chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received second COVID 19 vaccine in left arm on 03-08-2021.  Woke up on 03-09-21 with pain under my left arm pit.  Looked at my arm pit in the mirror.  My lymph  node was swollen approximately the size of a tennis ball and hanging down approximately 4" under my left arm pit.  I tucked the lymph node back under my arm and squeezed my arm against my side for approximately 1 hour.  The lymph node no longer hung under my arm pit.  I then used ice pack and a heating pad to for the next 5 days aid in reducing the swelling.  As of this date (04-02-2021)  the lymph node is still slightly swollen approximately 1"  to  about 1 1/2".  A little tender when pushing on it, but not painful.  This was the only side effect I had after receiving both Pfizer Covid 19 vaccinations.
Patient administered vaccineon 8-Apr-2022  after expiration date 07-apr-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered vaccineon 8-Apr-2022  after expiration date 07-apr-2022) in a 24-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered vaccineon 8-Apr-2022  after expiration date 07-apr-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered vaccineon 8-Apr-2022  after expiration date 07-apr-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported. Date the vial was initially stored in the refrigerator was unknown. Expiration date was reported as 07-Apr-2022. The vial did not undergo any temperature excursions. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received reporter address updated.
Woke up in the morning at 7am, I had vertigo and went back to bed and never fell asleep and in the afternoon went ER. They had me turn my head and fall backwards and cross my arms across my chest. Never had it again.
small blood spots on her face; a knot or pimple on her left jaw line; rash on left arm; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (small blood spots on her face), ACNE (a knot or pimple on her left jaw line) and RASH (rash on left arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (small blood spots on her face), ACNE (a knot or pimple on her left jaw line) and RASH (rash on left arm). At the time of the report, SKIN DISCOLOURATION (small blood spots on her face), ACNE (a knot or pimple on her left jaw line) and RASH (rash on left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Narrative:  Patient received Covid Pfizer vaccine first dose at right deltoid area and was waiting for 15 minutes in the observation room from 0930. at 0940, patient complains feeling hot all over the body and redness and swelling at the injection site and redness and flushes at the right side and face. Benadryl 25 mg given by RN in the observation room. Vitals are stable at the moment. wife is with him, and patient is awake, alert and oriented x4. patient transferred to Emergency Room by wheelchair.
no energy; pain all over body, feel like train wreck; pain all over body, feel like train wreck / every muscle in their body hurt; temperature 100F; patient is also very tired; shortness of breath; night of vaccination administration patient felt discomfort in neck and head on left side; night of vaccination administration patient felt discomfort in neck and head on left side; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA AT REST (shortness of breath) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Arthritis, Osteoporosis, Multiple sclerosis spinal cord lesion and COPD.    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced DYSPNOEA AT REST (shortness of breath) (seriousness criterion medically significant), HEAD DISCOMFORT (night of vaccination administration patient felt discomfort in neck and head on left side), NECK PAIN (night of vaccination administration patient felt discomfort in neck and head on left side), MYALGIA (pain all over body, feel like train wreck / every muscle in their body hurt), PYREXIA (temperature 100F) and FATIGUE (patient is also very tired). On an unknown date, the patient experienced ASTHENIA (no energy) and FEELING ABNORMAL (pain all over body, feel like train wreck). At the time of the report, DYSPNOEA AT REST (shortness of breath), HEAD DISCOMFORT (night of vaccination administration patient felt discomfort in neck and head on left side), NECK PAIN (night of vaccination administration patient felt discomfort in neck and head on left side), ASTHENIA (no energy), FEELING ABNORMAL (pain all over body, feel like train wreck), MYALGIA (pain all over body, feel like train wreck / every muscle in their body hurt), PYREXIA (temperature 100F) and FATIGUE (patient is also very tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Pyrexia: 100 (High) 100 F.     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.   There is no concomitant list provided. Treatment information was not provided.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
No additional AE details; A 49 year old patient was given a PROQUAD to save the patient money.; This spontaneous report has been received from a pharmacy manger, regarding a 49-years-old patient. The patient's pertinent medical history, current conditions, previous drugs reactions or allergies and concomitant medications were not reported.  On 16-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) (recombinant human albumin (rHA)) (lot number W002781, which was determined to be valid, with an expiration date on 23-JUL-2023 but after internal review it was determined to be on 24-JUL-2023) (+) sterile diluent as prophylaxis (dose, route and anatomical location of administration was not reported) (product administered to patient of inappropriate age). No additional adverse event was reported.
