chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Jaw operation; Jaw pain; Interchange of vaccine products; This is a solicited report received from contactable reporter(s) (Consumer or other non-HCP) for a sponsored program. Other Case identifier(s): 22K-163-4341506-00 (AbbVie).  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), intramuscular (Batch/Lot number: unknown) as dose 2, single and intramuscular (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Lot number: 1159928) for rheumatoid arthritis. Relevant medical history included: "Interchange of vaccines products" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: JAW OPERATION (medically significant), outcome "recovering", described as "Jaw operation"; PAIN IN JAW (non-serious), outcome "recovering", described as "Jaw pain"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "Interchange of vaccine products". The action taken for adalimumab was unknown.  Additional information: On unknown dates, the patient experienced Jaw Surgery and Jaw Pain. Moderna Covid-19 Vaccine (Elasomeran) And Pfizer BioNtech Covid-19 Vaccine (Tozinameran) were also considered suspect. Patient reported had jaw surgery and was now recovering. Still some pain but overall doing good. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The reporter's causality for the event(s) of Jaw Surgery and Jaw Pain with Humira (Adalimumab) Was No reasonable possibility. AbbVie's opinion is that there is no reasonable possibility that the events of Jaw Surgery and Jaw Pain Are Related to Humira (Adalimumab). The reporter's causality for the event(s) of Jaw Surgery and Jaw Pain with Moderna Covid-19 Vaccine was probable. The reporter's causality for the event(s) of Jaw Surgery and Jaw Pain with Pfizer BioNtech Covid-19 Vaccine (Tozinameran)(Tozinameran) was probable.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information, there is a reasonable possibility of a causal relationship between the suspect vaccine BNT162B2 (COMIRNATY) and reported event Jaw operation which cannot be fully assessed/excluded. The case will be reassessed if additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Pt vaccinated with DTP/OPV/HIB developed screaming for 3 hrs.
Headache, chills, body aches.  Tylenol, ibuprofen and Benadryl    Felt better after 24 hours
Information has been received on 18-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 02-APR-2009, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a physician's office as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 19-AUG-2012, the patient was treated by a physician at a physician's office for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
On return from doctor's office didn't feel well 1 hr later started with fever Tmx 102 degrees. Mom gave ibuprofen and she vomited 10 min later, and has vomited twice since. No diarrhea, no rash; does have hard swelling about size of dime and tender, no increased redness/heat positive headache with "swollen temples" at 3-4 pm until went to bed; this am temples not swollen but still had mild headache. Fever lasted 24 hrs, general malaise x 3 days.
Multiple sclerosis; Numbness in hands, on the right side of the body, on the left side of the body; Lost coordination; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M29) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Multiple sclerosis.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced HYPOAESTHESIA (Numbness in hands, on the right side of the body, on the left side of the body) and COORDINATION ABNORMAL (Lost coordination). On an unknown date, the patient experienced MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis) (seriousness criterion medically significant). At the time of the report, MULTIPLE SCLEROSIS RELAPSE (Multiple sclerosis), HYPOAESTHESIA (Numbness in hands, on the right side of the body, on the left side of the body) and COORDINATION ABNORMAL (Lost coordination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the 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 the events, a causal relationship cannot be excluded.
This spontaneous report as received from a head nurse in physician assistant office via the field representative refers to a male patient of age approximately 2 years. Concurrent conditions and medical history was not reported. In approximately 2013 (single dose given at 2, 4 and 6 months of age) the patient was vaccinated with ROTATEQ suspension 2, who received all series of doses (lot number, dose, frequency and route of administration not reported). Concomitant medications were not reported. In 2015 (reported as late February/early March) the patient experienced rotavirus infection after receiving the full series of ROTATEQ. On an unknown date approximately in 2015, the patient was taken to the emergency room and was admitted. The length of the stay in hospital was not reported and the patient was discharged on an unknown date approximately in 2015. The patient sought the medical attention. The outcome of rotavirus infection was reported as recovering. The causality assessment was not reported. No product quality complaint (PQC) was filed. It was also reported by the field representative that this event was reported through another adverse event reporting system and the Food and Drug Administration (FDA) and perhaps the Centers for Disease Control and Prevention (CDC) was reviewing this case, including checking temperature logs. No further information was provided. This is one of the 2 reports from the same source. Additional information has been requested.
