chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My arm was sore; Hard time sleeping; Pregnant and received the first dose of the moderna; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the first dose of the moderna) and INSOMNIA (Hard time sleeping) in a 28-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: ALCOHOL (2 drinks per week.) until 01-Dec-2020. Concurrent medical conditions included Fruit allergy (Grapes). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 07-Dec-2020 to an unknown date for Prenatal care, IRON from 07-Dec-2020 to an unknown date for an unknown indication.    On 11-Feb-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Nov-2020 and the estimated date of delivery was 17-Aug-2021. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the first dose of the moderna). On 12-Feb-2021, the patient experienced INSOMNIA (Hard time sleeping). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirteenth week of the pregnancy.  On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received the first dose of the moderna) had resolved. On 13-Feb-2021, INSOMNIA (Hard time sleeping) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Ultrasound foetal: normal (normal) 9 week ultrasound - No abnormal findings.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Date of positive pregnancy test was 07 Dec 2020. Estimated date of conception was 13 to 15 Nov 2020. No treatment information was reported.   This case was linked to MOD-2021-272233 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Reporter address, patient demographics, second dose details and event hard time sleeping were updated; Sender's Comments: This is a case of product exposure during pregnancy with associated AEs for this 28-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Information has been received from a Registered Nurse concerning to multiple unspecified patients (ages and genders not reported) who on unknown date were vaccinated with an improperly stored doses of VAQTA (Lot No. M017982, exp. 13-SEP-2017) (dose and route not reported). The doses were part of an excursion with temperature of 35F for 1 hour. There was no previous temperature excursion. The reporter did not know if any adverse effect were reported. This is one of several reports from the same source. Additional information has been requested.
Severe muscle cramps both legs simultaneously effecting equally my calf muscles, shin splints, both feet & toes. Came on suddenly, could not walk it off or stretch for relief & then just dissipated 5-7min later. Muscle soreness through the day after
After waking up I felt a pain in the right shoulder and tingle in the right hand fingers.  Had my coffee on the balcony and very soon after a heat rush took over my head and a general feeling of something not being ok. I started walking to the bathroom just as a precaution but didn't got there. My legs gave up and I collapsed in the middle of the leaving room. Woke up in a puddle of sweat, could have been 5 seconds or 10.  No chest pain, no rapid heart beat. Felt a little under the weather for the rest of the day but ok with the exception of the shoulder pain that didn't subside at all not even now, 2 days later.
Dtap and Prevnar 13 given in right thigh lateral to where we find a 2.0 cm x 3.5 cm depigmented area of skin and subcutaneous possible muscular tissue loss. There is no weakness or functional impairment. Child had unexplained decrease in weight gain between 6 and 12 months, gradually growing now. Development normal.
Swelling, Redness, Rash on vaccination site, rash on back, stomach pains, diharrea, headache, fatique.
Pt received PNEUMOVAX on 11/28 at about 2:20pm and call AM of 11/29, complaining of severe pain in right arm which was the arm that vaccinated the PNEUMOVAX. Also complained about warmth at injection site. She said could hardly move right arm, have been taking MOTRIN and TYLENOL but to no relief. Pt received FLUVIRIN in left arm but was ok with it.
An outbreak of pityriasis rosea two days following vaccine, which cleared up within 2 weeks. Also, intermittent severe left-sided occipital headaches after three weeks that have still not subsided.
Pt was given PREVNAR 13 on 01/25/19 at about almost 1:00 pm. After the injection, pharmacist put ice pack on the site to prevent pain as usual for any patient. Pt complained about the pain and headache but it was not severe. Pt stayed at the pharmacy for avoer 30 minutes for pharmacist to observe and advised that pt should take some Tylenol or Advil. on 01/30/19, pt called back and complained about the pain continue, after 2 days of vaccination, he found the redness above the injection site, feeling fatigue, chills, pain in the joints, He also stated that he lost his appetite, only want to eat sour fruit, feeling like having flu. He reported that the pain went down  a bit compare to few days ago. (7 now  versus 10 before). Pharmacist contacted the manufacture Pfizer to report the issue. Pharmacist also advised patient to use ice pack, take NSAIDS and followed up with his PCP. However, pt.'s PCP office is closed today so pharmacist will follow up tomorrow. Pt is currently traveling out of state, pharmacist advised patient  to seek medical help if he feel uncomfortable.
