chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Myositis : three weeks after vaccine given 11-19-04.  Medical Records received on 12/07/2004 states heart murmur and leg pain. Medical Records received on 2/02/2005 states 2/02/2005 states congestion, runny nose, fever, and heart murmur.
More pain during injection than usual, shoulder more sore than usual immediately after injection, shooting excruciating pain down arm while sleeping 7 hours later, pain reduced to sore arm 12 hours after injection.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE SADDLE PULMONARY EMBOLISM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN
Headaches, muscle pains and tingling in limbs began occurring 5 days following vaccination. Severe anxiety and panic attacks began 14 days after vaccination. Insomnia lasting 6 nights began 20 days after vaccination. Treatment with lorazepam and Lexapro for anxiety. Symptoms began subsiding 26 days after vaccination. Ongoing minor symptoms (headache).
Severe body aches and pains. I couldn?t sleep more than 1.5 hours at a time due to pain. All over body aches but more specifically in my hips. Harder to take deep breathes and felt in the back. Fever varied from 99.8-102.3. This lasted 32 hours.  Since then, I am weak, fatigued and sore.
This nurse/writer called this client to F/U on the need for the Covid-19 vaccination #2, as she had the 1st one given by someone @ this Dept of Health on 05/26/2021. She states PCP said not to get the 2nd dose D/T few days after having the 1st dose I had a stroke in my right eye with blindness. He is not sure if the vaccine caused it or not. I am doing better, but still blind in that rt. eye; but rt. neck vein is clear . Advised her to report in to VAERS and informed RN Supervisor; She stated "to report this to VAERS."
syringe issue; white part around the plunger where you put your fingers (finger tip) flew off during administration; patient was bloodied.; did not receive a full Boostrix dose / was given another, full Boostrix dose.; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 40-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33AT7, expiry date 7th November 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st March 2021, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. On 1st March 2021, immediately after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced injection site hemorrhage and accidental underdose. On an unknown date, the patient experienced syringe issue and pharmaceutical product complaint. On an unknown date, the outcome of the injection site hemorrhage, accidental underdose, syringe issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site hemorrhage to be related to Boostrix and Boostrix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the white part around the plunger where you put your fingers (finger tip) flew off during administration into male patient's deltoid. The white piece flew off across the room. The patient did not receive a full Boostrix dose due to the finger tip flying off, which led accidental underdose. Patient did not receive a full Boostrix dose due to the finger tip flying off and patient was bloodied. The patient was given another, full Boostrix dose. The reporter did not consent to followup.
Unknown time of onset. Mother brought in from school as teacher called and wanted her to get him checked out.  Childs skin was with warmth to touch, and skin is taught.  It begins at the deltoid and down to the area just above the elbow. He has good warm fingers good and equal grip doesn't complain of pain with any movement.  Good pulses.  Mom has placed a cool pack on it the evening before.  Instructed to give Benadryl as directed by physician.  Possible local reaction.  He has history of 2 previous seasonal influenza shots.  He also had the nasal mist for the h1n1 on the same day.  When shot was administered he did move and had to be stuck twice and his muscle was very tight. Mom has given Benadryl after leaving here and he is outside playing at this time.
Itchy and red again in her left arm; became hard as rock; Swelled and big red mark 2/3 cm diameters; Swelled and big red mark 2/3 cm diameters; A report was received from a consumer concerning a 58-year old, female patient who received Moderna's COVID-19 vaccine and developed swelled and big red mark 2/3 cm diameters and itchy and red again in her left arm..  The patient's medical history and concomitant medications were not provided.  On 30 Dec 2020 the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient experienced injection site swelling and a big red mark, approximately 2/3 centimeter. They drew a line around it and the next day it had extended outside the line and was "hard as a rock".  On 02 Jan 2021, the swelling and redness subside. On 06 Jan 2021, the injection site becomes itchy and is red again. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, injection site swelling, was considered recovered/resolved.  The outcome of the events, injection site redness and itching, were considered not recovered/ not resolved.   Follow-up received on 06 Jan 2021 included updated reporter information, updated patient information, additional events, and updated event outcome.; Reporter's Comments: 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.
