chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site pain; injection site redness; Injection site swelling; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling). At the time of the report, VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE PAIN (Injection site pain), VACCINATION SITE ERYTHEMA (injection site redness) and VACCINATION SITE SWELLING (Injection site swelling) to be related.    Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Initial additional included patient demographic details, allergy history, route of vaccine administration and event outcome.
2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ATRIAL FIBRILLATION (2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: inconclusive (Inconclusive) Inconclusive.         No treatment medications were provided by the reporter.  The doctors took an echocardiogram and his heart is wonderful and they can not figure out why he went into atrial fibrillation. He now have to take an expensive medication to prevent his heart going into atrial fibrillation and we are wondering if it was possible he got it from  Moderna Covid-19 vaccine.  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-2021-230049 (Patient Link).; 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.
Patient developed itching to front of neck, chest, arms, back, stomach and LLE. Patient unable to take Benadryl secondary to allergy. Patient stayed for extended observation and then discharged. Patient placed on flagged list.
Extreme body aches high fever chills nausea Extreme weakness. Felt like I was dying. Probably the sickest I've ever felt.
Rash at injection site developed after 9 days. Itchy and red area about the size of a half dollar.
Varicella - Information has been received from a physician concerning multiple children who were vaccinated with one dose of varicella virus vaccine live.  Subsequently the children developed varicella and were seen by a physician, An additional patient (waes 00031563) had a similar experience following exposure to varicella virus vaccine live
Swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 70-year-old male patient received bnt162b2 (Pfizer-Biontech Covid-19 vaccine), dose 1 via an unspecified route of administration on 11Feb2021 (Batch/Lot Number: EN6201) at the age of 70-years-old as dose 1, single for covid-19 immunisation.  The patient has no medical history and concomitant medication. On an unspecified date in Feb2021, the patient experienced swollen lymph nodes. The patient did not receive treatment for the event. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
My husband experienced sudden onset hearing loss in his left ear, near complete hearing loss.  He did also have a head cold following his third Moderna covid vaccine booster shot.  However, I thought it pertinent to report this even though there may be confounding factors (his head cold).   It is as yet unclear how much hearing he will regain.  He is currently steriods to reduce inflammation.
headache, fever, chills, nausea, body aches, for 2 nights and 1 day
while in the observation area the client reported that she had a feeling of  her tongue swelling, face tingling , dizzy,  lightheartedness , vision  changing "felt strange". Able to speak full sentences, lung sounds  clear, vital signs within normal limits. Calm and conversant. EMS  summoned for evaluation . Evaluated and per the medic team  father  requested transport to Hospital .
A report has been received from a Pharmacist concerning a 55 year old, Female subject, who had been receiving Nasal FLUMIST QUADRIVALENT. The patient's concurrent disease(s) included ALLERGY TO THIMEROSAL. FLUMIST QUADRIVALENT started on 27-Sep-2013. It was reported that pharmacist vaccinated 55 year old female with FLUMIST by mistake which started on 27-Sep-2013, not reported any symptoms. The outcome of the event of ADMINISTERED FLUMIST QUADRIVALENT TO A 55 YO is unknown. The report was considered to be non-serious.
It's itching at the site, it's not a large bite but it's itchy, it's like an elevated pimple; It's itching at the site, it's not a large bite but it's itchy, it's like an elevated pimple; This is a spontaneous report from a contactable consumer (patient herself).  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number was not reported)via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, she had a question, she received first dose with Pfizer and she was due to receive the second dose on Tuesday and on unspecified date she had tick bite, that she got about 2 or might be 3-4 days ago and it was itching at the site. It was not a large bite but it was itching as like an elevated pimple. She enquired was there any problem with receiving her second dose on Tuesday or not. She stated that her husband and she were due to get their second dose this Tuesday. The outcome of events was unknown.  Information about the lot/batch number has been requested.
Patient said he had 2 severe headaches with each followed by a nosebleed that relieved the headache.  Both incidences occured 10 days after the shot.  Patient called his doctor and is awaiting further instruction.
