chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a patient of unknown age. On a unknown date, the patient was vaccinated with the first and second dose of GARDASIL injection, (dose, frequency and lot # were not provided). On an unknown date in 2008 (administered between the dates of March 2008 and September 2008) the patient was vaccinated with the third dose of GARDASIL injection, (dose, frequency and lot # were not provided) which was invalid dose because the vaccine was stored incorrectly during that period of time. The patient was told that she needed to have her third dose of GARDASIL re-administered, because GARDASIL that was used for the third dose only, was warm, exact temperatures that the GARDASIL was exposed to was unspecified. No adverse effect reported. The outcome, action taken and causality were not provided. This is one of several reports from the same source. Additional information has been requested.
Sore throat; Stuffy nose; Runny nose; watery eyes; coughing; lost taste; Lost smell; Chills; Fever; Headaches; Left arm pain/left arm pain went away after three days; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), LACRIMATION INCREASED (watery eyes) and COUGH (coughing) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma (Respiratory asthma), Allergy NOS and Vegetable allergy (Allergic to carrots).    On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), LACRIMATION INCREASED (watery eyes), COUGH (coughing), AGEUSIA (lost taste), ANOSMIA (Lost smell), CHILLS (Chills ), PYREXIA (Fever ), HEADACHE (Headaches) and VACCINATION SITE PAIN (Left arm pain/left arm pain went away after three days). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; PARACETAMOL, PHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (THERAFLU COLD AND FLU) for Adverse event, at an unspecified dose and frequency and IBUPROFEN, PSEUDOEPHEDRINE HYDROCHLORIDE (VICKS ACTION) for Adverse event, at an unspecified dose and frequency. On 17-Aug-2021, VACCINATION SITE PAIN (Left arm pain/left arm pain went away after three days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), NASAL CONGESTION (Stuffy nose), RHINORRHOEA (Runny nose), LACRIMATION INCREASED (watery eyes), COUGH (coughing), AGEUSIA (lost taste), ANOSMIA (Lost smell), CHILLS (Chills ), PYREXIA (Fever ) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient stated that he experienced all symptoms and felt like a guinea pig.  Patient occasionally uses an Asthma Inhaler (unknown name) as concomitant medication.
Patient got a local reaction at the site of his flu shot, which he described as a wound. He happened to be visiting a dermatologist at a later date who noticed the wound on his arm. The dermatologist stated that it looked precancerous and she took a biopsy from the spot. The results are not known to the reporter at this time.
Huge visible lump on left side at the collar bone area.  Feels like a water balloon under the skin. Painful to touch. Also since the vaccination I have been urinating an unusual number of times.
Patient with a history of rash following Pfizer COVID-19 vaccine dose #2 developed a hypersensitivity reaction following dose #3. Patient reported self-medicating with cetirizine 10 mg PO approximately 10 minutes prior to arriving at the vaccination site. She arrived to the vaccination site on 9/24/21 at 4:55 pm to receive dose #3. Approximately 8 minutes post-dose, she reported facial itching, flushing and I was notified. I took the patient back to the exam room for further evaluation and gave her diphenhydramine 50 mg PO at 5:07 pm and called our medical director. At 5:21pm the patient reported feeling a burning sensation in her throat and she took own supply of famotidine 20mg PO. At 5:27 pm she reported itching extending from face to scalp in addition to itching on her tongue and abdomen and began coughing.  Patient was given epinephrine 0.3 mg IM and taken to the emergency department for further evaluation. Patient remained stable during transport to the ED and at 5:42pm the ED team took over her care  Other medical information: Allergy: latex (rash) ? the vaccination clinic does not use latex Chronic medical condition: asthma Home medications: albuterol, cetirizine, fluoxetine
Patient was accidently given only half of the vaccination, administered only the liquid portion and not the combination portion of HIB.
