chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vial was initially stored in the refrigerator Jun 20 2022; receiving doses after its beyond use date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator Jun 20 2022) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator Jun 20 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (receiving doses after its beyond use date) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator Jun 20 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  Total 4 doses from 1 vial were administered to 4 patients. The vial was initially stored in the refrigerator on Jun-20-2022. The vial did not undergo any temperature excursions              No treatment information was provided by the reporter
On Tuesday, 11/19 about 10 pm, I started feeling some discomfort in my left breast.  The next morning, I was fatigued, had a headache, and woke up with an elevated basal body temperature (I'm normally between 96.0 and 97.5 in the mornings, but ran at 98.2. Not a fever, but enough for me to think it was odd), and some discomfort in my left breast.  By the afternoon, part of my breast was red and warm to the touch.  My temperature was still in the normal range at 98.7 (I checked since I work in a hospital and wanted to make sure I reported any illness quickly).  I went to the ambulatory care center and was diagnosed with mastitis of the left breast and prescribed cephalexin 500 mg capsule QID x10.  After 7 doses, I am feeling better and the tenderness, discoloration, and warmth are gone.
Information has been received from a medical assistant concerning a 68 year old male who on 15-OCT-2008 was vaccinated with VARIVAX (Oka/Merck) 0.5ml IM.  But the patient should have received ZOSTAVAX.  No adverse effects noted.  Medical assistant reported all VARIVAX (Oka/Merck) she administered were given IM.  Telephone follow up information has been received from the medical assistant.  She indicated that the person who orders the vaccines put the vaccines put the vaccine in the wrong place, leading to medication error.  The office has taken measures to prevent this type of error in the future.  Additional information is not expected.
-Swelling, redness, itchiness at site of injection occurring after injection - noticed it 10/12/10
the patient had developed cervical dysplasia; Information has been received from a physician via a company representative, referring to a female patient of unknown age. Information of concurrent condition, medical history and concomitant therapy was not provided.   On an three different unknown dates, the patient was vaccinated with all three of her hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, lot# and expiration date were unknown) for prophylaxis.    On an unknown date, the physician learned from the patient's husband who was also a physician that the patient had developed cervical dysplasia and had to get a conization. The outcome of cervical dysplasia was unknown. The relationship between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was not reported.
FEVER, CHILLS, STOMACH PAIN, DIARRHEA, WITH 3RD COVID VACCINE DOSE
(R) thigh local reaction. 2cm x 1cm swelling and redness. BENADRYL given. Site monitor. Improved over next 12 hours.
The day after the 2nd dose, I was experiencing headaches and fatigue. After resting the day, I felt better in the evening with a slight headache. About 8:30 pm.  My right arm and hand began to go numb, then my entire left side.  At first I thought it was just "falling asleep" feeling, and then I could not move that side of my body for about 10-15 minutes.  I was seated and called for my husband, who  had me move my fingers, which I could do, I just could not lift my right arm or right leg.  It was almost as if my muscles had stopped working on that side of my body, which is the opposite side I had my injection on.  I have NEVER experienced anything like this before.  I was contemplating going to the ER, but not knowing how I would get to the car. I had no speech or facial problems, so I just sat for a bit.  As we were getting ready to leave, the symptoms disappeared  almost as quickly as they appeared. It was extremely scary. I am glad I was not driving. Perhaps, we should be told not to drive for 24-48 hrs.
Swelling from shoulder to elbow and into armpit.  Very red, very had and painful.  chills, general achiness.
Swelling and redness of left arm from shoulder to past elbow, Swelling of left side of face, dizziness, severe headache, nausea and vomiting, elevated pulse 143 at rest, lowered oxygen 94%, elevated BP 163/112, chest pain and tightness, muscle and joint pain throughout body, stomach pain
Big patch; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of patchy rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced patchy rash (Verbatim: Big patch). The outcome of the patchy rash was not reported.   It was unknown if the reporter considered the patchy rash to be related to Shingles vaccine.     It was unknown if the company considered the patchy rash to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 08-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that luckily, he/she received Shingles vaccine. The patient stated that when he/she received Shingles vaccine it was not very big patch. Follow-up would not possible as no contact details were available.
Chills; This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 88-year-old male patient who received Herpes zoster (Shingrix) (batch number 5KK99, expiry date 29th October 2021) for prophylaxis.   On 22nd October 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 9 days after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left deltoid. The patient experienced chills about 9 to 14 days after receiving the vaccine. The patient again reported second episode of chills around 15th November 2019 which lasted for 2 to 3 days. No additional information was provided The reporter consented to follow up.
Major draining of sinuses with no warning - was a constant stream of fluid running down back of throat. Hoarseness next day and then full blown sinus infection and draining into chest which resulted in asthmatic response and coughing. Started taking Motrin and used ProAir inhaler - then started Prednisone and antibiotics. Was sick for about 2 weeks. Was tested 3 times for Covid with 3 different types of tests to make sure it was not Covid
Patient had generalized itching all over her body, not just in the injection site.  No rash and no anaphylaxis symptoms are present.  Patient had immunization on 3/31/21 at 1:31pm and onset of itching was at approximately 9 am the following morning.  She also had light nausea and light fatigue and a sore arm but it wasn't severe.  Patient did not seek medical treatment at time of reporting and was planning to manage itching with benadryl.
