chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Rash at the injection site; Itchy injection site; Really warm injection site; Sore injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE WARMTH (Really warm injection site) and INJECTION SITE PAIN (Sore injection site) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN & MINERAL for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced INJECTION SITE PAIN (Sore injection site). On 15-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itchy injection site) and VACCINATION SITE WARMTH (Really warm injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE WARMTH (Really warm injection site) and INJECTION SITE PAIN (Sore injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Approx. 15 hrs. after vaccine, i woke up with severe fatigue, coughing and difficulty breathing. since the shot, I'm still coughing severely and still have difficulty breathing .
A 51 year old female pt, with no significant pre-existing medical conditions, received an IM injection of Fluzone, lot number U1826AA, in the left deltoid on 02/Nov/2005. Later that evening, she developed numbness in the left side of her face and left top part of her head. No treatment was recommended. (OMIC)
This spontaneous report as received from a physician refers to a patient of unknown age and unknown gender. The patient's current conditions and medical history was not reported. On 06-SEP-2001, the patient was vaccinated with first dose of an unknown hepatitis B vaccine (manufacturer unknown) (dose, frequency, lot # and route of administration were not reported). On 04-DEC-2014 (reported as now), was in the reporting physician's office to receive a second dose. No adverse symptoms were reported. No product quality complaint (PWC) was reported for hepatitis B vaccine (manufacturer unknown). Additional information has been requested.
Severe headache, nausea, fatigue, dizziness, felt pressure in head and sinuses, felt like my nose was bleeding but it wasn't but i could feel something draining down.
Vaccine given beyound 30 days of refrigeration period; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concurrent medical conditions included Paracetamol.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, the patient experienced PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period). On 27-Aug-2021, PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PRODUCT STORAGE ERROR (Vaccine given beyound 30 days of refrigeration period) to be not related.    No concomitant medication was reported.  Allergies to food medications and other products.  Patient received the injection in deltoid.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-313106 (Patient Link).
Right upper quadrant pain, just underneath the lower right side of sternum/ribs, feels like a sharp cramping or squeezing sensation, intermittent but daily
Parent wrote the wrong age on the consent form. The correct date of birth is written on the form but the parent wrote that the child was 12 instead of 11. Age was not verified and child received the vaccine at age 11. Parents were notified and told they cannot get child their second dose until they are 12 years old.
Patient was given this vaccination by mistake.  The nurse involved gave him to wrong one - he did not need it as the series was complete.  He reacted the last time and reacted the same again.  Swollen entire arm (shoulder - wrist).  Redness, painful, hot to the touch.  Motrin and Benadryl were given again to decrease pain.
I just wanted to report my reaction to the shingles vaccine, which was stronger than I had thought possible from the nurse's advice at the time. In fact I had much greater side effects than I've ever had to a shot, with acute symptoms over five days and milder symptoms persisting today, eight days later. The list: significant swelling (swollen bright-red area radiating 2+ inches from injection site) and pain in the injected arm first three days, sleeplessness and malaise over five days with mild headache on fifth day, gradually reduced swelling and return of sleep on days 5-8. Now the area is gradually less red but still tender and itchy.
Swollen tongue and lips, tight throat with coughing and wheezing.  Injection completed at approximately 1600 and reactions started about 4 hours later.  Gave two benadryl tablets which helped swelling but throat still feels tight.
Varivax vaccination given 01/14/2000. Came to clinic 11/29/2001 with chicken pox.
Patient is 10 years old and received 20 mcg/0.2 mL of the adult formulation (12 + age range). Patient received double of the intended dose due to use of the incorrect product.
Hospitalized 7/7/22-7/11/22 dyspnea, hypoxia, fever with chills, body aches, SOB, sore throat, respiratory failure, AKI, PNA,
weakness; sore throat; shortness of breath; Feel achy; muscle ache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), PAIN (Feel achy) and MYALGIA (muscle ache) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O25B21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included GLUCOSAMINE for Joint pain.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced ASTHENIA (weakness), OROPHARYNGEAL PAIN (sore throat), DYSPNOEA (shortness of breath), PAIN (Feel achy) and MYALGIA (muscle ache). At the time of the report, ASTHENIA (weakness) and MYALGIA (muscle ache) had not resolved, OROPHARYNGEAL PAIN (sore throat) and PAIN (Feel achy) outcome was unknown and DYSPNOEA (shortness of breath) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also includes vitamin supplements.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-067884 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-067884:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 27Sep2021 as dose 3 (booster), single (Lot number: 30145ba) at the age of 71 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypothyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; CRESTOR. Vaccination history included: Covid-19 vaccine (Dose manufacturer unknown), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Other medication in 2weeks: Yes, antiviral details [product=COVID 19 Treatment, brand paxlovid, treatment start date 09May2022, treatment stop date 10May2022, lot number 6A1513, indication Treatment of COVID-19. Adverse event: Strong metallic taste in mouth, nausea, diarrhea, Adverse event start date 09May2022, Adverse event start time 06:00 PM, If patient recovered : Recovered, Adverse event stop date :10May2022, If treatment AE :No and Device timestamp: 11May2022.  No follow-up attempts are possible. No further information was expected.
