chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Long heavy menstrual cycle. Cycle started June 24 and ended July 3. Then I started spotted for a few days (5days). Cycle became heavy July 19 and hasn?t stopped as of today July 21
feel dizzy/dizzy; Headache; Chills; Sore left deltoid muscle; Fever 100.4 degrees Farenheight; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (feel dizzy/dizzy), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Sore left deltoid muscle) and PYREXIA (Fever 100.4 degrees Farenheight) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A-1) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced DIZZINESS (feel dizzy/dizzy), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Sore left deltoid muscle) and PYREXIA (Fever 100.4 degrees Farenheight). At the time of the report, DIZZINESS (feel dizzy/dizzy), HEADACHE (Headache), CHILLS (Chills), MYALGIA (Sore left deltoid muscle) and PYREXIA (Fever 100.4 degrees Farenheight) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.4 (High) 100.4 degrees Farenheight.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. The treatment information was unknown.
This spontaneous report as received from a nurse refers to an 8 months 28 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Apr2021 as dose 1, single (Lot number: ER8729), in left arm and in May2021 as dose 2, single (Lot number: EW0173) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "seasonal allergies" (unspecified if ongoing); "Vaccine brand other: Moderna, Dose number:3/Vaccine brand: Pfizer/BioNTech, Dose number: 2 And 1." (unspecified if ongoing), notes: Vaccine brand other: Moderna, Dose number:3/Vaccine brand: Pfizer/BioNTech, Dose number: 2 And 1. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 09May2022, outcome "recovered" (May2022) and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative; (09May2022) Positive; (10May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid from 11May2022 to 16May2022.
Bell's Palsy; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 03Mar2021 15:00 (at the age of 67years) as single dose for Covid-19 immunization. Medical history included hypertension, type 2 diabetes mellitus, kidney disease, and known allergies to Penicillin and Sulfa drugs. Concomitant medications included amlodipine besylate (AMLODIPINE BESYLATE) and dulaglutide (TRULICITY); both taken for an unspecified indication, start and stop date were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 19Mar2021 (13:00 Friday), the patient experience left side of face became numb and droopy with droopy eye lid and numb lips. The patient sought medical care; stroke was ruled out. The diagnosis was Bell's Palsy. Valacyclovir hcl 1-gram tab was prescribed. The adverse event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient has not been tested for COVID-19 since the vaccination. The outcome of event was recovering. The event was considered serious (seriousness criteria: important medical event).  Information about lot and batch number was requested.
On 1/18/2021 I started having very swollen lymph nodes they were very painful it lasted about 2 months to go completely away.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 06-JUN-2016, the patient was vaccinated with incorrectly stored dose of M-M-R II lot # L026553, therapy type was not specified (dose and route of administration were not reported). This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a physician and a nurse concerning a 10 month old female who on 19-JUN-2007 was vaccinated with a first dose of ROTATEQ oral.  On 07-AUG-2007 the patient was vaccinated with a second dose of ROTATEQ (lot# 657515/0668U) oral.  On 05-OCT-2007 the patient was vaccinated with a third dose of ROTATEQ (lot# 657045/1053U) oral.  Concomitant therapy on 05-OCT-2007 included PREVNAR and PEDIARIX.  On 20-FEB-2008 the patient experienced vomiting and diarrhea.  The patient was taken to the hospital and was diagnosed with intussusception.  A CT scan was performed with no result provided.  The patient was then airlifted to a different hospital.  When the patient got to that hospital the intussusception was gone.  Intussusception was considered to be disabling and immediately life-threatening.  Additional information has been requested.  8/19/08 Reviewed hospital medical records of 2/21/2008. FINAL DX:  gastroenteritis; IS spontaneously resolved Records reveal patient had been transferred via helicopter from outlying ER with diagnosis of intussusception. Patient had experienced abdominal pain x 2 days w/nausea, vomiting, copious watery diarrhea, decreased urine output & irritability.  In outlying ER had abdominal distention.  CT scan done which was c/w IS & transferred to higher level of care.  Surgical consult done.  Tolerated PO fluids in ER & d/c to home.  8/26/08 Reviewed ER medical records of 2/20/2008. FINAL DX: Intussusception Records reveal patient experienced vomiting, diarrhea & reduced oral intake x 2 days.  In ER had fever 101, pulling at ears, behaving abnormally, decreased urine output, no tears w/crying.  Transferred to higher level of care.
The float pharmacist that came in administered the shingrix vaccine to a couple but did not mix both vaccines, instead he injected one patient with diluent only and the other with the vaccine.
Patient got first dose of moderna vaccine series on 2/5/22. The patient got her second dose on 2/26/22.  This is only a 21-day wait and not the 28-day wait recommended , and thus is a medication error.
Myalgia, Fever, chills fatigue Narrative:  Other Relevant History:
I picked up my grandson and was notified that people tested positive. So I got a COVID-19 test that was positive. I was completely asymptomatic. No symptoms. I tested negative within 10 days.
Pt received 1st Dose of Pfizer vaccine on 03/29/21. Mother reported that patient began to experience Fever; Drooping & Swelling on right side of face on 03/30/21. Swelling is decreasing but there is still some drooping. The patient is Epileptic and is also taking Dilantin and Phenobarbital to control the seizures.
