chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received dose from vials beyond 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date). On 14-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received dose from vials beyond 30-day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date of refrigeration was 07-05-2021 No relevant concomitant medications were reported. No treatment medication was  reported.
Patient shows inflammatory reaction in the left arm from the deltoid muscle to the elbow region.  It is warm to touch.
Information has been received from a Certified Medical Assistant concerning a 40 year old female patient with endometriosis and allergies to Cefzil and tetracycline and a history of vaginal cyst removal and tonsillectomy who on 10-MAY-2007 was vaccinated IM with a dose of Pneumovax 23, lot #655499/0988F. Concomitant therapy included Flonase, Elidel, Metrogel, Loestrin, Astelin and Pro-Air. On 11-MAY-2007, 24 hours after receiving the injection, the patient developed flu-like symptoms, was "burning all over the body", and had a temperature of 102-102.7 F. Red blotches developed on the same arm that the injection was administered. There was one red blotch that was the size of a quarter at the injection site. The red blotches covered most of her arm but were not continuous. The blotches were painful and warm to touch, but not itchy. The worst area was the inside of her arm. As of the report date, the patient had not recovered. Additional information has been requested. The reporter indicated that another patient also had red blotches on the arm that Pneumovax 23 was administered in. This is in follow-up to report(s) previously submitted on 7/30/2007. Information has been received from a Certified Medical Assistant concerning a patient who was vaccinated with a dose of PNEUMOVAX and on 11-MAY-2007 was seen in the office with large red blotches on the arm that the injection was administered in. The patient was started on unspecified antibiotics. The patient's outcome was unknown. Follow up information has been received from a health care professional concerning the 40 year old female homemaker with allergies to cefzil and tetracycline who on 10-MAY-2007 received her first dose of PNEUMOVAX (lot #655499/0985F) IM in left deltoid. The patient woke up the next day with flu like symptoms, fever of 100.2-102.7, burning sensation over body. She presented to office with erythematous patches on upper left arm. The patient also had a low blood pressure of 98/74. She was given 2 liters of IV fluid. After fluids her blood pressure went back to 121/80. On 14-MAY-2007 a CBC was within normal limits except high white blood cell count (11.0 thousand/uL); high absolute neutrophils (8712 cells/uL); and high C-Reactive protein (28.99 mg/dL). on 15-MAY-2007 the patient recovered. Additional information is not expected. The reporter indicated that another patient developed red blotches after receiving a dose of PNEUMOVAX.
Mom reported 30 minutes after getting MENACTRA and GARDASIL 9 vaccine, patient became feverish, chills, lethargic, headache and nauseated for 3-4 hrs. Patient slept must of the day and evening on the couch. He called in sick to work the next day and did not move until mid-morning. Right upper arm GARDASIL 9 injection site did get a "little" raised, red and tender for 2-3 days.
No reaction has happened. We gave the pt the Janssen vaccine because he said he had not had either Moderna or Pfizer and filled out paperwork saying the same. While we were logging immtrac stuff later in the day we say that he had received the first dose of Moderna on 3/19/21. We called the patient and he could not remember since he has severe memory issues. We called the clinic were it was given and confirmed. We instructed them to not give him a second shot and to flag it in their system. We then called the patient back and let them know. As of 1:00pm on 4/8/21 the patient has had now side effects.
was administered a vaccine punctured more than 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (was administered a vaccine punctured more than 24 hours) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (was administered a vaccine punctured more than 24 hours). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (was administered a vaccine punctured more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
PATIENT FELT LIGHTHEADED AFTER INITIAL 15 MINUTE WAIT TIME. PATIENT WAITED ADDITIONAL 15 MINS UNTIL HE FELT BETTER. PATIENT SYMPTOMS RESOLVED BEFORE HE LEFT.
Headache; Dizziness; Fatigue; Nausea; Swollen lymph node; Sore arm; This is a spontaneous report from a non-contactable consumer, the patient. A 60-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 10:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications included losartan (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN) and labetalol (MANUFACTURER UNKNOWN), all for unknown indication within two weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 20Mar2021, at 19:00, the patient experienced headache, dizziness, fatigue, nausea, swollen lymph nodes, sore arm. Adverse events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive treatment for the reported events. The clinical outcome of the events headache, dizziness, fatigue, nausea, swollen lymph nodes and sore arm was resolved on an unknown date in Mar2021.  Information about lot/batch number cannot be obtained. No further information is expected.
