chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Small itchy bumps on ears, neck and head, then disappeared in 2 days. New larger eruptions that are reddish and itchy appeared in other parts of the body (chest, back, hips, arms, legs) in the following days.
Patient reports feeling tight chest and respiratory difficulty, fatigue and phlegm, it was recommended to the lay from her Pneumologist to take Benadryl before the vaccine. Doctor is consulted and vitals are taken oxygen is supplied and she is stable vitals and saturation. After an hour patient feels calm and reports feeling better.
4 inch raised hot red itchy area, north to south line on injection site. Injection was given in upper rear arm not in deltoid area, ie posterior upper arm. Treated with Gold Bond ointment not which relieved itching. Area still 4 inches long raised hard red & hot on 12/17/2012.
Inappropriate schedule of vaccine; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 17-year-old male patient who received HAV (Havrix 720 Junior) (batch number yr532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HAV (Havrix 720 Junior).   On 2nd August 2021, the patient received the 2nd dose of Havrix 720 Junior (intramuscular) and Havrix Pre-Filled Syringe Device. On 2nd August 2021, unknown after receiving Havrix 720 Junior and Havrix Pre-Filled Syringe Device and an unknown time after receiving Havrix 720 Junior, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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 details provided were as follows: The nurse reported that the patient received the 1st dose and the 2nd dose in the left arm and the 2nd dose was administered before recommended interval, which led to shortening of vaccination schedule. No further details provided.
This spontaneous report as received from a Healthcare worker refers to an unspecified number of patients of unknown age. The pertinent medical history and concurrent conditions of patients were not reported. On an unknown dates, the patients were vaccinated with incorrectly stored VARIVAX lot # L037561, expiry date 29-SEP-2017 (dose and route not reported). The vaccine was exposed to the temperature of -10 degree Centigrade for 10 days. There were no previous excursion reported. The reporting healthcare worker was not aware of any adverse events. No additional information was reported. Additional information has been requested.
ARM SWOLLEN, SEVERE HEADACHES, HEART PALPITATIONS, PANIC ATTACKS, LEG PAIN, ARM STILL ITCHING AND RED AS OF 10/08/21
Within 8 hours of receiving the Moderna vaccination  (dose 1), I could not raise my left arm parallel to the floor, extend my arm or lie on my left arm/shoulder.  It has been 6 days, and it is somewhat better, but still quite limiting in what I can do. I sure wish I was told that this could happen.  I have osteoarthritis, and i rely on my left arm/shoulder when I take the stairs and do daily activities.  I am in a lot of discomfort and my activities have had to be quite limited.
flu; Initial information received on 22-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involved a patient of unknown age who experienced flu (influenza), while patient received vaccines INFLUENZA VACCINE.  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, patient who experienced flu (influenza) (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the event was unknown.  There will be no information available regarding batch number in this case.
Fever, chills, tremors that continued for several hours after onset around 2:30am. Took ibuprofen to bring fever down. Fever was gone by 6am, but came back around 8am. Took more ibuprofen and the fever is gone as of 3pm.
7 year old child was given a Kinrix vaccine, which should only be given prior to 7th birthday.
Day after receipt of Tdap and Hepatitis B vaccine vaccine recipient developed low grade fever, estimated at <100° F, nausea, generalized malaise and arthalgia which continues through report date.
PT WITH URTICARIA AND FACIAL SWELLING AFTER FLU VACCINE ADMINISTRATION. PT GIVEN BENADRYL 5ML, AND PREDNISONE 10ML IN OFFICE. SYMPTOMS DECREASED UPON DISCHARGE.
Fever of 99.4 for 3 hours one week post injection. Got the shot on Wednesday. Spent the weekend giving riding lessons to 4H kids in open arena. 6 foot distancing, no masks as we were shouting instructions to kids. One girl came down with Covid on Monday. I had fever on following Wednesday. Better by evening.
Tingling of upper lip and numbness of upper jaw, progressed to blockage of nose and head, alteration of hearing (my voice no longer sounded the same to me), increased pressure in my head, then tightening of my throat starting with the upper back of throat and progressing around and downward.  The nurse who administered the vaccine gave me adrenalin.
