chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse referring to multiple unspecified patients of unknown gender and age. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M010212, expiration date 21-JAN-2019, lot # L016427, expiration date 13-APR-2017 and lot # L045117, expiry 06-OCT-2018; dose and route were unknown). No adverse effects were reported. The reporter stated that the vaccines were exposed to 52 Fahrenheit degree for 15 hours and then they backed in range. There were no previous temperature excursion. No product quality complaint was involved. This is one of several reports received from the same reporter. Follow up information has been received on 17-SEP-2016. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested. Narrative was updated.
Fatigue, chills, nausea.  No treatment.  11am to 2 pm 11/23/2021.
V ARlV AX and MMR II that underwent multiple temperature excursions had been administered to patients.; no adverse event; This spontaneous report was received from a medical assistant regarding a 17 month old patient of unknown gender.  No information regarding concurrent conditions, medical history or concomitant medications was provided.  On 06-MAR-2021, the patient was administered improperly stored varicella virus vaccine live (Oka/Merck (VARIVAX) lot number T020652,  expiration date 16-JUN-2022 and recombinant Human albumin (rHA) Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II)  lot number S035352, expiration date 05-NOV-2021, for prophylaxis (dose number, route of administration, anatomical location, vaccination scheme was not reported). The involved vaccines underwent a temperature excursion of -14.03 degrees Celsius for 1 hour 15 minutes, -14.9 degrees Celsius for 9 minutes, -10.3 degrees Celsius for 1 hour and -6.3 degrees Celsius for 2 hours.  This information was due to a digital data logger, and there were previous temperature excursions of -14.03 degrees Celsius for 1 hour 15 minutes and -14.9 degrees Celsius for 9 minutes. No additional adverse events were reported.
Breakthrough COVID infection. Generalized body aches and fever with unsure onset. Tested positive 08/04/2022.
PNEUMOVAX 23 to (R) deltoid - edema, redness, pain, induration at injection site. Patient was hospitalized a few days after immunization for strep and pyelonephritis, treated with steroids and vancomycin. Had 103 fever. At 6 wks out induration at site still present.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 14-MAR-2017, the patient was vaccinated with an expired dose of VARIVAX lot # L008271 with expiration date 11-MAR-2017, for prophylaxis (dose and route were not reported). It was stated that the patient did not experience any adverse effect. A product quality complaint was not involved. Additional information has been requested.
Patient called complaining of pain in his left arm. He said it does not look infected and its only muscle pain. He said that the pain has gotten better but it still hurts.
Chills, headache, nausea tiredness and high fasting blood sugar. My fasting sugar as a diabetic is normally under 100. I woke up the next day wit my blood sugar at 300 requiring extra insulin. It took most of the day to bring my sugar level down to normal.
Red circular raised rash noted at injection site a few hours after received Moderna booster shot. The injection site was hardened, raised, hot to touch, and sore. Currently, bring treated with bactrim.
The dose was administered to the patient after expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The dose was administered to the patient after expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants are provided No treatments are provided.  The caller had a vaccine documented as expiring in November but the system had the lot number incorrect by one letter. The actual expiry date was October 10th 2021. Lot: 006C21A
rt arm began aching & hurting on day of vax;next morning, stiff neck on rt, back hurting in right;7x8 cm induration on rt arm-t100;APAP & DPH;
Child went limp within 10 minutes of receiving vaccine, skin turned gray and had circumoral cyanosis.  The Child's skin was clammy and he appeared disoriented.  He would not respond to mother or nurse.  His eyes remained open but his eyelids kept fluttering.  Child was transported by ambulance to emergency room.
When went to check up at dr office baby went limp no response this happened twice - went to hospital because dr office said was fine - was transported to NICU has spikes in brain that are unexplained.
This spontaneous report as received from a health professional via physician refers to a patient of unknown age and gender. On 22-AUG-2013 the patient was vaccinated intramuscularly with the first 0.5 ml dose of GARDASIL. On 01-MAR-2014 the patient was vaccinated intramuscularly with the second 0.5 ml dose of GARDASIL. On 12-MAY-2014 the patient was vaccinated intramuscularly with the third 0.5 ml dose of GARDASIL dose. No adverse effect was reported. Additional information has been requested.
