chrisvoncsefalvay/vaers-outcomes huggingface dataset:
fainting; hitting the floor; "knocking out" both of her front teeth when she fainted and hit the floor; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (fainting) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced SYNCOPE (fainting) (seriousness criterion medically significant), FALL (hitting the floor) and TOOTH INJURY ("knocking out" both of her front teeth when she fainted and hit the floor). On 12-Feb-2021, SYNCOPE (fainting) and FALL (hitting the floor) had resolved. At the time of the report, TOOTH INJURY ("knocking out" both of her front teeth when she fainted and hit the floor) was resolving. Unknown          She had a visit to Family Practice Physician, visit to Dentist and need for dental work.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, fainting and falling down, a causal relationship cannot be excluded. The event of tooth injury is  unlikely related to mRNA-1273 since this was directly related to the event, falling down.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, fainting and falling down, a causal relationship cannot be excluded. The event of tooth injury is  unlikely related to mRNA-1273 since this was directly related to the event, falling down.
This spontaneous report as received from person from practice via company representative refers to 3 patients of unknown ages and genders who on unknown dates were vaccinated with a dose of MMR II (dose, lot #, expiration date and route were not provided). On unknown dates the patients developed reactions (not specified) to unspecified lot of MMR II (vaccination complication). At the time of the report, the outcome of vaccination complication was not reported. This is one of several reports from the same source. Additional information is not expected. There was no consumer information to contact for follow-up.
lung infection; horrible cough; headache; chills; nasal congestion; Exhaustion; sweats; This is a spontaneous report from a contactable consumer (patient herself). A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in left arm on Feb2021 (reported as 27Jan2021; pending clarification) (lot number: EN62co) as single dose at the age of 71 years old for COVID-19 immunisation. Medical history included known allergies (unspecified). The patient was not pregnant at the time of vaccination. Concomitant medication included omeprazole (OMEPRAZEN), taken for an unspecified indication, start and stop date were not reported. The patient previously received first dose of bnt162b2 on 27Jan2021 05:30 PM (lot number: ELX47) for COVID-19 immunization. The patient developed a severe lung infection two weeks and two days after her second vaccine (06Mar2021 05:00). She had a horrible cough, headache, chills, sweats, nasal congestion and exhaustion. She has been in bed for 13 days. The AEs resulted in doctor or other healthcare professional office/clinic visit. The patient was given steroid shot and brea (unspecified) as treatment for the adverse events. The patient was not diagnosed with COVID prior to vaccination. The patient underwent lab tests and procedures which included two chest x-rays with unknown results, both on unspecified dates; and COVID-19 nasal swab: negative on 06Mar2021 and also negative on 08Mar2021. The patient has not recovered from all the events at the time of this report.
Severe swelling of entire arm. Hot red. Severe muscle pain. Continued for weeks.
My period was 2 weeks late, which is not typical. Then, my POTS symptoms became much worse, making it feel like my beta blocker wasn't working.  Symptoms include feeling dizzy, fatigued, headaches, shakiness, more adrenaline surges, rapid heartrate.
Information was received from a medical assistant regarding multiple unspecified patients with unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. The medical assistant reported that an unspecified number of unspecified patients received improperly stored PROQUAD lot# M004891/expiry date: 25-JUL-2017 and M022399/expiry date: 01-NOV-2017 on unspecified dates in 2016 (dosing details not reported). Temperature/time frame: 21-SEP-2016: 16.3F for 2 hours and 23-SEP-2016: 6.1F for 2 hours 15 minutes. The call was due to a data logger. Prior excursions on 15-SEP-2016: 13.5F for 4 hours and on 16-SEP-2016: 63.1F for 4 hours. No product quality complaint (PQC) was involved. This is one of the three same reporter linked case. Additional information has been requested.
Non reported Narrative: A 70yo male with history of HTN, DM, CAD with stent placements and ESRD (on Hemodialysis) Per nursing documentation, he received Covid-19 vaccine on January 23, 2021 at 8:45 and it was administered without complications per policy and protocol
TIGHTNESS THROUGH SHOULDER AND CHEST CONTINUING FOR ABOUT A WEEK AND A HALF AFTER INJECTION.  ALSO EXPERIENCE SENSATION OF DIFFICULTY BREATHING OVER THE COURSE OF TIME.
Admitted to local hospital 2/24 with weakness, malaise, cough and altered mental status 2 days after receiving 2nd dose of moderna SARS COV2 vaccine. He was initially tachycardic, febrile and had leukocytosis 18K, with admission labs with creatinine 1.8, lactate 2.4. He had need for supplemental oxygen and was placed on broad spectrum antibiotic therapy. Respiratory viral panel including SARS COV2 PCR was neg. Blood cultures from 2/24, 2/27, 3/3 were negative. CT chest showed some prominent mediastinal adenopathy which was increased from prior CT 2017. Also had axillary and inguinal lymphadenopathy. 2/27 he had a code blue called for bradycardia in context of receiving ativan for a CT study. Antibiotics  were changed to Vancomycin, ceftriaxone and ampicillin, acyclovir on 2/28. Multiple attempts by multiple providers at doing a lumbar puncture have been unsuccessful.  Bronchoscopy 3/2 with left lower lobe secretions. Cultures negative. He has stayed incessantly febrile and working diagnosis is probable underlying lymphoproliferative neoplasm immunostimulated by vaccine. At this time a bone marrow and lymph node excisional biopsy is planned. Patient is unstable to proceed for MRI imaging at this time due to hypotension.