Information has been received from a woman concerning a "medically fragile" male family member with Costello syndrome, an autosomal recessive disorder, who in 1998 was vaccinated with varicella. Subsequent laboratory evaluation revealed a lack of response. On 1/21/00, he was administered an additional dose of varicella virus vaccine. Unspecified medical attention was sought. No further information is available.
She recently developed a new allergy to apples and has an epi-pen; She also previously had shingles on her arm; This is a spontaneous report from a contactable consumer or other non HCP.    A 54-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Patient stated she had a crazy several months. She had been to the ER several times with severe oesophageal reflux and GERD. She is currently taking a break from Ibrance until October. She had been off for a couple of months. She had an endoscopy completed. Being off of Ibrance is not helping her issue as far as she can tell. She is on GERD medication and is still having breakthrough issues. She is so nauseated some days she cannot get out of bed. This could be connected to her autoimmune disease, but she does not think it is related to Ibrance. She has lost some weight which is good since she has struggled with weight gain. She has no energy to work out. She recently fell off a ladder. She is trying to better manage her stress. She was previously so sick that she had to keep getting fluids. When she is on Ibrance her platelets and counts go down. She has had her COVID vaccine and flu vaccine. She recently developed a new allergy to apples and has an epi-pen. She ate one and her throat got itchy, and her lips were numb and tingly. She also previously had shingles on her arm. The outcome of the event new allergy to apples and has an epi-pen, she also previously had shingles on her arm on an unspecified date with outcome of unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up  Follow-up (27Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 2/7/2023 Discharge Date: 2/16/2023  HOSPITAL COURSE:   History was obtained from the patient as well as extensive chart review which is highlighted and summarized below   87 y.o. male who  has a past medical history of Anxiety, CAD (coronary artery disease), COPD (chronic obstructive pulmonary disease) (HCC), GERD (gastroesophageal reflux disease), Glaucoma, Gynecomastia, History of mammogram, HTN (hypertension), Hyperlipidemia, Hypothyroid, Macular degeneration, Osteoarthritis, PVD (peripheral vascular disease) (HCC), Renal insufficiency, Statin intolerance, Stroke (HCC), Testicular hypofunction, Thyroid cancer (HCC), and Type 2 diabetes with nephropathy (HCC).   He initially presented to the hospital 1/27/23 for traumatic L tympanic membrane perforation and incidental diagnosis of COVID-19 infection. His hospital course was complicated by type 2 demand ischemic in setting of hypertensive emergency with troponin elevation as well as hospital acquired pneumonia and pericardial effusion. He required admission to ICU setting given requirement for multiple continuous IV antihypertensive drips. His home thyroid medication was decreased as there was thought that a component of iatrogenic hyperthyroidism could be contributing. He also developed AKI on CKD3, thought to be 2/2 ATN from hypertensive emergency. He was seen and evaluated by PT, OT, PM&R and felt to be an appropriate candidate for acute inpatient rehabilitation given cardiovascular deconditioning, impaired mobility and ADLs in setting of complex medical comorbidities as above and below.  Transferred 2/7/2023
Had Chest pains (thought lungs) went to urgent care, urgent care sent to Medical Center. Had Pulse of 168 thought drugs but too screen was all need. Told them had Covid shot 3 days before, said anxiety ended up admitting to hospital with tachycardia. Elevated D dimmer and WBC. They said I had anxiety, heart rate didn't go down after anxiety drugs x2. Ran lots of tests and sent home the rolling day with no answers and a pulse still around 100. Release from hospital at 5 pm last vitals were taken at 12pm with pulse of 96.
As I explained on the phone with a regulatory authority, I do not consider this an adverse reaction but was asked to fill out this report so that y'all have more information on vaccine reactions with people with chronic illness.   I received the Moderna Vaccine end of December and Early January (following the protocols for spacing the vaccine). After the vaccine, both times, I experienced a flare of my Rheumatoid Arthritis for approximately 5-10 days.   Symptoms included: running a low grade fever of approximately 100, increased fatigue, increased joint and general pain, slight dizzy spells.   All symptoms resolved fine, and I did not visit a clinic or contact my doctors as I was expecting this kind of flare. It is incredibly common for autoimmune diseases to react to vaccines or other medications (I also get flares when taking antibiotics or getting a flu vaccine).  I feel like the reporting system needs to be updated to accommodate patients like me who have reactions that are normal for our conditions. I hope that this report will also help  y'all have more research and data on patients like me.
