chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever for 8 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PYREXIA (Fever for 8 days) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient has never tested positive for COVID 19.  Concurrent medical conditions included Allergy to chemicals (Sulfur) and Blood pressure high.    On 12-Jul-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2022, the patient experienced PYREXIA (Fever for 8 days). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) for Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever for 8 days) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient took concomitant medication for high blood pressure. The patient was administered with 4th dose of the Moderna COVID 19 vaccine. Patient had already visited his HP and they could not do anything. Patient was very worried because the fevers do not stop since 8 days.  Patient did not have any issues with doses 1,2 or 3 .
CNP present after incident.  1550- Became pale, lightheaded - became unresponsive immediately following injection .  Assisted with lowering head to knees (pt was sitting in chair).  Pulse present, resp shallow.  After approx 10 sec, opened eyes agreed to being ok.  1600 - B/P 104/68 P-72 - R 28 .  Didn't become clammy.  Denies nausea 0/0 dizziness.  "Chest hurts - 1605 - BP 118/70 - 1610 HRT R 24 - Recalls little.  1630 Attempted to leave clinic with mother - very vague - c/o tight - numb throat Resp 28 - Began breathing in paper sack - feels better.  1640 - feels better O2 sat 99%.  Left with mother.  Instructed to go to ER if doesn't improve.
Chest pain, palpitations, tachycardia, arrhythmias, spikes in blood pressure, shortness of breath, weakness, dizziness, fatigue, night sweats.
vaccine administered at 16 years old; A spontaneous report was received from a Consumer concerning a 17 year-old male patient who experienced vaccine administered at 16 years old/ MedDRA PT: product administered to patient of inappropriate age.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, the patient received the first of two planned doses of mRNA-1273 (batch: unknown) for prophylaxis of COVID-19 infection.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the event, vaccine administered at 16 years old was resolved on an unknown date.; Reporter's Comments: This report refers to a case of inappropriate age at vaccine administration for mRNA-1273 (batch: unknown) with no associated AEs.
Palpitations  Tingling of arms and hands and slightly lips Dizziness  Clamminess
his blood pressure dropped; feeling itchy at the injection site/My son also had this feeling but it went away; almost fainted; This is a spontaneous report from a contactable consumer (patient's mother). This consumer reported similar events for three patients. This is one of the three reports.  A 17-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date as SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The mother stated that she has been feeling itchy at the injection site. The mother's son and cousin also had this feeling but it went away. The mother also stated that that her son almost fainted when he got the shot. The EMT told them that his blood pressure dropped but it went back up after 10 minutes. The patient was a very fit child. The EMT gave him water and some candy and he felt better. They said it could have been his nerves. The mother asked how to prepare the patient for the second shot so it doesn't happen again. They are scheduled for the next shot on April 28. They hydrated all week before the vaccine but that morning the patient didn't want to drink anything. As for the itching, it was once in a while, and asked if it was normal. Therapeutic measures were taken as a result of all events. On an unspecified date, the patient recovered from "feeling itchy at the injection site/My son also had this feeling but it went away" and his blood pressure dropped while outcome of the event almost fainted was unknown.  Information about lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021437157 same reporter/drug/similar event, different patient;US-PFIZER INC-2021438948 same reporter/drug/similar event, different patient
2 days post vax pt spiked temp of 103.5-104, pale, increased heart beat x 2 days;monitored by mom who kept MD informed;
PATIENT SUFFERED A STROKE SOMETIME THE NIGHT OF 11/28/21 OR THE MORNING OF 11/29/21 RESULTING IN HOSPITALIZATION AND DEATH. MAY NOT HAVE BEEN RELATED TO VACCINE, BUT HAPPENED VERY CLOSE TO VACCINATION.
