chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; a dose of VARIVAX was administered to the patient on 10AUG2022 after experiencing a temperautre excursion; This spontaneous report was received from a medical assistant referring to a 14-month-old female patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 10-AUG-2022, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL, subcutaneously (lot # U026207, expiration date: 24-AUG-2023; strength, and anatomical location were not provided) for prophylaxis. It was reported that the suspect vaccine was underwent temperature excursions of 18.6 Fahrenheit (F) for 30 minutes (product storage error). The previous temperature excursion as follow: 9.8 F for 30 minutes. No additional adverse event (AE) was reported (no adverse event).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA005443: US-009507513-2208USA005325: US-009507513-2208USA005272: US-009507513-2208USA005345: US-009507513-2208USA004819:
Patient received her 2nd Moderna vaccine, no previous issue with any vaccinations. Waited 15 minutes, felt fine, but when she stood up quickly to leave she felt faint. She kneeled/sat down on the ground, and briefly fainted without injury and immediately regained consciousness without intervention. I gave her ice packs for her neck and had her wait another 15 minutes. After 15 minutes she was feeling better but a little "shaky" still, she had an orange juice and waited a little longer until she felt well. I had her walk around a little before leaving, she was feeling well.
This spontaneous report as received from a medical assistant, refers to a patient of unknown age and gender. On 04-NOV-2013 the patient was vaccinated with VARIVAX (Merck) (dose, route and lot number were not provided) measles, mumps, and rubella (Wistar Ra 27-3) virus vaccine live (manufacturer unknown) (dose, route and lot number were not provided) and ZOSTAVAX (dose, route and lot number were not provided). The healthcare worker reported that the patient should have received VARIVAX (Merck) and measles, mumps, and rubella (Wistar Ra 27-3) virus vaccine, live (manufacturer unknown) vaccines, however, after the patient received VARIVAX (Merck), the patient got ZOSTAVAX instead of measles, mumps and rubella (Wistar Ra 27-3) virus vaccine, live (manufacturer unknown) due to human error. The patient received measles, mumps, and rubella (Wistar Ra 27-3) virus vaccine live (manufacturer unknown) after the error was detected. No adverse effect reported. Additional information has been requested.
Itching on sunday night starting on chest, monday morning rashes worsen and appeared on B UE and L LE. Cortisone cream applied otc not helping. Urgent care on Tuesday night and prescribed with triamcinolon.Friday, Rashes still itchy but redness slightly getting better
Information has been received from a licensed visiting nurse concerning a 65 yr old female pt who at the end of Sept or beginning of Oct 04, was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot number 649694/0386P). The pt developed a 3 inch area below the injection site which was swollen, red, and looked like cellulitis. Unspecified medical attention was sought. The pt was treated with unspecified antihistamines. Subsequently, the pt recovered. The nurse requested that a lot check be performed on lot 649694/0368P. It was reported that the pt's injection site swelling, erythema, and cellulitis were considered other medical events. The records of testing prior to release of this lot have been checked by quality assurance and found to be satisfactory. The lot complies with the standards and was released. The nurse also reported 4 additional pt's who developed injection site swelling, erythema and cellulitis post vaccination with pneumococcal 23v polysaccharide vaccine (WAES0410USA01334, 0410USA01622, 0410USA01624, 0410USA01625). Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot # L016429, expiration date: August 2017, (exact doses, injection site and route of administration were not reported). There were no concomitant medications reported. It was stated that the vaccines were exposed to the temperature of 30 degrees Fahrenheit for 20 hours and to the temperature of 53 degrees Fahrenheit for 19 hours. No previous temperature excursion was reported. No adverse effects were reported. No PQC (product quality complaint) was involved. Follow-up information received on 29-MAR-2016 indicated that all telephone attempts to obtain follow-up information had been unsuccessful. Follow up information has been received on 01-APR-2016 from the unspecified reporter concerning a patient of unknown age and gender who on 12-OCT-2015 was vaccinated with improperly stored dose of GARDASIL 9, lot # K016966, expiration date: May 2016. The reporter also stated that thermometer was malfunctioning during the excursion and clarified that no COMVAX (as previously reported) only GARDASIL 9 was involved. This is one of several reports received from the same reporter. Additional information is not expected as all required information has been received. Reporters, patient details, suspect details, event details and narrative were updated.