patient received MENACTRA 2 days after expiration date/no AE; Initial information was received on 03-Sep-2021 regarding an unsolicited valid non-serious case from other healthcare professional.  This case involves a 11-year-old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] 2 days after expiration date (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV VACCINE and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.  On 25-Aug-2021, the patient received first dose of 0.5 ml suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (solution for injection, lot U669OAB and expiry date 23-Aug-2021) via an intramuscular route in the left deltoid for prophylactic vaccination (expired product administered).  It was reported, "caller reports that a patient was given expired MENACTRA; MENACTRA was administered 2 days after expiration date. Caller asks for recommendations following administration of expired product. "  It was a case of an actual medication error due to expired vaccine administered (latency-same day).  At time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
pt recv vax & mom called 330PM stating daughter had 3 episodes of vomiting;recommend to keep NPO for 4hr & then to start clear liquids & to advance to 1/2 strength milk as tolerated;
a 38 year old female patient received a dose of Flublok Quadrivalent on 13-JAN-2020 the 8th but did not realize that they were not suitable for use due to shipment delay/No AE; a 38 year old female patient received a dose of Flublok Quadrivalent on the 8th but did not realize that they were not suitable for use/No AE; Initial information received on 13-Jan-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 38 years old female patient who received a 0.5 ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] on 13-JAN-2020 the 8th but did not realize that they were not suitable for use due to shipment delay lot QFAA1960, expiry date: 30-JUN-2020 via unknown route in the right arm.  Medical history, concomitant, medical treatment, vaccination and family history were not provided.  It was an actual medication error due to Incorrect product storage.  It was a case of product shipment delay.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
All adverse events lasted 3 days unless otherwise stated: Headache (7/10 on pain scale), muscle and bone aches (7/10), extreme fatigue (7/10), fever 100 degrees F, x only 2 days. Sore at injection site (4/10).
Resident experienced an overall decline in condition on 1/8/21 and continued to decline until he passed away on 1/13/21.
Patient developed swelling of lower than upper eyelid of right eye. about ten-15 minutes after vaccine. given Benadryl with minimal improvement
My knuckles on my left hand were swollen/right hand knuckles began to swell and ache; My knuckles on my left hand were swollen and sore//right hand knuckles began to swell and ache; The pain and tightness in my knuckles has increased over time; I was having trouble making a fist; I slept most of the day Monday and Tuesday; Chills; Tiredness; This is a spontaneous report from a contactable consumer or other non hcp. A 51-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8729), via an unspecified route of administration, administered in Arm Left on 18Apr2021 13:45 (at the age of 51-year-old) as dose 2, single for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination:175 levothyroxine. Medical history included hypothyroidism. Concomitant medication(s) included levothyroxine. Patient previously received comirnaty, dose 1 on 28Mar2021 (Batch/Lot Number: ER8727) on Left arm for covid-19 immunisation. On 18Apr2021, the patient experienced chills, fatigue and on 19Apr2021 ptaient experienced, joint swelling, arthralgia, somnolence, joint stiffness, loss of personal independence in daily activities. Adverse event: Had the normal reaction of chills and tiredness close to 10 hours after 2nd dose on Sunday 18Apr2021. On Monday patient noticed her knuckles on her left hand were swollen and sore. On Tuesday 20Apr2021 her right hand knuckles began to swell and ache. She slept most of the day Monday and Tuesday. She has waited the 2-week mark, as she has read some symptoms can linger up to 2 weeks. The pain and tightness in her knuckles have increased over time and today it hurt just to straighten her fingers and she was having trouble making a fist. She also experiencing pain in her ankles when she gets out of bed in the mornings. Prior to the vaccine she has never had any of these symptoms. The only health issue she has is hypothyroidism. She called her doctor, tonight to tell him about her symptoms. He told patient to take some Aleve and Pepcid tonight and he was calling in an order of prednisone for patient to start tomorrow, 02May2021. He told patient to report her reaction and follow up with him in 3 days. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Headaches, eye pain, dizziness 2 weeks after vaccination. Late uveitis seen about 2 months after.
Sporadic facial and arm numbness on vaccine side (left). Numbness locations in arm localized around shoulder, hand, and fingers. Noticeable Numbness in face localized to lower front jaw, top of left ear, and above left eye (around eyebrow)
Person stated he had no problems when flu shot was administered, painless and no complications, after several days it the shoulder area where shot was given was very sore and got black and blue, his entire shoulder area remained black and blue for several weeks and now 2 months later is still very sore. He had a doctor X-ray shoulder to see if he had done something to it and x-ray came back normal. He has had the flu shot every year for 20+ years and has never had a reaction before.
Continued pain and limited range of motion that has impacted her ADLs, as well as sleep. This has persisted with no improvement for 5+ days. Diagnosed with axillary neuritis.
Severe heart palpitations - Palpitations last throughout the entire day and are severe enough that sometimes I can sleep. I had a normal EKG last week. I'm currently wearing a holter monitor. Mild side effects included injection site pain, achiness and tingling legs.
With in a couple day started have shortness of breathe. By June it was really bad so I talked to my dr. They ran several tests showing a high d dimer and inflammatory markers. Shortness of breath is getting worse.
