chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Couldn't eat anything; Dry heaves and gagging; pretty weak; Fever; Wicked, bad headache; Sore arm/pain in arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Aug-2021 and was forwarded to Moderna on 30-Aug-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm/pain in arm), FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak) and PYREXIA (Fever) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood cholesterol abnormal, Acid reflux (oesophageal) and Blood pressure abnormal. Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), EVOLOCUMAB (REPATHA) for Blood cholesterol abnormal, TELMISARTAN for Blood pressure abnormal.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm/pain in arm). On an unknown date, the patient experienced FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak), PYREXIA (Fever) and HEADACHE (Wicked, bad headache). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm/pain in arm), FEEDING DISORDER (Couldn't eat anything), RETCHING (Dry heaves and gagging), ASTHENIA (pretty weak), PYREXIA (Fever) and HEADACHE (Wicked, bad headache) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-302252.
About 4-5 minutes after receiving the shot, experienced heart racing (180 bpm), and feeling faint.  Breathing was fine.  Felt slightly tight in the throat.  Also experienced diarrhea twice within the 40 minutes following the vaccine.   The heart racing and faint feeling lasted about 5 minutes.  The throat tightness lasted closer to 1.5 hours, but was never severe- just noticeable.  Within 2 hours of the vaccine, was feeling much better.  Never experienced actual difficulty breathing.  I reported to employee health RN and personal physician.
Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 23-Feb-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 24-Feb-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.            No Concomitant information  provided. No Treatment information  provided   This case was linked to MOD-2021-026020, MOD-2021-026068 (E2B Linked Report).; Sender's Comments:  MOD-2021-026068:same reporter, different patient and event MOD-2021-026020:same reporter, different patient and event
Swelling, redness at and around injection site that has extended to a larger area over the last 24 hours. Entire arm sore, muscles soreness, fatigue, upset stomach and headache,
This spontaneous report as received from a medical assistant referring to an patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, frequency and route of administration were not reported) (lot # N003703 expiry date: 29-OCT-2019) for prophylaxis. The GARDASIL 9 was exposed to a total time in the range at or above 0 °C to 1 °C for 8.25 hours. It was reported the exact temperature and time below 0°C was: -1.9 °C for 15 minutes, -1.2 °C for 15 minutes, -1.0 °C for 15 minutes, -0.8 °C for 15 minutes, -0.4 °C for 15 minutes and -0.2 °C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error.  Troubleshooting: Scribe and vaccinator did not validate age;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. All sections ignored the ID requirement put in place to prevent this situation from occurring.
Symptoms started about a week after second shot. Heavyness in chest ongoing but random chills and sweats and gerd symptoms that appear to becoming worse and having to sleep elavated so im not gagging at night.
Information has been received from a physician concerning an approximately 17 week old male who on 25-MAR-2008 was vaccinated PO with his first 2.0 ml dose of Rotateq. The patient was hospitalized for 8 days from 25-APR-2008 to 02-MAY-2008 with intussusception requiring surgery with a loss of a section of the terminal ileum. The patient was noted to be recovering. There was no product quality complaint. No additional information at this time. Intussusception was also considered to be an other important medical event (surgery) by the physician. Additional information has been requested. 7/23/08-records received for DOS 4/25-4/30/08-DC DX: Intussusception. Presented with 2 day history of abdominal pain and bright red blood per rectum morning of 4/24/08-Not interested in eating and decrease of diapers/decreased urine output. Pain, severe fussiness, lethargy, rectal bleeding. PE: abdomen positive bowel sounds with a palpable wave. Partial colectomy with excision of terminal ileum.
Sore Arm; Nausea; Light Headedness; This is a spontaneous report received from a contactable consumer (patient herself). A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and lot number EN5318) via an unspecified route of administration to left arm on 04Feb2021 at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. It was reported as patient experienced with Sore Arm, Nausea, Light Headedness on 04Feb2021. Patient did not receive any treatment for events. Outcome of events was recovered on an unspecified date.  No follow-up attempts are possible. No further information was provided.
15 minutes after vaccination: stomach queasy and burning in esophagus  12 hours after vaccination: vomiting and diarrhoea and sore arm
vomiting; body aches; neck pain; chills; fever up to 103; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Oct2021 10:00 (Lot number: 8841) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid", start date: Mar2020 (unspecified if ongoing), notes: Severe illness from covid; "Severe illness", start date: Mar2020 (unspecified if ongoing), notes: Severe illness from covid; "blood clot after birth" (unspecified if ongoing), notes: blood clot after birth; "intestinal resection after diverticulitis" (unspecified if ongoing), notes: intestinal resection after diverticulitis at age 27; "intestinal resection after diverticulitis" (unspecified if ongoing), notes: intestinal resection after diverticulitis at age 27; "pericarditis", start date: 2014 (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; BIOTIN; MAGNESIUM; MIRENA. The following information was reported: VOMITING (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "vomiting"; PAIN (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "body aches"; NECK PAIN (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "neck pain"; CHILLS (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "chills"; PYREXIA (non-serious) with onset 15Oct2021 00:30, outcome "not recovered", described as "fever up to 103". The events "vomiting", "body aches", "neck pain", "chills" and "fever up to 103" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of vomiting, pain, neck pain, chills, pyrexia.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient diagnosed with COVID-19 was yes. Since the vaccination, has the patient been tested for COVID-19 was no. Relevant past drug history was None. Reaction Allergy. List of any other medications the patient received within 2 weeks of vaccination: Vitamin c, vitamin D, biotin, magnesium and mirena.   No follow-up attempts are possible. No further information is expected.
