chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose given; Vial punctured at 10:39 on 12-APR-2022, Dose given 16:00 on 13-APR-2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose given) and PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12-APR-2022, Dose given 16:00 on 13-APR-2022) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose given). In April 2022, the patient experienced PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12-APR-2022, Dose given 16:00 on 13-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose given) and PRODUCT STORAGE ERROR (Vial punctured at 10:39 on 12-APR-2022, Dose given 16:00 on 13-APR-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. It was reported that vial was punctured at 10:39 on 12-APR-2022 and stored at room temperature. Dose given at 16:00 on 13-APR-2022. Vial was moved from freezer to fridge on 11-Apr-2022. No treatment medication were provided.
Initial report received from a healthcare profession on 01 July 2013. A male patient whose medical history and concomitant medications were not reported had received a dose of DAPTACEL vaccine (batch number-C4378AA, expiry date-18 July 2015, dose number and route of administration was not reported) in left thigh on an unspecified date. On an unspecified date, 2 days after vaccination patient went to emergency room then followed up with the provider for a swollen thigh. Majority of the upper thigh was darker in color (almost like a hematoma) and a red rash surrounded the darker area and wrapped around the leg. Laboratory details and corrective treatment details were not reported. Outcome of the events was not reported. Outcome of the events was not reported. Documents held by sender: None.
Retiree who received flu and ZOSTAVAX vaccine on 11/6/08 began to notice lethargy, myalgias, arthralgias that gradually grew worse. Was seen in ER and admitted to civilian hospital with dx of rhabdomylosis 2/2/09-records received for DOS 11/28-12/10/08-DC DX:Rhabdomyolysis. Secondary to influenza vaccination. Elevated transaminases. Three days prior to admission C/O severe muscle aches, weakness and decreased urine output. Edema.
I took the first Pfizer shot on 7/14 and have been experiencing challenging issues ever since. The issues began four hours after receiving the vaccine.  I experienced the expected flu like symptoms for which I was not concerned,  assuming they would soon subside.  However, later that day, and in the days and weeks following I experienced horrible side effects.  The first week, symptom included extreme spikes in blood pressure (i.e. 220+/130+),  extreme drops in blood pressure, chest pain, arm and hand numbness, nauseousness, dizziness, inability to speak, severe headaches and head pressure.  These symptoms would come in waves and sent me to the Emergency Room four times via paramedics with no resolution. In the weeks following, the symptoms continued and also included bouts of an adrenaline like feeling throughout my body resulting in nauseousness and sleeplessness.  In addition, a wave of severe pain in my head, neck and spine accompanied by a severe spike in blood pressure sending me to the Emergency Room for the 5th time within four weeks.  The doctors that have treated me do not know why I am having these issues since receiving the vaccine, and therefore are unable to diagnose and cure me of these symptoms.  Multiple doctors have told me that the mRNA vaccine technology is ?new? and there are many unknowns.  Let me tell you, this does not make me feel at ease at all.  Aside from the ER and urgent care doctors, I have seen my primary doctor, an internal medicine doctor, and infectious disease doctor, a neurologist and am scheduled to see a cardiologist in the coming weeks.  I have had a number of Xrays, a CT Scan, an MRI and blood work.  The blood work has been normal with the exception of inflammation markers.   It has now been a little over two months since I have had the vaccine and my episodes seem to be coming farther apart.  I am cautiously optimistic that the worst if over, but have felt this way several times before, then hit with another wave. I honestly feel that if I ever receive shot #2, I would not survive.
Child developed a fever of 103 then went into status epilepticus within 24 hours of Fluzone administration.  Taken to outside hospital and did not return to baseline in 48 hours so brain MRI performed and child had brain damage of ? cause.  Previous MRI of brain normal. Unsure if damage was due to status epilepticus, unsure if event was vaccine related.  Child reportedly did not have any other signs of illness.
