chrisvoncsefalvay/vaers-outcomes huggingface dataset:
soreness in the arm for like 3 days; little fever of maximum 99°F for 3-4 hours.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in the arm for like 3 days) and PYREXIA (little fever of maximum 99°F for 3-4 hours.) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PAIN IN EXTREMITY (soreness in the arm for like 3 days) and PYREXIA (little fever of maximum 99°F for 3-4 hours.). On 08-Apr-2021, PYREXIA (little fever of maximum 99°F for 3-4 hours.) had resolved. On 10-Apr-2021, PAIN IN EXTREMITY (soreness in the arm for like 3 days) had resolved.            The patient has an appointment to get the booster dose next Monday. They inquired if they should skip taking their supplements with bioflavonoids from grape seeds that act as blood thinner for that day. As concomitant medication the patient was taking 0.5mcg thyroid medication for less active thyroid and Metabolic supplement multivitamin twice, daily, not to get infections/inflammations natural products. regulates blood pressure.  No treatment medication details were provided.   This case was linked to MOD-2021-385733 (Patient Link).
6cm diameter area of warm, red, slightly swollen area over left upper arm.  No induration or s/s cellulitis.  Sx care.
Noted to have scattered tiny rashes at my arms, chest, abdomen, and back when I woke up this morning. I got the MMR and Varicella vaccines from Employee Health.
Information has been received from a nurse practitioner via Poison and Drug Center (manufacturer control # US17-013052) concerning a 51 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy information was unknown.    On an unknown date, the patient was vaccinated with PROQUAD (lot#, expiration date, strength, dose, frequency and route were not reported) and sterile diluent (STERILE DILUENT) (lot#, expiration date, strength, dose, frequency and route were not reported) for prophylaxis (inappropriate age at vaccine administration). The reporter was unknown if the patient had had any adverse reactions form this administered vaccine or if any treatments were provided and at the report time, the reporter was unknown if the patient continued on suspect therapies. Additional information has been requested.
17 year old patient was given Flublok in the left deltoid, no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1915, expiry date: 30-Jun-2020 via unknown route in the left deltoid, on 02-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information has been received from a pharmacist referring to an unspecified number of patients of unknown age. Between 05-NOV-2015 and 11-NOV-2015, the patients were vaccinated with improperly stored RECOMBIVAX HB (lot # L019298, expiration date 22-JUN-2017, strength, dose and route were unknown). No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Administered a Hib vaccine instead of Meningococcal  Conjugate. Outcome was Meningococcal was given as well.
pt recv vax 19MAY97 & chickenpox lesions appeared on 8JUN97;
This spontaneous report as received from a nurse refers to one of three patients of unknown age. On an unspecified date the patients was vaccinated with a dose of PNEUMOVAX23 (Lot#, dose and route not reported, but the three patients got the vaccine from the same lot number). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients experienced tenderness at the injection site. The patients sought for unspecified medical attention. This is one of several reports received from a same source.  Additional information has been requested.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates in 2016 (reported as after 20-JUL-2016), the patients were vaccinated with the improperly stored doses of GARDASIL 9 (intramuscularly, lot # reported as L037554, expiration date 25-DEC-2017; dose was not reported). The vaccines had a temperature excursion to 26 F for 90 minutes on 20-JUL-2016. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected as the reporter did not wish to be contacted.
milder fatigue; strong metal taste in mouth/tastes like nickel; This is a spontaneous report received from a contactable reporter nurse. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Feb2021 13:30 (batch/lot number: EN6202) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "pneumonia" (unspecified if ongoing); "valley fever" (unspecified if ongoing); "DOE" (unspecified if ongoing); "skin reaction to nickel in jewelry" (unspecified if ongoing), notes: long standing. Concomitant medication included: LOSARTAN; AMLODIPINE; IRON; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; BIOTIN. Past drug history included: Macrodantin, reactions: "allergies", "fever". Vaccination history included: Bnt162b2 (dose 1; administered in the left arm; batch/lot number EL9263), administration date: 29Jan2021, when the patient was 76 years old, for COVID-19 immunisation, reactions: "painful joints lasting 5 days", "fatigue". The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "milder fatigue"; DYSGEUSIA (non-serious) with onset Mar2021, outcome "not recovered", described as "strong metal taste in mouth/tastes like nickel". Therapeutic measures were not taken as a result of fatigue, dysgeusia.  Additional information: The patient informed that she had a strong metal taste in mouth and the patient had been attributing to some recent dental work until today. The reporter considered "strong metal taste in mouth/tastes like nickel" not related to bnt162b2.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Fatigue cannot be ruled out. Event Metallic taste is assessed as Unrelated.,Linked Report(s) : US-PFIZER INC-2021339126 same reporter/patient/product, different dose/event
2nd shot.  Red rash , swollen, hardness, itching  Applied topical Benadryl and took Tylenol extra strength.
