chrisvoncsefalvay/vaers-outcomes huggingface dataset:
6/23/04-slight swelling and pruritus 6/24/04-swollen rt arm, warm and slightly tender on palpation-very pruritic. Given Solumedrol 125mgIM, Allegra 60mg BID x 1wk. Cool compresses
I felt a rushing sensation on both sides of the back of my neck that was shooting upward into my head. My tongue was swollen and numb. Several days later, my tongue felt intermittently numb and tingly. About two weeks later on the side of my left calf, where a dog bit my leg two years earlier, I felt a shooting pain down my left leg in the outside of my left ankle and on the top of my left foot, between my big toe and the one beside it. I felt pain for a couple of months and now it is more intermittent pain. I went to my primary care physician when the pain in my left leg and foot did not subside.
Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 12 SEP-2014, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 29-OCT-2015, the patient was treated at Family Practice and a Hospital for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. She has been prescribed VALTREX for the management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
No additional AE; she received her second dose of the GARDASIL 9 vaccine in her buttocks instead of the intramuscular locations in the prescribing information.; received her first dose of the GARDASIL 9 vaccine on 3-MAR-2022, and did not receive the second dose until 01-SEP-2022; This spontaneous report has been received from a consumer and refers to a female patient of an unknown age.  The patient's medical history, concurrent conditions, concomitant therapies and pervious drugs reactions or allergies were not reported. Historical vaccine included Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL).  On 03-MAR-2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) administered for prophylaxis (dose description, lot #, expiry date, and route of administration were not provided). On 01-SEP-2022, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose description, lot #, expiry date were not provided) (inappropriate schedule of vaccine administered) intramuscularly in her buttocks instead of the location in the prescribing information as prophylaxis (Vaccine administered at inappropriate site). Patient mentioned that she had not experienced any symptoms (no adverse event). The outcome of the events was not provided.
Nausea; Vomiting; Headache; Fatigue; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in left arm on 18Apr2021 at 16:15 (at the age of 16-years old), as a single dose for COVID-19 immunisation. Medical history included allergy to shellfish. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Apr2021, the patient had experienced nausea, vomiting, headache and fatigue. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of events nausea, vomiting, headache and fatigue and which included treatment with acetaminophen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events, nausea, vomiting, headache and fatigue was recovering at the time of report.  No follow-up attempts are needed. No further information is expected.
ride sided muscle weakness; nerve pain; muscle weakness; she has muscle issues; Weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), in Aug2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Manufacturer: Unknown), for COVID-19 Immunization. The following information was reported: HEMIPARESIS (medically significant), outcome "unknown", described as "ride sided muscle weakness"; NEURALGIA (non-serious), outcome "unknown", described as "nerve pain"; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "muscle weakness"; MUSCLE DISORDER (non-serious), outcome "unknown", described as "she has muscle issues"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness". The patient underwent the following laboratory tests and procedures: lab work: Normal, notes: HCP says is normal.  Clinical course: The caller stated she had muscle issues, ride sided muscle weakness, nerve pain and muscle weakness. She was querying if these were possible side effects. Caller stated she was desperate to find answers, these symptoms may not have anything to do with the vaccine, but she was looking at everything. Caller stated she received her Primary dose #2 in Aug2021. It had been 10 months and she had lab work done to which the HCP says was normal. About 5 months after receiving her 2nd primary vaccine dose, she started to have these symptoms. She stated little things started happening about 5 months after the vaccine. She was asking if there was a diagnosis that was found that would help his HCP look in the right direction that was anything related to muscle weakness, muscle wasting, muscle atrophy and anything to do with nerve damage. Caller was 64 and states she was healthy until she was 62 years old. She got two of the vaccines and 3-4 months after she got it, started having issues. Unknown if anything to do with the vaccine. Trying to figure out going on with her. Doctor asked what changed. She was at her wits in and had been dealing with this for 10 months. She just wanted someone to listen to her who can give some advice. She declined to continue with safety report as she wanted to speak to someone who can answer her questions. Reporter later clarified issues she was questioning was having muscle issues and, nerve issues, nerve pain. She was mainly having muscle issues. She was also having weakness and muscle weakness.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had a Tdap vaccine as a booster shot and I that night I had a headache start then body aches and my glass under my arms hurt all that week. The headache turned into a full blown migraine the next morning and hasn?t stopped since. I?ve called my pcp multiple times about it I?ve been to urgent care once and ER twice and no one has been able to stop it. I?ve NEVER had a migraine and it?s been almost 4 weeks now and it?s not stopping. I know it was from the Tdap vaccine. I?ve never had these symptoms before and there?s nothing else it could be.
