chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE reported; Caller reports that a patient was scheduled to receive a dose of RECOMBIVAX HB but was inadvertently administered a dose of VAQTA instead on 15-JUL-2022; This spontaneous report has been received from a registered nurse concerning to a patient of unknown age and gender.      The patient's concurrent conditions, medical history, drug/allergy reactions, and concomitant therapies, were not reported.  The nurse stated that on 15-JUL-2022, the patient was scheduled to receive a dose of hepatitis B vaccine (recombinant) (RECOMBIVAX HB) (strength, dose/route/frequency of administration, lot number, and expiration date not reported) for prophylaxis but was inadvertently administered a dose of hepatitis A vaccine, inactivated (VAQTA) (wrong product administered) at a dose of 0.5 mL (strength, route/frequency of administration not reported) (lot number U012007 with expiration date on 18-JAN-2023) for prophylaxis.  The nurse denied that this was related to a product confusion and stated that the nurse simply grabbed the wrong vaccine to administer. No additional adverse events (AE) were reported (not adverse event).
Loss of taste; Tasted very salty; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the arm left on 24Mar2021 at 12:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation. Medical history included high cholesterol and gout (Taking tablets) both are under control. Concomitant medications included allopurinol (MANUFACTURER UNKNOWN) and atorvastatin (MANUFACTURER UNKNOWN); Both from unknown date for unknown indication. The patient had no known allergies to medications, food or other products. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6198) via an unspecified route of administration in the arm left on 03Mar2021 at 18:30 (at the age of 60-year-old) as a single dose for COVID-19 immunisation.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021 the patient experienced loss of taste. Everything was bland (no flavor), although some foods taste very salty back to normal the day after. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the event loss of taste and taste very salty was recovered on 26Mar2021.  No follow-up attempts are needed. No further information is expected.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE  ACUTE HYPOXEMIC RESPIRATORY FAILURE PULMONARY EMBOLISM, UNSPECIFIED. 9/26/2021  -  RECURRENCE OF SAME SYMPTOMS
Client verbalized feeling anxious after receiving the vaccine.  Client was evaluated by Fire Rescue Paramedics onsite and cleared to go home.  Patient wanted to be transported to the hospital for further evaluation.  Client was transported to Hospital at 10:am.
Moderate to severe left calf pain that started the night of my vaccine. I went and got an ultrasound to r/o dot which was negative but I am worried because my calf pain has continued. I?ve also had that leg have the pins and needles sensation multiple times and I keep getting muscle cramping. I do not have any injuries to that leg. I?m very afraid to get the second dose.
Swelling of lips, tongue and throat.  Numbness of her mouth and cheeks.
pt presented to hospital with "cold sx" and poor oral intake; positive test for COVID: hypoxic, metabolic encephalopathy; given O2 supplementation; dexamethasone, remdesivir, ABX; despite treatments, pt continued to deteriorate with worsening leukocytosis and severe anemia; DNI/DNR; comfort care measures only in the end and pt died in the hosptial
First my left ankle started to hurt then it started to swell then 4 days later my right ankle started to swell then both feet Were painful and swollen.  Then  I developed red lumps on mu shins  and calf?s. I had an x ray and it showed swollen lymph nodes they then did ct scan that showed nodules on lungs.   and my lymphocytes where at 66.7 they then had to do  bx on my lymph nodes lungs  and bronchus and trachea just today 1/14/22 I am now diagnosed with sarcadosis. Before the vaccine I was a healthy runner and  athlete
sore arm; This is a spontaneous report from a contactable pharmacist reporting for herself. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced a sore arm for about 2 hours after receiving the first dose of COVID-19 vaccine on 02Jan2021. The outcome of the event was unknown.  Information of lot/batch number has been requested.
p/vax pt exp induration, redness & a raised area @ the inj site & area was warm & tender to touch;
Kidney pain; Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (Kidney pain) and PAIN IN EXTREMITY (Arm pain) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Sickness (Patient was severely sick in January and got ride herself) in January 2021.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RENAL PAIN (Kidney pain) and PAIN IN EXTREMITY (Arm pain). At the time of the report, RENAL PAIN (Kidney pain) and PAIN IN EXTREMITY (Arm pain) 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.   No concomitant medications  were provided. No Treatment information was  provided. Reporter confirmed that patient never had COVID-19 also never tested positive for antibodies.   This case was linked to MOD-2021-332607 (Patient Link).
