chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I have a small tumor on pancreas; dark urine; Blond stools; yellowing skin; hilar cholangio carcinoma; small tumor on my liver; Persistent itching all over body/Itching moves; This spontaneous case was reported by a consumer and describes the occurrence of CHOLANGIOCARCINOMA (hilar cholangio carcinoma) and HEPATIC NEOPLASM (small tumor on my liver) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Chronic leukemia, Bile duct cancer and Liver spots (Spot on liver).   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PRURITUS (Persistent itching all over body/Itching moves). On an unknown date, the patient experienced CHOLANGIOCARCINOMA (hilar cholangio carcinoma) (seriousness criterion medically significant), HEPATIC NEOPLASM (small tumor on my liver) (seriousness criterion medically significant), PANCREATIC NEOPLASM (I have a small tumor on pancreas), CHROMATURIA (dark urine), FAECES DISCOLOURED (Blond stools) and YELLOW SKIN (yellowing skin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, CHOLANGIOCARCINOMA (hilar cholangio carcinoma), HEPATIC NEOPLASM (small tumor on my liver), PRURITUS (Persistent itching all over body/Itching moves), PANCREATIC NEOPLASM (I have a small tumor on pancreas), CHROMATURIA (dark urine), FAECES DISCOLOURED (Blond stools) and YELLOW SKIN (yellowing skin) outcome was unknown.            No concomitant medication reported.  Treatment included, anti-histamines couple of times a day and  steroids prescribed by the doctor was reported  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Cholangiocarcinoma, Hepatic neoplasm and Pancreatic neoplasm which could not have been caused by the vaccine and had to be pre-existing along with the patient's statement that they had GI symptoms pre-dating the first vaccine.   This case was linked to MOD21-035148 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up document contains new events.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Cholangiocarcinoma, Hepatic neoplasm and Pancreatic neoplasm which could not have been caused by the vaccine and had to be pre-existing along with the patient's statement that they had GI symptoms pre-dating the first vaccine. MOD21-035148:
Pt recvd vax on 16DEC91 in AM; mom gave pt APAP; Next morning mom had to wake pt up about 11AM; pt felt warm-inject site little swollen; t103 R; mom gave tepid bath & APAP & called MD; pt adm to hosp t 104 R;
PT RECEIVED PFIZER VACCINES ON 2/26/21 (LOT EL3248) + 3/29/21 (LOT EN6204); S/O 8/22/2021, TESTED + 8/25/2021.
Patient received her vaccine and stayed for the allotted time of 15 minutes and was allowed to leave. 10 minutes after the patient left the patient came back to the clinic and felt short of breathe and had a slight feeling of difficulty swallowing. A respiratory assessment was completed which no abnormal breathing was detected. Due to the slight difficulty breathing benedryl was given and patient stated for 30 minutes. Patient was reassessed and she stated she felt better with no difficulty breathing and was allowed to leave but was informed if feelings return to go to urgent care or emergency room.
After 1hour / 1 1/2hour from injection start tingling left side of tongue, lip, swelling the throat After 2hours find a red burning rash under breast/torax.Called health clinic, the Triage nurse directed me to hospital.Went to the Emergency room. Main Hospital Team Dr. Diagnose:allergic reatcion+Yeast infection. 7:28PM gave 3 pills prednisone. Pescription for Prednisone 20mg 3for4days, nyastatin podwder for rush, epinephrine injection in case of anaphylaxis, benadryl as needed.While I was at ER, the tingling/swelling expand my entire body left side. This night I had to remove wedding ring, today the face still swelling/warming+almost same/little bit worsening simptoms
immed urticarial eruption @ site of inject spreading down arm and over shoulder & upper back; resolved w/Epi injections;
Symptomps of myocarditis - chest pain, fatigue, abnormal heart rhythms and shortness of breath. Symptoms lasted more than two weeks and improved after I started taking 600mg ibuprofen to reduce chest pain. All symptomps have gone after 3 weeks of the vaccine shot.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown demographics. No medical histories, concurrent conditions or concomitant therapies were reported. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # L005295, expiration date: 17-AUG-2016, therapy type HSA; doses and route were not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Severe low back pain; This is a spontaneous report from a contactable physician (patient).   A 66-year-old male patient of BNT162B2 (PFIZER-BIONTECH COVID-19 m-RNA VACCINE, Solution for injection, Lot number: 301308A) via an unspecified route of administration at left arm on 23Sep2021 at 15.00 (at the age of 66-years) as dose number unknown, single for COVID-19 immunization. The patient medical history included hypertension from an unknown date and unknown if ongoing. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included lisonpril taken for unknown date, start and stop date were not reported (within 2 weeks of vaccination). On 25Sep2021 at 08:00, the patient experienced severe low back pain. The patient was received muscle relaxant as treatment medication for the adverse event. The patient was advised to visit doctor or other healthcare professional office/clinic visit as result of the event. The case is assessed as non-serious. The physician reported Pfizer product had a casual effect to adverse event. The outcome of the event severe low back pain was recovering.  Follow-up attempts are completed. No further information is expected.
