chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Patient received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) in a 21-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 006M21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Sep-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 20-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine).    No concomitant medications were reported. Anatomical location of administration was reported as left. It was unknown if patient had allergies to medication, foods and other products.  It was unknown if patient had ever been diagnosed with and or tested positive with COVID-19. Acute illness at the time of vaccination and up to one month before was unknown. Expired Moderna vaccine had been given to 21 patients. The reporter explained that the vial was taken out of the freezer recently. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 20-Sep-2022. The vial did not undergone any temperature excursion. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2022: Live follow-up contains updated reporter details.
My arm is sore, swollen and hot to the touch. A red rash, not itchy, has spread from the injection site to an area approximately 4" x 6".
Initial misuse report received from a nurse on 04 November 2013. A 20 months old patient had received expired FLUZONE. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant mediations was reported. On unknown dates, the patients were vaccinated with an unspecified number of doses of GARDASIL 9, (dose, route of administration, injection site, lot number and expiration date were not provided), which had been drawn into and stored in a syringe for "15 to 20 minutes" prior to administration. The reporter also stated that it routinely occurred with "all of their (unspecified) vaccines". However, at the time of the report it could not be determined whether any other Merck vaccines were involved. No adverse effects were reported. Additional information has been requested.
Information has been received from a physician concerning a 21 year old female patient who in August 2009, was vaccinated with a first dose of GARDASIL (lot number, route and site not reported). There were unknown concomitant therapies given. Within two weeks of receiving the first injection of GARDASIL, the patient developed malaise, neck swelling, headache, abdominal pain and Cushing's disease type symptoms. The patient had negative results on CT, MRI and blood work exams that were conducted. There was no hospitalization however the patient was reviewed by an emergency room physician, a pediatric endocrinology and a new internal medicine primary care physician. The patient was not required to be hospitalized. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
Headache, Myalgia Arthralgia NauseaVomiting, Localized swelling, pain; chills, fatigue Narrative:
Date and time adverse event started: 3-7-21 low grade fever X3 days,sore throat, itching to inside of ear, congestion, runny nose, wheezing- asthma. Benadryl   Recommended antihistamine (benadrly,claritin, zyretec), decongestion, analgesic (tylenol, ibuprofen, naproxen), lots of fluids; caller verbalized understanding. informed her to get covid tested due to expressing covid like symptoms & if + to wait until after her quarantine period to receive the 2nd dose; caller verbalized understanding.
In June I contracted Covid. I had nasal drip, congestion, headache and fatigue. I also had a low grade fever, and a bit of a stomach ache. I was out travelling. Two days later I began coughing and I came home and I tested and came back positive. The doctor prescribed me Paxlovid. My symptoms by this point was only fatigue, runny nose, and a cough. In 2 days all my symptoms went away. In total it lasted about 8 days before I tested negative.
Mom describes: about 2 hours after receiving the TRUMENBA vaccine patient was having severe pain on right arm on the injection site, numbness of hands/fingers, stiff neck, shaking of arms, teeth shattering, feeling like throat closing but especially in a lot of pain.
5mins post vaccination pt reported dizziness. Vitals: 14:45 96/51, 74, 18, 94.6F -- > 14:55 94/63, 75 Pt given apple juice and was lying down. Pt stable and released from the vaccination site @15:00 NAD feeling better.  Accompanied by Mom and Dad
Several days after the injection a rash appeared on patient's upper left side of chest. Did not go away with use of lotion or NYSTATIN powder. Patient's primary care doc viewed in zoom televisit and delivered it to be Erythma multiforme prescribed.
