chrisvoncsefalvay/vaers-outcomes huggingface dataset:
shortness of breath; asthma attack; itching in lower arms; This spontaneous case was reported by a patient and describes the occurrence of DYSPNOEA (shortness of breath), ASTHMA (asthma attack) and PRURITUS (itching in lower arms) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Allergy to antibiotic, Drug allergy (Z-pak), Asthma (since early 20s, was stable with medications except for asthma attack after 2nd dose) and Blood pressure high (2 years ago, stable). Concomitant products included DILTIAZEM, ALBUTEROL [SALBUTAMOL], BUDESONIDE (PULMICORT), THIORIDAZINE, ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), IBUPROFEN (ADVIL [IBUPROFEN]), IRON, MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) and CALCIUM CITRATE for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHMA (asthma attack) and PRURITUS (itching in lower arms). On 04-Feb-2021, DYSPNOEA (shortness of breath), ASTHMA (asthma attack) and PRURITUS (itching in lower arms) had resolved.            Patient had no history of COVID-19 infection and no history of Myocarditis or pericarditis. Patient did not receive any other vaccine within 1 month prior to Moderna COVID-19 vaccine.  Patient had asthma attacks before. Patient experienced itching in lower arms and shortness of breath during 15 minutes and 10 minutes later patient experienced an asthma attack. Patient used inhaler Albuterol and Pulmicort for asthma attack.   This case was linked to MOD-2022-661394 (Patient Link).
Patient received dose of improperly stored VARIVAX; no other AE reported; This spontaneous report as received from a nurse referring to a patient of unknown age.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route of administration were not provided, lot # T020650 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 16-JUN-2022) as prophylaxis.  The vaccine was exposed to a temperature of 35°F, during a time frame of 16 hours which was not called by a data logger. No previous temperature excursions was reported.
Cramps. Diarrhea, within 24 hours and lasted about 2 to 5 days.
While waiting 15 minutes after vaccine H1N1 pediatric dose no preservatives, child's cheeks and back of neck became extremely reddened; she had blotches on her upper back and upper arms. No respiratory problems. She was given Benadryl IM as per protocol. Redness continued 911 called and she was taken to local hospital for monitoring.
Neck locked up for 1.5 weeks, wasn't able to turn head had to turn whole body.  Once some neck movement came back still had to use hands to 'pick up head',  pain down back muscles after trying to stretch neck.  Lasted about 3.5 weeks. Headache felt like something stabbed above left eye for 5 days, worse around bright lights.
Did not get the vaccine intramuscularly; A spontaneous report was received from a Nurse, concerning herself a 57-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported Did not get the vaccine intramuscularly (Incorrect route of product administration).  The patient's medical history was not provided. Concomitant products were included Glipizide, Losartan, Hydrochlorothiazide, levothyroxine and doxycycline for unknown indication.  In Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: [unknown] for prophylaxis of COVID-19 infection.   On 10 Feb2021, the patient received their second of two planned doses of mRNA-1273 (Batch number: [unknown] via subcutaneous on right arm  for prophylaxis of COVID-19 infection.   On the same day it was reported that, patient states that she did not get the vaccine intramuscularly.It was subcutaneous. Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not applicable.   On 10 Feb 2021, the outcome of the event,  inappropriate route of vaccination administration was considered resolved.; Reporter's Comments: This report refers to a case of Incorrect route of product administration, for mRNA-1273, lot # unknown,  with no associated AEs.
DIZZINESS, DIARRHEA, BLACK STOOL, WEAKNESS AND UP SET STOMACH AND NO APPETITE.
Received Flumist morning of 10/21/10. Evening of 10/23 vomiting started.  Appeared better next morning, but more vomiting after awake a few hours. Appeared better 10/25 so went to school. After school at home pt. collapsed & fell for no apparent reason. Mom says no loss of consciousness. Vomiting again that evening. No fever, no lethargy. No one else in family ill. Able to eat some and drink. Kept home from school 10/26 with no vomiting as of 2PM. Mother made doctor appointment for 11/3.
Undereye dermal filler from 6 months ago became swollen and painful on right side of face only.  The filler started hurting in the morning then became red and swollen by mid day. Vaccine was received on my right side. The filler under my left eye is unaffected.   By evening it is still swollen but seems to be going down. No treatment has been sought out yet.
