chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported/ No side effects; She reported PROQUAD was administered with VARIVAX; The patient was suppose to receive MMR II but the PROQUAD was inadvertently administered instead.; This spontaneous report was received from a nurse practitioner and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history and drug reactions or allergies was provided.   On 30-JUN-2021, the patient was inadvertently vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), lot # T036562, expiration date 26-APR-2022, 1 injection for prophylaxis (exact dose, anatomical location and route of administration were not reported) (case # 2107USA000507) instead of planned measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). On the same date, the patient received a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T032316, expiration date 22-SEP-2022) for prophylaxis.    No additional adverse event reported.  Follow up information has been received on 21-JUL-2021, from the vaccine provider and refers to a 12 months old female patient. The patient was vaccinated with a first dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), subcutaneously in the right thigh and with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX), subcutaneously in the left thigh . Concomitant therapy included first dose of hepatitis A Vaccine, Inactivated (VAQTA), intramuscularly, lot # T037788, expiration date 30-APR-2022, in the left thigh. The vaccines were administered by healthcare professional at private doctor's office/ hospital.   The vaccine provider confirmed that there were no adverse reactions and no vaccines were disposed.  This is one of two reports regarding the same patient. ; Sender's Comments:  US-009507513-2107USA000507:
Got allergic reaction 1st dose (itching/burning and prescribed Antihistamine and Methylprednisolone); Got allergic reaction 1st dose (itching/burning and prescribed Antihistamine and Methylprednisolone); This is a spontaneous report from a contactable consumer (patient) received through Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1 SINGLE for covid-19 immunizations. The patient medical history was not reported. The patient's concomitant medications were not reported. on an unspecified date the patient got allergic reaction to 1st dose (itching/burning and prescribed Antihistamine and Methylprednisolone) patient wants to know if that will interfere with the 2nd dose 26Mar2021. Also, wants to know if taking Steroids will decrease the efficacy of the vaccine. The event outcome was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Hives and itchy rash all over body 8 days after vaccination. They come and go throughout the day. I have not changed anything in my daily life.
25yr old patient with no significant PMH presented to urgent care on 7/4 for left side chest pain x 4-5 days. Just prior, patient had upper back pain (thought to be muscle related) which resolved and then chest tightness/pain started. Patient denied sweats, nausea, lightheadedness, dizziness, palpitations, or shortness of breath. Patient did endorse sharp stabbing pain under left breastbone while taking a deep breath which improved slightly. Patient endorsed pain improved if "laying completely flat and stretching out upper body so heart is not touching his chest wall". Patient had been taking ibuprofen 200mg daily x several days and Tums. Patient developed upper respiratory infection with cough and congestion 2-3 we  Patient developed upper respiratory infection with cough and congestion 2-3 weeks ago, symptoms resolved. Self swab Covid test on 6/15 was negative. Patient endorsed receiving Pfizer vaccine (second dose 5/28/21). Unknown LOT number, sight of administration or details and date of first Pfizer vaccine administration. On 7/4, ECG noted ST elevation with multiple leads with concern for acute pericarditis. Provider noted "likely viral, related to recent URI which may have been COVID". VS normal, and chest x-ray normal. D-dimer negative (<100), cardiac panel/troponin normal (Troponin < 0.05). Patient prescribed ibuprofen 600mg TID and colchicine 0.6mg daily x 14 days (# 551151809). Cardiology referral pending EKG formal read. Patient returned to urgent care on 7/7 for follow up with resolution of symptoms. EKG still noted ST elevation in multiple leads but had improved from prior. Repeat labs deferred (as patient self pay). Patient placed on 3 week taper for ibuprofen and instructed to continue colchicine until completed (2 weeks). Provider noted while standard 3 month colchicine course typical for acute pericarditis, normal labs and mild symptoms supported discontinuing med early.