Broke out with shingles two days after injection; Severe headache; Joints aching; Chills; Nausea; Arm pain; Injection site pain; Redness at injection site; Fever; Diarrhea; Feeling unwell; Tiredness; Muscle pain; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 65-year-old male patient received third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3590) via an unspecified route of administration in the left arm on 14Oct2021 at 10:15 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included apixaban (ELIQUIS), omeprazole (MANUFACTURER UNKNOWN), pravastatin (MANUFACTURER UNKNOWN) and tamsulosin (MANUFACTURER UNKNOWN); all for unknown indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL8922) via an unspecified route of administration in the left arm on 29Jan2021 (at the age of 65-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9276) via an unspecified route of administration in the left arm on 19Feb2021 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. On 15Oct2021 at 18:00, the patient experienced severe headache, joints aching, chills, nausea, arm pain, injection site pain, redness at injection site, fever, diarrhea, feeling unwell, tiredness, muscle pain and on 16Oct2021, two days after injection, the patient broke out with shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the event broke out with shingles two days after injection and included treatment with valacyclovir (VALTREX). Since the vaccination, the patient had been tested for COVID-19. On 29Oct2021, the patient underwent COVID-19 virus test via nasal swab and the result was negative. The clinical outcome of the events severe headache, joints aching, chills, nausea, arm pain, injection site pain, redness at injection site, fever, diarrhea, feeling unwell, tiredness, muscle pain and broke out with shingles two days after injection was resolving at the time of this report.
SWOLLEN EYES; HIVES; BURNING SENSATION IN THE ARM; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, cat allergy, and bee sting allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On 05-APR-2021, the subject experienced burning sensation in the arm. On 06-APR-2021, the subject experienced swollen eyes. On 06-APR-2021, the subject experienced hives.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from hives, swollen eyes, and burning sensation in the arm. This report was non-serious.
This spontaneous report as received from a consumer refers to a her daughter, a female patient of unknown age. On an unknown date the patient was vaccinated GARDASIL, dose and route were not reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown the reporter thinks her daughter is having a reaction to GARDASIL. No treatment information was reported. The outcome of thinks her daughter is having a reaction is unknown. The relatedness for thinks her daughter is having a reaction was not reported for GARDASIL. Additional information is not expected.
Patient was given PNEUMOVAX and FLUZONE HD at the same time and in the same arm in close proximity (less than 1 inch apart). Patient has soreness of the right arm where the medication was given. She went to the emergency room and she was given a rx for Ibuprofen.
RASH THAT LOOKS LIKE RED DOTS AT THE SITE OF INJECTION, NO BLISTERS, NO EDEMA.
MODERNA COVID-19 VACCINE EUA Received vaccine at 1:12pm. At 2:05pm felt lightheaded and sweaty. Temperature was checked several times on forehead, upper arm, right palm, and ranged from 94.4F to 96.6F; BP187/117; HR 55; PO 95-97. Headache, tightness in chest, lightheaded, sweat, felt overheated, and heart palpitations. Evaluated by several nurse faculty and MD, monitored for 60 minutes. At 3:30pm,  BP was 173/112, HR 67, Temp 98.1; PO 97. Was released by staff to return home. At 5:10PM, temp was 97.8, BP unknown. Previous symptoms no longer present. General soreness in upper right arm.
Patient was hospitalized on 1/24/2021 with COVID-19. He reports symptoms started on 1/18/21, 7 days prior to admission, and 11 days after receiving his first dose of the Pfizer/BioNTech COVID19 Vaccine. During this time he experienced shortness of breath and non-radiating, pressure-like chest pain, the latter prompting him to go to the Emergency Department. Upon admission his oxygen saturation was 90% and was put on 2 L nasal cannula with oxygen saturation, increasing oxygen saturation to 95%. On 1/26/2021 oxygen was increased to 4 L nasal cannula with oxygen saturation at 94%. On 1/27/21 oxygen requirements improved and pt is now on 2 L nasal cannula with oxygen saturation at 99%.