Had severe joint pain and fatigue from 04/26/21-05/02/21, then woke up in the middle of the night with a burning sensation to left side of abdomen and flank. Severe numbness and burning from (05/02-05/07), diagnosed with Neuralgia 05/07 /21, then developed rash the night of 05/07/21. Went to urgent care the morning of 05/08 and diagnosed with Shingles. Prescribed Neurontin and Lyrica for Shingles. I do not have any auto-immmune disorders diagnosed currently but have been tested in the past, not immunocompromised, not under stress, and I have not been exposed to anyone with Shingles or chickenpox.
Lost his sense of taste and on smell on 10/28/2021 and tested positive for C19. Hospitalized from 11/1 to 11/3, although it was unknown that he had COVID. Readmitted to hospital on 11/16/21 and is being treated for C19
No additional AE information; LPN calling for stability data on vaccine that has been administered past expiration date.; This spontaneous report was received from a Licensed Practical Nurse (LPN) referring to a patient of unspecified age and gender. The patient's concurrent conditions, medical history, and concomitant therapies were not reported.  On 30-APR-2022, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) intramuscular injection, (strength, dose, frequency, and route of administration were not provided); lot # T035721 has been verified to be a valid lot number with expiration date: 15-APR-2022, administered as prophylaxis. The reporter was calling for stability data on vaccine that had been administered past the expiration date (expired product administered). When asked about prior temperature excursions, was transferred to the person who was in charge of vaccine storage, and she confirmed that the expired administered vaccine was never stored at a temperature outside of its recommended storage range. No additional adverse event (AE) information. No product quality complaint (PQC) involved.  This is one of several reports received from the same reporter.
I just got off the phone w/patient who runs the batch plant.  He said he had to call me today because he has been struggling since his 2nd Moderna dose on 5/14/21.   He said he drove in to work today and realized that he had forgotten to turn to go into work and could've easily had ended up in another town.  His neurological issues he said started 3-4 hours after his 2nd shot.  He said he didn't have any issues after his first shot on 4/9/21. He said he has medical bills and $5,400 left of his deductible for this year so he can't afford to go to the doctor for this but he said he needs help because of the issues of him living in a fog is affecting his work and his home life w/his wife. He said he was on morphine back in the day when he had a bad broken arm and he said this is so much worse than the "morphine" fog.   He gave me numerous examples, such as driving home from work he forgets to turn on his road and this has happened over 10 times.  He has been sending the wrong cement orders to customers which doesn't work in 80 degree heat. Having to use a calculator to do the math on how much cement is needed and he used to be able to do all of this in his head.  He's forgetting to call customers back.  His boss stopped in yesterday for the first time since April and they were going over the financial loans he said before the 2nd shot he could pull all the numbers right out of his head but yesterday had to look them up and and still gave his boss the wrong numbers.  He said the weakness is awful too, 5 years ago he said he passed the step test for the fire department and now he can't walk up 5 steps due to being too weak.  He said he won't drive a cement truck right now and it's been 2 months since the 2nd shot and it's their busy time.  He's very concerned because it isn't getting better and it's affecting work and the relationship w/his wife because he is short with her because he can't remember what she told him.  He was late to pay his propane bill, he said he's never late to pay that.  He said he is allergic to the flu shot but got this shot trying to do the right thing but he said there is talk of a 3rd shot and he said he could never get that because he believes it will kill him. He does smoke, he doesn't drink, he takes vitamin B,C and D.  He asked me to ask everyone I could what he could take or do to help him because he can't keep living like this.  I told him I would also do a VAERS but that doesn't help him.
pt exp hives-head, neck, trunk & w/intense itch; seen in ER 11SEP93;
After the vaccine I was asked did you drive here' On my reply of yes' I was told, please wait in your car for 15 minutes'; no adverse event; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Oct-2022 and was forwarded to Moderna on 11-Oct-2022.    This spontaneous case was reported by a patient and describes the occurrence of PRODUCT MONITORING ERROR (After the vaccine I was asked did you drive here' On my reply of yes' I was told, please wait in your car for 15 minutes') and NO ADVERSE EVENT (no adverse event) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT MONITORING ERROR (After the vaccine I was asked did you drive here' On my reply of yes' I was told, please wait in your car for 15 minutes') and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT MONITORING ERROR (After the vaccine I was asked did you drive here' On my reply of yes' I was told, please wait in your car for 15 minutes') and NO ADVERSE EVENT (no adverse event) outcome was unknown.            No concomitant information provided  Patient was interested to read this leaflet for two reasons. It started that Read all of this leaflet before you receive the vaccine. Patient was given it after receiving the vaccine. It said that during and after each injection of the vaccine, your doctor, nurse, or pharmacist will watch over you for at least 15 minutes. After the vaccine patient was asked if he drove to the vaccination center  On patients reply of yes patient was told to wait in car for 15 minutes. It seemed the vaccination center was not reading the same leaflet.  No treatment information provided
started out immediately has a circle diameter of a Nickle. It got bigger through the day and that night it was size of half dollar and then the next day it was the size  of the palm of my hand then the 3rd day it was even bigger and wraps around my triceps . It is hot, bright  red, each day it gets redder and bigger and misshaping my arm from the swelling, arm feels really heavy,  It melts an ice pack within minutes.
