chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 23-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot: Unknown , ), for COVID-19 immunization, reaction(s): "sharp pain in my stomach", "my Cycle was delayed". The following information was reported: AMENORRHOEA (non-serious) with onset 21Sep2021, outcome "not recovered", described as "cycle completely stopped"; POLYCYSTIC OVARIES (non-serious) with onset 21Sep2021, outcome "not recovered", described as "diagnosed with PCOS". The events "cycle completely stopped" and "diagnosed with pcos" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of amenorrhea, polycystic ovaries.  Additional information: It was reported that the patient used to have regular menstruation before the Pfizer vaccine after the Pfizer vaccine her Cycle was delayed for the first time in her life. She also experienced a sharp pain in her stomach after the vaccine. Then after she got her second dose a month later her cycle completely stopped and not too long after she was diagnosed with PCOS. She has a low end of normal BMI, and her lifestyle was unchanged before developing menstrual irregularities. She had no covid prior vaccination. She had not covid tested post vaccination. She had no known allergies. She was not received other vaccine in four weeks or other medications in two weeks.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Had an extremely elevated heart rate starting about 11 hours after the vaccine that lasted until 23 hours post-vaccine.   My usual resting heart rate is mid-60s and I was 90-110 all night.  Current in the mid-80s approaching 24 hours.  Still high for me. The pharmacist said that was abnormal so I'm hoping this report helps someone else!
MD was aware age outside of recommended age. Patient presented on 1-10-14 with an injection site reaction covering 3/4's of upper right arm. Arm had erythema, pain, swelling, and warmth. Patient was instructed to see MD if area didn't improve over next 12-24 hours (and go to ER if area got worse). Patient sought medical attention 1/10/14 and is recovering in hospital.
Rash Narrative:  noted approx. 6cm diameter red, minimally raised, localized rash around site of injection. +itch. denies all other s/s.
Evening after second dose of Pfizer sars-cov2 vaccine she developed a painful vesicular rash on her face consistent with shingles. She does have a fair amount of stress in her life and it could have been unrelated but figured I should report anyway.
I took a flu shot and got terribly sick; Initial information received on 23-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient) via social media.  This case involves patient (unknown demographics) reported I took a flu shot and got terribly sick (Illness) while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient took a flu shot and got terribly sick (Illness) unknown latency following the administration of INFLUENZA VACCINE.  Laboratory details were not reported.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.  There will be no information available on the batch number for this case.
Herpes infection; given a dose of the Pfizer Covid 19 Vaccine gray cap formulation which was already 72hours out of the refrigerator and after first puncture; given a dose of the Pfizer Covid 19 Vaccine gray cap formulation which was already 72hours out of the refrigerator and after first puncture.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 51-year-old male patient received BNT162b2 (BNT162B2), on 28Mar2022 at 10:45 as dose 3 (booster), single (Lot number: FM0698, Expiration Date: 11May2022) at the age of 51 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). Concomitant medication(s) included: ACYCLOVIR [ACICLOVIR] oral taken for herpes virus infection, start date: 30Mar2022. Vaccination history included: BNT162b2 (First dose, single), administration date: 24Apr2021, when the patient was 50-year-old, for COVID-19 Immunization; BNT162b2 (Second dose, single), administration date: 13May2021, when the patient was 50-year-old, for COVID-19 Immunization.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 28Mar2022, outcome "unknown", described as "given a dose of the Pfizer Covid 19 Vaccine gray cap formulation which was already 72hours out of the refrigerator and after first puncture"; PRODUCT ADMINISTRATION ERROR (non-serious) with onset 28Mar2022, outcome "unknown", described as "given a dose of the Pfizer Covid 19 Vaccine gray cap formulation which was already 72hours out of the refrigerator and after first puncture."; HERPES VIRUS INFECTION (non-serious) with onset 30Mar2022, outcome "unknown", described as "Herpes infection". Therapeutic measures were taken as a result of herpes virus infection.  Additional information: On Monday, 28Mar2022 at 10:45am, a vial of Pfizer Covid 19 vaccine was punctured. It had been left out from Friday 25Mar2022, 61 hours and 15 minutes, longer than Manufacturer's instructions. The original open date of the vial was 25Mar2022 at 9:30 am and expired 9:30pm that day. A second dose was taken from the vial on 28Mar2022 at approximately 10:40 am and administer to a patient at 10:45am. After error realized, the Provider was informed, and patient was contacted.   Follow up(27Apr2022):  New information received from a contactable Other HCP. This other HCP reported for male patient in response to HCP letter sent via follow-up letter which included that: Primary reporter institution name, fax no, and Email address added, RMH added, In historical vaccines dates added for 1st and 2nd dose and same added in notes as first dose and second dose, For suspect product dose no, anatomical site, route added, Vaccination facility name, address, city, state, type, postal code, phone no added, Concomitant coded, New event "Herpes infection" added, event onset date and treatment added.  No follow-up attempts are possible. No further information is expected.