Woke up on May 24, 2021 at around 445 am in excruciating pain very localized on my left thigh.  The pain was o intense I could walk sit or stand. Was take to the hospital by ambulance where I passed out from the numerous times. I explained the pain as burning as if my thigh was about to explode. They gave me lots of different medicine a scan where we were told it was my L5 or potential constipation.  A few days passed and I went to several stat cares with no answers.  About 7 days later I went to the Care Clinic where they tested me for my Fdimer and it proved elevated so they did a dopplor test with no visible clots. I was sent home with more medicine and a few days later ended up in the emergency room at Spohn South where I kept passing out from the pain. After some more x-rays and exams we were told that I had my l2 L3 bulging and that I need to see a spine specialist. Sent me home with more medicine.  I was told to called Dr. at The bone and Joint office  and Dr. saw me and gave me steroids and more pain meds. 2 weeks later no change I was barely able to walk and I finally got in to see the right Dr.  which was Dr. he evaluated me ran his own exam and MRI and after 2 weeks he along with other s doctor determined it was a side affect due to the vaccine.
Vaccination failure; Bad case of COVID Disease and was sick for 10 days after 2nd primary shot; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Bad case of COVID Disease and was sick for 10 days after 2nd primary shot) and VACCINATION FAILURE (Vaccination failure) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019871A and 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Hemochromatosis.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced COVID-19 (Bad case of COVID Disease and was sick for 10 days after 2nd primary shot). On an unknown date, the patient experienced VACCINATION FAILURE (Vaccination failure). In August 2021, COVID-19 (Bad case of COVID Disease and was sick for 10 days after 2nd primary shot) had resolved. At the time of the report, VACCINATION FAILURE (Vaccination failure) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported.  4 Months after 2nd shot patient had a bad case of COVID Disease and was sick for 10 days. He had a Positive PCR test at a testing center. He stayed at home and did not see a doctor. No treatment information was provided.  Company comment: This is a spontaneous case regarding a 63-year-old male patient, with concurrent medical condition of Hemochromatosis, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 approximately 4 months after the second dose. According to the patient, he had a bad case of COVID disease and was sick for 10 days. He had a Positive PCR test at a testing center. He stayed at home and did not see a doctor. An additional event of vaccination failure was also considered. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-644303 (Patient Link).; Sender's Comments: This is a spontaneous case regarding a 63-year-old male patient, with concurrent medical condition of Hemochromatosis, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 approximately 4 months after the second dose. According to the patient, he had a bad case of COVID disease and was sick for 10 days. He had a Positive PCR test at a testing center. He stayed at home and did not see a doctor. An additional event of vaccination failure was also considered. No further details were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Received MMR, Comvax, IPV on 8/7/04. Had left ptosis on 8/27/04 lasting around  hours. Checked by opthalmologist. No allergy. No infection. Left ptosis returned on 9/10/04: Checked by neurologist
Pain at injection site, redness and swelling at injection site,  hives, itchiness on left bicep. Treatment: drink water, take Claritin Allergy  24-hour, take Ibuprofen, rest
This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 53-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch No./lot Number: unknown/ Unable to locate or read the details), via an unspecified route, administered in right arm on 13Apr2021 (at the age of 53 years old) as dose 1, single for covid-19 immunization. Medical history included ongoing chronic kidney disease, hypertension from an unknown date and unknown if ongoing. Concomitant medications received in 2 weeks included losartan (LOSARTAN), carvedilol (CARVEDILOL) taken for an unspecified indication, start and stop date were not reported. No other vaccine administered in four weeks. Patient had covid prior vaccination. Patient did not test for covid, post vaccination. On 14Apr2021, the patient experienced hacking cough. No therapeutic measures were taken as result of event. The outcome of the event was not recovered. No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports no immediate symptoms other than some mild pain at the site of the injection during the observation period. She noted after the observation period but within the first 24 hours, some mild fatigue and local swelling but no fever, chills or myalgias. The swelling resolved and was without symptoms until 3 days later on 18 June 2021.On that evening she noted hives on her face and itching around her mouth. She heard faint wheezing and noted a bruise on her L wrist. Symptoms were not severe enough to seek care and that evening hives subsided but the following day on 19 June 2021, the hives returned/persisted. She took Benadryl with some transient relief every 6 hours. The hives persisted off/on through the following day through 20 Jun 2021. Because the hives persisted and noted some mild wheezing, she went to a civilian urgent care on 21 June 2021. She was prescribed prednisone and an albuterol inhaler. The lesions and dyspnea resolved within a few hours and was discharged. Labs were drawn. of note PT/PTT and platelet count normal. She reports that the bruise on her wrist persisted for 2 weeks. She reports no other symptoms currently but a day or so ago noted a bruise on her R ankle.
