chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at injection site/COVID Arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE RASH (Rash at injection site/COVID Arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at injection site/COVID Arm). At the time of the report, VACCINATION SITE RASH (Rash at injection site/COVID Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patient developed COVID arm 10 days after first dose of vaccine.  Concomitant medication and treatment information were not reported.
he broke out in a rash and it was diagnosed by the pediatrician as Pityriasis rosea; This spontaneous report was received from a consumer(mother of a patient, who was also a clinical research coordinator) and refers to a 12-year-old male patient. The patient was asthmatic and his concomitant therapy included fluticasone propionate (FLONASE). The patient's drugs reactions or allergies were not provided.  On unspecified date in 2020, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly (dose, lot # and expiration date were not provided) as a prophylaxis. On 11-NOV-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscularly (dose, lot # and expiration date were not provided) for prophylaxis. On the same day, within 12 hours, he"broke out in a rash" and it was diagnosed by the pediatrician as pityriasis rosea. Mother reported that the rash started on her sons stomach and has spread to his face down to his calves. She reported that the rash was diffuse, warm, itchy and "sloughing off'. One week after the start of the rash, the patient was seen by the allergist, who also diagnosed with pityriasis rosea and treatment has been topical steroid. Mother reported that in some areas the rash was resolving, some areas the rash has "dimmed" and other areas were still "lit up". The pityriasis rosea was ongoing at the time of report.  The causal relationship between pityriasis rosea and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.
Around 30 hours later, I started to break out in hives and nothing would bring them down. My lips began to swell considerably and it was hard to breath. I went to the Emergency room at around 12am that night for treatment. Months later, my lips swell randomly still and hives sometimes pop up too. They can last from half and hour to three hours and it happens at least once a week
PATIENT WAS GIVEN THE VACCINE AT 04:05PM. WITHIN 7 MINUTES THE PATIENT HAD COMPLAINED OF DIZZINESS AND PAIN WHICH WAS CAUSED BY THE VACCINATION. PATIENT FELT HOT TO TOUCH WHEN TAKING A TEMPERATURE READING PATIENT TEMPERATURE WAS 97.8 DEGREES F. EMERGENCY SERVICES WERE ALERTED THROUGH PHAMACY PROTOCOLS AND EPIPEN WAS PLACED NEARBY IF NEEDED. PATIENT VOMITTED STOMACH ACID AND SMALL AMOUNT OF LIQUID INTO TRASH RECEPTACLE. EMERGENCY SERVICES ARRIVED AND TOOK CARE OF THE SITUATION AT THE TIME BRINGING HER TO WATERBURY HOSPITAL FOR FURTHER EVALUATION WHERE AT 5:15PM SHE WAS MORE ALERT AND TREATED FOR HER CONDITION
Patient had anxiety and nausea.  Did vomit 1X.  Patient was given water and crackers.  25 min later feel better
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 30-SEP-2015, the patient was vaccinated with improperly stored (Oka/Merck) PROQUAD with lot number: L026728, expiry date: 15-JAN-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report was received from the mother's patient referring to a 1 year old male patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 29-SEP-2017, the reporter stated that her son was vaccinated with GARDASIL 9 lot number N010497 and expiration date of 15-JAN-2020 for prophylaxis (dose and route of administration were not reported).
No additional AE details; administered to a 4 year old patient as IM and not subcutaneous; This spontaneous report was received from a agent referring to a 4-year-old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication.   On 31-MAR-2021, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) intramuscularly instead of subcutaneously, lot number T025509 and expiration date of 23-JAN-2022 for prophylaxis (dose and anatomical location were not reported). The reporter wanted to know if this could be considered a valid dose. No additional adverse events details.