This case was reported by a nurse via call center representative and described the occurrence of nausea in a 20-year-old male patient who received BEXSERO (batch number 16D401, expiry date 28th February 2019). The patient's past medical history included thigh abscess. Concomitant products included BACTRIM, ZYRTEC and LEXAPRO. On 10th May 2018, the patient received BEXSERO (intramuscular). On 10th May 2018, less than a day after receiving BEXSERO, the patient experienced nausea, vomiting, headache and diarrhea. On 17th May 2018, the patient experienced bloating and abdominal discomfort. On an unknown date, the outcome of the nausea, vomiting and headache were recovering/resolving and the outcome of the bloating, abdominal discomfort and diarrhea were unknown. It was unknown if the reporter considered the nausea, bloating, abdominal discomfort, vomiting, headache and diarrhea to be related to BEXSERO. Additional information was received as follows: This case was previously reported to a doctor. The patient was immunized during a well check visit. During that visit and prior to the vaccination, the patient presented with an intermittent abscess on the thigh. In the morning, the patient received BEXSERO on right arm. Around noon, the patient called the office to report nausea, vomiting, diarrhea, and headache. About 1 week after receiving BEXSERO, the patient experienced bloating and abdominal discomfort. As a precaution, BACTRIM would be discontinued on the reporting day.
Active IgA nephropathy; Gross hematuria; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (Active IgA nephropathy) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.   LITERATURE REFERENCE: of gross hematuria following Moderna COVID-19 vaccine in patients with IgA nephropathy. Kidney Int. 2021     The patient's past medical history included Hematuria.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IGA NEPHROPATHY (Active IgA nephropathy) (seriousness criterion medically significant) and HAEMATURIA (Gross hematuria). At the time of the report, IGA NEPHROPATHY (Active IgA nephropathy) outcome was unknown and HAEMATURIA (Gross hematuria) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy kidney: abnormal (abnormal) IgA nephropathy. Among 25 glomeruli sampled, 1 was globally sclerotic. there was mild to moderate, diffuse and global, mesangial hyper cellularity. two glomeruli had segmental endocapillary hyper cellularity including infiltrating monocytes and neutrophils. one glomerulus with an incipient segmental scar contained an overlying segmental fibrous crescent. mild tubular atrophy and interstitial fibrosis involved approximately 10% of the cortex.. In 2021, Blood creatinine: 1.2 (High) 1.2 mg/dl. In 2021, Glomerular filtration rate: abnormal (abnormal) 87 ml/min per 1.73 m2. In 2021, IgA nephropathy: abnormal (abnormal) M1E1S1T0C0. In 2021, Immunology test: positive (Positive) 1 to 2+ granular global mesangial staining for IgA, C3, kappa and lambda. In 2021, Urine analysis: abnormal (abnormal) numerous red blood cells and no proteinuria.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered IGA NEPHROPATHY (Active IgA nephropathy) and HAEMATURIA (Gross hematuria) to be possibly related.    No concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-249638, MOD-2021-249637 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Local swelling, pain, within 3hours nausea, diaphoresis, myalgia, malaise.
On 4/7/21 I was extremely fatigue and had numbness on my left side. I never had any issues before getting vaccinated.
Female in her 60s received GARDASIL 9; No Adverse Event; This spontaneous report was received from a physician refers to a female patient of unknown age (reported as: in her 60s).  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, exact dose, route of administration and anatomical location were not reported) for prophylaxis (product administered to patient of inappropriate age). No additional adverse event (no adverse event).
ER note 11/21/2021:  Cough, body aches, congestion and right upper quadrant abdominal pain  -patient is found to be Covid positive.  She is febrile and tachycardic in the emergency department.  She states she has been taking Tylenol with the limited relief.  She was given ibuprofen for her fever and a small fluid bolus. EKG shows sinus tachycardia with no evidence of acute ischemic changes.  Her white blood cell count is minimally elevated at 14.2.  Hemoglobin, hematocrit and platelets are all found to be normal.  Patient is hyperglycemic at 375, however no evidence of DKA.  While her liver enzymes are minimally elevated with an alkaline phosphatase of 179, and AST of 103 and an ALT of 93 with a normal bilirubin patient does have a history of having elevated liver enzymes and had a remote cholecystectomy.  Lactic acid is elevated at 3.4.  Troponin is normal at 8.9.  Ferritin is elevated at 867.8.  Urine does not show any evidence of urinary tract infection.  Upon arrival to the emergency department her pulse ox was in the low 90s.  With ambulation it did stay above 88%.  She was resting in the room awaiting her test results when it did dip to 87%.  It then returned to the low 90s without oxygen administration.  Patient was given dexamethasone for treatment.  Bilateral patchy infiltrates are seen on the x-ray.  Patient's D-dimer is minimally elevated at 594.  Low suspicion for PE at this time.  Discussed with Dr. who is agreeable to admit the patient. At the time of this VAERS entry, the patient is still admitted to the Adult Care Unit.
