chrisvoncsefalvay/vaers-outcomes huggingface dataset:
EE states he received flu shot on 11/28/11 and presents to clinic 3 days s/p injection and states that he has a lump in left axillary. He states that he had flu-like symptoms with malaise and chills the day after shot. Last flu shot was 10 years ago and he did develop flu-like symptoms but no swelling or erythema. On subsequent follow up he states left should and neck pain with muscle weakness and pain. EE has history of bilateral shoulder surgery but was completely asymptomatic until 7 days after injection. EE referred to Ortho and completed a battery of exams, including MRI, PT and injection to left shoulder. EE referred to neuroDx joint pain possible error in placement of injection, possible inflammatory reaction to joint capsule or tendon/bursae (9/7/2012). EE referred back to Ortho(3/20/13) Dx-- Arthralgia left shoulder, temporary aggravation of pre-existing impingement syndrome.
After receiving the vaccine, increased amounts of heart palpitations were experienced for at least 3 weeks before noticing a little respite in their frequency.  Irregular periods and heavy menstruation have also been experienced. Period following vaccine was heavy and came at a much earlier date than usual for the cycle. The 2nd period after that one started at the end of April and is still going on (as of May 18th). I do not have any history of irregular periods or menorrhagia of this extent.
patient was administered pentacel, but it was not reconstituted with the HIB component with no adverse event; Initial information received on 10-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 months old male patient who was administered diphtheria/tetanus/5 hybrid AC pertussis /IPV(VERO)/HIB(PRP/T) vaccine [Pentacel], but it was not reconstituted with the hib component with no adverse event.  The patient's past medical history, medical treatment(s), concomitant medication(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect diphtheria/tetanus/5 hybrid AC pertussis /IPV(VERO)/HIB(PRP/T) vaccine, Suspension for injection (lot UJ788AAA, strength - standard, frequency - once, expiry dat - 18-Sep2023) via unknown route in unknown administration site for immunization but it was not reconstituted with the hib component with no adverse event (single component of a two-component product administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.
Patient stated that her arm was swollen down to her elbow, but not around her arm. Her shoulder and arm has been hurting, so she went to doctor. Doctor told her she has bursitis.
Patient developed blisters and sores in her mouth; Patient developed blisters and sores in her mouth; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Patient developed blisters and sores in her mouth) and ORAL PAIN (Patient developed blisters and sores in her mouth) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03HK20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced BLISTER (Patient developed blisters and sores in her mouth) and ORAL PAIN (Patient developed blisters and sores in her mouth). At the time of the report, BLISTER (Patient developed blisters and sores in her mouth) and ORAL PAIN (Patient developed blisters and sores in her mouth) outcome was unknown.            Reporter did not allow further contact
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The medical assistant reported the patient was administered a first dose of PNEUMOVAX23 (0.5 ml, intramuscular) on 18-APR-2014, and was inadvertently administered a second dose of PNEUMOVAX23 (0.5 ml, intramuscular) on 02-DEC-2014. No adverse effects reported. Additional information has been requested.
Pt recvd vax & devel encephalitis; It was felt that pt's exp was life threatening; addtl info has been requested;
About 2.5 weeks after receiving her second Pfizer COVID vaccine pt started feeling sick with fevers, achiness, sciatic nerve pain, muscle pain, joint pain. On 4-11-21 she started taking hydroxichloriquine and a z-pak from the front line COVID doctors. She took the medications and seemed to do well but on the 3rd or 4th day she started hurting again. After she finished the meds she went to the Center. She was put on supplements and Ivermectin and another course of hydrochloroquine. She also was in the oxygen chamber twice. She then started taking peptide shots twice a week which really seemed to help. These started wearing off after about 3 days. She took her last one on 6-7-21 and the pain was back by her first visit with me on 6-9-21. She did test positive for COVID between getting her second vaccine and the time I saw her. By the time I had my first visit with her she had muscle aches and pains in general and severe joint pain - mostly to shoulders, hips. Her legs were constantly achy. The pain seems to migrate. Her R sided sciatic pain is more severe and stretching doesn't seem to help. She has been experiencing muscle spasms to her legs/feet at night. I started her on Low Dose Naltrexone after our first visit and got labs.
This spontaneous report as received from a medical assistant refers to a 62-year-old female patient. The patient's current conditions included drug reactions/allergies to cephalexin (KEFLEX) and nitrofurantoin (MACROBID). Her pertinent medical history and concomitant medications were not reported. On 20-DEC-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe, lot # U018309, expiry date 08-JAN-2023, 0.5 milliliter, intramuscularly in the left arm for prophylaxis (reported as immunization). On 20-DEC-2021, the night of the administration of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), the patient experienced pain and weakness in her left arm, numbness, nausea, vomiting, lightheadedness, and "her arm had got cold". On 28-DEC-2021, the patient came to the physician's office and reported that she was still experiencing the adverse events that she initially had and the only change was the pain was only at the top half of her arm. No treatment was given for the adverse events. The outcome of the events was reported as not recovered. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-2112USA010039: US-009507513-2112USA010311: US-009507513-2112USA010181.