I experienced Epstein-barr virus for 6 weeks, then it cleared up for two weeks and came back. It has become a major problem ever since I got the vaccine.
still tested positive for COVID; still tested positive for COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "still tested positive for COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) positive, notes: still tested positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Completed a 5-day course of Paxlovid; at the end of day 5, he was still positive for COVID virus. A patient is calling about the medication Paxlovid. He mentioned that he got COVID after getting the primary series and booster series of the COVID-19 vaccine. He added that he completed the full dose of Paxlovid for 5 days and still tested positive on his antigen test. He wanted to know additional information on the effectiveness of Paxlovid and how soon can he take another antigen test.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
L Deltoid with 2 x 2 cm red warm area - only very sl warm
Mild fevers, body rashes, severe tendon joint pain that moves around body.  Been almost 3 months and not better at all
Within moments after receiving  vaccinations, patient started exhibiting shortness of breath, shakiness and felt cold (subjective), patient was alert and responsive. Patient was asked to lay down and take slow/deep breathes until she felt calm. Patients vital signs were assisted and normal. Provider assisted patient, gave one 25 mg capsule of diphenhydramine which per patients mother; patient tolerates fine. Pt was asked to stay seated until calm and was released per Provider.
Information has been received from a health professional concerning an 18 month old female with no allergies or medical history who on 15Jan05 was vaccinated SC in the left thigh with a first dose of varicella virus vaccine live (lot649271/0652P). There was no illness at the time of vaccination. On 13Jun05 the pt developed a rash. On 14Jun04 the pt presented to the office with 20-30 scattered papules, some with vesicular heads, consistent with chickenpox. Symptomatic treatment was provided. There was no product quality complaint involved. Follow up information indicated that the pt was seen in the office and it was noted that there were approx 20-30 scattered papules and some were vesicular heads. Diagnosis was varicella and the onset date was 14Jun05. The child was afebrile. No other labs or diagnostic tests were done. The pt recovered. Additional information is not expected.
Moderna covid-19 monovalent booster administered after 9/2/22. On 9/23/22 monovalent booster administered, no adverse reactions noted, informed pt and counseled.
Patient came in for WCC and 11 yr vaccines. Patient was given a Dtap instead of the Tdap that was due. No symptoms, signs or treatments needed. MA notified patient. Does not need extra dose per Immunization Coordinator.
Death; dizziness; hot flashes; felt like I was dying; This spontaneous case was reported by a nurse and describes the occurrence of DEATH (Death) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001B22A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Bladder infection and Open heart surgery. Concomitant products included CEFALEXIN (CEPHALEXINE), ATENOLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), ALLOPURINOL, VALSARTAN, HYDROCHLOROTHIAZIDE, MELATONIN and VITAMINS NOS for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced DIZZINESS (dizziness), HOT FLUSH (hot flashes) and FEELING ABNORMAL (felt like I was dying). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (dizziness), HOT FLUSH (hot flashes) and FEELING ABNORMAL (felt like I was dying) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication were reported.  Very limited information regarding this event/s has been provided at this time.   This case was linked to US-MODERNATX, INC.-MOD-2021-095209, US-MODERNATX, INC.-MOD-2021-094933 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Upon internal review on 08-DEC-2022 non-significant corrections performed to update "case received from field" to blank On 28-May-2021: attached. Patient died.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. US-MODERNATX, INC.-MOD-2021-095209: US-MODERNATX, INC.-MOD-2021-094933:; Reported Cause(s) of Death: unknown cause of death
ITCHING ON THE LOWER STOMACH AND HIP, FOLLWED BY COLD SWEATS AND FEVER FOR SEVERAL HOURS. BAD HEADCAHE AND EVEN SHORTNESS OF BREATH AND A COUGH. ALL SYMPTOMS WERE GANE AFTER 24 HOURS
Post giving vaccine "patient" quit breathing, eye rolled back and her body went limp for approx 5-10 sec. During vaccine administration "patient" was crying. Mother took "patient" immediately outside patted her back along; I dad talking to "patient" in her face and she started crying again. CHN immediately followed outside. Mother said this is the second time "patient" has done this when crying. It happens all the time and you think she is not to take a breath but she does", mother states. see routine note; Post episode skin , pale, alert, smiling, walking, color improved before leaving home. At home for approx. 30min after vaccine administration. No further episodes. AR HR 120. BP 198/50. Mother said chiropractor said "patient" may have "infant asthma". Mother also said "patient" dad did this when he was a baby.