redness in the IS; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (redness in the IS) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.  On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 23-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 05-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness in the IS).   At the time of the report, VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (redness in the IS) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Tenderness, redness, and swelling to injection site of right upper arm and left upper arm.
ball under the skin; week later she has a palm size area of redness; warmth; Area of injection felt too down for deltoid- sounds like it was given in subcutaneous site; This spontaneous case was reported by a physician assistant and describes the occurrence of SKIN MASS (ball under the skin), ERYTHEMA (week later she has a palm size area of redness), FEELING HOT (warmth) and PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Area of injection felt too down for deltoid- sounds like it was given in subcutaneous site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Area of injection felt too down for deltoid- sounds like it was given in subcutaneous site). On an unknown date, the patient experienced SKIN MASS (ball under the skin), ERYTHEMA (week later she has a palm size area of redness) and FEELING HOT (warmth). On 22-Mar-2021, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Area of injection felt too down for deltoid- sounds like it was given in subcutaneous site) had resolved. At the time of the report, SKIN MASS (ball under the skin), ERYTHEMA (week later she has a palm size area of redness) and FEELING HOT (warmth) 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 relevant concomitant medications were reported. No treatment details were provided.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
After patient received immunization with Gardasil, the patient began to shake and passed out for about 10 seconds.
rash on her legs; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 2N9CT, expiry date 18th March 2022) and (batch number 4MT3A, expiry date May 2022) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 19th September 2020, 24 hrs after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist was reporting a patient describing a rash on her legs beginning 24 hours after receiving her first dose of Shingrix. The pharmacist reported the patient's rash has not recovered and the patient will seek medical advice from her doctor.  The reporter did not consent to follow up.
The vaccine itself was well tolerated with just some injection site pain and minor body aches the next day. Then, last night I took miralax and had an allergic reaction to it. I have taken miralax in the past and I have tolerated it well. This is my first time taking miralax since the Covid vaccine and I suspect it is related since there is polyethylene glycol in the vaccine. About 10 minutes after taking the miralax (in water) I had chest and throat tightness, rash on my chest and face, severe facial flushing, and itching. After that began to resolve I had chills, rigors, and aches in every joint. I had not eaten or consumed anything else and had no exposure to any other potential allergens.
My arm hurt/ my whole left arm felt like someone took a bat to it; my left rib cage felt like I had broken ribs for a day or two.; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and experienced pain in arm refer case US2021AMR160228) and COVID-19 VACCINE (received both doses of on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm and rib pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the rib pain was recovered/resolved.   It was unknown if the reporter considered the pain in arm and rib pain to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself. The age at vaccination was not reported. Historical medication included first dose of Shingles and both doses of COVID-19  vaccines. The patient received the second dose of Shingles vaccine and his/ her arms started to hurt worse than the two Covid shots and the first shingles shot. The patient's whole left arm felt like someone took a bat to it and the left rib cage felt like he/ her had broken ribs for a day or two. The patient reported that everyone's symptoms may vary or may not be symptomatic at all. He had also heared the second one was a little rough, for some. But he would still take the odds of 97% coverage with the vaccine over getting shingles itself.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR161077:Invalid case US-GLAXOSMITHKLINE-US2021AMR160228:same reporter
Severe abdominal cramping & pain for 48 hours.  Severe vomiting & diarrhea for several hours.  No specific treatment
No additional AEs; PROQUAD was administered to a patient on 01/30/2023 after a temperature excursion.; This spontaneous report was received from medical assistant and refers to a 5-year-old patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 30-JAN-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) subcutaneous injection, lot # W024972, expiration date: 05-FEB-2024, administered for prophylaxis (anatomical location, and route of administration were not provided), after a temperature excursion (product storage error). Administrated measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 14 degrees Fahrenheit (F) up to 46 F (37 F) for 4 hours, no previous temperature excursion was reported.  There were no adverse events reported (no adverse event).
