chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vial expired on 17-Apr-2022, stored in refrigerator on 18-Apr-2022 and administered on 19-Apr-2022.; patient was administered an expired dose of the vaccine for the booster; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of the vaccine for the booster) and PRODUCT STORAGE ERROR (Vial expired on 17-Apr-2022, stored in refrigerator on 18-Apr-2022 and administered on 19-Apr-2022.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016J21-2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CARVEDILOL, VARENICLINE and VITAMIN C [ASCORBIC ACID] for an unknown indication.    On 19-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of the vaccine for the booster). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial expired on 17-Apr-2022, stored in refrigerator on 18-Apr-2022 and administered on 19-Apr-2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered an expired dose of the vaccine for the booster) and PRODUCT STORAGE ERROR (Vial expired on 17-Apr-2022, stored in refrigerator on 18-Apr-2022 and administered on 19-Apr-2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that patient received 1st booster dose. Treatment medications were not provided.  It was reported that the vial was stored in refrigerator after expiry on 18-Apr-2022. The vial did not undergo any temperature excursion.
This patient received yellow fever injection at 9:15 AM, symptoms occurred at 9:45 AM. The patient was sent to the ER with flushing, itching, dyspnea, nasal-ocular systems, burning skin.
FEVER ON NIGHT OF VACCINES WITH A RASH ON THIGHS  & FEVER.  10/06/2022 10/07/2022 RASH ON TRUNK AND VOMITING WITH FEVER.  GAVE TYLENOL FOR RELIEF ON FEVER, BROKE OUT IN RASH MORE. MOTHER DISCONTINUED TYLENOL AND PATIENT HAD FEBRILE SEIZURES.
This is a spontaneous report received from a contactable consumer via a Pfizer-sponsored program COVAX US SUPPORT. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had stroke like symptoms and he may have had a TIA or a migraine stroke. He was in hospital for 2 to 3 days. His second shot is scheduled. No lab test were reported. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
PT HAD A REACTION 10 MINUTES AFTER RECEIVING THE COVID VACCINATION.  PT STARTED HAVING SEIZURE LIKE ACTIVITY THAT LAST 30 SECONDS ABOUT 10 MINUTES POST COVID SHOT; PT WAS SENT TO THE ED BY RAPID RESPONSE TEAM.  PT WAS CHECKED OUT, DR THOUGHT IT TO BE A BASAVAGAL RESPONSE,BUT MONITORED HER IN THE ED. SHE WAS GIVEN NS BOLUS.  AFTER MONITORING PT SHE WAS DISCHARGED.
they are both experiencing sharp pain in the lower abdomen.; it kind of feel like cramps on my arms; This is a spontaneous report received via Medical Information Team and from a contactable consumer (patient). This 28-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number and expiry date- UNKNOWN) via an unspecified route of administration (at the age of 28-years-old) on an unspecified date as single dose for covid-19 immunization. Relevant medical history and concomitant medications were not reported. On an unknown date, the patient had sharp abdominal pain on my right side and then now it started to basically spread and feel like cramps on my arms and abdominal side. Outcome of the events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received Hepatitis B Vaccine as a child but they did not have hepatitis B antibodies when tested around age 9-10.; Currectly currently 16-17 years of age and antibody test was again negative; This spontaneous report was received from a physician via a company representative, referring to a child patient of unknown exact age and gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.     On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant)(manufacturer unknown) for prophylaxis (dose, route of administration, lot number, and expiration date were not reported).        Physician stated that their patient received hepatitis b vaccine (recombinant)(manufacturer unknown) as a child but they did not have hepatitis B antibodies on an unknown date, when tested around age 9-10 (hepatitis b surface antibody negative). Then, on an unknown date, patient was given a second series of 3 hepatitis b vaccine (recombinant)(manufacturer unknown) immunizations and the patient did have hepatitis B antibodies when they were checked around 1 year after second series. However, on an unknown date, the patient was currently 16-17 years of age and antibody test was again negative (hepatitis b surface antibody negative). It was unknown if the patient received treatment for the events. No additional adverse events.  At the reporting time, the outcome of both occurrences of hepatitis b surface antibody negative was unknown. The causality assessment between hepatitis b vaccine (recombinant)(manufacturer unknown) and the event was not reported.
