chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of sinusitis (sinus infection) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 034C21A) for COVID-19 immunization. Concurrent medical conditions included sinus infection. On May 27, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced sinusitis (sinus infection). At the time of the report, sinusitis (sinus infection) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of Merck sterile diluent.   No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
Since receiving the vaccine the adverse effects suffered have included but not limited to: fever, chills, night sweats, debilitating  fatigue, body tremors, body aches, weight loss, uncontrollable body twitches and movements, muscle cramps, dizziness, headache, ear pain, throat pain, cough, cold symptoms, rash, diarrhea, vomiting, racing heartbeat, body numbness, difficulty walking, difficulty swallowing
Pain in back and down the leg. Could not stand had to sit. Then a few months later numbness on left side then May 25th 2010 numbness on right side from chest to foot.
Pt has a raised, circumscribed red area on the deltoid approx 2.5 inches diameter that is warm and itchy, possibly allergic reaction.
administered liquid portion only; administered liquid portion only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA6588, expiry date 20th January 2023) for prophylaxis.   On 15th August 2022, the patient received Menveo. On 15th August 2022, 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: 15-Aug-2022 Reporter's comments: The medical assistant reported that patient was administered the liquid portion only of Menveo without prior reconstitution. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient was administered only the liquid portion of Menveo without prior reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
headache, chills, sweats, fever 103, swollen arm, skin peeled, thrush,
Itching rash with large hives and blisters, muscle and joint pain, fatigue.
This spontaneous report was received on 01-JUN-2017 from a female medical assistant regarding an unspecified patient with age and gender unknown. The medical assistant reported that on 01-JUN-2017 an expired dose of VAQTA [Product reported as VAQTA  INJ 25/0.5](Lot number M022556, expiration date 26-MAY-2017) (Dose, route of administration, and site of administration were not reported) was administered to an unspecified patient for prophylaxis.  No adverse effects reported. Additional information has been requested.
Narrative: LPN administered bivalent booster instead of requesting monovalent formulation as first dose of primary series.
Minor Face and Throat swelling. Irregular eye lid movement. Lips num and felt twisted.
The cough lasted about four days. It was a tightness in my chest and it went on for about a week. Each day it would get worse. When I would lay down at night it would get worse. On September 10, I had a gold tournament, and my cough was unstoppable. I had to go to an Urgent Care, and tested negative for COVID-19. They gave me Amoxicillin due to getting pneumonia. I got over the pneumonia, on the 29th of September I talked to a doctor and got a visit with doctor about a week ago. I got a prescription for a butanol inhaler and a cough medication, I'm not sure what it was, but it got rid of the cough. A lung x ray was done and they told me my pneumonia was gone. I recovered from the cough, but I still have a wheeze. Ascaris was found on my left lung, either a scarring or nerve damage.
pt recv vax 20MAY96 & 12JAN97 p/an exposure to wild type chickenpox, pt devel breakthrough chickenpox w/approx 20 lesions & a temp of 99-100;pt was seen by MD on 14JAN97 & dx w/varicella & OM;
Received Varicella vaccine 3/12/02. Notified by mom of development of pox noc of 5/7/02. States they are spreading rapidly over entire body. Has been feverish but is also cutting teeth. Mom has been giving Tylenol prn. 5/13/02 Child improved. Mom sure it was chicken pox D/T scabs or white tops to raised ar4ea. No concerns verbalized states. Child is better. Total > 50 pox.
Per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Moderna on 3/5. Patient is admitted for upper GI bleed on 3/7. He started experiencing GI bleed prior to receiving first Moderna dose.  ?
Hives on neck and chest . Took benadryl. Coughing and wheezing next day.