April 2021 shortness of breath but patient has allergies.  September shortness of breath continues to increase.  December Shortness of breath now limiting activities of daily living.
adm w/ 3 seizures 5-7 hrs post DTP; has had recurrent sz since then now controlled w/anticonvalsants delayed speech development suspected delayed congnitive development;
LIGHTHEADED, NAUSEA, "FEELING WARM AND HEAVY IN UPPER BODY, FEELS HEAVY WHEN I BREATHE".
On the 20th I was going to bed and had a sore throat. During the night I got a fever (100.6) and when I got up in the AM my sore throat was worse. I generally felt unwell. I had a raspy voice, so I took a test for COVID-19, and it was positive. I called the doctor and told them I took a test and that I have asthma history. I was able to get a same day appointment via telehealth. I did the telehealth visit but they picked up on my breathing and with me having a history of asthma I was prescribed PAXLOVID. I had a stuffy nose that ran a little, a fever, and fatigue. By the 3rd day I started to feel better. About seven days later I tested negative.
Swelling of tonsils; Sleeping difficulty; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLAR HYPERTROPHY (Swelling of tonsils), INSOMNIA (Sleeping difficulty) and HEADACHE (Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No relevant medical history provided).    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced TONSILLAR HYPERTROPHY (Swelling of tonsils), INSOMNIA (Sleeping difficulty) and HEADACHE (Headache). At the time of the report, TONSILLAR HYPERTROPHY (Swelling of tonsils), INSOMNIA (Sleeping difficulty) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       She stated that she had reactions to dogs in past that are similar to this symptom.  The patient's medical history and relevant concomitant medications weren't reported Treatment information was not provided
Information has been received from a Nurse Practitioner via a company representative referring to a patient of unknown age and gender. There was no medical history or drug reaction/allergies reported. In approximately June 2015, about one month ago, the patient was inadvertently administered (Oka/Merck) VARICELLA instead of ZOSTAVAX (wrong drug administered).  No adverse effect was reported. Additional information has been requested.
PATIENT BROKE OUT WITH SHINGLES ON THE RIGHT SIDE OF HER HEAD/FACE 2 DAYS AFTER RECEIVING THE MEDERNA VACCINE
On Wednesday June 29 I started feeling "odd" and as Friday progressed I felt worse.  I did not run fever but my throat was scratchy, sore and hoarse.  I began to have a terrible cough.  I took home COVID-19 test and it was positive.  I called the on-call nurse and got Paxlovid.  I began to take it Saturday and within 24 hours I was very nauseous and had bad taste in my mouth.  I also had no energy and no appetite.  I believe the COVID-19 symptoms were gone, except for my cough, but the side effects from Paxlovid were horrible.  I was so nauseous after dinner I vomitted my dinner and decided not to take my last dose of Paxlovid.  Today I did another home test and it was negative.  I have started to feel better today.
I felt my heart racing, skipping beats and chest pressure that progressively got worse. I was taken to the ED. The same night I had arm aching, body aches, headache.
positive for Covid; positive for Covid; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP).  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Sep2021 (Batch/Lot number: unknown) at the age of 60 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history and was of good health. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 01Jan2022, outcome "unknown" and all described as "positive for Covid". The patient experienced fever, congestion, bad aches, cough, sore throat and felt weak. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Jan2022) positive.  The lot number for BNT162B2 was not provided and will be requested during follow up.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age who in August 2011 was vaccinated with the first dose of GARDASIL (lot #, and dose were not reported). On 06-AUG-2012, the patient was vaccinated with the second dose of GARDASIL. No adverse event was reported. Additional information has been requested.
This spontaneous report was received from an office manager referring to a patients of unknown age and gender. No information regarding the patients' concurrent conditions, medical history, drug reactions or allergies, and concomitant therapies was provided. The reporter stated that, on unspecified date, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot# M007307, expiration date 30-NOV-2017) (strength, dose, frequency, route of administration and anatomical location were not reported) orally for prophylaxis. The vaccine dose was exposed to a temperature excursion of 55 degrees Fahrenheit for 3 hours; a digital data logger was involved. There were no previous temperature excursions.  No adverse symptoms were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Patient has experienced worsening right shoulder pain, radiating to distal clavicle and upper arm, ever since he was immunized with rabies post exposure prophylaxis series (after having been bit feral dog during routine patrol).  Reported lymphangitis has resolved put pain syndrome persists.  Patient was given steroid injections for presumptive bursitis in June and August.  He was also given short dose of oral prednisone.  Patient is currently awaiting appointments with sports medicine specialist and physical therapy.
