chrisvoncsefalvay/vaers-outcomes huggingface dataset:
03/23/22 presents to ED for "Abnormal labs with elevated calcium". PMHx of "sarcoidosis, migraines, glaucoma, COVID-19 in February 2022, and anxiety"
Patient started having redness/swelling/pain/heat at site of injection, became progressively firmer over the next 2-3 days. Patient was prescribed Bactrim, told to continue ibuprofen and Benadryl as needed, start cold compresses to site. Have not completed follow up call to patient/guardian yet.
No adverse effects reported; patient received one dose of improperly stored MMR II; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was not provided.  On 15-AUG-2019, the patient received an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # R031681 with expiration date 01-NOV-2020 (strength, dose, route not reported), for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent lot # N029636 with expiration date 29-MAR-2020. The dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was exposed to a temperature excursion above 47 degrees Fahrenheit (°F) (48.1 F) during a timeframe of 7 hours, which was detected by a digital data logger. There were no previous temperature excursions. No adverse effects reported.  The therapy type of the lot number R031681 is rHA.
This initial serious spontaneous case  was received on 05-Oct-2017, from other health professional, concerning a female patient of unspecified age. The patient's current conditions included rosacea and gluten intolerance. The patient had no concomitant medications. On an unspecified date (10 years ago), the patient was administered with INN Flu Vaccine  Seasonal  (dose, route of administration: subcutaneous, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On unspecified date after vaccination, the patient had her arm swelled up to 3 times the other arm, big red splotch to below elbow and lost her arm (as reported). The patient was hospitalized and diagnosed with fasciitis. The treatment medication included unspecified IV steroids. The patient was admitted for 7 days and was discharged as the patient recovered from the events. At the time of discharge, SOLU-MEDROL was given. The report was considered as serious due to hospitalization.
mom claims shortly  after receiving Flu vaccine, child develops rash on face. Mom gave benadryl to child thinking it was common rash due to time of year,, rash seemed to disappear, than mom claims rash returned. Child received 2nd vaccine in December 2020.Mom did not bring child in to see the dr regarding rash until December 12,2020. claims the rash was from both flu shots.
Breakthrough case admission after 2 vaccines: Moderna 7/22/21 Lot# 050C21A; Moderna 8/19/21 Lot# 088D21A.
I received my 2nd dose on May 5th.  On May 25th, three weeks later, I  experienced the exact same symptoms I had the day after my second shot.  Chills, headache, mild temperature of 100.3.  Both instances, May 5th and May 25th, lasted about 24 hours.  Today, May 27th, i feel back to my normal self.
Time of vaccine:  face flushing, warm face and throat Day 2 post vaccine; worst headache since I had a spinal fluid leak.  Immobilized in dark room, no sound.  Wrapped head in ice packs for 24 hours.  Nausea.  5 through 10 days post vaccine: severe dizziness, nausea, full body muscle aches, extreme fatigue.  Walking from room to room exhausts me.  Dizziness all the time.
The day after getting his vaccine, patient complained of sweating and also having a fever. He felt these symptoms since the morning the day after the vaccine. Patient went to hospital ER where he left shortly after.
COVID Vaccine administered was the Pfizer Pediatric COVID vaccine instead of the Pfizer Bivalent Booster vaccine. Pt has been advised to come back and receive the correct vaccine.
Headache, Chills, Sore joints and sore muscles. Low Fever (  Above normal to 99.5), quick sharp pains in legs. slight dizzy, cough and lower than normal 97% Blood/Ox, to a low of 88%, tiredness.  As far as I know, I do have Covid-19, or have never had it.  These side effects lasted from nightime of Feb. 5, 2021 (shot 1. of Moderma was Feb. 5, 2021 at 2:00pm.) unitl morning of Feb. 8, 2012 and varied in intensity.
