chrisvoncsefalvay/vaers-outcomes huggingface dataset:
reconstituted ActHIB with a sterile water and administered it to a patient with no reported adverse event; Initial information received on 20-Jun-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and gender patient who was administered with reconstituted HIB (PRP/T) vaccine [ACT-HIB] with a sterile water with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received an unknown dose of suspect HIB (PRP/T) vaccine, powder and solvent for solution for injection (batch number: UJ801AA; Expiry date: 31-Oct-2023) via unknown route in unknown administration site for immunization reconstituted with a sterile water with no reported adverse event (product preparation error) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event reconstituted acthib with a sterile water and administered it to a patient with no reported adverse event.  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 the guidelines. 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.
chills; Fever; This is a spontaneous report received from non-contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown"; PYREXIA (non-serious), outcome "unknown", described as "Fever". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dizzy; speech slurred; weak; high fever (100F); slight headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), DYSARTHRIA (speech slurred), ASTHENIA (weak), PYREXIA (high fever (100F)) and HEADACHE (slight headache) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced DIZZINESS (dizzy), DYSARTHRIA (speech slurred), ASTHENIA (weak), PYREXIA (high fever (100F)) and HEADACHE (slight headache). At the time of the report, DIZZINESS (dizzy), DYSARTHRIA (speech slurred), ASTHENIA (weak), PYREXIA (high fever (100F)) and HEADACHE (slight headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Pt developed hives on his back and his eyes started to swell 3 hours after administration. MOP gave pt Benadryl and symptoms subsided.
Employee complained of increased itching and redness at the site of injection.  Ice applied and vitals taken.  No dyspnea, swelling.  Patient reported on 11/04/2009 that she developed some throat tightening and went to an ER where she was treated with IV meds.
rash,rash started on his forearm,rash started on his back,rash spread to the rest of his body; breaking out on hives; Raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs; second dose on day 39 after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (breaking out on hives), ECZEMA (Raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs), RASH (rash,rash started on his forearm,rash started on his back,rash spread to the rest of his body) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 39 after the first dose) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 39 after the first dose). On 24-Sep-2021, the patient experienced URTICARIA (breaking out on hives) and ECZEMA (Raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs). On 25-Sep-2021, the patient experienced RASH (rash,rash started on his forearm,rash started on his back,rash spread to the rest of his body). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. On 23-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on day 39 after the first dose) had resolved. At the time of the report, URTICARIA (breaking out on hives), ECZEMA (Raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs) and RASH (rash,rash started on his forearm,rash started on his back,rash spread to the rest of his body) outcome was unknown.            No Concomitant medications were reported. Other Treatment medications include Anti-itch cream. Patient reported that after taking second dose he started breaking out on hives, a rash. It started on his forearm and back and this morning spread to the rest of his body. He has raised red bumps on his forearms that now spread to his legs, abdomen, whole arm, full hands, back of neck, head, scalp and across his legs.
Information has been received from a registered nurse concerning a female child who was vaccinated PO with a first 2 mL dose of RotaTeq vaccine after 12 weeks of age. No adverse affects. No other information. Unspecified medical attention was sought. There was no product quality complaint. Additional information has been requested. This is one report of several from the same source.
Mom called within 24 hours stating pt has severe swelling of right thigh from groin to below knee. Seen by MD, no warmth or abscess noted. Treated with Prelone.
Narrative: 71 year old male admitted on 3/26 with hypoxia requiring O2 supplementation found to have COVID-19 on admission. He was vaccinated x 3 (Moderna 1st dose 1/24/21, 2nd dose 3/2/21, 3rd dose (0.5 mL) 9/10/2021). He was treated with 5 days of remdesivir and dexamethasone and discharged on 3/30.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-APR-2017 the patient was vaccinated with ROTATEQ for prophylaxis. On 01-APR-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to ROTATEQ. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA004161: US-009507513-1708USA003618: US-009507513-1708USA004160:
This initial spontaneous report was received from a registered nurse concerning multiple unspecified patients of unknown ages and genders. Pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unspecified dates, the patients were vaccinated with improperly stored doses of VARIVAX injection (lot # K021487, with expiration date 03-NOV-2017, lot # L024250 with expiration date 30-JUN-2017 and lot # L042266 with expiration date 27-OCT-2017; dose, route and anatomical location were not reported). No adverse effects were reported and a product quality complaint (PQC) was not involved. It was unknown if the patients sought medical attention. This is one of several reports received from the same reporter. Additional information has been requested.
Nausea; Muscle ache; Headache; Tiredness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration in the left arm on 02Apr2021 at 10:15 (at the age of 48-year-old) as a single dose for COVID-19 immunisation. Medical history included autosomal dominant polycystic kidney disease (ADPKD). Concomitant medications included valsartan (MANUFACTURER UNKNOWN), terazosin (MANUFACTURER UNKNOWN), amlodipine (MANUFACTURER UNKNOWN), tolvaptan (MANUFACTURER UNKNOWN) and allopurinol (ALLOPRIM), all from unknown dates and for unknown indications. The patient had no known allergies. 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 COVID-19 vaccination. On 02Apr2021 at 16:00, the patient experienced nausea, muscle ache, headache and tiredness. The patient did not receive any treatment for the reported events. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the event nausea, muscle ache, headache and tiredness was recovered on an unspecified date in Apr2021.   No follow-up attempts are needed. No further information is expected.
