chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a nurse practitioner concerning a her daughter who was vaccinated IM with a 0.5 ml dose of GARDASIL and a short time after being vaccinated developed cardiac arrhythmia. Unknown medical attention was sought. Patient outcome was unknown. No product quality complaint was involved. No further information is available.
Fever, body chills for 4 - 5 hours, low grade fever next morning Took 2 Tylenol
(Left) arm feels heavy and hard to move along with severe dizziness, had to be picked up by mother at school.
administered expired product to patients; Initial information received on 29-May-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case is linked to cases 2019SA150849, 2019SA150850, 2019SA150840, 2019SA150851 and 2019SA150853 (same reporter).  This case involves a 4 years old female patient who received fifth dose of vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (formulation: unknown, lot: C52028A, expiry date: 17-May-2019) via unknown route in unknown administration site on 21-May-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR); POLIO VACCINE INACT 3V (VERO) (IPOL POLIO VACCINE); and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was a case of actual medication error due to Expired vaccine used.  It was unknown if any adverse event was occurred.  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.  Documents held by sender: none.
Patient had a seizure about an hour after receiving these vaccines. He had another seizure 2 days later.   Patient was put on levETIRAcetam 500 mg orally twice daily (started on 5/20/2022 after 2nd seizure). Patient was taken off levETIRAcetam on 7/22/2022 due to increase in agitation, anxiety, and bad temper. He was put on Sertraline 50 mg. He is awaiting appointment with Neurology, which is scheduled for 9/9/2022.
Shortly after receiving vax, the pt developed a flaky red rash on his face and arms. Additional information received 02/07/2001 from the physician indicated that the pt developed a dry scaly rash on his scalp, face, chest and arms. A diagnosis of cradle cap or seborrhea was made. The pt recovered.
This case was reported by a physician via call center representative and described the occurrence of shingles in a 76-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a year after receiving SHINGRIX, the patient experienced shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles was recovered/resolved. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: The Shingles were relatively mild. The patient was given Valtrex within 72 hrs and the Shingles resolved completely. The patient was asking when should she receive her 2nd dose of the SHINGRIX vaccine. This call was coming through the queue and the reporter did not provide all adverse event information.
Thrombosis with thrombocytopenia syndrome after COVID-19 vaccination; This is a literature report for the Regulatory Authority.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (medically significant), outcome "unknown", described as "Thrombosis with thrombocytopenia syndrome after COVID-19 vaccination". Authors conclusion: Thrombosis with thrombocytopenia syndrome is a rare but serious adverse event associated with Ad26.COV2.S vaccination; different demographic characteristics of the 3 cases reported after mRNA-based vaccines and the much lower reporting rate suggest that these cases represent a background rate.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: As there is limited information in the case provided, the causal association between the event thrombosis with thrombocytopenia syndrome with the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER_INC-202200162796 Same article/ drug/event and different patient;US-PFIZER_INC-202200162798 Same article/ drug/event and different patient
Severe migraine and head pain.  Onset 24 hours after vaccine.  Generalized itching from top of head to toes.  Both lasting about 48 hours
administrated vaccine reconstituted with another diluent; administrated vaccine reconstituted with another diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 6-June-2022 Reporter's comment: The pharmacist reported that patient was administrated with Hiberix. The vaccine was reconstituted with another diluent. No adverse event was reported. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. No patient's identifiers provided. No LOT number and expiration date provided. No vaccination date provided. Additional Supportive Information: The patient was administrated with Hiberix. The vaccine was reconstituted with another diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
ulcerative colitis flare; their physician advised them not to take the second dose.; This is a spontaneous report from a contactable other health care professional. A 40-years-old male patient received bnt162b2 (COVID-19 VACCINE, Manufacturer Unknown, Batch/Lot number: not reported), dose 1, via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation; tofacitinib citrate (XELJANZ, Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date at 10 mg twice daily for ulcerative colitis flare. Medical history included colitis ulcerative. Reportedly, patient reports their physician recently increased their dose back to 10mg twice daily due to an ulcerative colitis flare while on 5mg twice daily. The patient's concomitant medications were not reported. Patient reports the exacerbation correlated with the timing of their first COVID19 vaccine (unknown manufacturer) so their physician advised them not to take the second dose. On an unspecified date, the patient experienced ulcerative colitis flare and their physician advised them not to take the second dose. Outcome of the events was unknown.  Follow up needed, further information has been requested.