Anaphylaxis; Vocal cord tightened; immediate severe headache on left half; tongue swelling; tingling across face just above upper lip; face and neck turned red and swollen/ arms turned red under sleeves; face and neck turned red and swollen; dizzy; brain fog; Existing Tinnitus in left ear is louder; This is a spontaneous report from a contactable consumer reported for herself.   This 47-year-old female (non-pregnant) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 27Apr2021 15:15 (Batch/Lot Number: Unknown) as single dose (at 47 years old) for COVID-19 immunisation.  Medical history included fibromyalgia from (previously diagnosed as Rheumatoid Arthritis). Concomitant medications included fenofibrate, escitalopram, hydrochlorothiazide, losartan potassium (LOSARTAN/HCT), herbal sup, all taken for an unspecified indication, start and stop date were not reported. The patient previously took monosodium glutamate and experienced allergy, hydroxychloroquine sulfate and experienced allergy. On 27Apr2021 15:15, the patient experienced anaphylaxis, vocal cord tightened, immediate severe headache on left half, tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen/ arms turned red under sleeves, dizzy, brain fog, existing tinnitus in left ear is louder, all with outcome of not recovered (as reported). Therapeutic measures were taken as a result of the events included Diphenhydramine, Epinephrine, Famotidine, Zofran. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The patient stated that: "Sent to ER via ambulance: Diagnosed with Anaphylaxis. Vocal cord tightened, immediate severe headache on left half,  tongue swelling, tingling across face just above upper lip, face and neck turned red and swollen, arms turned red under sleeves, dizzy, brain fog. Existing Tinnitus in left ear is louder, and as of 04May2021, I still have the headache". Seriousness criteria of the events was reported as serious due to disability.  The information on the Lot / Batch number has been requested.
Bilateral tinnitus, onset 5 days after the first shot of Pfizer/BioNTech. Initial loud spike, volume 9/10. Accompanied by a sensation of heat and discomfort in the ears and back of the head. Tinnitus stayed loud for about a week. Disrupted daily activities. Admitted to the ER, did not respond to dexamethasone IV.   Progressively started improving over the following weeks. Still ongoing more than two months from the vaccine. Louder at night and early morning.
Swollen leg at site of injection, fussiness and constant crying for 2 hours straight.
Patient presented to emergency department on 12/18/2021 with acute hypoxia due to COVID-19 infection. Patient tested positive at assisted living facility on 12/17/2021. Patient was admitted for further management. She was treated with supplemental oxygen. She was discharged to her assisted living facility on 12/22/2021 with home oxygen. She presented again to emergency department on 12/23/2021 with altered mental status and was admitted. Patient was changed to comfort measures only on 12/25/2021 and expired on 12/26/2021.
PATIENT WAS SUPPOSSED TO GET HER 2ND PRIMARY DOSE BUT RECEIVED THE MODERNA BIVALENT BOOSTER  BY MISTAKE . PATIENT FELT ANXIOUS , HEADACHE ( OVERNIGHT ) AND SWELLING/ PAIN IN THE ARM . PATIENT RECOVERED THE DAY AFTER VACCINE WAS GIVEN .
This spontaneous report was received from a pharmacist concerning a 50 year old female patient with no drug reactions/allergies who on 11-JAN-2013 was vaccinated with a 0.65 ml of live ZOSTAVAX subcutaneous (lot number H019997, expiration date 02-FEB-2014). No other co-suspects were reported. No concomitant medications were reported. The consumer reported that 2 or 3 days after vaccination, on approximately 13-JAN-2013, the patient developed a red raised and itchy area around injection site which was warm and uncomfortable. She stated that the rash was about 2.5 inches in diameter. The patient reported that there were no vesicle in the reddened area and declined VZVIP packet. The patient had not seen a physician concerning this injection site reaction. At the time of the report, the patient had not recovered from the event. Additional information has been requested.
Fever of 102 degrees for 1 day, rash all over body for 3 days, and bulging anterior fontanel for 1 day.
Information has been received from a physician concerning a 46 year old male firefighter with a history of renal cell carcinoma (treated with nephrectomy "6-7 years" ago), and hepatitis B exposure (prior to June 2007). It was reported that 10-15 years ago the patient received his initial 3 dose series of hepatitis B vaccine (unspecified manufacturer). Beginning in June 2007, he began his second series of 3 doses of hepatitis B vaccine (unspecified manufacturer). On 10-OCT-2007, he received his seventh dose of RECOMBIVAX HB. He tested negative for hepatitis B after his exposure. He was also tested for titer levels of varicella, measles, mumps, and rubella that were all reported as normal. On 10-OCT-2007, prior to his seventh dose of vaccine, his hepatitis B titer was reported as negative. Current patient status was not reported. A product quality complaint was not reported. No further information was available. Follow up information from a physician reported that the patient finally seroconverted. It was reported that the patient received a total of four doses over four months (dates not reported). Additional information is not expected.