Felt normal reaction from 3 hours post injection until bedtime.  Upon awakening felt very faint, weak and somewhat dizzy.  During the course of the next four days I had numerous episodes of high heart rate [120-156] and multiple alarms [on smart watch] for Afib and several alarms for irregular heart rate.  Weakness continued for 48 hours.  Most concerning was the AFib and the racing heart rate. Last symptoms of Afib and increased heart rate were on Sunday October 23rd a full 9 days after the injection.
Patient received ZOSTAVAX at 11:51 am on 01-10-13 and called the pharmacy at 6:30 pm of same day to report that she had "head to toe hives". Patient treated with OTC BENADRYL.
Nausea; A spontaneous report was received from a consumer concerning a 69-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event nausea.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 031M20A) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 16 Feb 2021, the patient experienced the event nausea.  Treatment details included peppermint tea.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, nausea was unknown.
I have ulcers inside my mouth; Pain in the body; Tired; Pain in joints, in fingers, wrists, elbows and in general / I still have pain in my joints when i stand up; Tongue sores; Sore throat / I have sore throat, and inside my mouth; Cheeks swollen / my face has swollen 4 times; Swelling eyelids / my eyelids has swollen 4 times; Weak and lacks strength; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE ULCERATION (Tongue sores), OROPHARYNGEAL PAIN (Sore throat / I have sore throat, and inside my mouth), SWELLING FACE (Cheeks swollen / my face has swollen 4 times), SWELLING OF EYELID (Swelling eyelids / my eyelids has swollen 4 times) and ASTHENIA (Weak and lacks strength) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Gastric bypass (patient has had a gastric bypass for many years).    On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, the patient experienced TONGUE ULCERATION (Tongue sores), OROPHARYNGEAL PAIN (Sore throat / I have sore throat, and inside my mouth), SWELLING FACE (Cheeks swollen / my face has swollen 4 times), SWELLING OF EYELID (Swelling eyelids / my eyelids has swollen 4 times), ASTHENIA (Weak and lacks strength), PAIN (Pain in the body), FATIGUE (Tired) and ARTHRALGIA (Pain in joints, in fingers, wrists, elbows and in general / I still have pain in my joints when i stand up). On an unknown date, the patient experienced MOUTH ULCERATION (I have ulcers inside my mouth). The patient was treated with ACETAMINOPHEN for Pain, at a dose of 1 dosage form. At the time of the report, TONGUE ULCERATION (Tongue sores) was resolving, OROPHARYNGEAL PAIN (Sore throat / I have sore throat, and inside my mouth), SWELLING OF EYELID (Swelling eyelids / my eyelids has swollen 4 times), ASTHENIA (Weak and lacks strength), MOUTH ULCERATION (I have ulcers inside my mouth), PAIN (Pain in the body), FATIGUE (Tired) and ARTHRALGIA (Pain in joints, in fingers, wrists, elbows and in general / I still have pain in my joints when i stand up) had not resolved and SWELLING FACE (Cheeks swollen / my face has swollen 4 times) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported by the reporter. The patient reported the initial event of the swollen eyelids went away after taking an unknown medication, benadrine and this lasted for 4 days. Upon follow up, the patient reported the events of the swollen eyelids and swollen cheeks had reoccurred 4 times.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received with adverse event details. On 07-Jul-2021: Translated Document
Partial dose; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced partial dose (Incorrect dose administered by device).  The patient's medical history was not provided. Concomitant medications were not reported.  On 17 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly for the prophylaxis of COVID-19 infection.  On 17 Jan 2021, the reporter suspects the patient experienced a partial dose because the needle used was not long enough to accommodate the patient's body size. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, partial dose was considered resolved on 17 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
This spontaneous report as received from a Reimbursement OA Specialist, refers to a 43 year old patient of unknown gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, lot number and expiration date were not provided). No concomitant therapies were reported. According to the reporter the patient was vaccinated outside of the indicated age range. The outcome of the event was unknown at the time of this report. This is one of several reports from the same reporter. Additional information has been requested.