Swelling on the injection site, very tender and red size 4x3 1/2 inch rt arm.
Started with a severe HA the day after with extremely sore and hot arm.  Progressed to weakness and flu-like symptoms with low grade fever of 101.  Was off work for 2 days unable to hardly get out of bed.  Then on day 2 post vaccine, started with lower abd pain, sharp and continuous.  Day 3 post vaccine, feeling much better but not 100%, Stomach pains continue.
After receiving the vaccination, the patient's leg immediately began itching, turned red and developed a hive next to the injection site. The patient was treated with 12.5 mg of oral Benadryl. Per mom, the redness went away by the evening hours. The patient woke up with a bruise where the hive was and the patient had pain in the affected leg all day. 48 hours later, he is feeling well.
This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on an unknown date and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Jun2021 at 11:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The medical history included herpes simplex and allergy to ragweed. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within two weeks of vaccination. The patient previously took MORPHINE on an unknown date and experienced allergy. The patient stated there was no real adverse reaction and no area to report a possible potential treatment for other conditions with the vaccine. The patient stated that she had been plagued by herpes simplex in her entire adult life. Last year in 2020 and early in 2021, she had breakouts of cold sores almost monthly, but after she took the COVID-19 vaccine, she had not had any occurrences of an episode for the past 6 months, since 05May2021. She thought that the vaccine had helped her to control herpes and thought that it might be worth looking at the effect of it on the simplex in a clinical study. The adverse event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event after the COVID-19 vaccine, not had any occurrences of an episode of herpes simplex for the past 6 months was unknown at the time of this report.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
late 2nd dose, 1 year since the 1st; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in February 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's comment: The reporter asked could a patient receive 2nd dose of shringix if it had been over 1 year since the 1st dose.  The inquiry came via chat, chat dropped before any further details was provided. Additional Supportive Information: Till the time of reporting the did not receive the 2nd dose of Shingrix vaccine, which led to Incomplete course of vaccination.
This spontaneous report was received from a pharmacist refers to a 71 years old male patient with chronic obstructive pulmonary (COPD) who on 19-DEC-2012, was vaccinated with ZOSTAVAX (dose, route, and lot number not provided). Other co-suspects were not reported. Concomitant medications were not reported. The pharmacist reported that the patient typically takes prednisone (manufacturer unknown) 10 mg daily for his chronic obstructive pulmonary (COPD). On 19-DEC-2012, the patient experienced exacerbation of his chronic obstructive pulmonary disease (COPD). The patient sought medical attention. On the same date, following administration of ZOSTAVAX, the patient received prednisone (manufacturer unknown) 40mg once at that time. The outcome of exacerbation of his chronic obstructive pulmonary disease (COPD) was reported as not recovered. The relatedness for exacerbation of his chronic obstructive pulmonary disease (COPD) was unknown for ZOSTAVAX. Additional information has been requested.
wk of 4NOV91, began w/general aching; On 11NOV91 had chills & aching in both hips; 14NOV91, exp nausea & diarrhea;
5 mins after administering vaccine patient reported throat swelling, lip swelling and headache. Epinephrine was immediately administered, EMS was called and patient was transported to the ER by ambulance.
Body aches and fatigue about 20 hours post injection. Symptoms resolved themselves within 24 hours.
Moderna COVID-19 Vaccine EUA  First few days felt bad with no energy as the days progressed Medications no longer effected Essential Tremors and they have become worse.  Nervous all over.
Vaccine was administered after best use date (BUD) of 2.3.23. Expiration date of vial is 4.30.23. Vaccine was stored in monitored refrigerator under proper temperatures for a normal vial. Patient was notified of administration error 3/30/23.
Had spinal surgery 5/16 and was at an inpatient rehab facility until 6/3 where discharged and then readmitted back to  Hospital on 6/4 due to spinal complications.  She was then discharged on 6/9/2021 to home. Thus case was readmitted due to spinal surgery complications, not due to to COVID.
Covid19 breakthrough.  1st vaccine received on 02/10/2021.  79 y/o female with PMHx of Alzheimer's, dementia, Hypothyroidism, GERD, HLD, Left mastectomy sent from Nursing Home with increased O2 requirements, SOB and fecal impaction after being diagnosed with Covid19 the day before.  O2 3L NC sats 94%, afebrile, CXR without acute pathology. Treated with steroids.