Could not eat anything for 5 days she could only drink liquids; This spontaneous case was reported by a consumer and describes the occurrence of FEEDING DISORDER (Could not eat anything for 5 days she could only drink liquids) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 49E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced FEEDING DISORDER (Could not eat anything for 5 days she could only drink liquids). At the time of the report, FEEDING DISORDER (Could not eat anything for 5 days she could only drink liquids) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Follow up received contains non significant information
Raised, hard, red patch at site of injection.  Approximately 2 inches in diameter.  Itchy.
Pt developed a red rash with slight swelling on her arm. Extending from injection site and continuing down to bend of elbow.
Sore arm at injection site, about 6 hours after injection, ongoing Next morning stiff neck on left side, about 19 hours after injection, ongoing Swollen lymph node in neck area, collar bone, left side about 21 hours after injection, ongoing  Tiredness, off and on, about  7 hours after injection, sporadically ongoing
3-11-21 PFIZER 3-29-21 MODERNA 4-1-2021 PFIZER
Left arm swelling and tingling within 2 hours of injection, swollen lymph nodes in neck the following morning, within 72 hours severe abdominal pain, nausea, vomiting, and diarrhea that lasted 5 days, fatigue, and low grade fever (no higher than 100.8)
Monday(day of vaccine) Oct. 11th Morning(within2hrs after shot) Sweating/chills,Migraine, sore arms,fatigue  Evening- symptoms from morning progressed. Full body pain,vaginal bleeding (had menstruated the week before already) extremely tired, nausea. Unable to eat or drink without vomiting. Unable to use bathroom (bowel movement)  Tuesday Oct. 12th- Same symptoms as the first day(Monday) Late late evening shortness of breath and chest pain   Wednesday Oct. 13th- shortness of breath, chest pain, pulsating and shooting pains in lower abdomen and lower back near kidneys. Vaginal bleeding sporadically. Nausea and fatigue, extremely tired(low energy) little to no eating or drinking without feeling nauseous. Burning sensation in stomach after attempting to eat food. Still unable to use bathroom.  Thursday Oct.14- Same symptoms as Wednesday, headaches return   Friday Oct. 15- headaches, able to eat and drink small amounts, nausea near bedtime. Vaginal bleeding sporadically, lower back and lower abdomen aching pain.   Saturday, Sunday, Monday Oct. 16,17,18th- unable to taste 3 of 4 taste buds, nausea, headache, fatigue  Tuesday Oct. 19th-Thursday - No symptoms
Severe Headache from back of neck around back of head to above eyes for 4 days; fatigue neck stiffness, shoulder stiffness.
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  It was reported that the vial was stored in refrigerator on 30-Oct-2021, there were no temperature excursions. The patient did not experience any adverse event.  No treatment medications were provided.
Mother phoned clinic at 1330. stated child had a rash, approximately 2.5 cm, around site of injection, left lateral thigh. child had received Tylenol and had no other symptoms at that time. child awoke from nap at 7pm, was tremorous, rectal T 102.8, had emesis X1. was taken to emergency room, was told this is "expected reaction", child received Motrin, was discharged home. Child awoke 2/16/06 approx 0700, rectal T99.7, very irritable, reddened area left lateral thigh approximately 2cm.
Random stomach cramping every couple of days. Although I am diagnosed with IBS, I generally have my symptoms under control, and my diet has not changed recently.
Increased heart rate (over 120 beats per minute) for about five hours. Rate gradually decreased over the course of 24 hours, returning to normal after several days. Other reactions included body aches, nausea, fatigue.
Approx. 10-15 minutes after patient received vaccination, she fainted while walking out the front door. No injury and patient was placed on ground and regained consciousness.
Headaches and full body aches x 2 days, chills and fever two nights in a row
Lost control of muscles; ended up blacking out; could not move; could not talk; A spontaneous report was received from a Consumer concerning about a 82 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Paralysis, Syncope, Mobility decreased and Aphasia.  The patient's medical history was provided as diabetes, dementia as current illness. Relevant concomitant medication was reported as blood thinner for blood clots.  On 08 FEB 2021, prior to the onset of event, the patient received their first dose of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  On 10 FEB 2021, the patient experienced Paralysis, Syncope, Mobility decreased and Aphasia. Due to these events patient's required hospitalization and on oxygen.  Laboratory details was not provided.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event's Paralysis, Syncope, Mobility decreased, and Aphasia was as unknown.; Reporter's Comments: The events were consistent with increased risk of cerebrovascular complications associated with elderly age of patient. Company assessed the events to be unlikely related to company product.