Covid Breakthrough in January. Felt like a cold, super tired, my doctor prescribed paxlovid. I was very sick. I couldnt work for almost 2 weeks.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Unable to Sleep-Severe, Systemic: Weakness-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Approximately 1 week after the second dose in upper right arm, dull pain developed and crept up the arm, into the shoulder, and up left side of neck.  Approximately 3rd week after the second dose, a progressively growing sensitivity to a part of the sunlight spectrum began to develop (from minutes before sunup until sundown it feels as if my body is being microwaved on a cellular level) as well as marked increase in heat sensitivity with inability for body to process heat (takes hours to cool down from 20 minutes of indirect activity in sunlight, 10 minutes or less in direct sunlight).  This continued until I broke out in probably unrelated severe contact dermatitis from using baby oil (first time, and last time) , whom also broke out from the contact and also had the moderna vaccines on the same days with me.  I went to local Primary Care Physician and communicated about the problem, yet also let them know the effects of the sun and the microwaving feeling that was unrelated. Prescribed creams.   Wife's diminished of its own Accord. Mine healed slower over two weeks.  During this time, the sun spectrum sensitivity got worse and worse (possibly gamma rays...I have no idea. It feels like I am being microwaved as I type this and it is heavily cloudy outside and i can sleep in a completely dark room and feel it from sun up to sundown. After sundown it takes my body 5-6 hours to process the microwaving effect, and then starts all over again at sunup. It is absolute hell. I would not wish it on anyone for any reason ever.)  I feel like I am dying, and my skin started itching about 2 weeks ago, and is now so bad that I can barely stay sane and have to sleep in another room so my wife can sleep without me waking her.
Sacral Herpes Outbreak; Arm soreness; A spontaneous report  was received from a healthcare professional, who was a 69-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm soreness and a sacral herpes outbreak.  The patient's medical history was not provided. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the day of vaccination, the patient experienced arm soreness.   On 14 Jan 2021, the patient experienced a sacral herpes outbreak high on her right butt cheek. Treatment for the event, included valaciclovir.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, arm soreness and sacral herpes outbreak, was unknown.; Reporter's Comments: This case concerns a 69-years-old female patient, who experienced a serious unexpected event of herpes simplex and non-serious unexpected event of pain in extremity. The event of pain in extremity occurred 1 day (same day) after first dose of mRNA-1273, lot # 013L20A. The event of herpes simplex occurred 2 days after first dose of mRNA-1273, lot # 013L20A. Concomitant medication included Valacyclovir. Treatment details were not provided.  Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Red, swollen, firm, raised, and hot to the touch patches on arm below the site of injection. Two weeks after injection was received.  Redness went away after 4 days.
PATIENT HAD A NOSEBLEED 2 DAYS IN A ROW AND HAS NEVER HAD NOSEBLEEDS BEFORE.
Information has been received from a physician concerning a 19 year old female who in July 2009 and December 2009, was vaccinated with the first and second doses of GARDASIL, respectively. The patient experienced one week of feeling exhausted and brain fog after receiving her first dose of vaccine. She experienced severe brain fog and profound fatigue after the second dose. She was not able to attend spring semester of college as a result. Prior to receiving GARDASIL she was an athlete who excelled at track and excelled as a student and did not have an allergy to citrates prior to receiving GARDASIL. The patient was also experiencing a severe hypersensitivity to citrates and seemed to be more prone to Streptococcus infections. The physician also reported the patient just recently experienced intense bronchospasm for 1 hour after taking a lactobacillus mixture. It was discovered after the patient's reaction that the mixture contained an extremely small amount of citrate. At the time of report the patient had not recovered. No further information is available.
Patient had redness, swelling, and warmth around injection site. She had the vaccination on 04/25/2018. Reported the adverse reaction on 05/02/2018 and was instructed to use BENADRYL for the reaction. Followed up with patient on 05/08/2018 and symptoms had resolved after a few doses of the BENADRYL.
My sons pediatrician began the HPV series 10 weeks ago, received the second dose 8 weeks later, and today (12 weeks later) gave him a third dose by mistake when in the office for a flu shot. Should I bring him back in four months for the originally scheduled third dose (now the fourth)?
Client experienced dizziness and lightheadedness six minutes post vaccination. Client was aided to thefloor in a supine position with feet elevated. Ice packs were applied to client?s neck bilaterally. Patient reported resolution of symptoms at 20 minutes post vaccination. Patient then moved to sitting position, tolerated well. After 5 minutes patient assumed standing position, tolerated well. No additional treatment needed.
Tachycardia- occurred about 14 hours after the vaccine, and lasted for about 12 hours. Resting heart rate is usually 70 and was 100. Any activity it would climb to the 120-130s.
This spontaneous report has been received from a pharmacist and referred to a patient on an unknown age and gender. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not provided. It was reported by the pharmacist, that on an unknown date, the patient was inadvertently vaccinated with two doses of properly stored ZOSTAVAX 19400 "PFU" (dose, frequency, route of administration, lot number, and expiration date were not reported) for prophylaxis, that were reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported). There were no adverse effects reported. Additional information has been requested.