Red rash and swelling at injection site. Rash extended down patients arm to mid forearm. Rash also extend upwards onto the left side and front  of the face.
pain; itch; bumps on the back; chills; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MASS (bumps on the back), PAIN (pain), PRURITUS (itch), CHILLS (chills) and MYALGIA (body aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-May-2021, the patient experienced CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever). On 03-May-2021, the patient experienced MASS (bumps on the back) and PRURITUS (itch). On an unknown date, the patient experienced PAIN (pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 03-May-2021, CHILLS (chills), MYALGIA (body aches) and PYREXIA (fever) had resolved. At the time of the report, MASS (bumps on the back), PAIN (pain) and PRURITUS (itch) outcome was unknown.            No concomitant product use was reported
urinary tract infection; the vaccine stung when it went in and the site was tender; shingles / shingles rash; the vaccine stung when it went in and the site was tender; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in the left arm on 23Feb2021 at 12:00 (Batch/Lot number: EL9269) as 1ST DOSE, SINGLE for COVID-19 immunization. Medical history included pain, eye condition, Prediabetes, immunosuppressive - she is also taking immunosuppressive medication that is lowering her immunity: Mycophenolate since Dec2020. She also had a pain in her lower back on about 19Feb2021. Concomitant medications included prednisone (PREDNISONE) taken for eye condition from Aug2020 and ongoing-her immune system is attacking her retina, started a high dose in Aug2020 and has titrated down since then; mycophenolate mofetil (MYCOPHENOLATE) taken for eye condition and immunosuppressive from Dec2020 and ongoing; metformin (METFORMIN) taken for Prediabetes from an unspecified start date and ongoing and been on it about 6 years; and gabapentin for pain. The patient developed shingles on 03Mar2021. She is on prednisone, mycophenalate, and pain medications. She wants to know if it's ok to get the second dose since she is immunosuppressed. The patient was calling about the Covid-19 vaccine and reported that she got the first dose on 23Feb2021 and about 3.5 days later she got a shingles rash. She wanted to know if it is ok to get the second vaccine or if that is contraindicated. The patient said that she is also taking immunosuppressive medication that is lowering her immunity (Mycophenolate) and she has been on it since Dec2020. The patient said that she was on another immunosuppressive medication before this for a month that she had a reaction to. She said that was when she was switched to Mycophenolate. The doctor had her on an antiviral for shingles rash that she started on 03Mar2021. She clarified that it is Valacyclovir HCL 1 pill 3 times a day for 7 days, and she was given pain medicine called Gabapentin 100mg 1 pill 3 times a day by mouth. Her next dose of the Covid-19 Vaccine was scheduled for 16Mar2021. The patient said that the vaccine stung when it went in and the site was tender. Her arm is still a little tender at the site. She said that it seems since she has the shingles stuff it is a little tender. The patient said that she had a pain in her lower back on about 19Feb2021. She went to the doctor on 01Mar2020 because it was not going away. The doctor thought it was a urinary tract infection and gave her an antibiotic that she stopped on 04Mar2021 after being diagnosed with the shingles. The event shingles / shingles rash required a visit to Physician Office; she did a telehealth visit with her doctor for her shingles rash. The event shingles / shingles rash had not resolved while the outcome of the rest of the events was unknown.
This spontaneous report was received from medical assistant and referred to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported. On 17-FEB-2023, the patient was administered a dose of VARIVAX (valid lot #W021740 with the expiration date: 10-JUL-2024) for prophylaxis (strength, dose, route of administration, and anatomical location were not provided). This vaccine was involved in a temperature excursion, at a temperature of 14.7F for a time frame of 1 hour and 3 minutes. There was no previous temperature excursion. No additional clarifying statements or adverse event (AE) details were provided (No adverse event). This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-2303USA008911: US-009507513-2303USA008836: US-009507513-2303USA008836: US-009507513-2303USA008981.
patient was given 2 of these vaccine. she was given first dose on 9/29/22 and then another dose on 10/20/22. arm was sore and patient had chills.