Strong headache lasting about 2 weeks, nausea, red raised sores up to half inch diameter clearing some after 12 days on face and scalp
3 hours after vax Injection site soreness 15 hours after vax Fatigue 17 hours after vax elevated temp 99 degrees 21 hours after vax fever 100.3 degrees 24 hours after vax fever 101.0 degrees, chills 24 hours after vax took Tylenol 25 hours after vax fever down to 100.3 degrees (went to sleep) 34 hours after vax woke up and temp back to normal at 97.9 degrees 43 hours after vax slight headache and elevated temp to 99 degrees (went to sleep) 57 hours after vax woke up and temp back to normal at 97.7 degrees No further side effects
4cmx5cm redness/swollen area on left upper arm with multiple papular rash. Non-fluctuate. Happened one day after shot (DTaP, HIB, Prevnar). Treated with Keflex 250mg and Motrin1/2 teaspoon PO one time per day. Follow up tomorrow.
Dose number:03; pericarditis; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 11Nov2021 (Lot number: 320308D) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraine" (unspecified if ongoing); "Insulin resistance" (unspecified if ongoing); "Depression" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; TOPAMAX; LEVOTHYROXINE; TRINTELLIX. Past drug history included: Known_allergies:clindamycin, reaction(s): "Drug allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, rev_dose_lot_number=ek5730, prev_dose_vaccine_location= Left arm), administration date: 07Jan2021, when the patient was 48 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, prev_dose_lot_number=el1283, prev_dose_vaccine_location= Left arm), administration date: 28Jan2021, when the patient was 48 years old, for COVID-19 Immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: IMMUNISATION (hospitalization, medically significant) with onset 11Nov2021, outcome "unknown", described as "Dose number:03"; PERICARDITIS (hospitalization, medically significant) with onset 22Dec2021 08:00, outcome "recovering", described as "pericarditis". The patient was hospitalized for immunisation (start date: Dec2021); for pericarditis (start date: Dec2021, discharge date: Dec2021, hospitalization duration: 2 day(s)). The event "pericarditis" was evaluated at the emergency room visit. Since the vaccination, the patient has been tested for COVID-19. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (22Dec2021) negative. Therapeutic measures were not taken as a result of pericarditis. Device Date: 25Dec2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available reported information, the causal association between the events immunization and pericarditis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is 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.
SARS-CoV-2 test positive / Patient acquired COVID-19 Omnicron after being fully vaccinated and boostered; SARS-CoV-2 test positive / Patient acquired COVID-19 Omnicron after being fully vaccinated and boostered; received the third dose of BNT162B2; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 28Oct2021 (Lot number: ff2593) at the age of 33 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 26Jan2021 (Lot number: EL1686) as dose 2, single and intramuscular, administered in arm left, administration date 03Jan2021 (Lot number: EL0140) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Migraines" (unspecified if ongoing). Concomitant medication(s) included: TRINTELLIX; BUSPIRONE; ONDANSETRON; EMGALITY [GALCANEZUMAB]; WELLBUTRIN; BACLOFEN; LILETTA. The following information was reported: COVID-19 (medically significant), VACCINATION FAILURE (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "SARS-CoV-2 test positive / Patient acquired COVID-19 Omnicron after being fully vaccinated and boostered"; IMMUNISATION (non-serious) with onset 28Oct2021, outcome "unknown", described as "received the third dose of BNT162B2". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive, notes: third test; all within 24 hrs and at different sites; (30Dec2021) negative, notes: second test; all within 24 hrs and at different sites; (30Dec2021) negative, notes: first test; all within 24 hrs and at different sites. Therapeutic measures were not taken as a result of covid-19, vaccination failure. Addition information: The patient had COVID prior vaccination. Known allergy was none. The patient had COVID test post vaccination.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the vaccination failure (LOE) cannot be ruled out.
Got vaccine; That evening, was very fatigued so she went to bed early. The next morning, was very lightheaded when she woke up. Put her head between her knees but it didn't get better. Was experiencing palpitations and chest discomfort at the same time. The discomfort did radiate down her left arm. Tried to control her breathing but still wasn't able to stand up. Finally had her husband take her to the ER. By the time she got to the ER, was in Aflutter with RVR; palpitations has mostly resolved. However, her left chest and arm discomfort hadn't improved. By the time she left the ER, her discomfort had improved. Is taking her Diltiazem as directed at home; they considered cardioversion but didn?t end up doing it.
The injection site is sore; Overall body aches; Headache; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for covid-19 immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "The injection site is sore"; PAIN (non-serious), outcome "unknown", described as "Overall body aches"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; FATIGUE (non-serious), outcome "unknown", described as "tired".  Additional Information: Description of event, second covid shot. The injection site is sore. Overall body aches. Headache and tired, the day after.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Warm to the touch; More tired than usual; Three inch pink patch under the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Mar-2021 and was forwarded to Moderna on 10-Mar-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE WARMTH (Warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE ERYTHEMA (Three inch pink patch under the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included SOTALOL for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE ERYTHEMA (Three inch pink patch under the injection site). At the time of the report, VACCINATION SITE WARMTH (Warm to the touch), FATIGUE (More tired than usual) and VACCINATION SITE ERYTHEMA (Three inch pink patch under the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient did not take any medication as treatment for the events. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in the event is not applicable