Severe allergic reaction with itching, hives erythema. No respiratory symptoms. Given oatmeal cream, Benadryl, Solu-medrol IM and symptoms subsided. Given oral prednisone and instruction when to call and/or go to ER.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information on patients' concurrent conditions, medical history or drug allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX (Merck) injection (Lot number L003775 and expiry date 04-FEB-2017) (dosing regimen and route were unknown). No information on patients' concomitant medications was provided. No adverse effects were reported. Lot number L003775 had been verified to be a valid lot number for VARIVAX (Merck). Follow-up information has been received on 03-AUG-2015. All telephone attempts to obtain follow up information had been unsuccessful. Follow-up information has been received on 05-AUG-2015. The Certified Medical Assistant reported that she would have to research the request made for patient identifiers, lot number, expiration date and dates of vaccination. The company fax number was reviewed with the reporter, if information becomes available. Follow-up information has been received from the medical assistant's clinic on 22-OCT-2015. The patient was 12 month old. The patient was vaccinated with improperly stored dose of VARIVAX (Merck) on 15-SEP-2015. This is one of the several reports received from the same reporter. Additional information has been requested. Patient, event, product and narrative information was updated.
Medical assistant calling to report a dose of VAQTA that was administered after its expiration date. Date expired: 5/2/2022, date administered: 5/12/2022. Caller verified that the vaccine had no undergone any temperature excursions. No PQC. No addtio; This spontaneous report was received from a medical assistant, referring to patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 12-MAY-2022, the patient was vaccinated with and expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) lot# U003450, expiration date 02-MAY-2022, for prophylaxis (strength, dose, route and frequency were not reported) (Expired product administered). The vaccine had not undergone any temperature excursions. No PQC. No additional information.
2/29/12 - fever, back pain, neck pain - Tx: NAPROSYN. 3/12/12 - back pain, joint pain, swollen lymph nodes-neck, fatigue. Labs ordered: EBV twice, CMV titre, ANA, CRP, ESR, Lyme titre, CMP. 3/16/12 - phone call from parent: c/o arm pain & numbness - rheumatologist referral made.
Information has been received from a nurse concerning a female patient in her early twenties who was vaccinated intramuscular with her first 0.5 ml dose of GARDASIL. The patient became lightheaded and needed to lie down for 5 minutes after administration. The patient had gone several hours without eating prior to receiving GARDASIL. She has since received two more dose of GARDASIL without any problems. The patient has sought medical attention at office and had recovered (date unknown). Additional information has been requested.
localized swelling in area of inj site @ lt deltoid w/circumference of 4" accompanied w/erythema;no other sx reported;swelling reducing p/24 to 48hr;
This is a spontaneous report from a contactable consumer, the patient. A 68-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6213) via an unspecified route of administration in right arm on 18Mar2021 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high, diabetes and allergic to ibuprofen. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER6198) via an unspecified route of administration in left arm on 25Feb2021 at 12.15 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Mar2021 at 1600, the patient experienced injection site pain, 101.3-degree fever, chills, joint pain, headache, tiredness, feeling unwell, chest pain, dry throat and dry sinuses. No treatment was received for the adverse events. The clinical outcome of injection site pain, 101.3-degree fever, chills, joint pain, headache, tiredness, feeling unwell, chest pain, dry throat, dry sinuses was resolved on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Extreme fatigue and exhaustion which onset several weeks after vaccination and has persisted until today. This symptom has necessitated daily naps, late afternoon/early evening bedtimes, and made work difficult.
Woke the day after vaccination with severe pain in right hip and leg extending to right foot. This soon led to "foot drop" with severe sciatic pain. Received steroid shots from doctor as well as spinal shots from pain management specialist. Also received chiropractic care approx. 2 months. Currently receiving physical therapy for drop foot encompassing electrical stimulation and foot drop brace.