Arm was sore the next day and I had a mild headache and moderate fatigue, but slept 10 hrs. and woke up the nex t day feeling fine. Arm was still sore, but subsided entirely after 3-4 days after dose. Then this week, 8 days after first dose, that evening I noticed around where I received my injection it itched. Over night the itching stopped by the skin felt warm, very tender to the touch, and had some redness.
I had a delayed reaction - started with redness and swelling - shoulder to elbow (left arm); and pain.  That started resolving day before yesterday and it's completely gone now. I contacted my provider and they said to take oral steroids on hand that I have for allergies.  This is something that happens to me with a lot of vaccines.
Brown gums since yesterday; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL DISCOLOURATION (Brown gums since yesterday) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced GINGIVAL DISCOLOURATION (Brown gums since yesterday). At the time of the report, GINGIVAL DISCOLOURATION (Brown gums since yesterday) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Tenderness in left axilla radiating down left inner arm with a "pinching" type pain in left inner elbow when elbow extended.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 12-OCT-2014 the patient was vaccinated with expired PNEUMOVAX 23 lot number J004332, expiration date: 26-SEP-2014 dose, frequency and route of administration were not reported. No adverse events were noted. Additional information is not expected, as caller declined follow-up to this report, and there was no permission to contact physician.
pt recv vax 24JAN97 & 5FEB97 pt exp one lesions on labia;pt was to be cultured for herpes simplex;
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that there was an excursion from the freezer on 1 Oct 2021.  No concomitant medication was reported . No treatment medication was reported .
Post/vax, pt developed increasing pain in arm, shoulder, neck & head, followed by rash in left arm, shoulder & chest. Pt went to PMD for treatment.
Within 1/2 hour post vax, the pt developed an elevated temperature and irritability. Child placed on antibiotics and given injection of Bicillin/Depomedrol. Appears to be recovering as of 10/30/00.
This spontaneous report was received from a medical assistant concerning an unspecified number of patients of unknown age and gender. Prior medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. This is a non-valid case due to lack of patient identifiers. On 05-APR-2018, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # N022727, expiry date: 12-JUN-2020, for prophylaxis) (strength, dose, dosage schedule and anatomical location were not provided) (product storage error). No adverse effects were reported. The temperature excursion and time frame for GARDASIL 9 was between 32 degrees Fahrenheit to 35 degrees Fahrenheit for a time frame of 0.167 hours (approximately 10 minutes). No previous temperature excursion was reported. Data logger was reported. Lot number K084421 is an invalid lot number for rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast). Follow-up information was received from a medical assistant on 27-JUN-2018. On unknown dates, an unspecified number of unspecified patients were vaccinated with improperly stored doses of VAQTA (lot # N005274, expiration date: 03-APR-2018, lot # N026997, expiration date: 10-NOV-2018, strength, dose, dosage schedule and anatomical location were not provided) and ROTATEQ orally (lot M045546, expiration date: 12-JUN-2018, strength, dose, dosage schedule and anatomical location were not provided) for prophylaxis. The temperature excursion and time frame for VAQTA and ROTATEQ was between 47 degrees Fahrenheit to 77 degrees Fahrenheit, 32 degrees Fahrenheit up to 35 degrees Fahrenheit and below 32 degrees Fahrenheit for unknown time frame. No previous temperature excursion was reported. Data logger was reported. This is a non-valid case due to the lack of a patient identifier. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received. Follow up information has been received from the medical assistant on 23-AUG-2018. This report refers to a 11 year old patient of unknown gender. The medical assistant stated that only one patient was vaccinated on 05-APR-2018 with GARDASIL 9, lot #N022727, expiry date: 12-JUN-2020, for prophylaxis. Also, there were no invalid lot numbers.
flu like symptoms; This non-serious case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number 5777F) for prophylaxis.   On 25-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular). On 25-SEP-2023, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms (Verbatim: flu like symptoms).  The outcome of the influenza-like symptoms was not resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.     It was unknown if the company considered the influenza-like symptoms to be related to Shingrix.   Additional Information: GSK Receipt Date: 26-SEP-2023 The patient reported when he administered the first dose of Shingrix on 25 September 2023 and went home he had the flu like symptoms. He stated the flu like symptoms was still ongoing at the time of reporting. The patient did not elaborate on the flu-like symptoms. The patient was driving and was not able to answer many questions. He offered after call survey.
