chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a medical assistant and described the occurrence of swollen leg in a 5 year old male subject who was vaccinated with Infanrix for prophylaxis. On 14 April 2006, the subject received 5th dose of Infanrix in the right thigh (lot AC14A008AA). On April 2006, the subject also received inactivated Ipol in the right thigh and MMRII in the right arm. On 15 April 2006, one day after vaccination with Infanrix, the subject experienced injection site swelling, injection site induration, and swelling, "past the knee".  The subject was seen at a physician's office.  The events resolved on an unspecified date on or before 05 May 2006. The medical assistant considered the events to possibly be related to vaccination with Infanrix.
Lethargy; Wasn't feeling well; Sore arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy), MALAISE (Wasn't feeling well), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medication history was provided by the reporter.  Concomitant products included CALCIUM, MULTIVITAMINS [VITAMINS NOS], CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]) and PARACETAMOL (TYLENOL) for an unknown indication.    On 19-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Lethargy), MALAISE (Wasn't feeling well), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). At the time of the report, LETHARGY (Lethargy), MALAISE (Wasn't feeling well), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not reported.   This case was linked to MOD-2021-288138.
Customer complained of heart Palpitations after receiving her second dose.  EMS responded to Code Red.  BP 116/77, HR 93, O2 97, customer stated she was also feeling some dizziness also.  Customer changed seats with her husband so he could drive and said she felt a little better.
Pain, edema, induration and erythema and increase of volume in the site of administration (exterior side of the right thigh). Patient had these problems 18 hours after the administration of the vaccine. Treated with Augmentin 10 days.
Patient received H1N1 vaccine on 1/27/2010. Patient reports he broke out in hives/itching the evening of 1/27/10. No difficulty breathing or swelling of mouth or throat. Patient received a methylprednisolone 40mg injection in the ER and was sent home with a prednisone taper. Symptoms: 1. Urticaria Pruritus. Treatment Drugs Used: 1-Methylprednisolone Dose: 40 Units: MG Freq: Once Route: IV. 2-Prednisone Dose: 30 Units: MG Freq: UD Route: PO.
This case was reported by a pharmacist and described the occurrence of tachycardia in a female patient who received BOOSTRIX (batch number 3HY32, expiry date 8th November 2016). Concurrent medical conditions included hospitalization (The patient was already in the hospital on the day of adverse events). Concomitant products included Influenza vaccine, COLACE, ketorolac, simethicone, Lactated Ringers and NORCO. On 4th November 2014, the patient received BOOSTRIX (intravenous) 1 ml. In November 2014, Less than a month after receiving BOOSTRIX, the patient experienced tachycardia (serious criteria clinically significant/intervention required), fever and flushing. On an unknown date, the patient experienced inappropriate route of vaccination. On an unknown date, the outcome of the tachycardia, fever, flushing and inappropriate route of vaccination were unknown. It was unknown if the reporter considered the tachycardia, fever, flushing and inappropriate route of vaccination to be related to BOOSTRIX. Additional information received: The patient was inadvertently administered BOOSTRIX intravenously and subsequently spiked a body temperature of 105 Deg. F, and some tachycardia (heart rate was 120 bpm) and flushing.
CHEST TIGHTNESS; SHARP PAIN IN THE BACK BETWEEN HER SHOULDER BLADES; DIFFICULTY BREATHING; RAPID HEART BEAT; SEVERE HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa (hives) allergy, alcohol user (infrequently and just socially), and non smoker, and other pre-existing medical conditions included: Patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 21-SEP-2021) dose was not reported, administered on 29-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 30-AUG-2021, the patient experienced severe headache. On 30-AUG-2021, the patient experienced nausea. On 01-SEP-2021, the patient experienced chest tightness. On 01-SEP-2021, the patient experienced sharp pain in the back between her shoulder blades. On 01-SEP-2021, the patient experienced difficulty breathing. On 01-SEP-2021, the patient experienced rapid heart beat. On 04-SEP-2021, Laboratory data included: CT angiography (NR: not provided) no sign of heart attack or pulmonary embolism, Electrocardiogram (NR: not provided) no sign of heart attack or pulmonary embolism, and Laboratory test (NR: not provided) normal. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe headache, and nausea on 01-SEP-2021, and had not recovered from chest tightness, sharp pain in the back between her shoulder blades, difficulty breathing, and rapid heart beat. This report was non-serious.
