chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she experienced heat, rash, and hives on the left arm at that time; she experienced heat, rash, and hives on the left arm at that time; she experienced heat, rash, and hives on the left arm at that time; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 95R52, expiry date 08-NOV-2020) for prophylaxis.   Concomitant products included clobetasol propionate (Clobetasol Propionate Cream).   On 09-NOV-2019, the patient received the 1st dose of Shingrix (intramuscular, left deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced hives (Verbatim: she experienced heat, rash, and hives on the left arm at that time), rash (Verbatim: she experienced heat, rash, and hives on the left arm at that time) and feeling hot (Verbatim: she experienced heat, rash, and hives on the left arm at that time). Shingrix was discontinued. The outcome of the hives, rash and feeling hot were not resolved.   It was unknown if the reporter considered the hives, rash and feeling hot to be related to Shingrix.     It was unknown if the company considered the hives, rash and feeling hot to be related to Shingrix.   Additional Information: GSK Receipt Date: 10-JUL-2023 The reporter stated that she experienced heat, rash, and hives on the left arm at that time, and then on 3rd July 2023, the symptoms reoccurred.  The reporter stated that during the call that she never received her second dose and did not intend on getting the second dose.  The reporter consented to follow up.
NO ADVERSE EVENT; PROQUAD was improperly stored then administered; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-NOV-2020, the patient was vaccinated with an improperly stored dose of  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 0.5ml with lot number T025506 with expiration date on 23-JAN-2020 for prophylaxis (route of administration was not reported). The administered dose of the vaccine experienced a temperature excursion 22.8 degrees F for 13 hours and 25 minutes.   There was no adverse effect reported.  This call was because of a data logger.   No product quality complaint was involved.
This spontaneous report as received from a Licensed Practical Nurse refers to a 7 year old male patient with heart murmur and "ADHA". On 11-FEB-2016, at 10:44 pm, the patient was vaccinated with the second dose of PROQUAD (Merck) (lot# L040414, subcutaneous, dose unknown) which was improperly stored. Concomitant therapies included DTaP, influenza virus vaccine (unspecified), hepatitis A virus vaccine (unspecified), hepatitis B virus vaccine (unspecified) and IPV (unspecified). No adverse event was reported. There was no illness at time of vaccination. The outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information is not expected since all follow up attempts has been received.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with an improperly stored doses of (Merck) VARIVAX. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Myalgia Localized itching, pain, redness, swelling; chills,  fatigue  Narrative:   Other Relevant History:
The next morning after vaccine,, weakness in overall muscles in the entire body, left knee pain, and lower back pain L 4-5,  No energy , feeling  tired and slowly walking to bathroom, so I remained in bed with lots of fluids.        The next day the pain had all but gone and I was able to move around with out pain or weakness.
Second dose: Tiredness; Second dose: Headache; Second dose: Fever of 101.6 degrees Fahrenheit; Second dose: Muscle pain; Second dose: Chills; Second dose: Joint pain; Second dose: Nauseous; Second dose: Swollen lymph node gland under her left arm pit; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EW0150, Expiry date: 21Aug2021) (age at the time of vaccination was 65 years), via unspecified route administered Arm left on 23Apr2021 as dose 2, single for COVID-19 immunization. The patient's medical history included colitis and high blood pressure. The patient's concomitant medication included lisinopril hctz and delepamil for high blood pressure. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: not provided), via an unspecified route of administration, on 06Apr2021 as dose 1, single for COVID-19 immunization. No investigation assessment. On 23Apr2021 at 09:00 PM, the patient started symptoms. The patient has tiredness, joint pain, fever dropped down to 100.8 degrees fahrenheit. The patient has been checking for a fever, on an off and had headache. On 25Apr2021, the body temperature was 99.9 degrees fahrenheit. The patient had swollen lymph node gland under her left arm pit. The patient received the covid vaccine in her left arm which began in between 4:00 or 5:00 PM. It was about the same, a little bit better. Treatment received included tylenol for headache and fever. The patient underwent lab test and procedures included body temperature: 101.6 degrees Fahrenheit on 23 Apr2021 and 99.9 degrees Fahrenheit on 25Apr2021. The outcome of the events second dose: tiredness was resolving, Second dose: Headache, Second dose: Muscle pain, Second dose: Chills, Second dose: Joint pain, Second dose: Nauseous resolved on 26Apr2021, Second dose: Fever of 101.6 degrees Fahrenheit resolved on 25Apr2021, Second dose: Swollen lymph node gland under her left arm pit not resolved.  No follow-up attempts were needed. No further information as expected.
