chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2 rashes on both sides of face, one on each side, inside cast, on right arm, it has, muscle and behind the muscle area, all around the arm/have sores that popped over about eight, it's in each one; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Feb2023 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for COVID-19 immunization. The following information was reported: RASH (non-serious) with onset 2023, outcome "unknown", described as "2 rashes on both sides of face, one on each side, inside cast, on right arm, it has, muscle and behind the muscle area, all around the arm/have sores that popped over about eight, it's in each one".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Injection site reaction; Pain and swelling at injection site. Ranitidine 300 mg once, diphenhydramine 50 mg once, doxycycline 100 mg bid.
pt recvd MMR vax & had a syncopal or vasovagal episode; pt recovered w/o any residual effects; No further details were provided; MD reported 20 pts;
Nausea and chills began 9 hrs after dose, vomiting began 15 hours after dose and lasted for 3 hours. Chills and nausea abated after 24 hours, swollen and painful armpit began 36 hours after dose and continues currently at 48 hours post-dose.
was warm to the touch; felt "weird"; experienced muscle soreness; low grade fever; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt "weird"), FEELING HOT (was warm to the touch), PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue). On 21-Mar-2021, the patient experienced FEELING ABNORMAL (felt "weird") and MYALGIA (experienced muscle soreness). On 22-Mar-2021, the patient experienced FEELING HOT (was warm to the touch). On 19-Mar-2021, PYREXIA (low grade fever), CHILLS (chills) and FATIGUE (fatigue) had resolved. On 21-Mar-2021, FEELING ABNORMAL (felt "weird") and MYALGIA (experienced muscle soreness) had resolved. At the time of the report, FEELING HOT (was warm to the touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 99.6 (High) 99.6 F  low grade fever.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment was not provided.
This initial spontaneous report was received from a Medical Assistant/office manager and refers to an unspecified amount of patients. Medical history, concurrent conditions and concomitant medications were not provided. On 12-JUL-2017, an unspecified number of patients were administered doses of VARIVAX (lot numbers M038226; expiration 07-SEP-2018 and M041081; expiration 06-OCT-2018) and PROQUAD (lot numbers N000678; expiration 05-JUL-2018 and N004629; expiration 07-AUG-2018) that were improperly stored. The Medical Assistant did not have the lot numbers for the sterile diluent used to reconstitute the vaccines. Temperature/time: -14 degrees C to -10 degrees C (-13.5 degrees C) for one hour and nine minutes. Previous temperature excursion: No. Call was because of a data logger. No adverse effects were reported. Additional information has been requested.
This is a spontaneous report from a contactable nurse reporting for herself. This 66 year-old female patient of an unspecified race and ethnicity received PREVNAR 13 at single dose intramuscular in the arm on an unspecified date for immunization. The patient medical history and concomitant medications were not reported. The patient experienced a red spot and swelling around the red spot on an unspecified date. Events were described as follows: five days after the vaccination with pneumococcal 13-val conj vac (dipht crm197 protein) the patient experienced a red spot on the same arm but not right where she got the shot. It was an inch wide and 2 inches long. It was red but not itchy. She has had a localized injection site reaction to the flu shot (influenza vaccine) taken for immunization in the past, but this was nothing like that. The following day the red spot was bigger and around the red spot it was swollen around the perimeter and the swelling was the same color as her skin. Then it continued to grow, so she marked it. Again it was not itchy and it never looked like hives. Before it started going away, it went from the 1 by 2 inches to 5 inches by 4 inches. When it finally started going away, it went away from the center and it became less red, she could still see the edges advancing. It took four days to go away. She thought it was from the shot because she has done nothing else different, and if it was anything else, it would not have just been on her arm. The red would kind of blanche when she pushed on it. She was a pediatric emergency room nurse, she has seen all kinds of reactions and hives, but this was not itchy and it was kind of flat. When it started it was flat. She would like to know if this was a reaction to the vaccine. She thought it was strange that it happened where it did. With her flu shot reaction, they told her it was a localized reaction, but it was different this time. The patient recovered on an unspecified date.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 14-MAY-2015, the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot #, route of administration and dose were not reported). No adverse effects were reported. This is one of 3 reports received from same reporter. Additional information has been requested.