Not feeling by herself; Very Achy; Very Tired; Extreme thirst; Extremely chilly; Very nauseous throughout the day; A spontaneous report was received from a consumer concerning a 73-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events extremely chilly, very nauseous throughout the day, very achy, very tired, not feeling by herself, extreme thirst.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 001A21A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 6 Mar 2021, the patient experienced the events  extremely chilly, very nauseous throughout the day. On 7 Mar 2021, the patient experienced the events  very achy, very tired. On 8 Mar 2021, the patient experienced the events not feeling by herself, extreme thirst. She consented for follow up with safety. She agreed on follow up with her health care provider. Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, extremely chilly, very nauseous throughout the day, very achy, very tired, not feeling by herself, extreme thirst was unknown.
Bottoms of feet started to become numb, overall weakness around 11/29/14. 11/30/14 hands started to become numb and numbness started ascending up legs. Admitted into hospital 12/1/14 unable to walk unassisted.  OBGYN and Neurologist decided to deliver baby at 38 weeks. Paralysis continued up to torso. Admitted into ICU for almost 2 weeks, Neurologist confirmed Guillain Barre Syndrome, moved to Intensive Rehab Unit on 12/15/14 - 3/20/15. Participated in physical, occupational, and speech therapy. Outpatient rehab until May 2015.
Within 24 hours following Wyeth brand flu vaccine, the patient had a local reaction approximately 2 1/2" x 1 1/2" redness on her right deltoid, warmth, and itching. Started on Zyrtec. Resolved on it's own no antibiotic needed.
8SEP92 5 minutes p/vax, bug bites on lt neck area darkened from pink to deep purple; several petechiae were seen around the area; 1-2 minutes later, petechiae were noted under eyes bilaterally & other bites on arms appeared to be darkening;
This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a physician concerning an 18 year old female who on 30-JUN-2008 was vaccinated with the first dose of GARDASIL, on her left deltoid. The patient did not have any illnesses at the time of vaccination. The physician reported that she was vaccinated around 1 PM that day, and took a nap at home, then woke up at 7 PM with a rash on her back and sides of arms that had pustules like pimples, and on her chest had flushing. The bumps were itching and she scratched them. On 01-JUL-2008, the physician saw the patient and gave her BENADRYL. The physician planned to recommend a 2nd dose of GARDASIL. The patient sought medical attention. At the time of the report, the patient had recovered. Additional information has been requested. No further information is available.
Persistent, unconsolable crying started approx 1/2 hr after immunization. Latest for approximately one week.
Patient broke out with papular rash on his arms bilaterally. He used hydrocortisone on the rash but did not help so he sought evaluation at local clinic on Monday, 7/16/18. Upon physical examination the patient had papular lesion going up the arms bilaterally and some crusting on his ears bilaterally. On Tuesday (17July2018), papular lesions increasing and looking more vesicular. Dermatology evaluation: Skin biopsy was taken and patient given AQUAPHOR, benzoyl peroxide wash, and triamcinolone to use. Speciments sent to test for vaccinia. Over time, lesions gradually improved and resolved.