DIZZINESS; TIGHTNESS OF FACE; UNCOMFORTABLE FEELING; SEVERE MIGRAINE; DEHYDRATION; COLD CHILLS; WEAKNESS; DO NOT FEEL 100% OK; HEADACHE; NAUSEA; FEVER; CANNOT STAND UP; This spontaneous report received from a patient concerned a 38 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies.The patient received covid-19 vaccine (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 14-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced cannot stand up. Laboratory data included: CT scan (NR: not provided) NORMAL. On 14-APR-2021, the subject experienced dizziness. On 14-APR-2021, the subject experienced tightness of face. On 14-APR-2021, the subject experienced uncomfortable feeling. On 14-APR-2021, the subject experienced severe migraine. On 14-APR-2021, the subject experienced dehydration. On 14-APR-2021, the subject experienced cold chills. On 14-APR-2021, the subject experienced weakness. On 14-APR-2021, the subject experienced do not feel 100% ok. On 14-APR-2021, the subject experienced headache. On 14-APR-2021, the subject experienced nausea. On 14-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine  was not applicable. The patient recovered from cold chills, and fever on 2021, had not recovered from dizziness, weakness, headache, tightness of face, uncomfortable feeling, do not feel 100% ok, nausea, and severe migraine, and the outcome of dehydration and cannot stand up was not reported. This report was non-serious.
Patient who was administered 2 Corresponding, Separate GARDASIL 9 Doses when Corresponding Patient was 45 Years Old; no adverse event; This spontaneous report was received from Pharmacist and refers to a 45-year-old. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient was administered with 2 Corresponding Separate hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) Doses (strength, route, dosage schedule, lot number and expiration date were not reported) when the patient was 45 Years Old (unapproved population). No adverse events.
blood in the bandage\ bandage was soaked; blurred vision; having to squint; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (blood in the bandage\ bandage was soaked), VISION BLURRED (blurred vision) and STRABISMUS (having to squint) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included PYRIDOXINE HYDROCHLORIDE (VITAMIN B6), VITAMIN C [ASCORBIC ACID], VITAMIN B12 [VITAMIN B12 NOS] and VITAMIN A [RETINOL] for an unknown indication.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jul-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (blood in the bandage\ bandage was soaked), VISION BLURRED (blurred vision) and STRABISMUS (having to squint). At the time of the report, VACCINATION SITE HAEMORRHAGE (blood in the bandage\ bandage was soaked) outcome was unknown and VISION BLURRED (blurred vision) and STRABISMUS (having to squint) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Arm pain for 48 hours; Some tingling down to fingertips; This is a spontaneous report from a non-contactable consumer. A 46-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number EL8982; expiration date not reported), via an unspecified route (administered on right arm) at the age of 46-years-old on 21Jan2021 01:45 PM as single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included rosuvastatin calcium (CRESTOR) and levothyroxine sodium (SYNTHROID) both taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient is not pregnant at the time of vaccination. The patient has no allergies to medications, food, or other products. The patient experienced arm pain for 48 hours and some tingling down to fingertips on 21Jan2021 05:00 PM. Therapeutic measures were taken as a result of the events included ibuprofen and Tylenol. The events were reported as non-serious. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered/resolved.  No follow-up attempts are possible. No further information is expected.
Received shot on 1/27/12. Arm very tender. 1/28/12 severe sharp, burning pain went to emergency room. Very nauseous right arm has frozen shoulder and sharp (brachial neuritis) pain ever since.
This spontaneous report was received from a pharmacist refers to a 35 year old female patient. On 23-APR-2015, the patient was vaccinated with an expired dose of GARDASIL lot # H018019, expiry date 03-APR-2015. No adverse effects were reported. Additional information has been requested.
Member woke up morning following vaccination w/ swelling, redness, pain, hot to touch extending from vaccination site to elbow. Member saw PCM on 8-11-11 & was given steroid, ABX, BENADRYL.
