chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare worker refers to a female patient of an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-NOV-2016, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, intramuscularly, lot # M040004, expiry date 20-MAY-2018 (frequency reported as once, site of administration was not reported) for prophylaxis. On an unknown date in November 2016, the patient experienced injection site reaction described by the patient as hot and red. Either on 24-NOV-2016 or on 25-NOV-2016 (reported as either on Thursday or on Friday afterwards), the patient sought medical attention at an unspecified Urgent Care facility and was prescribed prednisone (manufacturer unknown) for treatment of injection site reactions. The outcome of the events was considered to be recovering/resolving as the reporter stated that the patient was getting better and did not contact the physician's office further as instructed at the Urgent Care facility if she got worse. The relatedness between the events and PNEUMOVAX 23 was not reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1611USA013894.
Vaccination failure; acute HAV infection;  This literature marketed report was received from authors of a published article, titled as above.  It refers to a 31 year old male patient with human immunodeficiency virus (HIV) infection. Information about concomitant medication and medical history was not provided. On an unknown date the patient completed a 2-dose series vaccination with hepatitis a vaccine, inactivated (manufacturer unknown) (dose, route, lot # and expiration date were not reported) for prophylaxis. After 5 years, the patient experienced acute hepatitis A virus (HAV) infection. Previous vaccination for hepatitis did not reliably provide protection among some persons with HIV infection (Vaccination failure). CD4 count before first HAV vaccine dose was 358 cells per cubic millimeter. HIV viral load before first HAV vaccine dose was 1886 copies per milliliter. CD4 count before HAV infection was 243 cells per cubic millimeter. HIV viral load before HAV infection was 28474 copies per milliliter. The patient did not received postexposure prophylaxis. The outcome of vaccination failure and hepatitis A was unknown.  A copy of the published article is attached as further documentation of the patient's experience.  This is one of the several reports received from the same literature (link reports # 1905USA003825, 1905USA005762).; Sender's Comments:  US-009507513-1905USA003825:
A LOT OF BLOOD DRIPPING DOWN THE ARM WITH SHOT; NEEDLE WENT TOO FAR IN TO THE ARM; SORE ARM; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight was 100 pounds, and height was not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-APR-2021 09:00 for prophylactic vaccination. No concomitant medications were reported.  On 08-APR-2021, the subject experienced a lot of blood dripping down the arm with shot. On 08-APR-2021, the subject experienced needle went too far in to the arm. On 08-APR-2021, the subject experienced sore arm. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from a lot of blood dripping down the arm with shot on 08-APR-2021, had not recovered from sore arm, and the outcome of needle went too far in to the arm was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment was not required as per standard procedure as case assessed as non-serious.
DOSES #1 & #2 WERE GIVEN OUTSIDE OUR FACILITY UNKNOWN TO US. DOSE #3 BOOSTER WAS ADMINISTERED AS DOSE #1 AFTER 8-31-22.
Donor reports from 04/05/2020 to 04/08/2020 spreading erythema from injection site, with concomitant warmth and tenderness.
passed out; super dizzy; falling into the walls trying to walk; blood pressure plummets; can´t eat and then drive or do much of anything. It´s very strange; This case was reported by a consumer via interactive digital media and described the occurrence of passed out in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of dizziness (1st dose received on an unknown date, and also experienced falling into the walls trying to walk, blood pressure plummets, refer case US2021AMR178275). Concurrent medical conditions included blood pressure high.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced passed out (serious criteria GSK medically significant), dizziness, walking difficulty, blood pressure decreased and feeling abnormal. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal were unknown.   It was unknown if the reporter considered the passed out, dizziness, walking difficulty, blood pressure decreased and feeling abnormal to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at the vaccination was not reported. The patient came home super dizzy, falling into the walls tried too walk. Ever since the vaccine the patient, every time the patient ate his/her blood pressure plummets and had passed out once. The patient could not eat and then drive or do much of anything and it as very strange. The patient had a weekly medical consultation to try to figure out how to counter that.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR178285:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178284:Same reporter- invalid case US-GLAXOSMITHKLINE-US2021AMR178275:Same reporter, same patient, different dose (1st)
pt recv vax vax 7FEB97 & 8FEB97 2PM pt exp swelling on of the lips & face;that noc whole arm was swollen & was seen in ER;DPh & claritin were prescribed;1MAR97 was seen by allergist who felt that the pt had devel allerg rxn;
Patient received his HIB, MMR, and flu vaccinations. She started to notice the rash on 9/23 and it was very light.  The fever broke and he is finally eating more. The rash has now spread to his face and torso. When asked about the face, Mom reports it is up around his hairline and a little bit on his cheeks. "It definitely looks like a measle rash". No new detergents etc. "Injection sites don't look worse than the rest of his body". He is still somewhat fussy.  Intervention Tried (OTC, Rx, Other): Monitoring symptoms. Pain Intensity: Denies  Fever: Afebrile.  I&O: Appetite better than it had been. Drinking fluids. Stools are a little loose. Having wet diapers. Activity/Functional Status: Acting more like himself today.