Started as pain throughout the whole body in the morning of the second day and by the end of the day my knees felt numb and tingley. Today is day 5 since the vaccine and the numbness is has not gone away.
Redness and itchiness at the injection site on day of injection and the next  few days. A rash on the seventh day after the injection at the site of the injection that has lasted for three days.
3FEB97 inc temp, cough;4FEB97 RCV obtained;6FEB97 cult positive influenza A;
incomplete dose was administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 27-month-old male patient who received HAV (Havrix) (batch number y3me2, expiry date 23-FEB-2025) for prophylaxis.   On 02-MAY-2023, the patient received Havrix. On 02-MAY-2023, an unknown time after receiving Havrix, the patient experienced incomplete dose administered (Verbatim: incomplete dose was administered). The outcome of the incomplete dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 04-MAY-2023 The reporter was a Medical Assistant. The reporter consented to follow up. Healthcare professional gave consent for safety team to follow up.  No additional adverse event details available at this time. An incomplete dose was administered a patient, which led to incomplete dose administered.
Drippage that causes sore throat; Fatigue; Running/runny nose; This spontaneous case was reported by a health care professional and describes the occurrence of RHINORRHOEA (Running/runny nose), UPPER-AIRWAY COUGH SYNDROME (Drippage that causes sore throat) and FATIGUE (Fatigue) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Stroke (Stroke x2) on 30-May-2016. Previously administered products included for an unreported indication: FLU in October 2020. Family history included Cancer (Mother), Diabetes (Father) and Blood pressure high (Father). Concurrent medical conditions included Seasonal allergy since 01-Jan-2012. Concomitant products included CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Anxiety, TOPIRAMATE (TOPAMAX) and ACETYLSALICYLIC ACID (BABY ASPIRIN) for Stroke.    On 15-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced RHINORRHOEA (Running/runny nose). On an unknown date, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Drippage that causes sore throat). an unknown date, the patient experienced FATIGUE (Fatigue). At the time of the report, RHINORRHOEA (Running/runny nose) and UPPER-AIRWAY COUGH SYNDROME (Drippage that causes sore throat) had not resolved and FATIGUE (Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2016, Magnetic resonance imaging: stroke (Inconclusive) MRI around "my strokes" and every year after.     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.   A self-report from a female health care professional was forwarded by Pfizer regarding the following reported events: Running nose (day after shot, also reported as 24-Jan-2021), drippage that caused sore throat (starting 2-3 days after vaccination) and fatigue. The patient reported that she went to Urgent Care and "believed it was a viral infection". Treatment information was not provided. The patient reported that her next dose of the Moderna vaccine was scheduled for 12-Feb-2021.
Ongoing dull throbbing ache. Was unable/is unable to lift arm. Cannot rotate arm. Now having pain in shoulder and down arm which wakes her up at night. +/- nerve issue ? not sure.
Right arm below injection site one day after receiving vaccine had a red raised area about pea size. 2nd day after vaccine area enlarged to 1" x 2".  3rd day area has flattened out but has spread a little larger.
Super-sore arm at injection site.  Chills on night of 4/6/21. Super-sore arm at injection site.  Flu like symptoms all day 4/7/2021. Lightheaded periods on 4/8/2021.
Received vaccine at living premises by outside source on 1/22/21.  On 1/26/21 caregiver called clinic (PCP) and appointment made.  Noted to have rash on trunk, and back that he said was burning.  Did not itch.  No difficulty breathing or swallowing, or other symptoms.
Palpitations, chest pressure, and shortness of breath.  Symptoms are intermittent and not constant.  All 3 do not necessarily occur together.  Patient feels the same as when she was having issues with ventricular dysrhythmia prior to ablation.  Nothing seems to bring the symptoms on and nothing seems to make the symptoms get better, though when short of breath or having chest pressure will slow down her activities.  Felt the feeling may go away, so did not seek evaluation for 2 weeks.
Information has been received from a physician concerning a female pt who was vaccinated with a dose of varicella zoster virus vaccine live. Subsequently, the pt developed shingles. Unspecified medical attention was sought. The pt was administered acyclovir for the shingles. A product quality complaint was not involved. Shingles was considered to be an other important medical event by the reporter (OMIC). Additional information has been requested.