Information has been received from a RN concerning a 59 yr old male with neck squamous cell carcinoma, metastases to lung and a history of left upper lobe lobectomy. On 11Oct05 the pt was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 649697/1038P). Concomitant suspect therapy included an unspecified influenza virus vaccine. On an unspecified date, the pt complained of a scratchy throat and cough after vaccination. On 14Oct05 the pt was treated for wheezing and a worsening of cough. The pt was ordered sulfamethoxazole (-) trimethoprim (Bactrim), codeine phosphate (+) promethazine hydrochloride (Phenergan with codeine) and an albuterol inhaler. It was reported that the pt was normally dyspneic. Several days later, the physician added fluticasone propionate (+) salmeterol xinafoate (Advair) inhaler. The pt was not getting better and he was started on oral prednisone. On 25Oct05, the nurse contacted the pt and it was reported that he was feeling better. At the time of this report, the pt was recovering from the events. Additional information has been requested.
Chills, chest pressure,  fatigue, body aches, headache, fever, lingering headache and spinal, neck and shoulder aches and loss of appetite. 48 hours from first symptoms almost fully recovered. First symptoms came on 10-11 hours after vaccine. I was active all day after an am vaccine. Evening I was hit by the vaccine freight train.
Fever - began around 0500 the day after my second injection Severe fatigue - began 2 hours after my injection Muscle aches - began around 0500 Rigors - began around 1200  Treated with ibuprofen and sleep Symptoms resolved by the morning of 1/13 at 0700
Boostrix and Infanrix on the same day; Received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-year-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) (batch number MY5G5, expiry date 31st January 2023) for prophylaxis.   On 23rd February 2022, the patient received Infanrix, Infanrix Pre-Filled Syringe Device and Boostrix. On 23rd February 2022, unknown after receiving Infanrix, Infanrix Pre-Filled Syringe Device and Boostrix, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a dose of Boostrix and Infanrix on the same day, which led to overdose. The patient received Infanrix at the age of 12 years, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
A wave came over me that felt like I was going to die, or at least pass out. motor skills were impaired, became drenched with sweat and then got the shivers. The worst part only lasted about 15 minutes but it scared the shit out of me. felt like crap the rest of the day, super fatigued. Slept well last night but still feel like I could sleep for another 10 hours. Not quite thinking clearly either.
Pt has no known allergies. Got flu shot last year without any issues. 30 seconds after giving shot, pt bleed a little and little swelling occurred right away around site. Monitored for 15-20 minutes no symptoms other than swelling. Given 10ml of diphenahydramine as patient requested. No other symptoms.
Began with a headache around 10:00am 4/19/07. Presented to health room at school with Temp. 101 and headache at approx 2:30pm.
Patient did make us aware he was prone to vasovagal reactions prior to receiving vaccine. Approx 5 minutes after administering vaccine patient began to experience dizziness, clammy, fainted. Within 10 minutes patient was alert and aware or surroundings and expressed feeling better and drank a bottle of orange juice. He did stay longer than the recommended 15 minutes and confirmed he was ok to drive himself home.
headache/progresses to bad headache after a week; dizziness; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 06Mar2021 at 12:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. The concomitant medication included High blood medicine and ibuprofen (MANUFACTURER UNKNOWN).Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to COVID vaccine. On 08Mar2021 at 04:00, the patient experienced headache and then headache progresses to bad headache after a week. On an unknown date in Mar2021, (last week as reported) the patient had dizziness when he moves, the patient still had and reported that he was not able to report to work. The adverse events resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measure  taken as a result of the event headache included ibuprofen (MANUFACTURER UNKNOWN) taken three times everyday. The clinical outcome of the event headache/progresses to bad headache after a week and dizziness was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Presented to clinic one day after immunization with fever/pain - treated with IV antibiotics-Temp 38 degrees, arm pain 7 on scale of 0 -10.
shingles; This spontaneous report was received from an attorney and refers to an elderly, currently 71 years old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant medications and medical history provided. On an unknown date, the patient was prescribed zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot# and expiration date were not reported) by a healthcare provided for long-term prevention of shingles and zoster-related conditions. On an unspecified date in 2014, the vaccine was administrated by a pharmacist.  On an unknown date, the patient experienced shingles, which was treated by a healthcare provider.  The outcome of the event was unknown.  The reporter considered herpes zoster to be related to zoster vaccine live (ZOSTAVAX).
Initial report received from health authority (reference number 267777) via CSL biotherapies on 22 Jun 2010: This patient received two doses of RABIPUR (batch number unknown). After each vaccination, the patient presented with brief periods of self limiting and distractible period of depersonalisation. The patient felt dissociated from arms and legs. The patient also presented with mild occipital headache. There were no focal neurology signs or symptoms related to intracranial pathology. On 04 May 2010, the patient recovered from the events.