I received the Pfizer shot on 5/28/2021 and the second on 6/18/2021. On 8/6/2021, I went to donate platelets and today received a letter stating there was an antibody in my system known as Human Leukocyte Antigen and it was detected in my blood.  While I feel totally normal, I would like to know if this could have been the result of the vaccinations
Took a Claritin prior to flu shot. No problems until about 3pm became very congested and developed thick cough. Took Benadryl 25mg. Copious amounts of mucous draining down back of throat and in chest. Couching up thick mucous. Severe nausea noted. Next morning (10/23/09) symptoms gone.
palpitations; same side effects as it did; COVID; felt like if it was a chicken was being killed; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (palpitations), VACCINATION COMPLICATION (same side effects as it did), COVID-19 (COVID) and FEELING ABNORMAL (felt like if it was a chicken was being killed) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure abnormal.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PALPITATIONS (palpitations), VACCINATION COMPLICATION (same side effects as it did), COVID-19 (COVID) and FEELING ABNORMAL (felt like if it was a chicken was being killed). At the time of the report, PALPITATIONS (palpitations), VACCINATION COMPLICATION (same side effects as it did), COVID-19 (COVID) and FEELING ABNORMAL (felt like if it was a chicken was being killed) outcome was unknown.            Concomitant medications included unspecified blood pressure pills. No treatment information was provided.
she got vaccinated and she is having them/ suspected vaccination failure; started her 6th time having them; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a elderly female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (6 months before vaccination).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The had shingles and the doctor had told her to wait for 6 months. The patient got the shingle shot and started her shingles 6th time having them. the patient was almost 90 at the time of reporting. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Site: Redness at Injection Site-Medium, Systemic: it became red at the injection site a week after the vaccine-Medium, Additional Details: Pt said she was fine for 1 week then she npticed her arm where we did the injection is red around the injection site. she has some appointments and will take benadryl after so shes not sleepy she said. She said she didnt take anything for it. she sais she feels fine otherwise. no swelling or itching all over or difficulty breathing
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-OCT-2017, the patient was vaccinated with an expired dose of GARDASIL 9 lot # M004116, expiry date 12-OCT-2017 (dose, route of administration were not reported).
here were 6 hours that she was feeling bad; neck ache; temperature of 100.7F; severe chills for 2 hours; severe aches in her legs; severe aches on her hips; headache; nausea; This spontaneous case was reported by a physician and describes the occurrence of FEELING ABNORMAL (here were 6 hours that she was feeling bad), NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (temperature of 100.7F), CHILLS (severe chills for 2 hours) and PAIN IN EXTREMITY (severe aches in her legs) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced FEELING ABNORMAL (here were 6 hours that she was feeling bad), NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (temperature of 100.7F), CHILLS (severe chills for 2 hours), PAIN IN EXTREMITY (severe aches in her legs), ARTHRALGIA (severe aches on her hips), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FEELING ABNORMAL (here were 6 hours that she was feeling bad), NECK PAIN (neck ache), BODY TEMPERATURE INCREASED (temperature of 100.7F), CHILLS (severe chills for 2 hours), PAIN IN EXTREMITY (severe aches in her legs), ARTHRALGIA (severe aches on her hips), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient treatment medication include Tylenol.  No concomitant mediction is reported.
This spontaneous report was received from an office manager who was the wife of the physician, via a sales representative, regarding his 17 year old son with a preexisting asthma and no known drug reactions/allergies. At the same visit, on an unknown date, within the last few months, the patient received a dose of VARIVAX (Merck) (dose, route, lot # and expiry date were not provided). Other suspect therapy included a dose of MENACTRA (dose, route, lot # and expiry date were not provided). Concomitant medications were unknown. It was reported that the patient who was a track runner, began to have exacerbations in his preexisting asthma one week after receiving the dose of VARIVAX (Merck) and MENACTRA. The reporter stated that her son had to start taking unspecified relief medications and a breathing treatment for the asthma after a running episode. No laboratory diagnostic test was performed. At the time of the report, the patient had not recovered from the event. The relatedness between the event and suspect therapies were not provided. Additional information has been requested.
