chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bivalent doses administered after the BUD to patients 12 and up; Bivalent doses administered after the BUD to patients 12 and up; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Bivalent doses administered after the BUD to patients 12 and up), EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Bivalent doses administered after the BUD to patients 12 and up), EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT STORAGE ERROR (Bivalent doses administered after the BUD to patients 12 and up), EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (Bivalent doses administered after the BUD to patients 12 and up) and EXPIRED PRODUCT ADMINISTERED (Bivalent doses administered after the BUD to patients 12 and up).    No relevant concomitant medications were reported. No treatment medication reported.
13 hours after injection: Typical chills, body aches, cold sweats lasting 24 hours. Relief with Acetaminophen and Ibuprofen.   On 1/25/21 around 4:00 PM: Following intercourse, shortness of breath and mild chest pain. Unable to go for walk with son and wife due to fatigue and mild chest pain. Discomfort ameliorated with rest.   On 1/26/21 around 6:00 AM: Shortness of breath and chest pain in shower with minimal effort. Pulse around 140 BPM. Drove to ER for workup. Transferred to hospital for admission.
Body aches (severe); Stomach cramping in upper left and right quadrants, resulting in vomiting multiple times over 4+ hours; Stomach cramping in upper left and right quadrants, resulting in vomiting multiple times over 4+ hours; Extreme exhaustion; Dizziness; Shakiness; Nausea; Fever of 101; This is a spontaneous report from a contactable consumer, the patient. A 30-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 10May2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and know allergies to penicillin (PCN), cephalosporins, almonds and peaches. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medication on an unknown date, for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 12Apr2021 at 16:45 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient also previously received nitrofurantoin (MACROBID) on an unknown date for unknown indication and experienced drug allergy. On 11May2021 at 06:00, the patient experienced body aches (severe), extreme exhaustion, dizziness, shakiness, nausea and stomach cramping in the upper left and right quadrants, resulting in vomiting multiple times over 4 plus hours. On the same day, about 24 hours after injection the patient experienced a fever of 101 (unspecified units). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever of 101 (units unspecified), body aches (severe), extreme exhaustion, dizziness, shakiness, nausea and stomach cramping in upper left and right quadrants, resulting in vomiting multiple times over 4+ hours was resolving at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
pretty severe arm pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pretty severe arm pain) and FATIGUE (fatigue) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced VACCINATION SITE PAIN (pretty severe arm pain) and FATIGUE (fatigue). On 24-May-2021, VACCINATION SITE PAIN (pretty severe arm pain) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided. List of concomitant medication were not given.   This case was linked to MOD-2021-260056 (Patient Link).
2 inch red circle at site warm to touch. Advise ice/MOTRIN/BENADRYL.
Patient stated he had a migraine after the vaccine. We were advised of a change in appetite on Thursday February 4th. Patient died on February 6th.
Approximately 30-45" after receiving DTap She developed a fine red entire body rash and swelling of fingers. She took Benadryl 50mg and rash resolved within an hour. Approximately 5-6 hours later rash appeared again but resolved again with Benadryl.
Parent emailed Dr. and stated his upper left thigh, where they administered his shot, is now extremely red, swollen and hot to the touch. Treatment recommended: Cold towel or an ice pack wrapped in a towel. Recommended to give him TYLENOL or ibuprofen to reduce his pain.
PATIENT WALK IN AT THE CLINIC TODAY REPORTED NOTED REDNESS ON RIGHT ARM BELOW  WHERE THE SHOT WAS GIVEN YESTERDAY PATIENT DID NOT REPORT TO PROVIDER IMMEDIATELY THINKING IT WILL GO AWAY.  RN NOTED REDNESS ON RIGHT ARM 5 FINGERS BELOW  FROM THE INJECTION SITE. FEELING WARMTH TO TOUCH. NO HARD LUMP NOTED, PATIENT DENIES SORENESS OR PAIN. AFEBRILE. DENIES DYSPNEA, DENIES CHEST PAIN, DENIES TIGHTNESS ON THROAT.