This report describes the occurrence of mercury poisoning in an 12 month old male who was vaccinated with hep B vaccine recombinant for prophylaxis. This report was received as part of litigation proceedings and has not been verified by a physician or other health care professional. The subject was allegedly "born a perfectly normal, healthy boy whose Apgar scores at birth were well within the normal range. Developmentally, neurologically and socially, he achieved every developmental milestone anticipated of all normally developing children until the age of 12 months. The subject received injections of Engerix B on 10/25/96 (2140A2) and 7/11/97 (2250A2). He also received injections of diphtheria and tetanus toxoids and pertussis vaccine 12/5/96, 1/27/97, and 3/21/97; Tripedia 4/27/98; Hib-titer 12/5/96 and 1/27/97; and influenza virus vaccine 11/2/98 and 12/9/98. The subject's attorney alleged that "At approximately 12 months of age, the subject was neurologiclly devastated by the accumulation of mercury in his body, having been exposed via IM vaccinations, and specifically including, but not limited to becoming withdrawn, unable to speak, unresponsive to his environment, engaging in repetitive behavior and the loss of language skills, motor skills and affect." Treatment and outcomes of these events were not specified. The mercury poisoning and developmental regression in this report are considered medically serious (OMIC). This subject's older brother experienced the same events following immunization. See report A0387134A.
This spontaneous report as received from a female consumer reporting on herself who last December in approximately December 2012, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). The consumer reported that now in approximately November 2013, she had broken out with a terrible pain across the belly accompanied by little red bumps. The consumer stated that her physician felt that she had developed neuralgia only, and had not had a full outbreak of shingles due to the lack of itchy legions usually indicative of the condition. The consumer confirmed that the area did not itch, but felt as though she had pain in and under the skin in that area. The consumer also mentioned that she had had shingles in the same area years before having the vaccine. Gabapentin 10mg had been unsuccessful and OTC biofreeze treats temporarily. At the time of the report, he patient's outcome was unknown. The relatedness for pain across the belly accompanied by little red bumps and neuralgia and ZOSTAVAX was unknown. Additional information is not expected.
The vial was exposed to room temperature for 26 hours; The vial was exposed to room temperature for 26 hours as 2nd booster dose was administered to a patient from it.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The vial was exposed to room temperature for 26 hours as 2nd booster dose was administered to a patient from it.) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 26 hours) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K21-2A, 016B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter. On 08-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (The vial was exposed to room temperature for 26 hours as 2nd booster dose was administered to a patient from it.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 26 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The vial was exposed to room temperature for 26 hours as 2nd booster dose was administered to a patient from it.) and PRODUCT STORAGE ERROR (The vial was exposed to room temperature for 26 hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment medication were provided.  On 18Mar2022, the vial was initially stored in the refrigerator.  The vial was taken out day before and HCP forgot to discard it at the end of the day but the following day, the vial was not checked prior to administering the vaccine dose. The vial was exposed to room temperature for 26 hours as 1 dose was administered to a patient from it.   This case was linked to MOD-2022-532408, MOD-2022-532364 (Patient Link).
Injection was extremely sore all day.  Fever and chills began around 1am 5/12/21 followed by joint and muscle pain and headache.  These symptoms persist as of now.
20 hours from the injection, I started having chills,; headache; fever. The fever went up to 102.1 and the whole event lasted 12 hours.; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration, administered in left arm on 22Feb2021 15:00 (at the age of 54-year-old) (Batch/Lot Number: EL3247) as dose 1, single for covid-19 immunisation. Medical history included covid-19 (Prior to vaccination) and allergies to penicillin. The patient's concomitant medications were not reported. On 23Feb2021 11:00, 20 hours from the injection, the patient started having chills, headache and fever. The fever went up to 102.1 and the whole event lasted 12 hours. The patient received treatment of the events and Tylenol tablets for fever. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine and did not any other medications the patient received within 2 weeks of vaccination. Since the vaccination, the patient had not been tested for covid-19. Outcome of events was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected.
Tested covid-19 positive 2 months after second dose; Tested covid-19 positive 2 months after second dose; pain in his legs during 2 days; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 10 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2 (tris), single and (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Tested covid-19 positive 2 months after second dose"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "pain in his legs during 2 days"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". The patient underwent the following laboratory tests and procedures: sars-cov-2 antibody test: positive, notes: Tested covid-19 positive.  Clinical course: Tested covid-19 positive 2 months after second dose. Experience fatigue and pain in his legs during 2 days.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Fatigue, muscle pain,  chills, feel like crap. No fever, no vomiting.