Information has been received from a healthcare worker (certified medical Assistant (C.M.A)) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 03-FEB-2015, the patient was administered with a dose of improperly stored ZOSTAVAX (lot#, expiration date and dose not provided), subcutaneously. No adverse effects were reported. This one of several report received from the same source. Additional information has been requested.
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not specified. On 14-APR-2015, the patient was vaccinated with improperly stored (temperature excursion: 32 F, time frame: 4 days) GARDASIL lot # J013277, expiry date 06-AUG-2015 (dose, strength, route, dose number, vaccination site unspecified). There was no previous temperature excursion. No adverse effects were reported. Product quality complaint (PQC) was not reported. Additional information has been requested.
headache; This is a spontaneous report from a contactable pharmacist. A female patient in her 60's (5-decade-old female patient) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. Medical history included hepatitis c from an unknown start and stop dates. The patient experienced headache on an unspecified date. The reporter stated the patient reports that the headache has lasted for 10 days and has not subsided, and patient is concerned whether the headache is related to the new medication or the Pfizer BioNTech COVID-19 Vaccine. The reporter stated she consulted the Prescribing Information for the Hepatitis C medication and it states that severe headache accounts for 10% to 20% of reported side effects. The adverse event was considered as non-serious. The outcome of the event was reported as not recovered.  Information on Lot/Batch number requested.
Developing an unusual sense of smell of metal mixed with formaldehyde and vinegar since yesterday. Smell is intermittent and lasts for about 5-10 seconds.
A report has been received from a Pharmacist concerning a 59 year old, female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT started on an unknown date. The pharmacist reported that they inadvertently administered FLUMIST QUADRIVALENT to a 59 years old patient which started on 04-Nov-2013. The outcome of the event of inadvertently administered to a patient who was 59 years old is unknown. The report was considered to be non-serious by the reporter.
Patient admitted to the hospital with acute respiratory failure due to asthma exacerbation and bronchitis. Symptoms presented as worsening dyspnea, wheezing, cough and fever, as well as hypoxia. She was admitted and treated with steroids and azithromycin. Hypoxia, cough, fever and wheezing resolved and she is discharged home to complete course of azithromycin, prednisone taper and duonebs. ED visit to hospital admission within 6 weeks of receiving the COVID vaccine.
contracted measles-rash-fever, 3 days;soaking in actibath & calamine;
it hurts; Rash; itches all on my arm, all my body itches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 65-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date 24Aug2021 05:00 (Lot number: EW0169) at the age of 65 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN.  The following information was reported: RASH (non-serious) with onset 05Sep2021, outcome "unknown", described as "Rash"; PRURITUS (non-serious) with onset 04Sep2021, outcome "unknown", described as "itches all on my arm, all my body itches"; PAIN (non-serious), outcome "unknown", described as "it hurts".  Additional Information: No investigation assessment. Prior vaccination (Within four week): Consumer stated, I have not received the vaccination for anything for long time except the COVID. Medical history related to adverse event: Consumer stated, I don't have any physical blood problem, I don't have anything like that. On the 4th I would say itching a little bit and on 5th I would say itching some more and then tonight my whole body itches and I got a rash.   Follow-up attempts are completed. No further information is expected.
Patient states she got the 2nd dose of the  COVID vaccine (Moderna per the patient) on Friday morning.  By Friday afternoon she had developed a rash, 2 blotches, that has hot to the touch.  She went to bed and slept.  The next morning the rash was one large blotch.  She called the pharmacy to ask if she could take Benadryl for the itching.
Patient awoke in the middle of the night (1:20am) with severe discomfort in the neck and throat.  Excess saliva.  As the pain persisted the pain radiated to the left arm/shoulder.  We sought help at our local emergency department where she was found to be in new onset atrial fibrillation.  A battery of tests were ordered including a troponin which was noted to be:  1.48.  She was transported via ambulance to the hospital to be admitted and undergo left heart cardiac catheterization with the presumptive diagnosis of NSTEMI.
This is an 83 years old lady who was presented to the emergency department because of increasing difficulty breathing, coughing, generalized body ache, and weakness.  She was diagnosed with COVID-19 on April 9, 2021.  The patient chest x-ray showed ill-defined bilateral opacities.  She was hypoxic on presentation.   1. Bilateral COVID-19 pneumonia.  Present on admission.  Associated with hypoxia.  The patient was diagnosed with COVID-19 on April 9th but her initial symptoms started even earlier
there was a little not in my arm so I rubbed it and now there is a hard spot the size of a half dollar; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of SKIN MASS (there was a little not in my arm so I rubbed it and now there is a hard spot the size of a half dollar) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN MASS (there was a little not in my arm so I rubbed it and now there is a hard spot the size of a half dollar). At the time of the report, SKIN MASS (there was a little not in my arm so I rubbed it and now there is a hard spot the size of a half dollar) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
He caught Covid; He caught Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2) (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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "He caught Covid".  Clinical course: He caught Covid while in withheld - posted that he was sick with it 4 days ago at the time of report submission, that he would stop posting videos for a bit, but that thankfully symptoms are mild so far. Pretty sure he was vaccinated but do not know with what vaccine or when. Probably late 20s / early 30s.  The lot number for bnt162b2 was not provided and will be requested during follow up.