chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The patient had no known side effects; Temperature excursion occure to ROTATEQ and one dose admnistered to a patient; This spontaneous report was received from an other health professional referring to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant medications, drug reactions or allergies were no reported.   On an unspecified date, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (Lot# 174228 and expiration date 09-JAN-2022, lot was not valid and did not match any company product) (exact dose and frequency were not reported) as prophylaxis. (product storage error). No additional adverse event reported, no further information provided.
Narrative:  74yo male pt with MEDICAL PROBLEM LIST: Long-term current use of insulin (SCT 71 Anemia (ICD-9-CM 285.9) Burns (ICD-9-CM 949.0) Neuropathy (ICD-9-CM 355.9) Diabetes mellitus (SCT 73211009) Health  Maintenance (ICD-9-CM V65.9) Osteoarthritis of knee (SCT 239873007) Allergic rhinitis (ICD-9-CM 477.9) Hyperlipidemia (SCT 55822004) Benign hypertension (SCT 10725009) Obesity (ICD-9-CM 278.00) died on 11/30/2021 at home. No information given on cause of pt's death. Pt had received covid vaccines  outside hospital on 3/17/21 & 4/15/21. This death is likely not related to the  vaccinations due to patient's comorbidities, advanced age, and length of time from vaccine administration.
violently shaking; fever; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (violently shaking), PYREXIA (fever) and PAIN IN EXTREMITY (arm was sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 021B21A) for COVID-19 vaccination.     The patient's past medical history included Carotid artery disease. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), RIVAROXABAN (XARELTO), LABETALOL, ALPRAZOLAM and ZOLPIDEM TARTRATE (AMBIEN) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 09-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced TREMOR (violently shaking) and PYREXIA (fever). At the time of the report, TREMOR (violently shaking), PYREXIA (fever) and PAIN IN EXTREMITY (arm was sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Apr-2021, Body temperature: degree Celsius (High) 38 38.05 38.1 38.6.         Patient was having anxiety medications as concomitant medication. He took four Tylenol for the treatment in 24 hours.
Patient received the flu shot in October, 2014. Patient has returned to the pharmacy on 2/25/16 stating that there was an adverse reaction to the vaccine, causing the patient to lose mobility in her left arm.
Swelling on left thigh where vaccines were given per parent, advised to apply ice and if not improving bring to clinic for office visit.
an episode of anaphylaxis where patient went to emergency room; experiencing mouth ulcers; facial swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (an episode of anaphylaxis where patient went to emergency room) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Nov-2021, the patient experienced MOUTH ULCERATION (experiencing mouth ulcers) and SWELLING FACE (facial swelling). On 06-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ANAPHYLACTIC REACTION (an episode of anaphylaxis where patient went to emergency room) (seriousness criterion medically significant). The patient was treated with EPINEPHRINE for Adverse event, at an unspecified dose and frequency; PREDNISONE for Adverse event, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; HYDROXYZINE for Adverse event, at an unspecified dose and frequency and FAMOTIDINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ANAPHYLACTIC REACTION (an episode of anaphylaxis where patient went to emergency room), MOUTH ULCERATION (experiencing mouth ulcers) and SWELLING FACE (facial swelling) had not resolved.            Patient reported that she was released from ER after an overnight stay. .  No relevant concomitant medications were reported. Company Comment This case concerns a 47-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of anaphylactic reaction. The event occurred 24 days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 47-year-old, female patient with no relevant medical history reported, who experienced the unexpected event of anaphylactic reaction. The event occurred 24 days after the third dose of mRNA-1273. The rechallenge was not applicable since the events happened after the third dose. The Benefit-risk relationship of mRNA-1273 is not affected by this report.
high fever x 3 days;dry cough;eyes rolling up in head 2-3 seconds x 1 day;screaming as if in pain x 1 day;rash x 3 days;
patient fainted; This serious case was reported by a nurse via sales rep and described the occurrence of faint in a 16-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 11-OCT-2023, the patient received Bexsero. On 11-OCT-2023, 3 min after receiving Bexsero, the patient experienced faint (Verbatim: patient fainted) (serious criteria GSK medically significant).  The outcome of the faint was not reported.   It was unknown if the reporter considered the faint to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the faint to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 11-OCT-2023 The nurse wanted to know if you knew of a lot of instances of patients fainting after receiving a dose of Bexsero. She had this happen to approximately 5 in the last year.  Bexsero was administered to the patient today, 11 October 2023 and he was standing and talking, while the mother and the nurse were conversing.  After about 3-5 minutes the patient fainted and in the nurse's work appeared to be seizing. An ambulance was called and he was taken to a local hospital. The reporter consented to follow up.
Needle leaked while patient was being administered Shingrix.; This case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix. On 24th January 2020, unknown after receiving Shingrix, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The needle leaked while patient was being administered Shingrix which led to accidental overdose and needle issue. Consented to follow up.
Swollen and sore ankles.  Sore calves, knees and other joints.