CHILLS, BODYACHES, FEVER,  MILD HEADACHE,  SYMPTOMS STATRED @0100. LASTED 20HOURS
pt became will on 22OCT97 w/ fever 102 & swelling RUA was seen in the ER on Wednesday & was started on IV ATB x 4 days & PO ATB x 5 days;dx cellulitis rt upper arm;
This spontaneous report was received from a nurse refers to a 4 months old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 10-OCT-2017, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012: US-009507513-1709USA007013: US-009507513-1709USA000054.
pt came in today with a 1 inch by 1/2inch yellowing-bruise on her arm - she said it was there the next day after her flu shot- arm doesn't hurt to move - muscle hurts a little
Lower back pain; Fatigue; This spontaneous case was reported by an other caregiver and describes the occurrence of BACK PAIN (Lower back pain) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced FATIGUE (Fatigue). On 19-Apr-2021, the patient experienced BACK PAIN (Lower back pain). At the time of the report, BACK PAIN (Lower back pain) and FATIGUE (Fatigue) outcome was unknown.            Concomitant medications were not reported Treatment received in response to the events was not reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. This spontaneous case was reported by an other caregiver and describes the occurrence of LOW BACK PAIN (Lower back pain) and FATIGUE (Fatigue) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  On 19-Apr-2021, the patient experienced LOW BACK PAIN (Lower back pain). At the time of the report, LOW  BACK PAIN (Lower back pain) and FATIGUE (Fatigue) outcome was unknown.; 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.
The vaccine was administered 7/15/2022 and I had an eye stroke (ischemic retinal) on my right eye.    I could only see  through the bottom portion of my right eye.  The top half was gray, completely non-transparent.    After 15-20 minutes, the gray began to dissipate from right to left.   Eye vision has been normal since the episode.
This spontaneous report was received from a pharmacist refers to a patient of unknown demographics. Patient's pertinent medical history and drug allergies were not reported. On an unknown date in April 2014, patient received his or her second dose of GARDASIL (dose, frequency, product lot #, expiration date not specified). On an unknown date in December 2014, the patient was present in the office to receive the third dose. Concomitant medications were not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. Causality was reported as not related to GARDASIL. This is one of several reports received from the same source (MARRS # 1412USA013447). Additional information has been requested.
After receiving the second dose of Moderna I started feeling fatigue and sleeping more often. I was also having having menstrual bleeding for weeks on and off. Started getting Petechiae and did blood work. Platelets came back at count of 40. Prior blood work done in October 2020 7 months before receiving covid vaccine and platelets were at 246. I have no history of low platelets or any health issues until the after the vaccine.
Sore arm; tiredness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a representative. The reporter is the patient.  A 50-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Nov2022 at 12:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 50 years intramuscular for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Nov2022, outcome "unknown", described as "Sore arm"; FATIGUE (non-serious) with onset 27Nov2022, outcome "unknown", described as "tiredness". Therapeutic measures were not taken as a result of pain in extremity, fatigue.  Additional information: It was unknown, if patient receive other vaccines within four weeks prior to COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
SHORTLY AFTER RECEIVING VACCINE FELT SLIGHT ACHE/BRUISED SENSATION AT THE VACCINATION SITE WITH WARMTH, REDNESS, TENDERNESS. 5X5 CM AREA OF WARMTH, REDNESS, TENDERNESS.
This case was reported by a consumer and described the occurrence of sneezing in a 90-year-old female patient who was vaccinated with influenza vaccine (manufacturer unspecified). A physician or other health care professional has not verified this report. The patient's past medical history included high blood pressure and sick. The patient reported that with the pneumonia vaccine (non-GSK) last year that she got sick. Concurrent medical conditions included diabetes, osteoporosis and pain. Concurrent medications included Valsartan+hydrochlorothiazide, ZOLOFT, citalopram, metformin, LASIX, clopidogrel, vitamin D, vitamin complex, CENTRUM, meloxicam and influenza vaccine. Co-suspect medication included ADVAIR. On September 2013 the patient started fluticasone propionate+salmeterol xinafoate 100/50 mcg (inhaled) at 1 puff(s) twice per day. On September 2013, the 50-year-old patient experienced wheezing. The dose of fluticasone propionate+salmeterol xinafoate was increased from ADVAIR 100/50 mcg to ADVAIR 500/50 mcg. On the ADVAIR 500/50 mcg, patient experienced unexpected benefits. At the time of reporting, the outcome of the wheezing was worse. On 08 November 2013, the patient received influenza vaccine (unknown route/dose, left arm; manufacturer unspecified). In November 2013, within 2 days of receiving the influenza unspecified, the 91-year-old patient developed sneezing and cold. At the time of reporting, the sneezing and cold were improved. Caller transferred from GSK Access program. She was seeking assistance to get back on ADVAIR medication. She used the product for about 2 months and is not able to continue to afford the medication. She noted that she had been a new person since starting the 500/50 ADVAIR. She began taking the 100/50 in September after she developed bronchitis and it became difficult to breathing. She did feel some improvement with the 100/50, however upon her return visit the Dr. noted she needed something stronger due to her wheezing. She was then placed on the 500/50 diskus at one puff a day and she feels like a new person. She is able to walk with a single cane now, from a walker, her sinuses are clearer. She was unable to afford the next diskus she has been placed on nebulizer treatments with PROFORM MIST and budesonide for her breathing. She states on these she is sleepy, has no energy, has a hard time breathing, she's worn out, she has had to go back to using a quad cane, and she is dizzy all the time. She added her blood pressure is 138/70 and her pulse is 60, so it is not due to those. She notes her sputum remains clear but alot. Caller noted she had also received a flu vaccine on 08 November 2013, of unknown manufacturer at pharmacy. She states it was in her left arm and that within a couple of days she was sneezing and then she got a cold. She is still sneezing but it has improved. The patient reported events with previous flu shots. See A1050442A for details.