This spontaneous report was received from a registered nurse referring to a 5 year old female patient. The patient's concomitant medications and drug reactions/allergies were reported as none. The patient's pertinent medical history included asthma. On 20-MAR-2017, the patient was vaccinated with a dose of PROQUAD, subcutaneously (lot # M015699 with expiration date of 26-SEP-2017; dose and anatomical location were not provided), for prophylaxis. It was reported that the patient returned to the office on 22-MAR-2017 with rash, redness and swelling at the injection site that started on an unknown date in March 2017 after vaccination with PROQUAD. Therefore, the patient was diagnosed with cellulitis and treated with an unspecified dose of trimethoprim (+) sulfamethoxazole (BACTRIM). However, lab diagnostics were not performed. No product quality complaint was involved. At the time of reporting, the patient had not recovered from the cellulitis. The causal relationship between the event and the PROQUAD was not reported. Upon internal review, the event of cellulitis was determined to be medically significant. Additional information has been requested.
Systemic: Dizziness / Lightheadness-Medium, Additional Details: patient recieved shot at 3pm. instructed to sit for 15 min, patient walked to counter and fainted at 305. patient states didnt hit head. when approached eyes open and alert. said ok. patient laid for 2 min, assisted patient to chair to put head between legs. sipped water. at 320 bp 139/79 hr 77. at 330 pb 129/76 hr 83. walked isels and states ok. called when got home got home ok.
1.) Diffuse erythematous macular rash on face/trunk/extremity  2.) local indurate erythema 3cm x 3cm right thigh
Pt woke up on 4/9 (the day after immunization) and left leg was very sore from the hip down.  She is needing to use a walker to get around.  Has hx of arthritis, but usually only her knees bother her.  Some OTC pain medicine will lesson the pain, but overall it has stayed the same since 4/9.
Within 24 hours of shot I developed a strong headache. During the next 6 days the headache became mild. On the 7th day the headache turned into a complete migraine with aura (migraine to include sensitivity to light, sound, etc.). I've now had a consistent migraine since February 20. Migraine is not manageable with medication.
After patient was administered Moderna COVID-19 vaccine, patient came into observation room feeling very nervous. At 4:55 PM, patient complained of intense itching on her face and scalp. This was accompanied by flushing of face. However, patient reported no breathing difficulties. Patient was immediately given ice packs and applied to groin, neck, and head. Patient did not feel any relief. 50 mg of diphenhydramine was given to patient to help with intense itch. Patient was feeling better and rested for some time in observation room. At 1740, patient had difficulties standing on her own. At 1745, patient voided in her clothes at her own request. Due to medical evaluation needed, EMS was called at 1800 and arrived at 18:08. EMS had to move her from the cot to the stretcher as patient couldn't stand on her own. EMS left with patient to emergency room around 18:15
General body pain; severe inflammation every where; bled from the needle the second; headache; Pain in hip; General body pain; Diarrhea; chills; This spontaneous case was reported by a consumer and describes the occurrence of INJURY ASSOCIATED WITH DEVICE (bled from the needle the second), the first episode of PAIN (General body pain), the second episode of PAIN (General body pain), INFLAMMATION (severe inflammation every where) and DIARRHOEA (Diarrhea) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced the first episode of PAIN (General body pain), DIARRHOEA (Diarrhea), CHILLS (chills) and ARTHRALGIA (Pain in hip). On 05-Mar-2021, the patient experienced HEADACHE (headache). On 28-Mar-2021, the patient experienced INJURY ASSOCIATED WITH DEVICE (bled from the needle the second). On 29-Mar-2021, the patient experienced INFLAMMATION (severe inflammation every where). On an unknown date, the patient experienced the second episode of PAIN (General body pain). On 22-Mar-2021, DIARRHOEA (Diarrhea), CHILLS (chills), HEADACHE (headache) and ARTHRALGIA (Pain in hip) had resolved. At the time of the report, INJURY ASSOCIATED WITH DEVICE (bled from the needle the second) and INFLAMMATION (severe inflammation every where) outcome was unknown and last episode of PAIN (General body pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-064585 (Patient Link).
10 minutes later after taking the vaccine COVID-19 PFIZER my son started to feel stomach pain, feeling of vomit, dizziness, sweating, his hands were cold, and he got pale. He asked me to take him to the bathroom and when he was there I asked the nurse for help, he lost consciousness. They took him to the stretcher and hooked him to some equipment. He regained consciousness but he was still without strength, pale, nauseous, we waited another 20 minutes and took him home. At 11 in the morning, he had a medical appointment. I took him to the doctor and they did some test.