a few heart flutter episodes; After the first vaccine a few heart flutter episodes and shortness of breath each day of the first week; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 at vaccination age of 34-year-old via an unspecified route of administration in the left arm on 02Aug2021 at 15:00 (Lot Number: EV00181) as dose 1, single for covid-19 immunisation. Medical history included supraventricular tachycardia (SVT) in 2004 and catheter ablation was performed. The patient was patient diagnosed with COVID-19 prior to vaccination. The patient has no known allergies. Concomitant medications included valacyclovir [valaciclovir] (VALACYCLOVIR); fish oil; and ascorbic acid, betacarotene, biotin, calcium amino acid chelate, calcium pantothenate, chromium amino acid chelate, copper amino acid chelate, cyanocobalamin, equisetum arvense stem, ferrous fumarate, folic acid, laminaria digitata powder, magnesium oxide, manganese amino acid chelate, nicotinamide, oenothera biennis oil, potassium amino acid chelate, pyridoxine hydrochloride, riboflavin, selenium amino acid chelate, thiamine mononitrate, zinc amino acid chelate (reported as OLLY WOMEN'S MULTI); all indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 02Aug2021 at 19:30 after the first vaccine, the patient experienced a few heart flutter episodes and shortness of breath each day of the first week. It was further reported that after the first vaccine, a few heart flutter episodes and shortness of breath each day of the first week but then she wore a heart monitor the week before the second dose. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient considered as the adverse events as non-serious. The events did not result in hospitalization. The patient has been tested for COVID-19 since vaccination. She had Pixel nasal swab on 02Sep2021 and on 07Sep2021 with both having the results of negative. The patient did not received treatment for the adverse events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Immediately after arm sore and before bed swelling and minor pain. I had been taken Naproxen for a back issues I had days before.  This morning I woke up and felt achy with muscular pains and arm sorer than yesterday and it was swollen a little. As the day went on I discovered aches and pains around my body and felt weak and not very robust. The aches and pains were unusual in my legs and elsewhere.  I had to cancel my physical activities today because I didn't have the energy to do them, like yesterday right after vaccination.  I didn't feel like I had the strength or energy to do anything.
onset 10min p/inj sl cough;in 20min copious nasal mucous;inc work of breathing;wheezing treated w/bronchodilator nebulized w/good response;
16 y/o female c/o upper left quadrant, abdominal px. Pt's mom states that she has a history of anxiety and abdominal px on lower right quadrant, from a previous cist.  Px does not radiate and changes with inspiration. Vitals - BP 108/70, HR  66,  RR 20.  Mom wants pt seen at the hospital. Pt transported to hospital via medical transportation.
pt states she had TD 21 Jun 07 and on 8/13/07 she still had pain and swelling at the injection site and swollen hands.