Hospitalization for UTI, failure to thrive, acute kidney injury (test COVID-19 positive on 9/3/2023) on dates 9/2/23- 9/6/23. Treated with no COVID-19 medications.
Inadvertent vaccination of small pox to a female patient who subsequently discovered she was pregnant.  No adverse reactions noted.
pt recvd vax & felt flushed, lightheaded, dizzy & shakey; denied resp difficulty; chest, neck, head, & arms bilateral-patches of erythema; c/o pruritis, R24, P110 & regular Epi;
Received the first and second dose during the first trimester; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Received the first and second dose during the first trimester) 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) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Received the first and second dose during the first trimester). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Received the first and second dose during the first trimester) had resolved.            Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Patient was given HPV #3.  Right arm today, complained of pain.  Stated she felt dizzy, tried to get patient to lie down.  Stated she felt better, walked out of room, fell forward, cold, clammy.  Blood pressure 120/80 immediately.  Pox 1007, pulse 103-124.  Stated had headache today.  RBS done 127.  Mother states patient's blood pressure has been up with headache.  170/95 per mother.  Eye doctor called for visit, stated she got pale and weak on days of appointment.
after the first dose I began getting headaches and dizziness that lasted for 5 months. I had heart palpitations after the 3rd dose that lasted for two months, as well as fatigue that is still ongoing
Initial unsolicited report received from a consumer (patient herself) on 01-Dec-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route, dose, dose in series and site of administration were not reported) on an unspecified date in 2013. (The reporting patient stated that she did not know name of flu vaccine she had received). The patient medical history and concomitant medication was not reported. On an unknown date, following vaccination the patient experienced hives on her chest, arms, thighs and calves. Relevant lab test and corrective treatment was not reported. On an unknown date, patient recovered from the event. List of documents held by sender: none.
mistakenly administered the patient Infanrix instead of Adacel; Initial information received on 06-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 72 years old patient (gender unknown) who received vaccine INFANRIX instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, concomitant medication and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFANRIX not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site instead of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported.  It was an actual medication error due to wrong vaccine administered.  It was reported that the provider had ordered TDaP (Adacel) but nurse mistakenly administered the patient DTaP (Infanrix).  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender- none.
no adverse effects reported; improperly stored dose of vaccine was administered to the patient; This spontaneous report as received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 30-APR-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) rHA, lot # R026720, expiration date: 17-MAR-2020 for prophylaxis (dose and route of administration were not reported) reconstituted in sterile diluent (STERILE DILUENT) (lot # and expiration date were not reported). It was unspecified of sterile diluent underwent any temperature excursions. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 16.6 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.  Lot No. R026720 has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), expiration date reported as 17-MAY-2020, but upon internal validation established as 17-MAR-2020.; Sender's Comments:  US-009507513-1905USA004595: US-009507513-1905USA011855: US-009507513-1905USA011856: US-009507513-1905USA011857: US-009507513-1905USA011858: US-009507513-1905USA011859: US-009507513-1905USA011860: US-009507513-1905USA011861:
Syncope reaction - IMMEDIATE REACTION. DROP IN BLOOD PRESSURE, FAINTNESS, PROFUSE SWEATING, BLURRED VISION, COLOR DRAINED FROM FACE, NEVER LOST CONSCIOUSNESS. WAS UNABLE TO GET BP DUE TO SMALL SIZE OF HIS ARMS. I HAD TROUBLE LOCATING THE PEDIATRIC CUFF. WHEN EMS ARRIVED THEY TOOK BP AND IT WAS 58/40. EMTS HUNG FLUIDS AND TOOK PT TO EMERGENCY DEPARTMENT. Pt called pharmacy at 8:30p reporting leaving emergency department feeling fine after fluids administered.