Next day had rash on neck then progress to area between scapula - lasted over a week.  Pt also had LLR started next day - 10x12 cm.  Seen in ER for tests 16Apr07.  Pt on 12Apr had "inefficient breathing"/fatigue while running 3 miles outside during allergy season.  Seen in ER, 16Apr07 - Tx with Benadryl, steroid 1 x3d, and Xopenex MDI.  Not had to use Xopenex MDI.
Pt presents to the ED with c/o abrupt onset and worsening left leg lesion that appeared after having the "monkey pox" vaccine Monday. Patient describes that they noticed the lesion yesterday, and it has gotten progressively worse since the onset after he tried to "pop" it. This patient went to a dermatologist this AM who marked the area of erythema, and he does note that he felt feverish yesterday.   Contacted CDC who described reports of virus being transferred by touch from vaccine site to other areas.
Rash like at site of injection. Dr thought it was cellulitis and gave rx for antibiotics.
No additional adverse effects reported.; A nurse states that on 08/17/2020 an improperly stored dose of PROQUAD was administered to a patient.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies were not reported.     On 17-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) injection (lot number T007396, which has been verified to be valid, expiration date reported and validated as 29-AUG-2021), as prophylaxis (product storage error) (dose, dose number, vaccination scheme, route of administration, and anatomical site of vaccination were not provided).   Additionally, it was reported that the vaccine was exposed to a temperature between 15 degrees Fahrenheit (F) to 46 degrees F: 19.2 degrees F, for a time frame of 1 hour and 46 minutes, as recorded by the digital data logger. There was no previous temperature excursion and no additional adverse effects were reported.
Nummular Eczema developed mid February.  Treated as Staph infection with E-mycin(oral).  Ketoconizale topical and oral(6weeks) for fungal infection.  Diagnosed by dermatologist as eczema 20 October 2003.  Being treated with topical steroid PRN
patient used Fluzone MDV which was exposed at 18.6 C (temp max) for 6.5 hours, was used after the excursions two times; Initial information received on 22-May-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case is related to cases 2019SA144003, 2019SA143997, 2019SA144005, 2019SA144006, 2019SA144007, 2019SA144008, same reporter.  This case involves a 17 years old male patient who received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE QD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-May-2019, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ005AE, expiry date 30-Jun-2019 via intramuscular route in the left deltoid.  It was an actual medication error due to incorrect product storage.  It was reported that patient used Fluzone MDV which was exposed at 18.6 C (temp max) for 6.5 hours, was used after the excursions two times.  It was unknown whether patient experienced any adverse reaction after the injection.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
Both eyelids were puffy with red and watery eyes, sneezing but no signs and symptoms of shortness of breath. Treatment with Epinephrine and Benadryl given.
