chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from registered nurse concerning a patient of unknown age and gender. The patient was vaccinated with the first dose of RECOMBIVAX HB (dose, route and lot not reported) on 22-OCT-2008. Second dose of RECOMBIVAX HB (dose, route and lot not reported) was given on 15-APR-2009. Nurse reported that the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route and lot not reported) only 6 weeks apart from second dose on 22-MAY-2009. Nurse reported that the patient was vaccinated with the third dose of RECOMBIVAX HB (dose, route and lot not reported) only 6 weeks apart from second dose on 22-MAY-2009. No other co-suspects were reported. No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Blurred Vision; Terrible headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred Vision), HEADACHE (Terrible headache) and PYREXIA (Fever) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISION BLURRED (Blurred Vision), HEADACHE (Terrible headache) and PYREXIA (Fever). At the time of the report, VISION BLURRED (Blurred Vision), HEADACHE (Terrible headache) and PYREXIA (Fever) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.  Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Pt developed rash on lower left quadrant of body - itchy + red - Pt went to urgent care and was prescribed an anti-viral medication Pt also experiencing headaches.
This spontaneous report as received from a 71 year old female patient with sulfa allergy (unspecified) and no pertinent medical history refers to herself. In approximately 2005, reported as 8 years ago, the patient was vaccinated with ZOSTAVAX left arm injection (strength, dose, route, lot number and expiration date not provided). The patient wanted to know if she could get shingles in her mouth. She stated that before the Thanksgiving holiday she visited her mother in the nursing home were her mother did have shingles and days later on 24-NOV-2013 caller felt a burning sensation on the left side of the roof of her mouth which then proceeded to break out in blisters. She sought unspecified medical attention. For a treatment AUGMENTIN was given. NO lab diagnostics studies was performed. The outcome of to break out in blisters and burning sensation on the left side of the roof of her mouth was not reported. The relatedness between vaccination with ZOSTAVAX and burning sensation on the left side of the roof of her mouth which then proceeded to break out in blisters was not reported. Additional information is not expected.
Arm a little sore at site but nothing out of the ordinary, then about 3 days later increased soreness and redness. As of this date, pain somewhat improved but redness is about 5-6 inches. Looks like an "ink spill". Denies accompanying fever, swelling, or chills. Denies ever having any adverse reaction following a vaccination other than mildly sore arm. Reporter recommended consultation with his PCP to assess arm as well as advise on whether to receive 2nd COVID vaccine.
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 25-JAN-2019, the patient was vaccinated with an improperly VARIVAX (the dosage regimen information was not reported) lot # N035937 (expiration date: 18-DEC-2019) for prophylaxis, reconstituted with properly stored sterile diluent. No adverse effects were reported. The vaccines were exposed to a temperature of -8.16 and -10.96 Celsius degrees for a timeframe of 50 minutes and 13 hours respectively. It was found because of a digital data logger. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1902USA005476: US-009507513-1902USA005477.
4/7/10 Woke in the night with severe sore throat. Took 2 ibuprofen, vitamin C, B and multi. Woke again at 8am with throat still very sore, but higher in the throat. Used Netti pot with salt water and gargled with salt water 2 or 3 times during the day and before bed. Continued to take vitamins and 2 more ibuprofen later in the day. No fever present. Very low energy/lethargic, but not sleepy.  At 10:30pm had diarrhea.  4/8/10 Woke with slight sore throat. Was fine by mid-morning.
Total time in excursion was 92 minutes and highest temp was 9.4 C/human error/no AE; one patient received Adacel after it underwent excursion/no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to 2019SA313263 (same reporter).  This case involves a patient of unknown demographics who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6378AA via unknown route in unknown administration site) on an unknown date after it underwent temperature excursion of 9.4 degree C for 92 minutes due to human error.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to incorrect product storage and Poor quality vaccine administered.  It was unknown whether adverse event was experienced or not.  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.
Patient has large rash on left deltoid warm to the touch, patient states it itches a lot. No fever or other complaints.
Patient vaccinated x2 (Pfizer: 4/1/21, 4/21/21)  Patient tested positive while hospitalized on 5/18/22
patient was supposed to receive Prevnar and was given MENACTRA by mistake, no AE; Initial information received on 16-Aug-2021 regarding an unsolicited valid  non-serious case received from a physician via Global Media Information (under the reference 00726178).  This case involved a 6 months old female patient who was supposed to receive PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR)and was given MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (Menactra) by mistake (wrong product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and HIB VACCINE CONJ (OMPC) (PEDVAXHIB) (lot number and expiration date not reported) via unknown route in an unknown site for prophylactic vaccination.  On 16-Aug-2021, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (lot U6921AA and expiration date :17-Apr-2022) via intramuscular route in the right thigh for prophylactic vaccination.  It was an actual medication error due to wrong vaccine administered (same day latency).  It was reported that "nurse supervisor asking if there are any adverse events reported in 6 month olds who are given MENACTRA, and how they should proceed".  At time of reporting, the outcome was unknown for the reported 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 by the regulatory authority. 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.
