chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had both my Shingles Shots and this is the third time getting it/ Suspected vaccination failure; this is the third time getting it; so painful; This serious 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles two times).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both my Shingles Shots and this is the third time getting it/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: this is the third time getting it) and pain (Verbatim: so painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 21-Jun-2023 The case was received from the patient via interactive digital media. The patient stated that use Blistex or Carmex (used for cold sores) it relieves pain. The patient had both the shingles shots and this was the third time he or she getting them. The patient stated so painful. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
SHORTNESS OF BREATH, MISSED MENSTRUAL CYCLE, CRAMPS, BRAIN FOG, SEVERE VERTIGO, HIGH HEART RATE, DIFFICULTY TAKING A DEEP BREATH, EXHAUSTION, SWELLING AND INFLAMMATION THAT HAS CAUSED 8LBS OF WEIGHT GAIN, RECURRING HEADACHES EVERY DAY
ADMINISTRATION OF EXPIRED VACCINE; INCORRECT PRODUCT STORAGE; This spontaneous report received from a pharmacist concerned a 65 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non smoker, and other pre-existing medical conditions included the patient had no known allergies and had no medical conditions.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1820096, expiry: 06-SEP-2021) .5 ml, administered on 09-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-JUL-2021, the subject experienced administration of expired vaccine. On 09-JUL-2021, the subject experienced incorrect product storage. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administration of expired vaccine and incorrect product storage was not reported. This report was non-serious. This case, from the same reporter is linked to 20210722813.
Pt states that pain in arm started evening after injection was given. Pt states that she could not lift arm and that it was so painful that she went to the emergency room. Notes provided of encounter below: History of Presenting Illness: The patient is a 72 Year Old Female who presents to the ED with complaints of left arm pain that started the evening after she received a pneumonia vaccine. Patient states that she has use hot packs and TYLENOL which was effective in relieving the pain for a while. She states she has increased pain with movement. She denies any fevers, chills, nausea or vomiting. She is not having any shortness of breath or chest pain. She states she has never had an issue after receiving vaccines in the past. ED Course: 72-year-old female presents with left arm pain that started after receiving a pneumonia vaccine. She does not have any other associated symptoms, she has not had any injury to the area. Most likely these symptoms are caused from the injection. She can continue trying hot packs and TYLENOL for the symptoms. I do not see any reason for further testing at this time. We did discuss return precautions. If she develops any fevers, chills, chest pain, shortness of breath or any other new or concerning symptoms she is to return for recheck. Patient is comfortable with this plan and is discharged in stable condition. Pt stated via follow up phone call today, 01/05/2018: Pain in arm went away for a couple of days but after sleeping on couch for the night pain came back and cannot lift arm again. Pt states that she is actually unsure if this is connected to vaccine or not, states she may have "torn rotator cuff". Pt states that if symptoms persist she will make an appointment with PCP on Monday.
Arm is really warm; Arm soreness; Redness; Swelling; Headaches; Body aches; Runny nose; A spontaneous report was received from a consumer who was a 25-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced arm soreness, redness, swelling, headache, body aches, runny nose and her arm was really warm.   The patient's medical history was not provided. Concomitant product use was not provided.  On 30 Dec 2020, the patient received her first dose of mRNA-1273 (Lot number: 011J20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection.   On 30 Dec 2020, after receiving the mRNA-1273 vaccine, she had a small amount of soreness, redness and swelling for two to three days and disappeared. However, she experienced them again on 06 Jan 2021.  On 08 Jan 2021 her arm was more swollen and her arm was really warm on that day.   On unreported date, she experienced headache, body aches and runny nose.   Treatment information was not provided.  Action taken with mRNA-1273 in response to the events were not provided.   The outcome of the events, arm soreness, redness, swelling, headache, body aches, runny nose and feeling of warm were not reported.; Reporter's Comments: This case concerns a 25-year-old, female patient. The patient's medical history was not provided. The patient experienced BS expected event of injection site pain, erythema, swelling, headache,  and unexpected event of Ache NOS, rhinorrhea and injection site warmth. The events of injection site pain, erythema and swelling after 1 day, injection site warmth after 8 days and headache, Ache NOS, rhinorrhea on unspecified date after the first dose of mRNA-1273 (Lot number: 011J20A) administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pt recv vax 3/20/89 & July of an unspecified year, pt devel mumps from which pt recovered;
patent given PEDIARIX combination vaccine and also given hepatitis B and polio vaccines. (These are components  of PEDIARIX). no reaction reported/observed.
A report has been received from a Health Professional concerning a patient of unknown gender, Height: 56.0 inches; Weight: 69.0 Pounds, who had been receiving FLUMIST, 0.2 millilitres, once/single. FLUMIST was started on 05-Jan-2016. The reporter stated that FLUMIST with an expiration date of 30-Dec-2015 today 5-Jan-2016 was given to a patient. FLUMIST was continued. The outcome of the event of caller reported giving FLUMIST with an expiration date of 30-DEC-2015 today 5-JAN-2016 was unknown. The report was considered to be non-serious.
