chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came to pharmacy to inform us that she experienced confusion about an hour after being vaccinated and lost her way on her way back home.  She also had an episode of sleepwalking or walking out of home at night along with hallucination the same night post. She still experience headaches, off and on along with ongoing nausea from her flu shot.  Patient is in the process of seeing her medical doctor for more guidance.
hematoma; immediate fatigue; light headache; nausea; lesser of a sore arm; This is a spontaneous report from a contactable consumer (patient). A 25-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 11Jun2021 09:00 (at the age of 25-year-old) as dose 2, single for covid-19 immunization. Medical history included known allergies to latex. It was unknown if patient had covid prior vaccination. Concomitant medication(s) included paracetamol (TYLENOL); ibuprofen, both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 21May2021 01:15 PM (at the age of 25-year-old) for covid-19 immunization and experienced sore arm that gradually worsened, immediate fatigue, fever, severe headache after 24 hours, and nausea. On 11Jun2021, the patient experienced hematoma within 4 hours, lesser of a sore arm, immediate fatigue, a light headache, and nausea. The patient did not receive any treatment for the events. The patient had not tested covid post vaccination. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
VERTIGO, WHEN STANDING OR MOVING, FEELING OF WEAKNESS AND UNSTEADY. LASTED UNTIL LATE AFTERNOON OF THE SAME DAY.
Patient reported today (2/16) that he had "red, hot" face with temperature followed by nausea with vomiting beginning about 3:00 am the morning after injection and lasting approximately 12 hours, then resolved.
Information has been received on 11-JUL-2017 from a medical assistant regarding an unspecified number of unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. The medical assistant reported that on unspecified dates an unspecified number of patients were administered improperly stored doses of GARDASIL 9 (lot # M042853 expiration 17-JUL-2019) unknown route for prophylaxis and ROTATEQ (lot # N045546 expiration 12-JUN-2018) oral for prophylaxis. The medical assistant reported that on unspecified dates an unspecified number of patients were administered improperly stored doses of M-M-R II (lot # M042846 expiration 21-OCT-2018) subcutaneous for prophylaxis which was reconstituted with properly stored sterile diluent (lot # and expiration unknown). No adverse effects were reported. The vaccines were stored at the temperature range of 47 degrees Fahrenheit and 77 degrees Fahrenheit for the time frame of 15 minutes. There were no previous temperature excursions. The call was made due to a data logger. Additional information has been requested.
Pt has diffuse rash to the bilateral upper and lower extremities in addition to the face. Sparing the trunk. Pruritic, painful in nature, many had a vesicle in the center.
Fever, unsteadiness of feet, increase falls. total assist with care resident normally is able to complete all ADL's on own.
Get Shingles, even though had the vaccine/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Get Shingles, even though had the vaccine/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient still got shingles, even though he/she had the shingles vaccine.  The reporter stated that he/she was glad that he/she was not in a risk group or had any side effects to the vaccine.  The reporter further stated that it was very annoying to still got shingles every now (at the time of reporting) and then. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available. The case had been linked to US2023AMR051223, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR051223:Same reporter
Started with itching. Immunization given in left deltoid.  Left deltoid swollen and hot to touch.  Lips itching, wheezing.  Chest and neck rash.
Patient presented to ED after abnormal labs from PCP. Platelets in ED = 2. Hgb 8.5. Possible rectal bleed at home, some bruising. Admitted and treated with dexamethasone 40mg PO daily, IVIG, platelet transfusions. EGD showed gastritis. Per hematologist "severe thrombocytopenia of acute on set after recent COVID-19 vaccination, which is likely due to ITP which has been previously reported to be associated with vaccination"
This case was reported by the mother of a consumer and described the occurrence of fever in a 6-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline). Previous vaccination included an unspecified brand (other than PEDIARIX) of DTAP/POLIO/Hib/ Hepatitis B (PENTAOL ?) given at 4 months of age. Concurrent vaccination included HIB PRPT (manufacturer unspecified), live attenuated human rotavirus vaccine (manufacturer unspecified) and unspecified vaccine (PNUCN 13?, manufacturer unknown) all given on 5 July 2011. A concurrent medication of RENATABEAN (?) was reported. On 5 July 2011 the subject received 3rd dose of PEDIARIX (unknown). On 5 July 2011, 12 hours after vaccination with PEDIARIX, the subject experienced fever to 101 degrees, vomiting, loss of appetite and crying. The events were resolved 48 hours after onset. No additional information was provided.