Deep muscle ache on arm where tetanus vaccination administered.  Could barely move arm for 1 week.  Constant throbbing and aching even after 2 weeks.  Still having sharp pain on arm muscle when rotating arm upwards.  Went to Urgent Care on 1/4/2013 -- referred me to orthopedist to evaluate muscle damage.
tiny bit of soreness in muscle tissue and about 24 hrs later at 2am woke up shaking for 2hrs, begin to feel super hot had a temp of 103 and she started hurting and felt weak. 3 day after shot felt a little better and started to slowly recover and on July 5 her body started shaking very hard and had pains and a low grade fever
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: Patient received a pfizer covid19 vaccine and sat on the floor during the monitoring period due to dizziness. Patient was given a bottle of water and reported fainting briefly before resuming consciousness. Patient waited at the pharmacy and was given a protein bar and gatorade to help because he reported not eating or sleeping. Blood pressure was taken and was 155/75 mmHg which then decreased to 119/82 mmHg a few minutes later and then normalized to 121/82 before the patient left. Full recovery
sl fever 20MAY97PM off & on 21MAY;APAP given by mom & sitter; 11PM 22MAY97 pt felt hot, was cranky t104.4 ax;APAP given taken to ER 12-12:30AM 23MAY97 temp 105.8 R;Ibuprofen given;dx broncopneumonia;25MAY rash devel;
It started with swelling itching and burn of injection site. It had spead to my whole body by morning. About a week maybe 2 weeks I call the on call doctor he gave me prednisone which I took even though it make me sick to my stomach. Call clinic and saw my doctor; she took me off the prednisone the Sept 12 she order test and put me on a group of drugs. They didnt work and by this time a burn feeling had set in. On the 18 of Sept. more blood work was ordered results in extra info. These sensations are still on going ice is my only relief. It is hard to sleep.
Migraine, dizziness, vomited, fever of about(101.7), extensive sweating and elevated heart rate. Lasted for 6 hours.
Information was received from a physician assistant and a licensed practical nurse regarding a 2 month old female patient. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On 02-MAR-2017 the patient was vaccinated with PNEUMOVAX23 lot # M022085, expiration 09-OCT-2017, 0.5 ml, intramuscular for prophylaxis instead of PREVNAR 13.  On 02-MAR-2017, during the same office visit, the patient received other unspecified routine vaccinations. The patient had not experienced any adverse effects. No further information was provided. Additional information has been requested.
Body pain; Rash on abdomen and back; Sleeplessness; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2022, the patient received the 1st dose of Shingrix. In August 2022, less than 3 weeks after receiving Shingrix, the patient experienced general body pain, rash and sleeplessness. On an unknown date, the outcome of the general body pain and sleeplessness were not recovered/not resolved and the outcome of the rash was unknown.   It was unknown if the reporter considered the general body pain, rash and sleeplessness to be related to Shingrix.     Additional Information: GSK receipt date:30-AUG-2022 Reporters comment: The patient experienced body pain, rash on his abdomen and back and sleeplessness.  The reporter given consent to follow-up. The emergency visit was required.
Information has been received from a physician concerning a 13 year old female, with no pertinent medical history, who on an unspecified date was vaccinated with a first dose of Gardasil. On 03-JUL-2007 was vaccinated IM, in her left arm, with a second dose of Gardasil (lot # 658094/0524U). There was no concomitant medication. On 04-JUL-2007 the patient experienced leg pain from knee to ankle. She went to the emergency room and was released. The emergency room physician thinks she might have experienced nerve damage. Additional information has been requested.
This spontaneous report was received from a pharmacist concerning an infant patient of unknown age and gender. Medical history or concurrent conditions were not reported. On an unspecified date, the infant patient was vaccinated with a dose of GARDASIL. (Dose, frequency, lot number and strength not provided). Co-suspect or concomitant therapies were not reported. Pharmacist had no specific details regarding the patient or the administration. No adverse effect reported. Additional information has been requested.