3RD DOSE, COMIRNATY VACCINE GIVEN 5/6/22, LOT #FJ4989; pt had a positive COVID test 7/25/22 with respiratory issues; admitted to hosp 8/17/22 with worsening hypoxic respiratory failure; SICU; on BiPAP; eventually required intubation due to declining condition; ABX; hemodialysis; diuresis; pt's condition deteriorated; transitioned to comfort measures; extubated palliatively and she passed away in the hospital
patient experienced a sagittal sinus venous thrombus as well as a right transverse-sigmoid junction sinus thrombus 12 days after the vaccine was given
sore arm; Congestion/feeling congestion and now she feels it in her nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 06Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; NASAL CONGESTION (non-serious) with onset 22Mar2021, outcome "unknown", described as "Congestion/feeling congestion and now she feels it in her nose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to 2018SA284709, 2018SA284710, 2018SA284711, 2018SA284707, 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284732, 2018SA284733, 2018SA284734, 2018SA284735, and 2018SA284736 (same reporter). This case involves a 15 years old patient who was vaccinated with FLUZONE QUADRIVALENT (Batch number: UI997AA, expiration date: 30-JUN-2019) via intramuscular in the left deltoid on 02-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage. It was reported that vaccines that were outside of the recommended temp range (below 32 F). It was not reported that the patient had any 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 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.
excruciating hip pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (excruciating hip pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for Thyroid disorder NOS, TOPIRAMATE (TOPAMAX) for an unknown indication.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ARTHRALGIA (excruciating hip pain). The patient was treated with Physical therapy for Arthralgia. At the time of the report, ARTHRALGIA (excruciating hip pain) outcome was unknown. Not Provided          Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.       This case was linked to US-MODERNATX, INC.-MOD-2021-103601 (E2B Linked Report). This case was linked to MOD-2021-102896 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-103601:
Runny nose, stuffy nose, fatigue, brain fog, cough, low grade fever, headache, nausea, feeling ill
SICK; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220603706 and 20220604218.
BREAKTHROUGH COVID INFECTION. PATIENT TESTED POSITIVE ON 10/12/2021. PATIENT FULLY VACCINATED ON 03/16/2021. PATIENT RECEIVED MONOCLONAL ANTIBODY ON 10/13/21.
Moderna 6-11 was drawn up in Moderna 12+ Bivalent booster syringe and administered to the patient.  The patient was notified of the error.  The patient wants booster Moderna 12+ Bivalent booster upon our return next month.
no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 05-APR-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002840: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002851:
She had a very sore arm; Nausea; She has extreme diarrhea; Feels 'pain'; I got a very sick wife; This is a spontaneous report from a contactable consumer or other non hcp (Patient's husband). A female patient of an unspecified age received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date of 2021 as dose 3 (booster), single for COVID-19 immunization. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as dose 1, single for COVID-19 immunization. Also received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration, administered on unspecified date as dose 2, single for COVID-19. The patient's medical history and concomitant medications were not reported. Reporter stated, his wife and he both got the booster shot, the Pfizer on thursday evening (unspecified date) and she had a very sore arm and nausea and things the following day, yesterday she felt pretty good, the arm was not that painful (Further clarification was unknown) but about 30 minutes ago she woke him up, she had extreme diarrhea, felt pain, nauseated, he was just wondering if this was the side effect of the vaccine. Also reported as he got a very sick wife, he needed to know whether he need to call the ambulance and take her to the hospital. Reporter was suggested to reach out to nearest emergency room in case of medical emergency: Reporter stated, they are not a help. The outcome for the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
A non-serious event of vaccine administration error has been received from a nurse concerning a 21-month-old female child. This case is submitted in accordance with post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist. The child has a medical history of asthma. No drug history information has been reported for this patient. The child received Flumist intranasally. The reporter indicated this child was inadvertently administered Flumist; the child did not meet Flumist labeling requirements. No adverse events were observed. Outcome: the child had no ill effects. Further dosing with Flumist is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 4/15/08 verified no adverse event experienced; lot # 500486E and vaccine administration date is Oct 10, 2007. The child received FLUMIST on 10-OCT-2007. The reporter indicated this child was inadvertently administered FLUMIST; the child did not meet FLUMIST labeling requirements. No adverse events were observed. Outcome: the child had no ill effects. On 12-Feb-2008 it was verified the child had no adverse events. Further dosing with FLUMIST is not indicated. The reporter did not provide a causality assessment for this medication error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow up obtained on 12-Feb-2008 verified the child expereinced no adverse events; corrected the child's initials and date of birth and provided the date of FLUMIST dosing.