LOOSING USE OF RIGHT HAND; EXTREME NERVE DAMAGE; HANDS WERE LIKE NUMB/NUMBNESS IN RIGHT HAND; This spontaneous report received from a patient concerned a 58 year old male. The patient's height, and weight were not reported. The patient's past medical history included back injuries, and right shoulder surgeries. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, and batch number: 1820096 expiry: UNKNOWN) dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the subject experienced extreme nerve damage. On JUN-2021, the subject experienced hands were like numb/numbness in right hand. On an unspecified date, the subject experienced loosing use of right hand. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme nerve damage, and hands were like numb/numbness in right hand, and the outcome of loosing use of right hand was not reported. This report was non-serious.
A week and a half after vaccine, rash started around injection site, by next day I was covered in rash/hives(?) from the chest down. Itchy, red, hot to the touch. Tried benadryl- this did not work well enough so employee health NP prescribed Atarax. I took this for 3 days and the rash started to go down. Today (1/29) rash is still not completely gone, but getting better
Hospitalization;  COVID-19 positive (9.7.21);  fully vaccinated Admission Date: 9/7/2021 Discharge Date: 9/9/2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: COVID-19 virus detected Pneumonia due to COVID-19 virus  HOSPITAL COURSE: Patient is a 86 y.o. male with a history diabetes mellitus type 2 on metformin and Lantus as well as hypertension, mild dementia, depression, BPH, aortic stenosis, paroxysmal atrial fibrillation and glaucoma, who presented with upper respiratory congestion and fatigue.  Patient did have his 1st Moderna vaccination in February and received a 2nd vaccination on 03/20.  Patient reports that he had been doing well, until this past weekend when he had developed upper respiratory congestion with a sore throat.  He also reported fatigue and decreased appetite. Patient had mechanical falls at home an due to weakness and inability to get up independently EMS was called. In the ED patient was hypoxic requiring 2L NC and febrile. Complete blood count showed normal white count, with chest x-ray showing bilateral infiltrates.  COVID swab was positive.    Patient was started on decadron and remdesivir. He was weaned off oxygen and remained on room air for 24 hours. Fevers resolved and he was afebrile for 24 hours. CRP and Ddimer trended down. Patients glucose was elevated due to steroids. Discussed with patient and he adjusts his qhs lantus dose based on glucose at night. Discussed with patient to continue this and metformin. Discussed with patient to call PCP if glucose > 300. PT / OT recommended home with home healthcare. Will discharge patient home to continue another 6 days of decadron. Discussed with patient quarantine due to COVID positive status. Patient discharged home in stable condition with follow up with his PCP on 9/16. Patient was feeling well and eager to discharge home.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information on patient's medical history or concurrent conditions provided. On 20-JUL-2015, the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX subcutaneous injection (dose, lot # and expiration date were not reported) instead of the intended ZOSTAVAX. No information on patient's concomitant medication was provided. No adverse effects were reported. Additional information has been requested.
Extreme Dizziness  Could not move head or lie back on pillow without the room spinning.  This began 4.5 hours after the injection (after dinner), and subsided 16 hours after it began (noon the next day).
Information has been received on 22-FEB-2019 regarding a case in litigation concerning a 51 year old female patient. The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. In January 2017, the patient was administered the ZOSTAVAX vaccine (lot# and route not specified) by a healthcare provider. In March 2017, the patient was treated by a healthcare provider for pneumonia as a result of vaccination with ZOSTAVAX. The outcome was not provided. Upon internal review pneumonia was considered medically significant.  Additional information has been requested.
