chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional adverse events reported; A dose of MMRlI and VARIVAX was given to a patient during a temperature excursion; This spontaneous report was received from a medical assistant concerning to a 3-days-old patient (discrepant information) of an unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 04-JAN-2020 (discrepant information), the patient was vaccinated with improperly stored doses of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter (ml) for prophylaxis, lot number reported as S029456 and expiration date as 19-SEP-2021 (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter for prophylaxis, lot number reported as T020650 and expiration date as 16-JUN-2022 (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported.  The administered vaccines had a temperature excursion of 5.6 degrees Celsius (°C) for a time frame of 16 hours and 20 minutes later found supported. There was not a digital data logger involved. It was also reported there was not a previous temperature excursion.
pancreatic cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PANCREATIC CARCINOMA (pancreatic cancer) in a 9-decade-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE INACT SAG 3V (FLUAD) for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE INACT SAG 3V (FLUAD) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATIC CARCINOMA (pancreatic cancer) (seriousness criterion medically significant). At the time of the report, PANCREATIC CARCINOMA (pancreatic cancer) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered PANCREATIC CARCINOMA (pancreatic cancer) to be related.    Concomitant medication not reported.   The patient was dying of pancreatic cancer. He never had any trouble with the pancreas before and he was almost 81. He was diagnosed with pancreatic cancer a few months after receiving the shot.  Treatment medication not reported. Company comment: This spontaneous case concerns a 9-decade-old male patient, with no medical history reported, who experienced the unexpected and serious (medically significant) event of PANCREATIC CARCINOMA, which occurred on an unknown onset latency with an unspecified dose of mRNA-1273 vaccine. The vaccination date and the onset of the event were not reported; hence, latency could not be properly assessed. Treatment medication not reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-737836, US-MODERNATX, INC.-MOD-2023-737856, US-MODERNATX, INC.-MOD-2023-737864 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-737836:Same Reporter US-MODERNATX, INC.-MOD-2023-737864: (same reporter) US-MODERNATX, INC.-MOD-2023-737856: (same reporter)
Increased aggression w/ sibling and peers (2 wks after and presently). Increased irritability (2 days after and presently). Obsessive, emotional, meltdowns for no reason, fatigued, disoriented, socially withdrawn, speaks less clearly and sometimes out of context, socially unaware and not receptive to cues (2-3 wks after and presently).
Since the morning after the vaccine have had a recurring low grade fever and steady fatigue. Headaches began on the second day after vaccine along with slight body aches. Was made known that I was in close contact with someone for several days prior who had tested positive for covid the same day as I received the vaccine.
Stomach pain; Diarrhea; This spontaneous case was reported by a physician and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 025A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 1985, Leukoencephalopathy, Hiatus hernia, Lumbar disc disease (L3 to L6), Constipation, Cholesterol, Stress, Dry eyes, Macular degeneration (Minor), Glaucoma and Urination difficulty. Concomitant products included PRUCALOPRIDE SUCCINATE (MOTEGRITY) from 12-Jul-2020 to an unknown date, LACTULOSE from 12-Jul-2020 to an unknown date and MINERAL OIL from 12-Jul-2020 to an unknown date for Constipation, CICLOSPORIN (RESTASIS) for Dry eyes, LATANOPROST for Glaucoma, OMEPRAZOLE for Hiatus hernia, ASCORBIC ACID, POLIGLUSAM (CHITOSAN C) for High cholesterol, CLONIDINE from 10-May-2014 to an unknown date and LABETALOL from 23-Dec-2020 to an unknown date for Hypertension, DIAZEPAM from 02-Aug-2018 to 18-Mar-2021 for Muscle relaxation, MIRTAZAPINE for Stress, TAMSULOSIN for Urination difficulty, VALSARTAN, AMLODIPINE from 08-Oct-2019 to an unknown date, GLUCOSE, POTASSIUM CITRATE, SODIUM CHLORIDE (PEDIALYTE 30) from 18-Jun-2020 to an unknown date, BUPROPION from 06-May-2020 to an unknown date, FISH OIL (FISH OIL OMEGA 3), ICAPS LUTEIN & ZEAXANTHIN FORMULA, LACTOBACILLUS ACIDOPHILUS (PROBIOTIC ACIDOPHILUS [LACTOBACILLUS ACIDOPHILUS]), UBIDECARENONE (CARDIO Q) from 16-Nov-2018 to an unknown date, CALCIUM, INOSITOL, NICOTINIC ACID (NIACIN AND INOSITOL), B COMPLEX SUPER POTENCY, MULTIVITAMINS [VITAMINS NOS], VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]), VITAMIN D3 and MUPIROCIN for an unknown indication.   On 03-Feb-2021 at 9:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (Diarrhea). On 04-Feb-2021, DIARRHOEA (Diarrhea) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Nov-2020, COVID-19: negitive (Negative) Negitive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Products known to have been used by the patient, within two weeks prior to the event, included ,amitiya 24 mcg for constipation.  The patient received both scheduled doses of mRNA-1273 prior to the events therefore, action taken with the drug in response to the event is not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Follow up information was received included, height, weight, race of the patient.second dose details with events were also added.Medical history/ current conditions , concomitant medications used by the patient were updated in the follow up.