Started with itching sensation, site started to feel numb and heavy, warm, swollen, red. The eyes also started to itch. I feel tired and chills.
pt recv vax & devel an inj site rxn characterized by redness & swelling;pt had recovered @ the date of this report;
10/03/19. Early night started aching all over a d chilling - at 7am  passed out for about 5 min and started vomiting.  Lasted about 30 min.  Aching and vertigo lasted 3 days to the degree of total incapacitation.  Gradually improved until about after 2 weeks the vertigo was gone.  Tiredness lasted another week.  By 10/24 no symptoms were remaining.
Intense headache (no photophobia or otophobia) Motrin helped some. Decreased appetite. No Know fever. On 11/28/2011 headache was a little better so went to school.
.Pt returned from gym 3/2 3 pm c/o dizzy, weak and took acetaminophen 500 mg 2 tab. At 10 pm fever at 102.5. 3/3 temp at 9 am 100.0 (repeated TYLENOL) and 11:30 temp 98.0. slight rt. arm pain/swelling and muscle ache. (ice, TYLENOL or ibuprofen) and f/u).
Erythema, minimal swelling, slight tenderness around injection site. Max size around 2.5-3 inches. Fever for 1 day (101.5F) Decreased activity and eating during time of fever. Improving when seen in clinic. Fever resolved, erythema decreasing. Eating and drinking. Continue to monitor.
AT APPROXIMATELY 12:00, TWO HOURS AFTER RECIEVING HER SECOND MODERNA VACCINE DOSE SHE COMPLAINED THAT HER LOWER LIP STARTED TO SWELL. SHE WAS TAKEN TO THE TREATMENT AND TRIAGE AREA ON WORK GROUNDS WHERE THE DOCTOR THERE TREATED HER WITH BENADRYL AND DEXAMETHASONE. AFTER SHE WAS OBSERVED AND WAS FEELING BETTER SHE LEFT WORK TO GO HOME AND GET SEEN AT A LOCAL URGENT CARE FOR FOLLOW UP.
6-month-old male inadvertently received expired Moderna (infant) for his 1st dose at around 9:30 am on 9/6/2022. The Moderna vial expired 34 hours from the manufacturer's recommendation date (expired on 9/4/2022).
10-15 minutes after vaccination, patient felt lightheaded and slumped to the floor.  Did not have complete loss of consciousness.
I have had the worse shoulder and arm pain since getting the Vaccine. I can hardly move my right arm. Pain radiates from my shoulder all the way down to my right elbow. After getting the shot, next morning till present, this has been going on plus after the shot i had the chills for days , extreme fatigue, nauseous and loss of appetite and had to sleep with 2 blankets i was so sick
Patient fainted approximately 5 minutes after receiving Varicella and HPV vaccine. Patient unconscious for appx. 10 seconds. Patient slow to recover. EMT called.
Moderna Covid Vaccine, 1st dose.  I experienced "covid arm" 6-7 days after  I received the vaccine.  I had itching and developed a 3" x 2" oval shaped red area near the site of the vaccine (upper left arm).  It is not too bothersome physically, but it does worry me mentally.  I also had some left armpit tenderness a couple days after the vaccine, which lasted about 3 days, but that has subsided.
This case was reported by a healthcare professional (nurse) and described the occurrence of rash in a 33-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline). Current medical conditions included liver biopsy. On 23 August 2012 the subject received 1st dose of TWINRIX (1 ml, unknown route, left deltoid). On 18 September 2012, 26 days after vaccination with TWINRIX, the subject experienced rash, itchy bumps described as "rash and raised itchy bumps all around the arms, legs, back and chest". The subject received TWINRIX on 23 August 2012 and when he returned fro the 2nd dose at the physician's office on 26 September 2012, he complained that he had developed the events on 18 September 2012. The subject did acknowledge that he had used a new detergent and had his carpet cleaned, but no exact cause was identified. The subject was also supposed to have a liver biopsy and the 2nd dose was not administered. The liver biopsy was not scheduled as a result of the 1st dose of TWINRIX. The subject had a liver biopsy scheduled for the same date that he was to receive the 2nd dose of TWINRIX. The second dose of TWINRIX was held (immunization series delayed). At the time of reporting the outcome of the events was unspecified.
fever, chills, body aches, nausea, headache, cough-over the counter meds symptoms lasted about 2-3 days
My left shoulder is in chronic pain and both sholders and back area are in pain as well as my hamstrings and i have a feeling of achiness in general.  NSAIDS help but do not alleviate the pain totally.