Left knee numbness/tingling, dehydration, headache, diarrhea, tiredness, weakness, loss of appetite?symptoms started around 2:30 am on 10/28 didn?t subside until 11/01? knee is still tingling
One week after the first dose of the vaccine I had breakthrough bleeding. It was enough to soak a sanitary pad. I went to the ER and they could not identify the reason for the vaginal bleeding. I was discharged the same night. It reoccurred three days after when I had been on a walk. It did not happen again and I did not have any problems after the second shot. The baby seems to be fine. Due Date -09/17/2021 Pregnancy-First
Metallic taste in mouth; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of DYSGEUSIA (Metallic taste in mouth) 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) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSGEUSIA (Metallic taste in mouth). At the time of the report, DYSGEUSIA (Metallic taste in mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Leg pain; Calf Pain; Facial swelling; facial bruising; L side of the body started to swell/ swelling neck; left side of her neck (swelling); left jaw joint hurt so bad; shortness of breath; like her jaw was locked; not feeling well; diarrhea; sweating; headache/head was pounding; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Facial swelling), CONTUSION (facial bruising), DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating) and SWELLING (L side of the body started to swell/ swelling neck) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (In spring 2020.) in 2020 and Bronchitis in January 2021.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), MALAISE (not feeling well), HEADACHE (headache/head was pounding), VOMITING (vomiting) and CHILLS (chills). On an unknown date, the patient experienced SWELLING FACE (Facial swelling), CONTUSION (facial bruising), SWELLING (L side of the body started to swell/ swelling neck), SWELLING (left side of her neck (swelling)), PAIN IN JAW (left jaw joint hurt so bad), DYSPNOEA (shortness of breath), TRISMUS (like her jaw was locked), PAIN IN EXTREMITY (Calf Pain) and PAIN IN EXTREMITY (Leg pain). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, SWELLING FACE (Facial swelling), CONTUSION (facial bruising), DIARRHOEA (diarrhea), HYPERHIDROSIS (sweating), SWELLING (L side of the body started to swell/ swelling neck), SWELLING (left side of her neck (swelling)), PAIN IN JAW (left jaw joint hurt so bad), DYSPNOEA (shortness of breath), TRISMUS (like her jaw was locked), MALAISE (not feeling well), PAIN IN EXTREMITY (Calf Pain), PAIN IN EXTREMITY (Leg pain), VOMITING (vomiting) and CHILLS (chills) was resolving and HEADACHE (headache/head was pounding) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 antibody test positive: positive (Positive) positive.     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 provided   This case was linked to MOD21-085334 (E2B Linked Report).; Sender's Comments:  MOD21-085334:
Shingles, antiviral given, pain resolved but still has HA. Has followed up w/PCP.
One day after first dose of Pfizer vaccine, patient was admitted for fever, weakness and altered mental status. At admission exhibited SIRS (fever, tachycardia), ultimately no infection was identified on work up.
bruising around injection site, red swelling from injection site to the elbow crease.  Patient also had flu-like symptoms and fever.  started shortly after vaccination
Abnormal vaginal bleeding at unexpected times / gush of blood; abnormal vaginal bleeding at unexpected times. Large clots and gush of blood; Irregular menses; worsened cramps; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the second dose of BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in Arm Right on 12Jun2021 (at the age of 34 years old) (Lot Number: EW0186) as dose 2, single for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing (COVID prior vaccination: yes). The patient was not pregnant at the time of vaccination. Patient has no known allergies. No other vaccine in four weeks. There were no concomitant medications. No other medications in two weeks. The patient took the first dose of BNT162B2 (Lot number: EW0176) administered to right arm on 15May2021 (at the age of 34 years old) for COVID-19 Immunization. On 16Jun2021, the patient experienced abnormal vaginal bleeding at unexpected times. Large clots and gush of blood was experienced after receiving the second dose. Patient has been experiencing irregular menses and worsened cramps since 16Jun2021. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures of tranexamic acid were taken as a result of the events. Patient has not been tested for COVID post vaccination. The outcome of the events was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
At 3 am I woke up and had to go to the bathroom, I sat on the edge of the bed then stood up and opened  my eyes.  The room was spinning, I fell down, vomited and peed.  I laid there for a while until I realized if I closed my eyes the room would stop spinning.  I got up off the floor, back into bed and stayed there for about 5 hours.  When I woke up, I was still dizzy, but not nearly as bad.   The dizzyness and nausia still hits me several times a day.
Sleeping a lot more than usual. fever 1/16/02 103F, fever 1/18/02 99F.