Last night, I started to experience chills in my body and a headache/tiredness. This morning, I still feel a bit tired, but I no longer am experiencing chills.
Started feeling body aches and a sharp pain in my ovary around 4PM the following day 9/24.  I was drinking more water than normal.  When I urinated it felt warmer than usual.  As the evening went on I the aches increased, I had a severe all over headache, had occasional  sharp pains in my right ovary,  and I was vomiting, not able to keep anything down.  I was not urinating nor did I have a BM on 9/25.  Although much better today 9/26, I am fully functioning, but still feeling weak and noticed a rash on both sides of my neck. My headache is still present but much better (from an 8 pain score to a 3), but only after I took some Aleve this morning.
pt recvd vax @ approx 1300 or 1330 on 10NOV93; pt was taken to hosp ER; pt became white, pale & having problems breathing according to mom's report-acted like was choking;
Developed hives after crying. No respiratory distress-wheezing noted. Given Benadryl at 3:10 with good response, decreased hives and erythema.
Patient developed localized swelling, redness, and warmth to the touch. No fever. Sx resolved without treatment.
patient reports that a "couple days" after getting his Pfizer covid 19 vaccine he started to not feel well. He states it started out feeling like  a bad chest cold with severe muscle aches and then moved to his hands. He states his hands swelled up and he was put on Prednisone. He continues to take the prednisone to this day. He states he also could barely walk. He also reports that his C reactive protein level was 166 which is extremely high. He is seeing Dr. who knows much more about his medical history regarding this situation
Suspected vaccination failure/Got vaccine on 8/28, 3 days ago got Shingles; Shingles/ 3days ago got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2022, the patient received Shingrix. On 8th November 2022, 72 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: The case  was received from the patient via interactive digital media. The patient had received the Shingrix vaccine and 3 days ago from the reporting date, got shingles. The patient was getting ready to do. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The vaccination date year was captured as 2022, conservatively considered that the patient got the vaccine on 28th August 2022.
Headache, Myalgia & NauseaVomiting Narrative:  dose 1- day 1-3- sorearm dose 2- day 1-2 sore arm; day 2-chills, fatigue, nausea, vomiting, ha
Information has been received from a physician concerning a 17 year old female patient who on 20-AUG-2007, was vaccinated IM with a first dose of Gardasil (Lot to be determined). Concomitant therapy included a dose of (Havrix). On approximately 22-AUG-2007 "about 2 days later", the patient developed a rash on her legs. It was reported that the patient's mother called and reported that the rash had spread all over the patient's entire body. Unspecified medical attention was sought. At the time of this report, the patient's outcome was unknown. No product quality complaint was involved. Additional information has been requested.
Patient had fever & abd. pain on 7/5/2020-went to UC and was swabbed for COVID19 (negative) Later that night child had a seizure and was taken to ER. Subsequently admitted to PICU. Admitted from 7/6 to 7/8, dx: fever, new onset seizure, altered mental status, meningoencephalitis. Patient was in PICU at hospital for two days following new onset seizure and to R/O meningoencephalitis. Labs done. CSF Protein, glucose cell count, culture (protein & WBC were elevated rest WNL). Also had testing done for COVID19, Respiratory virus panel, meningitis/encephalitis panel, Lyme, Respiratory Atypical bacterial panel, ICU panel & Arbovirus Antibody panel - IGM CSF. Also several misc labs sent for variety of infectious etiologies - CSF serum. EEG & MRI also done and were unremarkable. Most labs have been negative for infectious agents but some encephalitis lab tests are still pending. Patient had follow up in our office on 7/10/2020 and is currently stable, except for c/o headache and back pain at times. She has planned follow up with Neurology.
Pain in jaw, tightness, heart burn. Self treated at 3:00am with aspirin and Pepto Bismol, later was seen at Urgent care and was diagnosed with HBP (06/04/2021).