Severe chills that started about 11 hours after the injection. Moderate muscle aches.
I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 5/3/2023 ANEMIA DUE TO BLOOD LOSS
Patient said he felt warm after the TWINRIX was injected. He claimed to feel different compared to the BOOSTRIX and FLUCELVAX. He then suddenly dazed off and not responsive even though he was still conscious. He started to have the jerking movement from his hands while his head was tilted to one said as if he was losing control. Patient slowly gain his response. Everything happened in less than 5 minutes. He was able to squeeze my hand, answer my questions, and was able to have conversation with us.
1 day p/vax pt exp inconsolable crying;no po intake;negative workup including cult, corneal abrasions, x-rays;recovered over next 24hr w/ IVF; 2-3 days later nl
Patient developed fever of 101, red area with swelling and induration that is warm to touch and painful.
Redness and swelling of the left shoulder. Noticed 3 days after injection was given. S/S gone by5th day with no treatment.
Not trying to be funny but I felt like I was tripping. I had all the side effects listed per my research. I had a vivid dream like when I used the patch to stop smoking.  It was a surreal experience that started happening about 12 hours after the shot.
3SEP97 site are painful-swollen (hard lump);4SEP/15SEP97 site area painful, swollen, warm to the touch, throbbing pain-radiating;lt shoulder down arm to hand & fingers, deep burning itch @ site & surrounding areas;reddish rash about 2";
Two days post vax, pt developed an injection site reaction characterized by redness, and area of hardness measuring 4" in diameter and 1/4 to 1/2 inch in height and burning which lasted days. Pts entire arm became swollen and red. Pt developed long strips of red from the back of her neck to the right side of her jaw measuring 1/4 to 1/2 inch wide. Pt developed red patches on her arm extending to her wrist. Her arm remained red and swollen for 3 days. Pt was treated with dicloxacillin.  Pt then developed swollen lymph glands in her neck which increased in size over the next several days. Pt then developed hives. On 07/14, the neck swelling decreased but the arm remained sore and red. Pt then developed swollen ankles double to triple in size and experienced itching of her feet. Her knees swelled and she experienced muscle spasms in her calves and thighs. She could hardly walk. Pt was treated with Advil. On 08/08 she developed severe swelling of her right knee and left calf and both thighs were in spasm.  Pt was seen by an orthopedic physician and was diagnosed with severe inflammation. Pt was treated with methylprednisone.
Changes in period- I started my period 3 days after getting my first short of Pfizer. I have noticed that my period has lasted 10 days (usually always lasts 4-5), with unusual spotting.   I have also noticed inflammation of my eyes about a week after my first short. They have felt strained and have been sensitive to light. I have had to schedule an appointment with my eye doctor.
2/15/07 AWAKENED WITH SOME HIGH TEP:MOTHER NOTED SOME REDDESH COLOR ON LEFT DELTOID AREA (ABOUT 6MM). AS DAY PROGRESSED AREA ENLARGED.  AREA WAS WARM TO TOUCH.  THIS A.M. 2/16/07 AREA SOME WHAT LARGER THAN LAST EVENING. STILL WARM TO TOUCH, CHILD HAS NO COMPLAINT OF HIGH FEVER, BUT, STATES ARM IS SRILL SOME WHAT ENCOMFORTABLE. CHILD "STATES HE FEELS FINE"
This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 29-JAN-2010, the patient was vaccinated with first dose of GARDASIL. On 03-AUG-2010, the patient was vaccinated with the second dose of GARDASIL. On 10-APR-2013, at the time of reporting, the patient was in the office to get the third dose of GARDASIL. No adverse effect reported. Additional information has been requested.
Patient states that she experiencing, Muscle Spasms, Numbness/tingling sensation in limbs and tongue and face. Headaches, Dizziness.
This spontaneous report was received from a physician via office manager refers to a patient of unknown age. On 31-MAY-2013, the patient was vaccinated with a dose of VAQTA, (lot # H019104, expiry date 19-JUL-2015), which was exposed to 31 degree Fahrenheit. Concomitant medications were not reported. No adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported. On 18-OCT-2017, the patient was vaccinated with improperly stored doses of ROTATEQ lot # N005619, expiration date 29-OCT-2018, orally, for prophylaxis (strength, dose and frequency were not reported). The temperature/Time frame was 34.8° F for 8 hours 23 minutes and 34.8° F for 8 hours 15 minutes. The previous temperature excursion was 47.6° F for 5 minutes. There was a data logger involved. No adverse effects reported. This is one of several cases from the same source. Sender's Comments: US-009507513-1710USA010653: US-009507513-1710USA010655: US-009507513-1710USA010656: US-009507513-1710USA010312.