After receiving the Pfizer vaccination all those fore-mentioned things were gone/cloudiness went away in her head after getting vaccine; After receiving the Pfizer vaccination all those fore-mentioned things were gone/cloudiness went away in her head after getting vaccine; 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 54-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 16:30 (Lot number: ER8734) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "head beginning to feel cloudy/cloudiness in her head" (unspecified if ongoing), notes: I was not able to walk in a constant circle without my head beginning to feel cloudy. Neither was I able to squat for any amount of time without feeling light-headed upon standing.; "Surgery" (unspecified if ongoing), notes: I had not felt like this since having an IV in my arm when I had major surgery over 30 years ago. The patient's concomitant medications were not reported. The following information was reported: PRE-EXISTING CONDITION IMPROVED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious) all with onset 02Apr2021 07:00, outcome "unknown" and all described as "After receiving the Pfizer vaccination all those fore-mentioned things were gone/cloudiness went away in her head after getting vaccine". Therapeutic measures were not taken as a result of pre-existing condition improved, therapeutic response unexpected.  Additional Information: Before taking the PFIZER Vaccine, the patient was not able to walk in a constant circle without head beginning to feel cloudy. Neither was able to squat for any amount of time without feeling lightheaded upon standing. But the day after receiving the Pfizer vaccination, all those fore-mentioned things were gone. She was doing them without any feelings after. She had not noticed her ability to perform these tasks until a co-worker brought it to her attention. She had nothing but the effects of the PFIZER Vaccine to thank for her increased endurance and energy. She had not felt like this since having an IV in her arm when had major surgery over 30 years ago.   No follow-up attempts are possible. No further information is expected.
I was returning from an outing and was walking across the room.  I felt a numbness and weakness ascending my left leg.  I couldn?t put weight on it at all.  I was near a sofa, and I sat down.  I thought I had done something to my back but then my left arm became numb as well.  My husband immediately took me to the emergency room.  I was taken to a room and examined.  I had some positive neuro exam results.  They did a telemedicine with a stroke specialist while I was there.  I was advised to take TNK which would break down any clots in my systems.  Then I was observed and sent to the ICU.  I spent one night in ICU.  After that I was sent to another room to be monitored overnight.  I then had an MRI of my brain.  They did find a very small aneurysm on my left carotid artery.  It did not cause anything,  but it was an incidental finding.  There was not bleeding found or evidence of damage, so I was allowed to be discharged.  I am now taking Plavix, baby aspirin, Lansoprazole, Atorvastatin.  I have a follow up with a neurologist and vascular doctor.  As of today I am able to do most of my things.  My left leg fatigues easy.
Developed a infrapopliteal DVT in the left leg two days after vaccine was received. I also had minor knee surgery on December 18, four days prior to receiving the vaccine. No risk factors/medical history for developing a DVT.
The symptoms started around 4:30pm on 2/10/21. I have a fever, chills, headache and muscle aches.
Approximately 1 week after receiving the first Covid dose (in my left arm), I developed a red spot on my (right) arm that did not go away.  To be clear, I do not know whether this has anything to do with the Moderna vaccine but figured I should report it (and also want to be clear that the red spot is in my right arm, whereas the vaccine was in my left arm).  After waiting a few weeks, I visited the doctor a dermatologist.  She did a punch biopsy, which recently returned an "unusual" result.  The lab showed it to multiple people, including a physician with a hematopathology specialty and the Dermatopathology.   Their conclusion was that "overall findings are consistent with a florid hypersensitivity reaction in the appropriate clinical setting."  However, they also suggest another biopsy if deemed clinically appropriate.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Lot number: EL3247), in left arm, on 10Mar2021 as dose 2, single (Lot number: EN6203), in left arm, on 29Sep2021 as dose 3 (booster), single (Lot number: EW0186), in left arm and on 04May2022 as dose 4 (booster), single (Lot number: FL3197) at the age of 57 years, in left arm, all intramuscular for Covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "High Blood Pressure" (unspecified if ongoing); "Anxiety/Depression" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; ATORVASTATIN; PRISTIQ; METFORMIN; AMLODIPINE. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 31May2022 at 09:00, outcome "not recovered" and all described as "Had a positive COVID test". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (31May2022) Positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, Covid-19. Clinical Information: Reporter stated, Age group as adult (18-64 Years). Current age is reported 47, Patient received More than 3 doses, No other vaccine in four weeks, Other medications in two weeks was Losartan, Atorvastatin, Pristiq, Metformin, Amlodipine. Adverse event reported as, Had a positive COVID test. Experiencing congestion, sore throat, knee joint pain and leg muscle pain, Adverse event started on 31May2022, 09:00 AM, patient was Not recovered, No treatment AE, No Covid prior vaccination, Covid tested post vaccination. Covid test type post vaccination was Nasal Swab, Covid test name post vaccination was reported as Unknown, Covid tested on 31May2022 and Covid test result was Positive. Known allergies reported as, Sulfa and Other medical history was Diabetes, High Blood Pressure, Anxiety/Depression. No follow-up attempts are possible. No further information is expected.
Breakthrough case admission after 4 vaccines Moderna 4/6/21 Lot# 007B21A;  Moderna 5/4/21 Lot# 043B21A;  Moderna 12/7/21 Lot# 030H21B;  Moderna 7/19/22 Lot# 017B22A
Child developed a red, blotchy rash to entire body less than 24 hours after getting Hep B vaccine. No resp involvement. Rash lessened with dose of BENADRYL.