Pt presented at office today to report that she was advised by her midwife that her ultrasound revealed a corpus luteum indicating pt had been pregnant, but must have miscarried.  Pt reports that she passed some tissue in February but did not report it because she didn't know what it was.  She is concerned that miscarriage may have resulted from H1N1 vaccination.
3hr of high pitched, inconsolable crying (unusual cry-not baby's usual);marked local rxn-10cm of induration;highest temp 1st 6hr 101.2;
blood clot in rt pinky; felt like a heart attack; Pain for several weeks; didnt bleed when I cut myself shaving/ Blood still thick; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 10:00 (Lot number: EW0162) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low level asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Hydromet cough syrup, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6202, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 12Mar2021, for COVID-19 immunization. The following information was reported: THROMBOSIS (medically significant) with onset 25May2021, outcome "unknown", described as "blood clot in rt pinky"; MYOCARDIAL INFARCTION (medically significant) with onset 25May2021, outcome "unknown", described as "felt like a heart attack"; PAIN (non-serious) with onset 25May2021, outcome "recovered" (2021), described as "Pain for several weeks"; BLOOD DISORDER (non-serious) with onset 25May2021, outcome "unknown", described as "didnt bleed when I cut myself shaving/ Blood still thick". The events "blood clot in rt pinky", "felt like a heart attack", "pain for several weeks" and "didnt bleed when i cut myself shaving/ blood still thick" were evaluated at the physician office visit. Therapeutic measures were taken as a result of thrombosis, myocardial infarction, pain, blood disorder. Addition information: it was reported that: believe clot eventually traveled to rt side of arm (june) to left side of neck (July 22) to left side of chest (23Jul2021), felt like heart attack. Covid prior vaccination was none. Covid tested post vaccination was none. Other vaccine in four weeks was none. Other medication in two weeks was none. Pain dimished within week. When it got to neck. Took aspirin 2 daily then one.
Case number PHEH2014US019677 is an initial spontaneous report received from a medical assistant on 29 SEP 2014. This report refers to a 33 years old female patient.  Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: 141001/141301) intramuscularly at a dose of 0.5 ml on unspecified date between 19 SEP 2014 to 23 SEP 2014. It was reported that the patient received FLUVIRIN that was stored at a temperature of -1.7 to 11.8 degree C for 191 hours. No adverse events reported after the maladministration (incorrect storage of drug).
pt request we report her adverse event on 8/10/22  @ 4:20pm from her second Shingrix vaccination administered on 12/31/21.  Patient states her sore arm is continuing and evolved into limited movement.  She states she has no pain but constant limited movement of her left arm.  She struggles to put on her bra. She is unable to do arm circles behind her with the left arm. She is unable to reach behind her lower back and around to the right side of her body.  She states the limited movement is horrible.  She does have pain in the left arm if she moves it suddenly behind her body for any reason.  She notified her PCP and she will refer her to a neurologist.  She states she has been having numbness in her left thigh for over 5 years.  She is also having tingling back & forth between both feet once every 3 to 4 days. She attributes the left arm soreness and limitation to the second dose of Shingrix. I requested she keep us posted 8/10/22 4:20pm
Lyophilized component  left in the box.; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date 28th February 2023) for prophylaxis.   On 23rd July 2022, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 25-Jul-2022 Reporter's Comments: Practice Manager stated that she believed that only the liquid component of Menveo was administered to a patient as only the lyophilized component was left in the box. The reporter consented to follow up. Additional Supportive Information: The reporter believed that only the liquid component of Menveo was administered to a patient as only the lyophilized component was left in the box, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
He got his vaccine, had fever, fatigue, headaches, body aches.  Fever up to 102.  On Wednesday a friend of his called who he had close contact with and informed him that he was positive for monkey pox.  He is still having the same symptoms, and has been Tylenol for the fever.   He did call his doctor and has appointment today to be seen.
Myalgia, Fever &  SkinRash Narrative:  Other Relevant History:
I had extreme fatigue and a headache with nausea about 5-6 hours after receiving the vaccine. These symptoms were pretty severe for a week. I thought they would subside but still continue to have headaches, fatigue and nausea and have just started noticing a lot of memory loss that became more noticeable and bothersome within the last week (started 09/01/2021) I overall just don't feel my normal self.
within 2 days I was sick with severe sinus issues and headache requiring doctor care, within 4 days I got a severe rash on the arm and underarm where the injection happened. Day 10, rash is getting worse.