Client was anxious but cooperative prior to administration of vaccines.  Client received Tdap first and Menactra second in left deltoid, then Gardasi in the right deltoid. Immediately after receiving the Gardasil, the client lost consciousness and subsequently had a syncopal seizure, lasting maybe 30 - 60 seconds? Client was cold and clammy. The child's grandmother and myself had to hold onto him to keep him  from sliding off exam bench. Client regained consciousness slowly and  stated he didn't remember what happened.  Vitals were taken and were WNL. When client appeared to be fully recovered, he left with his grandmother,stating he felt fine.
pt devel big whelps on torso around 5PM on day of #1 vax;described rash as rounded red areas w/white centers on chest & back;stated areas itching;states applied over the counter cortisone cream & affected area were clear of any breaking out
Muscle spasms in left thigh, surging sensation in both thighs that woke me up; twitching on cheek next to the left side of my mouth; This is a spontaneous report from a contactable consumer (patient himself).  A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Arm Left in Feb2021 (Lot Number: en5318) at single dose for COVID-19 immunisation. Medical history included high blood pressure, and pre diabetes. It was unknown if there was any known allergies. Concomitant medications included allopurinol, lisinopril, pantoprazole, metformin. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Jan2021 (lot number: el1284) in Left arm at single dose for COVID-19 immunisation. The patient experienced muscle spasms in left thigh, surging sensation in both thighs that woke him up, and twitching on cheek next to the left side of his mouth on 07Feb2021 19:45. The events did not result in emergency room visit or physician office visit. No treatment was received for the events. There was no COVID prior vaccination or no COVID  tested post vaccination. The outcome of events was unknown.
Pain and soreness at injection site; Pain and soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 14:00 (Lot number: EL3247) at the age of 33 years as dose 1 single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN (non-serious) all with onset 09Mar2021 14:30, outcome "not recovered" and all described as "Pain and soreness at injection site". Therapeutic measures were not taken as a result of vaccination site pain, pain. No follow-up attempts are possible. No further information is expected.
dizziness; weakness; fatigue; loss of appetite; shortness of breath; This is a spontaneous report from a contactable Nurse. An 80-year-old male patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL1284, Expiration date was not reported), via intramuscular, administered in left arm on 14Jan2021 15:00 as first dose single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation (A-Fib), coronary artery disease (CAD), hypercholesterolemia, GERD, benign prostatic hyperplasia (BPH) and peripheral vascular disorder (PVD). The patient concomitant medication was not reported. Patient did not receive any other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient did not test covid post vaccination. Resident within 15 minutes of vaccination complained of dizziness, he then subsequently had other symptoms of weakness, fatigue, no fever, loss of appetite, shortness of breath on 14Jan2021 03:15 AM. Patient received treatment of prednisone. The patient underwent lab tests and procedures which included nasal swab test: negative on 03Feb2021. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Pt. has an extremely sore arm that he can't hardly move. This started the morning after the shot. He is having difficulty sleeping b/c of the discomfort in his arm. Pt. also complains of diarrhea, loss of appetite & numbness in his thumb. As of 9-20-10 still having problems. Pt. will go to MD on 9-21-10 if still having problems.
Headache, Body aches, Nausea, Chills, Sweats, Took Tylenol
Injection site warm; Injection site itchy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jan-2021 and was forwarded to Moderna on 16-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) 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 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy). At the time of the report, INJECTION SITE WARMTH (Injection site warm) and INJECTION SITE PRURITUS (Injection site itchy) outcome was unknown. Crosslinked with case number MOD21-06047, MOD21-06146 and MOD21-06161 Warm transferred from Costumer Care, case number 000 21316 Caller states she, her husband, daughter and granddaughter got their first shot of the Moderna COVID-19.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. The treatment information was unknown.   This case was linked to MOD-2021-008434 (Patient Link).
severe vomiting for one hour non stop; A spontaneous report was received from a consumer concerning a 70 year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed severe vomiting.   The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.     On 17 Feb 2021, approximately 1 day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 18 Feb 2021, he had severe vomiting for 1 hour non stop. He was hospitalised on that day and received treatment for that. On 19 Feb 2021, he was discharged from hospital.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The event, vomiting, was considered resolved on 19 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient woke at midnight to use restroom. Too dizzy to walk, had to crawl. No other symptoms.  Woke again at 3:00 am, again had to crawl to restroom, too dizzy to walk.   Called clinic at 8:30 am. Feeling better. Able to walk, but still dizzy.