S/sx started at approximately 2130 with fever, chills, body aches. Fever was 102.9. Administered Tylenol 1gm to decrease fever. Rechecked after one hour and temp was still 102.7. S/sx cont throughout night with nausea, body aches, chills, headache, fever. Fever has still yet to break and it?s 1630 on 1/5/2021.
Pt recvd series of Engerix-B on 11FEB88, 18MAR88, 29SEP88 respectively; Titer drawn 17APR91 revealed that pt had no protection; Booster dose will be given;
shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number 4X733, expiry date 8th March 2021) for prophylaxis.   On 28th March 2019, the patient received the 1st dose of Shingrix .5 ml. In April 2019, 7 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm. Approximately one week following the vaccination, the patient developed a mild case of shingles.
Patient received dose of a vaccine from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial). On 11-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received dose of a vaccine from an expired vial) had resolved.        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 relevant concomitant medications were reported.  No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-122422, US-MODERNATX, INC.-MOD-2021-122588, US-MODERNATX, INC.-MOD-2021-122557 (Patient Link).
Approx. 5 min after receiving vaccine, patient lost consciousness, fell out of the chair and hit his head.  Patient was moved to a stretcher and regained consciousness, was able to say where he was.  HR and BP were low, patient given apple juice and water.  When EMS arrived they gave additional fluid and patient was transferred. Patient was admitted to cardiology for observation,  Cardiology diagnosed patient with syncopal episode 2/2 vasovagal reaction.   Patient has history of vasovagal syncope related to needles.
Severe migraine all week; Just red; Fist-size, hard lump at injection site; Itches when touched; Lump is raised around the edges; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Fist-size, hard lump at injection site), MIGRAINE (Severe migraine all week), VACCINATION SITE PRURITUS (Itches when touched), VACCINATION SITE SWELLING (Lump is raised around the edges) and VACCINATION SITE ERYTHEMA (Just red) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Migraine.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE MASS (Fist-size, hard lump at injection site), VACCINATION SITE PRURITUS (Itches when touched) and VACCINATION SITE SWELLING (Lump is raised around the edges). On an unknown date, the patient experienced MIGRAINE (Severe migraine all week) and VACCINATION SITE ERYTHEMA (Just red). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Fist-size, hard lump at injection site), MIGRAINE (Severe migraine all week), VACCINATION SITE PRURITUS (Itches when touched), VACCINATION SITE SWELLING (Lump is raised around the edges) and VACCINATION SITE ERYTHEMA (Just red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       patient used ice pack.
Childs left arm was swollen, red and warm. Child had pain from deltoid to elbow. Tx: BENADRYL warm and cold compress PRN ASAP PRN.
Patient up to date on COVID vaccines who admitted with complications r/t COVID and COVID detected PCR.  Provider d/c note:  "94 F with PMH HLD, Anemia, HTN, OA, Mild Cognitive impairment with memory loss, Chronic Insomnia, Depression  who is presenting to the ED for evaluation of worsening weakness, cough, and SOB.   Patient is on chronic O2 nasal cannula at home.  Was found outpatient to be COVID positive and started on Paxlovid   Initial workup included a CTA that was negative for PE.  Patient was found to be COVID positive.  Patient was started on Decadron as well as remdesivir and monitored overnight.  Patient maintained on her home O2 nasal cannula and her strength improved.  Patient was discharged home to resume Paxlovid therapy and follow-up with primary care provider for continued care."