About 7 or 8 days later my daughter developed a rash on her arm near the injection site. Went to an Urgent Care *name and information is unknown* and they gave steroid  cream. About 2 days she developed itching and a lesion that was very round and red and about 2-3 inches in diameter. She returned to the Urgent Care was they gave oral steroid. The steroid did help with the itching but the lesion did not disappear it started to dry and scab but at the present time I am not sure if it is still there or not.
Yes I did and I got the flu; Have been sick for over a week; Initial information received on 25-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-healthcare professional.  This case involves an unknown age and unknown gender patient who got the flu and have been sick for over a week after receiving vaccine Influenza Vaccine.  The patient's past medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received unknown dose of suspect  Influenza Vaccine produced by unknown manufacturer (lot number, strength, formulation, expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  Patient reported that "i got the flu (influenza) and have been sick for over a week (illness) during Christmas following the administration of Influenza Vaccine.  It is unknown if there were lab data/results available.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for both the events.   Outcome: Unknown for both the events.
Patient c/o left upper arm pain in the evening of 11 April 2023 after received his 3rd dose of Anthrax vaccine. Patient reported to Urgent Care the next day c/o deltoid area pain that radiating to whole left arm. Pt has a small 3mm raised erythemic bump and pain of 7/10. Loss of sensation/numbness to entire left arm around 0900, he is able to move the arm but unable to fully assess strength. Patient has sharp/dull sensation fully intact to his right arm with some sensation of pressure to anterior right finger but unable to identify which finger. Patient had hx of vasovagal reaction to the 2nd Anthrax vaccination.  Consulted with neurologist regarding the symptoms, unlikely to be a nerve related injury but recommended 20mg of prednisone x5 days.
Severe to VERY severe continuous  lymph node/breast pain on shot side 1/27 through 2/4. Starting 2/4 intensity started to vary i.e  no pain  during hot shower but still severe pain majority of time. Slight reduction breast pain as spread to back pain and movement seems to help. On night of 2/3 spread to back ? shot side line of nodes paralleling spine  and shoulder/neck area-  back pain not as severe as original breast area and heat helps to reduce back pain Pain interferes with sleep - 2/4 finally able to get 4 hours sleep ( hot shower temporary relief while showering)( normal is 7 hrs) As of 2/5 still in moderate to severe breast area pain almost continuously. Hope I am recovering but its 10 days and still mostly constant incapacitating pain. Very slight intermittent node pain by Feb 17 when got second shot in other arm per Physician Assistant?s recommendation. So far after 51 hours 2nd shot adverse effects minimal and does not interfere with thinking or sleeping
hives/welts; red spots; My arms were itchy with hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: URTICARIA (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "hives/welts"; RASH MACULAR (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "red spots"; PRURITUS (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "My arms were itchy with hives". Therapeutic measures were taken as a result of urticaria, rash macular, pruritus. Additional information: Patient received the new Covid vaccine recently and 10 days later have had hives, welts and red spots. The arms were itchy with hives. The welts and red spots on the thighs and torso were not itchy. After 2 days, patient took diphenhydramine (this morning) and that has helped a lot. Patient asking if it was a side effect of the vaccine stated "I'm not one to have skin problems or issues like that".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Upper body rash 7 hours after no burning and no itching,  same on 03232021, and not severe just a red blotchy rash again no heat no itching, just not sure if it was the vaccine first shot.