Patient's mother picked up patient at Father's house Right leg was red with golf ball sized swelling, and left leg was red with grapefruit sized swelling, Mother states child does not appear to have any pain at this time, Mother to call PCP, will call back if family has any questions.
pt recv vax 26SEP96 & pt began exp coldness & burning sensations in lower extremities;bone scan, EMS, MRI & neuro rheumatological consults have been found to be unrevealing of the etiology of sx;sx persisted as of 13MAR97;
COVID breakthrough case report. I received my 1st booster shot on 11/11/2021. My adverse event started on 04/28/2022 with cough, with a little fever. I went to a HCF to get tested my result came out positive on 04/30/2022. My mild symptoms continued for few days. I called my doctor he advised me to take Tylenol if needed. I didn't need any treatment. When I was breathing I was feeling pressured. I recovered slowly. I treated this as a common flu.
This spontaneous report was received from a pharmacist refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 17-SEP-2016, the patient was vaccinated with improperly stored ZOSTAVAX vial, lot # L046295 (expiry date: 17-FEB-2017), subcutaneously (dosage not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information is not expected, as there is no consent to contact.
Appendicitis; pain from my incisions; terrible stomach aches/pains; vomiting; soreness and redness, but it wasn't intense; barely felt any soreness; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078C21A and 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Jul-2021, the patient experienced VACCINATION SITE PAIN (barely felt any soreness). On 17-Jul-2021, the patient experienced ERYTHEMA (soreness and redness, but it wasn't intense). On 19-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (terrible stomach aches/pains) and VOMITING (vomiting). On 20-Jul-2021, the patient experienced INCISION SITE PAIN (pain from my incisions). On an unknown date, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization prolonged and medically significant). The patient was treated with OXYCODONE at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and Surgery (to remove appendix) for Appendicitis. On 16-Jul-2021, VACCINATION SITE PAIN (barely felt any soreness) had resolved. On 20-Jul-2021, ABDOMINAL PAIN UPPER (terrible stomach aches/pains) and VOMITING (vomiting) had resolved. On 22-Jul-2021, ERYTHEMA (soreness and redness, but it wasn't intense) had resolved. At the time of the report, APPENDICITIS (Appendicitis) and INCISION SITE PAIN (pain from my incisions) outcome was unknown.            No concomitant medication information was provided. she was given blood work, urine tests, an EKG, a CT scan, and an Ultrasound. Then she was diagnosed with appendicitis and admitted around 4:30 PM. She given medicines in preparation for surgery including IV antibiotics, and oxycodone. Then had surgery to remove her appendix. After the surgery she has not had the same pain as prior, but has had pain from her incisions.  Company comment-Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Approximately 5 minutes receiving the Gardasil vaccine, while waiting in the waiting room, patient experience dizziness and sweatiness.  Patient was responsive and had no difficulty breathing or hives.  Patient was cold to touch. however patient was sweating at the same time. After about 20 minutes patient was ok and walked away on their own, and refuse paramedic assistance.
I then passed out and ended up on the floor; got sick in the stomach; This is a spontaneous report from a contactable consumer (patient). An 86-year-old non-pregnant female patient received bnt162b2 (Pfizer Covid vaccine), dose 1 on an unspecified date and dose 2 administered in left arm on 20Apr2021 00:15 (Lot Number: 101 #EP7534); both via an unspecified route of administration, as single dose for COVID-19 immunisation. Medical history included post phlebitic syndrome, macular degeneration and arthritis from an unknown date and unknown if ongoing. Concomitant medications included pravastatin taken for an unspecified indication, start and stop date were not reported; gabapentin taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (LEVOTHYROXIN) taken for an unspecified indication, start and stop date were not reported. The patient has not received other vaccine in four weeks. The patient had known allergies to Sulfer Plus (also reported as Sulfer). On 08Apr2021 10:00, the patient suddenly got sick in the stomach and thought was going to throw up. She then passed out and ended up on the floor. She was only out a second and woke up when she hit the floor. Outcome of the events was recovering. No treatment given for AEs. The patient was not diagnosed of Covid prior vaccination and has not been tested for Covid post vaccination.  Information on the lot/batch number of first dose has been requested.
pt recvd vax;redness at site at lt deltoid muscle p/ 11 days; felt nauseous but no fever p/ shot;apap 2 days later;
At time of injection, patient seemed tense and told his dad he was dizzy.  Vaccinator noticed "clenching of the muscle" and thought they saw a hematoma bump when the muscle clenched.  Gave patient apple juice and let patient rest with father and observed for 15 minutes. Patient and family (father and sibling) left pharmacy by walking on their own with no issues
General muscle aches and stiffness the day after the vaccine, fatigue, pain in right hip and weakness in right leg causing difficulty lifting right leg requiring my to lift it with my hands to get in bed or to lift it into a foot rest.  When lifting there was increased pain and tingling in my hip. The next day, the symptoms were resolved.
pt recvd vax & devel hives around upper & lower trunk & extremities; hives on face; went to MD dx w/ allergic rxn to vax; tx w/ meds;
Presents for vasovagal syncope & fall from bed. Admit for sycope from nausea/dehydration in setting of COVID. Dx with COVID pneumonia x7days PTA. Tx: supportive (was already started on Prednisone while in rehab facility).  DC back to rehab.