Woke up with a headache and mild nausea at 6:00 AM, took ibuprofen which did not seem to help at all. Around 10 AM every joint in her body hurt so bad that she had to lay down on a sofa. It got worse and was a 7/10 on a pain scale. Took hydrocodone to help alleviate the pain. By 4 PM it was all resolved.
Pt received COVID booster shot at approx 8:45 AM. Pt reports went grocery shopping and as she went to pay chest pressure 10/10, cold sweats, SOB, sensation of needing to vomit. Pt returned to clinic approx 10:30 reports blurry vision, dizziness, chest pressure. EKGs ordered by Dr. Due to ongoing chest pressure, pt instructed to go to hospital for further evaluation.
Pfizer: BUD Date 04/07/2022 administered on 04/11/2022. Pfizer could not provide stability data beyond 04/09/2022 and recommended re-vaccination.
Swollen axillary lymph node left arm pit; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the left arm on 10Apr2021 at 15:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included histoplasmosis, COVID-19. The patient's concomitant medications included adalimumab (HUMIRA), methotrexate (MANUFACTURER UNKNOWN), folinic acid (LEUCOVORIN) and levothyroxine (MANUFACTURER UNKNOWN) all for unknown indications on started on an unknown date and unknown if ongoing. The patient previously received Macrobid and fluorescein dye and experienced allergy. Prior to the vaccination, the patient was 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 four weeks prior to the vaccination. On 11Apr2021 at 23:00, the patient experienced swollen axillary lymph node in the left armpit. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event swollen axillary lymph node left armpit was not resolved at the time of the report.  No follow-up attempts are needed. No further information is expected.
Positive test results of covid-19; Positive test results of covid-19; This is a spontaneous report from a contactable consumer (patient). A 6-decade-old male patient who was in his 50's received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 25Jan2021 (Batch/Lot number was not reported) as dose 1, single and dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced positive test results of covid-19 after two doses of vaccine. The patient underwent lab tests and procedures which included covid-19: positive on an unspecified date in 2021. The outcome of the event was unknown.   Information on Lot/Batch number has been requested.
Hemiparesis; Hypoaesthesia; Lacunar infarction; Neurological symptom; This case was received FDA VAERS on 11-May-2021 and was forwarded to Moderna on 11-May-2021.    This regulatory authority case was reported by an other health care professional and describes the occurrence of HEMIPARESIS (Hemiparesis), HYPOAESTHESIA (Hypoaesthesia), LACUNAR INFARCTION (Lacunar infarction) and NEUROLOGICAL SYMPTOM (Neurological symptom) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia, Hypothyroidism and Drug allergy (Amoxicillin, sulfa, azithromycin). Concomitant products included AMLODIPINE, ATORVASTATIN, DILTIAZEM, LISINOPRIL, HYDROCHLOROTHIAZIDE and LEVOTHYROXINE for an unknown indication.   On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced HEMIPARESIS (Hemiparesis) (seriousness criteria hospitalization and medically significant), HYPOAESTHESIA (Hypoaesthesia) (seriousness criterion hospitalization), LACUNAR INFARCTION (Lacunar infarction) (seriousness criteria hospitalization and medically significant) and NEUROLOGICAL SYMPTOM (Neurological symptom) (seriousness criterion hospitalization). At the time of the report, HEMIPARESIS (Hemiparesis), HYPOAESTHESIA (Hypoaesthesia), LACUNAR INFARCTION (Lacunar infarction) and NEUROLOGICAL SYMPTOM (Neurological symptom) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Computerised tomogram abnormal: 4/5 (abnormal) abnormal. On 02-Apr-2021, Magnetic resonance imaging: 4/5 (abnormal) abnormal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided.   On 02 Apr 2021, the patient developed stroke like symptoms that included weakness and numbness of the right extremities. A primary care provided ordered an magnetic resonance imaging the following Monday which showed an acute lacunar infarct of the left periventricular white matter between the caudate nucleus and thalamus, likely embolic from untreated afibrillation and CHADS-VASC 4.  Company comment: 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.
Information has been received from a licensed practical nurse (LPN) concerning a 68 year old patient who on 24-OCT-2007 was vaccinated at 12:00 pm, into the right arm with pneumococcal 23v polysaccharide vaccine, (Lot # 658555/0964U). The number of previous doses that the patient received was reportedly unknown. Subsequently the patient experienced right arm swelling, very painful and hot to touch. At the time of the report it was unknown if the patient recovered. Additional information has been requested.