SHINGRIX Vial (10 PK) Kit. Several hours after the injection, I experienced severe (not life threatening obviously) adverse effects: No energy, sore muscles/joints, chills, fever (101 degrees), stomach ache, swelling/pain in left neck muscle, and a fevered injection site. These side effects continued throughout April 16 but subsided somewhat with ADVIL and BENADRYL. During the early morning of April 17, I broke out in a sweat when the fever subsided. The inject site experienced extreme redness, fever, and swelling. Except for the injection site, I felt well on April 17. During the night of April 17, I developed hives adjacent to the injection site which continues today.
Inflammatory response.  Sudden onset of sSevere pain in both shoulder joints and both hip joints and associated muscles.  Woken up in middle of the night with the severe pain. Unable to find any comfortable position.  Much difficulty getting up, walking. Continues three months later.  Need help with ADLs. Can only walk short distances.
REDNESS, HEAT AND SWELLING     WILL SEE DR. TOMORROW MONDAY 08-15-2011   HAS TAKEN DIPHENHYDRAMINE AND IBUPROFEN UNTIL SHE SEES DR.
Patient came into pharmacy 9/25 and states that she has a blistery rash on her armpit and chest that started when she received her flu vaccine on 9/15.
patient was administered with an improperly stored dose of PEDVAX HIB; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 02-JAN-2020, the patient was vaccinated with a dose of improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (strength and route of administration were not reported) (lot # S007079 and expiration date: 24-JAN-2022) for prophylaxis (product storage error). The suspect vaccine underwent a temperature excursion of 8.64 degree Celsius for a duration of 30 minutes. The digital data logger was involved. There was no previous temperature excursion. The product quality complaint was not involved.
Brain fog followed by muscle and joint aches then severe vomiting diarrhea and chills. Blood in stool
My son was given the FluMist even though he was not the recommended minimum age (2yo). Prior to the administration of the FluMist the provider deferred to my judgement about the route of administration. A conversation was had about the benefits/costs of both mist and injection. The provider repeatedly said it was the same and continued to defer to my judgment. After she administered the FluMist she "remembered" that the minimum age for FluMist was 2yo and informed me that they would follow up with us about best course of action. Needless to say, I was furious.   My son started to experience significant symptoms 48 hours later, including coughing, congestion, mucous, and sneezing. My son is fairly healthy and has never experienced symptoms as significant as he did after receiving the FluMist. His symptoms lasted approximately 7 days. Because my son is only 1.5yo we only used babyVicks, humidifier, and childrens strength Sambucas (elderberry extract) as forms of treatment. My son is now fully recovered and does not appear to having any residual symptoms.
Vial diluted incorrectly. Patient received 42mcg of Pfizer vaccine.  No adverse reaction reported by patient.
Fever < 101F; Extreme body ache, Nausea, Shivering, head ache which advil or tylenol would not control taken at max levels. Both shots were given in same arm and that arm had stiff/cold fingers. Arm sore to touch and could not raise.  These happened the evening of the shot.  The next day:  fever <101F, shivering, body stiffness, stiff neck and joints, massive headaches, sore throat when swallowing, skin sensitivity to the point where hair/follicles hurt, red oval area around shot area. Next evening:  flu-like symptons, shivering then during sleep woke up completly wet with sweat.  11/7/07: Redness around shot area and tender to touch.
Initially, with the second vaccine I ran a high temperature of 102.5 for two days, but when my fever broke, I was wiped out and called in sick to work on Monday (my term as many others I have read, It kicked my butt").  I probably should not have gone back to work on Tuesday, but I did.  I was very fuzzy, and somewhat less fuzzy on Tuesday.  However, my long term issue is that now I have developed high blood pressure. You must understand:  I have no ADRENALS.  People without adrenals do not have high blood pressure.  In fact, the worry going into any procedure is that that individual might develope LOW BLOOD PRESSURE.  So, I checked in for my colonoscopy/endoscopy, knowing that my body was compromised (because of my endorcine issue) and thinking  it was because of the fact that 5-6 years ago I had ulcers from top to bottom, but lo and behold, I had zero ulcers.  In fact when I checked in, my blood pressure was 187/systolic, to my shock!!!   They gave me the spell that the will not follow any medical directives and they willl revive me if I...(stroke out, have a heart attack..whatever.  I guess I quit listening I was so blown away.  I got through the colonscopy/endoscopy and was overoyed that I did not think about my new and previousl unknown blood pressure issues.  So, I did the colonoscopy because I felt my body was compromied and it was my blood pressure.   Since that time my blood pressure has become extremely high, and at times gone back to normal.   I am putting this squarely on the shoulder of Moderna.
Severe pain in the back. Burning across top of back after 2nd shot with no relief, it has been over 2 weeks and I am seriously ready to just put myself down. Swollen bumps down spine painful to touch. Pain bump on lower back that throbs, pain in nerve bundle by tail bone, right buttocks and pain down legs. Extreme fatigue.