COVID-19; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (COVID-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ODM2A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Asthma and Sulfonamide allergy (Sulfa).    On 05-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 04-May-2022 to 08-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. On 17-May-2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive rapid antigen test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. It was unknown that patient has taken any other medications/products within 2 weeks of starting COVID-19 treatment. It was reported that patient experienced renewed COVID symptoms and prolonged positive rapid antigen test (until Day 14) after completing 5 day course of PaxlovPfizer have permission to contact about this report but does not have permission to contact the patient's healthcare provider. The device date was reported as 18-May-2022.  COMPANY COMMENT:  This spontaneous case concerns a 70-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 1 month after fourth dose mRNA-1273 vaccine Patient was administered with RITONAVIR (Paxlovid) for 5 days as treatment for COVID-19, after the treatment he was prolonged positive ( rapid antigen test) for covid-19. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a 70-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19 which occurred approximately 1 month after fourth dose mRNA-1273 vaccine Patient was administered with RITONAVIR (Paxlovid) for 5 days as treatment for COVID-19, after the treatment he was prolonged positive ( rapid antigen test) for covid-19. COVID-19 pandemic could be confounding for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
pulmonary embolism; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 30 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) at the age of 30 years as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "Clotting Disorder" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PULMONARY EMBOLISM (death, medically significant), outcome "fatal", described as "pulmonary embolism". The event "pulmonary embolism" was evaluated at the emergency room visit. It was reported that within an hour he was in the emergency department and died from a pulmonary embolism. The patient date of death was unknown. The reported cause of death was pulmonary embolism. It was not reported if an autopsy was performed.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: pulmonary embolism
Patient received MMR on 2/5/08. Developed a rash all over her body. Mother states rash compared to picture of measles rash was the same. Patient also has developed symptoms of a cold therefore this rash may be due to a virus. This rash is a possible reaction.
Patient is not reported to have any symptomatic side effects; A patient was inadvertently administered a GARDASIL 9 after it's expiration date.; This spontaneous report was received from a pharmacy technician referring to a patient of unspecified age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not provided.  On 05-JUL-2022, the patient was inadvertently administered an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, route of administration and anatomical site of vaccination were not reported; lot number T008151 has been verified to be valid, expiration date reported as 22-JUN-2022 but upon internal verification was established as 21-JUN-2022) (expired product administered).   No symptomatic side effects were reported (no adverse event).
Rt arm swelling and redness which is improving x 24 hours with no treatment needed.
This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 25th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular) 0.5 ml. On 29th March 2019, 4 days after receiving SHINGRIX, the patient experienced dizziness. On an unknown date, the outcome of the dizziness was unknown. It was unknown if the reporter considered the dizziness to be related to SHINGRIX. Additional details were provided as follows: The patient's husband reported the case. The age at vaccination was not reported but it could be 74 years or 75 years. On Monday 25th March 2019, the patient and her spouse had their 1st SHINGRIX shot. The patient received SHINGRIX in right deltoid. On the day of reporting, the patient woke up with dizziness. Her spouse encouraged to report the adverse event to her physician. The patient did not consent to follow-up.
Severe and uncontrollable diarrhea still continuing after two weeks.  Sore arm and joints.  After fasting for over 5 days, diarrhea resumed when I began eating again.
cold sores; ill; This case was reported by a nurse via sales rep and described the occurrence of cold sores in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd January 2020, the patient received Shingrix .5 ml. In January 2020, less than 2 weeks after receiving Shingrix, the patient experienced cold sores and unwell. On an unknown date, the outcome of the cold sores and unwell were recovered/resolved.   It was unknown if the reporter considered the cold sores and unwell to be related to Shingrix.  Additional details were provided as follows: The patient felt cold sore and also felt ill for three days following that prevented her from going to work.
Stabbing arm pain/collar bone down to fingers.; rash at injection site area; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Apr-2021 and was forwarded to Moderna on 01-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Stabbing arm pain/collar bone down to fingers.) and VACCINATION SITE RASH (rash at injection site area) in a 43-year-old female patient who received mRNA-1273 (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Apr-2021, the patient received first dose of mRNA-1273 (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Stabbing arm pain/collar bone down to fingers.) and VACCINATION SITE RASH (rash at injection site area). At the time of the report, PAIN IN EXTREMITY (Stabbing arm pain/collar bone down to fingers.) and VACCINATION SITE RASH (rash at injection site area) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.       Relevant concomitant medications were not reported.  Treatment information was not provided.
Other adverse events after receiving the moderna cov-19; Had some joint pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Other adverse events after receiving the moderna cov-19) and ARTHRALGIA (Had some joint pain) in a 60-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Other adverse events after receiving the moderna cov-19) and ARTHRALGIA (Had some joint pain). At the time of the report, VACCINATION COMPLICATION (Other adverse events after receiving the moderna cov-19) and ARTHRALGIA (Had some joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.