This case was reported by a nurse and described the occurrence of inappropriate schedule of vaccine administered in a 4-year-old female patient who received KINRIX (batch number 95237, expiry date October 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate schedule of vaccine administered and wrong vaccine administered. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and wrong vaccine administered were unknown. Additional information received: KINRIX given as dose 1 of a Dtap series.
heartburn; heaviness in chest.; Swelling; difficulty breathing; itchy; rash spread; very tired; Vaccination site induration; Vaccination site swelling; Vaccination site erythema; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing), PRURITUS (itchy), RASH (rash spread), DYSPEPSIA (heartburn) and CHEST DISCOMFORT (heaviness in chest.) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history) since an unknown date.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema). On 05-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Vaccination site induration) and VACCINATION SITE SWELLING (Vaccination site swelling). On 06-Feb-2021, the patient experienced PRURITUS (itchy), RASH (rash spread) and FATIGUE (very tired). On 07-Feb-2021, the patient experienced DYSPNOEA (difficulty breathing), DYSPEPSIA (heartburn), CHEST DISCOMFORT (heaviness in chest.) and SWELLING (Swelling). At the time of the report, DYSPNOEA (difficulty breathing), PRURITUS (itchy), RASH (rash spread), DYSPEPSIA (heartburn), CHEST DISCOMFORT (heaviness in chest.), SWELLING (Swelling), FATIGUE (very tired), VACCINATION SITE INDURATION (Vaccination site induration), VACCINATION SITE SWELLING (Vaccination site swelling) and VACCINATION SITE ERYTHEMA (Vaccination site erythema) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported.
On the 15th  I noticed a swollen supraclavicular lymph node  (above the clavicle and at the base of the neck) on my left side. It is slightly tender to the touch and otherwise there's a general feeling of pressure at the site.  As of today, the 23rd, it is still swollen and similar in size.
Client phoned on 1-4-02 to report that td vaccine received on 11-27-01 caused reaction. States symptoms began one day after getting shot. Left elbow and shoulder very sore now. Having difficulty lifting with that arm. States that also had severe swelling with hardness & redness that lasted 2 weeks after shot given. Referred to PCP. Will do f/u next week with client. Advised using ice packs & OTC pain meds. to get symptoms relief.
LETHARGIC; BURSITIS IN LEFT SHOULDER; FALLS ASLEEP A LOT WHEN SITTING DOWN AND WATCHING TV; PAIN IN ARM; PAIN AT INJECTION SITE; FEELS OVERALL MUCH WEAKER AND CAN NO LONGER DO A PUSHUP; TIRED; ANXIETY; HEART PALPITATIONS/POUNDING; LOST 10 POUNDS; This spontaneous report received from a patient concerned a 53 year old male. The patient's weight was 158 pounds, and height was 70 inches. The patient's concurrent conditions included: no alcohol use, and smoker, and other pre-existing medical conditions included: The patient had no known allergies and no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-APR-2021, the patient experienced lost 10 pounds. On 08-APR-2021, the patient experienced anxiety. On 08-APR-2021, the patient experienced heart palpitations/pounding. On an unspecified date, the patient experienced lethargic, bursitis in left shoulder, falls asleep a lot when sitting down and watching tv, pain in arm, pain at injection site, feels overall much weaker and can no longer do a pushup, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from anxiety, and heart palpitations/pounding, had not recovered from lethargic, lost 10 pounds, bursitis in left shoulder, pain at injection site, feels overall much weaker and can no longer do a pushup, and pain in arm, and the outcome of tired and falls asleep a lot when sitting down and watching tv was not reported. This report was non-serious.
Total rash all over body. Small, bumpy red rash started on trunk and spread all over body.More confluent on trunk. Itchy.