Describe Event, Problem, or Product Use Error: [Jansen] use for COVID-19 under Emergency Use Authorization (EUA): Gave a Covid 19 Janssen immunization that was expired. Manager notified, who contacted the Johnson and Johnson medical directors who stated no data to confirm whether patient considered immunized. Per medical director patient should be revaccinated as soon as possible. Contacted patient by phone to explain what had happened and that it was recommended he get revaccinated. He said he would "think about it"-and discuss with his family.
dose #2 given 2 wks after dose #1 (6/25/22) instead of 3 weeks
Headache, Myalgia, chills, soreness Narrative:  Headache, chills, myalgia, soreness at injection site
Felt very sick, fever and flu like systems for 24 hours.  Lessened over the next two days.
swelling in injection arm; heat in injection arm; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (swelling in injection arm) and FEELING HOT (heat in injection arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced PERIPHERAL SWELLING (swelling in injection arm) and FEELING HOT (heat in injection arm). At the time of the report, PERIPHERAL SWELLING (swelling in injection arm) and FEELING HOT (heat in injection arm) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
No other AE; Customer reported an AE for MMRII. The caller said she reported this to Merck previously, however original case was not able to be located. Company awareness date marked 7/12/2023. The caller said the patient received a dose of MMRII on 6/30/2023, af; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 30-JUN-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status rHA) (M-M-R II) subcutaneous injection, 1 dose, administered for prophylaxis, lot number W039699 verified as valid, expiration date upon internal review established as 25-MAY-2024 (strength and route of administration were not provided) after a temperature excursion (product storage error) with a temperature of 48.8 degree Fahrenheits. No adverse event reported.
Left arm red and swollen. Not itchy but warm to touch. Dr. examined it and gave Mom instructions.
every year for the past 5yr pt noticed a sore throat & cold sx 1wk p/flu vax; no tx;
achiness; fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achiness) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     The patient's past medical history included Hip replacement on 28-Jul-2021.   On 08-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achiness) and PYREXIA (fever). At the time of the report, PAIN (achiness) and PYREXIA (fever) outcome was unknown.            Patient got a Hip Replacement surgery done on 28th july , she was in the hospital for a week and was taking antibiotics for almost a month , she wants to know when can she take her 3rd dose vaccine and if it will affect her surgery site  Concomitant medication was not provided treatment information was not provided
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot#, expiration date, dose and route not reported). No adverse events were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Nose bleed which lasted all day - lasted all day but wasn't heavy enough for patient to seek medical care. Muscle cramping, loss of appetite, and extreme exhaustion all reported by patient at the same time.  Patient has been keeping hydrated, tylenol for pain, resting.
Influenza vaccine (inactivated 0.25ml) IM 1-13-2011 in the morning (9 am) at 3pm foster mother reports temp 102 & child c/o leg sore. Improved w/TYLENOL resolved < 48hrs after injection.
This spontaneous report was received from a field representative who was informed by a physician of a female patient of an unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX for the prevention of shingles. Past medical history and concomitant medications were not reported. "About a year ago the patient (demographics unknown) received ZOSTAVAX and has been experiencing flair ups at the injection site, it is a dermatitis like scalpy spot that becomes red and irritated." The representative also reported, "judging from the injection site which is on the backside of the deltoid, the ZOSTAVAX may have been administered intramuscularly and not subcutaneous." The adverse events were treated with an unspecified cream. The outcome of the patient has been experiencing flair ups at the injection site, the ZOSTAVAX may have been administered intramuscularly and not subcutaneous and a dermatitis like scaly spot that becomes red and irritated was reported as not recovered/not resolved. The reporter considered the ZOSTAVAX may have been administered intramuscularly and not subcutaneous to be not related to ZOSTAVAX. No further adverse event information was provided. Additional information has been requested.