Cerebral venous sinus thrombosis, intracranial hemorrhage, and cerebral edema
temperature excursion on GARDASIL 9; No other adverse events - No signs or symptoms reported; Information has been received from a registered nurse reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication.  On an unknown date, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 0.5 mL for prophylaxis, lot# 1687293 and expiration date reported as 25-AUG-2022, but upon internal validation was established as 30-APR-2023 (route of administration not reported). No adverse events were reported.  On an unknown date, the vaccine underwent a temperature excursion of 47.1 Fahrenheit degree for 13 minutes. No previous temperature excursions were reported. The call was not placed because a digital data logger.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1687293; expirationdate: 30-APR-2023; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA005285: US-009507513-2104USA003211: US-009507513-2104USA003212: US-009507513-2104USA003213: US-009507513-2104USA003214: US-009507513-2104USA003215: US-009507513-2104USA003216: US-009507513-2104USA003217: US-009507513-2104USA003218: US-009507513-2104USA003219: US-009507513-2104USA003220: US-009507513-2104USA003222: US-009507513-2104USA003223: US-009507513-2104USA003224: US-009507513-2104USA003225: US-009507513-2104USA003196: US-009507513-2104USA003197: US-009507513-2104USA003198: US-009507513-2104USA003199: US-009507513-2104USA003200: US-009507513-2104USA003201: US-009507513-2104USA003202: US-009507513-2104USA003203: US-009507513-2104USA003204: US-009507513-2104USA003205: US-009507513-2104USA003206: US-009507513-2104USA003210: US-009507513-2104USA003207: US-009507513-2104USA003208: US-009507513-2104USA003209:
Information has been received from a consumer concerning her 4 year old son with no drug reactions or allergies who, "about 3 years ago", in approximately 2006 was vaccinated with a first dose of VARIVAX (Merck).  "A few days ago", on 17-FEB-2009 the patient developed a breakthrough of chicken pox and had about 20 lesions.  Unspecified medical attention was sought but no laboratory test was performed.  The patient was scheduled to receive his second dose of VARIVAX in the next two weeks.  At the time of this report, 18-FEB-2009, the event persisted.  The patient's twin brother also experienced an AE following (WAES# 0902USA03715).  Additional information has been requested.
Urticarial rash on extremities within 22-24 hours after flu shot.
Narrowing of vision as if I were passing out initially  Tightness in chest then burning in stomach Feeling cold  and as if I had a fever
Patient has stated that he's been experiencing muscle pain and insomnia after getting the Shingrix vaccine which starting the same night. He also said that the muscle pains radiating to the whole body and it's really bother him. The events have been going on since he got the vaccine (on 07/03/2020) and still going on until now (08/01/2020). He had been seen by  his PCP and also to ER room, however,  according to him, no other treatment has been rendered for this on going issues. He has been taking Advil/Ibuprofen in which he thinks it's helping.
Cellulitis with erythema; mass approximately 3cm diameter with erythema 9cm in diameter. Warm to touch, patient with SIRS symptoms.
Received a COVID-19 vaccination in his left arm and 9:15 on 12/182020 and states that he felt some swelling sensation in his throat.  He received 25 mg of Benadryl there initially and then a few minutes later got another 25.  He had no chest pain or shortness of breath.  He had no difficulty swallowing.  He has had somewhat of a similar reaction in the past when he is exposed to cat hair.  He was sent to ED by EMS for further evaluation.   No rash.  Arrived 10:16am, given pepcid, declined steroids and discharged at 11:47am.  Felt normal within 2-3 hrs after receiving the vaccine.  Given EpiPen for second dose.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL (Lot number, expiry date, route and dose were not reported). On an unknown date, the patient developed rheumatoid arthritis after receiving GARDASIL. It was unknown which dose of GARDASIL the patient had received or whether the patient would continue with the series. The patient sought medical attention for the same (spoke to the physician). The outcome of rheumatoid arthritis was unknown. Additional information has been requested.