Vomiting, high fever, body aches, chills, terrible headache, could not eat. No energy.
PT recd vax 15APR91 & 16MAY91; experienced abdominal cramping @ 430PM; 17MAY91 @ 530AM PT exp'd tongue & face swelling; PT went to ER & was rx'd w/Benadryl IM for swelling; swelling dec; exp'd abdominal cramping on 16MAY91 @ 430PM;
COVID-19 breakthrough case. Symptoms began: Lab confirmed: 09/21/2021.
No additional AEs; Vaccine was administered after temperature excursion; This spontaneous report as received from a medical assistant and refers to a patient of unknown age and gender. No information on patient medical history, current conditions and concomitant medications was provided.      On 19-JAN-2023 the patient was vaccinated with dose of improperly storaged varicella virus vaccine live (oka/merck) (VARIVAX) lot# W02294 (not valid for varicella virus vaccine live (Oka/Merck) and does not match any Company product) for prophylaxis (exact dose and route of administration was not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2304USA002131:
This spontaneous report was received from a pharmacist via company representative concerning a female patient in her early 60's (age). On an unknown date, the patient was vaccinated with ZOSTAVAX (injection site unspecified) lot # J011339, expiry date: 13-DEC-2014. No concomitant therapy was reported. On an unknown date, the patient experienced redness and swelling at injection site. No product quality complaint was filed. No interventioned initiated to prevent serious criteria as there were none. The action taken was assessed as not applicable. The outcome of event was reported as recovered on an unknown date. The causality was not reported. This is one of two reports received from the same reporter. Additional information has been requested.
Narrative: Patient received Moderna COVID vaccine #1 on 4/12/21. This was the first time she had ever been seen at our facility. She then had a date of death recorded as 5/9/21. There are no notes or scanned records to indicate what happened from the time of vaccine to her death. No autopsy report available. Time from vaccine to death is 27 days.
Flu like symptoms with fever.  Vomiting malaise. Symptoms continued through to the 14th when mother called office - Patient referred immediately to Emergency room.  Patient was hospitalized at Medical Center x 6 days.  Following endocrine consult-found that parathyroid was not operating properly causing deficiencies in Calcium, Potassium, and Magnesium.  Patient also needing to take Vitamin D.
Arm pain radiating down arm to hands and fingers felt numb.  Tenderness in Right arm and had a localized rash with redness.
My menstrual cycle is normally like clockwork; very predictable, but it's 5 days late; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809) via an unspecified route of administration in the left arm on 26Mar2021 at 12:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included tubal ligation (tubes have been tied for 9 years). The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included Vitamins C&D (MANUFACTURER UNKNOWN), multivitamins (MANUFACTURER UNKNOWN) and black elderberry (MANUFACTURER UNKNOWN); all medications for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 45-year-old), as a single dose for COVID-19 immunisation. On 11Apr2021, the patient experienced late period. The patient reported that her menstrual cycle was normally like clockwork; very predictable, but it was 5 days late and her tubes have been tied for 9 years. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event period 5 days late was unknown at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a medical assistant via company representative and refers to a 14 year old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 01-JUL-2014 (at the age of 12 years), the patient was vaccinated with first dose GARDASIL prophylaxis. On 26-JUL-2016 (at the age of 14 years), the patient was vaccinated with second dose of GARDASIL 9 for prophylaxis (Interchange of vaccine products, Inappropriate schedule of vaccine administered). No adverse events were reported.
Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion; Administered vaccine from vials that may have been compromised; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 9:16 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 9:16 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccines were stored in an unapproved freezer/some of the freezers there was a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine from vials that may have been compromised) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.    On 31-Mar-2021, Excursion time was 8 AM, temp was 32 , total doses given for the day was 199, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vial was moved to clinic. Vaccine BUD date was 22-Apr-2021.  Vials only punctured right before administration  Treatment medications were not reported
2" red circular bump at injection site. Swollen and tender. No fever. Patient contacted PCP and is taking ibuprofen and icing site.
PRURITUS. Information has been received from a registered nurse concerning a 13 year old female with an unknown medical history who on 20-MAY-2003 was vaccinated with a first dose of hepatitis B virus vaccine rHBsAg (yeast). It was unknown if the patient was on concomitant medication. It was reported that at the time of vaccination the patient also "got a sunburn earlier in the week so the child already had redness". On 22-may-2003 the patient developed pruritus on her face. There was no rash or peeling. It was unknown if diagnostic studies were performed. Unspecified medical attention was sought. No additional patient information was provided. No product quality complaint was noted. Additional information has been requested.
when mom went to check child in AM felt hot & sz, eyes rolling back in head;went to ER;
This case was reported by a physician via call center representative and described the occurrence of tingling in a adult patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included SHINGRIX (1st dose received on an unknown date). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced tingling and burning sensation skin. On an unknown date, the outcome of the tingling and burning sensation skin were unknown. It was unknown if the reporter considered the tingling and burning sensation skin to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. No patient demographics or other information was provided. The reporter had a question if a patient received SHINGRIX two doses and then developed shingles, was it considered a failure if it is within a few months of receiving the second injection. The question at the time of reporting was general but there was tingling and burning but no rash. The reporter confirmed that there was a patient and the healthcare professional states that she was not certain that the definitive diagnosis was shingles but there was tingling and burning in a previous area of shingles after receiving the SHINGRIX vaccine.