I developed a red, hot, itchy site on my left arm, near the injection site. I also have a tattoo on my upper torso on the left hand side. It became raised and very itchy. Throughout the week, the red area became larger and larger. I went to an Urgent Care place because my doc?s office said I needed to be seen right away. I was diagnosed with Cellulitis on the 29th and prescribed an antibiotic and a cream. By Friday, Sept 1st, (6 days after the injection) the area had spread from just below my shoulder down to just above my elbow and 75% around the width of my arm, very hot and itchy.  Sept 1 I went to my general practitioner who prescribed a different antibiotic and prednisone. With the prednisone, the heat and redness finally lessened, but the area is still faintly red and swollen.
Patient states noticing red bumps that look like bites along back, thighs, and now going down legs toward feet.  Does not look like in a particular pattern.  States they are not itchy but starting to have some pain.  Didn't notice them until the morning after the shot.  Doesn't look like shingles (not following dermatomes and not one side of trunk nor blistering) and patients states wasn't out where could have chiggers nor believes it is from bed bug bites.  Patient states no having reactions to flu shots in past.  Has not had any new medications, no changes to clothing/detergent/soap.  When they talked to dr they advised pt to use hydrocortisone and observe for now and follow up if they are still there.
got starched by a squirrel; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANIMAL SCRATCH (non-serious), outcome "unknown", described as "got starched by a squirrel".  Additional Information: The patient was scheduled to receive the second dose on 09Apr2021. He got starched by a squirrel and was going to the emergency room tomorrow (date unspecified) to receive the rabies vaccine. He wanted to know if the two vaccines can be administered close to one another and what's the longest interval between two doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
A non-serious spontaneous report of administration of expired vaccine was received from a registered nurse/health professional concerning a four-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. The product expired on 29-Mar-2010. On 31-Mar-2010, the patient received expired H1N1, Intranasal for an unknown indication. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable and the event was considered to be resolved.
Narrative: COVID infection following COVID vaccine series 04/29 Janssen, dose #1 08/27 COVID swab, result: detected 08/27 Pt cc: cough, fatigue, rhinorrhea, sore throat, exposure: family 08/27 SARS-COV-2 Variant Sequencing result: pending 08/27 pt admit to ED cc: cough dx: PUI LOS: 1 day
I woke up around 3am short of breath. I, called 911 they took me to the hospital. They diagnosed me with collapsed of the left lung. Pneumothorax. I spent 5 days in intensive care. After surgery.
A nurse reported that 4 pt's experienced hoarse voice or cry a few days post vax. No further information was available at the time of this report. Additional cases will be created upon receipt of individual pt specific information. A follow up report received 10/25/2001 adds: Follow-up info received on 08/03/2001 frmo the Center for Biologics Evaluation and Research (VAERS ID #172698) revealed the patients also received DTaP (manufacturer unknown) vaccine.
This spontaneous report as received from a 75 year old male consumer regarding himself. Patient concurrent condition included gastroesophageal reflux disease, herpes and sinusitis. The patient's medical history included thyroid removed. On 18-DEC-2006 the patient was vaccinated with ZOSTAVAX dose 1. Concomitant therapies included ACYCLOVIR, METHOCARBAMOL, DICLOFENAC, GABAPENTIN, CARVEDILOL, ATORVASTATIN, SYNTHROID, PRILOSEC and FLUTICASONE. The patient stated that the vaccine was left out at room temperature before administration. On 25-JAN-2013 the patient experienced sore muscle around his neck which he felt he recovered from one month later (approximately February 2013). On 01-NOV-2013, the patient experienced a sore muscle around his neck pain and burning sensation which he described as a bee sting or bad sunburn. The patient was treated with CAPZASIN HP (unspecified dose and frequency) and the patient reported that CAPZASIN burned his skin. The patient was also used BIOFREEZE as a treatment for the events. On an unknown date the patient also underwent kidney function test, GFR test and VAP test- results not provided. The patient sought medical attention and visited the physician. The outcome of burning sensation which he described as a bee sting or bad sunburn and a sore muscle around his neck again was reported as not recovered/not resolved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Lot number: EN6208), in left arm, on 01Apr2021 as dose 2, single (Lot number: EW01503), in left arm and on 02Dec2021 as dose 3 (booster), single (Lot number: FH8027) at the age of 61 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing); "enlarged prostate" (unspecified if ongoing); "boarder line diabetes" (unspecified if ongoing), notes: boarder line diabetes; "Known allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin. Concomitant medication(s) included: FAMOTIDINE, start date: Jan2009; ATORVASTATIN, start date: Jan2010, stop date: 18Jul2022; MYRBETRIQ, start date: Jan2016, stop date: 18Jul2022; TAMSULOSIN, start date: Jan2016, stop date: 18Jul2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of covid-19.  Clinical Course: Patient received other medication in 2 weeks. Anti viral details product=COVID 19 Treatment, brand=Plaxovid, Treatment start date=19Jul2022, Treatment stop date=24Jul2022, Indication=Treatment of COVID-19.Device timestamp: 29Jul2022.