He stopped talking almost 2 weeks after the shots and he is 5 and hasn?t said anything. Was diagnosed with autism a year after these shots.
This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 79-year-old male patient who received SHINGRIX (batch number 5MG5E, expiry date May 2019) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX (subcutaneous). On an unknown date, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected adult as per vaccine indication. The reporter asked if 1st dose of SHINGRIX was given subcutaneously (which could lead to incorrect route of vaccine administration), could the patient still receive the 2nd dose. Follow up information received from pharmacist on 7th February 2019: The reporter's contact details were updated. The patient's demographic details were updated. The age of patient was reported as 79 years and 3 months old. The batch number and expiry date of SHINGRIX was updated. On 18th December 2018, the patient received 1st dose of SHINGRIX subcutaneously instead of intramuscular. The SHINGRIX was not premixed, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. Less than a year after receiving SHINGRIX, the patient experienced redness at left elbow not at injection site. At the time of reporting, the patient was fine with no harm at all. The VAERS details were updated. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX.
pt awoke 1230AM w/fever 104 & vomited, crying pt taken to ER; given Prediaprofen seen by MD next day;
Moderna vaccine is only for patients older than 18 years of age. Patient was 15 years at the time of first dose. Per parent there was no adverse or allergic reaction from vaccine.
Developed a rash on abdomen. Very itchy and causing discomfort. Was  on a cruise so didn't attend to it. Took Prednisone orally to abate the symptoms. Still miserable after returning  home after the cruise and went to an Urgent Care on 10/11/2021 and was diagnosed with Shingles. I asked the doctor if this could be related to the vaccine and was told yes.
started getting SOB, difficulty getting air in; throat was closing up; Initial information received on 15-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a 71 years old female patient started getting SOB, difficulty getting air in (dyspnoea) and throat was closing up (throat tightness), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history included Cardiac operation and Dyspnoea. The patient's past vaccination(s) included Fluzone in 2018, Flucelvax in 2015 and Fluarix. The patient's past medical treatment(s) and family history were not provided.  At the time of the event, the patient had ongoing Diabetes mellitus and allergic to aspirin and contrast dye (Her throat usually closed up with those).  On 14-Oct-2019, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient started getting SOB, difficulty getting air in (dyspnoea) and throat was closing up (throat tightness) one hour 30 minutes  following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.  Other relevant tests not reported.      Final diagnosis was dyspnoea and throat tightness.  It was not reported if the patient received a corrective treatment.  The patient had not recovered from the events.  Information on the batch number was requested.
Chills, Body Aches , Fever, Headache, Nausea,   Slept for 36 Hours, then felt fine.
I experienced a terrible headache, nausea, uncontrollable chills and shaking. My whole body ached so I went to the bathroom to take my temperature and I fainted. When I awoke, I had shattered my right collarbone during the fall, plus I had bruises on my head and hip.
Fever, Chills, diarrhea, fatigue. Lasted about 15 hours
No adverse event from vaccine in clinic.  Patient has previously received Pfizer both doses from another provider earlier this year. Patient was asked on two separate occasions if this was her first COVID-19 vaccine that she stated "yes", patient also registered herself through VRAS state platform for COVID-19 vaccines scheduling.  After discovering that patient had Pfizer doses listed in database, admin staff questioned patient again if she had ever received COVID-19 vaccine, she again stated that she had not, when she was shown her record to verify that information was actually her, she finally stated that she did get both doses of Pfizer as indicated in database. She went on to say that her physician instructed her to not tell facility she had been previously vaccinated and to specifically get the Johnson & Johnson COVID-19 vaccine due to a medication she is taking.  Notified Nursing Director.
Mild diarrhea within 1 hour of 1st vaccine Pfizer shot. Mild intermittent nausea, no vomiting. Severe injection site upper arm pain, difficulty lifting the arm for 2 days. Genital herpes outbreak within 4 hours of 1st shot, pre-existing condition.
70 year old patient recently hospitalized for aspiration PNA directly admitted from TCC after testing positive for Covid-19 at their facility.  Patient reports intermittent diarrhea.  Patient was discharged from facility and expired on 03/07/2022.