Headache, fever (max 101.8), generalized aches, discomfort and redness at injection site
Patient states they were fine for 3 days, then on 4th day they started having breathing issues, severe abdominal pain, unable to get out of bed for 4 days.  Made appointment with lung doctor, and sent patient to get  covid test, mri of lungs.
5/29/2021 Breathing Problem      DIB, pulse ox 68% on RA     Source of Information:  Patient and Available medical record   History of Present Illness:  This is a 72y.o. male with extensive pmh as mentioned below Hypertension D.m. Copd on home o2 chf  Cad  Sleep apnea  ckd and multiple other   presented to ed with cc of sudden onset of sob and chills which started night before the presentation and associated with body aches.paitent was requiring bi pap on arival and was hypoxic Patient receive both doses of covid vaccine. Work up in er shows elevated d- dimer aqnd cta was not done because of his elevated kidney functions. Patient was tested positive for covid and id and pulmonary were consulted. troponins were elevated and cardiology also was consulted. Recommendations form the consultants were noted
Flushing, dizziness, sweating and disoriented. Then he had an asthma attack. Was put on steroids. They helped minimally. Within the next few days he lost appetite, started hallucinating, lost continence and 17 days after his vaccination, he died.
The evening after receiving PREVNAR vaccine patient states she began having pain and redness at the injection site. She also experienced body aches, headache, fever and dizziness. Arm remains red and painful. Still has occasional dizziness.
Tuesday - Cold chills all day, body aches, headache.  Evening fever 101.1  took Tylenol to reduce fever and went to bed. Wednesday - body aches, diarrhea in afternoon.
Threw up; Stomach started hurting / Stomach cramps; Shivering; Loss of appetite; Nausea; Pain that went up the back of neck into the back of head; Slight headache / Pain that went up into the back of head; Off Balance; Felt weak; Shaky; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 72-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Concurrent medical conditions included asthma and arthritis.   On 23rd October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). In October 2019, 3 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced balance disorder, weakness and tremor. On 23rd October 2019, the patient experienced neck pain and headache. On 4th November 2019, the patient experienced appetite lost and nausea. On an unknown date, the patient experienced vomiting, stomach pain and shivering. On an unknown date, the outcome of the neck pain, vomiting, balance disorder, weakness, tremor and shivering were recovered/resolved and the outcome of the headache was unknown and the outcome of the stomach pain, appetite lost and nausea were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, headache, vomiting, stomach pain, balance disorder, weakness, tremor, appetite lost, nausea and shivering to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received dose of Flulaval vaccine in the left arm at around 10 am. Immediately after receiving the vaccine, the patient had pain that went up the back of her neck into the back of her head which lasted most of the day. Few days after vaccination, the patient had stomach pain and vomitting. Few days after this the patient threw up again and described that this time it was just clear liquid and mucus and again threw up on some unknown day last week from the date of reporting. The patient reported that, on the day of reporting, the stomach still hurts a little bit but not as bad. Three to four days after receiving the vaccine, the patient felt weak, shaky, and off balance. This symptoms occurred on and off a few times within a week of getting the vaccine. On the day of reporting, the patient stated that, now experiencing nausea, stomach cramps, and a loss of appetite and still had slight headache. The reporter consented to follow up.