Gained one pound; Feverish; Right arm soreness; Hardly able to eat; This spontaneous case was reported by an other health care professional and describes the occurrence of FEEDING DISORDER (Hardly able to eat), WEIGHT INCREASED (Gained one pound), PYREXIA (Feverish) and PAIN IN EXTREMITY (Right arm soreness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product PALBOCICLIB (IBRANCE) for Breast cancer.    Concomitant products included EXEMESTANE (AROMASIN) for an unknown indication.   On 09-Sep-2021, the patient started PALBOCICLIB (IBRANCE) (Oral) 125 milligram once a day. On 22-Oct-2021, PALBOCICLIB (IBRANCE) (Oral) dosage was changed to 100 milligram once a day. In January 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEEDING DISORDER (Hardly able to eat), PYREXIA (Feverish) and PAIN IN EXTREMITY (Right arm soreness). On an unknown date, the patient experienced WEIGHT INCREASED (Gained one pound). In January 2022, FEEDING DISORDER (Hardly able to eat), PYREXIA (Feverish) and PAIN IN EXTREMITY (Right arm soreness) had resolved. At the time of the report, WEIGHT INCREASED (Gained one pound) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Platelet count: 191. On an unknown date, Weight: gained one pound.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Recommended dose per prescribing information was 125 mg. Current dose prescription per file was 100 mg 21 days on/ 7 days off, patient reported on and off week of 125 mg dose. Patients platelets dropped down relay low from 17 to 7, so did hemoglobin. The patient was sent to the emergency room to received a blood and platelet transfusion. Patient was instructed to hold Ibrance for 7 days after off week and resume therapy at lower 100 mg dose, while off therapy patient experienced the following "nasal allergy, could not breath, it was not sinusitis like patient thought before. Physician started patient on a nasal spray (Azelastine), patient was weak, hard to talk, rashes all over, bruises and had no energy". Since restarting Ibrance 100mg dose, patient felt a little more energy, improved appetite and still felt a little weak.  Patient received Moderna booster dose. Other labs everything was ok according to physician.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
This spontaneous report as received from a other refers to two patients of unknown demographics. On 15-AUG-2017 the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N011305, expiry date: 20-JAN-2019) for prophylaxis. The doses of PNEUMOVAX 23 were stored at a temperature of 47 degree Fahrenheit (F) to 77 F for time frame of 19 days. No adverse effects reported. No Product Quality complaint (PQC) was involved. This case is cross-referenced with 1708USA007541 (Same Reporter link). Sender's Comments: US-009507513-1708USA007541.
PATIENT WAS GIVEN AN EXPIRED COVID VACCINTATION.  NO ADVERSE REACTIONS NOTED.
No additional AEs; The nurse states V ARlV AX was inadvertently administered to a patient by the intramuscular route instead of the subcutaneous route; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not provided.     On 09-JUL-2021, the patient was inadvertently vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml, lot # T035398, expiration date 16-OCT-2022; strength was unknown) by the intramuscular route instead of the subcutaneous route for prophylaxis (incorrect route of product administration). No additional adverse event was provided. The nurse preferred any follow up with herself rather than prescribing physician assistant.
some scarring going on; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Smallpox vaccine (at the age of 9 years old got the smallpox vaccine which is on the same site), for Immunization, reaction(s): "skin reaction"; Bnt162b2 (DOSE NUMBER UNKNOWN, SINGLE, Anatomical site: Deltoid), for COVID-19 immunisation; Bnt162b2, bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE, Anatomical site: Deltoid), for COVID-19 immunisation. The following information was reported: SCAR (non-serious), outcome "not recovered", described as "some scarring going on".  Additional information: Patient said it looks very much to him like when he was 9 years old when he got the smallpox vaccine which was on the same site. It was also in the same deltoid where he got the previous Pfizer Covid original vaccines as well boosters including the last Bivalent one and he never had a problem with any of them. He had the injection on Sunday, took the bandage off the next morning and it looked about the same as it looks now, doesn't look infected and getting better almost gone but it looks like there's some scarring going on. He was a physician for over 30 years and was curious to see if they have anything reported like that as it happened immediately after the vaccine and definitely has to do with some kind of skin reaction to the vaccine. He said they may want to pass it on to other people maybe it will help somebody else. Then he asked was it possible if this was something more common that's been happening and they start getting reports of this that Pfizer can get to back to him and let him know.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Severe chills, spliting headaches and upset stomach about 48 hr after 2nd dose. Lasted 1 full day then a heaviness in chest set in and I am still short of breath now on day 7.