I had the vaccine and the next day my arm started swelling and the temperature of that arm was 104 and the other arm was 96.1. My blood pressure went up to 183/101. The next day it was 163/91, I had to make an appointment with my doctor because it was stroke level and my resting heart rate was 99.  They did and EKG which was normal, they took my blood pressure at the beginning and end it was roughly about the same. She gave me blood pressure medication. After a week she gave me a second blood pressure in addition to that one because my blood pressure was not coming down. After 2 weeks I started to noticed some changes. She said I should finish the medications and if my blood pressure goes to low I should stop using them.
Information has been received from a physician concerning a female patient who on an unknown date was vaccinated intramuscularly with 0.5 mL of GARDASIL (Lot # was not provided and dose in series was not reported). Subsequently, six months after vaccination, the patient had neurological problems not specified. The physician did not believe the neurological problems were related to GARDASIL. A neurologist who examined the patient after the neurological problems started also said the neurological problems were not related to GARDASIL. The reporter contacted during the telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status. The health care professional contacted during telephone follow-up could not supply the following information: patient name, date of birth, dates of vaccination/therapy, dose number, lot number, date of event, recovery status, hospital name. No further information is available.
Developed Type 2 Diabetes and diabetic retinopathy in right eye.  Diagnosed with insulin resistance in 2001 that was controlled with diet.  Eye issues non-existent previously - cataract surgery in2019 with multi-focal IOLs - and no retinopathy found.
Specifically unknown, but patient (he's now deceased) was concerned about throwing up so much that he'd lose his stomach lining.
Severe uticaria with angioedema beginning about 30 hours post injection. Sweating followed by rash, itching and facial and oral and throat edema. Treatment with Benedryl 50 mg q 4 hrs, and when no response began Prednisone 24 mg po with tapered dose schedule over 6 days.
This case was reported by a other health professional and described the occurrence of intussusception in a 8-month-old male patient who received ROTARIX (batch number A41CB393A, expiry date 5th October 2016). Concomitant products included ROTARIX, PEDIARIX, PREVENAR and HIB. On 4th June 2014 11:30, the patient received the 2nd dose of ROTARIX (oral). On 1st October 2014, 119 days after receiving ROTARIX, the patient experienced intussusception (serious criteria hospitalization, GSK medically significant, life threatening and clinically significant/intervention required), bloody stool (serious criteria GSK medically significant) and absent bowel sounds. On an unknown date, the outcome of the intussusception, bloody stool and absent bowel sounds were not recovered/not resolved. It was unknown if the reporter considered the intussusception, bloody stool and absent bowel sounds to be related to ROTARIX. Additional information was provided. The patient had no known allergy, no relevant medical history and no reaction to previous vaccinations. The patient had no current medication. At the time of reporting, the patient was hospitalized, the events were worsened and the patient was possibly having surgery.
FLUZONE High Dose was administered IM into left arm of patient at 12:30 pm 8/29/16. Beginning around 2:30 pm same day. patient had chills and "shakes", developed a fever of a 100 F, and blood pressure increased (SBP) to approximately 150. Pt went to ER in evening and returned to pharmacy next day.
chills at night; muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to penicillin" (unspecified if ongoing), notes: She says she has an allergy to penicillin.; "anesthesia" (unspecified if ongoing), notes: gives her tachycardia when she receives very strong anesthesia.; "tachycardia" (unspecified if ongoing), notes: gives her tachycardia when she receives very strong anesthesia. The patient's concomitant medications were not reported. Past drug history included: Iron, reaction(s): "allergy to iron", notes: she has an allergy to iron. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills at night"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain".  Additional information: The caller wants to get their fourth dose of the Pfizer COVID-19 vaccine and wants to know if the formulation has changed.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 02-OCT-2013 the patient was vaccinated with M-M-R II (reported batch # H018950 corresponding with lot # 1483AA; expiration date 18-OCT-2014). The vaccine was exposed to temperature exposures for 50F for 85 minutes, 47F for 15 minutes, 48F for 35 minutes, 52 F for 95 minutes, 48F for 30 minutes on 20-SEP-2013 and 48F for 45 minutes on 25-SEP-2013. No known adverse effects. This case is linked to case 1310USA001610, 1310USA008360, 1310USA008361, 1310USA008362, 1310USA008363, 1310USA008364, 1310USA008365, 1310USA008366, 1310USA008367, 1310USA008368, 1310USA008369, 1310USA008370, 1310USA008371, 1310USA008372, 1310USA008373, 1310USA008374, 1310USA008375, 1310USA008376, 1310USA008377, 1310USA008378, 1310USA008379, 1310USA008380, 1310USA008381, 1310USA008382, 1310USA008383, 1310USA008384, 1310USA008385, 1310USA008386, 1310USA008387, 1310USA008388, 1310USA008389, 1310USA008390, 1310USA008391, 1310USA008392, 1310USA008393, 1310USA008394, 1310USA008395, 1310USA008396, 1310USA008397, 1310USA008398, 1310USA008399, 1310USA008400, 1310USA008401, 1310USA008402, 1310USA008403, 1310USA008404, 1310USA008405 and 1310USA008407 (same reporter link). Additional information has been requested.