Patient reports feeling some dizziness 5mins into wait s/p vaccine.  PO2=98%; HR=64. BP refused. Color WNL. Had breakfast but no lunch.  Provided saltines & water.  Patient stated felt better after saltines. @2:04pm: PO2=98%, HR=65.  Patient states dizziness resolved.  Assisted to car via w/chair; accompanied by her caretaker.
Pain in left back shoulder blade after 2 days; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Apr2021 at 16:15(at the age of 61-year-old) as a single dose for COVID-19 immunisation. Relevant medical history included rheumatoid arthritis (RA) and asthma. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), methotrexate (MANUFACTURER UNKNOWN), furosemide (FUROSIMIDE) and spironolactone (SPIRONOLACTON); all for unknown indication from an unknown date. The patient previously 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 17:00 (at the age of 61-year-old) for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021 at 16:00, the patient experienced pain in left back shoulder blade after 2 days. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event pain in left back shoulder blade after 2 days was not recovered at the time this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
patient called the day following vaccine administration to report a few small itchy bumps on her lower arm after receiving the Arexvy vaccine in the same arm.  Followed up with patient and the bumps are clearing up. Today (10/2) she reports that there is no more itching and less bumps
Nausea/vomiting, diarrhea, unable to move, severe headache.
Initial and follow-up information has been received from a physician concerning a 16 year old female patient with no known allergies who on an unspecified date, was vaccinated with 0.5 ml of a second dose of GARDASIL (lot# 659439/1267U), fainted and was pale post vaccination. Subsequently, the patient receovered from her experienced. No other information available. This is one of several reports from the same source. No further ifnormation available. The physician was not certain if the event occurred after the patient's first or second dose of GARDASIL but knew it was definitely not with administration of the third dose.  Additional information has been requested.  This is one of several reports from the same source.
One day after the vaccine, I could not move my arm upward, swollen, red rashes appeared, very painful. I went to Immediate Care who prescribed antibiotics 3 times a day for seven days and steroid cream for my arm. That same evening, felt like Flu symptoms, could not sleep well. By the 4th day Oct. 28 was feeling better but still slight headaches.
Onset 9/19/19 at 7:30 pm of bout of severe crying.  Went to Ed 09/20/19 at 0400.  Ultrasound showed transient Intussusception of the small bowel.  Pt admitted to hospital for 1 day and resolved on its own.
I have had a sharp pain in my left arm that stems from the injection site with any movement of my left arm. This has been going on for exactly one month now. Since the vaccine
Mother reported that patient passed out and his lips turned blue. His symptoms lasted for 6 hours and has been resolved.
This spontaneous report has been received from a medical assistant referring to a female adult patient of an unknown age. The patient's medical history, drug and allergy and current condionts were not reported. It was reported that on 15-MAY-2017 the patient was vaccinated with a properly stored dose of PNEUMOVAX23 with a lot number: M006139 and an expiration date on 13-MAY-2017. The patient's concomitant therapies were not provided. No adverse effects were reported. Additional information has been requested.
(L) upper arm, edematous, hot to touch and erythematous. IZ given at 10 am - swelling started 5 pm on same day=3/2/11 size 10cm x 9cm.
Patient had his second Moderna COVID vaccine on 5/7 while at dialysis. He would then have a stroke a few hours later. He did receive TPA as well as thrombectomy, without significant improvement in his deficits.
Throiditis - Inflammation of the thyroid Slightly visible goiter 30 Lb weight gain in 1-2 months of getting the vaccine +1 Pitting Edema to Bilateral ankles Horrible  mood swings Increase in depression and anxiety All related to new Throid issue Never had history of throid or any issues, EVER
Woke up the day after vaccination with fever of 101. Headache, tiredness, soreness all over. Lasted until about 7:00 PM. Took ibuprofen throughout the day. At around  9:00 PM, my arm started getting red, hot, and swollen at injection site.
This spontaneous report was received from a pharmacist via company representative refers to a 80 year (reported as patient in his 80s) old male patient. The patient was vaccinated with ZOSTAVAX, (lot number, expiration date and route was not reported) on 23-JAN-2013. No concomitant medications were reported. On 23-JAN-2013, the patient experienced intermittent loss of vision after receiving ZOSTAVAX, within the same day of administration. The outcome of the event was unknown. The patient did not seek medical attention. Additional information has been requested.
