chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath; chest pains; bad rash on upper body; light headed; diarrhea; tightening of chest; numbness in half of her head/numbness in thigh; loss of brain sharpness, brain fog; chills; Headache; lost of appetite; tired; couldn't sleep; nauseous; achy; weak; arm pain; A spontaneous report was received from a consumer concerning a 61 year old, female patient who developed chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea, achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort .   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number:032L20A on 25 Jan 2021.  On 22 Feb 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number:004M20A) intramuscularly for prophylaxis of COVID-19 infection.    On 25 Jan 2021,patient received first dose of vaccine and on 22 Feb 2021 received  second dose of vaccine .patient experienced events chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness, dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort.  Treatment for the event included Allegra, farbivent inhaler, Tylenol and Qvar.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.  The outcome of the events, chest pains, bad rash on upper body/rash , shortness of breath/ dyspnoea , light headed/ dizziness , dizziness, diarrhoea, numbness in half of her head/ hypoesthesia , numbness in thigh/ hypoesthesia , loss of brain sharpness, brain fog/ feeling abnormal, chills, headache, loss of appetite/ decreased appetite , tired/fatigue , couldn't sleep/ insomnia , nausea , achy/ myalgia , weak/ asthenia , arm pain/ pain in extremity and tightening of chest/chest discomfort were not reported.
Information has been received on 04-JAN-2018 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 10-FEB-2009, a physician at a physician's office administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. In 2011, the patient was treated by a physician at a physician's office for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
For about three weeks after the vaccine I had an adverse reaction to drinking alcohol even to the extent of feeling strange and bad after two drinks and having to stop drinking. The feeling has since receded.
the office inadvertently administered Quadracel to an 8 year old in her left deltoid; Initial information received on 26-Jun-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves an 8 years old female patient who received vaccine DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and reported that the office inadvertently administered Quadracel to an 8 year old in her left deltoid.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 20-Jun-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5500LA and expiry date: 16 Aug-2020 via unknown route in the left deltoid.  It was a case of actual medication error due to inappropriate age at vaccine administration.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
temperature excursion due to human error to Ipol, and Tenivac maximum 37.6F due to the refrigerator went out of range for about 30 minutes, no AE; Temperature excursion with stability data not reported. Hence considered as non case.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, 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 EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 119th of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:master case
The day after the vaccine was administered, the patient experienced high fever (103 degrees), body aches, tiredness, and heart rate over 90 bpm.
Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Seizure-Severe, Additional Details: The incident happened at COVID clinic. Patient was recieving the 2nd dose of the vaccine. The first time we administered the vaccine to the patient, she informed the immunizer that she had a bad cough for 3 days. The patient did mention that she suffers from seizures often. The 2nd dose was administerd by the RPH immunizer and was directed to the waiting area for 15 minutes. During that time in the waiting area, she was talking to the.
Body aches, chills, headache and low grade temp (100.4 to 100.9). Lasted from evening of 4/28 and back to normal morning of 4/30
Did not get second dose within the one month time frame; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not get second dose within the one month time frame) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 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 PRODUCT DOSE OMISSION ISSUE (Did not get second dose within the one month time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not get second dose within the one month time frame) 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.   No concomitant medication were reported. No treatment information was reported.
This spontaneous report as received from a healthcare worker refers to a patient of unspecified age and gender. No current or historical conditions were reported. On 11-DEC-2014 the patient was vaccinated with the first dose of ROTATEQ (lot # K005394; expiration date: 23-FEB-2016, dosage information was not provided) orally, which was improperly stored. There were no concomitant medications reported. No adverse effect reported. There was no product quality complaint (PQC) involved. The outcome was unknown. This is one of several reports received from the same reporter. Additional information is not expected because the reporter had no further information available.
Within 30 minutes - Skin flush to hands and forearms. Denied shortness of breath or problem with swallowing. Declined Epinephrine. Monitored for 45 minutes then she was escorted back to work within the building. 15-25 minutes  later stated she was  having trouble swallowing and was jittery.  She walked herself to the Emergency room for triage.
No additional AE; HCP reported VARIVAX was administered after a temperature excursion. Temperature: 19.2F; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions, and concomitant drugs were not reported.   On 22-MAY-2023, the patient was vaccinated with one dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous injection 0.5 ml (lot#: W032370, expiration date: 10-OCT-2024; strength, route of administration, and anatomical location were not provided) as prophylaxis. The vaccine administered experienced a temperature excursion of 19.2 F for 8 hours 20 minutes (product storage error). Moreover, it was stated that there were no previous temperature excursions. No additional adverse events (AE) (no adverse event) were reported.; Sender's Comments:  US-009507513-2305USA007766:
RED BUMPS STARED TO APPEAR ON MY BACK, FEVER/HEADACHES, CHEST PAINS. WENT TO THE DOCTORS, AMBULANCE TOOK ME TO THE HOSPITAL, AFTER 5 DAYS OF QUARANTEED THEY FIGURED OUT IT WAS SWEET'S SYNDROME, TREATED WITH PREDNISONE 2/19/08-records recived for DOS 11/27-12/5/07-DC DX: Ishcemic heart disease secondary to vasculitis. Non-ST segment elevation myocardial infarction. Sweet syndrome. Hypercholesterolemia. Presented with non-ST segment elevation myocardial infarction, many skin lesions. Non purulent and no drainage boils. Headache.