my arm has a hot; I have not felt good; my arm has a red circle; my arm has a rash; have a slight fever 99.6; Headache; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (my arm has a hot), FEELING ABNORMAL (I have not felt good), VACCINATION SITE ERYTHEMA (my arm has a red circle), VACCINATION SITE RASH (my arm has a rash) and PYREXIA (have a slight fever 99.6) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (my arm has a hot), FEELING ABNORMAL (I have not felt good), VACCINATION SITE ERYTHEMA (my arm has a red circle), VACCINATION SITE RASH (my arm has a rash), PYREXIA (have a slight fever 99.6) and HEADACHE (Headache). At the time of the report, VACCINATION SITE WARMTH (my arm has a hot), FEELING ABNORMAL (I have not felt good), VACCINATION SITE ERYTHEMA (my arm has a red circle), VACCINATION SITE RASH (my arm has a rash), PYREXIA (have a slight fever 99.6) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: Slight fever 99.6.   No concomitant medications were reported.  It was reported patient had let my dr know.  No treatment medications were reported.
The patient's mother called the physician's office to let them know that her child had been sent home from school on 11/30/2000 with "chickenpox". In follow up, the patient recovered form this experience. No further information is available.
No adverse effects; patients received improperly stored vaccines; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 08-MAY-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) 0,5 milliliter injection, intramuscularly, lot # N007750, expiration date 29-NOV-2019 (dose, and anatomical location were not reported) for prophylaxis.  The reported vaccines were exposed to the temperature of 35.4 degrees Fahrenheit for 32 hours and 30 minutes. No previous temperature excursions were reported. A digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA014098: US-009507513-1905USA014099: US-009507513-1905USA014106: US-009507513-1905USA014101: US-009507513-1905USA014102: US-009507513-1905USA014103: US-009507513-1905USA014104: US-009507513-1905USA014105: US-009507513-1905USA014097: US-009507513-1905USA014096: US-009507513-1905USA008566:
No adverse event; Administration of expired drug; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired drug) and NO ADVERSE EVENT (No adverse event) in a 31-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7180B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 18-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 18-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired drug). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired drug) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administration of expired drug).    Concomitant medications were not reported.  On 7/18/2023 patient administered a 0.5 mL dose of Moderna 6+ bivalent booster who had never been vaccinated. The vaccine from lot AS7180B was expired.  BUD was reported as 6/24/2023.   The patient had no adverse reaction.   Treatment information was not reported.
Headache at the base of my skull that is lingering  For about 24 hours body aches, hot cold chills, tired felt like I was going to throw up  I don?t get headaches and I have had. Lingering headache at the base of my skull where the spinal chord attaches to the brain
Left Shoulder Pain 2 hours after Tdap vaccine. Noticeable with overhead motion, sleeping on arm and when moving arm to take on and off clothing. Moderate weakness. No shoulder pain at a resting position or with minimal to moderate palpation. No arm pain at site of injection. No numbness.  Treatment includes medication, hot/cold compresses and exercises. No change in shoulder pain since 3 March 2022.
I received the first Pfizer shot in April of 2020 and got Covid about 4 to 5 days later.; This is a spontaneous report from a contactable consumer (patient); this report regards event under bnt162b2.  A 62-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on Apr2020 (also reported as Mar or Apr) as single dose for covid-19 immunisation.The patient medical history and concomitant medications were not reported. The patient received the first shot in Apr2020 and got Covid about 4 to 5 days later (unknown date in 2020). While ill she received an infusion of Monoclonal antibodies over the course of several hours. The final outcome of the event was unknown. The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Fever over 104 F, within hours of injection right hip pain radiating up the right side and down right leg. The first 24 hours I thought I was having a stroke or dying, I was so weak and right side was completely numb and I needed assistance moving. Now I  have chronic tingling in right hand, fingers and right foot. I am having loss of control of right hand.  I have been dropping items.  Intermittently have sharp nerve numbing type pain since the vaccine and it occurs daily. It affects my activities of daily living.
Tetanus shot on 1/19/15-immediate stinging pain shoulder to fingertips-pain has been a solid constant 8 on scale of 1-10 (10 being natural child birth)-sharp intense pain w/certain movements-can't sleep for pain-difficult to dress, drive-pick items up.
01/17/22 presents to ED for "covid/hypoxia". PMHx of "hypertension, prostate cancer status post radiation treatment, hepatitis C, dementia and end-stage renal disease"
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first 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, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.            No Concomitant medication were provided No treatment were provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.