-Severe headache beginning day after vaccination and continuing approximately 10 days  -Extreme joint pain throughout body, worst in elbows, knees and hips -**Rash developed approximately 18 days after vaccination. Painful and red. Went to ER - diagnosed with shingles.  Patient was given valacyclovir and has since completed therapy. Was also prescribed acyclovir cream that she did not pick up to due high cost. Shingles rash has not improved and is currently located on trunk, breasts, armpit and shoulder. Seeing primary doctor on Monday for  further treatment.
Symptomatic SVT resulting in near syncope requiring treatment with valsalva and vagal maneuvers for treatment
Patient complained about having a shortness of breath the night of the vaccination (Thursday 5/17/18) after a few hours (she didn't remember the exact time), but it was at night, the shortness of breath didn't last very long. But the next day (Friday 5/18/18) she started feeling a weakness like if she was having the flu, pressure on the chest, fatigue and a low grade fever, and also feeling like a blockage in her arteries (because she already has a stent). She ended up at the Hospital the same Friday at 11 pm, she stayed in for 3 days and was discharged on Monday 5/21. The doctor had told her that these symptoms could be due to the SHINGRIX vaccine
A non-serious spontaneous report of received expired FLUMIST was received from a health professional concerning a 13-year-old female. Neither medical history nor concomitant medication was reported for this patient. The product expired on 02-Jan-2011. On 04-Jan-2011, the patient received expired FLUMIST. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
all 3 individuals had a sore arm; 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 PAIN IN EXTREMITY (all 3 individuals had a sore arm) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (all 3 individuals had a sore arm). At the time of the report, PAIN IN EXTREMITY (all 3 individuals had a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The reporter stated that all three different physical therapists had a sore arm after vaccine.  Concomitant medications were not reported. Treatment information was reported as unknown.   Reporter did not allow further contact
CT with contrast emergently done this Sunday 11Apr2021 revealing Mid right lobe pulmonary; Experienced pleural pain; chest "Feels like a broken limb; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (CT with contrast emergently done this Sunday 11Apr2021 revealing Mid right lobe pulmonary) in a 64-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.     Concurrent medical conditions included Diabetes, Stenosis (cervical spine stenosis), Carcinoma (on face) and Vomiting (Vomited every other day for 2 weeks straight after 1st dose. ). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID] for Prophylactic.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Apr-2021, the patient experienced PULMONARY EMBOLISM (CT with contrast emergently done this Sunday 11Apr2021 revealing Mid right lobe pulmonary) (seriousness criterion medically significant), PLEURITIC PAIN (Experienced pleural pain) and CHEST DISCOMFORT (chest "Feels like a broken limb). At the time of the report, PULMONARY EMBOLISM (CT with contrast emergently done this Sunday 11Apr2021 revealing Mid right lobe pulmonary), PLEURITIC PAIN (Experienced pleural pain) and CHEST DISCOMFORT (chest "Feels like a broken limb) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Computerised tomogram: unknown (Inconclusive) ct scan with contrast revealed Mid right lobe pulmonary embolism.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment included as heavy thrombolytics.  Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to US-MODERNATX, INC.-MOD-2021-075787 (E2B Linked Report).; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075787:Case for first dose
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Shakiness-Mild, Additional Details: 10 minutes after injection, patient was pale diaphoretic, placed supine, vital signs and blood sugar assessed , mild hypotension, bradycardia 911 called for eval, patient states that he had not eaten for over 24 hours, gave gatorade, fully recovered when paramedics arrived, assessment done, negative orthostatics. Patient d/c'd home with a ride.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 24-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
body and leg weakness; body and leg weakness; fever; chills; headaches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (body and leg weakness), ASTHENIA (body and leg weakness), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     There was no reported medical history.     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 MUSCULAR WEAKNESS (body and leg weakness), ASTHENIA (body and leg weakness), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches). At the time of the report, MUSCULAR WEAKNESS (body and leg weakness), ASTHENIA (body and leg weakness), PYREXIA (fever), CHILLS (chills) and HEADACHE (headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       There were no Concomitant medications provided. No treatment medication information was provided.  The patient noted the events felt like an MS relapse, but was not an MS relapse.
Arm was swollen and red for several weeks. Patient used cool compresses and BENADRYL and symptoms have subsided.
(L)/(R) upper arm swelling nontender with redness. LSQ/RD.