Information has been received from a healthcare professional concerning an unknown number of unspecified patients. In November 2015, the patients were vaccinated with improperly stored ROTATEQ (lot # K024700, expiry date 30-SEP-2016) and, also in November 2015, with another lot of the vaccine (reported as L022446, expiry date: 14-FEB-2017). Route and dose for both lots was not reported. It was reported that the vaccination took place "since 09-NOV-2015", but since another vaccine was also involved, the exact date of administration is unknown. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
traces of protein in urine; This spontaneous case was reported by a consumer and describes the occurrence of PROTEINURIA (traces of protein in urine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 066D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PROTEINURIA (traces of protein in urine). At the time of the report, PROTEINURIA (traces of protein in urine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Oct-2021, Urine analysis: abnormal (abnormal) traces of protein in urine.         Concomitant medication was not reported. Treatment information was not reported. Patient reports that she is healthy,does not have kidney problems and traces of protein  has never shown before in her urine.   Reporter did not allow further contact
Severe bloody noses around 28 hours after first dose; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the right  arm on 10Apr2021 at 12:45 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit hyperactivity disorder (ADHD), bipolar II disorder, depression, polycystic ovarian syndrome(PCOS), gastroesophageal reflux disease (GERD).The patient had known allergy to insect bite (bee venom). The patient had other medications received in two weeks which had not enough room to list. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Apr2021 at 15:45 ,the patient experienced severe bloody noses around 28 hours after first dose. The patient did not have any history of prior bloody noses. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event severe bloody noses around 28 hours after first dose was resolving at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Developed a hive on right knee within hours of vaccine. next morning hives on face an by the afternoon, hives on arms. No respiratory distress, abdominal discomfort, no fever. Stayed happy and fed well. PE-ved AVERS and small hives. No wheal and flare.
Head ache within 10 minutes of shot, neck pain within an hour after shot. Headache continued into the next day and lights made it worse. Injection site felt bruised, neck continued to fell stiff the next day, sinus pressure and runny nose began the next day, appetite lessend and felt nauseous after eating, tachycardia several times, ear pain, menstration abnomality- cycle lasted/bled for 19 days.
Within 3 hours, my jaw was stiff and numb, including my tongue.  I could hardly chew my dinner meal or clean out food around my teeth with my tongue.  The jaw stiffness last 3 days until it was over, but the numbness extended 15 days before it was mostly gone.  In the beginning, the inside of my cheeks felt like a short-napped corduroy fabric.  The feeling has returned slowly, improving day by day with the texture of my skin inside my mouth feeling more normal.
My Crohns seems to be worse, with more digestive issues since the vaccination.; My Crohns seems to be worse, with more digestive issues since the vaccination.; This is a spontaneous report from a contactable consumer. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 15Jan2021 17:45 (Batch/Lot Number: ek9231), and dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 (Batch/Lot Number: en5318) as a single dose for covid-19 immunization (given at the age of 49 years). The patient's medical history included crohns disease, damaged kidneys, and allergies to almonds, watermelon, pineapple, avocado, peanuts. Concomitant medications included ustekinumab (STELARA); ciprofloxacin; famotidine (PEPCID [FAMOTIDINE]); omeprazole (OMEPRAZOLE); and montelukast (MONTELUKAST). The patient previously took morphine and experienced drug allergies. On 15Feb2021, the patient experienced his crohns seems to be worse, with more digestive issues since the vaccination. Patient was not treated for the events. The patient underwent lab tests and procedures which included negative covid-19 test on (RNA, Qualitative RT-PCR TF) 09Feb2021, 11Mar2021 and on (RNA, Qualitative RT-PCR TF) 06Apr2021. The outcome of the events was unknown.
This spontaneous report was received from the patient's parent via Twitter refers a 21 year old female patient. On an unknown date the patient was vaccinated with GARDASIL (strength, dose and route of administration were not reported). There was no concomitant medication reported. The reporter stated that the patient was disabled (she was one-less) by GARDASIL. The outcome of the event was unknown. The reporter considered the event to be related to GARDASIL. Additional information has been requested.