Vaccine administered on 01/31/2018, vaccine expired on 01/27/2018. No adverse even noted to patient.
Shoulder pain that is severe. Has not gone away since first shot. Going to a dr on monday may 17 th
Patient is a 54 yo M who presents to the office unaccompanied with symptoms of right upper extremity redness, swelling, tenderness x 2 days-- immediately adjacent to injection site of right deltoid.
Tinnitus both ears. Still present. No Rx  Floater in R eye. Still present.  No Rx
Painful but non-itchy red rash on left bicep about 4 inches down from the injection site (feels like pressing on a deep bruise). I got my second dose of the Moderna COVID-19 vaccine in my left deltoid on 02/08/2021 at 09:40. I noticed the rash on 02/09/2021 at 7:30, at which time it was the size of a quarter. Approximately 13 hours later it is now three inches long. Of note, I did not experience any adverse reactions other than injection site soreness with the first dose, which I received in my left deltoid on 01/11/2021 at 9:40. That reaction fully resolved within 72 hours with no sequelae.
Patient received COVID vaccine on 1/6/2021. He felt pale and tachycardic the next day but didn't notify us. He had follow-up on 1/12/2021 at the cancer center. The labs were consistent with acute hemolytic anemia, and patient is closely followed by hematology. He is on immunotherapy for cancer treatment, but there is concern for COVID vaccine contributing the hemolytic anemia.
103-104 fever, night sweats, severe headache/dizziness upon rising, mild shortness of breath/chest tightness.
Breakthrough case admission after 2 vaccines Pfizer 4/11/21 Lot# Ew0162;  Pfizer 5/2/21 Lot# Ew0179
Fever Body aches Body chills Rashes all over body Headache Brain fog Out of breath  Exhausted Lethargic Depressed Anger and sadness This lasted for two weeks
Soreness, chills, body aches, fever, fatigue, pain, headache, sleepy
approximately 6" below injection site - swelling, itching, and redness.   was hot to the touch, as compared with tissue surrounding site. Actual areainvolved  approximately 4" across and 3" top to bottom.    Started resolution next day.   Hot to touch subsided and slowly swelling went down.    Was not a "dramatic" reaction.  However, two weeks later (today) I can still see the redness slightly..
Headache, Myalgia, Tachypnea, Rash, NauseaVomiting & Tachycardia Narrative:
Patient initially presented to the ER with worsening shortness of breath, cough for the past 1 week. Patient has a history of COPD using oxygen nasal cannula at night never been on any CPAP or did not have any sleep study. Patient was tested positive for COVID-19 infection, patient started on Decadron, was seen and evaluated by ID and pulmonary, initially he was requiring high oxygen, gradually patient became better, oxygen requirements went down to 4 L.  Patient was cleared and was discharged after home O2 evaluation. Patient was discharged in medical stable condition.
Evening chills the night of the vaccine (2/8) Slight headache and fever (low 100 degrees) and very tired on 2/9
I only had a sore arm after the vaccine.  I tested positive for COVID-19 on 07/21/2022.  I had allergy symptoms from the beginning so it was difficult to detect differently.  When I started feeling nauseated and very tired  or sleeping much more and longer than normal. That is when I decided to get test with a home test and when I went to the clinic they confirmed the positive test. They could hear wheezing in my chest/lungs. They prescribed Paxlovid and I started to feel better but then my symptoms came back. As of today, I continue to test positive.
headache; This is a spontaneous report from a contactable consumer received via Medical Information Team.  A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced headache on 23Dec2020. The patient outcome of the event was not recovered.    Information about Lot/Batch number has been requested.