Developed Left lower extremity DVT 24 hours after vaccine; This is a spontaneous report from a non-contactable Physician.   A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 24Mar2021 (at the age of 59-year-old) at a single dose for COVID-19 immunisation. Relevant medical history included hypertension (HTN), diabetes mellitus (DM) and hyperlipidemia (HLD). The patient did not have history of deep vein thrombosis (DVT) and no other risk factors. The patient was not diagnosed with COVID-19 before vaccination. No relevant concomitant medications were provided. She developed left lower extremity DVT 24 hours after vaccine, on 25Mar2021. The event required emergency room visit. The patient was treated with an anticoagulation therapy. Post vaccination COVID-19 test was not done. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information currently available, the event deep vein thrombosis was most likely due to the patient's underlying hypertension, diabetes mellitus and hyperlipidemia. However a possible contributory role of vaccine BNT162B2 to the event can not be totally excluded. Case will be re-assessed upon the additional information provided. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Within 10 seconds of receiving MMR and Varicella, both arms of patient became red and swollen.  The child began pulling at his arms and crying.  Dr. was notified and patient was givne benedryl 5cc prostat
Pt had alopecia ophiasis only to areas above ears prior to vaccine. The next day after vaccine given, the rest of her hair on her head fell out in clumps and thinned out and she had alopecia totalis within a week. To this day, patient has lost her eyebrows, has no hair on her head and she has alopecia universalis (an autoimmune disease.) She now also has many food and environmental allergies and asthma (autoimmune diseases). After her 1 year vaccines given 9/29/15- Prevnar 13, MMR, Hep A, Influenza  (Fluzone) HIB and DTAP patient developed wheezing, asthma symptoms on 12/21/15 along with Oititis media and was given Fluzone that same day. She had multiple MD visits for viral problems since then until 10/3/16.
Pt vomited 1 hr after getting vaccine 2nd several times during day, mom said and she though pt ran a fever but had no thermometer-2nd day pt. feeling better
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021 at 9:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 07-Jan-2021 at 9:30 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided.  On 07-jan-2021, Excursion time was 09 AM and 10 AM, with temperature as 34, and 34 respectively. Total doses given for the day was 96 for 9AM vials. Condition of vaccine prior to administration was not frozen. 9 AM and 10AM vaccine was moved to fridge on 05-Jan-2021 and. Vial was moved to clinic on 07-jan-2021. 6 vials from 9 AM and 10 AM were sent to clinic. Vaccine BUD date was 27-jan-2021 for 9AM,10 AM respectively On 07-jan-2021, no hourly temperature recordings available.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
About 6am morning of 12/24 Dizziness , vertigo, extreme fatigue, nausea and vomiting ( 3 times) injection site pain    May go to ER if condition gets worst or unable to keep anything down. Took zofran twice but has since thrown it up
Immediate reaction of wheezing and chest tightness with cough, within 15 minutes of receiving vaccine, lasted 12 hours. Vaccine administered at Pharmacy. Nursing instructor and nursing student detected wheezing with stethoscope. 12 hours after vaccine sudden sinus congestion and sneezing lasted  few minutes. Deep hacking cough developed 24 hours after vaccine. Had  visit with primary care doctor on March 3rd who recommended steroid injection if no improvement by weekend. Received steroid injection, Decadron 6mg IM, on March 5th. Saw Dr. on March 19th who ordered lab work and chest X-ray after detecting upper airway wheezing. Now scheduled for Johnson & Johnson vaccine on April 7th with Dr.
soreness in my left arm started 12/29/20 late afternoon .... still  sore on 12/30/20 all day  no treatment, minor discomfort
Swelling and redness of almost entire upper arm including part of elbow area. Not much pain. Arm was hot and hard to the touch. Doctor prescribed BENADRYL beginning on Nov. 5. Swelling and redness began to subside, but skin on part of arm was discolored and appeared to be bruised. Symptoms mostly gone by Nov. 8 but still some discoloration.
yellow fever; Initial information received on 03-May-2021 regarding an unsolicited valid serious case received from a consumer/non-healthcare Professional.  This case involves a adult patient (unspecified gender and age) who had yellow fever while receiving YELLOW FEVER VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect YELLOW FEVER VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious yellow fever (unknown latency) following the administration of YELLOW FEVER VACCINE. This event was assessed as medically significant.  Medication Details and reason for taking the medicine: prophylactic vaccination It is unknown if the patient had any medical history, concomitant disease or risk factor.  It was unknown if there were lab data/results available. causality not reported  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was unknown.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns a patients (unspecified age and gender) who had yellow fever after vaccination with YELLOW FEVER VACCINE produced by unknown manufacturer. The time to onset is unknown. Additional information regarding medical history, condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
pt recv vax 5NOV98 & mom stated pt broke out in rash from head to toe on 6NOV98;took child to another clinic on 7NOV98;recv med;
low grade fever, rapid heart rate, body aches, joint pain, headache, weakness, fatigue, sore arm, light headed
Tonic clonic seizure for 5 min immediately after vaccination (started within 1 minute).