Dr. visit due to pain in shoulder joint since day of shot - hurts to move right arm in most directions - shot was injected very high on my arm. Given anti-inflammatory rx.
Initial first three days - Rash, swollen arm, headache and sore arm.  It went away and two weeks later after exertion the rash returned along with the swelling and soreness.
pt resides in a facility with a tracheostomy and PEG tube due to brainstem CVA; 9/2/22 admitted to hospital with hypotension and hypoxia; mucus plug; treated and placed on mechanical ventilation; positive COVID test; pneumonia; given ABX, Baricitinib; multiple pressure wounds; MDR organisms infecting airway; pt's condition worsened and he passed away in the hospital
The night the patient received the 2nd booster (4th dose) of the pfizer covid-19 vaccine they experienced pain on entire left side of body from shoulder to lower back.  this is not consistent with their previous doses which only caused minor discomfort.  Patient stated they took a tylenol for relief but still experienced pain and had trouble sleeping.  experienced this while sitting down and even laying down. This has persisted for 24hours but they report it is  slowly going away.
Doesn't know if after first or second dose Vaccine, had normal aches and was really fatigued for two days; Doesn't know if after first or second dose Vaccine, had normal aches and was really fatigued for two days; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 12Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm and on 01Apr2021 as dose 2, single (Lot number: ER8733) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "carpal tunnel", start date: 07Mar2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), PAIN (non-serious), outcome "unknown" and all described as "Doesn't know if after first or second dose Vaccine, had normal aches and was really fatigued for two days". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Additional Context: The caller is a consumer who received second booster shot at (Name) in (City), (State) where the caller lives. Agent attempts to clarify product name multiple times, caller states Pfizer Vaccine and provides lot: FM7553. The caller received the Second booster Pfizer Vaccine at 1600 and had a really severe reaction, nothing like caller had experienced with original Pfizer Vaccine shots. Doesn't know if after first or second dose Vaccine, had normal aches and was really fatigued for two days: The caller doesn't know if it was after first or second dose Pfizer Vaccine, but the caller had normal aches and was really fatigued for two days. The normal aches and fatigue were no big deal. Pfizer Vaccine: First dose: 12Mar2021, Pfizer Vaccine: First dose: 12Mar2021. Patient Age at Time of Vaccination in Months: or Years: 70 years    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feeling faint, labor breathing, report of eyes rolling back, syncopal epidsode (a few seconds), flushed, "blacked-out a few seconds"!  BP-140/86-84-22 Sat 99% O2 at 2L
MALAISE, FATIGUE, MUSCLE ACHES THROUGHOUT ENTIRE BODY.   WORST THROUGH 24 HOURS.  MILD MUSCLE ACHES AT36-48 HOURS. MALAISE AND FATIGUE HAVE RESOLVED ON DAY 2
Patient had complaint of dizziness and fatigue with heaviness and tingling in left arm. Patient insisted on being seen by EMS. EMS assessed patient and determined patient was stable and dehydrated and released to go home.
Ongoing aching pain, tingling and weakness in joints, primarily in lower extremities. I have had to take extra strength Advil everyday since my vaccine to complete adls and work. I am a nurse. I have a high deductable insurance and have not sought medical care. I  start Medicare in July. On 3/19/21 my right knee gave out on the stairs and I suffered a tibial plateau fracture. I did tell the ER that I thought I had had ongoing vaccine side effects  prior to injury but I do not know if he documented that. I was seen at emergency room. I have an orthopedic appt on 3/24 .