MMR vaccination administered into left posterior arm. Mom and patient were directed to front desk to schedule 2nd vaccine.  While in line to schedule, patient stated her heart was racing and felt dizzy.  She "collapsed" onto floor.  Patient was disoriented when coming to.  When VS were obtained and stable, she was sent home.  Over next several days, Patient struggled with headaches, severe stomach pain, aches in neck, back, hips and legs.  Patient slept several hours during the day and felt "groggy".  Day 6, the patient was at work when her head started to feel "spacey," and she describes that her stomach started feeling "sick" and "squeezing."  She was able to walk to the break room, sat down, and passed out.  The patient does note that she was losing her hearing before losing consciousness.  She fell onto her right side.  The patient states that she "probably" hit her head on the ground.  The patient does not know how long she was unconscious for.    The patient went to the ER after the second incident.  All blood work, EKG and CT reported normal findings.  Vasovagal syncope was noted as likely contributing to her symptoms.
received 2nd dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received 2nd dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received 2nd dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours). On 08-Jul-2021, EXPIRED PRODUCT ADMINISTERED (received 2nd dose of the Moderna COVID-19 vaccine from a vial that had been first punctured on 07Jul2021 @ 3:42p with the syringe having been at room temperature approximately 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information, if any, was not provided by the reporter.
This spontaneous report has been received from a licensed practical  nurse referring to multiple unspecified patients. On unknown dates the patients were vaccinated with doses of (Oka/Merck) VARIVAX lot # L019124 (expiration date 27-MAY-2017), lot # L017144 (expiration date 13-MAY-2017), which were improperly stored at -14.7 C for 1 hour and 30 minutes (incorrect product storage). There was no previous temperature excursion. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Flu-like symptoms; Headache; Chills; Felt dehydrated; This is a spontaneous report from a non-contactable consumer.  A 39-years-old male patient (Age at vaccination was 39 Years) received bnt162b2 (BNT162B2, Batch/Lot Number: EL3246), via an unspecified route of administration, administered in Right Arm on 06Mar2021 16:15 as 2nd dose, single dose for COVID-19 immunisation. Medical history included anxiety from an unknown date and unknown if ongoing. Historical vaccine includes bnt162b2 (BNT162B2) 1st dose on 13Feb2021, administration site (right arm), lot number EL3246. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included adderall and lexapro taken for an unspecified indication, start and stop date were not reported. Since the vaccination, the patient has not been tested for COVID-19. The Pfizer US Drug safety unit questioned regarding confirmation of the primary reporter. Was asked that this primary reporter was the person who reported the events to you and If you were not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events, also asked would you please help to provide who reported the events to you. Whether the patient reported the events to you or not? This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. Reply was responded to mail that I was not the patient in this case the primary reporter was a patient the form indicated I could include the initials of the patient. The patient reported the events directly to me and the awareness date was Sunday, 07Mar and the report was submitted the same day. On 07Mar2021The patient experienced, flu-like symptoms, headache, chills, felt dehydrated. No treatment received for the adverse event. The outcome of all event was reported as recovering.   Follow-up(11Mar2021): This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of reporter. This report included the confirmation reporter as primary reporter was a patient and awareness date.  No follow-up attempts are needed. No further information is expected.
Swollen lymph nodes in left armpit causing disturbance in motion and sleep due to pain.  Pain/swelling began around 24 hours post vaccination and continued to worsen over next 24 hours. Will try to manage with OTC ibuprofen. Also having symptoms of nasopharyngeal irritation (dry throat/swollen lymph nodes) with drainage and occasional cough occurring in same time frame as other lymph node swelling. Also having mild headache since 12 hours post vaccine continuing through day 2 managed by OTC headache pain reliever (generic excederine).
In the evening of the same day (11/23/2021) that I received my third/booster vaccine shot, I began feeling a tightness/pain on the left side of my chest (right around where my heart is), which persisted through the night and into the next morning (11/24/2021). This was on top of the more normal/expected symptoms of chills, a light fever, and general fatigue that I experience (I had also experienced those symptoms minus the chest pain after my first and second doses). I began to feel better the day after my booster shot (11/24/2021), but still felt a little under the weather, and though the chest pain had subsided a little bit, it was still enough for me to reach out to a healthcare provider and get a basic chest exam (continued below).  The chest pain and any other symptoms completely subsided by about two days after the booster shot (11/25/2021), although I am now hyper-aware of my heartbeat and sometimes feel like it is beating out of rhythm or faster than normal.
