chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE; PROQUAD mistakenly given to 16 year old instead of MMR II. Patient has had a prior dose of MMR II in the past. No additional AE. No PQC.; PROQUAD mistakenly given to 16 year old instead of MMR II. Patient has had a prior dose of MMR II in the past. No additional AE. No PQC.; This spontaneous report was received from a registered nurse referring to a 16-year-old patient of unknown gender. Patient's historical vaccine included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). No more information regarding the patient's pertinent medical history, drug reactions or allergies, or concomitant therapies was provided.   On 29-JUL-2022, the 16-year-old patient was mistakenly vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, lot #, expiry date, and route of administration were not provided) (product administered to patient of inappropriate age) for prophylaxis, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (wrong product administered). No additional adverse event (AE) was reported.
within three hours of vaccination she had extreme arm pain, nausea, vomiting, chills, and blood pressure was up over 200
pain; red area where she had the shot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain) and INJECTION SITE ERYTHEMA (red area where she had the shot) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LATANOPROST for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1. On an unknown date, the patient experienced PAIN (pain) and INJECTION SITE ERYTHEMA (red area where she had the shot). At the time of the report, PAIN (pain) and INJECTION SITE ERYTHEMA (red area where she had the shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
FLUZONE HD administered 10/23/15. On 10/25/15, pt reported itching/redness at injection site started on 10/24/15. By 10/25/15, itching/redness started to travel down her arm.
Patient started feeling dizzy after receiving the second dose.  He was given water and asked to sit for a while.  He felt somewhat better and went home.
allergic reaction; Rash on her hand/Rash on her neck/Rash on her face/Rash on her legs and chest; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (allergic reaction) and RASH (Rash on her hand/Rash on her neck/Rash on her face/Rash on her legs and chest) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced RASH (Rash on her hand/Rash on her neck/Rash on her face/Rash on her legs and chest). On an unknown date, the patient experienced HYPERSENSITIVITY (allergic reaction). At the time of the report, HYPERSENSITIVITY (allergic reaction) and RASH (Rash on her hand/Rash on her neck/Rash on her face/Rash on her legs and chest) outcome was unknown.        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 reported. The patient was given treatment for allergic reactions.
Information has been received from a registered nurse concerning a 11 year old female who on 01-AUG-2007 was vaccinated with a dose of Gardasil. Concomitant vaccination on 01-AUG-2007 included Vaqta and Varivax. On 02-AUG-2007 it was reported via phone by the patient's mother that the patient developed an itchy rash on bottom of her feet and hands. the physician prescribed BENADRYL to relieve the symptoms. On 02-AUG-2007 the patient was going to be seen in the office, and had not recovered. Additional information has been requested.
This spontaneous report was received from a medical assistant and refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (orally, dose, lot# and expiration date were not provided). No adverse effects were reported. Temperature and time frame: 32 degrees Fahrenheit to 35 degrees Fahrenheit for 67 minutes and 47 degrees Fahrenheit to 77 degrees Fahrenheit for 139 minutes. Previous temperature excursion?: No. Was call because of a "data logger"?: Yes. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1708USA013411.
Low grade fever (max 100.0), body aches, nausea for first 12 hours, headache.
Information has been received from aphysician concerning a 50+ year old female patient who on 06/30/2004 was vaccinated with a dose of hepatitis B virus vaccine rHBsAg(yeast)(lot# not available). The physician reported that the patient developed nausea and lack of appetitie (approximately 06/30/2004) after receiving the hep b virus vaccine rHBsAg(yeast). No treatment was required. The physician also mentioned that nine other patients were vaccinated with the same lot and none of them had anyproblems. No other information was available at the time of this report. There was no product quality complaint reported. Unspecified medical attention was sought. Additional information has been requested.
soreness, cracking of the tongue; took 1 capsule 10SEP then sx occured on 2nd capsule but cont to take them & did complete all regiments;
Around Oct 17, 2 weeks later after the vaccine, started with dry throat, cold, cough, symptoms were gone by the 26, but I still have the cough, the nurse said it was not unusually to have the cold for several weeks. I am taking cough pills and it's helping. I had a home COVID-19 test and it was negative.