Immunocompromised patient received booster dose of the Moderna Covid 19 vaccine instead of third primary dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose of the Moderna Covid 19 vaccine instead of third primary dose.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Heart disease, unspecified and Immunocompromised.    In February 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In February 2022, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose of the Moderna Covid 19 vaccine instead of third primary dose.). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose of the Moderna Covid 19 vaccine instead of third primary dose.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the patient had received first 2 doses in Aug-2021 and Sep-2021, came for booster. The patient was immunocompromised and should have had a full dose in Feb-2022, but was given half (booster) dose of 0.25 milliliter. No treatment medications were reported.
shortly p/vax pt began sneezing, wheezing, SOB, periorbital edema, itchy throat;
Information has been received on 25-APR-2017 from a medical assistant regarding an unspecified number of patients of unknown ages and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. From 13-APR-2017 through 25-APR-2017, an unspecified number of patients were vaccinated with doses of PROQUAD lot # M043306, expiration 24-APR-2018 and lot # M042502, expiration 17-APR-2018 subcutaneous for prophylaxis which were improperly stored. Other suspect therapy included STERILE DILUENT lot # M034763 expiration 22-APR-2019. The vaccines were stored between 6 degrees Fahrenheit and 14 degrees Fahrenheit for 4 hours and 14 minutes. There was no previous temperature excursion. The call was not made due to a data logger. The medical assistant confirmed that the STERILE DILUENT used to reconstitute the PROQUAD was not improperly stored. No adverse effects were reported. No further information was reported. Follow up information was received from the medical assistant on 17-MAY-2017, referring to a 4 year old male patient. The patient administered the vaccine on 24-APR-2017. The medical assistant reported that they did not exactly know what caused the temperature excursion in April 2017, but they were thinking the door to the refrigerator might have been left slightly open. There had been no temperature excursions since that time. All telephone attempts to obtain follow-up information on 17-MAY-2017 had been unsuccessful. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA013406: US-009507513-1705USA014055: US-009507513-1705USA014056: US-009507513-1705USA014057: US-009507513-1705USA014058: US-009507513-1705USA014059: US-009507513-1705USA014060: US-009507513-1705USA014061: US-009507513-1705USA014062: US-009507513-1705USA014063: US-009507513-1705USA014065: US-009507513-1705USA014066: US-009507513-1705USA014067: US-009507513-1705USA014068.
Patient received MMR and HIB 3/15/2019, then received the Varicella. On 4/10/2019 he developed new onset eczema- progressed to severe total body eczema over the course of the next month. No other changes in home environment/ no illness
Vaccine was administered in left deltoid at 10:40, reaction began at 10:45. Pt initially had no concerns, then felt a rush of warmth from left shoulder across chest. The warmth across her chest made her cough, denied SOB and chest pain. She then began having spasms down spine and into lower back. This continued for approximately 10 min. Pt then was transported to a lying position on an exam table. Spasms were alleviated. After another 15 minutes or so pt was re-evaluated by doctor (neuro, lung, and heart exams clear), and vitals obtained. Pt stated she felt 100% better and left facility. I called pt at her home two hours later, she stated she felt well, but tired.
Developed petechial rash on inner thighs, abdomen, behind knees 5 days after vaccine give. No itch - No vesicles. No rash at injection site. Platelet count normal (273). rash resolved spontaneously and was completely gone by 3/27/09.
temp elevation w/vomiting treatment APAP duration approx 24 hrs no other sx;
Patient reported an area of raised bumps and redness around her injection site. She said the area of raised bumps was about the size of the bottom of a drinking glass with a light pink area expanding beyond that that had no bumps (only the pink discoloration). Upon follow up on 3/2/16 she said her symptoms were improving. She experienced no pain or itching and did not seek any treatment.
pt recvd #1 dose of vax;recvd 2nd dose & rt eye was swollen,closed next day;seen by MD who recommended not to give 3rd dose of vax;
A spontaneous report was received from an 83 year old male consumer who on 11-NOV-2014 received an injection of ZOSTAVAX for the prevention of shingles. Concomitant medications included DELTAZINE and ramipril. The patient stated he had no pertinent medical history. On 14-NOV-2014 (reported as three days after receiving ZOSTAVAX, he began experiencing muscle cramps in his neck and shoulders and he had difficulty sleeping. He was treated with hot/cold packs and went to a massage therapist. The outcome of the events was recovering. Additional information is not expected as the patient did not provided contact details.
itchy inner ears, face and arms- started within the hour and lasted 6-24 hours hot flashes- no temp 1/4-1/6 off and on fatigued, headache Diarrhea 1/7-1/8
Tested Positive for Covid on May 20, symptoms since May 18 but negative on May 18 and May 19