chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.   On 01-OCT-2019, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # S012246 and expiration date: 10-FEB-2021) for prophylaxis (strength, dose, unit, route and anatomical location were not reported) (product storage error). No adverse effects were reported. The administered dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) experienced temperature excursion at 68ºF for a time frame of eight hours. The previous temperature excursion occurred at 57ºF for 2 hours. The call was due to digital data logger. The outcome of the product storage error was unknown.
the patient had a measles IGG indes, mumps index performed which showed no titres / no immunity to measles and mumps; the patient had a measles IGG indes, mumps index performed which showed no titres / no immunity to measles and mumps; This spontaneous report was received from a pharmacist and refers to a 72-years-old female patient. The patient's concurrent conditions included: essential thrombocythemia, herpes and shingles. It was reported that the patient had no drug reactions or allergies. On an unknown date reported as years ago, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administrations, therapy type, lot# and expiration date were not provided) for prophylaxis. Concomitant therapies included valacyclovir hydrochloride and hydroxyurea. On 02-MAY-2019, the patient had a measles immunoglobulin G (IgG) index, mumps immunoglobulin (Ig) index performed which showed no titers/no immunity to measles and mumps. There was no treatment given for the event. The outcome of the event was reported as not recovered/not resolved. The causality assessment was not recovered.
Patient felt hot, dizzy, lightheaded, hands were clammy, tight fisted, tingly and patient was breathing hard and fast
Information has been received from a licensed practical nurse (L.P.N.) concerning a 54-year-old female with a penicillin allergy, sulfonamide allergy, belladona allergy, iodine allergy and an allergy to ULTRACET; who on 14-SEP-2006 was vaccinated intramuscularly in the left deltoid with a third dose of Recombivax HB (lot#647547/0031P). One to two days following vaccination, on approximately 15-SEP-2006, the patient experienced soreness to her left arm after injection. It was unspecified if medical attention was sought, no laboratory or diagnostic test were performed. No outcome was reported. Additional information has been requested.
one of the vials was expired/ was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA379A, expiry date 31st August 2021) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The age at vaccination was not reported. An employee health nurse administered Menveo which got expired on 31st August 2021, which led to expired vaccine used. After the dose was given and the nurse went to complete the documentation, the nurse noticed that one of the vials was expired.  The nurse enquired to provide information regarding the effectiveness of the dose in this situation. The batch number of other Menveo vial was AMVA379A and expiry date July 2021. No additional information provided.
A report has been received from a physician concerning a 1 year old, female subject, who had been receiving FLUMIST (Intranasal). The patient's concurrent disease(s) included bronchitis and migraine. FLUMIST (Intranasal) started on 24-Oct-2013. They inadvertently given FLUMIST to a 21 month old patient on 24-oct-2013. The outcome of the event of inadvertently gave FLUMIST to a 21 month old patient is unknown. The report was considered to be non-serious.
Chest pain and heart feels like its pounding. Been going on for a few days without feeling of getting better. Have scheduled an appointment with doctor about this.
Estimated delivery March 11, 2022. I had muscle pain, fever, runny nose, sore throat, headaches, and bloody nose. I felt like this for about 4 to 5 days. I still don't feel well. I also had soreness in my arm and itching at injection site.
04/18/2003: Client noted.........reaction site (day 9) 04/19/2003: Increase...............left upper arm 04/25/2003: Pain, swelling..........noted redness LUE. 04/21/2003: Saw............................antibiotic prescribed. 04/22/2003: Left message................call this nurse to follow up. 04/25/2003: Left message..................call this nurse to follow up.