A 1ST DOSE COVID19 VACCINE (PFIZER) WAS ADMINISTERED TO PATIENT ON 4/17/21 AT 11:05AM. AFTER RECEIVING THE VACCINE, HE WAS TOLD TO SIT IN OUR LOBBY FOR 15 MIN AFTER 5 MIN. HE DEVELOPED A HEADACHE AND BLURRY VISION THEN PASSED OUT ONTO THE FLOOR. EMS ARRIVED 10 MINUTES LATER TO TREAT HIM. THEY CLEARED HIM FOR ANYTHING LIFETHREATENING.
This case is part of a cluster of 3 cases and is linked with AER# 2013-04277, 2013-04530, (adverse events after DAPTACEL lot number C4310BA reported by the same HCP). Initial report received from a healthcare professional on 22 March 2013 and follow-up information received on 01 April 2013. A 12-month-old male patient, whose medical history and concomitant medications were not reported, had received a dose of DAPTACEL (lot number: C4310BA, route of administration was not reported) in right thigh and PREVNAR 13 (lot number: F45137, route of administration was not reported) in left leg on 01 February 2013. On same day i.e on 01 February 2013, the patient experienced a "horrible local reaction" (redness and swelling at injection site) and inflammation in both legs. Laboratory investigations were not reported. Corrective treatments were not prescribed. At the time of this report, the patient outcome was not reported. Documents held by sender: None. Follow up information received from a healthcare professional on 25 April 2013. The patient was 18-month-old. The patient had no illness at time of vaccination. The patient had one brother and both were twins and both had the reactions. The patient mother reported that the localized erythema around shots as well as swelling of legs (worse in one child but present in both) and had no fever, rash and nausea or vomiting. The patient mother did not seek, at time the symptoms resolved within 24 hours and patient was not evaluated of time reaction. The patient was recovered on an unspecified date.
The vaccine led to swelling and redness of the arm, a rash on the left side of the neck, arm, shoulder, and torso.  Pain on the left arm continued for months, as well as decreased range of motion, shoulder pain, and muscle weakness up to this day.
Redness and rash at injection site right deltoid area; unknown which vaccine administered in right arm.
Per medical record, patient had a positive COVID test on 1/11/22 while patient was in nursing home. Patient was nauseated; placed on ABX and Zofran; patient passed away in the nursing home.
Dose administered at a pharmacy to an 11 year old. Birthdate was submitted incorrectly.
Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2019SA022342.(same reporter). This case involves a 70 years old male patient who got FLUZONE QUADRIVALENT instead of FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given. On 14-Sep-2018, the patient received 0.5 ml single first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot 25228 expiry date: 01-May-2019 via intramuscular route in the right deltoid. On an unknown date, patient presented with flu post vaccination with INFLUENZA QUADRIVAL A-B VACCINE. It was also a case of actual medication error due to wrong vaccine administered. No lab test was reported. As corrective treatment, patient received Tamiflu. Outcome of the event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Hospitalization for hyponatremia, abdominal pain, hypokalemia, and COVID-19 infection on dates 8/14/2023-8/28/2023. Treated with vitamin C 1,000 mg PO daily, vitamin D 25 mcg PO daily, zinc 50 mg PO daily.
