chrisvoncsefalvay/vaers-outcomes huggingface dataset:
son with COVID visited him and then he had sx sneezing ST itchy nose and fatigue, fever on 5/13 and + Ag 5/15; son with COVID visited him and then he had sx sneezing ST itchy nose and fatigue, fever on 5/13 and + Ag 5/15; sneezing; itchy nose; This is a spontaneous report received from a non-contactable reporter(s) (Nurse).  A 59-year-old male patient received BNT162b2 (BNT162B2), on 22Feb2021 as dose 1, single (Lot number: EL3247), on 15Mar2021 as dose 2, single (Lot number: EL3247) and on 19Oct2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 58 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 01Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PRURITUS (non-serious) with onset 13May2022, outcome "unknown", described as "itchy nose"; SNEEZING (non-serious) with onset 13May2022, outcome "unknown"; VACCINATION FAILURE (medically significant) with onset 13May2022, outcome "unknown", COVID-19 (medically significant) with onset 13May2022, outcome "unknown" and all described as "son with COVID visited him and then he had sx sneezing ST itchy nose and fatigue, fever on 5/13 and + Ag 5/15". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (15May2022) Positive, notes: unknown suspect home Ag. It was unknown if therapeutic measures were taken as a result of vaccination failure, covid-19, sneezing, pruritus. Clinical course: It was unknown if patient had covid prior vaccination or not.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Vaccination failure, COVID-19 and the administration of the vaccine cannot be excluded.
Skin reaction to an injectable therapy but not to routine vaccines; This case was reported by a physician via call center representative and described the occurrence of skin reaction in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced skin reaction. On an unknown date, the outcome of the skin reaction was unknown.   It was unknown if the reporter considered the skin reaction to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The patient received influenza vaccine and experienced skin reaction. The reporter wanted to know about the ingredient list in influenza vaccine as his patient had skin reaction to an injectable therapy but not to routine vaccines so he was trying to figure out which ingredient might cause it. The reporter did not consent to follow up. No other information was reported.
pt recvd vax;the "needle has not been changed";following vax devel local rxn of swelling of arm;devel 1 cm indurated raised rxn area of 3-4cm & erythema;tx w/ diprolene cream & dph;
04/19/22 presents to ED for "High Blood Sugar". PMHx of "type 1 diabetes with multiple episodes of diabetic ketoacidosis in the past".
03aug89 pt vax 2nd hepta B. pt woke 130 am w/ severe frontal h/a, n\v. photophobia.  ER exam revealed pt was in obvious discomfort. neg for visual acuity, tinnitus, paresthesia, and anesthesia. pt treated w/ demerol and phenazine.h/a impr
I experienced a loss of taste and smell beginning on 11/1/21 and has been intermittent with some smell and taste sensations but has not resolved fully. During my telehealth visit with PCP for loss of taste and smell, she recommended a COVID 19 test which was negative on 12/15/21. My PCP referred me to Ear, Nose, and throat doctor who required a COVID 19 antibody test which showed high antibodies present, and recommended I begin smell therapy after cat scan of my sinuses showed clear (no anatomical reason for loss of taste and smell).