I have never had a flu shot before but thought with COVID, it would be smart to get one. I did have the flu in Feb 2020 for the first time in over 20 years.  Oct 8, 2020 Within 20 minutes of receiving the vaccine I felt flushed and a bit dizzy. By the end of the day I was very fatigued. Oct 9 felt fatigued and noticed a red patch at the shot site that was very tender. Oct 10 shot site is size of baseball and red. Had "episode" where I felt flushed, jittery and thought I was going to pass out. Oct 11 symptoms worse, almost passed out while in backyard and had to sit on the ground until I could get help. Oct 12 Almost passed out at work, was very red in the face and thought I might be having something happening with blood pressure. Called DR and was told to get a COVID test. Bought a BP cuff and BP was 165/80 and heart rate was 45. This continued for a week. I went to a Urgent Care clinic and was told to see a cardiologist asap.  Pulse continued to be very low and BP high. This has never happened to me. I have never had high BP and my heart rate has been in the 50's-60's over the last couple of years but not considered a problem.  Cardiologist (10-20, 2020) ran tests, put me on a BP medication and concluded that I needed a pacemaker as my pulse was in the high 30's-50 range and not getting better. The BP medication helped lower my numbers but my heart rate stayed low. No one can explain why my heart rate was so low. With the fatigue and dizzyness I was unable to work or do everyday tasks for this entire time.  10-26 after heart echo the cardiologist called to say my heart looked fine but I needed a pacemaker. The process started. 11-9-2020 Pacemaker insertion. Since the pacemaker has been installed I feel wonderful, back to my full functioning self. No one believes that the flu shot caused this but I know in my body that something happened. The tingles and flushing and dizzyness hit me as soon as I got off of the table after the shot. Prior to the shot my BP was 120/80 and heart rate in the 60's.
I have had severe diarrhea ever since the shot.  Nothing has changed in my diet or lifestyle.  I have had no other symptoms other than nauseas the first couple days
This spontaneous report was received from a regulatory authority (AU-TGA-0000470983) and refers to a 70-year-old male patient. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On an unknown date the patient was vaccinated with Zoster vaccine live (ZOSTAVAX) (exact dose, dose number, lot #, expiration date, route of administration and anatomical location were not reported) for immunisation. On an unknown date the patient experienced concomitant disease aggravated. The consumer stated, that previously, quiescent Herpes Simplex infection became quite active over a 9 to 12 month period. Rather than skin eruptions appeared to effect the bladder/urinary tract system. Comments were made to General Practitioner (GP). After more than 30 years, wife was finally infected (without the patient's skin lesions appearing). The patient was referred to urologist without results (or interest) due to blood in seminal fluid. The outcome of concomitant disease aggravated was reported as recovered/resolved. on an unknown date.  The causality assessment between the event and Zoster Vaccine Live (ZOSTAVAX) was reported as possible.
PATIENT PRESENTED WITH A RASH ABOUT 1 INCH WIDE AROUND THE CIRCUMFERENCE OF HIS ARM AROUND THE INJECTION SITE. IT WAS NOT BOTHERING THE PATIENT IN ANY WAY.
low grade fever x 8hr;swelling & redness of approx 4in x 4in upper lt arm;circular area w/some trailing red areas on medial side of arm;warm to touch;
Pt presented w/Ataxia, areflexia; Dysarthria; Ophthalmoplegia; paresthesia weakness, ptosis; buphthalmos working diagnosis is Miller  Fisher Syndrome a type of Guillain Barre Syndrome. As per annual follow up report 68 yr old male admitted for increasing ataxia, distal paresthesias and opthamoplegia, arreflexia, vocal cord paralysis.