First night. Fever body aches, sore throat ( almost like swelling and sore) , body aches, joint aches, fever 103.7, dizziness, fog, massive headache, unbalanced  .. walking like drunk, short of breath, feeling like passing out, exhaused like wiped out, Throwing up. Called emergency, clinic dr.., said expected. 4 days of this( went to GP) did blood work, seemed ok he said other than the thyroid) ) didn?t know what to do. Still had massive head aches, this feeling of off unbalance, sometimes feeling light headed like passing out. Eyes feel like im trying to focus to see, joint ache. Weakness and fatigue in muscles. Shortness of breath, .. went to emergency room too baffled.. said i need time.. its now 24 days!!! No one seems to be able to help. Why is this happening? What do I do??  Suggestions?
After administration of 1st MMR, pt developed tender, red area at administration site (approx 3cm diameter) on right upper thigh. This was during the 20 minutes we keep pt for observation. Pt given 100 mg Motrin and then an ice bag to leg intermittently for 20 minutes.
Sudden multiple occurrences of ocular and retinal migraines - visual aura, have had 6 episodes since the first vaccine (2 after the first dose) and already 4 after the 2nd dose. I haven't had ocular migraines since 2010 associated with mold exposure and when I moved, they went away. Now, suddenly, with no other changes except for receiving the vaccine, I am getting them more than 1x/week.
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 45 years old male patient who experienced experienced pain in the affected arm with limited range of motion, tender and sore, while he received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On 20-Oct-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT6258MA and expiry date: 30-Jun-2019) via intramuscular route in the left arm. On an unspecified date, the patient developed a non-serious experienced pain in the affected arm with limited range of motion (injection site pain and mobility decreased)administration of INFLUENZA QUADRIVAL A-B VACCINE  On an unspecified date, the patient developed a non-serious he was tender and sore (tenderness) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Patient was visited to the emergency room on 02-Nov-2018. Other relevant tests included No Lab data was reported. Final diagnosis was he was tender and sore and experienced pain in the affected arm with limited range of motion. The patient was treated with 60 mg PREDNISONE (PREDNISONE) and 1 week taper starting on 02-Nov-2018. The patient outcome is reported as Unknown (reported as limited range of motion that is progressively getting worse) for experienced pain in the affected arm with limited range of motion and as Unknown for he was tender and sore. Documents held by the sender: none.
Radiating very red painful rash. Began at the hips, went down legs, then arms, torso and face. Hands and feet. Left large bruises. Rash diminished to small spots with prednisone/benadryl. Have photos.
This spontaneous report as received from an other health professional refers to a patient of an unknown age. On an unknown date in 2012, the patient was vaccinated with GARDASIL for prophylaxis. Other suspect therapies included GARDASIL 9 administered on 13-APR-2017. On 13-APR-2017, the patient experienced interchange of vaccine products, inappropriate schedule of drug administration and wrong drug administered. No adverse effect was reported.
Arm is still sore (from first covid vaccine dose); first covid vaccine dose caused a bleed to the left arm; This is a spontaneous report based on the information received by Pfizer from Sanofi (Mfr. Report#: 2021SA156335). A contactable consumer (patient) reported for a 27-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date in Apr2021 (at the age of 27-year-old) as dose 1, single for COVID-19 vaccination; efmoroctocog alfa (ELOCTATE), via an unspecified route of administration from an unspecified date to an unspecified date, at 4536 iU (intravascular route) and intravenous from an unspecified date to an unspecified date, at 4500 iU (4500 U, IV NOS) for an unspecified indication in the context of COVID 19 crisis. The patient medical history, medical treatments, concomitant medications and family history were not provided. On 29Apr2021 after unknown latency, patient's first covid vaccine dose caused a bleed to the left arm (medically significant) for which patient used 1 dose after calling the hospital, continued from chief complaint on next morning around 5AM. Patient stated the arm was still sore (from first covid vaccine dose) on 30Apr2021 (latency unknown). The action taken in response to the event(s) for efmoroctocog alfa was unknown. The clinical outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.