Narrative: Patient with severe aphasia and only able to say "hey, hey, hey" or "uh huh" or shake his head no as a way to communicate. Patient previously able to ambulate with significant limp and hyperextension of right knee, but mostly wheelchair bound over last several years as he had had a slow and steady decline in overall health and mobility. Patient developed aggressive behavior of shouting "hey" and grabbing of groin in 2016. This was worked up with CT scans, labs, referral to urology, neurology, and referrals to psychiatry. The exact etiology of this action was never able to be affirmed, but thought to be more psychiatrically related. It improved significantly with addition of antipsychotics, worsened when antipsychotics were reduced, and improved again with addition of injectable antipsychotic on 12-10-2020.Patient suffered from falls on occasion given his significantly impaired physical mobility. His last documented fall was 8-31-2019. Patient began utilizing wheelchair most of time following that fall. No significant injuries noted in documentation of the falls. In the last 3 months, patient would often refuse medications. He would sometimes indicate that they would cause dizziness, and other times he would simply refuse. We attempted to hide medications in his food/fluid (with wife's blessing) and when he detected this he would occasionally refuse to eat. Patient previously on DOAC. After pharmacy review in 12/2020 it was recommended to discontinue this as no clear indication to continue use. He was high fall risk and would often refuse this medication as well since 10/2020. Noted to be in NSR on EKGs and decision made to discontinue the DOAC. Patient had no evidence of adverse effects noted after vaccination on December 28th. Patient seen by provider on the morning of his death (1/4/2021) with no noticeable significant change in health condition. Temperature 36.8Con January 4th at 19:45. During routine bedtime cares, patient suddenly collapsed and death was pronounced January 4, 2021 at 20:05. Autopsy was requested from next of kin and no autopsy was granted. Symptoms: & DEATH Treatment:
I was pregnant, due date was March 31,2022.  I got the vaccine on August 9, 2021 when I was almost 7 weeks pregnant. I felt no symptoms, just tired. Then a few days later I no longer felt pregnant. I had lost all of my pervious pregnancy symptoms. My first prenatal appointment was August 30, 2021.  The midwife performed an ultrasound to determine approximately how far along I was and discovered that the sack was empty. It appeared that based on the size of the sack the baby stopped growing at approximately 7 weeks.  I had had a silent miscarriage.
While seated still: eye balls rolled back in his head. Started to convulse, hit his head on the wall, helped down to the ground, 911 called unresponsive, administered EPIPEN, seizure/convulsions stopped, kept him on the ground in lying down position until paramedics arrived (All happened over about 5 minutes when paramedics arrived).
Redness, soreness, swelling, itching, hot skin at site, large raised round area, fast heart beat, elevated blood pressure (as much as 151/99)
Diarrhea throughout the night about 10 times or more. I had the flu with diarrhea all night long the day after my nasal H1N1 nasal was given. I was weak & not normal energy level for 1 week after this. Do I need to report this? i was thinking that someone would have only report death or permanent damage & temporary 1 week illness might not qualify. Can you help me with this question if I could report to the Compensation Program?
Pt recieved 4 immunizations. After the 3rd vaccine she complained of nausea and passed out in the nurse's arms immediately after the 4th injection. She was moved to the floor and legs were raised. Blueing of the lips was noted, but she was breathing on her own. Pt awake within 5 min and asking what happened. Her BP was stable and 02 was not needed. Pt said she had missed breakfast that morning.
Information has been received from a licensed practical nurse concerning an approximately 12 year old male patient who on 11-AUG-1997 was vaccinated with a dose of VARIVAX (Merck) (lot# 660407/0103X), subcutaneously into his left arm. Concomitant therapy included Tdap. The nurse reported that the patient developed hives over his whole body one week after vaccination with VARIVAX, on approximately 18-AUG-1997. The patient was treated with prednisone and ZYRTEC. At the time of the report, the patient had not recovered. The patient sought medical attention by phone. Follow-up information indicated per the physician, that the patient did not have an adverse experience following VARIVAX. No further information is available.