Shortly after receiving the vaccine, the patient began to feel dizzy. He then started to feel numbness on his upper lip which slowly spread to his whole face and tongue. His blood pressure was measured at 169/83mmHg. We called 911, and he was given diphenhydramine 50mg PO and epinephrine 0.3mg IM. The patient was able to communicate with EMT when they arrived, and they took him to the emergency room.
Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Mar-2022; Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Mar-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Mar-2022) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Mar-2022) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     Acute illness at the time of vaccination and up to one month before was reported as unknown. Chronic or long-standing health conditions was reported as unknown.     On 12-Mar-2022 at 9:49 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Mar-2022 at 9:49 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Mar-2022) and PRODUCT STORAGE ERROR (Vaccines went into 2-8 C thaw state on or about 24-Dec-2021 and administered on 12-Mar-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient ethnicity reported as White.  Prescriptions, over the counter medications, dietary supplements or herbal remedies being taken at time of vaccination  or at the time of the adverse event were reported as unknown.  Other vaccines given on the same day as Moderna COVID-19 vaccine and other vaccines received within one month prior to any dose of Moderna COVID-19 vaccine were reported as unknown.  On 12-Mar-2022 at 09:49:59 , the patient received a booster dose (Lot: 066H21A and expiry date 04-APR-2022) of Moderna vaccine.  Reported that patient received Vaccine past its 30 day expiry date, vaccines went into 2-8 degree C thaw state on or about 24-Dec-2021.  No treatment information was reported.   This case was linked to MOD-2022-542869 (Patient Link).
Left arm swelling; Hot to the touch; 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 PERIPHERAL SWELLING (Left arm swelling) and FEELING HOT (Hot to the touch) 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, the patient experienced PERIPHERAL SWELLING (Left arm swelling) and FEELING HOT (Hot to the touch). At the time of the report, PERIPHERAL SWELLING (Left arm swelling) and FEELING HOT (Hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Medication Error: Administered COVID-19 vaccine in person less than 12 years old in error. No adverse events reported.
S/S began 4/21 c/o pruritus, then rash, red, then hives. DR prescribed Prednisone 20mg and Hydrocortisone 1% cream. Today 4/26 stomach upset.
SWOLLEN LYMPH NODES IN COLLARBONE AREA OF INJECTION SIDE THAT WERE GROSSLY PRESENT FOR 3 WEEKS, UP UNTIL RECEIVING SECOND DOSE
Patient presents to the ED the day after receiving her 2nd shingles vaccine. Patient has redness and swelling at the injection site which has been present for 5 hours and has been becoming more painful starting 2 hours before coming into ED. Patient reports pain radiating into neck and down her arm. Patient denies having a reaction to first dose. Patient's workup determined to also have cellulitis secondary to immunization. Patient was treated with diphenhydramine and started on ceftriaxone.
Rapid onset, acute vertigo - unable to stand or walk, opening eyes brought on severe nausea and vomiting, sweating, headache
herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 72 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 05-FEB-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
I went to the emergency room after feeling a strong feeling of heart racing and trouble breathing. The symptoms occur starting 06/12/2021 and got severe on 6/15/2021 causing my emergency room visit. This hospital didn't know what was happening to me so It was ruled a panic attack and heart palpitations. But the symptoms lasted days at this point.
Information has been received from a 67 year old female patient referring to herself with gastrooesophageal reflux disease (GERD), diabetes and arthritis. The patient was allergic to "polyethylene glycol 3350 (MIRALAX) and other stuff they give you before colonoscopy", aspirin, ALEVE, sulfa, "the mycins" and latex. The patient had been vaccinated with a dose of PNEUMOVAX 22 on 17-AUG-2015. On 15-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX 19400 PFU, 0.65 ml, subcutaneously. Concomitant therapies included LANTUS, HUMALOG, CRESTOR, CYMBALTA, tizanidine, TEKTURNA and "Tricipium Chloride". "Within 24 hours", on 16-DEC-2015, the patient developed tiny blisters on her forehead that turned into blisters and she developed blisters in her mouth and tongue. The patient's lips swelled up and she developed a rash below her ankle that had spread to the middle of her legs. Her neck swelled up too. The patient wen to the emergency room (ER) but the staff there was unable to determine what the cause was, but they told the patient that they didn't think it was due to the ZOSTAVAX. The patient stated that she took BENADRYL for her swollen lips and the swelling went down and on 21-JAN-2016 she used BENADRYL cream for itching she experienced from the rash, and the itching had since stopped. The rash had continued to spread since the event began. The patient's present status was unspecified. Additional information has been requested.
