chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received a dose of improperly stored PROQUAD; No adverse event; This spontaneous case was received from and healthcare professional regarding to a patient of unknown age, gender and ethnicity. The patient's concurrent conditions, medical history, drug allergies and concomitant therapies were not reported.   On 09-MAR-2021, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114 with expiration date reported as 07-FEB-2022) 0.5 (units not reported) (route of administration and anatomical location of vaccine were not reported) for prophylaxis. The vaccine was exposed to a temperature between 5.0 °F and 8.0 °F for 8 hours and 40 minutes. A previous temperature excursion was reported. No adverse effect was reported.  Albumin status has been verified for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T027114) to be recombinant human albumin (rHa).  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2103USA003425:
A spontaneous report was received  from a other health care professional  concerning a female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced to receive her 1st dose but she states that immediately the vaccine and syringe broke and the liquid splashed all over her arm, she didn't feel nothing, didn't feel any puncture and she claims she didn't receive any vaccine at all. As provided by the reporter the patient does not have medical history. No concomitant medication reported. On 18 MAR 2021 , the patient received their first of first planned doses of mRNA-1273 (Lot number: 045A21A) was administered intramuscularly via unknown site for prophylaxis of COVID-19 infection. On  18 MAR 2021, After  receiving mRNA-1273, the patient experienced to receive her first dose but she states that immediately the vaccine and syringe broke and the liquid splashed all over her arm, she didn't feel nothing, didn't feel any puncture and she claims she didn't receive any vaccine at all.  Action taken with mRNA-1273 in response to the events was not reported. The event(s) immediately the vaccine and syringe broke and the liquid splashed all over her arm, she didn't feel nothing, didn't feel any puncture and she claims she didn't receive any vaccine at all were resolved on 18 Mar 2021.; Reporter's Comments: This report refers to a case of Accidental underdose, Syringe issue, Wrong technique in device usage process for mRNA-1273, lot # 045A21A  with no associated Adverse Events.
Vaccine manufacturer and lot number unknown, vaccine given at alternate location.  2/23/21  8:27 PM: The patient is a 68-year-old male   comes to the emergency department by paramedic ambulance for altered mental status that, began at around noon in association fever temp 102.9.  PMH of myelofibrosis (on Jakafi and hydroxychloroquine), depression, anxiety, OSA, and history of AVR.  Given history of myelodysplasia and Jak inhibitor predisposing to some opportunistic infections most notably viral reactivation with history of HSV and possible bacterial endocarditis he was admitted to the ICU for further monitoring and pressors.    Patient has a MOS procedure 14 days prior   - Status post MOSs procedure with large wound deficit on forehead -- Does not appear to be overtly infected at the time of admission.   ED physician indicated mild facial cellulitis.  2/23/21- WBC 16.1 on admission.     ECHO 2/26 indicated - no vegetation visualized. Of note second COVID vaccine 2 days prior to admission. Dr. felt incident was possible cardiogenic shock secondary to COVID vaccine.  He did not feel the patient has a source of infection upon admission.  Questionable given wounds on forehead Dr. (CMO) review of case- his impression was  septic shock with and underlying case of chronic cardiac compromise making the hemodynamics worse
Crankiness, fatigue, loss of appetite started ~1 day post vaccine (9/17/22). Fever of ~102 F started around 3 days post vaccine (9/19/22).  Controlled with Tylenol. Mild rash started on neck ~6 days post vaccine (9/22/22) and continued to get worse over several days. Rash (looked like moderate sunburn in circular patches on face, legs, arms, back... not raised, no weeping, no itching or pain). Fever varied around 99-102 F for several days. No elevated temperature as of 9/29/22. As of 10/02/22, fatigue and lack of appetite has persisted and has just started to get better. Rash significantly improved as of 10/02/22 - rashes began to fade from center of circle outward.
Breakthrough case: My symptoms included loss of taste & smell (which lasted for 6 weeks), tiredness, and brain fog (lasted for 4-5 days).