2ND DAY AFTER 2ND SHOT, EXTREME PAIN IN HIP JOINT YOU SIT ON; NO UPPER BACK PAIN.  TOOK 2 EXTRA STRENGTH TYLENOL ACCORDING TO DIRECTIONS EVERY 6 HRS UP TO LIMIT FOR 2 DAYS.  AFTER 1ST SHOT, 2ND DAY, EXTREME PAIN ONLY IN RIGHT HIP; TOOK EXTRA  2 STRENGTH TYLENOL EVERY 6 HOURS FOR ONE DAY.  WASN'T SURE IF CAUSE WAS WEATHER(THOUGH I'VE NEVER HAD THIS HAPPEN BEFORE) OR SHOT.  TODAY i AM SEEING MY MIND HAD BEEN FOGGY, ONCE AGAIN NOT FORGETTING TO TAKE MEDS; RETURNING TO DOING DAILY LIVING TASKS, BED AND DISHES ETC.
pt recv 11DEC95 & 24DEC95 pt exp approx 15 pustular macules which were center scattered;the macules went away by 28DEC95 or 29DEC95;no further details were provided;
patient received vaccination 7/24/2019 and noticed in the morning on 7/25/2019 that the injection site was welted up, red, and warm to the touch; she did not experience fever or any flu-like symptoms; her arthritis also flared up and continues to be; the redness and warmth subsided by 7/28/2019 but still has traces of discoloration
Developed varicella after 2 doses of vaccine - failed protection.  1st varivax given 3-30-04 Merck 0884N and 2nd varivax given 5-29-07 Merck 1391F.
No adverse events reported as of 8/30/21. Patient was given DTaP-Hep B-IPV (Pediarix) and IPV vaccinations instead of DTaP and IPV.
I started with a bad headache and body aches. By night by body ache got worse. I
Pt received Pneumococcal vaccine 0.5 IM lt deltoid 10/10/06. States noticed pain and swelling that PM. Presented to clinic 10/12/06. Lt arm noted with redness, swelling from elbow up to approx 3 inches below shoulder. Skin is warm to touch. Reports pain is less now.
Injection Muscle Site Reaction: Swollen hard induration/lump, Redness and Itching still a week later.
Large red confluent area on ant. abdomen & chest. Few raised red irregular areas on torso. No rash at site of injection. Gave Benadryl 1/2 tsp po. Swelling & redness lessened over 1 1/2 hours. Completely recovered by 10-31-05. Medical records state facial edema, agitation, rash. msv
shoulder pain rated 7/10, dull ache, no redness, no swelling at the site.   headache has been occuring later in the days.  No fever
received Menveo powder vial mixed with MMR Merck diluent vial or with sterile; received Menveo powder vial mixed with MMR Merck diluent vial or with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number amva9468, expiry date 31-JUL-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received Menveo powder vial mixed with MMR Merck diluent vial or with sterile) and inappropriate dose of vaccine administered (Verbatim: received Menveo powder vial mixed with MMR Merck diluent vial or with sterile water ).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 22-Aug-2023 The reporter had just found it an empty box of Menveo with only one liquid conjugated component of Menveo left.  It looks like one unknown patient received Menveo powder vial mixed with MMR Merck diluent vial or with sterile water. The reporter consented to follow-up. The patient received Menveo vaccine which was reconstituted with non-approved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Patient stated that his chest was itchy for a while afterwards. Patient said it might have been to his new laundry detergent.
Low grade fever, chills, shivering, joint pain, muscle aches, headache, upset stomach, very sore arm at injection site
Local swelling, pain 2 weeks Fatigue 5 days Body aches 3 days
2 weeks after shot, he continues with fatigue, had chills again today and fever for last 2 nights. Also has a cough.
This patient attended a community vaccination event. His guardian requested that he be vaccinated while he was there with her. The medical assistant complied with the request. Moderna vaccine is not approved for people under the age of 18. This patient should not have received the vaccine. He has not had any adverse effects from the vaccine at this point.
11 days after Moderna shot, woke up with a rash on my left arm that progressively got worse over the next 4 days, eventually covering arm from the injection site down to the elbow. Rash was hot to the touch, painful, hard and tender. Rash resolved completely in 7 days. Took Benedryl and tylenol with and used ice.
Post vax, the pt developed diarrhea and hematoemesis. Subsequent dx of c diff colitis on 11/12/00. Pt developed acute severe hypercarbic respiratory failure. On 11/14/00, suspects respiratory failure from possible muscle weakness.