Information has been received from a pharmacist concerning a patient who on 04-SEP-2007 was vaccinated with the first dose of Gardasil (lot# 658558/1061U). On 30-OCT-2007 the patient received the second dose of Gardasil (lot# 658563/1063U). Concomitant therapy included LOESTRIN. One month after the first dose the patient experienced lots of nausea and vomiting and a 15 pound weight loss. At the time of 2nd dose of vaccination the patient still had nausea and vomiting. Unknown medical attention was sought. The patient had a lot of unspecified tests that were negative. The patient's outcome is unknown. No product quality complaint was involved. Additional information has been requested.
Chest pressure and mild shortness of breath. Mild facial tingling when taking a deep breath. Resolved with water.
fever; Joint pain; Headache; nausea; feeingl like throwing up; whole body aching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (whole body aching), PYREXIA (fever), ARTHRALGIA (Joint pain), HEADACHE (Headache) and NAUSEA (nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. H031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN (whole body aching), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea) and VOMITING (feeingl like throwing up). On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PAIN (whole body aching), PYREXIA (fever), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (nausea) and VOMITING (feeingl like throwing up) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided
Severe Back Pain; Unable to stand from sitting position; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe Back Pain) and MOBILITY DECREASED (Unable to stand from sitting position) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A2114) for COVID-19 vaccination.     The patient's past medical history included Back injury (3 years ago patients  back was injured).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Mar-2021, the patient experienced BACK PAIN (Severe Back Pain) and MOBILITY DECREASED (Unable to stand from sitting position). The patient was treated with NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, BACK PAIN (Severe Back Pain) and MOBILITY DECREASED (Unable to stand from sitting position) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication details were not reported.  No treatment information was provided.
Pt received vaccine and then began to feel nauseated and fatigue. Pt laid down on a cot, with small sips of water and less than 15 minutes later patient said the symptoms resolved.
Kidney injury - nephrotic range proteinuria, requiring dialysis. Complicated by uremia - cardiac tamponade
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 28-JUL-2015, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB (lot # K015464; expiration date 09-SEP-2017) dose and route of administration were not reported. Concomitant therapy was not reported. No adverse events have been reported. This is one of several reports received from the same reporter. Additional information has been requested.
fever 101.3; bad headaches like migraines; back of neck was stiff and sore; back of neck was stiff and sore; body ached and felt funny; body ached and felt funny; had no appetite and had to force himself to eat; felt woozy; watery mouth; his body was tingling; Chills; This is a spontaneous report from a contactable consumer (the patient).  A 64-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1283), via an unspecified route of administration in the left arm on 15Jan2021 at 13:00 (at the age of 64-years-old) as a single dose for COVID-19 immunization. Medical history included he had gotten sick way before talk of COVID. In late Dec and Jan he was sick and didn't feel better until Feb (unspecified dates prior to vaccination). He went to numerous doctors. He didn't have the flu. They weren't sure what he had. They gave him ibuprofen (MOTRIN) to take. He also had a really bad sinus infection. In Mar2020, he had really bad problems with his eye. His right eye could only move halfway towards his nose. It would not move to the right the all. Then his left eye was twisted. His mouth tasted sour. He does not taste food. This was all prior to receiving the vaccine. Concomitant medication included gabapentin from an unspecified date 6 years ago and ongoing for nerves. He also concomitantly took medication for blood pressure, diabetes, and cholesterol. He declined to provide details. The patient received the first dose of the vaccine on 15Jan2021 around 13:00. He had reactions to the vaccine. He felt the injection site that was given in his left arm. That evening, 15Jan2021, he felt woozy, his mouth was watery, his body was tingling, and he had chills. The next day was concerning. On Saturday, 16Jan2021, he had a fever of 101.3, bad headaches like migraines, watery mouth, the back of his neck was stiff and sore, and his body ached and felt funny. He had no appetite and had to force himself to eat as nothing tasted good (16Jan2021). He was scheduled to take the second dose. He was unsure if it was 21 or 22 days after the first one.  He asked if he should get the second dose. The clinical outcome of felt woozy, chills, fever 101.3 was recovered on 17Jan2021. The clinical outcome of watery mouth was recovered with sequelae on 16Jan2021. The clinical outcome of his body was tingling was recovered on 16Jan2021. The clinical outcome of bad headaches like migraines, back of neck was stiff and sore, body ached and felt funny, had no appetite and had to force himself to eat was recovered on 18Jan2021.