This spontaneous report as received from a licensed practical nurse refers to a 9 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that on 08-AUG-2014 the patient was vaccinated with a dose (unspecified in series) of RECOMBIVAX HB (lot # 0386AE; expiration date reported as 10-NOV-2014), 0.5 ml, intramuscularly, that had been exposed to 1 degree C for 4 hours. No adverse effects reported. This case is linked to cases MARRS # 1408UISA015578 and MARRS # 1409USA002597 (same reporter link0. Additional information has been requested.
Fever, chills, muscle aches, shortness of breath, fatigue, headache, extreme sweating, loss of appetite.
Pain in the back becoming so severe level 8.  Went to local doctors in Healthcare for four weeks trying to get help. Could not walk after the fourth week. Went to medical center and diagnosed within two hours of having acute osteomyelitis.  On the verge of sepsis.
Date and time of vaccination: (list both if they received both shots): 1-15-21 4:15PM MODERNA LOT # 012L20A,    2-12-21 4:15PM MODERNA LOT # 010M20A. Fever 104F, took one Tylenol.
Dose administered after 30-day Use By Date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No allergy or disease on file.    On 17-Jan-2023, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date).    Concomitant and treatment medications were reported.  Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.   This case was linked to MOD-2023-704736 (Parent-Child Link).   See case MOD-2023-704736 for details regarding the child case.
Treatment of COVID-19; 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 61-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 25Oct2022 at 13:00 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 61 years 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: hyperlipidemia, history of breast cancer with chemotherapy and radiation. The patient's concomitant medications were not reported. Past drug history included: PCN (Penicillin), reaction(s): "known allergies: PCN", notes: known allergies: PCN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 for which patient received PF-07321332, ritonavir (PAXLOVID) from to 11Feb2023 to 15Feb2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from an office manager (also reported as a healthcare worker) concerning an approximately 26 year old female patient with no drug reactions or allergies. On 11-APR-2013, the patient was vaccinated with dose 1 of, 0.5 milliliter (ml) of GARDASIL (lot number and expiry date reported as H015863 and 24-FEB-2015 respectively) intramuscularly. There were no concomitant medications. On 11-APR-2013, the patient fainted and possibly had a seizure immediately after receiving the vaccination. Initially the eyes of the patient rolled back, fainted and woke up crying. The patient had not eaten any food on the day of reporting. The patient sought medical attention (patient was still in the office at the time of reporting). No treatment was provided. On an unknown date, a pap test was was performed and the result was found to be abnormal, (also reported as no lab tests were performed). At the time of reporting, the patient was recovering from all the events (also reported as the entire episode lasted for 30 seconds). The relatedness for all the events was unknown for GARDASIL. Upon internal review, seizure was considered as medically significant. Additional information has been requested.
Violent and continuous vomitting, diarhea, headaches, dizziness, exhaustion, loss of mental ability for 4-5 days.  Occurred afternoon of vaccination date.  Treatment included plenty of hydration and restriction of solid food.
Patient reported redness and swelling at the injection site, also reported "red dots" in this area as well.  She did state that she felt numbness from the injection site to the elbow and finger tingling.   She noticed itching at the injection site first at approximately 11am on 10/24 and later on 10/24 experienced the other symptoms
Injection site arm spots that are itchy; Injection site slightly swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Injection site arm spots that are itchy) and VACCINATION SITE SWELLING (Injection site slightly swollen) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history provided).    On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Injection site arm spots that are itchy) and VACCINATION SITE SWELLING (Injection site slightly swollen). At the time of the report, VACCINATION SITE PRURITUS (Injection site arm spots that are itchy) and VACCINATION SITE SWELLING (Injection site slightly swollen) outcome was unknown.            no concomitant medication provided no treatment given
We had two patients who came to get vaccinated together. We only had 1 adult dose left in our open vial of adult pfizer vaccine, so the immunizing technician pulled a vial out of the refrigerator. The vial that was pulled was a pediatric vial.  The vial was not diluted (since we do not dilute adult vials) and a dose of 0.3 mLs was drawn up into the syringe. In error, the dose of 0.3 mLs of undiluted pediatric vaccine was given to one of two patients. We are unsure which one received which dose because they were both in the immunization room at the same time.
Patient stated she was very nervous and had bad anxiety but had to get the vaccine for work. Patient felt dizzy and lightheaded, drank cold water, started sweating and eventually vomited.  She stated she felt much better afterwards. She stated she had been drinking and had not eaten. She was taken to treatment area.
This 39 year old pt who 3 days prior to admission had 3 vaccines and shortly thereafter, he had a headache. The headache persisted until the day of admission. On the evening prior to admission, he noticed the insidious onset of left-sided weakness involving his upper and lower extremity as well as difficulty swallowing and a left facial droop. He was treated empirically for an acute CVA based on his symptoms, but after discussing the case at length with neurology, we decided to stop his heparin and treat him for an allergic response to his vaccines. He was started on prednisone and will be discharged on a Medrol Dosepak. He had improvement, albeit minimal, with regard to his presenting symptoms. I have recommended that he not travel for 2 weeks and that he follow-up with a neurologist in 4 weeks. Discharge medications besides Medrol Dosepak include Enteric-coated aspirin 81mg #1 po qd and Synthroid 0.12mg po qd.
Injection site soreness; Muscle ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness), MYALGIA (Muscle ache) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 15-Jan-2019. Concomitant products included LOSARTAN from 15-Jan-2019 to an unknown date for Blood pressure, MULTIVITAMIN [VITAMINS NOS], WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]), VITAMIN D3 and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). March 2021, the patient experienced MYALGIA (Muscle ache) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Injection site soreness), MYALGIA (Muscle ache) and FATIGUE (Fatigue) outcome was unknown.            Treatment information provided.     This case was linked to MOD-2021-025267 (Patient Link).
Child states left arm was itching at 03:00 on 8/14/07. At  630am it looked like a mosquito bite on the arm. The site of injection became red, swollen, itchy and tender worsening over today. Child came to health clinic at 3PM for evaluation. Red, swollen, hot, tender area 6 x 6cm noted. Prescribed Benadryl and Keflex. Phone update on 8/15 per grandmother - improve.
Get heavy flow on what would normally be my 'time of the month'; It affects my daily life to detrimental proportions.; Tired; Headache; Bloating throughout every month; My menstrual cycle is now 3 weeks+ long flow and never really stops.; Cramps, spotting, clotting; Cramps, spotting, clotting; Cramps, spotting, clotting; This is a spontaneous report from a contactable consumer. This 44-year-old female consumer (patient) reported for herself that.  A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration, administered in Arm Left on 26Apr2021 13:45 as (At the age of 44-years) dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included acetaminophen taken for an unspecified indication, start and stop date were not reported. Patient was not pregnant at the time of Vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not diagnose with COVID-19 Prior to vaccination. Patient did not test for COVID-19 Since the vaccination. The patient previously took Erythromycin, penicillin and all derivatives, Epinephrine shot (the way it is prepared) and experienced drug hypersensitivity (Allergies). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 03Apr2021 01:30 PM as (At the age of 44-years) dose 1, single for covid-19 immunisation and experienced intermenstrual bleeding. On 29Apr2021 12:00 patient experienced menstrual cycle is now 3 weeks long flow and never really stops. Cramps, spotting, clotting, the whole nine yards almost all month, every month since his second dose. First dose had made spot some between periods, too. It was reported that patient still get heavy flow on what would normally be his 'time of the month'. If patient lucky, might get up to a week after his 'time' flow-free, but never more and often less. Patient cannot go even one day without wearing a pad at least or I'll bleed through clothing. Tired, headache, cramps, even a bit of bloating throughout every month since vaccination. This suck, it affects his daily life to detrimental proportions. Patient did not receive any Treatment for events. No Prolonged Hospitalization for events. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Received vaccine 11/2/04: returned to office 11/11/04 for fever and rash : diagnosed with a likely MMR reaction and sent home (saw doctor) they returned 11/12/04 because of fever and decreased intake: admitted by doctor for dehydration.
This spontaneous report was received from a pharmacist via a company representative concerning a patient of unknown age and gender. No concurrent conditions or medical history were reported. On an unknown date, reported as "several years ago", the patient was vaccinated with ZOSTAVAX 19400 PFU, 0.65 ml one time (Lot No. expiration date and anatomical location of administration were not reported). No concomitant therapy was provided. On an unknown date, reported as "several years ago", the patient developed shingles following the administration of the vaccine. No Product Quality Company (PQC) was involved. The outcome of herpes zoster was unknown. Additional information has been.
Since I woke from an afternoon nap, I can hardly hear and there is intense ringing in my ears (right worse than left).  My injection was at 11:23am and I woke up with this at 5:20pm. I have no cold or sinus symptoms and never have ear problems.
Large pink flat nontender non pruritic slightly indurated warm area 12x10 cm at right upper outer thigh.
11 days post vaccination, patient experienced itching, redness, warmth, and swelling at the injection site.
My 11 year old son had severe vomiting 12 hours after getting a first dose of GARDASIL 9. That's not a serious side effect, but vomiting is not listed as a side effect for GARDASIL on its website or the CDC's website. It may be possible that it's a coincidence, but he was not ill prior and seems to be fine the next day.
Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash (specify: facial area, extremities)-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Tingling (specify: facial area, extremities)-Medium
Systemic: Exhaustion / Lethargy-Medium, Systemic: Shakiness-Medium, Additional Details: Patient's wife called letting us know that he was very tired and shaking after receiving the vaccine. However, he has a condition that causes shakiness anyways, but it was worse today, one day after he received the vaccine booster dose.
cHILD SEEN FOR 4 MONTH WELL EXAM 8/1/2006 NORMAL EXAM RECEIVED ROUTINE IMMUNIZATIONS AND DURING THE NIGHT THE PATIENT EXPIRED
Patient given TDaP and MENACTRA in right arm. Patient developed redness and swelling in upper arm extending to axilla. It was warm to touch. Area measures 7cm X 6cm tender to touch.
has shingles; This is a spontaneous report from a contactable consumer (patient). A 90-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: unknown) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced shingles. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Hives. Diarrhea. Patient took Benadryl (3 doses yesterday and 1 dose today). Patient reported hives were more numerous and very itchy today. Patient sought medical help from local provider and was prescribed Prednisone 20 mg once daily for 5 days.
For about 4 days after the vaccine I had chills, vertigo, fatigue, loss of appetite, hot flashes, and general malaise.   Then, after the first week of having the vaccine, I began to have these symptoms about once a week. Last week, it was on 5/6 when I gradually become colder regardless of layers and my stomach was repelling the idea of food (no vomiting or actual nausea). I went to bed and I was better by morning.   Yesterday (5/12), I had the same thing. Chills and the inability to stay warm, loss of appetite, and a sort of sleepy vertigo.
PULSING AT INJECTION SITE; ARMS HURT; LEGS HURT; CHILLS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 22 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 041A21A expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, treatment medications included: paracetamol. On 08-APR-2021, the subject experienced arms hurt. On 08-APR-2021, the subject experienced legs hurt. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced headache. On 26-APR-2021, the subject experienced pulsing at injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arms hurt, legs hurt, fever, and headache on 11-APR-2021, and chills on 09-APR-2021, and had not recovered from pulsing at injection site. This report was non-serious.
Since 8 hours post shot patient experiencing: shakes, chills, fatigue, nausea, temperature of 101°  Muscle pain, body aches, diapharetic.
arm is a little heavy; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 08Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The patient's medical history was not reported. Concomitant medication included ibuprofen taken for an unspecified indication from 08Apr2021 to an unspecified stop date.  The patient got her first dose a few hours ago on 08Apr2021 and she took 400mg of Ibuprofen after her first dose. Patient said that she was advised by her friend to take it. Patient asked if it would affect the efficacy of the vaccine. Patient also mentioned that her arm is a little heavy on 08Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Nine days following my first Moderna Covid vaccination in my left arm I am experiencing around the injection site redness swelling itching warmth. Immediately following the vaccination I was fine. The next few days I felt some soreness. Mid morning today? Nine days later I am having a reaction around the injection site.