2/8/23 I experienced a sudden onset of a pain on the left side of the back of my neck. The pain did not go away for about 7-8 days. On 2/16/23 I went to the urgent care. I was told I had occipital neuralgia. The concern was a brain bleed because I am on ELIQUIS and felt I needed a CT. I went to the emergency room. I had tests and ended up being given BENADRYL, REGLAN, steroid and ringer's lactate by IV. They sent me home. I was given a prescription for the REGLAN and steroid. My vision was affected, I was jittery and had difficulty controlling my emotions. I was also anxious. My Neurologist said I had an allergy to REGLAN, not to take it anymore. My Cardiologist told me I had ventricular tachycardia that was caused by the REGLAN.
Swelling at site of injection the size of an egg. Pt treated with ice and acetaminophen and was improving at last contact on 12/26/17.
Fever geographical tongue induration at site as well as anterior, posterior lateral and medial adjacent areas hives vomiting headache.
sore throat; swollen neck; hives; This is a spontaneous report from a contactable consumer or other non-HCP (patient herself). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6205), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 15:45 (at the age of 55-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included pulmonary issues, asthma issues and allergies. The patient had no other medical history. The patient's concomitant medications included unspecified asthma medications, nothing that would affect the vaccine. The patient had no history of previous immunizations with the Pfizer vaccine. The patient had no additional vaccines administered on same date of the Pfizer suspect. The patient had no prior vaccinations within 4 weeks. The patient had no adverse events (AEs) following prior vaccinations. It was reported that, the caller on the line calling about the COVID 19 Vaccine. The patient received her first one yesterday on 08Mar2021 and she had some different side effects than she was expecting. She mentioned she had swelling in the neck, hives, and a sore throat. She did not have any trouble breathing, talking or swallowing. She was calling because she wants to know if she can take Benadryl ahead before getting the second shot. She stated she was hoping to avoid this reaction. Caller did not have full contact details for HCP to provide. The swelling in the neck started to swell an hour after getting the vaccine. Treatment: Placed ice over the area. The swelling in neck went away over night because it was not there when she woke up this morning. For Hives: She applied a Benadryl topical solution. She mentioned she has allergies, and it was not unusual for her to get hives. That was why she wants to know if she can take Benadryl before getting the second shot to try and get ahead of it. Sore throat: This started four hours after getting the vaccine. The adverse events not required visit to the Emergency Room and Physician's Office. The patient had no relevant test. The outcome of the event swollen neck was recovered on 08Mar2021. The outcome of the events hives and sore throat was not recovered.   No follow-up attempts are possible. No further information is expected.
Patient is a volunteer at the hospital, complained of numbness of tongue and mouth about 10 minutes post administration of vaccine. Patient denied having difficulty breathing or itching, recommended patient to go to the ER if symptoms worsened or difficulty breathing developed. Patient refused to go to the ER and left with friend.
An rash that got itchy after 2 days and dull pain after 4 days
pt recvd Engerix-B it was determined that pt did not respond; A booster dose of Engerix-B was administered 10APR92; titer result was neg;
No other AE; HBP calling to report an administration of the GARDASIL 9 vaccine to a 2 month old patient on 03/29/2023.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information on patient's medical history, current conditions and concomitant medications was provided.      On 29-MAR-2023 the patient that was too young to receive vaccine was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # W010663 and expiration date 11-MAR-2024 for prophylaxis (exact dose, dose number, route and site of administration were not provided) (product administered to patient of inappropriate age and no adverse event).
pt recvd vax & 7 days later exp nausea & abdo pain which lasted for more than 2 wks; Outcome: not subsided;
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 673029/0616AE, expiration date not listed, dose not reported) on 22-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006069, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. On 26th October 2018, the patient received SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced pain in arm, erythema, shingles, fever, pruritus, fatigue, tingling and chills. On an unknown date, the outcome of the pain in arm, erythema, shingles, fever, pruritus, tingling and chills were unknown and the outcome of the fatigue was not recovered/not resolved. It was unknown if the reporter considered the pain in arm, erythema, shingles, fever, pruritus, fatigue, tingling and chills to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on left arm. The patient experienced tingling in lower hip. The reporter did not consent to follow-up. The reporter did not give permission to contact physician.