sweating; he slept a lot the day after the shot; chills; fever; This spontaneous case was reported by a non-health professional and describes the occurrence of HYPERHIDROSIS (sweating), HYPERSOMNIA (he slept a lot the day after the shot), CHILLS (chills) and PYREXIA (fever) in a 14-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) 1 dosage form. On 15-Oct-2023, the patient experienced HYPERHIDROSIS (sweating), HYPERSOMNIA (he slept a lot the day after the shot), CHILLS (chills) and PYREXIA (fever). At the time of the report, HYPERHIDROSIS (sweating), CHILLS (chills) and PYREXIA (fever) had resolved and HYPERSOMNIA (he slept a lot the day after the shot) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Intramuscular use) was unknown.       Concomitant medication not reported.   The patient received shot around 2pm on 14 Oct 2023 and developed symptoms overnight of chills, fever and sweating. Symptoms lasted the entire next day, and he slept a lot the day after the shot. It was unknown if the patient experienced any additional symptoms or events.  Treatment medication not reported. Company Comment: This is a spontaneous case concerning a 14-year-old male patient with no reported medical history, who experienced the non-serious unexpected, AESI event of Hypersomnia, which occurred on the following day after a dose of mRNA-1273.815 (Spikevax 2023-2024 PFS) vaccine, together with other non-serious events. It was reported that the patient received shot and developed symptoms overnight of chills, fever and sweating. Symptoms lasted the entire next day, and he slept a lot the day after the shot. The benefit-risk relationship of mRNA-1273.815 (Spikevax 2023-2024 PFS) vaccine is not affected by this report.   Reporter did not allow further contact
24 hour after imm - fever, chills, headache, vomiting, bilat hip pn, cough slight, soreness in arm but no redness or swelling
Patient developed a reddened area 4in x 3in at its largest points-to the center was a deeper reddened area about the size and length of a Band aid the area is red, swollen and painful, as well as hot to the touch.
The patient had lymph node enlargement on the left side of her neck and axilla. PCP gave the patient a steroid and told the patient to rest.
Pt was given first dose of Moderna on June 29,2021 and came back and was administered 2nd dose of Moderna same lot number 051c2a on today. no reaction observed. pt tolerated first vaccine without any reaction or response. will follow up with pt daily.  Pt was assessed by FNP and was given Tylenol in the clinic no reaction observed. no fever.
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 22-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
No adverse effects were reported; patients received improperly stored vaccine; This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. Information about concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 22-APR-2019, the patient was vaccinated with one dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot # R026548, expiration date 17-SEP-2020 for prophylaxis (dose detail, anatomical location and route of administration). The sterile diluent was stored according to the prescribing information. No adverse effects were reported.  The vaccines were exposed to temperature excursion in the range (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 13.7 degree C) for a time frame of 30 minutes with previous temperature excursion (minus 14 degree Celsius (C) to minus 10 degree C) (average minus 12.6 degree C). Data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA005759: US-009507513-1905USA005756: US-009507513-1905USA005757: US-009507513-1905USA005758: US-009507513-1905USA005760: US-009507513-1905USA005843: US-009507513-1905USA005844: US-009507513-1905USA005845: US-009507513-1905USA005846: US-009507513-1905USA005851: US-009507513-1905USA005852:
Patient developed macular like rash over torso, back, neck, and face some 4-8 hrs after receiving his immunizations here at office see below for type 4 vaccines. Low grade temp of 99 degrees noted 24 hours later.
I experienced the usual soreness in my shoulder for 1-2 days following the shot. (I've received flu shots yearly for 15-20 years) However, this time 1-2 weeks after the shot my shoulder became sore again, no visible inflammation or redness. There was no other injury to the shoulder or arm after the vaccination. I have a pain in the shoulder when lifting the arm, especially to remove clothing over my head or lifting a gallon of milk. Some days it aches at rest and is worse in the morning; it is not painful every day. I have taken Naproxen and applied heat some days when it is especially sore. Today is 5 weeks and it is not improving.
Patinet reports  excessive menstrual bleeding, left leg and side numbness, ear pain, blood shot eyes
unspecified number of MMR II doses have been sent to unspecified independent laboratories and have been found to contain glycosates, "which are toxins"; the worst chronic (unspecified) conditions in children; product quality complaint; This spontaneous report was received from a consumer refers to an unknown number of childrens of unknown ages and genders. The patients historical condition, concomitant medications and drug reactions or allergies were not reported.       On an unknown date, the patient s were vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) reconstitute with sterile diluent for prophylaxis(dosage schedule, route, anatomical location, lot number and expiration date were not reported).      Consumer stated that measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) vaccine has produced the worst chronic (unspecified) conditions in children (adverse event). Additionally, stated that an unspecified number of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) doses have been sent to unspecified independent laboratories and have been found to contain "glycosates" which are toxins (product contamination chemical )(product quality issue).   The outcome of product contamination chemical, product quality issue and adverse event was unknown.  At the time of the report, the causality between the aforementioned events and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) was not provided.