About 10 days following  the vaccine, developed an itchy, slightly painful, papular and petechial rash, primarily in underarms, arms, and legs.  Antihistamine helped reduce symptoms.   Rash has persisted, but improving.
couldn't breathe very well; can't sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: DYSPNOEA (non-serious) with onset Nov2021, outcome "not recovered", described as "couldn't breathe very well"; INSOMNIA (non-serious) with onset Nov2021, outcome "not recovered", described as "can't sleep".  Additional information: As the patient is the reporter, states that booster shot could not breath very well, patient could not sleep at night because of breathing disturbance and he did not have this problem with first and second dose. when the patient sleeps at night he can't slepp anymore because of this, later he struggled with his breath and this isn't good for his high blood pressure and thinks that he and his son had the same event. patient thinks that this began sometime this month or late November, he cannot remember. patient confirms that he is talking about the third dose of the Pfizer covid vaccine, he scared he will stop breathing when he sleeps so he is having a hard time sleeping. caller was really worried.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Headache, diarrhea fatigue, nausea, muscle and joint aches and pains. Continues to get worse, On May 5, 2017 in addition to other symptoms started with SOB, weakness, increase muscle ache.
Muscle pain and weakness that has been ongoing since receiving the vaccination in October. Pt sometimes cannot use that arm to the extent that she could previously, even when getting dressed, and sometimes wakes in the middle of the night with arm pain.
suspected vaccination failure; Had the two doses of Shingrex over a year ago but am having an outbreak; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. Over a year ago, the patient two doses of Shingrix and had an outbreak of shingles. The patient had taken 7 days of an antiviral but still having symptoms. The patient asked did they have a suggestion or have booster shots. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for shingles was unknown.
Pt's mother called in for a phone triage c/o rash on pt - small, red, itchy bumps that started on pt's neck and spread to trunk of back, mother stated it looks like a heat rash. Mother denied pt having a fever, difficulty breathing, and any other s/s. No new foods, soaps, lotions have been introduced that mother is aware of. Pt had MMRV, flu, Hep A 10 days ago. Advised mother may be an allergic reaction, give pt cool bath w/ Aveeno, baking soda, or oatmeal. Advised of UC/ER precautions, mother stated she will bring pt into UC. Left msg advised of Children's BENADRYL 12.5 mg/tsp, 1 tsp by mouth every 6 hours based on pt's age, clarified by RN.
I started getting symptoms of dry eyes, nose, and mouth. I had a really bad headache. I started getting a fever as well as a cough. I went to the urgent care and received a positive COVID-19 test. I suggested to get the antibody infusion but before my appointment came, I was feeling better and called and canceled. The fever lasted a day and a half. I took TYLENOL and a cough medication. The cough remained for about 3 weeks. I had a headache for 2 weeks. I still have a lingering affect of partial loss of taste.
The day after the vaccinations (9/15) the patient experienced a bad headache and fever, which resolved with Tylenol. On 9/16, the patient noticed a red rash from her neck down across her chest which is warm to touch but is not painful or itchy. The patient reports no swelling or redness at the injection sites, only some soreness the day after the vaccine.
While administering the Maderna Covid Vaccine, the needle portion came separated from the syringe and an undetermined amount of the vaccine sprayed out and was not administered to patient
Tired, queasy, slightly dizzy, low energy, thirsty, slight vision reduction, brain fog, washed out, shaky
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 64-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Mar2021 at 14:15 as dose 1, single (Lot number: EN6199), in left arm, on 13Apr2021 at 15:30 as dose 2, single (Lot number: ER8729), in left arm, on 17Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "htn" (unspecified if ongoing); "GERD" (unspecified if ongoing); "allergic rhinitis" (unspecified if ongoing); "history hsv" (unspecified if ongoing); "hx of nonmelanoma skin cancer" (unspecified if ongoing); "Allergies: sulfa" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovered" (19Jul2022) and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Still positive on day 5 of illness; (06Jul2022) Positive, notes: Tested positive 06Jul2022; (14Jul2022) Negative, notes: Tested positive 14Jul2022 (day 11). Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical information: Treatment received as Paxlovid, Treatment start date: 06Jul2022, Treatment stop date: 10Jul2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162b2 to the reported events of vaccination failure and COVID-19 cannot be ruled out given the known suspect product profile and temporal association.