achy and cruddy; "I got real cold"; fever (101); felt really tired; slept long.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy and cruddy), NASOPHARYNGITIS ("I got real cold"), PYREXIA (fever (101)), FATIGUE (felt really tired) and HYPERSOMNIA (slept long.) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced PAIN (achy and cruddy), NASOPHARYNGITIS ("I got real cold"), PYREXIA (fever (101)), FATIGUE (felt really tired) and HYPERSOMNIA (slept long.). At the time of the report, PAIN (achy and cruddy), NASOPHARYNGITIS ("I got real cold"), PYREXIA (fever (101)), FATIGUE (felt really tired) and HYPERSOMNIA (slept long.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Shots 4pm, 7pm short episode high pitched cry & sore legs; asleep 8pm, awoke 9:40pm crying, trouble breathing, then vomited; stiff & shaking, felt hot, eyes big, called 911.  Normal when paramedics checked.  Fine since.
Information has been received from a nurse practitioner referring to an 11 year old female patient. The patient's pertinent medical history included anxiety, elevated thyroid, precocious puberty and heavy periods. The patient had no drug reactions or allergies. Concomitant medication was reported as topical medications. Information about concurrent condition and medication history was not reported. No lab diagnostics or studies was performed. On 04-DEC-2017, the patient was vaccinated with a dose of GARDASIL 9 (lot # N007931, expiration date 17-NOV-2019, intramuscular) for prophylaxis. On an unknown date in December 2017 (reported as "late December"), the patient developed menstrual spotting "for a week or two" after she had her period. No treatment was given for the event. The patient intended to complete the vaccine series. The outcome of the event was reported as recovered. The causality assessment of the event was reported as unknown.
pt recv vax 7/12; pt devel papular vesicular lesions on back & left forearm
Headache, Chills, Fever, nausea, vomiting, shortness of breath
Site: Swelling at Injection Site-Mild, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Mild, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient also claimed to have a decrease in appetite post vaccination.
PFIZER VACCINE WAS DILUTED WITH STERILE WATER INSTEAD OF SODIUM CHLORIDE, NO SITE REACTIONS REPORTED. PATIENT CONTACTED SAME DAY AND INFORMED OF EVENTS. PATIENT FEELS FINE AND WILL NOT BE CONTACTING MD AT THIS TIME PHARMACIST WILL FOLLOW UP IN 14 DAYS
INJECTION SITE WARM TO TOUCH AND ITCHY. NOT RELIEVED WITH TOPICAL HYDROCORTISONE CREAM OR BENADRYL CREAM. SYMPTOMS BEGAN SAME DAY AS INJECTION AND CONTINUED THROUGH 24 HOURS SO FAR.
Pt had a low grade fever at exam on 9/21/15. She held her breath during vaccines, but was crying and alert when she left the office. Mom states sleepy and decreased appetite last night. This morning developed a flat, red, blanchable rash on face and torso and extremities.
Saturday I could hardly move; I had my 2nd shot on Friday was in so much pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 22nd April 2022, the patient received the 2nd dose of Shingles vaccine. In April 2022, less than a day after receiving Shingles vaccine, the patient experienced pain. On 23rd April 2022, the patient experienced mobility decreased. On an unknown date, the outcome of the pain and mobility decreased were recovering/resolving.   It was unknown if the reporter considered the pain and mobility decreased to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-APR-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient had second shingles shot on Friday and was in so much pain and on Saturday, the patient could hardly move. On reporting day, the patient felt much better and went to church as usual. The patient also stated that it took two or three days to feel better. Additional Supportive Information: The follow up was not possible due to no contact details