Barely felt anything for 48 hours other than a slightly sore arm.   As Sunday progressed, I became weak, lightheaded, very nauseous, extremely fatigued and had heart palps, shortness of breath with walking, a very sore breast (opposite side of shot) and a fever of 99.5.  Day 4 was less intense but all the symptoms remained minus the fever.  On Day 5 I went to urgent care... Sore throat, weakness, lightheaded, unable to think, tired to the core, heart palps, racing heart with little exersion, and sore breasts.  Day 6 onward still feeling off. A LOT of brain fog and fatigue. Shortness of breath when doing light movement like walking. VERy sensitive to heat.
RED, PAINFUL CIRCLE AROUND INJECTION SITE - PT ADVISED TO SEEK MEDICAL TREATMENT FROM PCP AND REPORT BACK
ITCHY ARM; SWOLLEN ARM; REDNESS IN ARM; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination on arm. No concomitant medications were reported. On an unspecified date, the subject experienced itchy arm, swollen arm, and redness in arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the itchy arm, swollen arm and redness in arm was not reported. This report was non-serious.
Developed rash and hives 4:20 PM. Fast melt Benadryl 12.5mg (children tablet)- per Dr.
Patient admitted to hospital 5/31 with worsening of baseline weakness, also found to have UTI.
administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) 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 relevant concomitant medications were reported. No treatment information was reported.
The patient is experiencing swelling (gout-like) to the large toe and adjacent toe of both feet. No other symptoms at this time.
Narrative: COVID infection following COVID vaccine series 12/29/2020, Pfizer, dose #1 01/19/2021 , Pfizer, dose #2 08/05 COVID swab, result: not detected 08/1 pt cc: chills, cough, fever, headache, loss of taste or smell, myalgias, rhinorrhea, sore throat exposure: wife and kids tested positive 09/01 COVID swab, result: detected 09/01 SARS-COV-2 LINEAGE AY .25 09/01 SARS-COV-2 CLADE 21J DELTA
Initial report received from a health care professional on 02 September 2011. A female patient in her 30's (birth date not provided) received an intramuscular left deltoid injection of FLUZONE, sanofi pasteur Inc. lot number UH453AA, on 31 August 2011. The patient's medical history was unknown. On 02 September 2011, the patient experienced warmth, and swelling at the injection site. She has a fever and general flu like symptoms. The outcome was reported as not recovered. Documents held by sender: None.
Patient, received her 2nd dose of the Pfizer vaccine at 0925 8/17/21. While patient was in observation area, she started to complain of itchiness and burning of the skin, blurry vision, itchiness of the tongue, and lightheadedness at 1015. Notified RN Supervisor.  Blood pressure was taken 111/77, HR 95, O2 98%. Patient was laid on gurney with legs elevated, ice pack applied, juice given but symptoms did not improve. Patient began to report mild tongue swelling around 1045 and refused 911 call. Patient had her own Epipen and it was administered in left upper thigh, patient was instructed to go to the ER immediately. She verbalized understanding and left the vaccine clinic with her husband to drive to the ER.
Pt is a 85 year old female who had her 1st dose of Pfizer today. Approximately 30 minutes after having the vaccination, she was sitting in her chair getting ready to leave observation area when she complained of a dry throat with no other associated symptoms.  Patient was assesed and released via the process.  Patient had symptoms decrease in severity during assesment.  Additionally a full set of vital signs were obtained.  Refer to POD 1's patient care report for further details.
In bed with parents, early am stopped breathing, legs blue, then swallow respiration, vacant stare and bubbly froth from mouth. To ER via ambulance. Limp, unresponsive for 30 min.
Patient was given the 2nd HEP A vaccine too soon. Patient mother informed to check for unusa
Myocarditis... Heart palpitations, light headedness, post vaccine while engaging in strenuous cardiovascular activities.