chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Ache; Fatigue/exhausted; 104 fever that lasted for 24 hours; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 09-Mar-2021. The most recent information was received on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Ache), FATIGUE (Fatigue/exhausted) and PYREXIA (104 fever that lasted for 24 hours) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-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 (Ache), FATIGUE (Fatigue/exhausted) and PYREXIA (104 fever that lasted for 24 hours). At the time of the report, PAIN (Ache) and FATIGUE (Fatigue/exhausted) outcome was unknown and PYREXIA (104 fever that lasted for 24 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 fever.         No relevant concomitant medications were reported.  It was reported that patient currently was fine, and her last shot was 4 months ago.  No treatment information was reported.  Action taken with mRNA-1273 in response to the events was not applicable.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received on 13-Jul-2021 and included New event (Pyrexia) was added, Description as reported for event Fatigue was updated to Fatigue/exhausted, Lab data (Body temperature) was added and details about patient second dose and event description was added in narrative.
This spontaneous report as received from a consumer referring to herself a 79-year-old female patient. On 11-DEC-2014 the patient was vaccinated with pneumococcal vaccine. Then on 26-OCT-2017, PNEUMOVAX 23 injection (anatomical injection site, lot # and expiration date were not reported) unknown for prophylaxis. Then on 26-OCT-2017, the patient was vaccinated with PREVNAR 13 (anatomical injection site, lot # and expiration date were not reported) (Interchange of vaccine products). The outcome and causality assessment of the interchange of vaccine products were not provided.
Information has been received from nurse referring to a patient of unknown age and gender. Information about concurrent condition, drug reactions/allergies and medical history was unknown. Concomitant therapies included sterile diluent (manufacturer unknown). On an unknown date, the patient was vaccinated with an improperly stored dose of one of the following vaccines: PROQUAD (lot # N001488 with expiration date 12-JUL-2018, dose and route unknown) or VARIVAX (lot # M038859 with expiration date 14-SEP-2018 or lot # N008827 with expiration date 16-MAR-2019, dose and route unknown) for prophylaxis (incorrect product storage). The vaccines had been exposed under temperature in the range of -9 degree Celsius to 8 degree Celsius for 2 hours, but did not undergo previous excursion. Data logger was used.
COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), in Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 23Oct2023, outcome "unknown" and all described as "COVID 19". Event details: the patient and her husband have taken all of the COVID 19 vaccines produced by Pfizer. They took the most current vaccine two weeks ago. Two days ago they contracted COVID 19. They were surprised to have contracted the virus with the current vaccine.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300349430 same reporter/vaccine/event, different patient;
Left arm red and swollen from shoulder to elbow (started next day (Sat) to present). Red raised rash above belly button and small area on upper chest (non-vesicular). Started Saturday to present.
patient got pfizer 1st dose, about 10-15 minutes later he passed out, came back to alert state right away. no problems with breathing, no epi-pen was required
No Additional AE; MMR II vaccine was administered after undergoing temperature excursions; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.     On 10-JAN-2022, the patient was vaccinated with second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) (lot # T027914 and expiration date reported 18-AUG-2022), 0.5 milliliter for prophylaxis after undergoing temperature excursions (Product storage error).  The temperature of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) was 9.6 Celsius 47 and there were previous temperature excursions on 18-DEC-2021 was 13.7 Celsius for 6 hours. No additional AE. No PQC.  This is one of several reports received from the same reporter.