The morning of may 9 2021 I Felt significant pain in left arm (had pain in left arm following the 2nd shot but went away after 2 days but on May 9th the pain came back much stronger) and was painful to the touch and I couldn?t raise my arm up at all, I went to sleep that night and woke up with continued left arm pain that was traveling to my chest and I went to the ER (morning of May 10, 2021) where they diagnosed me with multiple, bilateral pulmonary embolisms resulting in the need to take blood thinners for the rest of my life due to this event.
Pfizer-BioNTech COVID-19 Vaccine EUA  Received dose #1 in drive thru vaccine clinic and reports shortness of breath,  lightheadedness, left hand tingling post vaccination on right arm. Taken to ED for further assessment.  Pt has COPD but patient feels these symptoms are different. After some time, daughter feels patient is back to baseline.   ED visit on 2/12/21 (12:03p - 15:02p)
5 days post injection, pt had significant left deltoid pain, painfull mass, heat and erythema 1/2 way down humerix. Tx'd antihistamine and cool compress. Area marked and ie checked 1 day later. Improved. CBC checked for cellulitis.
Patient received dose of COVID19 (Pfizer-BioNTech) past the vial BUD (Beyond Use Date) of 32 days from transfer of deep freeze to refrigeration temperature. BUD date of dose was 1/7/22 at 0900, patient received vaccination on 1/7/22 at approximately 10:10am. When error discovered facility contacted for course of action. At direction of the, patient contacted regarding occurrence to offer re-vaccination of dose. Patient declined revaccination. No adverse side effects or event as result of dose reported.
Large local reaction with pruritis developed approximately 24 hours after vaccination. Treatment with prn BENADRYL.
About a week (6 days) after I had my first Moderna shot, Inflammation of the hands and fingers started in the forms or red/skin color welts like Hives. Excessive burning and itching sensations, difficult even to wash or rub hands together, scratching was increasing the pain and was resulting in swelling of fingers. Fingertips had pain gotten super sensitive with inflammation.  Couldn't even form my fist because of swelling and pain. Had a lot of discomfort and difficulty sleeping so took a Tylenol PM one night to reduce the inflammation and to aid the sleep. Only took it once as not much of a fan of medicines. I also soaked my hands in water with baking soda which provided some comfort and reduced the pain and inflammation, applied some coconut oil to soothe the inflammation.  As I thought it was happening because of hives and/or excessive heat increase in the body, I changed my diets, started with foods and ingredients that cools down the body which felt like working and the swelling, pain, burning/itching sensations were slowly pacifying in 3-4 days. I also got acupuncture treatment after 5 days which has helped a lot now. Now after a week and all that I did, I don't feel the pain and burning sensations anymore, no swelling and the skin is getting clear, red spots/welts are disappearing and I am able to sleep better.
Parents describe child as excessively sleepy after receiving Hepatitis B vaccine.  Woke for feeding, but slept other times, unlike usual behavior.  Cranky 12/29-12/30.  Normal behavior thereafter.
Admitted to hospital on 10/25/2014 w/ left upper arm cellulitis, sepsis secondary to left upper arm cellulitis.
SICK; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was in perfect health. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious.
Nurse giving vaccination injected high in the deltoid causing pain  in arm and  shoulder. Pain with use of arm.
Significant swelling and pain in right lymph node (plum Size), primarily from 12 /8-11. Swelling in deltoid muscle of right arm continuing at least 7 days. (muscle felt hard).
She developed weeping cellulitis of the left forearm 3 days after the 2nd dose of the Moderna COVID19 vaccine in the left arm. She was placed on bactrim and a triamcinolone cream. Patient's infection is slightly better and doing fine on the antibiotic and cream but also developed another rash on her right forearm, this time not draining fluid.
Temperature excursion 46.2 degree celsius; This case was reported by a consumer via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) (batch number TB3KN, expiry date unknown) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 7YA99, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Engerix B and Havrix. On an unknown date, unknown after receiving Engerix B and Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 28-Jul-2022 Reporter's Comments: The reporter stated that they had temperature excursion last night it went from a temperature of 46.2 degree Celsius at 7:14, at 9 o clock temperature went back to normal. It was unknown if the vaccine was administered to any patient. The reporter wanted to know if the vaccine still ok. Additional supportive Information: The Havrix and Engerix B stored at temperature of 46.2 degree Celsius, which leads to Incorrect storage of drug.