104.5 temperature  Dizzy exhausted  Body aches vomiting  Severe diarrhea  Headache
Beginning the evening of the vaccine pt spiked a fever, experienced migraine-like symptoms and excessive joint pain in the hips. That evening sleep was irregular with waves of chills and excessive sweating.  The following day a headache continued until about 12pm and then the body seemed to go back to normal.  Two days after the initial vaccine there has remained consistent muscle weakness in OS (left) knee and numbness in OS leg from the knee down. There is also infrequent dizziness. Both symptoms are becoming more regular.
Severe pain in upper left arm within a day of the injection. Lump (2-inch diameter) developed in the middle of the antero-lateral upper arm within a month of the injection. By February 2022, the lump became increasingly painful so that I was unable to sleep on the L side or fully lift my arm. The pain spread to the front of the upper arm near the shoulder and to the front of the shoulder; by the end of Feb 2022 I was having numbness in my L hand so I called for a dr's appt. After numerous appointments, attempts at diagnosis, and shoulder PT, it became clear that I have SIRVA (and likely biceps tendinitis) from the 11/5/21 injection. The lump is now 4 inches long, running diagonally along the middle of my upper arm. The pain continues and is sometimes quite disabling -- interfereing with sleep and activities, including work. I treat the condition myself with KT Taping, TENS, NSAIDS, and Salon Pas lidocaine patches, which each offer some relief but do not eliminate the pain. So far, drs have only prescribed an anti-inflammatory diet and shoulder PT, which latter seems to have made the pain worse and the lump larger. I will be seeing a new dr on October 3.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 09-OCT-2012 13:10, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Per doctor, states mom brought child in 1 day later (5/23/03). Complained of child had convulsions and elevated temp 6 hours after shots given on 5/22/03. Doctor noted pink throat. Stated diagnosed febrile seizures due to possible undetected illness.
rt deltoid area down to elbow very swollen, hot to touch w/deep red erythema;movement of arm diff-cause great pain;high temp 102;chills, nausea, gen achy feeling;was seen by pvt MD
Severe sustained migraine headache lasting for two weeks. Headache dissipated after two weeks and cyclical migraines continued and continue to this day. This requires ongoing treatment.
Severe back pain resulting in incapacitation for 5 days, requiring prescription pain meds & muscle relaxants
Headache; Vomitting; 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 HEADACHE (Headache) and VOMITING (Vomitting) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and VOMITING (Vomitting). At the time of the report, HEADACHE (Headache) and VOMITING (Vomitting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.   Reporter did not allow further contact
"pin + needles" feeling after injection, pain radiating down (L) arm next day 10/25/19- urgent care. Urgent care referred to ortho. 10/28 Severe pain in arm - Orth - cortisone shot
Information has been received from a registered nurse concerning a 20 year old female with no pertinent medical history and no drug allergies/reactions who on 19-MAr-2008 was vaccinated with a first dose of GARDASIL (lot # 659962/1740U) 0.5 ml IM. Concomitant therapy included oral hormonal contraceptives (unspecified). Subsequently, after receiving the first dose of vaccine, the patient was diagnosed with Epstein-Barr virus. The patient sought medical attention with another physician. At the time of reporting, the outcome was unknown. Additional information has been requested.
20MAY92 pt devel an elevated temp & a blister formed on lt shoulder; blister size approx 2" in diameter; no itching; c/o sore throat-no difficulty breathing or swallowing;