excessive itching in her vagina; Urinating more than normal; This spontaneous case was reported by a consumer and describes the occurrence of VULVOVAGINAL PRURITUS (excessive itching in her vagina) and POLLAKIURIA (Urinating more than normal) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, the patient experienced VULVOVAGINAL PRURITUS (excessive itching in her vagina) and POLLAKIURIA (Urinating more than normal). On 07-Feb-2021, VULVOVAGINAL PRURITUS (excessive itching in her vagina) and POLLAKIURIA (Urinating more than normal) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment and concomitant medications were not provided by reporter.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK STERILE DILUENT). No adverse effect was reported. No product quality complaint was involved.  This is one of the several reports from the same source.; Sender's Comments:  US-009507513-1801USA005992:
No adverse events occurred due to error*- patient was inadvertently given flu vaccine instead of COVID booster. Patient aware. Check on with no adverse side effects from error. Med sheet colors changed to distinguish and avoid future errors.
she has experienced issues with restriction of motion in her left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for COVID-19 immunization, reaction(s): "issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for COVID-19 immunization, reaction(s): "issues with restriction of motion in her left arm"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE, Lot number: unknown), for COVID-19 immunization, reaction(s): "issues with restriction of motion in her left arm". The following information was reported: JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "she has experienced issues with restriction of motion in her left arm".  Additional information: Caller referred to an inquiry asking if any clinical trials supported the bivalent COVID-19 booster administration in buttocks or other muscles in the gluteus area. The caller referred that with the previous COVID-19 vaccines and boosters, which had all been Pfizer's, she had experienced issues with restriction of motion in her left arm.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) :PFIZER INC-202201368440 Same patient, drug, event, different dose;
PATIENT HAD NOT HAD ANYTHING TO EAT THAT MORNING AND WAS NERVOUS ABOUT THE SHOTS. HE RECEIVED HIS SHOTS AROUND 11:15 AM THAT MORNING OF TDAP, MCV4, VARICELLA AND A TB TEST. RIGHT AFTER RECEIVING HIS SHOTS HE GOT UP FROM THE CHAIR AND FOLLOWED HIS MOM TO THE CASHIER WINDOW AND FAINTED AND FELL BACK ON TO THE FLOOR HITTING THE BACK OF HIS HEAD. THERE WAS NO INJURY TO HIS HEAD. HE CAME TO RIGHT AWAY AND WE HAD HIM LAY THERE FOR ABOUT 5 MINUTES TIL HE FELT BETTER. THEN WE WALKED HIM BACK TO THE ROOM WHERE WE HAD HIM WAIT FOR ABOUT 20 MINUTES. HE SAID HE FELT FINE AND WAS READY TO LEAVE. DURING THE WAIT WE FED HIM SOME CRACKERS AND DR. PEPPER. PATIENT WAS BROUGHT BACK FOR A TB READING ON MONDAY 6/9/08 TWO DAYS LATER, (THE INCIDENT HAPPENED ON 6/07/08 AND HAS HAD NO PROBLEMS.
(L) dt area where she got ADACEL is tight, hot, red, swollen (about size 4-6" wide and red from elbow to shoulder). Hasn't taken any otc. meds or used compresses. I/co try BENADRYL and cool compresses, will come in.
Developed a rash starting on the abdomen. Progressively got worse spreading up my neck and face then lower legs and arms. Minimal rash on the back and thighs.  Mild to moderate itch. Eyes feel dry and slight itch inside of nose. Prescribed Zyrtec am, benadryl pm, Hydrocortisone 2.5% cream to face, clobetasol .05 to body on 4/22 Showing improvement to rash on face and abdomen.
Severe anaphylaxis allergic reaction; Passed out on the ground; A spontaneous report was received from a consumer concerning a 22-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out on the ground and had a severe anaphylaxis allergic reaction.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.     On an unknown date, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.    About 10 minutes after receiving the second dose of the Moderna vaccine, the patient passed out on the ground having a severe anaphylaxis allergic reaction.  Treatment for the event included two doses of epinephrine IM in addition to diphenhydramine, ondansetron, and steroids to prevent a rebound reaction. 911 was called and after epinephrine and diphenhydramine were administered, the patient was immediately transported to the hospital where she stayed for 6 more hours for observation, fluids, and further medications.    Action taken with mRNA-1273 in response to the events was not applicable.  The events, passed out on the ground and severe anaphylaxis allergic reaction, were considered resolved; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Anaphylactic reaction is a listed event in CCDS.