Vomited within thirty minutes of receiving Moderna vaccine. Diarrhea began and lasted for one day.
Information has been received from a physician concerning a 5 year old female who on 07-MAR-2001, was vaccinated with subcutaneous Varivax. On 08-FEB-2006, the patient experienced mild breakthrough varicella. Subsequently, the patient recovered from  mild breakthrough varicella. Additional information has been requested.
Anaphylaxis; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis) (seriousness criterion medically significant). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported. Treatment information was not provided.   Very limited information regarding this event has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Could not close eye and mouth would not move; A spontaneous report was sent by a consumer who was a 68-year old, female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced an episode of "could not close eye and mouth " and was diagnosed with Bell's palsy.  The patient's medical history is unknown. Concomitant medication include Metformin 500 twice in a day, Losartan 50 mg, Atorvastatin, valacyclovir 1000 mg thrice in a day, Hydrochloride 12.5 mg, Prednisone.  On 18 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection.   On 09 Mar 2021, the patient reported she noticed her eye would not close and her mouth would not move. She has no events prior to this date. The patient went to the emergency room and was prescribed valacyclovir 1000 milligrams and prednisone 60 milligrams. At the time of this report, the patient reported she was feeling fine and her speech was improving, but her eye still would not shut.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event of Bell's palsy, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
The day after recieving the vaccine he noticed a rash around the vacination site. He doesn't report any itching. He has reached out to his provider.
Fainted after varicella, Tdap, HPV and meningo. Had not eaten since 8am. Vaccines given at 4pm.
Fatigue, body aches, initially, June 29, 30th. Then fever and respiratory difficulty July 6 and 7th.  Cough on July 8th, then labored breathing on July 10th, went to the ED.
After 2-3 days, suffered fever, swollen glands, cough, nasal congestion. After a day or 2, beginning to feel better. Received flu shot alone before with no issue.
Patient was administered the incorrect dose required to complete the series. Pt received Pfizer 6 month to 4 years old vaccine instead of 5-11yr vaccine. Pt had no adverse reaction to the vaccine administered after waiting in office for 15 minutes.
Pt reported adverse muscle pain in (R) arm that became significantly worse the day after PNEUMOVAX was received. Pt. states that the pain has not been relieved from heat, topical analgesics or oral analgesics (10/13/11).
I have painful swollen glands under my neck area. I went to my primary doctor, ran a cbc and came back negative but my glands are painful, mostly on the right side where the vaccine was administered.
Sore throat; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route, administered in left arm on 25Feb2021 at 13:30 as Dose 1, Single (at the age of 45-year-old) for Covid-19 immunization at workplace clinic. Medical history included covid-19 prior to vaccination. The patient had no known allergies. The patient had received other medicine (unspecified) within two weeks of vaccination. The patient had no received other vaccine in four weeks prior to vaccination. The patient was not tested Covid post vaccination. On 26Feb2021 05:30, the patient experienced sore throat. AE did not resulted in emergency room/physician visit. The patient had not received any treatment medication for resulted event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
Came in 8/6/08.  Complained of feeling hot the night of 8/5/08.  Went to sleep, woke up hot, hives over entire body.  Came into our office at 11:30AM 8/6/08 vitals: pulse 120, resp 20, temp 101.2.  Patient was short of breath, weak, fatigue, itchy hives over entire body.  Patient had difficulty speaking and was sent to the E.D.
2/25 early AM severe left side chest pain. 4/1 rash on back Grover's Disease, 5/22 extreme ankle pain swollen and red foot for 24 hours, 5/31 extreme lower back pain for 12 hours. Unusually Fatigued, sad, and lifeless.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received vaccine but did not received other medications in 2 weeks. Treatment started on 28Aug2022 and stopped on 01Sep2022 for treatment of COVID-19. Lot number and dose number was unknown. The patient had no known allergies.  The information on the batch/lot number for (BNT162B2), has been requested and will be submitted if and when received.
Mom reported that patient felt pain, warmth and swelling at the injection site within the hour he had a fever of 101. Fever of 102.8 on next day with puffy swelling from shoulder to elbow.
Left arm numb 15 minutes after shot.  Pain in left arm, upper back, shoulder blade, left armpit and into left side of chest.  Pain across shoulder blade extended to spine and up neck.  Had general, all over headache.  Chills, runny nose, nausea, fatigue and loose bowel movements.  Neck/thyroid/goiter area - neck felt swollen.  Sunday 2/28 into Monday 3/1 - joint pain, i.e., toes, ankles, knees, hips, elbows, arms.  Monday, March 8th, notice left arm felt like sleeve rubbing my skins.  At evening shower, notice large, redden area that felt swollen and hot to touch at injection site.  As of Saturday, March 13th, still have pain at injection site, cap of left shoulder and left armpit, and still have fatigue and loose bowel movements.