Matter coming out of ear; This is a spontaneous report from a contactable consumer or other non hcp (patient's friend). A male patient of an unspecified age received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on an unspecified date, as a SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced matter coming out of ear. He dunked his head under water, and it helped him, but it didn't work for her. Her friend said his has gotten better. On an unspecified date, the outcome of the event was recovering.  Communication: Report 2 of 3. Caller declines to complete a full report. Additional details unable to be obtained.  Information about batch no/lot no has been requested.
#Hypoxic resp failure in setting of Covid 19 D-Dimer 6.46 today  Supplemental O2 Dexamethasone 6 mg daily  He is not a candidate for Remdesivir due to renal failure.
This spontaneous report as received from a company representative refers to a nurse/patient of unknown age. The patient was vaccinated with ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. On an unknown the date of the nurse experienced itchy, hands, prickleness, flushing and redness after she administers ZOSTAVAX to patient. And redness on her neck. Patient is the nurse who told the rep she received ZOSTAVAX a few years ago and is experiencing adverse reaction when she administers ZOSTAVAX to patients, the reactions have occurred 30 to 40 minutes after reconstitutioning and administering ZOSTAVAX to patients and has happened four or fives times even when the nurse wears gloves. The outcome of itchy, hands, prickleness, flushing and redness after she administers ZOSTAVAX to patient. And redness on her back is unknown. The relatedness for itchy, hands, prickleness, flushing and redness after she administers ZOSTAVAX to patient. And redness on her neck is unknown for ZOSTAVAX. Additional information is not expected.
headache; body aches; fever; chills; nausea; swelling; redness at injection site; hardness; muscle aches; A spontaneous report was received from a healthcare professional concerning a 67-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events body aches, headache, fever, chills, muscle aches, nausea, swelling, hardness, redness at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031L20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 10 Feb 2021, the patient experienced the event(s) body aches, headache, fever, chills, muscle aches, nausea, swelling, hardness, redness at injection site.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), body aches, headache, fever, chills, muscle aches, nausea, swelling, hardness, redness at injection site was unknown.
Inflammation in left elbow and shoulders; Hand inflammation; After COVID vaccination felt run down for a day or two; This spontaneous case was reported by a consumer and describes the occurrence of DEPRESSED MOOD (After COVID vaccination felt run down for a day or two), ARTHRITIS (Inflammation in left elbow and shoulders) and INFLAMMATION (Hand inflammation) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    The patient's medical history was not reported.  Concomitant products included METHOTREXATE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Solution for injection in pre-filled pen. In 2021, the patient experienced DEPRESSED MOOD (After COVID vaccination felt run down for a day or two). On an unknown date, the patient experienced ARTHRITIS (Inflammation in left elbow and shoulders) and INFLAMMATION (Hand inflammation). In 2021, DEPRESSED MOOD (After COVID vaccination felt run down for a day or two) had resolved. At the time of the report, ARTHRITIS (Inflammation in left elbow and shoulders) and INFLAMMATION (Hand inflammation) had resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The causality for event after COVID vaccination felt run down for a day or two with Humira(Adalimumab) was no reasonable possibility.  No treatment information was provided by the reporter.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.; Sender's Comments: Company comment: This is a spontaneous case concerning a 78-year-old female patient with Rheumatoid arthritis on treatment with Adalimumab and Mehotrexate, who experienced the serious (medically significant) unexpected event arthritis, on an unknown date after the second dose of mRNA-1273. Patient report inflammation in left elbow and shoulders. Additional Clinical findings, diagnostic tests and treatment details were not provided. Adalimumab was reported as a co-suspect product. Events was reported as non serious and upgraded seriousness as per IME list. The benefit-risk relationship of mRNA-1273 is not affected by this report.
This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2018, reported as on an unspecified date since 09-JUL-2018, the patient was vaccinated with improperly stored dose of PEDVAXHIB (lot # N024570 with expiration date: 01-MAY-2020) or (lot# N024571 with expiration date: 01-MAY-2020) intramuscularly (dose and frequency were not reported) for prophylaxis. No adverse effects were reported. The vaccine was exposed to a temperature excursion of 47 to 77 degrees Fahrenheit (F) (57 degrees Fahrenheit (F)) for 14 hours. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1808USA006189.
Itchy rash near moderna booster shot injection site. It also appears to be a bit swollen and red under the injection site a few inches and a burst capillary just below  the swelling.