has not eaten anything; Stomach was sore; felt sick; dry heaves; threw up; headache; sore arm; having achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), ILLNESS (felt sick), RETCHING (dry heaves), FEEDING DISORDER (has not eaten anything) and ABDOMINAL PAIN UPPER (Stomach was sore) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulphur) and Food allergy (bananas). Concomitant products included MONTELUKAST SODIUM (SINGULAIR) from 08-Mar-1998 to an unknown date, SALBUTAMOL (ALBUTEROL HFA) from 10-Mar-2020 to an unknown date and ELWENDIA PERSICA OIL (BLACK SEED [ELWENDIA PERSICA OIL]) from 01-Mar-2021 to 15-Mar-2021 for Allergy, DULOXETINE HYDROCHLORIDE (CYMBALTA) from 01-Mar-2000 to an unknown date for Depression, ALOE VERA, MALUS DOMESTICA (VINEGAR APPLE CIDER PLUS) from 01-Mar-2021 to 15-Mar-2021 for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (having achy). On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 15-Mar-2021, the patient experienced ILLNESS (felt sick), RETCHING (dry heaves) and VOMITING (threw up). 15-Mar-2021, the patient experienced HEADACHE (headache). On an unknown date, the patient experienced FEEDING DISORDER (has not eaten anything) and ABDOMINAL PAIN UPPER (Stomach was sore). The patient was treated with IBUPROFEN for Myalgia and Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm), ILLNESS (felt sick), RETCHING (dry heaves), FEEDING DISORDER (has not eaten anything), ABDOMINAL PAIN UPPER (Stomach was sore), MYALGIA (having achy), VOMITING (threw up) and HEADACHE (headache) outcome was unknown.            Reportedly, the patient laid in bed all day. On an unspecified day the patient started feeling better.   Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Initial additional : Patient demographic details were added. Medical history information is added.  Concomitant drugs were added. Additional event added.
sore throat, mouth lesions, tongue lesions, body ache, headache, fatigue
On 1/9/22 Pt noticed hives all over body, with horrible itching. Pt had telehealth  visit on 01/27 and was referred to an allergist. Saw allergist on 05/23/22 but no medicine was given. Doctor said chronic allergy was due to booster. Diagnosed with chronic hives.
I have been having irregular menstural bleeding. My cycles have been heavy and with a large amounts of blood clots.
Patient received both Fluad and Pneumovax 23 on 9/26/19 in the morning. Both were administered in the left arm (deltoid muscle) at least 1 inch apart. By Thursday evening, patient had massive headaches and soreness at injection site. The next morning,  patient had fever of 101 degrees Fahrenheit and has body aches as well as lack of appetite for 3 days. Patient's left arm is also hot and inflamed with an area of about 4.5 inches by 7.5 inches. Patient went to her primary care physician and was prescribed cephalexin in case of skin infection. Ibuprofen and Benadryl was also ordered as needed for pain and itching. Will follow up with patient in the next couple days to see if low grade fever subsides.