Extreme swelling and soreness of left shoulder, tongue swelled - extreme thirst, loss of balance - couldn't walk. Called paramedics Nov 2 and admitted to hospital.
This case was reported by a physician via sales rep and described the occurrence of injection site discoloration in a 16-month-old patient who received HIBERIX. Co-suspect products included HIBERIX. In September 2016, the patient received HIBERIX. In November 2016, the patient received HIBERIX. On an unknown date, less than a year after receiving HIBERIX and not applicable after receiving HIBERIX, the patient experienced injection site discoloration and injection site discoloration. On an unknown date, the outcome of the injection site discoloration and injection site discoloration were unknown. It was unknown if the reporter considered the injection site discoloration to be related to HIBERIX. It was unknown if the reporter considered the injection site discoloration to be related to HIBERIX. Additional details were reported as follows: The patient's age was 16 months at the time of reporting. The age at vaccination was not reported. Less than a year after receiving a dose of HIBERIX in November 2016 (unspecified dose number), the patient experienced injection site discoloration. The physician believed that in September and November 2016, after administration with HIBERIX, the patient experienced 2 black dots. On 2nd August 2017, the patient received another dose of HIBERIX. The physician found a way to change the needle so the patient would not have a black dot. There was no black dot with the administration on 2nd August 2017 because the physician used a different needle for the reconstitution step. The reporter denied permission to be contacted for follow up.
Fever, chills, fatigue, body aches (lower back, hips, knees, shoulders), mental fog
Increase in seizures approx. 4 weeks after immunization with global regression in development. SZ now better controlled--Lamictal-development progressing-still sign. Approximately 4 week later pt had increased in her seizure activity and experienced global regression in her development that had been normal up to this point. Her seizures are currently controlled better and her development is again progressing, however she still has significant delays. Multiple therapies include OT, ST. Pt has been multiple specialists including four different neurologist, metabolic specialists, a gastroenterologist, and an allergist. She has also been under the care of a chiropractor and works with MD. Her seizure disorder was diagnosed at 14 month of age and was initially most consistent with and treated as infantile spasms (Sz, EEG, MRI head). Her neurologist recommended at 20 months that she could receive her immunizations as she had no previous adverse reactions and her seizure disorder was stable with normal developmental progress. Different medications have been used to control her seizures with variable effect, current treatment is lamictal. The ketogenic diet was not effective. She was diagnosed with Lennox Gastaut syndrome given the mixture of seizure types and developmental regression. Developmental regression is associated with myoclonic seizures. Pt's seizures and development appear sensitive to her diets content of gluten and diary. No metabolic or gastroentestinal disease have been identified in spite of extensive evaluation by her neurologist inlcuding the clinic, her gastroenterologist MD and MD at the university. Two MRI's of the head were normal except for a small and stable frontal cortical dysplasia. It has been debated whether her seizures are related to this dysplasia. After consulting the VAERS in Feb 2002 we were referred to MD at the emasles lab. A detailed evaluation of pt's CSF did not reveal evidence of CNS infection nor any serologic evidence of MMR injury to the brain (negative CSF measles/MMR ab, neg. 60 day follow up report states (08/20/03): Vaccine recipient did not recover from the adverse events that were reported for this vaccination.  We reported a possible association between his immunizations and the ensuing increase in her size-activity with developmental regression.  As discussed wit her neurologist and CDC, the workup does not indicate a causal relationship.  Her current diagnosis include: Sz-disorder and PPD-NOS.  She continues to progress in her development (OT/ST).  Please call me if you have further questions.
Huge red spot at injection site for more the 2+ days with tenderness and later nausea and vomiting along with a fever and chills.
sore arm; very low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 006B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Penicillin allergy, Latex allergy and Multiple sclerosis since 1995. Concomitant products included OCRELIZUMAB (OCREVUS), GABAPENTIN, ROPINIROLE, BACLOFEN, PANTOPRAZOLE, BUPROPION HYDROCHLORIDE (WELLBUTRIN), DIAZEPAM, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE AND HYDROCHLOROTHIAZIDE), DICYCLOMINE [DICYCLOVERINE], PROMETHAZINE and MELOXICAM (MOBIC) for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever). On 25-Feb-2021, PAIN IN EXTREMITY (sore arm) and PYREXIA (very low grade fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concurrent conditions also included heart problems. No treatment medications were reported for second dose.   This case was linked to MOD-2022-517704, MOD-2022-517635 (Patient Link).
Local soreness in shoulder, varies in severity and is still present as of 2/8/14.  Also, loss of range of motion, times when it is very painful to lift arm above head to put on clothes, reach for items on high shelves, etc.
pt admitted to hosp on 9/1/21 with a positive COVID test; COVID pneumonia; dc'd to SNF on 9/13/21; was then dc'd to home; pt c/o increasing SOB  and productive cough past 4 days; pt tachycardic; large left pneumothorax and bilateral interstitial lung disease; thoracostomy tube placed; pt's condition worsened; labored breathing; family decided to transition pt to comfort measures; the next day the son decided to not transition pt to comfort measures; treatments began again; the following day, pt's family decided to again transition pt to comfort measures only and he passed away; med records and death certificate submitted to info@vaers.org per VAERS request
"34 Y O female reports that she received Moderna covid vaccine 3/5/2021 on her left arm and it has been hurting since then. It feels warm and hard when she touches it. Also reports chills, sharp frontal headache 5/10, nausea, blurred vision on and off. Last dose of excedrin was around 10am with no relief of symptoms."