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Oct2022 at 13:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 47 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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 included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Dec2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient became Covid positive with mild symptoms 5 days after stopping Plaxlovid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient reports at immediate time of injection she started to have right arm pain that has persisted since time of vaccination.
Patient was administered a COVID-19 vaccine from an expired vial. Vial had been opened the day prior to the day it was administered. Maximum time opened vial should be used is 12 hours.
Fever, chills, dizzy, nausea, fast heart beat, headache, very tired , and weakness. Taking Tylenol. It?s been 4 days and still ongoing.
s/p vaccine 10 min, patient began to feel lightheaded and faint.  She was safely lowered to the floor at which time sx improved.  She was transported via litter to observation 1.  No syncope, CP, SOB, paresthesia.  Observed patient while supine with some improvement of sx.  Positive h/o similar sx that lasted "all day:  Pt drove self here from work. Mild HA   Vitals: @ 1507 lying HR 101, BP 157/81, O2 97, @1519 lying HR 90, BP 136/81, O2 98,  @1529 sitting HR 93, BP 150/89, O2 99 Pt feeling better with minimal dizziness
Insomnia; warm inside; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Insomnia) and FEELING HOT (warm inside) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced INSOMNIA (Insomnia) and FEELING HOT (warm inside). At the time of the report, INSOMNIA (Insomnia) and FEELING HOT (warm inside) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator  No treatment medications provided by the reporter.
Continued bruising and swelling. Joint stiffness, muscle pain, numbness, headache confusion. Increased tremors throughout body. All symptoms continue to worsen and am unable to work due to the pain, numbness, mental fog and limb weakness and control.
Passed out 3 minutes after shot, after 30 mins or more laying down I was okay. About 3 hours after the shot I got a severe headache and a runny nose. Then 24 hours after I felt 100% normal again.
Pt previously tested positive COVID on 1/20/21, then tested positive COVID again on 4/8/2021 >14 days post fully vaccinated
Patient received vaccines 01/20/23, died 01/22/23. Diagnosed with Influenza A 1/2/23- Asymptomatic at time of vaccines. Do not suspect vaccines contributed to death of patient.
One hour after receiving vaccine, the patient developed nausea and tiredness. She also developed an intense, pounding headache. Patient was treated with Imitrex without relief. She went to the clinic and was treated with 2 Advil and 2 Excedrin with relief. As of 4/18/01, the patient had no nausea and a slight headache treated with 2 Advil.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot # M042504, expiration date: 30-NOV-2017) (dose and route of administration were not reported) for prophylaxis. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 20 degrees Fahrenheit (F) >14°F but < 46°F for 14 hours and 24 minutes. Data logger was involved. There were no previous excursions reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-US-009507513-1702USA002724.
CYANOSIS NOS. Information has been received from a pharmacist concerning a 6 or 7 day old female who on approximately 12JUN2003 was vaccinated with a dose of hepatitis b virus vaccine rHBsAg (yeast) (Lot #643366/C054N). Subsequently the patient is having episodes of cyanosis. The reporter indicated that "the doctors are trying to rule out GERD or GI Reflux Disease but are not sure if there is a link" to the vaccine. Date of administration, current medications and other patient information was not available at the time of the report. Unspecified medical attention was sought. the outcome was reported as not recovered. There was no product quality complaint. Follow up information indicated that no other information is available. No further information is expected.
noticed very light pink color on the upper arm where the injection was one week after. The next morning (day 8), it was more noticeable, about 3 x 4 cm. No itching or warmth, maybe a little swollen. Gone the next morning (Jan 6).
PATIENT STATES THAT SHE TESTED POSITIVE FOR COVID-19 ON 7/24/21, 11 DAYS AFTER HER FIRST PFIZER COVID-19 VACCINE DOSE
The patient woke up with warmth, redness, and swelling of the right thigh at the vaccine site.