This spontaneous report as received from a nurse refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) lot K007784, expiration date: 28-MAY-2016 and lot # K021936, expiration date: 10-NOV-2016. There were no adverse effects. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt developed swelling and itching of his right forearm, hand, and fingers that started on wednesday 6/14/23
Pentacel  vaccine administered to pt with only diluent (which contains DTap and IPV)  and not the HIB.  Hib vail was not activated with vaccine. Pt has no symptoms and no adverse reaction.  Pt will return to receive HIB only vaccine.
When client was checking out at front desk, he fell backwards and hit his head. Client was pale and feeling hot. Client moved to sitting in chair and was given snacks and beverages to eat while resting. Clients head was checked for any signs of injury. No signs noted. Within 5-10 minutes of resting, clients color was back and he stated he was feeling better. Client rested for an additional 10-15 minutes before leaving the clinic in good condition. Facility incident report filled.
SO I just had noticed pain in my left ear on July 9 2021. It was painful and felt clogged. By the 11th of July I went to an ER clinic to get checked out. They prescribed me Amoxicillin for an ear infection and I am still taking that now, for the past 9 days or so and it gradually got better.
SEVERE TINITUS IN BOTH EARS AND EXTREME BRAIN FOG AND LOSS OF MEMORY SHORT TERM AND SOME LONG TERM
TEETH FELT NUMB, BODY VERY ITCHY AND DIARRHEA.
Yesterday I experienced muscle aches, a sore throat, and intermittent head aches, all of which have continued to today. Yesterday morning I noticed a sore red bump on my leg, which felt like a bruise. I have more of these bumps on both legs now, mostly located on my shins. I took a Benadryl, and that seems to have slowed their progress, although my sore throat has gotten worse and the muscle aches are persistent. I plan to visit the clinic tomorrow morning if these symptoms do not dissipate.
Sharp Pain at the administration that made y fingers fell pain ( all the way down my arm). Ongoing pain at the site of the needle injections. Now it hurts to lift my arm or press on the spot where the needle punctured. Pain persists when I move my arm to lift or when I try to lay on that side in the bed. It hurt to even try to change my shirt. Pain has worsened since 10/26/16 to present.
Patient admitted with myocarditis s/p dose #2 of the Pfizer COVID-19 vaccine.  At the time of the report, she is still hospitalized. From EHR note: Patient was in her usual state of health when she received her second dose of the Pfizer mRNA Covid vaccine on 6/3.  She experienced mild myalgias in the day following the vaccine.  However, on 6/5 she developed new severe substernal chest pain, dizziness, and dyspnea.  Pain radiated to her throat.  Given severity of pain, she presented to the emergency department.  In the ED she was afebrile, tachycardic, and initially hypertensive.  Labs demonstrated WBC 10.9 (N 49, L 27), Hb 11.7, PLT 315.  ESR 25, CRP 7.61.  Troponin T was mildly elevated at 0.08, consistent with mild cardiac inflammation.  SARS-CoV-2 PCR and antibody testing were negative. An EKG was normal. However, an echo demonstrated low-normal LVEF (55%).  Otherwise, patient denies nausea, vomiting, diarrhea, cough, runny nose, conjunctivitis, new rashes, arthralgias. Patient was admitted to the cardiology service for further monitoring.  Following admission, she was started on ibuprofen.  She notes that her substernal chest pain has improved somewhat since admission.  Differential for patient's presentation includes infectious, post-infectious, and non-infectious causes of myocarditis. Although post-vaccination mild myocarditis seems likely, we agree with the infectious workup already undertaken, and recommend additional EBV and CMV PCR testing.
burning sensation in her right arm (not where she received the shot); This is a spontaneous report from a contactable consumer reporting for herself. A 45-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL3247/expiration date: not provided), via an unspecified route of administration, on 21Jan2021 10:15 (at the age of 45 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history was none. The patient did not have any known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included birth control pills.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Jan2021 at 23:30, the patient experienced burning sensation in her right arm (not where she received the shot) late at night, lasting for about 20minutes. The patient did not receive any treatment for these events. The event did not require hospitalization. The outcome of the event burning sensation in her right arm (not where she received the shot) was recovered on an unspecified date in Jan2021. Since the vaccination, the patient had not been tested for COVID-19.