Prodrome of headache and gastric upset over 2 days following second dose.  Then felt fine.  Found the following day dead in bed.  Autopsy pending
Patient was given 3rd Moderna vaccine. Vaccine was #21 out of a vial that should only have had #20 drawn out of it.
Patient experienced intense leg cramping and nausea after receiving FLUCELVAX. The patient stated that her symptoms were those of when she consumed eggs.
Rash onset 1/27. Fever? Runny nose, loose cough.
24 hours after the injection there were 2 red spots near injection site. Then we noticed there were 2 more in a line up his left shoulder and 5 more making a line that track up his left check and end above his eye. At this time (24 hours after vaccine) Then at 31 hours after vaccine a;; of these marks became indurated and quite firm. it was only at 4.5 days after injection that induration became to lessen.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 30Sep2021 as dose 3 (booster), single (Lot number: FC3184) at the age of 30 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Blood Pressure" (unspecified if ongoing); "bicuspid aortic valve" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Reoccurrence/rebound of Covid symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19. No follow-up attempts are possible. No further information is expected.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. Pharmacist reported that sometime in 2007 and 2008, an unspecified number of patients received improperly stored doses of GARDASIL (dose, route and lot number not reported). However, he stated that more dates were involved (unspecified what the other dates were) and multiple patients were involved (unspecified number). He did not have patient information. No symptoms were reported. This is one of several reports from the same source. Additional information has been requested.
No additional AE information provided; an unspecified number of patients were administered an improperly stored dose of VARIVAX since 2/27/2020; This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent.  Since 27-FEB-2020, the patients were vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) with lot # S010297, expiration date 03-APR-2021 (dose number, frequency, route of administration, anatomical location were not reported) for prophylaxis (product storage error).  Temperature excursion of this vaccine was minus 14 degrees Celsius to minus 10 degrees Celsius (minus 10.4 degree Celsius) for 6 hours 2 minutes. There was no previous temperature excursion. No additional adverse event was reported. Data logger was involved.  This is a non-valid case due to lack of patient identifiers and unspecified number of patients.  Follow up information has been received on 29-JUL-2020, the medical assistant was not about to talk due to office being busy. Telephone call and fax numbers were provided.  Follow-up information has been received from the medical assistant on 26-AUG-2020.  The case is valid. The identifiers of 8 patients were provided.  The patient was 1 year old. On 13-MAR-2020, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX).  This is one of the eight reports from the same reporter.; Sender's Comments:  US-009507513-2008USA013489: US-009507513-2008USA013494: US-009507513-2003USA007542: US-009507513-2008USA013492: US-009507513-2008USA013493: US-009507513-2008USA013488: US-009507513-2008USA013490:
blood clot in the lungs; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (BNT162B2), first single dose via an unspecified route of administration, administered in arm right on 10Sep2021 (Batch/Lot Number: FC3182) for covid-19 immunisation at age of 50-year-old. The patient was not pregnant at vaccination. Medical history included covid-19. No other vaccine received in four weeks. There were no concomitant medications. There was no covid tested post vaccination. The patient experienced blood clot in the lungs (death, life threatening) on 21Sep2021. No treatment received for the event.  The patient died on 21Sep2021. It was unknown if an autopsy was performed.   Follow-up attempts are completed. No further information is expected.; Reported Cause(s) of Death: blood clot in the lungs
I have no idea if this is related to taking the vaccine, but I thought I would report it in case. Patient took the vaccine on Monday Nov 8. On Wed Nov 10 he had a routine check-up with the pediatrician. The doctor today called me and told me his LDL cholesterol level is 167 which is high. He had not fasted for the test and will be retested end of Nov. He is skinny, active, and eats well so a high cholesterol reading is surprising. Since it was so close to the vaccine (he also took a flu vaccine one week prior) I thought I would report it.
Shot was given at shoulder/arm joint, and resulted in pain, swelling, fever for about 1 month, after that, only the shoulder pain, which renders me unable to do many things, and many days cannot move more than a few inches.
Severe nerve pain in left arm. Hand and fingers kept going numb. High fever 103. Aches and pains all throughout body.