The same day after first inject got a sore arm as expected.   The arm continue to stay sore up until second injection which I had doubted getting but did receive in the same arm on March 17,2021.  My arm continued to hurt and went to see my general practice doctor who gave me naproxen to take in april 2021.  On follow up appointment the arm still continued to be very sore and it was injected with a steroid.  My arm never got better even after steroid so I made an appointment with Orthopedics.  They took an xray, assessed it, and gave a diagnosis of frozen shoulder.  I was prescribed a solumedrol dose pack which I completed this week but feel the soreness coming back after 3 days off dose pack.  I have a follow up appointment on Monday 5/24/21 to evaluate effectiveness of steroids and other possible treatment plans.
Information has been received from a 32 year old female consumer who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast). On 05-MAY-2008, the patient received her second dose of GARDASIL vaccine (yeast), 0.5 ml, IM (lot # not specified). Concomitant therapy included influenza virus vaccine (unspecified), two weeks prior to receiving GARDASIL vaccine (yeast). Subsequently the patient experienced muscle aches and pains. The patient reported that she sought unspecified medical attention and had diagnostic blood work performed. No results were reported. Therapy with GARDASIL vaccine (yeast) was discontinued. At the time of reporting the patient had not recovered. No additional information is expected.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 27-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history is provided and concomitant drugs are provided.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), PRENATAL + DHA and INSULIN from an unknown date to 22-Feb-2021 for an unknown indication.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on 15-Jul-2020 and the estimated date of delivery was 21-Apr-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-fifth week of the pregnancy.  On 09-Jan-2021, EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Aug-2020, Pregnancy test: positive (Positive) Positive. On 15-Dec-2020, Ultrasound foetal: normal (normal) Good. On 30-Jan-2021, Glucose tolerance test: abnormal (abnormal) abnormal- diagnosed with gestational diabetes.     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.   Treatment medication was not reported. 19 May 2020 misscarriage 10 weeks was reported.    Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2021: concomitant drugs are added and patient demographics are added
After taking a shower this evening my arm turned red.  It wasn't red prior to taking the shower.
This spontaneous report was received from a nurse practitioner refers to multiple unspecified patients of unknown age and gender. Information regarding patients' medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # M021124, expiry date: 02-FEB-2018). No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
flu symptoms. Pt received J&J vaccine yesterday morning. Pt states his HA, body aches, and chills started at 2200. Pt denies cp/sob/n/v/d/c.  History:  Pt here with progressively worse bitemporal/occipital headache, chills, body ache, since about 2pm yesterday here for eval.  Had J&J COVID-19 vaccine yesterday morning and reports no symptoms prior to the vaccine.  No recent surgery/procedure, sick contact, COVID-19 hotspot visit, vomit/diarrhea/rash, dysuria, use of any meds.  Had remote cardiac ablation for arrhythmia.
An LVN drew up and gave the lower dose Moderna Bivalent (0.2ml/10mcg) for the second dose in the series instead of giving the correct higher dose Moderna bivalent (0.25ml/25mcg). No adverse reactions were reported by the parents. The parents were notified by the patient's primary care provider and by the manager of the clinic. The guidelines for incorrect dosage administered was reviewed by the PCP and the patient.
32 year old healthy, white female, 6'0', 175lb, NKDA. No previous medical issues other than mild Crohn's disease. She diagnosed with a spontaneous subarachnoid hemorrhage. No previous problems with neurologic or hematologic systems. Bleed believed to be either aneursymal or truly spontaneous. Neither of which the female had any pre-existing knowledge of, nor any risk factors.
Dizziness, vertigo, fast heart beat, fatigue, restlessness, cough, fever,
Patient came in and said the day after he received the flu shot he felt dizzy, lightheaded, and weak. He reported to having no appetite. The symptoms were gone 24 hours later.
5 minutes after injections were given, patient had a hive-like rash develop on her lower extremities. Redness also noted to her extremities from the knee down.
I am feeling COVID-like symptoms a week after I received the second vaccine. Body aches, chills, sore throat, cough, runny nose, loss of taste/smell.