diffuse arthralgias; pain in the plantar fascia; flushed w/o fever; pins & needles sensation diffusely (face, arms, legs),; fatigue; This is a spontaneous report from a contactable physician. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 01Apr2021 at 13:15 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, Graves' disease, seasonal allergy, migraine, cerebral aneurysm and the patient was allergic to sulfa drugs and IV dye. Concomitant medications included thiamazole (METHIMAZOLE), taken chronically for thyroid disorder from an unknown date. The patient previously took melatonin and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en7534) via an unspecified route of administration in the left arm on 11Mar2021 at 14:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Apr2021, the patient experienced diffuse arthralgias, pain in the plantar fascia, flushed without fever, pins and needles sensation diffusely in face, arms, legs and fatigue. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events and included treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDS), benadryl, baby Acetyl Salicylic Acid (ASA), tylenol and prednisone one daily. The patient reported that there was no relief with NSAIDS. The clinical outcome of the events diffuse arthralgias, pain in the plantar fascia, flushed without fever, pins and needles sensation diffusely in face, arms, legs and fatigue were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Pharmacy student injected into my left deltoid. Blood started running down my arm immediately and took several minutes to hold pressure and stop the bleeding.   I've been having vertigo since the injection
After a day of fatigue and fever, which I experienced with the first shot too and didn't worry me, around 4 PM on the day after I got the shot I started having difficulty breathing. It felt like there was a large pressure pushing down on my diaphram keeping me from taking even small breaths, and if I tried I'd cough. After about two hours of this I took ibuprofen and that relieved the pressure entirely. It came back around 2 AM and once I got up around 8 I took more ibuprofen, but I still feel some pressure.
Information has been received from a physician concerning a female student who was vaccinated "twice in her childhood" with a dose of MMR II. It was reported that she may have been vaccinated in another country. The physician reported that the pt experienced did not develop immunity to mumps. Unspecified medical attention was sought. Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of adverse event in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination not reported. The patient had tendency to have reactions to vaccines and always had a weird reaction to the flu vaccine. She did not provide any further details regarding that. The patient did not consent to follow-up. This case was linked with US2018225911, reported for the same patient.
patient was given an expired vaccine/no AE; Initial information received on 26-Mar-2021 and additional information received on 12-Apr-2021 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 13 years old male patient who received expired dose of IPV (VERO) [IPOL].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE for Immunisation.  On 12-Apr-2021, the patient received a 0.5 mL dose of suspect IPV (VERO) (lot R1B251M, expiry date- 13-Mar-2021, Injection) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  The caller would like to know if the patient must be revaccinated and if so, when is it safe to revaccinate the patient. The caller also wants to know of any possible side effects for the patient at this time. Treatment- will be repeated.  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 holder's 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.
Patient stated that she did not feel well. Increased perspiration, felt hot, racing heart. Temperature taken and normal 98.1 degrees Took oral Benadryl and went to ER shortly thereafter.
I have ?Covid Arm?. It has been eight days since my first shot and suddenly today I noticed that the injection site started to swell, turn red and hurt. It?s also a little itchy. I also started feeling very tired and got a head ache.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at time of arrival) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. On 1-Dec-2021, vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 2C to 8C. Treatment information was not reported.