chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a patient of unknown age and gender. The patient's medical history, drug reactions/allergies and concomitant medications were not reported. On 29-AUG-2016, the patient was vaccinated with improperly stored PROQUAD, lot # M019232, expiry date 17-OCT-2017, rHA, 0.5 ml. Vaccine was exposed to a maximum of 9F and a minimum of 6.8F for a cumulative time frame out of recommended storage range for 23 hours. Data logger in use yes. No adverse effects reported. The outcome of the events was unknown. No product quality complaint (PAC) was involved. No further information provided. This is one of several reports received from the same reporter. Additional information has been requested.
Patient developed onset of symptoms on or around 7/31/21 of general fatigue and malaise.  sinus congestion, cough, fever, decreased oral intake and sob.  Daughter is unvaccinated and is currently in the hospital with COVID.  Patient is fully vaccinated prior to this.
Patient received 2 moderna covid vaccines on 4/1/21 and 4/29/21. Patient presented to hospital on 10/30/21 with significant orthopnea, dyspnea on exertion and cough with inspiration. cMRI on 11/1 was consistent with acute myocarditis, EF 25% (new HFrEF).  EKG showed ST depressions in inferior and lateral leads, troponin 954, NT-proBNP 6252, d-dimer 1834.
Heart attack - Sudden onset chest pressure, shortness of breath, bilateral arm numbness. Found to have clot in LAD requiring stent. No cardiac risk factors.
pt recvd vax 9AUG93 & devel a large mass in the lt quadriceps of the injected leg; No further details were provided;
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 30-JAN-2019, the patient was vaccinated with improperly stored vaccines: LIQUID PEDVAXHIB injection, intramuscularly, lot # R021076, expiry date: 11-JUN-2021 (dose and anatomical location were not provided) and with ROTATEQ orally, lot # R025732, expiry date: 25-MAR-2020 (dose was not provided), both for prophylaxis. The vaccines were stored in temperature above 47 degrees Fahrenheit (47.3) for 18 minutes. On unknown date in the past, there was one more temperature excursion, the vaccines were stored in temperature above 47 degrees Fahrenheit for 4 minutes. Digital data logger was involved in this case. No adverse effects were reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1902USA000784.
Strange taste in mouth, slightly metallic and bitter after vaccination.  Continuing into today with nausea starting just after noon on 9/29/2021.  Pain at injection site.
Guardian for pt informed this public health nurse of having rash resembling hives all over his body since 9/19/02. The rash is better today. Pt is in school today.
Patient reports nausea, throat felt "funny", thick mucus feeling in mouth and throat.  Around 3:50 symptoms began to improve.  Around 4:00p patient reported dizziness.  After sitting with feet elevated, patient began to report improvement in symptoms.
History of increasing pain of arm from deltoid to elbow and in armpit to breast level. No discoloration or lumps. Has pain and tenderness to touch and is afebrile. Using sports cream on left arm and taking acetaminophen. Pain described as worse when raising left arm. Had first flu shot 5 years ago via air gun with similar symptoms, therefore she wanted to file report. Pain described as worse now. (4 days later)
look very similar/could easily be confused; look very similar/could easily be confused; This is a spontaneous report received from contactable reporter(s) (Nurse, Pharmacist and Physician). Other Case identifier(s): 2022M1009764.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; adrenalin [epinephrine] (ADRENALIN [EPINEPHRINE]), (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT CONFUSION (non-serious), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), outcome "unknown" and all described as "look very similar/could easily be confused".  Additional information: Numerous mix-ups between epinephrine injection and the COVID-19 vaccine have been reported. According to the Centers for Disease Control and Prevention (CDC), Epinephrine injection should be readily available to treat anaphylactic reactions to the COVID-19 vaccines. Most of the mix-ups occurred between look-alike, predrawn syringes of epinephrine and the vaccine withheld. Also, ADRENALIN (epinephrine) vials from Pharmaceutical look very similar to the Pfizer-BioNTechCOVID-19 vaccine formulation for 12 years and older with the purple cap (withheld) and could easily be confused. Both vials are about the same size and shape, with purple caps and mostly black print on white labels. Vaccination sites should only stock epinephrine autoinjectors, which look different than predrawn vaccine syringes. With training, the autoinjectors are easy to use in an emergency. Doses of epinephrine and vaccine should be kept in different storage locations but close enough to vaccinators so they can be quickly retrieved when needed. Consider storing epinephrine autoinjectors in an anaphylaxis kit with a tear-off lock. Ideally, utilize barcode scanning of vaccines and epinephrine autoinjectors prior to administration.  The lot number for BNT162B2 was not provided and will be requested during follow up.  Follow-up (02Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Amendment: This follow up is being submitted to amend previously reported information: case reassessed as valid.