Patient had varicella vaccine on 4/19/19 on her right arm. On 4/20/19 she had fever of 101 and continued to feel bad through the next day. Right arm began to swell on 4/21/19. Patient says it was tender and warm to touch. Was seen at clinic on 4/22/19. Treated with Keflex for secondary skin infection. Patient was advised to do cool compresses and avoid strenuous activity.
LIGHT HEADED; FATIGUE; WEAK; This spontaneous report received from a patient concerned a 55 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 1816022, and batch number: 1816022 expiry: UNKNOWN) dose was not reported, administered on 07-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On MAY-2021, the subject experienced light headed. On MAY-2021, the subject experienced fatigue. On MAY-2021, the subject experienced weak. The action taken with covid-19 vaccine was not applicable. The outcome of the fatigue, light headed and weak was not reported. This report was non-serious.
Started on 11/9/10 around 11:00 AM pt at school and had no ride to return to clinic. Pt presents with large welt size: L 5.5 cm, W 6.3 cm, erythema and swollen right upper lateral arm.
January 2022 started to experience what I thought was tooth pain on the left side of my mouth. Around the spring of 2022 I visited by dentist, who didn't detect any tooth issues. I went back to her again for pain on the left side and she did not find anything that would indicate why I was having facial pain on the left side. I was then referred to an oral surgeon who completed an x-ray-Dr. in July 2022. He said that he saw something on the left side of my head, but was unable detect what it was. He gave me some nerve blockers to reduce the pain. The following week, I visited by primary care practictioner who suggested that I receive a MRI of the brain to rule out any potential factors. I was uanble to have the MRI and a few days later began to experience headaches, vomiting, and dizziness. I went to the emergency room at a local healthcare facility and it was discovered through numerous tests, that I had a CVST. I was a patient in the ER for about 3 days where I had a series of blood tests to determine if I had some type of clotting disorder or an  autoimmune disorder. None of that was detected. I did however have a low blood levels, but that was not a result of the stroke activity.
This spontaneous report was received from a nurse referring to a patient of unknown age and unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 06-SEP-2018, the patient was vaccinated with VARIVAX (lot # R012531, expiration date 01-MAY-2020; strength, dose and route were not reported) for prophylaxis. On 21-SEP-2018 the patient was vaccinated with M-M-R II (lot # R000556, expiration date 08-JAN-2020; strength, dose and route were not reported) for prophylaxis. No adverse effects were reported in the patient.
Pain at injection site x 2.5 days. Body aches x 2.5 days. Headache x 1 day. Possible low grade fever x 2 days. Fatigue x 2.5 days.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021 at 11:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Apr-2021 at 11:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 24.20.  Concomitant products were not provided.  On 27-Apr-2021, Excursion time was 09 AM, temperature was 35, total doses given for the day was 42, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 27-Apr-2021. 8 vials were sent to clinic. Vaccine BUD date was 19-May-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Had a night fever at 3am on June 19. Felt hot, dehydrated, and weak. Took 200mg ibuprofen pill with water and slept again but was uncomfortable. Also felt dizzy and fatigue at night. My heart was also beating fast. When I woke up at 10am the symptoms seem to be less intense and better. I didn't feel hot. However, I still felt weak in my body. At 1pm when I started earing lunch I felt hot, tired and dizzy again, I was really sleepy, didn't feel like eating, and felt like vomiting. I drank coke soda instead and slept until 4pm and I took another 200mg ibuprofen pill with water, after which I felt better.
Pt exp fever 105 thru nite now 99.5, irritable, screaming continuously approx 12 hrs; Swollen thigh rt & lt started 8 hrs p/immun;
itchy; hurting/warm and tender to touch; broke out in a big rash on her arm and the pink area is expanding; expanding pink area, is very itchy; Off label use; Booster; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). An 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021 as DOSE 3 (BOOSTER), SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historically the patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. On an unspecified date in 2021, the patient experienced itchy, hurting/warm, and tender to touch, broke out in a big rash on her arm and the pink area is expanding and expanding pink area, is very itchy. The patient stated that she got her booster on Thursday and has been itchy and hurting but today broke out in a big rash on her arm and the pink area was expanding. She asked if she could take something like Benadryl. The patient stated that she had the booster on Thursday and was okay on Friday and Saturday she started to itch. She stated she woke up with a huge rash, expanding pink area, is very itchy, warm, and tender to touch. She asked what she could do and if she could take Benadryl. She stated it was the Pfizer 3rd dose of the Covid. Investigation Assessment was not Provided. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient was given vaccine that was over diluted with NS. Typical draw from Pfizer COVID vaccine is 10 .2ml doses. Vile pulled 13 .2ml doses with .1ml extra.