Arm pain; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's parent. The age at vaccination was not reported. The patient had got his first shot along with his parent and had arm pain for several days. The reporter stated that he/she hated to go back for the second dose as that year it was 2 shots instead of one. This case has been linked with US2021AMR203606 (parent's case), reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203606:same reporter, same suspect, different patient (parent's case)
Unilateral vocal fold paralysis (left), anxiety, panic attacks, throat closure and tightness, ringing in ears tinnitus,  sore throat, neck stiffness, severe rhinitis, ears plugged, runny nose,  brain fog, exhaustion, gut pain, loss of appetite, cough,
Fever, chills, N/V/D, myalgias, arthralgias for 48 hours.
Since the first booster vax, I have had consistent generalized, constant body aches and pains. Prior to the booster, I have had occasional ached and pains, but they generally resolved for awhile. This time they have remained constant, so in January 2022 I saw my PCP, who thought I might have rheumatoid arthritis. After doing lab work to rule out an inflammatory process related to R.A., the tests were negative. He thought the booster could have set off some kind of inflammatory response that didn't show up in the lab work. Since then i have seen an orthopedist who did x-rays, showing worsening OA in my lumbar spine and right knee. I just finished 12 sessions of PT without any relief. So, I really don't know if my pain is from the booster or just a part of aging I have to live with now.
Shortly after receiving the vaccine I experienced what I could only describe as what felt like being bitten by horse flies in my limbs.  This happened 5-6 over the course of a couple hours.  I then woke up with my right upper thigh completely numb on the surface.  As the day went on I then proceeded to have the same bite like sensation in my thigh even though it was numb.  I made a doctors appointment.  When I saw my doctor, she stated she had seen this sort of thing before with the vaccine, but could not guide me as to when it would resolve.  It's is now 13 days later, with no resolution.  The biting pain wakes me in the night.  I've never felt anything like this before.
Deltoid was red, warm to touch and tingly and patient awoke with nasal congestion
pt recv vax 19AUG97 & 2wk post vax pt exp sleeplessness, malaise & a low grade fever;on the weekend of 8SEP97 devel a fever of 104, cervical adenitis & stiff neck;tx w/amoxicillin for sx;
This spontaneous report as received from healthcare worker refers to an unspecified number of patients of unknown age. On 25-FEB-2015 the patients was vaccinated with RECOMBIVAX HB (dose, lot number, was unknown), intramuscular, which was improperly stored. No adverse event was reported. The outcome of the event was unknown. This is one of the several reports from the same reporter. No additional information was reported. Additional information has been requested.
pt recvd vax & c/o pain in the rt arm when dose 3 was administered; 15 mins later c/o pain in middle upper back where pain localized; no tx given; pt did not inform reporter/physician of any additional and/or inc sx;
having several reactions; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (having several reactions) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (having several reactions). At the time of the report, VACCINATION COMPLICATION (having several reactions) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.
Headache, soreness and muscle aches (full body), fever and chills, painful red/raised rash at injection site
Felt flu; aching; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2, administration date: 18Jan2021, for COVID-19 Immunization. The following information was reported: INFLUENZA (non-serious) with onset Feb2021, outcome "unknown", described as "Felt flu"; PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "aching"; HEADACHE (non-serious) with onset Feb2021, outcome "unknown", described as "headache". It was unknown if therapeutic measures were taken as a result of influenza, pain, headache.  Additional information: Caller (Name) had her 1st dose (28Jan2021) and 2nd dose (18Feb2021) she didn't have a sticker for her 2nd dose and wanted to get answers for that. Felt flu symptoms after 2nd dose (nothing major) aching and headache.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Miscarriage on 10/31/18. Original estimated date of delivery 6/16/19.
10min p/vax  pt devel spotty vision, lightheadedness, SOB, heaviness in chest, shakiness & nausea, BP 56/67, P65, R12 no wheezing;T96.6;solumedrol;230PM felt significantly better remainder of day cont w/sl epigastric discomfort & lethargy