chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I might not get the second dose for more than 35 days; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I might not get the second dose for more than 35 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21H) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm). On 22-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I might not get the second dose for more than 35 days). At the time of the report, PAIN IN EXTREMITY (soreness in her arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I might not get the second dose for more than 35 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported. No treatment information was provided
10/10/17 Employee called to notify that she is continuing to have left shoulder bursitis type pain after receiving her flu shot 3 weeks ago. She said the pain started within 2 hours of receiving the flu shot. She has been using OTC pain tablets/ice for some relief. Advised to f/u with PCP if symptoms worsen or if no improvement in near future. 11/7/17 F/U with employee states difficulty getting shirt on and off over her head and having difficulty sleeping as usually tucks arm under pillow but cannot due to pain in shoulder. Encouraged to f/u with PCP. 11/28/17 F/u email to employee with following response: Still having difficulty when sleeping as bringing arm up under pillow produces pain in shoulder. Getting shirt on and off over head has improved. Saw PCP with no new recommendations. This is an employee who gets her flu shot every year and has not had any symptoms like this in the past.
I got a flu shot at work October 5th as I usually do. By Sunday night I had become sore and achy all across my body. I went to an emergency room on Monday as I knew something was very wrong. Unfortunately the doctor who saw me ignored most of my symptoms and diagnosed me with arthritis in the knee. Later that week I saw Dr and he diagnosed a bad reaction to the flu vaccine. He referred me to a rheumatologist  as the vaccine seems to have triggered arthritis.
Information has been received from a medical assistant, referring a patient of unknown age and gender. Information on medical history, concomitant medications and drug allergies was not provided.   On an unknown date, the patient was vaccinated with a dose of improperly stored VARIVAX (lot# M038858, expire date: 14-SEP-2018) for prophylaxis (dose and route of administration were not reported). The temperature of storage for VARIVAX was above -10 Celsius and below 8 Celsius for 1 hour and 2 minutes (2 excursions). A data logger was involved. There was no previous temperature excursion. No adverse effects were reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011638: US-009507513-1706USA000480: US-009507513-1706USA000481: US-009507513-1706USA000482: US-009507513-1703USA002284: US-009507513-1706USA000487: US-009507513-1706USA000489: US-009507513-1706USA000490: US-009507513-1706USA000491: US-009507513-1706USA000492:
Information has been received from a physician concerning a 15 month old male who on 02-JUL-2008 was vaccinated subcutaneously with a first 0.5 ml dose of VARIVAX (lot # 659935/1900U). Concomitant therapy included MMR II, RECOMBIVAX HB (manufacturer unknown) and VAQTA (manufacturer unknown). Subsequently on 22-OCT-2008 the patient experienced shingles on his left leg after the vaccination. The patient sought medical attention, and lab test "DSA test for varicella-zoster virus" was performed. At the time of reporting, 29-OCT-2008, the patient had not recovered. Additional information has been requested.
States "Flu Shot" given in right deltoid. Right shoulder sore cannot raise above shoulder level without pain - injection given 3 weeks prior and symptoms have been present since injection (next am).
Suspected vaccination failure; shingles on my forehead and the side of the face; Very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter reported for himself or herself. The age at vaccination was not reported. The patient had shingles on forehead and the side of the face. The patient stated it was very painful. The patient had to get eyes checked as someone said to patient that he or she could go blind from having the shingles so close to eyes. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided. No further information would be available.
BRAIN ANEURYSM; CHEST PAIN; This spontaneous report received from consumer (company representative) and concerned a female patient of unspecified age received via social media. 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, start therapy date were not reported administered 1 total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, one day after vaccination, the patient started with chest pain and paralysis on her left side. She rushed to the hospital where numerus tests were performed. She had about 8 seizures in previous 2 days. She never had seizures before. Patient was continuously monitoring via EEG (electroencephalogram). Doctor found 3 millimeter brain aneurysm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of brain aneurysm and chest pain was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0-20210421076- Covid-19 vaccine ad26.cov2.s- Brain aneurysm and chest pain. These event are considered unassessable. The event have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
NO ADVERSE REACTIONS DURING THE OBSERVATION PERIOD, PATIENT LEFT WITH NO REACTIONS.
Received two doses (1st dose was administered on the 8th of October, 2021).