W/in 15-20 of vax, pt had acute onset of somnolence/lethargy, & shallow breathing. No strider, wheezing, rash or swelling. Pt brought back to clinic. Sleepy, rousable by noxious stimuli. Had dec breast feeding. Pt became more alert.
Information has been received from a physician referring to a 7 month old patient of unknown gender. On 09-AUG-2017 the patient was vaccinated with a first dose of ROTATEQ (strength, dosage and frequency unspecified) orally for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported.
Body rash on torso developed about 3.5 days after vaccination.  Rash starting to clear the next day.  No itching.
Muscle aches; Injection site soreness; Extreme vertigo; nausea; This is a spontaneous report from a contactable healthcare professional (patient). A 52-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142, expiry date: unknown), via an unspecified route of administration, in the left arm, on 18Jan2021 07:15 at a single dose for covid-19 immunization. Medical history included Meniere's disease and known allergies: shellfish. There were no concomitant medications. The patient previously took morphine and experienced known allergies: morphine, and first dose of bnt162b2 at the age of 52-year-old; lot number: EL1284 on 27Dec2020 0700, in the left arm for covid-19 immunization. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 post vaccination. On 23Jan2021 0500, the patient experienced muscle aches, injection site soreness, extreme vertigo and nausea. All the events resulted in emergency room (ER) visit. Therapeutic measures were taken for all the events which included diphenhydramine (BENADRYL)and prochlorperazine (COMPAZINE). Outcome of all the events was recovered on unspecified date in Jan2021.
diarrhea; nausea; fever; Dyspnoea/shortness of breath; pneumonia; This is a spontaneous report from a contactable other health professional (patient's child). A 74-year-old male patient received bnt162b2 (COMIRNATY), dose 1 intramuscular, administered in arm left on 08Mar2021 12:00 (Lot Number: unknown) as single dose for covid-19 immunisation at the age of 74-year-old. Medical history included colitis. There was no other vaccine in four weeks. Patient had no known allergies and no covid prior vaccination. Concomitant medications included azathioprine sodium (IMURAN) from an unspecified date and ongoing taken for colitis ulcerosa and steroid etc. The patient experienced diarrhea, nausea, fever, dyspnoea/shortness of breath and pneumonia on 10Mar2021 at 01:00 AM. The patient was hospitalized for events for 4 days.  Events resulted in physician or other hcp office visit, emergency or emergency medicine, hospital treatment and patient died. He had negative COVID test. The patient underwent lab tests and procedures which included nasal swab: negative on 25Mar2021. The patient died on 28Mar2021.  An autopsy was not performed. Patient received oxygen and antibiotics therapy for events. Outcome of events was fatal.   Events occurred in a country different from that of the reporter.  This may be a duplicate if the reporter also submitted directly to his/her local agency.  The lot number for BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the events and 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 and on the conduct of the study 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.; Reported Cause(s) of Death: Pneumonia; Dyspnoea/shortness of breath; fever; nausea; diarrhea
Pt states that she developed two cold sores on 1/5 and 1/6 on either side of her mouth. The coldsore's have healed, however the Pt still has the "tingling feeling" on the left side of her cheek around her lip; not numb but still tingling that started on 1/5. Pt does not have any other symptoms
Per Fire EMS client reported dizziness during observation after COVID vaccine administered. Vital signs and 12 lead EKG performed. Observed for approximately 30 minutes, no other treatment documented.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case pertains to the 168th patient of the total 190 patients. It was unknown if patient received any other vaccines in the 4 weeks prior to the COVID-19 vaccine administration.  No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
anaphylaxis; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE), for covid-19 immunisation. The following information was reported: ANAPHYLACTIC REACTION (medically significant) with onset Mar2021, outcome "unknown", described as "anaphylaxis".  Clinical Course: A female patient who called into the meeting, indicated they took the PFIZER COVID Vaccine and developed anaphylaxis after the second dose in Mar2021.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Hospitalization: 12/24/2022 - 1/3/23 (10 days) Presentation to the ED: worsening diarrhea. COVID + date: 12/24/2022 Treatment: no treatment specific to COVID.  Discharge to: SNF   Moderna 002A21A 3/12/2021 Moderna 046B21A 4/9/2021. Pfizer FH8030 11/17/2021 Pfizer Bivalent GJ5342 9/15/2022