12/31/2022 pt had a positive COVID test in Healthcare Center; DNR; 01/05/2022 pt went to ED at Hospital for SOB; per death certificate, pt expired at her house with causes of death being acute on chronic hypoxia and hypercapneic respiratory failure, exacerbation of COPD at end stage, and COVID 19 infection;
Expired vaccine used; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 09-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 09-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.  The vaccine was stored in 21 Oct 2021. 13 patients were administered. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up received stated that the patient experienced no adverse event.
Covid exposure after 1 dose; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Covid exposure after 1 dose) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025S20A) for COVID-19 vaccination.     Concomitant products included LORAZEPAM from 05-Feb-2021 to an unknown date for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced EXPOSURE TO SARS-COV-2 (Covid exposure after 1 dose). At the time of the report, EXPOSURE TO SARS-COV-2 (Covid exposure after 1 dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21-JUL-2021 contains: Updated contact details- Email ID;
Bilateral numbness to legs. Numbness lasted 45 min. That was followed by several near syncopal events which lasted 2 days. Ha x 5 hours which was unlike migraines patient has in the past before a gluten free diet.
Moderna COVID-19 Vaccine EUA Patient received Moderna Vaccine - first dose on 3/15/21 around 3 pm.  Patient returned to the vaccine clinic to speak with doctor (reporter of event) on Wednesday 3/17 to inquire on the left-sided facial numbness and droopiness the patient was experiencing. Pt stated the left-sided facial reactions started on Tuesday, 3/16 in the morning.  Doctor assessed for further signs of other neurodeficit (i.e. stroke) and patient denied. Doctor encouraged  patient to contact PCP.  Patient contacted PCP that day (3/17), and then saw her PCP on Thursday 3/18.  From phone follow up with patient on Monday, 3/22, patient stated her PCP diagnosed her with Bells Palsy, and initiated her on a 10 day course of prednisone along with valacyclovir.  Pt since last Thursday, 3/18 has taken a leave of absence from work.  Pt has upcoming physical therapy scheduled for Wednesday, 3/24.  Follow up still in progress.
Information has been received from a registered nurse concerning a 17 year old female who was vaccinated in the deltoid with a first dose of Gardasil. Concomitant vaccination included Menactra into a different injection site. Subsequently a day after vaccination with Gardasil the patient developed pain in her underarm and lymph area in the same arm which lasted 3-4 days. There were no laboratory or diagnostic tests performed. Unspecified medical attention was sought. At the time of the report the patient had not recovered. Additional information has been requested.
No adverse effects or symptoms following administration. The vaccine had no temperature excursions. No other AE/no PQC.; Caller is a medical assistant who reports an expired dose of ROTATEQ was given to a patient today. No adverse effects or symptoms following administration. The vaccine had no temperature excursions. Dose was supported by post-expiry memo.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 13-MAY-2022, the patient was vaccinated with an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) 2 ml once, orally, lot# 1707449, expiration date reported as 28-MAR-2022,  for prophylaxis (strength was not reported) (Expired product administered). No adverse effects or symptoms following administration. The vaccine had no temperature excursions, no PQC.
BREAKTHROUGH COVID:  PT FULLY VACCINATED AND BOOSTED Patient was found to have covid with acute hypoxic resp failure, that improved to baseline without need for supplemental o2 after treatment with remdesivir and steroids. He was also found to have enterococcus in urine, pseudomonas from peg site and strep from blood cultures He completed IV abx at discharge.
Pericarditis; Shortness of Breath; Pain in Chest; This spontaneous case was reported by a physician and describes the occurrence of PERICARDITIS (Pericarditis) in a 27-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.     No Medical History information was reported.    On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced PERICARDITIS (Pericarditis) (seriousness criterion medically significant), DYSPNOEA (Shortness of Breath) and CHEST PAIN (Pain in Chest). At the time of the report, PERICARDITIS (Pericarditis), DYSPNOEA (Shortness of Breath) and CHEST PAIN (Pain in Chest) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications and treatment medications were reported  Patient was went through Electrocardiogram and treated for the symptoms  One week after the side effects subsided and are no longer present  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.; 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.
numbness in his arm; Initial information received on 17-Jul-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves male patient (age not reported) who experienced numbness in his arm, while he received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  In June 2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious numbness in his arm (hypoaesthesia) with unknown latency following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.  Final diagnosis was numbness in his arm.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for numbness in his arm.  Information on the batch number was requested.  List of documents held by sender: none.
diagnosed with shingles; This case was reported by a medical representative via call center representative and described the occurrence of shingles in a 87-year-old female patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 19th November 2021) for prophylaxis.   On 12th May 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 28th May 2020, 16 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were reported as follows: The patient received shingrix vaccine in left deltoid and diagnosed with shingles. No additional information provided. The reporter consented to follow up.