shingles; Information has been received from a lawyer regarding a case in litigation referring to a female patient (pt) of unknown age. Information about concurrent condition, medical history and concomitant medication was not reported. In or around August 2017, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In 2017 (reported as approximately two weeks after the zoster vaccine live (ZOSTAVAX) vaccine was administered), the pt developed a dark rash, which caused such pain that pt could not bear to have anything touching her skin, and which lasted well into the following year, 2018. The pt sought relief, advice, and treatment from doctors. In addition, she presented at the emergency room in search of relief. The pt was diagnosed with shingles by a doctor in 2017. The pt first learned of the link between zoster vaccine live (ZOSTAVAX) and injuries such those from which she suffered, in or about 22-DEC-2018, when a friend shared information found on internet. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using the product. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her (conflict information, also reported as "his") condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. All damage proximately caused by the aforementioned characteristics of the zoster vaccine live (ZOSTAVAX) product that rendered the product unreasonably dangerous, arose from the reasonably anticipated use of the product by the pt. The outcome of the event shingles was not recovered. The causality assessment was considered as related by the lawyer.  The event shingles was considered to be disabling by the lawyer.
I was positive for COVID-19 on 20DEC2022 , I felt tired and fatigued. I was congested and drainage in the back of my throat. That lasted for about 8 days and I started feeling better, unfortunately I got a rebound right after. I contacted my doctor and he prescribed me paxlovid.
This spontaneous report as received from a medical assistant refers to an unknown number of patients. On unknown dates the patients were inadvertently vaccinated with improperly stored VARIVAX (Merck). No adverse effects reported. This is one of several reports received from same source. Additional information has been requested.
I felt fine other than a sore arm at the injection sight. About 26 hours after the vaccine I started getting short, quick dizzy spells. I didn't think much of it, I was almost off work and thought I was just tired. The dizziness progressed in to severe vertigo. If I turned my head in any direction I wouldn't be able to see anything for about 5 minute because of the severity of the vertigo. I woke up in the middle of the night around 1am and the room was spinning. I sat up, held still and waited about 10 minutes, the vertigo only got worse. My husband called 911. The EMT's took my vitals which were WNL but mildly elevated blood pressure and fever. He said vertigo is a more rare adverse reaction to the vaccine. He said that there's a small percentage of people who have a progressively worse reaction to each covid vaccine. I was not taken to the hospital. I took Tylenol and was able to fall asleep flat on my back. The next morning I was still very dizzy while walking around, but I could see enough to take basic care of myself. The dizziness has improved slowly and I noticed a positive difference after taking Dramamine. I have also had a consistent headache which is treatable with Tylenol.   I am extremely confident the vertigo is from the vaccine. Vertigo typically doesn't have a gradual onset. I didn't treat the vertigo with any sort of inner ear cleaner or the Eply maneuver and it is slowly resolving.
Patient presented with chest pain 2 days after his vaccination.  He had some mild shortness of breath.  He had a EKG that showed sinus tachycardia, no pericardial effusion on bedside ultrasound, troponin slightly elevated at 0.95, CRP 29.9, sed rate at 32.
Soreness in left arm, felt a soreness sensation; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in left arm, felt a soreness sensation) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy and Blood pressure. Concomitant products included LISINOPRIL for Blood pressure high, IBUPROFEN and VITAMINS NOS.   On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 26-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness in left arm, felt a soreness sensation). On 28-Dec-2020, VACCINATION SITE PAIN (Soreness in left arm, felt a soreness sensation) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   This case was linked to MOD-2021-078689 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Non-Significant: Reporters email contact information has been updated.
pt received vaccine on 5/5/2021, shortly thereafter had severe diarrhea/vomiting. came to ER and was admitted on 5/6 @0104. Pt receiving fluids, Zofran, morphine and potassium. Admitted on observation status. Lot number for vaccine 1808980
Vaccinated in left deltoid at 3:00pm by 7:00pm in the evening uncontrollable pain in left arm down to fingers and up to shoulder, decreased mobility. No redness or swelling at injection site. Patient seen by medical provider and received toradol IM in clinic for pain. This relieved the pain until 9:00pm Saturday 1/9/21 and then the pain returned back to 9/10. Patient received PO pain medication Sunday AM. This helps bring pain down to 5/10. Pain is mainly with movement. If arm is stabilized pain is decreased. Patient still in pain this morning 1/11/21 and unable to work today.