Started to swell; Face was red like a rash; Arm was swollen; Face was reddish; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Face was reddish), SWELLING FACE (Started to swell) and RASH ERYTHEMATOUS (Face was red like a rash) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (apricot), Food allergy (dumplings), Food allergy (a type of tea) and Allergy to plants (aloe vera).    On 10-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2022, the patient experienced PERIPHERAL SWELLING (Arm was swollen) and ERYTHEMA (Face was reddish). On an unknown date, the patient experienced SWELLING FACE (Started to swell) and RASH ERYTHEMATOUS (Face was red like a rash). At the time of the report, PERIPHERAL SWELLING (Arm was swollen), ERYTHEMA (Face was reddish), SWELLING FACE (Started to swell) and RASH ERYTHEMATOUS (Face was red like a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  Patient had no allergies to medicines or vaccines.  Reporter stated that patient had not had a previous diagnosis of covid-19. She was currently at a clinic awaiting treatment at the time of this call. No tests or medications have been administered at this time.
received Moderna vaccine and experiencing unspecified side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (received Moderna vaccine and experiencing unspecified side effects) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (received Moderna vaccine and experiencing unspecified side effects). At the time of the report, VACCINATION COMPLICATION (received Moderna vaccine and experiencing unspecified side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were provided by the reporter.
Patient started with fever about 22 hrs after injection was given. Patient's mother then noted that he started having redness around the injection area with rash in area as well. Mother reported that redness continued to get larger in the area of the injection site when mother brought patient into the office redness and rash was about 12 centimeters in radius. Patient was seen in the office for this reaction and was discussed with mother as to what to continue to watch for and to no longer get this injection.
received / 1st dose / on 27Nov2020 and / 2nd dose on 28Dec2020; mild sore arm; This case was reported by a physician via call center representative and described the occurrence of pain in arm in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 28th December 2020, the patient received the 2nd dose of Shingrix. On 28th December 2020, less than a day after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too short. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows:  After receiving 2nd dose of Shingrix, the patient experienced mild sore arm that resolved after 1 day. The patient received 2nd dose of Shingrix, before than the recommended interval, which led to shortening of vaccination schedule. The HCP did not have the lot/exp at the time of report. The reporter consent to follow up.
Heavy wheezing/headache. Wheezing lasted around 20 minutes. Headache at time of this email.
Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022) and NO ADVERSE EVENT (No adverse event) in a 28-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 002M21A and 002M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 02-Jun-2022, received second dose of mRNA-1273 (Spikevax) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 21Apr2022 and administered on 2Jun2022).    No concomitant drug information was provided.  On 21-Apr-2022, the vial was initially stored in the refrigerator and administered on 02-Jun-2022. The vial did not undergo any temperature excursions.  Patient did not experienced any symptoms following vaccination.  No additional doses, medications, or treatments have been administered at the time.   This case was linked to US-MODERNATX, INC.-MOD-2022-637070 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-637070:Same reporter (Patient C-A)
11/23/99, 14:30, child developed fever of 105 and had 3 seizures in hospital. Child was admitted and had lumber puncture (neg). Had seizure in the hospital at approx 01:00. Follow-up: Temperature up to 105 degrees seizures, generalized swelling of body. Hospitalized x 4 days. Pat on Prednisone. 2/10/00 haven't be able to reach reporter by phone x 5 attempts since 12/22, have left messages. Also has not responded to mailed request of 1/11/00. Placed another call to her today. Could not speak w/ her directly- gave message and # to operator.
12 mo M who was sleepy after immunizations. Mom reports that pt had several "staring spells" during which he was unresponsive, lasting several seconds. Pt seen in clinic on 7/7/11 - nl exam.
I had not been experiencing any regular allergy symptoms for at least a year before I got the vaccine - all of my symptoms were well controlled by the Cetirizine pills that I take daily.   Approximately 45 minutes after I received the vaccine, my tongue started to feel numb, my tongue started to itch, and my throat started to feel like it I had a swollen and sore throat.  So, I took a Cetirizine tablet.  But, these symptoms continued for about 2 more hours so I went to an urgent care center and the doctor gave me a prescription for Medrol dosepak and an Epi-Pen.  The steroids seemed to help relief my tongue itching & sore throat. A few days later, I noticed that the skin around my injection site was dark & discolored for a while and after a few days there was a rash from the injection site down the length of my arm that remained there for almost three weeks.  There are still a few small flesh colored bumps near the injection site and my throat continues to feel sore  - especially when my Cetirizine tablets wear off.
8:00 PM, arm started to get sore at injection site,   9:00 PM started feeling body aches and fatigue.  11:00 PM had fever, chills, shaking, and more body aches, headache.  The nerves in my back feel sensitive like happens with shingles but shingles only break out on the back of my thighs.  By 2:30 AM felt terrible, couldn't sleep, took Tylenol and bundled up.  Finally stopped shaking and got warm.  By 6:30 AM fever seemed to have broken but body aches and headache continue.  Took Tylenol at 6:30 AM, 10:30 AM.  Feeling somewhat better but still have body aches and injection site soreness.  Have I recovered?  Not yet, not completely but going in right direction.
soreness at the injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 20Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "soreness at the injection site".  Additional Information: Gender: Female, Verbatim & Event Terms: (Withheld) received her COVID-19 vaccine on Saturday evening, 20Mar. She reported severe soreness at the injection site on her arm yesterday afternoon (Sunday, 21Mar).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 2/14/21 I had fever, dizziness,  and extreme pain at injection site. On 2/15/21 I had slight fever, no dizziness, arm still very sore and now with 4? by 3? oval raised red rash and with approx. quarter inch blister in the center of oval rash. The entire site is also hot to the touch.