I have long standing ulcerative colitis which has been quite benign. The last flare up I had was more than six years ago. I experienced a flare up of my ulcerative colitis within a couple of weeks of receiving the second dose of the vaccine. It has been the most severe flare up I have experienced in 35 years with this disease. It took me a while to get in to see the doctor after the symptoms began and by the time I was seen, I was as sick as I have ever been with this illness.
This spontaneous report was received from a physician and from a support services director via company representatives and refers to a patient of an unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 04-JAN-2016, the patient was vaccinated with a dose of an improperly stored GARDASIL 9 (strength: 0.5 ml) lot # L014198 and expiration date: 05-SEP-2017 (dose, anatomical location and route of administration were not reported). No adverse effects were reported. The dose of the vaccine was exposed to different temperature excursions (date unspecified): lasting for 240, and 144 hours, with the lowest recorded temperature of 34, and 33 degrees Fahrenheit (1.11, and 0.55 degrees Celsius) respectively. The vaccine was stored in a refrigerator. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Patient stated difficulty breathing, facial tightness, skin tingling 30 minutes after receiving the vaccine
Deltoid swelling, tenderness, decreased ROM starting 1 mos s/p immunization in that deltoid. Also small eczematous skin lesion at site of injection present.
tired; swollen eyelid; eyelid hurts/sore; muscle pain; diarrhea; headache; nausea; soreness in her arm; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiration date: 31Mar2021), via an unspecified route of administration on 28Dec2020 at 0.3 mL, single for COVID-19 immunization. The patient's medical history included ventricular tachycardia from 2010 and defibrillator in her chest. There were no concomitant medications. She was scared initially so she waited for her coworkers to get the vaccine. Now, she is scared for the second dose. The night after the injection, on 28Dec2020, she had soreness in her arm. It was really bad. After two days, on 30Dec2020, she developed muscle pain, diarrhea, nausea, and headache. On Saturday (02Jan2021), she had an issue with her left eye wherein the eye lid became sore, and it got worse and worse. Her left eyelid was swollen and hurts. Now it is all swollen up. Her eye is not red. The top of the eyelid is so sore. She was really tired initially on an unspecified date. Outcome of the pain in arm and tiredness was unknown, of the swollen eyelid and eyelid pain was not recovered, of the muscle pain was recovered on 31Dec2020, while of the remaining events was recovered on an unspecified date.
Fatigue, headache muscle and joint pain, some chills and heat as if you had the flu. Some rash like red dots on skin in torso area. Injection site very painful all day after shot along with the effects above.
Information has been received from a physician concerning a 64 or 65 year old female with diabetes who on 16-MAY-2008 at 16:00 was vaccinated with a dose of ZOSTAVAX (Oka/Merck) at the pharmacy. There was no illness at time of vaccination. The patient broke out in shingles six hours later. In the morning on 12-JUN-2008, VALTREX was used. On 16-JUN-2008 an unspecified exam was done and no result provided. Subsequently, the patient recovered from shingles. The patient called the physician. Shingles were considered to be an other important medical event by the reporter. Additional information is not expected.
Left arm redness, heat, swelling, pain, itch 05/09/2003.  Left arm redness and increased swelling traveling down arm to elbow, low grade fever, to MD for antibiotics.  Treatment 05/09/2003.
HR maintaining 120+ at rest; Fever 103.5; extreme body aches; headaches; 8/10 pain in L axillary and chest area; 8/10 pain in L axillary and chest area; This is a spontaneous report from a contactable other healthcare professional (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1685), intramuscularly on the left arm, first dose on 17Dec2020 07:15 and second dose on 08Jan2021 07:15, both at a single dose for COVID-19 immunization. There were no medical history nor concomitant medications (within two weeks of vaccination). The patient was not diagnosed with/did not have COVID-19 prior to vaccination, did not receive other vaccines in four weeks prior to vaccination, had no known allergies to medications, food, or other products, and was not pregnant. The most recent COVID-19 vaccine was administered at a hospital facility. On 07Jan2021 18:00, the patient experienced fever 103.5, extreme body aches, headaches 8/10 pain in left axillary and chest area, and HR maintaining 120+ at rest. The patient underwent lab tests and procedures which included COVID test post vaccination with a curative oral swab: negative on 08Jan2021. No treatment was received for the adverse events. Outcome of the events was recovering. The events were reported as non-serious.
Patient states she initially had pain when the pneumonia vaccine was administered, as the day/night went on the pain radiated down her arm to her hands. By the next day she could barely lift her arm.