Pt was on antibiotics following bronchitis, but no signs of illness at time of vacc. 2 days post vacc, pt was cranky, day 3 pt had fever, diarrhea vomiting, worse on day 4, listless and not thirsty as well as other sx's. Red dots on hands.
had ?focal sz w/fever 6FEB98 approx 10min;2nd sz-afeb 4min gen nl EEG & MRI on phenobarb;
Injection site redness (Injection site reaction, injection site reaction)(Inject site react) not recovered/not resolved  Injection site raised (Injection site edema, injection site edema)(Edema inject site) - not recovered/not resolved Injection site sore (Injection site pain)(Pain inject site) - not recovered/not resolved Injection site hot (Injection site reaction, Injection site reaction)(Inject site react) - not recovered/not resolved Diarrhea (Diarrhea, Diarrhea) (Diarrhea) - not recovered/not resolved A report was received from a consumer on 05 November 2003, concerning a 44 year old female vaccinee who developed a red, raised, hot to touch spot at the site of injection approximately 3 and a half hours after receiving Fluvirin on 03 November 2003 and also experienced 3 episodes of diarrhea on 04 November 2003. On 03 November 2003, the vaccinee developed a red, raised, hot to touch spot at the site of injection. The vaccinee did not experience any fever. The spot on the vaccinee's arm increased in size to approximately 3 inches in diameter and the soreness worsened. On 04 November 2003, the vaccinee experienced 3 episodes of diarrhea. Follow-up pending.
PATIENT GOT A GOLF BALL SIZED RASH WHICH IS  ITCHY,WARM AND PAINFUL TO TOUCH AT THE INJECTION SITE. SHE GOT ELEVATED TEMPERATURE 100.07 AND RELIEVED BY TYLENOL. SHE WAS ADVISED TO TAKE BENADRYL FOR ITCHINESS. REPORT TO HER PCP, AND GO TO ER IF PROBLEM GOT WORSE.
swollen left arm (injection site) with redness Narrative:  Swollen left arm with redness. Has not  missed any work. Advised ibuprofen and ice pack.
Vomiting, redness, warmth, swelling and pain to left upper arm. Treatment - MEDROL dose pack, CLARITIN and BENADRYL, ice.
Headache, Myalgia, Arthralgia, Fever, Diarrhea, NauseaVomiting, Within the first 30 minutes of being administered I did feel two "flutters" in my chest. Breathing remained fine. Throughout the remainder of the day, I began to feel low level nausea to the point of vomit. It was consistent in nature over a periof of tw Narrative: Within the first 30 minutes of being administered I did feel two "flutters" in my chest. Breathing remained fine. Throughout the remainder of the day, I began to feel low level nausea to the point of vomit. It was consistent in nature over a period of two days to include into Friday when I returned to work; also diarrhea in the evening. I felt feverish and sweaty but monitored my temperature and did not have a reading above 97.6. I did feel body and joint aches on my left side from my left big toe, ankle, knee, hip, lower ribs, shoulder, elbow and wrist. I did have a headache that did come and go over the two days.
Clots; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Clots) in a 38-year-old male patient 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) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced THROMBOSIS (Clots) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Apr-2021 due to THROMBOSIS. At the time of the report, THROMBOSIS (Clots) outcome was unknown.        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.   No concomitant medications reported.  No treatment information provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Shaking, headache at base of skull/back of neck, inability to focus, vertigo
A non-serious spontaneous report of administered expired FLUMIST has been received from a nurse concerning a 46-year-old of unknown gender. No medical history nor concomitant medications were provided. On 26-Nov-2008, the county health department inadvertently administered expired FLUMIST to 10 patients (ages 3 to 46). The product was expired by one day. The patients did not experience any adverse events and will be revaccinated in four weeks. There was no adverse event associated with these medication errors; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from the previous season and 2) product expiring during the peak of the flu season resulting in some medication errors that occurred shortly after the product expired. Additional information was received on 09-Apr-2009: product complaint investigation results.
Swelling of arm, arm redness, fever in the arm, body aching, headaches, treatment with aspirin and TYLENOL. I slept for about 3 days on the sofa and bed with an ice pack on my arm and neck. Just woke up to take more TYLENOL. I had chills on the second night. Eventually took temp and it was 100.2 F. Called consulting nurses. Still having headaches off and on.
