. old an adult dose 0.5ml of FLUZONE QUAD. The patient did not experience any adverse reaction after the injection. 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.
I have a history of SVT, which occurs on and off throughout the year. About a week after getting my 2nd Moderna shot and again after my booster shot I experienced an unusually high number of SVT episodes that occured daily for almost a month. I normally do not have episodes of this length and frequency.
pt recv vax & approx 30min post vax pt exp dizziness;VS were nl;MD indicated that 8 other pt had similar exp (WAES97100694 & 97100696 through 97100702);
CHIEF COMPLAINT:   pt reports about 1 week of RLQ abd pain, worse today. no n/v/d/c.   HISTORY OF PRESENT ILLNESS:     Patient is an 89-year-old female, diagnosed with Covid roughly 1 month ago with no significant complaints of chest pain, shortness of breath, fever chills, who presents with a 1 week history of right-sided abdominal pain with no associated nausea, vomiting, diarrhea or constipation.  Did report some dysuria several days ago but no dysuria, hematuria or increased urinary urge or frequency.  No headache, myalgias, sore throat.  No focal paresthesias or weakness.
Red rash on interior chest, Chest felt hot 4 days after vaccination 10pm evening. skin on my chest was swollen burning and itching.  I applied triamcimolone cream 0.01%. Rash only appeared at night, cream applied made help reduce redness by morning.  Doctor provided oral steroids prednisone.
stiffness in neck and shoulder to the point that I almost could not raise my head, persisting overnight and into a second day
Acneiform rash started 10 days after vaccine. Painful: pruritic. Treated with Allegraa nd Mytsin.
No additional AE details; PNEUMOVAX 23 was inadvertently administered after a non-supported temp excursion; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported.  On 11-APR-2022, the patient was inadvertently vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, lot #U022819, expiration date: 14-JAN-2023 (strength, dose, site, and route of administration were not provided) administered for prophylaxis, after a non-supported temperature excursion (product storage error).   Vaccine was improperly stored for 96 hours in temperature of 70 Fahrenheit degrees. There were no previous excursions. It was not reported whether the digital data logger was involved to capture the temperature excursion. No additional adverse events details or product quality complaints were reported.
INADVERTENTLY GIVEN VACCINE TO A 16 YEAR OLD; OFF-LABEL USE; This spontaneous report received from a pharmacist concerned a 16 year old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced inadvertently given to a 16 year old. On 08-APR-2021, the subject experienced off-label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inadvertently given to a 16 year old and off-label use was not reported. This report was non-serious.
had a cough following the booster shot that just did not improve.  Then on December 2nd I  was constantly coughing late evening when I suddenly couldn't breath.  Ended up called the ambulance at which time I was taken to the Emergency room.  I was wheezing bad and coughing at the same time.  Breathing treatment was done, antibiotic and steroid given and then was released.  I had fatigue and lingering cough and was unable to go to work for over a week after.  Doctor had prescribed inhalers and medicines which helped.
Left arm sore when touched and there was a small bump. Unable to sleep on my left-side because of the pain. Over the past week, bump has grown to about 1½ - 2 inches in length and hard. Soreness decreased some. Also experienced bouts of nausea on several days and an increase in bowel movements.