Brain fog; Foggy feeling; Pressure on their head; Memory loss; Moderna Vaccine induced Benign Paroxysmal Positional Vertigo for 5 months now. It was 100% confirmed that I had crystals out of place on both ears after injection; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 21-Jan-2021. The most recent information was received on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (Brain fog), FEELING ABNORMAL (Foggy feeling), HEAD DISCOMFORT (Pressure on their head), AMNESIA (Memory loss) and VERTIGO POSITIONAL (Moderna Vaccine induced Benign Paroxysmal Positional Vertigo for 5 months now. It was 100% confirmed that I had crystals out of place on both ears after injection) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISORIENTATION (Brain fog), FEELING ABNORMAL (Foggy feeling), HEAD DISCOMFORT (Pressure on their head), AMNESIA (Memory loss) and VERTIGO POSITIONAL (Moderna Vaccine induced Benign Paroxysmal Positional Vertigo for 5 months now. It was 100% confirmed that I had crystals out of place on both ears after injection). At the time of the report, DISORIENTATION (Brain fog), FEELING ABNORMAL (Foggy feeling), HEAD DISCOMFORT (Pressure on their head), AMNESIA (Memory loss) and VERTIGO POSITIONAL (Moderna Vaccine induced Benign Paroxysmal Positional Vertigo for 5 months now. It was 100% confirmed that I had crystals out of place on both ears after injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment for the events included unspecified steroids for about a week that resulted in better results, however, patient reported that symptoms came back.   This case was linked to MOD-2021-005650 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Mar-2021: Additional information_01 On 08-Jun-2021: Diagnosis of new AE reported in FU. Event added; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
mixed Covid Vaccine series: Given Moderna vaccine to patient that had Pfizer as 1st vaccine
Cough, congestion, head cold, fever methylprednisolone Monitor home O2 level
Patient developed chest pain within 24 hours of vaccine, presented to ED 4 days later d/t worsening CP. Extensive workup led to diagnosis of myocarditis. Discharged with 2-week prednisone taper
Made felt dizzy, disoriented :15 minutes :50 minutes face, chest and neck became blochey with redness and heart beat was racing or elavated heart rate nd took benydrol after became  back of hands and face became flushed red again and took more benydrol  and next day face and cheeks was still blouchey and red. Hot flashes and chills .
I have heavy heart problems; Congestive heart failure, supposedly severe; I never went back for my 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (I have heavy heart problems) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure, supposedly severe) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cardioversion. Concurrent medical conditions included Congestive heart failure. Concomitant products included LEVOTHYROXINE, LIOTHYRONINE (NP THYROID), SPIRONOLACTONE, METOPROLOL, AMIODARONE, HYDRALAZINE, APIXABAN (ELIQUIS) and BUMETANIDE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (I never went back for my 2nd dose). On an unknown date, the patient experienced CARDIAC DISORDER (I have heavy heart problems) (seriousness criterion hospitalization) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure, supposedly severe) (seriousness criteria hospitalization and medically significant). At the time of the report, CARDIAC DISORDER (I have heavy heart problems) and CARDIAC FAILURE CONGESTIVE (Congestive heart failure, supposedly severe) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (I never went back for my 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Of note patient had CHF and CARDIOVERSION . Very limited information has been provided at this time .Please send the appropriate Adverse Event Follow-up form. Please close your Action Items when done Further information is expected; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Of note patient had CHF and CARDIOVERSION . Very limited information has been provided at this time.Please send the appropriate Adverse Event Follow-up form. Please close your Action Items when done Further information is expected
2-inch round rash at injection site (began on day 12 after vaccination, lasting for 2 days only).  No itching or swelling.
(R) thigh swelling to knee, mild redness, N/V intact, resolving after 3 days.
I felt like I had a head cold, cough, sore throat. The very next day I started PAXLOVID. My symptoms went away very quickly and reappeared 10 days later and tested positive again. Same symptoms the second go around, fatigue, sore throat, cough.
This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. No pertinent medical history was reported. On 15-APR-2015, the patient was vaccinated with expired dose of PNEUMOVAX 23 (Inj 10 vials of 1) (lot # K005957 and expiration date 08-MAR-2015) 0.5 ml, intramuscular. No adverse effects reported. This is one of the two reports from the same source. Additional information has been requested.