I had the flu shot on Monday 10/20/2003, after that I had a low grade fever with muscle ache, running nose, coughing for 2 weeks.  (I have had flu shot every year for more than 10 years, but I have never felt sick for so long like this before).
HYPOTENSION 3/22/2022 ATHEROSCLEROSIS OF AORTA
pt recvd Engerix-B vax & w/in a few minutes of inject felt funny feeling between eyes devel a stiff neck 20 minutes later; also was shaky, legs like jello, SOB, achy all over, nervous, upset & confused; seen in ER;
Sore arm - at 4 days - subsiding Fever - 2 days Chills - 1 day Shortness of breath - ongoing since 2nd day Dizziness/lightheaded - ongoing since 2nd day
Gall bladder removal; multiple attacks of pancreatitis; This spontaneous report was received from a consumer (patient's wife) refers to an adult male patient of unknown age. The patient's allergies included cramps from codeine. Pertinent medical history and concomitant medication were reported to ne none. On an unspecified date (reported as when the patient was infant), the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, strength, lot and expiry was not reported) via subcutaneous route for prophylaxis. The measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was reconstituted with Merck sterile diluent. On an unknown date in approximately 1988 (reported as at the age of 26), the patient was hospitalized and had gallbladder removal (cholecystectomy) done (hospital details unspecified). On an unknown date in November 2018, the patient experienced multiple attacks of pancreatitis and that got recovered on an unknown date of March 2019. On an unknown date of 2019, the patient visited the emergency room where he was diagnosed with pancreatitis and he was started therapy with fentanyl for his pain and subsequently was sent home. On unknown dates, the patient performed computerized axial tomography (cat scan), endoscopy, magnetic resonance imaging (MRI) and blood test (details and results were unspecified). Causality assessment was not provided.  Upon internal review, the event pancreatitis was considered to be medically significant.
began running on elevated temp the afternoon of the vax temp reached 104.2 while on APAP pt was also fretful during this time; pt cont to run temp x 5 days; temp ranged from 99-102;
I received my Vaccinations of ZOSTAVAX on 10/06/2012. Lot #H009779 expDte 23 MAR 2013. On Monday 10/07/2012 I experienced a sensation on my right arm above the biflex...the vaccination was given in my left arm. By Tuesday 10/08/2012 I had a number of blisters forming on my right arm like a Herpes Virus blister. On Wednesday I called the pharmacy and asked if I could take the medication for Herpes and they said not for 14 days after the vaccination. By Saturday a large area on my upper arm was covered with painful blisters. On Monday I attended the physician who prescribed the vaccination and she said she had never seen this kind of reaction to the ZOSTAVAX and stated that it looked as though it was spreading more and could possibly got infected so she had put me on antibiotics and pain medication. I have a location on my leg that breaks out in Herpes if I get too much exposure to the Sun and I know how to treat it...none of this treatment antibiotic salve and bandages works on this outbreak on my arm.
This case was reported by a physician via call center representative and described the occurrence of localized muscle pain in a 44-year-old female patient who received BOOSTRIX (batch number B54KE, expiry date 2nd April 2017). This case was associated with a product complaint. Concurrent medical conditions included hypertension. On 5th June 2015, the patient received BOOSTRIX (subcutaneous) .5 ml. On 5th June 2015, less than a day after receiving BOOSTRIX, the patient experienced localized muscle pain, axillary pain and local swelling. On an unknown date, the outcome of the localized muscle pain, axillary pain, local swelling and product complaint were unknown. It was unknown if the reporter considered the localized muscle pain, axillary pain, local swelling and product complaint to be related to BOOSTRIX. Additional  information provided: The physician suspected a Quality Concern with this vaccine and their office has withheld the rest of this lot number. QA filed UV20150062. This case is one of the 2 cases reported by the same reporter for the same vaccine. Follow-up received on 19 June 2015: Some information was received as follow-up but for the other patient. Clarification has been requested.
Redness and swelling on left upper arm (from about the shoulder to elbow - hot, inflamed and swollen). Started the morning after receiving shot. Tx: Advil, hot packs, etc.
We had a pt today , saying that he got Fluzone HD last week and his arm started turning red and was  swollen from around one week. Almost the whole arm turned red and swollen which is not subsided with Advil
Per phone conversation with mother she states upper left are is red, warm to touch and slightly swollen.