Fever, all over body aches, severe headache and chills, all this started about 11:00PM on 12/23/2020,  about 11 hours after I received the vaccine. lasted throughout the night, around 0830 the next morning, felt better, still had a headache. Had low grade fever and slightly achy (not as bad as evening before) on 12/24/2020 evening. Felt completey back to normal by morning of 12/25/2020. I tool OTC extra strength Tylenol and Advil for my symptoms.
This case was reported by a healthcare professional and described the occurrence of decreased therapeutic response in a male subject of unspecified age who was vaccinated with hepatitis B vaccine (manufacturer unspecified). On unspecified dates the subject received 3rd dose, 2nd dose and 1st dose of hepatitis B vaccine (unknown) to complete the series. The subject's hepatitis B titer was tested later on an unspecified date and found to be low. The subject received a booster dose of hepatitis B vaccine from his physician, was tested again, and titers were still found to be low. No additional details were provided.
Felt feverish in late afternoon, did not measure temp; took ASA; approx 1830 noted onset of rash to neck & breast areas; @ this point decided to shower & when stood up had episode of near syncope;stated had not eaten all day;
initial response to vaccine included severe dizziness, rash and itching to arm, flu like symptoms for 2 days. resolved and then red, raised rash with severe swelling occurred 7 days later to same arm, resolved after 3 days
Patient developed hives and rash directly after given PNEUMOVAX 23 IM administered at the pharmacy.
GI symptoms, loss of appetite, fever, body aches  Between 10am-2pm day following vaccination.
Pain in right arm immediate after vaccine. Lymph nodes swelled under arm along with swelling in upper arm. ob/gyn ordered a mamogram and ultrasound of right breast. Swelling went away
Patient went to ER on 4/12/2022 with swelling in RLE for two days.  Pfizer vaccine administered on 4/7/2022, developed symptoms on 4/10/2022.  No prior history of DVT, no recent trauma or no recent trips.  Doppler showed (R) leg DVT, patient started on Eliquis from ER.  Office visit 4/20/2022 with PCP, continues to have swelling and some pain, relieved  with Tylenol.  Denies any SOB or chest pain.  Patient provided prescription for Xarelto 20 mg, insurance will not cover Eliquis.  Discussion with patient to follow up with Dr. (vascular), keep already established appointment for May.  Patient also instructed to report to VSAFE.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED =============================================================================  ACUTE HYPOXEMIC RESPIRATORY FAILURE 1/18/2023 COVID-19 DISEASE
Pt recvd 3 doses of Hep B vax; 3rd dose given w/Engerix B & was given 20AUG90; It was determined that pt was not immune to Hep B;
12-1-09 site was red and hard size of grapefruit no fever. Patient complains it hurt, itches. 12-2-09 site bigger, top of thigh to knee cap. Warm to touch.
PATIENT FELT NAUSEATED AFTER THE SHOT BUT REMAINED SEATED FOR 20 MINUTES.  AFTER 20 MINUTES SHE DECIDED TO LEAVE BUT FELT LIGHT HEADED AND NAUSEATED AND SAT DOWN IN A CHAIR AND PASSED OUT FOR ABOUT 1 MINUTE.  SHE WAS PALE BUT CAME TO WITHIN A MINUTE.  VITAL SIGNS WERE CHECKED BY EMS AND CAME BACK NORMAL AND SHE WAS ABLE TO LEAVE 30 MINUTES LATER.
About one week after Covid vaccination employee developed a red circle at the injection site which was itchy.  It resolved after 5 days.