Patient received vaccine and 2 minutes later reported feeling nauseous and was fainting. Breathing was good, ambulance was called to assess patient efforts were made to help with fainting, put feet up, offered water and orange juice. Patient was assessed by EMTs and then left pharmacy
Systemic: Confusion-Severe, Systemic: Headache-Severe, Systemic: Nausea-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe, Additional Details: pt developed severe headache within minutes of vaccine felt like eyes were bulging out of head. She had tingling/numbness in arms then couldn't move arms. Her mental cognition declined and she was unable to speak. Patient had fluid coming out of her nostrils and eyes. Transported to ER by ambulance.
Headache, UrticariaPruritus, HYPERtension, Flushing/Itching of scalp
She woke early and didn't feel well, she couldn't do anything; She woke early and didn't feel well, she couldn't do anything; She woke early and didn't feel well, she couldn't do anything; she was really pretty awful sick the next day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64-year-old female patient received BNT162b2 (BNT162B2), on 02Oct2021 at 18:00 as dose 3 (booster), single (Batch/Lot number: unknown, Expiration Date: 31Dec2021) at the age of 64 years, in left arm for covid-19 immunisation; influenza vaccine (FLU), on 02Oct2021 as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WELLBUTRIN; LEVOTHYROXINE; BUPROPION HYDROCHLORIDE; CLONAZEPAM. Vaccination history included: BNT162b2 (DOSE 2, SINGLE, Lot/batch number: EP7533), administration date: 08Apr2021, when the patient was 63-year-old, for COVID-19 immunization; BNT162b2 (DOSE 1, SINGLE, Lot/batch number: EP7534), administration date: 18Mar2021, when the patient was 63-year-old, for COVID-19 immunization, reaction(s): "with the 1st shot she didn't feel great". The following information was reported: ILLNESS (non-serious) with onset 03Oct2021, outcome "unknown", described as "she was really pretty awful sick the next day"; MALAISE (non-serious), SLEEP DEFICIT (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "recovered" and all described as "She woke early and didn't feel well, she couldn't do anything".  Additional information: After received the booster dose at around 6 pm in her left arm and flu shot at the same time and wouldn't recommend it. The patient was really pretty awful sick the next day. The patient felt horrible with booster dose and flu shot at the same time that might have caused it. On 03Oct2021 Sunday, the patient woke up early and did not felt well, could not do anything. The patient did not require medical attention, she knew that it was a reaction.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had no appetite; Experienced overwhelming weakness; No energy at all, fatigue was getting worse; Became breathless; She had anxiety about this; Stayed awake the entire night because she was afraid she would go to sleep and not wake up again; Very sleepy, stayed in bed until 2:00 PM; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Became breathless), ANXIETY (She had anxiety about this), INSOMNIA (Stayed awake the entire night because she was afraid she would go to sleep and not wake up again), SOMNOLENCE (Very sleepy, stayed in bed until 2:00 PM) and DECREASED APPETITE (Had no appetite) in a 75-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.     Concurrent medical conditions included COPD and Emphysema.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SOMNOLENCE (Very sleepy, stayed in bed until 2:00 PM). On 03-Mar-2021, the patient experienced DYSPNOEA (Became breathless), ANXIETY (She had anxiety about this) and INSOMNIA (Stayed awake the entire night because she was afraid she would go to sleep and not wake up again). On 04-Mar-2021, the patient experienced DECREASED APPETITE (Had no appetite), ASTHENIA (Experienced overwhelming weakness) and FATIGUE (No energy at all, fatigue was getting worse). On 10-Mar-2021, DYSPNOEA (Became breathless), ANXIETY (She had anxiety about this), INSOMNIA (Stayed awake the entire night because she was afraid she would go to sleep and not wake up again), SOMNOLENCE (Very sleepy, stayed in bed until 2:00 PM), DECREASED APPETITE (Had no appetite), ASTHENIA (Experienced overwhelming weakness) and FATIGUE (No energy at all, fatigue was getting worse) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment medications was not provided by the reporter