This spontaneous report as received from a medical assistant refers to a 55 year old female patient with drug reaction/allergies to codeine. No concurrent condition and medical history was reported. On 29-SEP-2014 the patient was vaccinated with PNEUMOVAX 23, inj 10 vials of 1 (lot# K004281 and expiration date 22-MAR-2014) (0.5ml), intramuscularly in the right arm. Concomitant therapies included amitriptyline hydrochloride, calcium, vitamin D, MAXALT, ZANTAC, naproxen and PROZAC. On 01-OCT-2014, the patient experienced red circular swelling around injection site after receiving PNEUMOVAX 23 and patient was diagnosed with cellulitis. The patient developed 2 to 3 red, circular swelling in the right arm where PNEUMOVAX 23 was administered. No diagnostic tests were reported. The patient did seek medical attention by visiting the office. The treatment of MEDROL DOSE PAK and KEFLEX was given for all the events. The outcome of all the events was reported as not recovered/not resolved. The relatedness between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
severe case of shingles after receiving the shingles vaccine/suspected vaccination failure; severe case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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: 5-June-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The case was reported by patient's son/ daughter. The reporter stated that the patient  broke out with a severe case of shingles after receiving the shingles vaccine. This jab was such bullshit. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not provided.
Patient presented to Hospital on 08/17/2021 via EMS for low O2 saturation.  Family members noted patient to be more confused than normal and lethargic with worsening SOB.  Lab results in ED indicated significantly elevated WBC of 21.6, hypoxemia on ABG results with a PO2 of 74 on 6 L NC, hyperglycemic with a blood glucose of 214, elevated CRP >190, elevated proBNP 2364, elevated lactic acid of 4.4.  Patients rapid Covid test was positive.  Patient underwent CTA of the chest which indicated bilateral pneumonia.  Patient was admitted and treated with antibiotic therapy, steroids, remdesivir, convalescent plasma, Ivermectin.  Patient needed increased oxygen requirements.  Patients family made him a DNR and placed on comfort care.  Patient expired on 08/24/2021.
Initially after shot there was light headedness. After 30 min wait throbbing on left side of head and left arm where injection was hurt. Headache on left side of head range from probing pain to throbbing not letting up for week. Left arm swollen and pained to touch and sleep for 2 weeks. Then pain changed from side of injection to under arm pain on left arm swollen under arm and painfully to left to date 4/15/21. Headache happens on left side of head suddenly throughout day
Feeling fatigue on January 15th and 16th, slight sore throat.  Feeling better by Monday January 18th.
headache; atrial fibrillation with abnormal heart rate; A spontaneous report was received from a consumer concerning a 87 years old, male patient who experienced atrial fibrillation with abnormal heart rate/ PT: Atrial fibrillation and mild headache.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included unspecified medications.   On 03 Feb 2021 (at 2:01 pm), approximately three hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 03 Feb 2021 (at 5:00 pm), approximately 3 hours later, the patient experienced atrial fibrillation with abnormal heart rate. The patient's heart rate was 145.  The patient went to the emergency room and the cardiologist gave him a pill to lower the heart rate.  The patient was also told to take his regular pills and was sent home.  The patient reported having atrial fibrillation for the past five days and that he had a scheduled appointment with his health care professional for an EKG on another date.  On an unknown date, the patient also reported that he experienced mild headache.  The event atrial fibrillation with abnormal heart rate was considered medically significant.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events, atrial fibrillation with abnormal heart rate and mild headache, was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.
