chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 25-MAR-2015, the patient was vaccinated with a dose of ZOSTAVAX, 0.65 ml, once, subcutaneously, (lot # J014810, expiration date: 21-FEB-2015), (strength and anatomical location was not reported) which was expired. No adverse events were reported and product quality complaint (PQC) was not involved. Additional information has been requested.
Site: Pain at Injection Site-Mild, Systemic: menstrual changes-Mild
This spontaneous report was received from a nurse who refers, via company representative, to her mother with lupus. The nurse reported that she was vaccinated with a dose of VARIVAX (merck) (dose, route and lot# not reported) when she was child (date and age not specified). It was reported that nurse's mother had chicken pox multiple times, although reporter did not specify if it was before or after she received the vaccine or even if her mother had received VARIVAX (merck). The outcome for reported adverse event was unknown. Additional information has been requested. This is one of several reports from the same source.
Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Additional Details: big red circle below the injection site. hot, swollen and red.
Employee received 2nd dose of Pfizer vaccine. Approximately 24 hours hour had onset of fatigue, headache, muscle/joint aches. Interfered with normal daily activities. Lasted approximately 15 hours. Reporting per leadership guidance.
erythematous papular rash scattered throughout abdomen, torso, neck with areas Onset of symptoms noticed 6hrs from vaccine, rash has continued to spread 4 days from time of vaccination sparing most of the extremities.
Severe pain in the shoulder shot was given with difficulty moving the arm. Pain growing to the side of the arm and chest/neck area.
Fever 100.5.   Nausea, vomiting, headache and left arm pain
After 30 days still didn't get the vaccine/ delayed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (After 30 days still didn't get the vaccine/ delayed) 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 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (After 30 days still didn't get the vaccine/ delayed). At the time of the report, PRODUCT DOSE OMISSION ISSUE (After 30 days still didn't get the vaccine/ delayed) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.
Ongoing left arm injection site pain and has not been able to lift arm past her left shoulder due to the pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Ongoing left arm injection site pain and has not been able to lift arm past her left shoulder due to the pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 078621A and 016C214) for COVID-19 vaccination.     No medical history reported.    On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (Ongoing left arm injection site pain and has not been able to lift arm past her left shoulder due to the pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Ongoing left arm injection site pain and has not been able to lift arm past her left shoulder due to the pain) had not resolved.            Concomitant medication reported as Balance of Nature Vitamins Fruits 3 pills daily & Vegetable tablet .   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up Received - Contain No New Information.
Dose 1 - Loss of smell by that evening. Rash about the size of a tennis ball where injection was given. Regained smell the evening of 2-21-2021. Went to Dr. 2-22-2021. Tested positive for COVID19. Was given a Z pack and Ivermectin. Also put on Vitamin D, C, Multi-Vitamin, Quercertin and Green Tea.  Dose 2 - 03-19-2021  Rash about the size of a tennis ball w/ hard lump and fever and still that way today. Was told to apply ice pack, hydrocortizone cream, and take Tylenol and Benedryl. Was in bed for 2 days (03-20-21 & 03-21-21) with fatigue, aches, chills, fever, headache, dizziness, nausea
This spontaneous report was received from a licensed Practical Nurse on 13-DEC-2016, concerning a 4 years old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 20-SEP-2016, the patient was vaccinated with an improperly stored dose of PROQUAD for prophylaxis (lot number reported as: M015699) (dose number, frequency, route of administration and anatomical location were not reported). No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1610USA013756: US-009507513-1610USA013820: US-009507513-1610USA013819: US-009507513-1612USA008581: US-009507513-1612USA008582: US-009507513-1612USA008583: US-009507513-1610USA010040: US-009507513-1612USA008585
Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Tachycardia-Mild, Additional Details: Patient stated she felt like her heart was racing and was having a some trouble clearing her throat. Patient was brought for direct observation with RN, and given 1 dose of 25mg Benadryl. She was placed in front of a fan. Talked with her for 15 minutes to calm her nerves. After 30 minutes patient felt better and was kept in the waiting chairs for another 15 minutes. At the end of this time the patient stated she felt fine and was safe to leave.
Seen for minor URI, temp 100.4 in office noted to have vaccines not up to date. Given DtaP, PREVNAR at approximately noon. Noted to have fever, stiffening, eyes rolling back. EMS called, temp 100.6. EMS checked child who had stopped seizure by then. Parents brought him to ER, temp 40.1 observed for 3 hrs. Exam looked good. No further episodes.