Developed symptoms shortly after injection; Vasovagal response, dizziness, abdominal cramps, nausea; 21 y.o. female with no pertinent medical history other than ADHD is presenting with dizziness and "blacking out" after receiving her second dose of the Moderna COVID-19 vaccine at 12:20 pm today. Patient had no symptoms when she received her first dose of the vaccine. Patient reports that she became dizzy, diaphoretic, and lost vision after receiving the vaccine.  Per triage note staff at Walgreens reported no loss of consciousness, however.  Patient otherwise currently reports she is feeling fine.
Pt had "flu-like" symptoms starting 6 days after vaccination including nausea, body ache (no vaccine site reactions reported).
A golf ball size rash appeared  at the injection site (left shoulder) 9 days after the vaccine was administered.  There's no soreness.  the area is red and slightly raised compared to the surrounding tissue.
Pt presented 10/20 with fingertip fullness and drooping eyelids following flu vaccine 10/14/2009.  No resp depression or dysphagia. To ER for eval d/c with ? Myasthenia Gravis.  Pt returned 10/21 with ascending numbness to hands and soles of feet.  Drooling with po intake.  No Resp Depression. Oxygen saturation 99%. Normal reflex arcs. Emergency eval by Neurologist confirmed Guillan Barre. Patient admitted to Hospital. 10/23/09:  Primary care records received for dates of service 10/21/09 and 10/22/09.  Vaccination record for 10/14/09 received. Provisional Diagnosis:  MG vs. GBS. Assessment:  Presented 1 week after flu vaccine with bilateral eyelid drooping, numbness and tingling in hands and feet bilaterally, dribbling water as he was unable to seal his mouth around water bottle, midline tongue protrusion, no problem swallowing but having trouble spitting.   Motor sensory intact with normal reflexes.  Referral made to neurologist. 10/27/09 MR records received for date 10/21/09 to 10/24/09. Neurology DX: Bi-lat. Ptosis. Presenting SX: Pt c/o bi-lat eyelid heaviness and unable to open eyes entirely. (+) vision obscured, denies blurred vision. Assessment: PE WNL except (+)eye ptosis bilat. approx. ¾". Extraoccular movements are diminished bilat for upgaze and rt. greater than left horizontal gaze w/o nystagmus. Diminution of left greater than right gag reflex. Bilateral stocking and glove hypesthesia to sharpe and light touch with prominent hypesthesia over bilat patellar regions. Absent achilles reflexes bilat.
Nausea and diarrhea starting the day after the vaccine (24+ hours after). Symptoms worsened over the following days and patient had to go to the hospital for N/V/D. As of 4/21 (6 days after vaccine) patient is still feeling weak/dehydrated.
The patient received the vaccine and waited in the room while the parent received the vaccine. The patient then walked to sit in the waiting area, lost vision while walking, sat down, eyes began to roll, and the patient passed out momentarily (less than a minute).  Was moved to an area to lie down and remained there for approximately 15 minutes.
Red and swollen. Responds to ibuprofen. Pt thinks sensitivity. Is not concerned.
Sore arm, muscle pain, swollen/painful axillary lymph nodes on the right side, fatigue, brain fog,  increased nerve pain, abdominal pain, diarrhea
Temp increased 102 in Day 13 and mild viral stomatitis on trunk on Day 14 after MMR
The patient is a very pleasant 65 year old gentleman with a history of hypertension who presents to the hospital reporting a fever, cough, and chest pain starting two weeks ago.  He states that he has had flu-like symptoms for the previous two weeks with a prominent nighttime fever and sweats.  He states that he had a similar episode approximately one year ago.  He reports that since Saturday he became short of breath.  He states that when he goes and feeds the horses and walks back he is short of breath and needs to rest.  He denies any myalgias, nausea, vomiting, diarrhea, or abdominal pain.  He reports that he has chest heaviness.  In the emergency department he was diagnosed with pulmonary emboli with large clot burden.  He states that he has never had a blood clot.  He has no family history of cancer, deep venous thrombosis, or pulmonary embolus.  He denies any melena or hematochezia.  He states he has not had a colonoscopy.  He reports that over the past two weeks he has not been moving around much, saying that he has been largely confined to his chair due to his illness
This initial spontaneous report was received on 06-OCT-2017 from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The female patient was inoculated with ZOSTAVAX on or about 01-NOV-2011, and again on 26-OCT-2015 at the pharmacy 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). Despite being inoculated twice over the span of four year, the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 22-SEP-2016, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir (VALTREX) for management of her painful condition. 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.