Pain from hand to shoulder - severe; Pain going into back too; Pain in arm; This is a spontaneous report from a contactable consumer, the patient. A 51-years-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 left arm on 07Apr2021 at 18:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had known allergies to tetanus shot and penicillin. The patient received other medications within two weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 23:00, the patient experienced pain from hand to shoulder - severe, pain going into back too and pain in arm. The patient reported that she can't lift arm due to pain and can hardly hold anything in left hand. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No therapeutic measures were taken as a result of reported events. The clinical outcome of pain from hand to shoulder -severe, pain going into back too and pain in arm was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt found 5-15-08 @ 2110 by mother unresponsive, not breathing. He had been fed 4 oz and given TYLENOL for temp at 2040 hrs, then put in his crib, on abdomen with face turned to side, at 2100 she rushed him to ER at local hospital where CPR was performed and pt transferred via helicopter to another hospital. Pt on life support until 5-18-08 when it was stopped and he expired. 8/1/08-records received for DOS 5/16/08-5/18/08-presented in cardiopulmonary arrest, resuscitative efforts included CPR, intubation, mechanical ventilation. Hypothermic on presentation with rectal temperature of 91.6, hypoglycemia with blood sugar 16, metabolic acidosis. Prior to event C/O fussy all day running low grade fever, placed in crib on abdomen, found white, lump with face buried in cover. Drove child to hospital. PE: agonal respirations not compatible with life. Pupils nonreactive to light, fixed. No spontaneous movement of extremities. Deep tendon reflexes absent.  8/11/08-records received-Findings:Myocarditis. Inflammation and necrosis, myocardium. Interstitial edema, epiglottis. Tracheobronchitis, chronic. The inflammatory lesions observed in heart are consistent with either acute viral infection or post-viral syndrome.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the incorrectly stored (33.1 F for 90 minutes) doses of GARDASIL 9 (lot # reported as M028323, expiration date 26-SEP-2018; dose and route of administration were not reported). No previous excursion was reported. The call was made because of the data logger. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On 01/11/2002 seen by a doctor treatment for cellulitis. Left arm around side of injection, redness, edema.
Face became reddened within 1/2 hour after adminis. Face. eventually began to swell. Hives/reddened skin over many parts of body. Even ankles swollen. Treated at ER facility. All info above reported to me from mother on 5/8/02. Still has some hives as reported by mom 5/8/02.
began w/sx of pain to lt arm, next day pt states had numbness to lt arm from shoulder to hand, the next day pt states severe pain to lt arm, pain & numbness then subsided however pt c/o cont occassional milder pain & numbness to lt ar
Spoke to Pt who states received Covid #2 (Moderna) 5/13/21 and noticed left arm swelling that evening. Pt states woke up Saturday and swelling resolved. Pt states by Sunday 5/15 felt left side of neck swollen (by clavicle). Pt also state left side of chest and breast now swollen. Pt also c/o areas warm to touch. Pt denies fever or chills. Pt advised to take Motrin w/food.
Patient experienced "spinning" sensation when getting out of bed in the early morning, nausea x 4 hours.