Developed fever, body aches, but the most unusual, unexpected reaction was intense red color in both eyes, discharge swollen eyes, with pain, symptoms lasted into the second day. cleared on 3rd day.
Child c/o fever, headache, light sensitivity, and neck pain x 2 days mother reported. Called back and said pt symptoms went away and would not be seen.
Dizzy, weak. Patient felt better after going outside. Patient suffered panic attacks in the past, felt better 10  minutes after symptoms onset. Refused to go to hospital.
However, this morning he woke up feeling bad again; Her son is 6 years old and was provided a higher dose than recommended, and received a 30mcg dose.; was provided a higher dose than recommended, and received a 30mcg dose.; Her son is 6 years old and was provided a higher dose than recommended, and received a 30mcg dose.; Got adult vaccine; headache; low grade fever; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 6 year-old male patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 31Oct2021 11:30 (Lot number: 30135BA) at the age of 6 years as dose 1, 30 ug single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT USE ISSUE (non-serious), INCORRECT DOSE ADMINISTERED (non-serious) all with onset 31Oct2021 11:30, outcome "unknown" and all described as "Her son is 6 years old and was provided a higher dose than recommended, and received a 30mcg dose."; OVERDOSE (non-serious) with onset 31Oct2021 11:30, outcome "unknown", described as "was provided a higher dose than recommended, and received a 30mcg dose."; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 31Oct2021 11:30, outcome "unknown", described as "Got adult vaccine"; HEADACHE (non-serious) with onset 31Oct2021, outcome "unknown", described as "headache"; PYREXIA (non-serious) with onset 31Oct2021, outcome "unknown", described as "low grade fever"; FEELING ABNORMAL (non-serious) with onset 01Nov2021, outcome "unknown", described as "However, this morning he woke up feeling bad again". The patient underwent the following laboratory tests and procedures: body temperature: (31Oct2021) 99-100; (01Nov2021) unknown results. Therapeutic measures were taken as a result of headache, pyrexia.  Additional information: Reporter had her 6 year old with her who got the vaccine. She mentioned her son is experiencing side effects already. He has a headache and running a low grade fever. Headache- Started yesterday, a few hours after the shot. When it first started the headache came and went; it went away at first yesterday. However, this morning he woke up feeling bad again. The headache had come back. He had taken Tylenol. The headache comes and goes with Tylenol. Low grade fever- has had since yesterday. It comes and goes with the Tylenol as well. It has been between 99-100. This morning the fever was back again too.   Follow-up attempts are completed. No further information is expected.
The pt was inconsolable, experienced extreme irritability for 24 hours. No fever was noted. The pt developed a small hematoma at the injection site. The symptoms occurred approximately 24 hours post vax. Symptoms resolved within 24 hours.
pt to ED with dyspnea; found to be positive for COVID; Pulmonary Edema; admitted; given IV steroids and O2 supplementation; increase in anxiety; more hypoxic; placed on NRB; pt's condition worsened; suffered respiratory arrest requiring intubation; transferred to ICU with vasopressors; CTA of head/neck showed multifocal stenosis of intracranial arteries; critically ill; pt passed away in the hospital
Information has been received from a physician concerning a 41 month old patient who on an unspecified date was vaccinated with a dose of VARVAX (Oka/Merck). The patient was diagnosed with Acute Lymphocytic Leukemia (ALL) by a pediatric oncologist in April 2008. A the time of her ALL diagnosis in April 2008, VZV IgG titers test was done. The titer result was 2.43 which was positive (titer results above 1.1 were positive) and meant that the patient was vaccinated prior to her diagnosis with leukemia. On an unspecified date, the patient had a rash compatible with chickenpox. On 18-JAN-2010, the patient was hospitalized. But the reporter was not sure if chickenpox was the reason for the patient's hospitalization. It was noted that the patient was hospitalized frequently because of her leukemia. On 18-JAN-2010, the samples were obtained and will be sent on 20-JAN-2010. At the time of the report, the patient's outcome was unknown. Acute Lymphocytic Leukemia (ALL) was considered to be an other important medical event. VZVIP case# 610. Additional information has been requested.
pt received monoconal antibody 30 day before and now got his booster dose 30 after not 90 days
Pt's mom called & left message for MD to call re fever; several attempts were made the same day & no answer; recvd call from Hosp stating pt has poss Rye synd; lenght of stay unk;