The injection site became painful, itchy, swollen, and increased in redness; Pain, swelling, and redness immediately below the site of injection; Pain, swelling, and redness immediately below the site of injection; Pain, swelling, and redness immediately below the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain, swelling, and redness immediately below the site of injection), VACCINATION SITE SWELLING (Pain, swelling, and redness immediately below the site of injection), VACCINATION SITE ERYTHEMA (Pain, swelling, and redness immediately below the site of injection) and VACCINATION SITE PRURITUS (The injection site became painful, itchy, swollen, and increased in redness) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain, swelling, and redness immediately below the site of injection), VACCINATION SITE SWELLING (Pain, swelling, and redness immediately below the site of injection) and VACCINATION SITE ERYTHEMA (Pain, swelling, and redness immediately below the site of injection). On 15-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (The injection site became painful, itchy, swollen, and increased in redness). On 12-Jan-2021, VACCINATION SITE PAIN (Pain, swelling, and redness immediately below the site of injection), VACCINATION SITE SWELLING (Pain, swelling, and redness immediately below the site of injection) and VACCINATION SITE ERYTHEMA (Pain, swelling, and redness immediately below the site of injection) had resolved. At the time of the report, VACCINATION SITE PRURITUS (The injection site became painful, itchy, swollen, and increased in redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was treated with antibiotics and steroids.   Reporter did not allow further contact
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Known allergies: Latex" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Series of vaccination complete; Manufacturer Unknown.), for Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  Clinical course: Other medication in 2weeks was no. Patient received anti viral medicine (Pfizer band) for covid 19 treatment from 01May2022 to 05May2022.  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 known drug safety profile, there is reasonable possibility of causal association between the events and BNT162b2.
Needed to increase b vitamins and other supplements; Joint disorder; Pain; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Needed to increase b vitamins and other supplements), ARTHROPATHY (Joint disorder) and PAIN (Pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On an unknown date, the patient experienced UNEVALUABLE EVENT (Needed to increase b vitamins and other supplements), ARTHROPATHY (Joint disorder) and PAIN (Pain). At the time of the report, UNEVALUABLE EVENT (Needed to increase b vitamins and other supplements) outcome was unknown and ARTHROPATHY (Joint disorder) and PAIN (Pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Laboratory test: needed to increase b vitamins and other supplement needed to increase B vitamins and other supplements.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       No concomitant medication was reported.  The patient needed to increase B vitamins and other supplements so took Rinvoq.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The causality with the events was reported as reasonable possibility.  No treatment medication was reported.
Patient had redness measuring 2.5 in x 3 in. on left deltoid. Area is warm to touch with burning sensation. No itching. No fever. No other symptoms.
Came for routine physical; gave the provider all papers -except the prescription stating that she had received a HPV Vaccine that same day in morning.  Dr. went over the vacccines to be given and patient expressed understanding.  After the nurse had given seven vaccines patient provided the nurse with a prescripition for HPV and stated she received this shot this am.  Patient got HPV in am and HPV in pm.
3/11/21: patient presented and was admitted through ED for Shortness of Breath and choking on food. His saturation was as low as 70s and placed on nonrebreather.  Patient was brought to ED and eventually required to be intubated because of hypoxic respiratory failure. During hospitalization patient has one episode of seizure.  Patient had similar presentation in May 2019 and he had to be intubated for choking fluid.  per the EUA, hospitalizations to be reported irrespective of attribution of vaccine.
It was a bizarre feeling; my lips and tongue were tingling for about  4 days; started to feel itchy on back, foot, eyelids, and inside of her ears/feel itchy and the itching moves around my body; like bugs were crawling on my skin; This is a spontaneous report from a contactable consumer or other non-health care professional. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 22Mar2021 17:45 (at the age of 39 years old) (Batch/Lot Number: ER8727) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that she received her 1st Pfizer Vaccine dose on 22Mar21 17:30 pm. Around10pm that night she felt itchy on her back then it moved to her foot and the itching moves around her body, like bugs were crawling on her skin all over her body, it was all day long, 24/7. It was a bizarre feeling. And she explains that it was irritating. Then Tuesday evening, on 23Mar2201, her lips and tongue were tingling for about 4 days. She clarifies that her throat did not swell up, itch, or anything, her lips and tongue were just tingling. The patient enquired if this is a normal side effect and she still get her 2nd vaccine dose and she mentioned that she has never had reactions to vaccines or medications before. Patient states that there is not a whole lot of information about the itching. She saw information on the Covid rash, but her biggest fear was the lips and tongue tingling. Her only concern is that her allergic reaction is going to be worse with the second dose. If the reaction is not going to be worse, she will get the second one which was scheduled on 16Apr2021and will deal with the itching and tingling. Patient states that she thought maybe she was going crazy, but then she researched more and found that it was a reaction according to Pfizer's literature, it is known as pruritus. The literature did not specify if she should get the second one and wants to make sure if based on what Pfizer has seen, she's not going to get worse with the second dose. The patient reports she is still itching, the itching has improved, but it is still there very slightly. She explains that on Thursday or Friday, it was the worst, but it has been subsiding since then. She had most of the tingling of the lips and tongue then too. Since then, it's pretty much gone away, there is a little itch and tingling here and there, but nothing like what it was. She tried Benadryl and it didn't seem to do anything. The patient explains that she took one and it wasn't really working so she took another one a couple hours later, and that didn't seem to help. She didn't take any other after that because she didn't want to keep taking them if they weren't going to help. No other vaccines were administered on Same Date of the Pfizer Suspect. No adverse events required visit to emergency room or physician office. Prior vaccination there was no adverse events. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.