Information has been received from a registered pharmacist concerning a 35 year old female who on approx. 05/14/2001 was vaccinated with the third dose of hep b vaccine recombinant. On 05/16/2001 the pt experienced quiet bit of achiness and swelling of her hand s and subsequently sought medical attention. It was reported that the pt did not experience these symptoms with the administration of the first or second dose of the vaccine. No other info is available.
nose bleeds every day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent. Other Case identifier(s): US-PFIZER INC-202101689601 (Pfizer).  A 8 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 13Nov2021 (Lot number: FK5127, Expiration Date: 31Jan2022) at the age of 8 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma. There were no concomitant medications. The following information was reported: EPISTAXIS (non-serious) with onset 18Nov2021, outcome "not recovered", described as "nose bleeds every day".  Additional Information: it was a Pfizer COVID Vaccine for age group 5 to 11 a Pfizer product. She had asthma, but it was not severe anymore like it was. She was not on any medications now. Nose bleeds every day: it started 5 days after the vaccine. It either happens during the night when she sleeps and will wake her up or it happens during the day. It happens everyday. There have been no other changes besides getting vaccine. She was a tall girl and weight was around 85 to 90 pounds. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. She didn't even get her flu vaccine. Adverse event did not required visit to emergency room or physician office. No Prior Vaccinations within 4 weeks. No AE(s) following prior vaccinations. no relevant tests. Caller was calling on behalf of her 8 year old daughter that got her first dose of the Pfizer pediatric (5-11years old) vaccine on 13nov2021. Five days after the vaccine, she started having nose bleeds. She's been bleeding everyday since. Caller wants to know if this is a common side effect. Caller stated that she just wanted to know if this was a common side effect. Had heard stories about blood clots and bleeding and she wanted to make sure it is nothing serious.  No follow-up attempts are possible. No further information is expected.
headache, severe dizziness, fatigue, slight fever, slight nausea, soreness at injection site
No additional AE details were provided and no additional AE's were reported; patients that were administered vaccines after they were involved in a TE.; This spontaneous report was received from a licensed practical nurse and referred to a 6-month-old patient of unspecified gender. The patient's medical history, concurrent conditions, concomitant therapies were not reported.  On 09-NOV-2022 13:02 PM, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ), 2 milliliter(ml) oral liquid, 2 ml, lot #1879861, expiration date: 20-OCT-2023, administered orally for prophylaxis after the vaccine was involved in a temperature excursion (Product storage error). The storage temperature of the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) was 11.4 degrees Celsius for a time frame of 1 hour 30 minutes. There was no previous temperature excursion. No additional adverse effect (AE) details were provided (no adverse event).  This is one of 9 reports received from the same reporter.; Sender's Comments:  US-009507513-2212USA000031: US-009507513-2212USA000032: US-009507513-2212USA000033: US-009507513-2212USA000034: US-009507513-2212USA000035: US-009507513-2212USA000036: US-009507513-2212USA000038: US-009507513-2211USA004171:
Mucousy cough that has progressively become worse over the last 48 hours. Mild fever (100F and below) started on morning of 05/04/2011. Fever broke in response to acetaminophen. Child is otherwise in good spirits despite the impeding cough.
Pericarditis, chest pain, inability to sit up in a chair. Lasted for almost a month. Initial pain was 9-10 on the pain scale, had to take percocet for the pain.
Moderna vaccine leaked out on her arm; This spontaneous case was reported by a consumer and describes the occurrence of MEDICATION ERROR (Moderna vaccine leaked out on her arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 037A21B) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MEDICATION ERROR (Moderna vaccine leaked out on her arm). At the time of the report, MEDICATION ERROR (Moderna vaccine leaked out on her arm) outcome was unknown. Not Provided          Concomitant medication was not provided. Treatment information was not provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Vaccine was administered on 1/14/21. Approximately 15 minutes later patient complained of being dizzy and lightheaded and having a metallic taste, injection area was sore. She waited with EMS for 30 minutes, felt better and left. The next 24 hours she had fatigue, joint pain in her knees and fingers, discomfort under left arm and left breast. For the next 10-14 days her left deltoid area was warm and red. She had a virtual appointment with her nurse practitioner, no treatment was necessary, just to continue to monitor. The next day all symptoms were resolved.