Information has been received from an investigator concerning a 67 year old male with diabetes, potassium replacement, gastrooesophageal reflux disease, depression, oedema, hypercholesterolaemia, diverticulitis and osteoarthritis who entered a study.  The patient was vaccinated with blinded therapy on 07-FEB-2008.  Concomitant therapy included GLUCOPHAGE XR, sitagliptin phosphate (MSD), K-DUR, NEXIUM, PROZAC, HCTZ/triamterene and ezetimibe (+) simvastatin (MSD).  On 15-FEB-2008 the patient experienced severe headaches and severe nausea and vomiting and was hospitalized.  The patient was diagnosed with aseptic meningitis.  He was discharged from the hospital on 18-FEB-2008.  The patient's aseptic meningitis persisted, with the patient still experiencing moderate headaches and nausea approx. 3-4 times per week.  The reporting investigator felt that the aseptic meningitis was possibly related to study therapy.  The record for this patient was unblinded on 18-MAR-2008.  The patient was treated with Zostavax (Oka/Merck) 0.65 ml.  Additional information has been requested.
Large red hive to left arm , itching , warm to touch . Some pain/discomfort to under arm which radiated to left breast
Child was given 0.2ml dose of undiluted Pfizer 5-12 year old vaccine.  Parent contacted 1/26/2022 and there had been no adverse reaction experience up to that date/time of contact.  Parent stated sore arm only.
This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 05-OCT-2017, the patient was vaccinated with an improperly stored dose of ZOSTAVAX lot # M042851 and expiration date 18-JAN-2018 (strength, dose number and route were not provided) for prophylaxis. Concomitant therapies included sterile diluent, no adverse events were reported. The ZOSTAVAX was improperly stored with a temperature of 6 °F (Fahrenheit) to 14°F for 5 hours 15 minutes. The report was due to data logger. It was reported that there was a previous temperature excursion of 15° F to 46 °F for 3 hours and 20 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1710USA013116: US-009507513-1710USA004870.
21NOV96 12PM fatigue, h/a, t102 oral, APAP given;rt arm sore, temp dec to 99;22NOV96 t98.6, no h/a. clo sore rt arm & fatigue;
Swelling at injection site. (left arm) firm, not painful. Patient did not want to continue vitals. Stated she felt fine 5:22pm
patient reported redness and swelling in unilateral right arm from shoulder to elbow that waxed over a period of 3 days. the patient said the redness and swelling got better over previous 1 day.  upon presentation, the redness was present, but limited and edema was more significant. presented with skin-syndrome akin to SJS, but not as severe. skin symptoms were unilateral.
I woke up at 5am on 12/27/2021 with body aches all over my body. I had a fever of 102.8. I had body chills, my back ached, chest pressure/pain that felt like I had a 100lb weight on my chest. I took ibuprofen/acetaminophen to try to keep my fever down. I had a telephone visit with a doctor on 12/27/2021 at 12:15pm and they had me take a covid test that came back positive. My fever lasted 8 days. My back ache and chest pressure/pain lasted 13 days. I had to go back into urgent care on day 11 of having my symptoms. They did blood work, and a chest x-ray. I was prescribed Medrol dose Pak, methylprednisolone which I took for 6 days.
Information has been received from a physician concerning a 24 year old female with no pertinent medical history and no known adverse drug reactions or allergies reported. On 16-JAN-2007, the patient was vaccinated with the first dose of Gardasil (yeast). There were no concomitant medications reported. On 27-JAN--2007, the patient developed a rash on her arms and legs. At the time of this report, the outcome of the event was unknown. Additional information has been requested. This is in follow-up information has been rceived from a physician concerning a 24 year old female with no pertinent medical history and no known adverse drug reactions or allergies reported. On 25-JAN-2007 (previously reported as 15-JAN-2007), at approximately 5:45 p.m. the patient was vaccinated IM in the left deltoid with the first dose of GARDASIL (lot #6551565/1425P). There were no concomitant medications reported. On 28-JAN-2007 (previously reported as 27-JAN-2007), the patient developed a red, itchy rash on her arms and legs, reported as worse on the side the patient received her vaccination. The patient was treated with BENADRYL, as directed by the physician. On 01-FEB-2007, the physician spoke to the patient and reported that, at the time of the call, there was improvement of the patient's rash. No additional information is expected.
mom noted 8 vesicles-rash appearing just like sister that broke out w/chicken pox 2wk ago;afeb;all areas scabbed over w/in 24-36hr;
tested positive for Covid-19; soreness in left arm at the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in left arm at the site of the injection) and COVID-19 (tested positive for Covid-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ORAL CONTRACEPTIVE NOS for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in left arm at the site of the injection). On 17-Mar-2021, the patient experienced COVID-19 (tested positive for Covid-19). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in left arm at the site of the injection) had resolved and COVID-19 (tested positive for Covid-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
(L) knee swelling and pain. 16 days after vaccine. Patient placed on Augmentin 600/5 ml, 4 ml PO BID. Sent to lab for blood work and stat x-ray. Referral to ortho.