Pt called 3 days after vaccine saying she felt excessive soreness the day of vaccine and started having numbness/tingling in between fingers of hand she got shot. Pt refused suggestion to see MD.
erythema multiforme rash, t101 starting 8 days p/vax;
Twelve hours after receiving  Vx at 12:30pm on April 13, 2021, was very cold.  Woke up at 4am shivering, headache, nauseated, could not move left arm where Vx was received.  Took some Tylenol and went back to bed.  Slept most of day as extreme fatigue had set in.   I had no reactions to first Vx except for a sore left arm for a couple of days.  I DID have COVID November 2020, and self care was administered at home.
pt recvd vax & pt devel redness, tenderness @ warmth @ inject site;
Presents to the hospital  nausea and vomiting and diarrhea for the past 3-4 days, had a nonproductive cough,some generalized weakness. Patient incidentally found to have novel coronavirus,Not requiring oxygen.  s/p Symptomatic treatment. With mild respiratory symptoms,Infused monoclonal antibodies while in patient. Disposition:She will be discharged 8/21/2021 today to home.
pain in rt arm also shoulder & neck limited use-unable to lift above eye level; rx w/Cephalexin, Codeine, ASA;
Got the first dose of the vaccine "on the butt"; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Got the first dose of the vaccine "on the butt") in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Amputation (double amputee (no arms)).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Got the first dose of the vaccine "on the butt"). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Got the first dose of the vaccine "on the butt") had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.  The patient was a double amputee and had no arms. It was reported that patient got the first dose of the vaccine on the butt. Patient had administered a 3rd dose of the vaccine in the anterolateral thigh.   Most recent FOLLOW-UP information incorporated above includes: On 23-Sep-2021: Follow up received contains significant information of third dose administration. which is  in the I-narrative
Pfizer / BioNTech: Dose number 1, 2, 3; Paxlovid: Treatment of COVID-19; Pfizer / BioNTech: Dose number 1, 2, 3; Paxlovid: Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Feb2021 at 17:00 as dose 1, single (Lot number: EN6201), in left arm, on 11Mar2021 at 17:00 as dose 2, single (Lot number: EN6208), in left arm and on 15Nov2021 at 11:00 as dose 3 (booster), single (Lot number: FF2590) at the age of 58 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Autoimmune" (unspecified if ongoing); "anemia" (unspecified if ongoing); "hyocellular bone marrow" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "paroxysmal afib" (unspecified if ongoing); "known allergies Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" and all described as "Pfizer / BioNTech: Dose number 1, 2, 3; Paxlovid: Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13May2022) negative, notes: Tested negative on 13May2022 and negative on 15May and had no symptoms; (15May2022) negative, notes: Tested negative on 13May2022 and negative on 15May and had no symptoms; (24May2022) positive, notes: Tested on 24May and was positive; (27May2022) negative, notes: Symptoms went away on 25May and tested on 27May and was negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient did not received any other medications in two weeks.
Six years ago the patient received an influenza virus vaccine 1987-88 formula (manufacturer unknown) and developed a reaction at the injection site described as "ulceration". On follow up, the physician noted that he did not know the patient, nor was he aware of any such reaction in his patient population.
27 hours after the vaccination I suffered an episode of total body muscle weakness including my bowels.  I was too weak to stand.  When my husband arrived home he helped me into the tub and to bed.  I was fine the next morning except for some lingering fatigue that has continued.
Felt his throat tingling, then noted (and confirmed by his wife) that his nose was swelling.  Never had tongue, pharynx or lip swelling, only the nose.
Information has been received form a RN concerning an adult pt who as a child was vaccinated with a series of doses of MMR. On 08/19/04 it was reported that the pt is now failing to show seroconversion on his titers drawn recently for employment. It was noted that two years ago the pt had proof of seroconversion. The pt did not have any adverse reaction. No medical attention was sought. No product quality complaint was involved. No further information is expected.
Malaise, exhaustion, missed work, symptoms lessened 2 days later but still present.
Stung by a bee which is disappeared within the hour and I have been in Poison Ivy and it's not spreading normally; This is a spontaneous report from a contactable consumer (Patient) from a medical team.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient was already been vaccinated with Pfizer COVID-19 vaccine. The patient had been stung by a bee which got disappeared within an hour. On an unspecified date, the patient had been in Poison Ivy and it was not spreading normally. It got spread throughout the body in a heartbeat. Patient took prednisone to get rid of it. The clinical outcome for the event was reported as unknown.   Information about lot/batch number is requested.