Flu-like symptoms lasting 3+ days, including  lethargy, body aches, light sensitivity/headache, nausea, chest pain
Side effects; This case was reported by a consumer via interactive digital media and described the occurrence of adverse drug reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2020 16:00, the patient received the 2nd dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced adverse drug reaction. On an unknown date, the outcome of the adverse drug reaction was not recovered/not resolved.   It was unknown if the reporter considered the adverse drug reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as an adult as per vaccine indication. The patient received Shingrix and experienced most of the side effects listed but not severely. The patient asked how long the side effects lasts.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR133646:same reporter
Pt received Gardasil and FluMist and had a vasovagal reaction. Pt went unconscious for a few seconds. Pt was placed in the recovery position and was administered O2. Pt's vital signs were taken every 5 minutes and she was released per responding provider.
High pitched crying x 3 hrs; pale, lethargic @ home; In office same day, pt pale, lethargic, mild ill-appearing rest of exam nl w/2+ DTR's; emesis x 2 in office prior to admit;
Moderna 2/24/21, 3/25/21, 11/8/21. Positive on 8/16/22
Feels like worst flu he's ever had; Muscle pain; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Feels like worst flu he's ever had), MYALGIA (Muscle pain), NAUSEA (Nausea) and HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Feels like worst flu he's ever had), MYALGIA (Muscle pain), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, INFLUENZA LIKE ILLNESS (Feels like worst flu he's ever had), MYALGIA (Muscle pain), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.             The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported
Same day and next day: Pain in right arm, followed by pain in whole right body side (incl leg and feet). Headache, feverish Starting next day and ongoing (getting worse): Pain in chest, shallow breathing, feeling pressure in lungs, occasional cough with mucus, sweating after small physical "exercise" (e.g., walking down and up 10 stairs), feeling weak and tired, difficulty to concentrate
This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (affecting her movement), VACCINATION SITE MASS (lump on the injection site the size of a golf ball , size of the lump has receded a bit this time), AXILLARY PAIN (hurts even in her armpit), VACCINATION SITE PAIN (hurts when you touch it) and PYREXIA (low grade fever) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 prophylaxis. The patient had no allergies.  Previously administered products included for Product used for unknown indication: flu vaccine in October 2021. Past adverse reactions to the above products included No adverse event with flu vaccine. Concurrent medical conditions included Diabetes, Blood pressure high (high blood pressure), Aneurysm of heart (heart aneurysm (watching out)) and Blood cholesterol abnormal (cholesterol). Concomitant products included METFORMIN, LIRAGLUTIDE (VICTOZA), INSULIN GLARGINE (LANTUS), METOPROLOL TARTRATE (LOPRESSOR), ROSUVASTATIN, LOSARTAN POTASSIUM (COZAR), COLECALCIFEROL (VIT D3) and CYANOCOBALAMIN (VIT B12) for an unknown indication. On 02-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Nov-2021, the patient experienced PYREXIA (low grade fever). On 04-Nov-2021, the patient experienced VACCINATION SITE MASS (lump on the injection site the size of a golf ball , size of the lump has receded a bit this time). On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (affecting her movement), AXILLARY PAIN (hurts even in her armpit) and VACCINATION SITE PAIN (hurts when you touch it). On 03-Nov-2021, PYREXIA (low grade fever) had resolved. At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (affecting her movement), VACCINATION SITE MASS (lump on the injection site the size of a golf ball , size of the lump has receded a bit this time), AXILLARY PAIN (hurts even in her armpit) and VACCINATION SITE PAIN (hurts when you touch it) had not resolved. Patient never had COVID positive test or diagnosis. No X-rays were done. No treatment medication was reported. This case was linked to MOD-2022-613438 (Patient Link).
Diarrhea within 20 minutes of Seasonal and H1N1 vax.
HEAVY PERIOD; SORENESS AND ACHING OF BOTH CALVES; HEADACHE; TIRED; DIZZY ON-AND-OFF; This spontaneous report received from a patient concerned a 51 year old female. 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, route of admin not reported, batch number: 1822809, expiry: UNKNOWN) dose was not reported, administered on 09-OCT-2021 16:15 for prophylactic vaccination. No concomitant medications were reported.  On 10-OCT-2021, the patient experienced dizzy on-and-off. On 10-OCT-2021, the patient experienced headache. On 10-OCT-2021, the patient experienced tired. On 26-OCT-2021, the patient experienced soreness and aching of both calves. On 28-OCT-2021, the patient experienced heavy period. Treatment medications (dates unspecified) included: arnica montana. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness and aching of both calves and heavy period, and the outcome of headache, tired and dizzy on-and-off was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case is assessed as non-serious.