About 2 days after receiving the second shot, diarrhea and horizontal burning in lower left side of abdomen.; Horizontal burning in lower left side of abdomen; This is a spontaneous report from a contactable consumer, the patient. A 71-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 11Feb2021 (at the age of 71-year-old) as a single dose for COVID-19 immunisation. Medical history included diverticulosis. Concomitant medications included simvastatin (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) 100mg and multi-vitamin (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient received codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. 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 4 weeks prior to the vaccination. On 14Feb2021, about 2 days after receiving the second shot the patient experienced diarrhea and horizontal burning in lower left side of abdomen. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with computerized tomography (Cat) scan, blood work and upper Gastrointestinal (GI). The clinical outcome of the events diarrhea and horizontal burning in lower left side of abdomen were not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Information has been received from a healthcare worker refers to an unspecified number of patients of unknown age and gender who were administered an unspecified number of doses of GARDASIL (lot#, expiration date, dose, strength and route not reported) on unspecified dates since 28-OCT-2014 which had been improperly stored (considered as incorrect product storage). No adverse effects reported. It was unspecified if the patients sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Information has been received describing a 69 year old female with a history of osteoporosis and rheumatoid arthritis who received an influenza virus vaccine on 1/30/01, the same day that she also received her quarterly infusion of pamidronate. Concomitant therapy included Enbrel (etanercept), prednisone, omeprazole, atenolol, levothyroxine, aspirin and simvastatin. Two days later, on 2/01/01, she developed fever of 106F with joint pains. She was hospitalized and treated with amoxicillin clavulanic acid for 2 days. Therapy was discontinued when the possibility of an infection was ruled out by her physician. The pt recovered. The reporter noted that the treating rheumatologist considered the events to be temporally related to the pamidronate infusion or the influenza virus vaccine. See related Enbrel report HQ0850614MAY2001.
Patient complained of high fever, chills, shaking, and malaise.  He said his arm was red, hot, and swollen.
This is a spontaneous report from a contactable consumer, the patient. A 61-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Lot number: UNKNOWN) on 04Mar2021 (at the age of 61-years-old) as a single dose for COVID-19 immunization and received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via unspecified route of administration in the left arm on 24Mar2021 at 11:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included obesity, mitral valve prolapse (MVP) and osteoarthritis. The patient did not have allergies to medications, food, or other products. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Mar2021, after first vaccine the patient experienced cold sore - left side of tongue for a couple of days. On 25Mar2021 after Second vaccine, the patient experienced cold sore- right side of tongue for a couple of days. The adverse events did not result in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the reported events. The clinical outcome of the events cold sore (after first vaccine) and after second vaccine was recovered on an unknown date in Mar2021. No follow-up attempts are needed; information about lot number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021357059 same patient/drug/event occurred in different place
Initially there was a sharp pain and tingling on injection. Progressed to a deep seated aching pain which impaired her ability to function normally over the course of a week. Patient experiences additional sharp pain upon movement or weight bearing.  Treated with 10 day course of steroids during which time pain subsided, only to return upon completion of therapy. Patient as recommended ibuprofen 800 mg tid but was uneffective. Dr. wants to initiate Neurontin bid.
Red marks running down arm from injection site to down below the elbow. Diagnosed as cellulitis.
Hives began on hand moved to face - all the way to feet. July 28 (8th day of vaccine) was first day. I also had swelling of the knees and ankles - uncomfortable. About 5 days later with Benadryl ceased.
While driving home after receiving the vaccine I was very close to losing consciousness.  After laying down in my car for 20 minutes I was able to drive home.  I developed a headache that did not subside fully until three days later.  On Friday December 18th, I woke up with a very sore arm, from my shoulder to my wrist, I still had a headache, developed; fever, chills, body aches, and nausea.
Patient was seen for his 2nd dose of Meningococcal B.  After receiving the vaccine he fainted and fell off the table hitting his head on he ground. Do to the fall he was then transported to the ER where he received 3 stiches on his laceration about his eyebrow.
Narrative: Patient tested positive for breakthrough COVID infection (8/10/21) via out-patient test. No details on initial symptoms documented. Patient presented to ER on 8/17/21 with intractable nausea, vomiting, diarrhea ongoing for the past 2 weeks. Since COVID dx, unable to keep any of his food or medications down. Reports fever, chills, cough productive of sputum, body aches, fatigue, and loss of taste and smell. Has a history of CLL (s/p Bendamustine and Rituximab 4 years ago) currently on oral ibrutinib therapy. Given age, medical history, persistent symptoms, patient was admitted. Treated with IV Remdesivir 08/17 - 08/21 (x 3 days) and dexamethasone 08/17 - 8/26 (x 10 day course). Supportive treatment with ascorbic acid, zinc sulfate, benzonatate, acetaminophen, albuterol inhaler and supplemental O2. Discharged on 8/20/21 with dexamethasone for 7 more days
the day following pneumococcal vax pt devel inj site pain w/redness, warmth, & swelling of the arm from shoulder to elbow; MD attention sought; still had bruise arm at time of rpt; used ice pack; recovered approx 2weeks following onset;
Felt a little dizzy no more than 15 minutes after; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt a little dizzy no more than 15 minutes after) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (Felt a little dizzy no more than 15 minutes after). On 02-Feb-2021, DIZZINESS (Felt a little dizzy no more than 15 minutes after) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant Concomitant medications were reported. No Treatment information was provided.
Headache, NauseaVomiting, chills, muscle aches Narrative:
received a late 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number df4sfm, expiry date 18th December 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th June 2019).   On 21st June 2021, the patient received the 2nd dose of Shingrix. On 21st June 2021, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient received 2nd dose of Shingrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
herpes zoster; Information has been received from a lawyer referring to a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 27-AUG-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events herpes zoster to be disability.
Fever - up to 105 degrees myalgia vaginal bleeding went to Medical Center labs - thrombocytopenia.