Initial report received from a consumer 02 October 2013. A 26-year-old female patient had received a dose of FLUZONE vaccine (lot number, dose number, route and anatomical site of administration were not reported) on an unspecified date. On an unspecified date, the patient had developed experienced tingling down arm and into hand, site became red, sore, swollen. Laboratory investigation was and corrective treatments were not reported. At the time of this report, the patient had not recovered from events. Documents held by sender: none.
tested positive on their covid test, tested positive three days after receiving the vaccine; This is Spontaneous report from a contactable Pharmacist . This Pharmacist reported similar events for two patients. This is a 2nd of 2 reports.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient tested positive on their covid test, tested positive three days after receiving the vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021276371 Same reporter/events/ drug/diff patient
Vaccine stored outside of manufacturer guidelines, product stability is unknown. Potential expired product used for immunization.  pt stated he did not experience any adverse events after vaccine was administered.
Case number PHEH2016US023408 is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 58-year-old patient of an unknown gender. Medical history and concomitant medication was not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml intramuscularly in the left arm on 01 Dec 2015. It was reported that the patient received FLUVIRIN that had temperature excursion. The patient did not experience any adverse events following vaccination.
sugar was elevated a whole lot/went real high; This is a spontaneous report from a contactable consumer (patient). A 79-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 12Jan2021 at single dose for Covid-19 immunization (wanted to get because of the virus). The patient's medical history included hard of hearing and diabetes (reported as "diabetes and stuff). Concomitant medications included empagliflozin (JARDIANCE), dulaglutide (TRULICITY), and other medications (as reported " I take stuff for blood pressure all kind of stuff"). The patient reported that he got the vaccine on Tuesday (12Jan2021), he stated that he has diabetes and stuff and he noticed on Wednesday, Thursday, Friday his sugar was elevated a whole lot and he thought that would be possibly from the vaccine or it might be stressed because the Covid (unspecified). He stated that he doesn't know but it's unusual, he means it went real high. He wanted to know if there are any reports of like affects it might cause on hi sugar to go high. The patient checked this morning (unspecified date) it was high and just checked about 20 minutes ago and it has come down again so (further not clarified)." The patient mentioned that he takes Jardiance and Trulicity, once a week; he took Trulicity this morning (unspecified date) and stated, "so that probably helped". He had an unspecified laboratory test about 3 months ago, and there was no problem." The outcome of event was unknown.  Information on the lot/batch number has been requested.
WITHOUT A PULSE NOR HEARTBEAT (DEATH); This spontaneous report received from a health care professional concerned a 78 year old male of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: advanced parkinson's disease, hyperlipidemia, anxiety, vitamin D deficiency, vascular dementia, hypothyroidism, major depressive disorder and aphasia. The patient previously received covid-19 vaccine ad26. cov2.s (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose was not reported, (dose number in series was 1), 01 in total was administered on 05-MAY-2021 for prophylactic vaccination. The reporter did not report any adverse events following covid-19 vaccine ad26. cov2.s vaccination. The patient was admitted to facility on 14-DEC-2021 for nursing care due to advanced Parkinson's Disease, hyperlipidemia, anxiety, vitamin D deficiency, vascular dementia, hypothyroidism, major depressive disorder and aphasia. On an unspecified date in DEC-2021, outbreak COVID 19 testing revealed negative tests on the resident throughout course of the stay. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 213D21A, expiry: 11-APR-2022) 0.5 ml, (dose number in series was 2), 01 in total was administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-DEC-2021, following the vaccination with covid-19 vaccine ad26.cov2.s, at approximately 11:44 hours, he was found without a pulse nor heartbeat (death) (dose number in series was 2). It was not reported whether autopsy was performed or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of without a pulse nor heartbeat (death) was fatal (dose number in series was 2). This report was serious (Death). This case, from the same reporter is linked to 20220124404 and 20220130332.; Sender's Comments: V0-20220124221-covid-19 vaccine ad26.cov2.s-without a pulse nor heartbeat (death). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: WITHOUT A PULSE NOR HEARTBEAT (DEATH)
Information was received from a registered nurse concerning an unspecified number of patients (demographics not provided). On unknown dates, 10 doses of improperly stored VARIVAX (dosages and routes of administration, lot numbers and expiration dates were not provided) were administered to an unspecified number of patients. No adverse symptoms were reported. The temperature excursion for VARIVAX was found to be supported with in-house stability data. This is one of several reports received from the same reporter. Follow up information has been received from a registered nurse on 19-DEC-2014 during a phone call. The nurse was able to provide lot numbers, expiration dates, number of doses affected by the temperature excursion and remaining doses. The nurse provided that the approximate ages of the patients who received the vaccinations were 1 year old and 4 years old. Additional walk-in patients who received the vaccinations, were older from other countries. There have been no adverse events reported since administration of the vaccinations and there was no need for revaccination. On an unknown dates, an unspecified number of patient received improperly stored doses of VARIVAX lot # reported as K002928, expiration date: 26-FEB-2016. The nurse also reported that 20 doses of vaccine with lot # reported as K002928 were affected and 20 doses were remaining. This is one of several reports received from the same reporter. Additional information has been requested.
p/vax pt has rash resembling chickenpox;examined 11/9/99 confirmed exposure x 1-2wk;+rash of varicella;a