Patient came into receive a flu vaccine in a nurse visit.  The patient was with his sibling that was having a 6 month well child visit. The sibling was receiving all the 6 month well child shots that included rota, hib, Prevnar, Pediarix with the addition of a flu vaccine.  When this MA administered the flu vaccine to this patient this MA actually picked up the Pediarix and administered it to the wrong patient.  The parent was immediately notified of the mistake at 1108  This MA went and talked to the provider and informed her of the mistake and asked her if the extra dose of Pediarix which included Dtap, Hep B and Polio was okay. Provider said that it was fine.  This MA went ahead and gave the patient the correct Flu vaccine at 1113. This MA apologized and the mother didn't seem worried but felt a bit overwhelmed because the patient was screaming.
Mom requested this be reported, but is aware that this is not a true contraindication to vaccine.  5 hrs. after vaccine, mom noted fever <105 degrees, vomiting x2, and child c/o neck pain.  No further vomiting today, fever 100 degrees today.  Child eating & drinking.  Mom was reluctant to get shots on the day of visit.
Felt extremely fatigue and sleepiness for two days beginning the day of injection. On 12/23/2020 my period came which was two weeks early. I am normally regular for years and this was unusual. Period lasted 4 days and then stopped and now my cycle is off.
got it even after getting the shingles vaccine/suspected vaccination failure; got it even after getting the shingles vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-SEP-2022 Reporter's Comments: This case was reported by consumer via interactive digital media. The patient received a dose of Shingles vaccine and had got it (shingles). The reporter reported that one of the Covid vaccine's side effects. Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory test and time to onset confirming shingles were unknown at the time of reporting. Note: From the narrative it was not clear if the patient got Covid vaccine and experienced shingles hence not captured as suspect. The follow-up would not possible as no contact details were available.
PLAQUE PSORIASIS FLARE UP ON A SPOT ON SCALP; This spontaneous report received from a patient concerned a 64 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose was not reported, administered on 12-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported.  On an unspecified date, the patient experienced plaque psoriasis flare up on a spot on scalp. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient was recovering from plaque psoriasis flare up on a spot on scalp. This report was non-serious.
Syncope.  Pt fainted for 10 seconds.  Pt sat up and then advised to lay and have legs elevated above head. Pt refused and sat on chair.  We asked pt flex arms and legs to return blood flow.  Pt was also given a cold pack.
Systemic: Body Aches Generalized-Mild, Systemic: Diarrhea-Medium, Systemic: Nausea-Mild, Systemic: Vomiting-Mild
Greetings, My 21 year old daughter developed myocarditis after receiving the Covid 19 booster. Apparently the medical community has known for some time that exercising after the vaccine can cause myocarditis, especially in young adults, but they haven't made this information aware to the public very well.  EVERYONE SHOULD BE TOLD NOT TO EXERCISE AFTER RECEIVING THE COVID VACCINES THE DAY THEY RECEIVE THEIR SHOTS BY WHOEVER IS GIVING THEM!! My daughter has never had any heart problems and developed symptoms within a few days after the booster. She used to exercise everyday. Now she is told not to exercise for 6 months and has to rest all the time. If this could have been avoided simply by pharmacy telling her not to exercise, it is negligence. My mission now as a parent is to prevent this from happening to anyone else's child. Will you help?
Patient received vaccine after the expiry time allowed in the fridge; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after the expiry time allowed in the fridge) 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 did not provide any causality assessments.
This is a spontaneous report from a contactable consumer via Pfizer sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date to at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced Severe redness, puffiness and heat from shoulder to elbow for several days along with limitation of arm movement on an unspecified date with outcome of unknown. No follow-up attempts are possible. No further information is expected.
PATIENT RECEIVED THE VACCINE 9.5 HOURS AFTER VIAL PUNCTURE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a health care professional concerned multiple patients.  No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 05-AUG-2021) dose was not reported, administered on 10-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 10-JUN-2021, the patient experienced patient received the vaccine 9.5 hours after vial puncture. On 10-JUN-2021, the patient experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the patient received the vaccine 9.5 hours after vial puncture and incorrect product storage was not reported. This report was non-serious.
Post vax, the pt developed a thick rash and fever to 101. Rash is on torso, head, and neck; fever persisting to 105. Taken to ER. Streaks and rash still there but fading on 10/12/00. Temperature was still at 100-101, but is controlled with ibuprofen. Physician's visit on 10/10.
Pain in back of head, neck, behind ears, abdomen, and groin leading to intermittent headaches. Muscle fatigue.  Symptoms started early morning after vaccine dose and interrupted sleep. Symptoms have continued into evening.