SUICIDAL IDEATION (PATIENT HAD SOME TALK OF DYING); HERNIA (HERNIA WAS STICKING OUT WHEN EATING AND DID NOT WENT BACK IN); ADVERSE FOOD REACTION (EATING ANYTHING MADE PATIENT BLEW UP); AGORAPHOBIA; DEPRESSION; RIB PAIN; FATIGUE AGGRAVATED; This spontaneous report received from a consumer concerned a 6 decade old (age at the time of vaccination 56 years) female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had history of needing this contact (suicide prevention hotline contact information) in 2019. The patient was previously treated with cyanocobalamin given one month before vaccine for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 12-NOV-2021 for covid-19 vaccination. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number and expiry were not reported) dose, frequency, and therapy dates were not reported for moderate to severe adult Crohn's disease. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included Vitamin B12(cyanocobalamin) for drug used for unknown indication.  On an unspecified date, the patient had some talk of dying (suicidal ideation) and suicide prevention hotline contact information was provided. The patient's hernia was sticking out when eating and did not went back in, she was tired/exhausted/excessive fatigue and eating anything made the patient blew up. It was reported that the patient was tired on constant basis, exhausted. It was reported that the patient's going to the bathroom was less, had improved. The patient was depressed, had excessive fatigue and had tiredness for six months, this was part of her condition. The patient's ribs were in pain, she asked her boyfriend to crack her back harder and it did not hurt but next day her ribs were sore the next day (ribs pain/ribs sore), it might be wrong angle. The patient was agoraphobic (agoraphobia), did not like to leave house, relative due to her depression. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient was recovering from fatigue aggravated, depression, and rib pain, had not recovered from hernia (hernia was sticking out when eating and did not went back in), and the outcome of suicidal ideation (patient had some talk of dying), adverse food reaction (eating anything made patient blew up) and agoraphobia was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220335052-covid-19 vaccine ad26.cov2.s-suicidal ideation (patient had some talk of dying). The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Child received 0.5 cc of pediatric Moderna vaccine that was labelled as a "single-dose vial" and should have received only 0.25 cc
He sat for maybe 5 minutes and then passed out. He woke up and didn't know why he was on the floor. He again went in a daze with his eyes open and they had to rub his chest to get him to respond. Started throwing up, and not feeling g well.
Received varicella vaccine.  After leaving the clinic and walking to get in his car (~ 15 min), became pale & limp and told mom he couldn't breathe.  Vomited many times & came back into clinic.  Respire shallow, pale, BP 71/41, tone decreased.  Gave 0.15mg epinephrine SQ. Responded well with improved profusion.  Transported by squad to ER - received IVF's & BENADRYL.  No rash at the injection site.  Recovered uneventfully.
Patient had reported having tingling in throat and pre-medicating for first Moderna vaccine. Patient received second dose and was observed for 30 minutes. She reported feeling tingling in her throat as well as "heaving tongue and top lip." She reported that this happens when she eats grouper and she usually takes Benadryl to resolve it. Her O2 sat was 98% and HR 82 bpm. She was given Benadryl 25 mg, then monitored an additional 45 minutes. Her O2 sat was now 100% and HR 78 bpm. She reported feeling back to normal and left.
SHORTNESS OF BREATH; FEELING LIKE HEART WAS GOING TO  BEAT OUT OF CHEST; HOT FLASH ON FACE; HURTING LEG; TEETH SHATTERING CHILLS; STINGING AT INJECTION SITE; FEVER OF 103.7; SEVERE HEADACHE; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies and did not had history of reactions to vaccine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: 206A21A, expiry: Unknown) dose was not reported, administered on 10-APR-2021 10:15 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: ibuprofen. On 10-APR-2021, the subject experienced shortness of breath. On 10-APR-2021, the subject experienced feeling like heart was going to beat out of chest. On 10-APR-2021, the subject experienced hot flash on face. On 10-APR-2021, the subject experienced hurting leg. On 10-APR-2021, the subject experienced teeth shattering chills. On 10-APR-2021, the subject experienced stinging at injection site. On 10-APR-2021, the subject experienced fever of 103.7. On 10-APR-2021, the subject experienced severe headache. Laboratory data included: Body temperature (NR: not provided) 103.7 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feeling like heart was going to beat out of chest, hot flash on face, hurting leg, teeth shattering chills, and fever of 103.7 on 11-APR-2021, and stinging at injection site on 10-APR-2021, was recovering from shortness of breath, and had not recovered from severe headache. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is considered non serious.
Next day I woke up with hives all over my body including scalp and bottom of feet. Tongue swelled, difficult in t breathing and swallowing. Fatigue, weakness, passed out and threw up.