Receive preservative free Flu shot, felt dizzy, on and off for 10 minutes. Walked off and was talking with someone for 20 or 25 minutes. Felt very tired. 15 minutes later, my mouth got really dry and my throat felt "weird". I disregarded it. 15 minutes later I felt dizzy again, very strong this time. Went to see the nurse, I was sitting on a chair and I said to her, I don't feel well and I passed out. Not completely, I felt exhausted and I could hear them talking but I was too exhausted to respond or move. Then I got up, and then passed out again. The ambulance came and I felt 2 more episodes in the ambulance. At the ER, one episode of syncope, then I felt diggling feeling in my torso, then it traveled to my legs. I felt, exhausted and winded for the next 5 days, on and off. I still do not feel right since then. The last 3 years I felt sick after the Flu shot, then I thought maybe it was the perservatives but I received preservative free shot and that was worse. I still get dizzy spells every now and then. Seeing a doctor today for it.
No additional adverse events were reported.; first shot of GARDASIL 9 on 11/14/2019 and second dose of GARDASIL 9 on 12/12/2019; This spontaneous report has been received from the patient's father referring to a male patient of unknown age. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.     On 14-NOV-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, route and dose details were unknown) for prophylaxis at a health center. On 12-DEC-2019, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, route and dose details were unknown) (inappropriate schedule of product administration). No additional adverse events were reported.
Information has been received from a nurse who is the mother of a 17 year old female who in February 2009, was vaccinated intramuscularly with a 0.5 ml first dose of GARDASIL (lot no. not reported). Concomitant therapy included hormonal contraceptives (unspecified). In February 2009, one week after vaccination the patient experienced aches and pains in her arms and legs. The patient had not received second dose of GARDASIL and the mother had not yet decided whether to discontinue the series. The patient recovered a few days later. The patient sought unspecified medical attention. No further information is available.
patient receiving the Menquadifi during pregnant with no reported adverse event.; Initial information received on 08-Sep-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves an adult female patient who was exposed to vaccine MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE [MENQUADFI] who was receiving the menquadifi during pregnant with no reported adverse event.. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient receiving the Menquadifi during pregnant with no reported adverse event occurred at unknown gestation period.  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any medical history, concomitant disease or risk factor.  On an unknown date, the patient received an unknown dose of suspect MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE, Solution for injection (strength: unknown) lot number not reported via unknown route in unknown administration site as Prophylactic vaccination.  On an unknown date the patient receiving the menquadifi during pregnant with no reported adverse event (exposure during pregnancy) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (T CONJ) VACCINE.  It was unknown if there were lab data/results available. It was unknown if the company suspect product was inappropriately used as per local Marketing authorization.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event (patient receiving the Menquadifi during pregnant with no reported adverse event.).  At time of reporting, the outcome was Unknown for the event. Additionally, at time of reporting, the outcome of the pregnancy is unknown.
Information has been received from a physician assistant concerning a 30 year old white female with seasonal allergy, chronic sinusitis and anaemia who on 01-AUG-2008 was vaccinated with the first VARIVAX (Merck) 0.5 ml SC in the right arm.  Concomitant therapy included CLARITIN and iron supplements.  There was no illness at time of vaccination.  On 13--AUG-2008 ( also reported as 14-AUG-2008) the patient developed itch red bumps in right upper arm at the injection site, appearance consistent with herpes ZOSTER rash.  No other symptoms or treatment reported.  The patient's event was treated with VALTREX for 7 days as herpes ZOSTER rash.  Before and 6 weeks after vaccination, serum VARICELLA ZOSTER virus antibody test were performed with IgG equivocal.  The patient sought medical attention in the office visit.  On 19-AUG-2008 the patient recovered from VARICELLA like rash at the injection site.  Additional information has been requested.