ER for shortness of breath for 3-4 days; they took x-rays of lungs - clear; inhaler - Albuterol ; tested for COVID - negative
Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.; No adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.) and NO ADVERSE EVENT (No adverse event) in a 65-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AZ7166B) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    On 21-Feb-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 21-Feb-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (Vaccine was initially stored in the refrigerator on 17-Dec-2022 and administered on 21-FEB-2023.).    Concomitant medications details were not reported by the reporter. Dosage text was reported as Additional booster. Vial did not undergo any temperature excursions. Treatment details was not reported by the reporter.
On 8/30/11 pt given TDAP vaccine on 9/1/11 pt seen in office for localized swelling of arm -> treated with antibiotics & steroids -> no hospitalization. Now on 12/6/11 mom c/o (L) upper arm occasional red bumps appearing.
On 3-24 07 patient developed pain on her left shoulder /left elbow/left knee / left shin/and left ankle (no arthritis) (injection was left arm)
This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 67-year-old male patient who received SHINGRIX for prophylaxis. On 24th September 2018, the patient received the 2nd dose of SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced poor quality sleep. On 25th September 2018, the patient experienced joint pain, muscle pain and tiredness. On an unknown date, the outcome of the joint pain, poor quality sleep, muscle pain and tiredness were unknown. It was unknown if the reporter considered the joint pain, poor quality sleep, muscle pain and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported via a live click to chat. The patient had terrible night sleep, awoke with muscle aches, joint pains and general tired feeling. The call center representative transferred the call to product specialist who works closely with this product and who was the pharmacist. The patient said that the side effects reported by the pharmacist were pretty common, they seemed to be fading with exercise and general movement, but he awoke with a SHINGRIX hangover. The patient was going to see his doctor on Wednesday and his wife had immediate access to her doctor as well, they just wanted to touch base to see if this was a normal reaction, which it appeared to be. This case was linked with the case US2018GSK174207, reported for his wife.
On the evening of Friday, February 19th, I noticed a slight burning sensation in my upper right arm, and it began itching sporadically. On the morning of Saturday, February 20th, I noticed the injection area on my right arm was red and appeared raised/puffy-kind of welt like. It alternated between the same burn/tingle and itching sensation for the duration of the day, and only slightly itched on Sunday, February 21st, 2021. I did not treat the symptoms in any way and they went away on their own.
erythema/Redness; discomfort; This non-serious case was reported by a physician via sales rep and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 3 days after receiving Shingrix, the patient experienced erythema (Verbatim: erythema/Redness) and discomfort (Verbatim: discomfort). The outcome of the erythema and discomfort were resolved.   It was unknown if the reporter considered the erythema and discomfort to be related to Shingrix.     It was unknown if the company considered the erythema and discomfort to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-NOV-2023 The physician reported that one of his patients experienced erythema and discomfort, 3 days after first dose of Shingrix vaccine administration.  The physician reported that he was unaware of the patient's injection site location. Redness and discomfort were resolved without intervention in both cases. This case had been linked with US2023AMR154557, reported by the same reporter for himself. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR154557:Same Reporter
Information has been received from a physician concerning an 8 year old patient who was vaccinated with the second dose of varicella virus vaccine live (Oka/Merck) (Lot #658059/0838U). Subsequently, the patient experienced cellulitis, abnormal swelling and redness at the injection site. The patient's outcome was not reported. Additional information has been requested.
This medically confirmed spontaneous report (initial receipt 13-Nov-2014) concerns a 36 year-old female patient who received the flu shot last year without any issues. On 11-Nov-2014, the patient received intramuscular AFLURIA (batch number: T51208) 0.5 mL annually in the left arm. On 12-Nov-2014, the patient began to experience stiffness and pain at the injection site. On 13-Nov-2014, the patient intensified and she also experienced numbness which was very concerning to the patient. The outcome was not recovered
Patient was admitted to Hospital admitted as inpatient on 12/24/21 due to severe sepsis, secondary to covid 19 and suspected bacterial infection given history of endocarditis. Patient was tested for COVID-19 and was positive on 12/24/21.