Moderna COVID?19 Vaccine:  I was recovering from a mild sprained ankle/foot  for about a week.  At the time of vaccination I had very little pain and could easily put full weight on the foot.  About 13 hours after the injection, I awoke to a throbbing foot and severe pain in that foot.  I could no longer apply any weight to it and it exhibited considerable swelling.  I visited the doctor and am now resting, icing, compressing, and elevating the foot.  Diclofenac Sodium was prescribed for pain.  Vaccine induced stimulation of an inflammation response is a possible explanation.
Day of booster vaccination had headache all night long. Following day had muscle aches in neck, shoulder, back, chills, low grade fever. On the third day, woke up feeling fine. Around 11:00 am, started to lose concentration and ability to complete a sentence. It got worse to the point where I couldn't even state a question. My friend was with me and did not notice anything else like paralysis to indicate a stroke, but brought me home to phone my doctor and pharmacist. Symptoms lasted for close to 1 hour and 30 minutes, and then everything returned to normal speech and thought processes. Both doctor and pharmacist said they both have seen three or four patients who reported the same thing happened to them.
Given 3 Doses of Heplisav-B; Initial Report Received on 21-Oct-2022, 27-Oct-2022, 08-Nov-2022  This is a spontaneous report, received from a pharmacist regarding a 63-year-old male patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 3 of HEPLISAV B (Lot #937234, expiration date 12-SSep-2023, NDC # unknown), route not specified, was administered in the left deltoid for hepatitis B immunization.   The patient was given 3 doses of HEPLISAV B. No adverse reactions were reported.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Patient received Pfizer COVID vaccine on 4/1/21 (lot # ER8737), 4/26/21 (lot # ER8736), 8/29/21 (lot # FF2588), 3/4/22 (lot # FK9894), and 8/24/22 (lot # FP7137). On 10/28/22, patient admitted to our inpatient facility (med/surg unit) with acute hypoxic respiratory failure secondary to COVID-19 pneumonia and AKI superimposed on CKD s/p renal transplant. As of today (11/7/22), patient is still admitted in our med/surg unit.
Pt went to ER 4 days after receiving Menactra, c/o dizziness and confusion lasting 2 days or so.
PRETTY SEVERE SORENESS OR PAIN; SWELLING ARM; This spontaneous report received from a patient concerned a 30 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergy, non alcohol user, and non smoker, and other pre-existing medical conditions included the 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: 1808978 expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced pretty severe soreness or pain. On 01-APR-2021, the subject experienced swelling arm. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pretty severe soreness or pain, and swelling arm. This report was non-serious.
Headache, Myalgia, Arthralgia, Fever, CoughWheeze, weak, chills, tired Narrative:
Fever (100.6-101.8) and aches, headache began about 10 hours after the injection. 14 hours: strong nausea when attempted to drink/eat, vision started to black out so sat down and it passed in 10 minutes. 19 hours: walked to kitchen and vision blacked out and I collapsed on the floor, I think loss of consciousness was only a second or two. Slowly worked back up to sitting then standing in about 15 minutes. There was a lot of tingling in my hands and I remained a little unsteady and ?woozy? until I fell asleep 30 minutes later. At 24 hours: temp back to 98.6, able to walk slowly without blacking out, moderate headache, sinus pain, and general aches continue.  Had drunk about 3.5 liters of water and half a bottle of Gatorade over the course of the 24 hours, and had eaten normally prior to the onset of effects.