Heart attack; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a male patient of an unknown age 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 MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown.            Concomitant product information was not provided by the reporter.   The reporter's father had been vaccinated multiple times and had been in and out of the hospital. The reporter's father had a heart attack. Now that there was overwhelming evidence that Moderna vaccine was killing people and harming people. The reporter did not see why it would be a problem to get money through the court system.  Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-707862, US-MODERNATX, INC.-MOD-2023-707866 (E2B Linked Report).; Reporter's Comments: This spontaneous case concerns an unknown-years-old male patient, with no medical history related who experienced the medically significant expected AESI of myocardial infarction unknown days after a  dose of  mRNA- 1273 bivalent vaccine. The outcome was unknown.    The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-707862:case for grandfather US-MODERNATX, INC.-MOD-2023-707866:case for mother
weakness; bone pain; nerve pain; feeling unwell; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), BONE PAIN (bone pain), NEURALGIA (nerve pain) and MALAISE (feeling unwell) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder NOS. Concomitant products included GABAPENTIN, MELOXICAM (MOBIC), HYDROCODONE BITARTRATE, PARACETAMOL (NORCO), TRAZODONE, METHOCARBAMOL, ZINC, CALCIUM and MAGNESIUM for an unknown indication.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced ASTHENIA (weakness), BONE PAIN (bone pain), NEURALGIA (nerve pain) and MALAISE (feeling unwell). At the time of the report, ASTHENIA (weakness), BONE PAIN (bone pain), NEURALGIA (nerve pain) and MALAISE (feeling unwell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included MULTI VITAMIN & MINERAL for an unknown indication There was no treatment medication reported.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up was received on 09-JUN-2021 Contains No new information. On 28-Jun-2021: Follow-up was received on 28-JUN-2021 contains No new information
Had flu shot on 12/5/03 she reports 5-10 mins post injection she felt dizzy but didn't say anything. 6 hrs later she started having rash on her face and itching which spread all over her body. She also reports some tightness on her chest. Seen client on 12/8/03 noted hives on her chest neck and her legs not much on her face also c/o of itching. Benadryl 25mg give q 4-6 hrs. Denies resp. distress at this time.
Near-syncopal event; dizziness; lightheadedness; diaphoresis; nausea. Event began at approximately 5:10 pm. Vitals taken; child taken in wheelchair to cot to lie down; vitals monitored, stable. After nausea subsided, juice and crackers given. No complaints of nausea, dizziness, lightheadedness, and no diaphoresis noted.  Child released at 5:42pm.
Patient reported entire body itching, tight throat, and difficulty swallowing. She took Benadryl at 2:00 AM on this morning February 26, 2023 and again about two hours before being seen in the clinic today. She reported only mild and temporary relief with Benadryl and still continues to experience itching sensation all over her body and a tight throat. Patient referred to higher care of service to the local ER for further evaluation.
Dull pain at injection site during the day, extreme pain while sleeping on my left side, enough to wake me up and keep me awake until the pain subsides (about 1 hour after moving to my right shoulder).  This happens nearly nightly, the symptoms have worsened over the past two months.  I also have minor popping/crackling sounds when rotating my arm.
At 9:00 pm 11/01/08, developed pain and numbness to right elbow. Took ADVIL at that time. On 11/02/08 pain and numbness still present. Placed ice pack on area at 12:00 pm on elbow. At 3:00 pm on 11/02/08 there was still pain and numbness to area.
This spontaneous report was received from a health care worker regarding two patients of unknown age and gender. Information on the concurrent conditions, medical history and drug allergies of the patients were not reported. On 06-APR-2016, the patients were vaccinated with improperly stored M-M-R II lot # L024268, expiry date 01-JUL-2017 (dose, frequency, route and anatomical location were not specified). Concomitant medication were not specified. There were no adverse effects reported. There was no product Quality Complaint (PQC) involved. Vaccines was stored at temperature of 20 degree centigrade for 11 hours, 15 minutes. There was no previous temperature excursion performed. Also GARDASIL 9 appeared in the product list as it was involved in the excursion, however no improperly stored doses of it were administered. This is one of several reports received from same reporter. Additional information has been requested.
Development of pleuritic, positional chest discomfort, friction rub on auscultation, ECG with diffuse ST elevations, elevated CRP consistent with a diagnosis of acute pericarditis