EASY TO BLEED; This spontaneous report received from a White, not Hispanic and Latino female patient of unspecified age. The patient's height and weight were not reported. The patient's pre-existing medical conditions included the patient was not pregnant at the time of report. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) 1 total, dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 11-MAY-2021, the patient found herself easy to bleed every time she touched anything. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of easy to bleed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210522266-Covid-19 vaccine ad26.cov2.s-A White, not Hispanic and Latino female patient of unspecified age presents with Easy to bleed. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
sore arm; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 70-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 09Feb2021 (Lot number: EN9581, Expiration Date: May2021) at the age of 70 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "thyroid disorder" (unspecified if ongoing); "thyroidectomy", start date: 2013 (unspecified if ongoing), notes: about 8 years ago. Concomitant medication included: SYNTHROID taken for thyroid hormone replacement therapy. Vaccination history included: Flu shot (she took a paracetamol [TYLENOL] before her flu shot), administration date: Sep2020, for immunisation, reaction: "none". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "sore arm".  Additional information: The patient stated that the event was over in 2 days. She had no family medical history relevant to the event.  No follow-up attempts are possible. No further information is expected.
24 hrs post injection of DTaP redness, swelling and tenderness L deltoid. At 48 hr, erythema and warmth measures 6x8cm. Some tenderness
Patient states next day (10/12/19) they started getting rash on upper back. Patient went to walk-in and was given Valtrex for 7 day course.
Syncope lasting few seconds after receiving vaccine H1N1. Increased blood pressure 180/105. Dizziness.
redness and mild swelling at injection site; redness and mild swelling at injection site; sore arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: 5730), via intramuscular route of administration on the left arm on 18Dec2020 17:15, then the second dose via an unspecified route of administration on the left arm on  07Jan2021, both at single dose for COVID-19 immunization administered at hospital facility. Medical history included asthma, anxiety, vitamin d deficiency, eczema and rosacea, and known allergies: nickel and latex. Concomitant medications included influenza vaccine (FLU) on 11Nov2020 received within 4 weeks prior to the COVID vaccine; minocycline, cetirizine hydrochloride (ZYRTEC), ethinylestradiol, norgestrel (CRYSELLE), colecalciferol (VITAMIN D) , calcium, and vitamin b complex received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient experienced redness and mild swelling at injection site, sore arm on 19Dec2020. The events were reported as non-serious and no treatment was given. The patient underwent COVID test/ nasal swab: negative on 24Nov2020. The outcome of the events was  recovered on an unspecified date. No follow-up attempts are possible. No further information is expected.
Recipient began to bleed at the vaccine administration site immediately upon administration. She developed a hematoma the size of a quarter. Direct pressure applied along with an ice pack. She was monitored for 30 minutes and the bleeding had stopped at that point and the hematoma size had decreased.
Swollen lymph nodes,  chills,  body aches, fever, shortness of breath, cough
The shot was very painful. I got it mid-afternoon. In the evening, I developed severe diarrhea which lasted all evening, the next morning my left arm at the injection site was red, swollen and painful. It was hot to the touch. The area of the shot that became elevated and red was approximately 3 inches in diameter. These symptoms lasted for 6 days. It took about 1 month for the redness to fade.
sore throat, productive cough, runny nose, diarrhea-normaly has diarrhea.        Patient denies headache, fever, shortness of breath, loss of taste, loss of smell, chest congestion, chest tightness,chest pain. starting 11/11/21
This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 27-MAR-2015, the patient was vaccinated with an improperly stored dose of (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. Product quality complain (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Arms are sore; Initial information regarding an unsolicited valid serious case was received from a pharmacist via Medical Information (MI) via call-center (Reference number- 00342347) and transmitted to Sanofi on 02-Nov-2020.  Initial information received on 02-Nov-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2020SA320485 and 2020SA307661 (same reporter).  This case involves a 36-years-old male patient who experienced arms are sore (pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (prefilled syringe, lot number LUT7007NA and expiry date: 30-Jun-2021) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious arms are sore (pain in extremity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.