Muscle spasms and leg cramps Treated with Oxycodone and Cyclobenzaprine
Inj site pain Narrative:  MAR 02, 2021@13:19:35 by ORIGINATOR First dose of covid vaccine on 2/2. 4 days later patient had headache and vomited once, 7 days post vaccine he had similar headache and vomited again. Also had a few days of pain at injection site. Note that ADR was entered on same day that patient got his second shot.
Pt. received vaccines on the afternoon of 9/21/10 while at well child check. Parents state that child was irritable on that evening. On 9/22/10 at approximately 11:20am, pt. had likely a febrile seizure mth recorded temp of 103.5 tympanic, episode resolved after approximately 5 minutes; brought to physician for eval.
Patient came into clinic for vaccine, upon chart review it was noticed he had received one Moderna prior. Patient was given a primary series Moderna 0.5 mL thinking this would complete his series.  I failed to see he had also received a Janseen vaccine the first time.  He would then have needed to have the Moderna Bivalent administered instead.
Pt fainted in 15 minute waiting area falling on her face & hitting L/cheek & chin. Per w/c taken to Observation area with cold compress to face.  BP 95/85 P 55. 5:50PM Sitting up BP 96/67 P 59 clammy 6:11pm BP 109/71 P 58. Feeling much better.  Left w/o assistance.
Fatigue, dizziness, neck pain, chest pain, nausea, diarrhea, chills and headaches.
10/28/99 - phone call to pt for follow up.  Approximately 4 hours post vax, pt began feeling "achy and running a low temp.  Family physician authorized ibuprofen.
On 01/14/01, this patient presented with an elevated temp of 106 at home with seizure activity, stated the parent. They called EMT, who transported the patient to the ER. Per ER report, the child with elevated temp of 102.5 at 22:40  on 01/14/01. Primary diagnosis was left otitis media. Prescribed Amoxicillin and Tylenol, and discharged home.
Patient was given Hepatitis A Peds instead of Hepatitis A adult. at time check out patient had no adverse reaction.
Mar 6 - Tingling in mouth about 15 minutes after shot, flushed - took more claritin and was monitored by RN One hour which continued - wheezing, congestion, headache, flushed - took Benadryl every 4 hours  (in hindsight, wish I had gone to ER),  Mar 12 - saw Dr on call - did chest x-ray, ECG (both normal), prescribed Prednisone (helped some), nebulizer treatments Mar to present - continuing Nebulizer treatments and Wixela inhaler 500/50 (2x day)
Pt with SEVERE RT arm pain/swelling for over 3 weeks.  Pt states she was up for several nights with the pain and could not use her hand due to swelling.  No f/c/s.  Continues to have aching in arm.
Low grade fever and body aches.  On 11/19/2011 child developed severe cough, causing him to wretch and vomit.
racing heart; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 12:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Bartter Syndrome" (unspecified if ongoing); "previous Broken Syndrome" (unspecified if ongoing), notes: other medical history: previous Broken Syndrome; "GERD" (unspecified if ongoing); "allergy" (unspecified if ongoing), notes: Known allergies: Yes. Concomitant medication(s) included: SPIRONOLACTONE; TOPROL XL; SLOW MAG B6. The following information was reported: PALPITATIONS (non-serious) with onset Mar2021, outcome "not recovered", described as "racing heart"; FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "fatigue". The events "racing heart" and "fatigue" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of palpitations, fatigue.   Additional information: The patient took second dose of vaccine on 09Apr2021.  Reported verbatim: First dose racing heart and severe fatigue during first week with 1 emergency room visit. Second dose caused racing heart and much, much more severe pounding heart and overwhelming fatigue with 2 emergency room visits. I am 19 days out from second dose and still feeling deep fatigue and not able to resume normal activities. I feel as bad as I did within the first week of reactions. No other vaccine in four weeks. Other medications in two weeks included unspecified multivitamins. Ae treatment included replenishing electrolytes, ekg, blood tests, urine tests. No covid prior vaccination. No covid tested post vaccination. Known allergies: Yes    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.