The nurse had intentions of administering IPV (polio). She accidently administered MENACTRA.  After investigating possible causes, MENACTRA was found sitting in front of the polio vaccine in the refrigerator. These vaccines have similar looking boxes and labels. Although the provider confirmed that this vaccine was safe for his age, the facility chose to report this incident due to an error in administration. The patient tolerated the vaccine without reported adverse effects. No further action was determined to be needed. He will receive his IPV Inactivated Poliovirus vaccine at his next well child visit at 6 months. This will be in the time frame for the vaccine. The caregiver was notified of this error and voices understanding.
Pt developed arthralgia (knees, legs, ankles) and a blotchy rash over legs (purpura) on 10/9/10 - Seen in Emergency Room and diagnosed with (HSP) Henoch-Schonlein purpura. (Had flu vaccine 10/5/10).
Pt exp a h/a & a flare-up of rheumatoid arthritis p/recvd flu vax;
Malaise; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Malaise) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    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 MALAISE (Malaise) and HEADACHE (Headache). At the time of the report, MALAISE (Malaise) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were provided. No concomitant medications were reported. .   This case was linked to MOD-2021-020456 (Patient Link).
Patient came into pharmacy to report injection site reaction. Surrounding the injection site the patients arm had knot under the skin with soreness of the whole arm. Recommended the patient take some benadryl and ibuprofen for the inflammation. If no resolution advised her to see her primary care physician.
3:03PM: Patient received Pfizer Covid vaccine  and went to waiting room for 15-minute observation period 3:17 PM: Nurse Called to waiting room; patient states of warmness and dizziness, alert with eyes half open 3:17 PM: Non-responsive to name; head back and nonresponsive; Eased to floor; remains non- responsive for approximately 22 seconds.  Opens eyes and responds to name. 3:18 PM:  NP present.  Neuro assessment completed. Pt remains alert and responsive, skin warm and moist.  B/P 132/78 3:24 PM: Remains alert and oriented; states of feeling better; assisted to sitting position 3:25 PM:  B/P 110/62 Pulse remains strong at 68, denies dizziness; placed in chair with supervised presence in waiting room 3:35 PM: Offered juice and granola bar; eating without discomfort 3:40: B/P 112/62, 68 and regular, skin warm and dry; encouraged to find ride home or back to work  3:50 PM:  B/P 118/72, pulse 72 and regular, continues to state of feeling weak, oriented and alert 4:08 PM:  Walked around waiting room without dizziness or dyspnea.  Pulse 78 and regular;   B/P 112/62 4:18PM: walking around room without discomfort or change in consciousness; B/P 116/72, pulse is 72 and regular.  4:30 PM:  Remains alert, skin warm and dry, Pulse 74 and regular.
On 12/11/22 I was exposed to someone with COVID-19.  On 12/13/22, I became symptomatic.  On 12/14/22, I tested positive for COVID-19.  I remained sick, and in bed for 17 days, testing positive the entire time.  I took Paxlovid, beginning day 2 of illness, but had minimal improvement.  I was asked to fill out this report because of the length and severity of my illness.
Within 5 mintues of injection, pt had approximately 5 cm erythema with mild swelling at injection site, primarily distal to it. Otherwise feeling well, no trouble breathing, no acute distress, lungs clear ot auscultation bilaterally. Possible allergic reaction to vaccine.
A report was received from a health care professional on 12/9/03 concerning a female vaccinee between 4 and 8 years of age who inadvertently received a sub-optimal dose of Fluvirin on an unspecified date in early December 2003. On an unspecified date in early December 2003, the vaccinee received half of the recommended dose of Fluvirin. It was not reported whether or not the vaccinee had experienced any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Severe body aches, chills, fever,  rash on shot site and severe headache lasting 48 hours so far.
Loose stool/Diarhhea - 3 times between 1 PM & 5 PM afternoon following injection
Contracted COVID 19.  Symptoms: fatigue, cough, sore throat Treatment: Paxlovid Tested positive for 5 days; had rebound positive after 10 days; remained positive for additional 5 days