product administered after temperature excursion from 07-Mar-2022 to 31-Mar-2022 at 2.1C with no reported adverse event; Initial information was received on 19-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 46years old female to whom product was administered after temperature excursion from 07-Mar-2022 to 31-Mar-2022 at 2.1C with no reported adverse event while receiving vaccine Diphtheria-2/TetanuS/5 AC Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles vaccine, mumps vaccine, rubella vaccine (MMR) for Immunisation.  On 18-Mar-2022, the patient received 0.5 ml dose of suspect Diphtheria-2/TetanuS/5 AC Pertussis Vaccine (formulation, strength: unknown) via intramuscular route (batch/lot number: C5854AA, expiration date: 14-Apr-2023) in the right deltoid for immunization.  On 18-Mar-2022, the patient received Diphtheria-2/TetanuS/5 AC Pertussis Vaccine after temperature excursion from 07-Mar-2022 to 31-Mar-2022 at 2.1C with no reported adverse event (product temperature excursion issue) (latency: same day).  Action taken: not applicable  At time of reporting, the outcome was Unknown for the event (product temperature excursion issue).; Sender's Comments:  01068813: 01068814: 01068816: 01068817: 01068825: 01068827: 01068828: 01068830: 01068831: 01068832: 01068834: 01068835: 01068838:
PAIN IN RIGHT FACIAL AREA AROUND AND BEHIND EARS, SUDDENLY DEVELOPED A RASH. MACULAR VESICULAR RASH IN CERVICAL C2 DISTRIBUTION, COMPATIBLE W/SHINGLES. GIVEN FAMVIR 500 AND LYRICA 75MG. IF NO BETTER RETURN IN 1 WEEK
STARTING THE DAY AFTER VACCINATION, PATIENT EXPERIENCED RED, SWOLLEN BLOTCHES NEAR THE INJECTION SITE. THE BLOTCHES COVERED AN 8 INCH BY 4 INCH AREA.
From telephone contact received at manufacturer, on 2/15/02, it was reported that a 22 y.o. female PT received an Imovax Rabies vaccine lot #T0863-2 on 2/8/02. The PT reported to physician on 2/15/02 that she was very tired all the time and was falling asleep in class and sleeping long hrs at night. From add'l correspondence received from physician on 2/19/02 it was reported that the PT has mono and is the reason has her tiredness.
Received her 1st Varivax 7/6/09 in her left thigh.  It started to become red that day and became the size of a nickle.  The site was red, no tenderness, slight warmth, no pus and did not appear infected upon examination.
Mother called 7/9/04. Stated child had VZV 6/25/04 and now has chickenpox. Seen at Urgent Care. 7/8/04 They advised parent to call for report to be sent in.
for about 24 to 36hr after the shot I had joint pain, fatigue, and Myalgia.
Rash, cough, congestion, sore throat, sx started Monday 4-11-11.
covid-19 infection; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (covid-19 infection) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Seasonal allergy.    In September 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In October 2023, the patient experienced COVID-19 (covid-19 infection). At the time of the report, COVID-19 (covid-19 infection) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2023, SARS-CoV-2 test: Positive, Positive, Positive and Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Patient had the moderna booster about a month ago and about a week ago had minor symptoms common with upper respiratory infection and seasonal allergies. patient did a covid test and the results were positive. Redid the test 3 times all with positive result. Were the positive test results caused by patients body creating antibodies from the booster or did have a mild case of covid?. Patient did not have a fever, cough or body aches. Patient was tired and had an off and on again headache for a few days.   Most recent FOLLOW-UP information incorporated above includes: On 29-Oct-2023: Significant live-follow-up received on 29-Oct-2023. Reference number added.
patient description of event was that he was going in and out of consciousness, and while unconscious vomited and inhaled vomit, woke up gasping for air and coughing up vomit.
This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received SHINGRIX for prophylaxis. In June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced injection site erythema, injection site warmth, injection site swelling, injection site itching, injection site dryness and exhaustion. On an unknown date, the outcome of the injection site erythema, injection site warmth, injection site swelling, injection site itching, injection site dryness and exhaustion were unknown. It was unknown if the reporter considered the injection site erythema, injection site warmth, injection site swelling, injection site itching, injection site dryness and exhaustion to be related to SHINGRIX. Additional details reported as follows: The age at vaccination was not reported. This case was previously not reported to anyone. The reporter received the SHINGRIX vaccine approximately two weeks before the day of reporting. The patient noted that two hours after the vaccination she felt exhausted. The next day after the vaccination she noted that she had a red circle at the injection site approximately three inches across. The red circle began to itch. Over the time it became raised and swollen, and felt warm to the touch. Currently it was resolving but was still red and the skin looked dry. The reporter did not want to provide additional information and ended the call.
Shortness of breath, tightness of chest, heart racing about an hour after having influenza vaccination. Tried albuterol with only momentary relief. Was at work, nurses checked her B/P which was a bit higher than usual, O2 sat fine. Took a Benadryl at 3 pm which helped. Sx completely went away at 10 pm.
Mammogram in 2021 was clear. Had Mammogram on 9/22 and they notated DCIS of the right breast. Still waiting on further testing. Performed needle biopsy which was inconclusive. I am waiting a more invasive biopsy and have been seeing an oncologist.