27 MAR: Received dose #2. Gradual onset of headache and unusually fatigued. 28 MAR: Slight headache, achy joints, sore lower back (kidneys), diarrhea, congestion and runny nose, slight fever (100), unusually fatigued. 29 MAR: Significantly improved, but severe congestion on left side while extremely runny nose on right side. 30 MAR: Regression - complete congestion (only able to mouth-breathe all day). By mid-day, achy joints returned. 31 MAR: Still heavy congestion, but able to breathe through nose. Very sore lower back. Minor achy joints. Mild sweating (with no fever - 98.5) shortly after waking up.
Fibro neuropathy; Sick for 2 days; Couldn't sleep that night; Very breathy; My hands were turning blue for the circulation or like that; Not feeling healthier; 101°F Fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (Fibro neuropathy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Fibro neuropathy) (seriousness criterion medically significant), ILLNESS (Sick for 2 days), INSOMNIA (Couldn't sleep that night), DYSPNOEA (Very breathy), CYANOSIS (My hands were turning blue for the circulation or like that), FEELING ABNORMAL (Not feeling healthier), PYREXIA (101°F Fever) and NAUSEA (Nausea). At the time of the report, NEUROPATHY PERIPHERAL (Fibro neuropathy), INSOMNIA (Couldn't sleep that night), DYSPNOEA (Very breathy), CYANOSIS (My hands were turning blue for the circulation or like that), FEELING ABNORMAL (Not feeling healthier), PYREXIA (101°F Fever) and NAUSEA (Nausea) outcome was unknown and ILLNESS (Sick for 2 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101°F Fever.         No relevant concomitant medications were reported.  No treatment information was provided.  Company comment: This case concerns a female patient of unknown age with previous relevant medical history reported who experienced the unexpected event of neuropathy peripheral. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.   This case was linked to MOD-2021-360198 (Patient Link).; Sender's Comments: This case concerns a female patient of unknown age with previous relevant medical history reported who experienced the unexpected event of neuropathy peripheral. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Information has been received on 07-Oct-2003 from an elementary school licensed practical nurse concerning a 7 year old who on 07-Oct-1996 was vaccinated with varicella virus vaccine live (site unknown). Subsequently, "within the last month," the patient developed chicken pox. The patient sought unspecified medical attention. It was also reported that five other children also developed chicken pox (WAES #0310USA01069 through WAES #0310USA01069, WAES #0310USA01244 through WAES #0310USA01247). Additional information has been requested.
"Tactile" fever and fussiness the evening of 4/7/03. 4/8/03 a.m. extremely fussy, them crying inconsolably for 3-4 hrs. His behavior and physical exam were normal. When PT seen at 16:00 4/8/03.
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 male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GJ2524), in left arm and on 28Apr2023 as dose 6 (booster), single (Lot number: GJ3268) at the age of 74 years, in left arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 04Feb2021 as dose 1, single (Lot number: EL9260), in left arm, on 25Feb2021 as dose 2, single (Lot number: EN6202), in left arm, on 23Aug2021 as dose 3 (booster), single (Lot number: EC3080), in left arm and on 18Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (unspecified if ongoing); "saccular brochiectasis" (unspecified if ongoing); "Allergy: tomatoes" (unspecified if ongoing); "Allergy: Quinolones" (unspecified if ongoing); "Allergy: Hydroxychloroquine" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE, start date: Jan2000. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 17Oct2023 to 21Oct2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300360326 Same patient, different drug, different event.;
pt came in 2 days p/vax w/cellulitis involving most of arm of tetanus inj;vax given in rt arm;
Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039k20-2A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Live, full-term birth) on 18-May-2019, Alcohol use and Nicotine dependence. Concurrent medical conditions included Drug hypersensitivity (Hives, swelling). Concomitant products included COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) from 01-May-2020 to an unknown date, FISH OIL (DHA NATAL) from 01-May-2020 to an unknown date and MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-May-2020 to an unknown date for an unknown indication.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 05-May-2020 and the estimated date of delivery was 07-Feb-2021. On 30-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-fourth week of the pregnancy. The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 30-Dec-2020, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2020, Gene mutation identification test: normal (normal) normal. On 05-May-2020, Ultrasound antenatal screen: normal (normal) normal. On an unknown date, Glucose tolerance test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 32-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Information has been received from a physician concerning a 2 month old pt who was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). The physician reported that the pt subsequently developed hives. Unspecified medical attention was sought and the pt was treated with diphenhydramine HC1 (Benadryl) and steroids. At the time of this report, the pt was noted to be recovering. Additional information has been requested.