Myalgia, Arthralgia, Diarrhea,  Insomnia Narrative:
felt facial flushing  later that day, felt unstable on legs, felt like would buckle, pains in legs--sx has improved but still feeling it for next 3 days, felt very tired then head to toe, felt tightness in muscles--sx has improved then having hard beating of heart; also beating fast; also fluttering, feeling dizzy--worse with exertion feeling SOB
soreness and swelling to her arm at the injection site; soreness and swelling to her arm at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administered in arm, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "auto immune system/a weak immune system" (unspecified if ongoing); "cancer" (unspecified if ongoing); "low melatonin count" (unspecified if ongoing), notes: because of the cancer she has no melatonin; "insomnia" (unspecified if ongoing), notes: takes Xanax for sleep because she has insomnia. Concomitant medication(s) included: XANAX taken for insomnia. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 02Mar2021, outcome "unknown" and all described as "soreness and swelling to her arm at the injection site". Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling.  Additional information: TYLENOL every 6 hours was taken as treatment for the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I developed a maculopapular rash over my chest, abdomen, back and proximal extremities but sparing my face, hands and feet.  I was otherwise asymptomatic and the rash was not painful or itchy.  It resolved on its own after 24 hours.
About 10 minutes in to the waiting period after the shot was given, the pt started complaining of chest pain. She was breathing really fast and alternated between feeling hot and cold. 911 was called and the EMT's on the scene checked her vitals, all which were normal. Blood pressure, sugar, pulse ox were all in normal range. She responded to commands and turned her head when the light was shined in the eye. Mom was called and was asked about her history of seizures. She remembered a MD saying something about pseudo seizures in her past. EMT's seemed to think that that was the case this time, would not be sure until they did a full work up. Patient said she wanted to go to hospital.
3/8/20 patient developed diffuse erythema with swelling and itching. She was seen in a local ER and treated for severe allergic reaction - per patient description sounds like diffuse urticaria with possible angioedema
All the joints in body to be in pain after the booster/ joint pain all over body; This spontaneous case was reported by a pharmacist and describes the occurrence of ARTHRALGIA (All the joints in body to be in pain after the booster/ joint pain all over body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (All the joints in body to be in pain after the booster/ joint pain all over body). At the time of the report, ARTHRALGIA (All the joints in body to be in pain after the booster/ joint pain all over body) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment details were reported.
Knot that is warm to the touch, red, and swollen. Counseled use of cold compress, since anti-inflammatory was not to be administered to patient.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with improperly stored RECOMBIVAX HB (lot#, expiration date, dose and route not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information is not expected since the reporter did not want to be contacted.
I had unexpected and severe bleeding from my uterus. I've had 2 surgical procedures D&C and Ablation. As a result from the first procedure I developed a blood clot in my leg. Which has lead me to be on a blood thinner medication.
I developed symptoms on 12/31. I was very very sleepy, tired, and congested, particularly sinus congestion. Then in the middle of the night I took my temperature and it was 99.7. My husband took his temperature and his was elevated as well, but he had no symptoms. We both took COVID19 tests and were both positive. We called the advice nurse who told us we would have to isolate, and recommended we take Paxlovid. We had to adjust our medications a little bit to take the Paxlovid, but within 3 days the symptoms were gone. I'm pretty sure we picked up the virus at the airport on our way back from away, the timing was perfect. We wore masks but I don't think we were careful enough.
Fatigue; Chills; Sweating; Sore joints; Sore muscles especially in left mid back on same side as injection,; Headache; Nausea; Inability to get comfortable; Inability to sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 11:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medicines within two weeks prior to the COVID-19 vaccine. The patient previously 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 05Apr2021 at 11:30 (at the age of 40-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 26Apr2021 at 20:00, the patient experienced fatigue, chills, sweating, sore joints, sore muscles especially in left mid back on same side as injection, headache, nausea, inability to get comfortable and inability to sleep. 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 events. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the events fatigue, chills, sweating, sore joints, sore muscles especially in left mid back on same side as injection, headache, nausea, inability to get comfortable and inability to sleep were recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 60-year-old male patient received BNT162b2 (BNT162B2), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE oral, start date: Jan2022; SIMVASTATIN oral, start date: Jan2022, stop date: 11Jul2022; LISINOPRIL oral, start date: Jan2022; LEVOTHYROXINE oral, start date: Jan2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Results. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 12Jul2022 till Jul2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all the reported events Drug ineffective,covid 19 cannot be completely excluded based on temporal association and known drug safety profile