5X10 cm red raised non-tender area to right deltoid. 2 days post anthrax vaccine.
This spontaneous report was received from an other health professional (nurse) refers to unspecified number of patients of unknown demographics. On an unknown date, unspecified number of patients were vaccinated with PEDVAXHIB, intramuscular, which was improperly stored. No adverse symptoms were reported. The temperature excursion for PEDVAXHIB was supported with in-house stability data. Outcome of the event is unknown. No product quality complaint (PQC) was reported. Causality assessment was reported as not related to therapy with PEDVAXHIB. This case is related to MARRS# 1410USA015943, 1410USA015944 and 1410USA015945. Additional information has been requested.
Around 10 pm aches and muscle soreness were noted. Throughout the night following the booster shot I also experienced chills, fever, very strong headache, and aversion to food. I also got a migraine the next day. These were treated with rest and Tylenol and were resolved. On 1/24/22 I noticed strong itching sensation when I got up at 6 am. It was especially strong on my scalp. Throughout the day I had travelling hives on my body especially my back, neck, chest, and arms. I treated it with 1%  hydrocortisone cream which gave temporary mild relief. On 1/25/22 I had more severe hives that appeared and disappeared on various parts of my body, especially my ears, neck, arms, and trunk. I took Benadryl and used the 1% hydrocortisone cream but was still very itch most of the day. The issue has not been resolved at this time.
One eye shut close. Swelling of face and hands. Red spots on face. I am not sure vaccine caused this reaction.
she became violently ill; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (she became violently ill) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (one year ago) in 2020.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (she became violently ill). At the time of the report, ILLNESS (she became violently ill) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 test: positive (Positive) positive.         Concomitant medications details were not reported by the reporter. Treatment details were reported by the reporter.  The patient received the first dose of Moderna vaccine on 26Apr2021. She stated that 14 hours later, she became 'violently ill' for 3 days. The patient received the second dose of Moderna vaccine on 26May2021 and the same thing happened again. She became very sick.  Company Comment: This spontaneous case concerns an 87-year-old, female patient with relevant medical history of COVID-19 (unspecified date in 2020), who experienced the unexpected, non-serious event of illness after administration of the second dose of the Moderna mRNA-1273 vaccine on 26May2021. The start date of the event was not provided. The report stated that the patient became very sick. No further details were provided. Treatment information was also not provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable for the second dose. The medical history of COVID-19, which may cause Post-COVID syndrome, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-405713, MOD-2021-405744 (Patient Link).; Sender's Comments: This spontaneous case concerns an 87-year-old, female patient with relevant medical history of COVID-19 (unspecified date in 2020), who experienced the unexpected, non-serious event of illness after administration of the second dose of the Moderna mRNA-1273 vaccine on 26May2021. The start date of the event was not provided. The report stated that the patient became very sick. No further details were provided. Treatment information was also not provided. The outcome of the event was unknown at the time of the report. The rechallenge was not applicable for the second dose. The medical history of COVID-19, which may cause Post-COVID syndrome, remains a confounder. The benefit-risk relationship of the Moderna mRNA-1273 vaccine is not affected by this report.
pt recvd vax;2dec94 pt reported fine red nonraised rash to abdo especially joint swelling & pain;discussed w/ MD who advised on general care,believes possible rxn to MMR;
Information has been received on 15-FEB-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient was prescribed the ZOSTAVAX by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 30-AUG-2013, the patient was administered the ZOSTAVAX (lot number, expiration, dose and route unknown) by a pharmacist at a pharmacy. On an unknown date, the patient was treated by a physician at a physician's office for the following injuries resulting from the patient's ZOSTAVAX use: shingles. The patient claims damages as a result of injury to self and economic losses. The outcome of the event is unknown. The causality of the event is related. Additional information has been requested.
A report has been received from a Physician concerning an 8 year old, female subject, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent stared on 06-NOV-2014. The patient experienced patient tested positive for influenza which started on 02-DEC-2014. The outcome of the event of patient tested positive for influenza was unknown. The report was considered to be non-serious.