8th day after vaccine, had a large, red, raised hot spot, just 2 inches below where injection was; Arm pit had a lump, was sore; 9th day, red raised spots got larger and redder, soreness got worse; 9th day, red raised spots got larger and redder, soreness got worse; Feels like a bruise or ligament is pulling; Arm pit had a lump, was sore; Then soreness continued and lump under arm got larger on day 10; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DEPIGMENTATION (8th day after vaccine, had a large, red, raised hot spot, just 2 inches below where injection was), MASS (Arm pit had a lump, was sore), RASH MACULAR (9th day, red raised spots got larger and redder, soreness got worse), PAIN IN EXTREMITY (9th day, red raised spots got larger and redder, soreness got worse) and CONTUSION (Feels like a bruise or ligament is pulling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.     On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DEPIGMENTATION (8th day after vaccine, had a large, red, raised hot spot, just 2 inches below where injection was), MASS (Arm pit had a lump, was sore), RASH MACULAR (9th day, red raised spots got larger and redder, soreness got worse), PAIN IN EXTREMITY (9th day, red raised spots got larger and redder, soreness got worse), CONTUSION (Feels like a bruise or ligament is pulling), PAIN IN EXTREMITY (Arm pit had a lump, was sore) and MASS (Then soreness continued and lump under arm got larger on day 10). The patient was treated with IBUPROFEN (MOTRIN [IBUPROFEN]) at a dose of 800 mg. At the time of the report, SKIN DEPIGMENTATION (8th day after vaccine, had a large, red, raised hot spot, just 2 inches below where injection was), MASS (Arm pit had a lump, was sore), RASH MACULAR (9th day, red raised spots got larger and redder, soreness got worse), PAIN IN EXTREMITY (9th day, red raised spots got larger and redder, soreness got worse), CONTUSION (Feels like a bruise or ligament is pulling), PAIN IN EXTREMITY (Arm pit had a lump, was sore) and MASS (Then soreness continued and lump under arm got larger on day 10) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up received and contain no new information.The reporter declined further follow-up.
Patient reporting chills, fever, headaches, and burning sensation within digestive tract. Patient stated that digestive tract took 8 months to heal. Patient felling weak after booster, day before broke out in shingles. Extremely sick for past 2 weeks, went to doctor several times. Patient was prescibed sucralfate and nausea meds.
This case was reported by a pharmacist and described the occurrence of maculopapular rash all over the body in a 18-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Hib (non-gsk), seasonal influenza vaccine (non-gsk), MMR (non-gsk), PREVNAR 13 (non-gsk) and varicella virus vaccine (non-gsk). The subject's medical history included neonatal jaundice. On 23 January 2014 the subject received a dose of PEDIARIX (.5 ml, unknown, right deltoid), 4th dose of Hib (Non-GSK) (unknown), 2nd dose of Seasonal influenza vaccine (Non-GSK) (unknown), 1st dose of MMR (Non-GSK) (unknown), 3rd dose of PREVNAR 13 (unknown), 1st dose of Varicella virus vaccine (Non-GSK) (unknown). The PEDIARIX was given as the 4th dose in the DTaP series, the 3rd in the hepatitis B series, and the 4th dose in the IPV series and experienced wrong vaccine administered. PEDIARIX is indicated as the 1st, 2nd, and 3rd doses of DTaP, Hepatitis B and IPV series. On 23 January 2014, 6 days after vaccination with Hib (Non-GSK), MMR (Non-GSK), PEDIARIX, PREVNAR 13, Seasonal influenza vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the subject experienced maculopapular rash all over the body. Per the pharmacist, the immunization series was not discontinued or delayed. The subject was treated with BENADRYL. At the time of reporting the events were unresolved.
I have had side effects from my moderna vaccine since March 2021; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (I have had side effects from my moderna vaccine since March 2021) 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 VACCINATION COMPLICATION (I have had side effects from my moderna vaccine since March 2021). At the time of the report, VACCINATION COMPLICATION (I have had side effects from my moderna vaccine since March 2021) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Pt reports about 4 h after injection headache, n/v/generalized malaise that has lasted for about 3 days now.
(1-2 mins) total - pupils dilated, eyes rolled back, tremors/twitches for 1 min then stopped. Patient's face pale, lips somewhat blue, breathing, unresponsive to sound, then patient woke up, conscious and responsive, vital signs stable, patient safety maintained.
17SEP91 pt recvd Engerix-B vax & about 2 1/2 wks later devel diarrhea, fatigue, nausea & stomach ache; recvd Maalox for nausea & is reported to be better today;
Nauseous 9:50am Patient left feeling much better. 122/86, HR 68, O2Sat 100
Myalgia Nerve Pain Narrative: History of nerve pain and lower back pain. Pain worsened about 2  weeks after 2nd dose. Right side neck pain from base to lower ear also occurred. Took muscle relaxer and aspirin. Instructed to follow up with PCP.