Initial misuse report received from a healthcare professional on 22 October 2013.  A patient under the age of 35 months had received 0.5 ml dose of FLUZONE on an unspecified date. No adverse event was reported. List of documents held by sender: none
Patient passed out and became unresponsive. An ambulance was called and she was taken to the hospital. We are unsure of outcomes at this time.
itchiness in the palms of his hands; This is a spontaneous report from a contactable consumer (patient's daughter) reported for the patient. A 89-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 11Feb2021 at 16:00 pm (age at vaccination was 88 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient's concomitant medications were not reported. The caller was calling on behalf of her dad who received the first dose of the vaccine on last Thursday, 11Feb2021 around 16:00 pm. The patient was fine while he was waiting at the vaccination site for 15-20 minutes and on the ride home, and when she called to check on him at 20:00 pm that evening he was fine. But when she spoke with him again she said he reported later in the evening he had some itchiness in the palms of his hands at bedtime. Itching began the same day on 11Feb2021 at 22:30 pm. She asked if that was an allergic reaction and wanted to know whether that was pointing towards an allergic. She stated that by the next morning the itching was gone, he got the shot at about 16:00 pm and then he was experiencing the itching at about 22:30 pm and then in the morning the next day, he wasn't having anything. She could not think of anything else it could been unless it was hand sanitizer. She stated that she had been hearing that the second dose was the one that can make people not feel good. She stated she was also hearing that it was more prevalent in the younger people that have more robust immune systems. She asked if that was true. The case was reported as non-serious. The outcome of the event was unknown.  Follow-up (16Feb2021 and 13May2021): New information received from a contactable consumer reported for a patient included: Updated the patient's demographics, age at vaccination (88 years) and details regarding follow-up attempts (Follow-up attempts completed. No further information expected).
Feeling dizzy after 24 hours of receiving the first shot of the MODERNA COVID vaccine. Ater three days, felt the house was spinning when waking up.
no adverse event; multiple patients were vaccinated with an improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 18-JUN-2019, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 ml, orally, LOT# R027157, expiry date 14-JUL-2020 for prophylaxis. The vaccine was exposed to a temperature of 34.2 F for 4 hours and 54 minutes. This call was made because of a digital data logger. There were no previous temperature excursions. No adverse effects were reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-1906USA011674: US-009507513-1907USA000862: US-009507513-1907USA000882: US-009507513-1907USA000883: US-009507513-1907USA000884: US-009507513-1907USA000885: US-009507513-1907USA000886: US-009507513-1907USA000887: US-009507513-1907USA000889: US-009507513-1907USA000890: US-009507513-1907USA000891: US-009507513-1907USA000892: US-009507513-1907USA000893: US-009507513-1907USA000894: US-009507513-1907USA000895: US-009507513-1907USA000896: US-009507513-1907USA000897: US-009507513-1907USA000898: US-009507513-1907USA000899: US-009507513-1907USA000900: US-009507513-1907USA000901: US-009507513-1907USA000902: US-009507513-1907USA000904: US-009507513-1907USA000905: US-009507513-1907USA000906: US-009507513-1907USA000907: US-009507513-1907USA000908: US-009507513-1907USA000909: US-009507513-1907USA000910: US-009507513-1907USA000911: US-009507513-1907USA000912: US-009507513-1907USA000913: US-009507513-1907USA000914: US-009507513-1907USA000915: US-009507513-1907USA000916: US-009507513-1907USA000917: US-009507513-1907USA000918: US-009507513-1907USA000919: US-009507513-1907USA000920: US-009507513-1907USA000921: US-009507513-1907USA000922: US-009507513-1907USA000923: US-009507513-1907USA000924: US-009507513-1907USA000925: US-009507513-1907USA000926: US-009507513-1907USA000927: US-009507513-1907USA000928: US-009507513-1907USA000929: US-009507513-1907USA000930: US-009507513-1907USA000931: US-009507513-1907USA000932: US-009507513-1907USA000933: US-009507513-1907USA000934: US-009507513-1907USA000935: US-009507513-1907USA000936: US-009507513-1907USA000937: US-009507513-1907USA000938: US-009507513-1907USA000903: