chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sometime she has back problems., not comfortable. not normal.; Her arm hurt as well and was swollen; Her arm hurt as well and was swollen; Almost like the flu; She has no energy; Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over; Jaws hurt; Gums hurt; This spontaneous case was reported by a consumer and describes the occurrence of BACK DISORDER (Sometime she has back problems., not comfortable. not normal.), PAIN (Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over), PAIN IN JAW (Jaws hurt), GINGIVAL PAIN (Gums hurt) and PAIN IN EXTREMITY (Her arm hurt as well and was swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939905, 046B21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Blood pressure high.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PAIN (Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over), PAIN IN JAW (Jaws hurt) and GINGIVAL PAIN (Gums hurt). On an unknown date, the patient experienced BACK DISORDER (Sometime she has back problems., not comfortable. not normal.), PAIN IN EXTREMITY (Her arm hurt as well and was swollen), PERIPHERAL SWELLING (Her arm hurt as well and was swollen), INFLUENZA (Almost like the flu) and ASTHENIA (She has no energy). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK DISORDER (Sometime she has back problems., not comfortable. not normal.) outcome was unknown and PAIN (Shot went into the muscle, and everything hurt/everything hurt/pains and aches everywhere/she was achy all over), PAIN IN JAW (Jaws hurt), GINGIVAL PAIN (Gums hurt), PAIN IN EXTREMITY (Her arm hurt as well and was swollen), PERIPHERAL SWELLING (Her arm hurt as well and was swollen), INFLUENZA (Almost like the flu) and ASTHENIA (She has no energy) was resolving.      The patient was on unspecified medications for diabetic and high blood pressure conditions.  The patient received the vaccine in her left arm, which is the non-dominant arm.  The patient was feeling a little better, but she did not feel herself and still not back to normal. The patient was waiting to see her doctor, because the doctor will check her blood work and will check to see if the Moderna COVID-19 vaccine was working.
Adult dose given to a 12 year-old; Adult dose given to a 12 year-old; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 12-year-old male patient who received HBV (Engerix B adult) (batch number NT9X3, expiry date 9th September 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th January 2023, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 17th January 2023, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 17-Jan-2023 Reporter's comment: Nurse administered Engerix-B adult dose to 12 year old pediatric patient. Adverse event contains all reported information. The reporter gave consent for safety team follow-up. The reporter consented to follow-up. Additional supportive information: The pediatric patient received an adult dose of Engerix-B, which led to overdose and adult product administered to child.
Fever of 100.7 with joint pain and body aches.  Took Ibuprofen 2 200mg at onset and approximately 12 hours later
This is in follow-up to report (s) previously submitted on 3/27/2009. Information has been received from a physician concerning a patient who in approximately 2008 "about a year ago" was vaccinated subcutaneously with a dose of ZOSTAVAX. The physician reported that in approximately September 2008 in "the fall of 2008" the patient developed shingles. The patient had since recovered and a VZV analysis was not required. The patient sought medical attention. Additional information has been requested. This is an amened report. The Initial Report Date has been changed from 06-JAN-2009 to 16-JAN-2009.
Patient complain of a bruised back. She cannot lift anything heavy and above the waist. Cannot sleep on left side. Had to take meloxicam for pain.
Pale, dizziness, rapid heart rate to 160s multiple times went to ER total of 3 times. Multiplayer labs drawn. Being seen for unknown cause of symptoms to endocrinologist and cardiologist. Holter monitor for 2 weeks and to be seen by electophysian for electrical activity of heart.  Had to be intubated for ablation procedure.  Unable to work since 10-17-2021. Unknown outcome since still feeling palpitations.
chills; body aches; disorientation; redness on legs, arm & abdomen; This is a spontaneous report from a contactable consumer (patient) via Team. A 76-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 12Feb2021 as a dose 1, single for COVID-19 immunisation. Co-suspect medication included CEFEPIME HCL (Formulation: unknown), via an unspecified route of administration on an unspecified date as 100 mg, unknown for an unspecified indication. The patient's medical history was not reported. The patient's concomitant medications included other unspecified medications. Enquired, the patient reported that, he received first pfizer covid vaccine on Friday 12Feb2021 during the morning. Stated that, on Saturday 13Feb2021, he started having chills, body aches, disorientation, redness on legs, arm and abdomen. Stated that, the patient was currently taking cefepime 100 mg which he has been on for a little over two weeks, along with other medications and had concerns about the vaccine and other medications. Stated that, the patient took Nyquil last night to help him rest. Treatment was received for the events. The outcome of the events was unknown.  Pfizer is a marketing authorization holder of [Cefepime HCl] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Cefepime HCl] has submitted the same report to the regulatory authorities.  Information about lot/batch number was requested. Follow-up attempts are completed. No further information is expected.
Breakthrough case admission after 4 vaccines Moderna 2/19/21 Lot# 024M20A; Moderna 3/19/21 Lot# 047A21A;  Moderna 10/29/21 Lot# 939903;  Moderna 9/14/22 Lot# 857140C
Body hives and whelps; This case was reported by a consumer via call center representative and described the occurrence of hives in a 9-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Concurrent medical conditions included milk allergy, egg allergy, peanut allergy and allergy to nuts.   On 12th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season. On 12th October 2022, 2 hrs after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to FluLaval Quadrivalent 2022-2023 season.     Additional Information: Reporter's comment: The case was reported by patient's parent on behalf of her daughter.  The reporter stated that the patient (daughter) received the Flulaval vaccine yesterday (before reporting day) at pediatrician's office. About two hours later, the patient experienced full body hives and whelps.  The adverse event was filed.  The reporter consented to follow up.
Inject given pm, Thurs am woke up tired as day progressed very fatigued unable to function, nauseated Thurs & Fri. Still tired Sat & Sun, Ok back to normal Mon.
64 year old Female was administered 18minutes beyond the 6hours labelled time; 64 year old Female was administered 18minutes beyond the 6hours labelled time; 64 year old Female was administered 18minutes beyond the 6hours labelled time; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A 64 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE X; MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), outcome "unknown" and all described as "64 year old Female was administered 18minutes beyond the 6hours labelled time".  Additional information: Nurse who is seeking information regarding re-vaccination of booster shot. she states that two patients were administered with Pfizer BioNtech covid vaccines that were diluted beyond the 6hours storage.   The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101676401 same reporter/different patients/same event
Pregnancy history: 3 full term LIVE pregnancies No previous miscarriages Due date was December 7th, 2021 Genetic/chromosomal blood testing was performed at 10 weeks and 2 days gestation on May 13, 2021: confirmed gender was male and everything was normal and healthy.  Ultrasounds were performed both at 9 weeks gestation and at 13 weeks gestation (genetic/chromosomal screening) and everything was normal and healthy.  On June 24th (16 weeks 3 days): was seen in ER due to upper abdominal pain. Was diagnosed with a miscarriage that occurred around 14 weeks gestation.   Procesure (D&E) to remove fetus took place June 29, 2021. I lost over 3 pounds of blood and almost died following procedure.
Pt says she got vaccine at pharmacy and then developed redness, temperature, flu like symptoms and pain at injection site. I saw her 4/5/2019. Redness at injection site was still there. She said she was improving and wanted to let me know about what had happened.
At 9:44 PM patient reported severe nausea and feeling "hot". Her temperature was normal, but her forehead was warm.  Her pulse was normal.  Her oxygen levels were normal. She looked pale. We asked for medical assistance from Amazon. Four blood pressure readings were taken and all were slightly elevated.  Her lips were not swollen, but she reported her lips were tingling and her tongue felt thick.
3/10/10 client received nasal H1N1/MedImmune at facility. H1N1 outreach received message left on phone 3/12/10 per client, able to contact client on 3/15/10 and obtain report, client c/o headache about 1 hour after vaccination and 24 hours after "face broke out".  Explain receiving the nasal vaccine what the common side effects were. She reported taking over the counter ibuprofen, she reported this did give her relief. Upon questioning her about her "face breakout", she explained her face had "dry patches", denied any redness or swelling. She reports putting lotion on her face with gradual improvement of condition. She reports never experiencing this before or had problems with her "face breaking out". Upon further questions she denied any MD visits or other medications to relief symptoms. Allowed her to verbalize her concerns. I informed her I would report this to our medical director. Upon discussion with the Dr it was felt VAERS should be filled out accordingly. Also, clients report no other c/o after receiving H1N1 nasal.
10 after I received the Janssen Covid-19 vaccine, I admitted myself to the emergency room with severe chest pain and very difficult time breathing.  They ran CT scans and found multiple blood clots in both lungs, pulmonary embolism.  They put me on blood thinners and transferred me to another hospital.  There they monitored me for a couple days and released me with a prescription for blood thinners.
intense itching on hand; hives on hand, spread to collarbone and other arm and also appeared on the backs of knees; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 06Apr2021 at 13:00(at the age of 58-year-old) as a single dose for COVID-19 immunisation. Medical history included mitral valve prolapse. Concomitant medications included zinc (MANUFACTURER UNKNOWN), estradiol (FEMRING), ascorbic acid (VITAMIN C), magnesium sulfate (MAGNESIUM)  and cod-liver oil (FISH OIL), all from unknown dates and for unknown indications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 at 02:30, the patient experienced intense itching and hives on hand. It was reported that when the patient woke up at 05:30, the hives had spread to collarbone and other arm. At 09:00, they had appeared on the backs of her knees. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for intense itching and hives which included anti histamine and steroid cream. The clinical outcome of the events intense itching and hives on hand, collarbone, other arm and back of knees were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient received his second dose of the Pfizer vaccine in the mid afternoon of April 21st 2021 and by the mid afternoon on April 24th he complained of severe pain in his chest. I took his vital signs with a pulse oximeter and his saturation was in the high 90's and his pulse was normal in the 80's range. He pointed to his chest and he said it hurt him and for about three hours he appeared to experience moderate to severe pain. I called the pediatrician who said these symptoms were not uncommon. I can't remember if I gave my son tylenol or advil to help alleviate symptoms. His symptoms appeared to resolve within 3-5 hours. Also, he had felt feverish and sluggish after the administration of the vaccine for the three days leading up to the symptoms of chest pain.
This spontaneous report as received from a certified medical assistant refers to a 14 year old female patient. In 2011, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly and on 08-NOV-2013, the patient received the second 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly. No adverse effects were reported. Additional information is not expected.
This is an 82 year old male, , with past medical history significant for Parkinson's Disease, CAD, HTN, HLP, Dementia, Subarachnoid hemorrhage, who presented to the ED for weakness, fatigue, AMS, s/p fall. The patient is + for Covid 19. The patient's wife and Daughters are all positive. His wife is admitted here as well. He is fully vaccinated with Moderna x 2 in March/April 2021. One of the patient's Daughter's is not vaccinated. Apparently he lost his balance and fell at home. He denies any loss of consciousness. A chest xray showed poor lung volumes, linear bibasilar atelectasis, no infiltrate, stable right sided diaphragmatic hernia. . His sats were 89% on room air and improved to 98% on 2L n/c.
This spontaneous report was received from a female registered nurse reporting on herself. No medical history or concurrent conditions were reported. On 18-NOV-2014, the reporter because of a PQC (product quality complaint) PNEUMOVAX 23, had leaked onto both of her hands (topical route). She experienced no adverse effects. Additional information had been requested.
tested positive with Covid; tested positive with Covid; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer Sponsored program. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 12Mar2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced tested positive with COVID. The consumer would like to cancel her and the patient's second dose schedule that was due the next day because her husband tested positive with COVID. The patient underwent lab tests and procedures which included SARS-COV-2 test: Positive on unspecified date in Mar2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
After receiving the second dose of the COVID-19 vaccine, I had side effects of hives on my stomach, intense fatigue, and headache pain.
PYREXIA  Information has been received from a physician concerning a female who was vaccinated with a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck upgrade process). Subsequently the patient developed a very high fever of 104 five days post-vaccination.  Unspecified medical attention was sought. The patient's outcome was not reported.  There was no product quality complaint involved.  Additional information has been requested.
the next day after my 2nd shot, I started experiencing hemifacial spasms on the left side.  lip, eye, neck, cheek, all twitching at random times.  Now 2 weeks after the 2nd shot the spasms continue.
headaches that have stayed for more than 12 hours, fainted at pharmacy minutes after receiving vaccine, blurry vision for around 8 minutes, dehydrated before fainting, a little difficulty breathing
No event; Improperly stored vaccines on unspecified dates; Information has been received from a nurse concerning a 2-months-old male patient. Patient's concomitant medications included hepatitis b vaccine, diphtheria vaccine toxoid (+) hib vaccine conj (tet tox) (+) pertussis vaccine acellular 5-component (+) polio vaccine inact 3v (mrc 5) (+) tetanus vaccine toxoid (PENTACEL) and pneumococcal vaccine conj 13v (crm197) (PREVNAR 13). Patient's concurrent condition's and pertinent medical history were not provided.  On 20-JUN-2023, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # 1968385 with expiration date 07-MAR-2024, for prophylaxis (strength, frequency, and dose were not reported) that underwent a temperature excursion (incorrect product storage). It was reported that the alarm believed to be due to sensory issues. Monitoring temperatures were in range again with new data logger in use. Vaccines were returned and waste was in progress.  No adverse effects were reported.  This is one of several cases from the same reporter.
Had a hard, flat, painful swelling about the size of a nickle.; This is a spontaneous report from a contactable consumer, the patient. A 74-year-old, non-pregnant female patient received second dose of BNT162B2[PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6198], via Left arm and an unspecified route of administration2nd dose on 02Mar2021 at 04.15 pm (at the age of 74-years-old) as a single dose for Covid 19 immunisation. Medical history included Heart stent, overweight, and arthritis. The patient had a history of Lisinopril allergy. Patient previously received BNT162B2[PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN5318] 1st dose on 09Feb2021 at 04.15 pm as a single dose for Covid 19 immunisation. Concomitant medications included Atorvastatin (Manufacturer unknown) and aspirin (Manufacturer unknown) for an unspecified indication. On 02Mar2021 06:00 PM, the patient experienced hard, flat, painful swelling about the size of a nickle. It lasted about 5 days. The patient had recovered from the event of painful swelling at the time of reporting. No follow-up attempts are needed. No further information is expected.
increased heart rate; blood pressure increased; fatigue; headahe; muscle pain; vomiting; chills; nausea; Dizziness; weakness; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe) and MYALGIA (muscle pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 06-Mar-2021, the patient experienced HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe), MYALGIA (muscle pain), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea), DIZZINESS (Dizziness) and ASTHENIA (weakness). At the time of the report, HEART RATE INCREASED (increased heart rate), BLOOD PRESSURE INCREASED (blood pressure increased), FATIGUE (fatigue), HEADACHE (headahe), MYALGIA (muscle pain), VOMITING (vomiting), CHILLS (chills), NAUSEA (nausea), DIZZINESS (Dizziness) and ASTHENIA (weakness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Pepto-Bismol   Reporter did not allow further contact
Flulike symptoms including malaise, joint aches and pains and 101.1 degrees F.
severe first outbreak of shingles with post-herpetic pain now improving but not resolved , severe worsening of chronic pains due to Diffuse Idiopathic Skeletal Hyperostosis now improving but not resolved, new shortness of breath requiring inhaled steroid use
This spontaneous report as received from a registered nurse refers to a 13 year old patient. The nurse reported that the patient received a dose of 0.5 ml expired VARIVAX (merck) (lot # 668253/0926Z; Expire date 15-JUL-2012) subcutaneous on 19-JUL-2012. No adverse effect was reported. This is one of several reports received from the same source. No further information is available.
Patient called morning of 7/22/13, 3 days after vaccination reporting a 3 inch diameter rash around injection site on right deltoid. Instructed patient to apply hydrocortisone cream and all if symptoms persist.
Extreme fatigue, dizziness, brain fog, blood vessel on right side of head pulsing occasionally, pain in back, loss of focus