Initial information has been received from a physician via Sanofi Pasteur on 06-JUL-2015, referring to a 2 year old female baby patient. Concurrent conditions or pertinent medical history were not reported. On 01-JUL-2015, the patient was vaccinated with one dose of PNEUMOVAX 23 (lot# K012824, expiry date was unknown) intramuscular into deltoid of right upper (dose was not reported) arm. Concomitant therapies were not reported. On 01-JUL-2015, 5 min after vaccination, the patient experienced difficult breathing, cyanosis, purpura on bilateral cheeks and about 1 cm size of purpura behind left ear, scattered bleeding spots on head and neck; this patient's condition was considered as allergy to PNEUMOVAX 23 (allergy to vaccine). The patient was given oxygen in lying position, anti-allergic and symptomatic treatments also were given. It was stated that this symptoms resolved after 10 minutes, therefore, the patient was admitted to superior hospital for further observation. At the time of the report, the patient was recovering from allergy to vaccine. The relatedness between PNEUMOVAX 23 and allergy to vaccine was related, and this adverse event was considered as serious by the physician due to hospitalization, and life threatening by the nurse. Additional information has been requested.
FEVER AND SEIZURES, LESS THAN 2 MINUTES. Medical records state otitis, irritable, viral infection. msv
Only received first dose of COVID19 Pfizer vaccine 02/17/2021. Hospitalization for COVID19 7/21/21-7/23/21. Received dexamethasone IV and Remdesivir.
severe joint pain/My husband also has this; This is a spontaneous report from a contactable consumer or other non hcp (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown, Expiration date: unknown) via an unspecified route of administration on an unspecified date as a DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient did not receive other vaccine in four weeks. The patient was not experienced covid prior to vaccination and was not tested covid post vaccination. The patient had no known allergies. The reporter stated that, approximately 3 weeks on 10Apr2021, after the 2nd vaccine patient began having severe joint pain that she has never had before. Her husband (patient) also has this (on an unspecified date). Patient did not receive any treatment for the AE. Outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-2021495003 same reporter/drug/event , different patient
Increased chronic swelling of feet and ankles assosiated with Primary Lymphedema, with swelling begining to show in the lower legs. Sypmtoms have not subsided after  2 weeks.
Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient called on 12/28/21 to report had a pronounced body rash on 12/27/21 the day after receiving her booster shot....she said it was the same kind of rash that she gets when she takes a medication that she is allergic to.....I asked her if she got this same reaction when she received her intial and second doses of moderna and she said she did not have any reaction....patient was also calling her doctor as well to report.
Fever; body aches; cough congestion; headache; nausea; diarrhea; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine, asthma, fruit allergy (citrus fruits) and penicillin allergy. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 12Mar2021 at 08:30 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patient previously took Morphine and Codeine and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 07Apr2021 at 10:00, the patient experienced fever, body aches, cough congestion, headache, nausea and diarrhea. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events. The clinical outcome of the events fever, body aches, cough congestion, headache, nausea and diarrhea were recovering at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 01-NOV-2014, the patient was vaccinated with the first dose of GARDASIL injection (dose, route of administration, lot # and expiry date were not reported). On 08-JAN-2015, the patient was vaccinated with the second dose of GARDASIL injection (dose, route of administration, lot# and expiry date were not reported). On 07-APR-2015, earlier than recommended, the patient received the third dose of GARDASIL injection (dose, route of administration, lot # and expiry date were not reported). There were no concomitant therapies reported. No adverse reactions were reported. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant therapies, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with doses of oral, ROTATEQ (dose, route of administration, anatomical location, lot# and exp.date were not reported) that underwent a temperature excursion. No adverse effects were reported. The outcome of the event was unknown. Additional information has been requested.
Rec'd BEXERO 12/5/16 - within 24 hours pt. had red/swollen/tingling toes and distal feet. Persistent signs and symptoms x 2 months. Patient is uncomfortable. Attempted topical ointment (steroid) without relief. No fever. Similar incident with BEXSERO #1 8/1/2016 - lasted approx 10 days.
3 patients received a Moderna COVID-19 vaccine came from 2 days expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 patients received a Moderna COVID-19 vaccine came from 2 days expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 patients received a Moderna COVID-19 vaccine came from 2 days expired vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 patients received a Moderna COVID-19 vaccine came from 2 days expired vial) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant  medications were provided. No Treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 31-Aug-2021: Follow up received on 31 Aug 2021,contains No New Information and event date updated from initial