This case was reported by a healthcare professional, via a GSK representative, and described the occurrence of erythema in a subject of unspecified age and gender who was vaccinated with KINRIX, (GlaxoSmithKline).  On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, route unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced erythema, hardness injection site, swelling injection site and injection site warmth.  At the time of reporting the outcome of the events was unspecified.  The healthcare professional considered the events were possibly related to vaccination with KINRIX.  This case corresponds to a pharmaceutical product complaint.  The healthcare professional reported that 15 subjects experienced the same events in the same time period after vaccination with KINRIX.  At the time of reporting, no additional information was available.  This is case 1 or 15 (see case IDs A0860688A, A0860690A - A0860702A for the other reports).
about 3 hrs p/vax pt became extremely pale & limp w/shallow resp; 02 & IV fluids were administered; full sepsis work-up done due to age-was r/o;
Nausea, vomiting, diarrhea, lethargy, fever, chills.  Out of work x7 days.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Mar2021 as dose 1, single (Lot number: EN6200), in left arm, on 04Apr2021 as dose 2, single (Lot number: EP7533), in left arm, on 22Oct2021 as dose 3 (booster), single (Lot number: FF2593), in left arm and on 05May2022 as dose 4 (booster), single (Lot number: F4989) at the age of 74 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Acid reflux" (unspecified if ongoing); "known allergies : sulfa" (unspecified if ongoing), notes: known allergies : sulfa. There were no concomitant medications. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative, notes: After receiving Paxlovid 5 days, tested negative until 31Jul2022; (unspecified date) Positive, notes: then tested positive; (2020) Unknown results, notes: I probably got COVID before there were tests for it in early 2020. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: The patient received Paxlovid from 22Jul2022 to 27Jul2022 for COVID 19 Treatment. The patient did not take other medications in 2 Weeks.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044M21A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 20-Nov-2020 and the estimated date of delivery was 27-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Dec-2020, Pregnancy test: positive (Positive) Positive. On 18-Feb-2021, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient had 3 previous pregnancies which included one live full time birth and two miscarriages. Patient reported that this pregnancy resulted from fertility treatment.  No concomitant or treatment information was reported.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 28Feb2022 as dose 3 (booster), single (Lot number: FG3527) at the age of 72 years intramuscular, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 10Feb2021 as dose 1, single (Lot number: 016M20A), in right arm, on 10Mar2021 as dose 2, single (Lot number: 032M20A), in right arm and on 03Apr2022 as dose 4 (booster), single (Lot number: 002M21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sesame, reaction(s): "known allergies: sesame"; Sunflower seed, reaction(s): "known allergies: Sunflower seed". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (08Jul2022) Negative; (11Jul2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid from 02Jul2022 to 07Jul2022 as treatment of COVID-19. COVID rebound. One day after finishing Paxlovid, COVID test was negative. Two days later new symptoms developed. Retest for COVID was positive (11Jul2022).  This is a notification generated from the gQTS system. As part of the LOE simplification process, the following Complaint Records were classified as Product Use Attributes Lack of Effect and have been moved to Closed (No Investigation) state referencing a previously completed investigation for the same product and lot as per the One and Done business process according to in PQS Q1215 and or Q1252. Refer to the below table for details: Product Description (CR): COMPOUND BNT 162 COVID 19 VACCINE SUSPENSION FOR INTRAMUSCUL AR 2ML MULTIPLE DOSE VIAL X 1. Lot-# (CR): FG3527. Conclusion of Previously Completed Investigation (FCI/SI/OffCI): The complaint for lack of effect of the PFIZER BIONTECH COVID-19 VACCINE lot FG3527 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FG3527, fill lot FG3512, and the formulated drug product lot FJ8500. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.
DIED; RARE INFECTION OF THE HEART; COULD NOT WALK THERE AFTER; This spontaneous report received from a consumer via a company representative via social media concerned a male of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. 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 got sick right away after vaccination. The patient could not walk there after and then got rare infection of the heart. On an unspecified date, the patient died from unknown cause of death. It was unspecified whether an autopsy was performed or not.  As per the consumer, "My Brother got the shot and got sick right away, he could not walk there after and then got rare infection of the heart and died ". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of could not walk there after and rare infection of the heart was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0-20221214459-Died. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.  V0-20221214459- Rare infection of the heart. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable..; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Subject experienced tenderness and swelling at injection site. He also had a general feeling of malaise. About a week and a half after the last shot, he experienced lymph node swelling in his neck and axillary area along with insomnia. He also developed sore throat, tremors and night sweats. The subject had had numerous blood tests and has been seen by many doctors. Test for mono, HIV, CMV have been negative. White blood cell count has been low. The subject was seen by an Oncologist who ruled out lymphoma. Additional information received 4/3/03: Subject reports all symptoms have resolved. White blood cell level has returned to normal.
NAUSEA, VOMITTING, HEADACHE.  STARTED ABOUT 13 HOURS AFTER INJECTION. UNABLE TO HOLD ANY FOOD OR LIQUIDS FOR 24 HOURS, STILL NAUSEA AND TIRED, PLUS HEADACHE 36 HOURS POST INJECTION.
rph found that the product was expired by one day , contacted pfizer and they said it is ok and doesn't need revaccination .
Day 0 = no adverse events Day 1 = fever, chills, headaches, body aches.  Day 2 = above symptoms resolved. New symptom of bilateral hand tingling. Day 3 = Hand tingling resolved. New symptom of bilateral palmar macular erythematous rash.  Day 4 = Similar rash appeared on bilateral shoulders and posterolateral neck.
I was extremely dizzy and light headed for a few days starting the day after the vaccine. In addition, my menstrual cycle started almost two weeks early and has continued past the typical 4-6 day window despite taking my birth control regularly. This particular period is much stronger and longer, even continuing past the re-starting of my new birth control packet.