L arm redness & induration-beginning within hours after shot-worst at 24 hours-improving by 48 hours measuring 5" x 5" - treated with ice, TYLENOL, BENADRYL.
dizzy; body ache; chills; arm was sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), LIMB DISCOMFORT (arm was sore), HEADACHE (headache), DIZZINESS (dizzy) and PAIN (body ache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for an unknown indication.     The patient's past medical history included Bipolar affective disorder since an unknown date and Depression since an unknown date.    On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced CHILLS (chills), LIMB DISCOMFORT (arm was sore) and HEADACHE (headache). On 22-Feb-2021, the patient experienced PAIN (body ache). On 25-Feb-2021, the patient experienced DIZZINESS (dizzy). On 24-Feb-2021, HEADACHE (headache) outcome was unknown. At the time of the report, CHILLS (chills), LIMB DISCOMFORT (arm was sore), DIZZINESS (dizzy) and PAIN (body ache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
pt recv vax;hearing test;eating dirt;going off by self,still maintaining eye contact, talking not sleeping;platelet drop;acted like could not hear;dx as autistic;
pt was given DT because mom reports pt was stiff in the playpen for 2 days p/vax;
Tdap IM Right deltoid localized angry red swollen to size of tennis ball. Site extremely sensitive to degree that it hurt to have a sleeve touch it. Site itchy. Had mild nausea, no vomiting, headache. No neuro-type symptoms, shortness of breath, or tachycardia. Redness extended down to elbow. Redness/swelling lasted 6-7 days.
This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 80 years adult female patient who received SHINGRIX for prophylaxis.  Concurrent medical conditions included post herpetic neuralgia (4 months after the shingles, post herpetic neuralgia for 2 months and she was in pain and it went into an itch for an additional) and shingles (history of shingles 5 years ago). On 7th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a month after receiving SHINGRIX, the patient experienced erythema of extremities, tissue puffing, itchy upper limbs and allergic skin reaction. On an unknown date, the outcome of the erythema of extremities, tissue puffing, itchy upper limbs and allergic skin reaction were recovered/resolved. The reporter considered the erythema of extremities, tissue puffing and itchy upper limbs to be related to SHINGRIX. It was unknown if the reporter considered the allergic skin reaction to be related to SHINGRIX. Additional details were reported as follows: Patient reported that she had a reaction after receiving the SHINGRIX vaccine which included muscle redness, terrible itch and puffiness. The patient visited her physician and he prescribed an ointment which helped her condition. She claimed that the itchiness and redness were on her whole muscle and the injection site was at her outer arm. The physician thought that she might had an allergy to something in the vaccine.  He described her condition as a topical allergic reaction. The patient's reactions lasted for two weeks after the vaccination. The patient had denied permission to contact their physician.
Swelling - warmth - tenderness at injection site. Some axillary ademopathes on side of injection.
4 days after vaccine started light headed; 4 days after vaccine had a lot of trouble remembering things; 4 days after vaccine started feeling tired; 4 days after vaccine started feeling nauseous; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 29Mar2021 at 05:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included celiac disease and allergic to gluten (just gluten due to celiac but it's very well managed). Concomitant medications included paracetamol (TYLENOL 500mg) taken 4 days later when symptoms started (06Apr2021) for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 14:00, the patient started to feeling tired, nauseous, light headed and had a lot of trouble remembering things. The patient still feeling that way 4 days after the onset of symptoms. The patient reported that she was unsure if related to vaccine but she knows one other person in the same situation, which she felt was enough to make her question. The patient wants to know whether the vaccine was safe to get her second dose if it was vaccine abs. The patient reported that she figured that she could just sleep it off abs be fine but its still lingering and memory loss part is worrisome. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of started to feeling tired, nauseous, light headed and had a lot of trouble remembering things not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
ADR, treatments, outcomes 79yo female with DM on prednisone at home developed a severe rash 24 hours after receiving the moderna vaccine. Patient has extensive skin rash and sloughing superficial venous involving extensive area on the back. Red blanching papules and patches on back, buttocks, legs, arms. Sparing face, hands and feet. Ears with some ulceration. Exfoliation and superficial ulcerations of hte buttocks. Nikolskly sign is negative. Information was shared with local burn center with clinically suspicion for Stevens-Johnson sx or TEN. Patient denies any fever chills. Hemodynamically stable wit no evidence of involvement - improving with prednisone and topicals. Thrush appears to be developing in the mouth today as well. Differential diagnosis: Symmetri, drug related intertriginous and flexural exanthema (previously bad bone syndrome) has been reported with COVID-19 infection but not with the vaccine. DRESS. Dermatomyositis rash flare after covid vaccine. Treated with prednisone 30 mg daily, halobetasol BID x2 weeks. Silver sulfadiazine, mupirocin BID.