A consumer report has been received concerning a, male patient. The patient had received FLUMIST, once/single administration. Reporter stated that a male child received last years FLUMIST vaccine intranasally 2014 to 2015 season. The reporter stated that the patient tested positive for the flu after he received last years FLUMIST vaccine 2014-2015. The reporter stated an adverse event for himself as well submitted under IL207058. No additional information provided. Action taken was continuing. The outcome of the tested positive for the flu was unknown. The company physician considered the tested positive for the flu to be non-serious.
Since June 1999, the pt has experienced pain in her right arm, which hurts all the time. she also has diminished strength in her hand as she cannot raise it.
IPV, MMR, Varicella given within 2 to 3 minutes. Became pale, sweaty, hemorrhagic, rash, .5cm size, covered scalp and down forehead to a few around eyes. Smaller lesions. Sent to ER and given Benadryl. Discharged home.
Pt received pediatric dose of Pfizer (10mcg, 0.2mL) at age 12.
This spontaneous report was received from a consumer via poison and drug center regarding an 82 year old female patient. The patient's medical history includes pneumonia and seasonal flu vaccinations. The patient's concomitant medications include a long list including FLUAD vaccination received on 13-OCT-2018. On the same day, the patient was vaccinated with PNEUMOVAX 23 once in the left deltoid for prophylaxis (dose and lot# were not reported). On the same day, after receiving the vaccination, the patient experienced pain at the injection site (vaccination site pain) and swelling from left elbow to left armpit (peripheral swelling). She had no relevant laboratory test. As of 14-OCT-2018, it was unknown if she would continue PNEUMOVAX 23 and the outcome of the events was unknown. Causality assessment was not provided.
Patient received vaccines in the morning. In the evening she developed tactile fever and became tonic > 10 mn with eyes deviation. Called 911 then went to ER.
Patient has what looks to be bruising down her arm much lower than the injection site. She said her arm felt tingly and hurt around the injection site and under her arm starting when she woke up the morning after her vaccine. She is worried that the injection leaked out into the subcutaneous tissue in her arm and will therefore not provide adequate flu protection.
Tingling of LA where vaccine administered. Tightening of chest/throat numbness of lips, tongue & teeth, headache.
Red circle rash around injection site showed up about a week after.  It's about a three inch diameter white ring with redness inside the circle. It is hot, red, itchy, and there feels like a hard knot in the center.
Rash noted on all extreme tries and body trunk back and front.  Also complain of mild chest pain and some difficulty swallowing was taken to the emergency room.  Received a shot did not know what medication given.  No other discharge instructions.
No other AE reported; Patient given a dose of expired Varivax.; This spontaneous report was received from a pharmacist, who refers to a patient of unknown age and gender. Information regarding the patient's drug reactions or allergies, concomitant therapies and pertinent medical history was not provided. On 07-JAN-2021, the patient was vaccinated with expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R027989, expiration date 01-OCT-2020, dose reported as 0.5 milliliter, for prophylaxis (formulation, concentration, dose number, route of administration, frequency were not reported). No additional adverse event reported. No product quality complaint (PQC) was involved. The pharmacists needed to know if the dose needed to be repeated and were there any adverse reactions the reporter needed to look for.
Vertigo, Brain Fog, Headache, Unsteady gate, dizziness
Red rash localized edema warm to touch. Ice pack 9/17/03 in PM. Tylenol for 3 days.
Initial report received on 24 November 2009 via telephone conversation with a health care professional. A pregnant 22-year-old female patient was vaccinated via intramuscular injection with ADACEL (Sanofi Pasteur, lot number UF500BA) and Influenza A (H1N1) 2009 Monovalent vaccine (Sanofi Pasteur, lot number UP012AA) on 29 October 2009. The patient's medical history includes asthma, migraines and depression. Concomitant medications include PROZAC 20 mg and prenatal vitamins. Past obstetric history included one prior pregnancy with full term delivery (cesarean section for possible fetal distress). The patient's current pregnancy includes an unremarkable ultrasound from 27 August 2009. The patient's estimated due date for delivery is 01 January 2010 (corrected). The patient has not experienced any adverse events since being vaccinated. Follow-up information was received from the reporter on 29 March 2010. Based upon this new information, it was determined that the event met serious criteria, and has been upgraded to serious. The patient's last menstrual period was 05 April 2009, with an estimated delivery date of 10 January 2010. On 16 December 2009, at 36.2 weeks gestation, the patient experienced pre-term labor (reported as "repeat"). She was treated with Terbutaline, and delivered an infant weighing 6 pounds 2 ounces via C-section. Apgars scores were 8. No additional information was reported. Documents held by sender: None.