Patient was administered vaccine that was improperly stored (in freezer for too long and considered expired by manufacturer at date of administration due to lack of study data). Patient acknowledged recommendation and will schedule revaccination in future.
heart just felt like it was fluttering so fast; Heart was racing; throwing up; weak; Shaking; eyes were rolling back into patient''s head; sick; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jun2021 15:00 (Lot number: EW0217) at the age of 16 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, Time the Vaccination Was Given: First dose: Around 1100 or 1200, lot: EW0178, Route of administration: left arm), administration date: 28May2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: CARDIAC FLUTTER (medically significant) with onset 27Jun2021, outcome "not recovered", described as "heart just felt like it was fluttering so fast"; PALPITATIONS (medically significant) with onset 27Jun2021, outcome "not recovered", described as "Heart was racing"; VOMITING (non-serious) with onset 27Jun2021, outcome "recovered" (2021), described as "throwing up"; ASTHENIA (non-serious) with onset 27Jun2021, outcome "recovered" (2021), described as "weak"; TREMOR (non-serious) with onset 27Jun2021, outcome "recovered" (28Jun2021), described as "Shaking"; EYE MOVEMENT DISORDER (non-serious) with onset 27Jun2021, outcome "recovered" (27Jun2021), described as "eyes were rolling back into patient''s head"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Nausea". The events "heart just felt like it was fluttering so fast", "heart was racing" and "sick" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of palpitations, vomiting, nausea.  Clinical course: The patient was rushed past other gurneys and hooked up to immediately in the emergency room. The patient received an IV to give medication to get the patient's heart rate down. patient stayed in the emergency room for several hours until stabilized, the patient was not admitted and was kept in the emergency room just to make sure the medicine was working and such before being discharged from the emergency room.  Follow-up attempts are completed. No further information is expected.
Continued extreme fatigue, fever, hypertension, bradycardia, severe facial redness and swelling. I am unable to give a detailed report due to this website expiring in 20 minutes. I will be more than happy to submit a complete timeline if needed.
Pt states that all was well until she awoke at 2am with nause. Nausea lasted intermittently until later that day. No known previously diagnosed illnesses.
Tingling numbness in right fingertips and back of right hand noticed at approx 11:55.  2:00 PM noticed back of head numb and left fingertips numb and tingling as well as back of left hand.  Seen by ER DR. at 2:30 PM, said symptoms most likely due to flu vaccine and to come back if symptoms get worse or any muscle weakness. By 6 PM that day tingling noticed in bottom of both feet.  10-12-16 at 6 PM tingling sensation increased up both arms and both legs to knees.  10-13-16 at 4 AM woke up with tip of tongue tingling and face, proceeded to ER again. ER doctor said it should resolve over the next three days and if not see my own physician, or if have any muscle weakness to come back to ER.  Over following three days tingling sensation and numb feeling spread all over my body with a slight itchy, prickly, heat sensation.  Symptoms have not let up over a 13 day period.  Have noticed last 5 days a sensitivity to hot water.  No noticeable muscle weakness, only tired.