chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BRUISING TO BOTH ARMS, LEFT UPPER LEG, AND RIGHT BREAST 3 DAYS AFTER VACCINE.  WITH ASSOCIATED HEADACHE 7:10 X 9 DAYS. HAS IMPROVED TO 3:10 BUT STILL PRESENT.
Hives on legs, gone after 2 days of benadryl. Swollen tonsils. Perscribed prednisoLONE 15mg/5ml. Tonsils are still swollen as of 10:29pm 08/22/2019
Patient received 3 vaccines. Approx 5 minutes later patient was standing and fainted to floor. MD responded immediately. LOC for approximately 30 seconds. Woke with head pain from hitting head on floor. Rested for about 15 minutes and able to walk w/dad.
Power outage Max/Low Temperature reached: 47.60 F Duration out of labelled range: 3 hours with no reported adverse event; vaccine was adminsitered post excursion with no reported adverse event; Initial information was received on 22-Dec-2022 regarding an unsolicited valid non-serious case received from a consumer/non-health-care professional.  This case involves 11 months old female patient who was adminsitered post excursion with no reported adverse event and power outage max/low temperature reached: 47.60 f duration out of labelled range: 3 hours with no reported adverse event ,after receiving vaccine ipv (VERO) [Ipol].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (Daptacel) for Immunisation.   On 16-Dec-2022, the patient received a dose number 3 of suspect ipv (VERO) (lot V1B901M  and expiration date: 02-Jun-2024) at a dose of 0.5ml via intramuscular route in the left thigh for immunization.  On an unknown date , the reporter stated the vaccine had temperature excursion due to power outage max/low temperature reached: 47.60 f duration out of labelled range: 3 hours with no reported adverse event (product storage error).  On 16-Dec-2022(latency: same day),  the patient developed a non-serious event " vaccine was adminsitered post excursion with no reported adverse event "(poor quality product administered)same day following the first dose administration.    Action taken :not applicable.  It was not reported if the patient received a corrective treatment for the events.   Outcome: unknown for both events   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 the 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.
sore arm; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (sore arm) and MYALGIA (body aches) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, 010A21A and 024M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Feb-2022, the patient experienced MYALGIA (body aches). On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown and MYALGIA (body aches) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant information provided  After receiving the dose patient experienced body aches starting 4-8 hours after receiving each dose and lasting 12-24 hours. She also experienced a sore arm with these doses. She took some ibuprofen for her symptoms. Patient was concerned with an allergic reaction.   This case was linked to MOD-2022-670598 (Patient Link).
Presents for INJECTION SITE REACTION. Skin: Skin is warm and dry. Rash noted. There is erythema. Hive like rash over R deltoid, about 1 cm from vaccines sites? Tender, erythematous (pink) and slightly raised 682.9 CELLULITIS (primary encounter diagnosis) 502079 VACCINES ADVERSE REACTION 692.9 DERMATITIS, ALLERGIC.
Pt reported itching on left arm, numbness left hand.  MD offered Zyrtec, pt refused.
The day after my first dose, the veins in the back of my hands began painfully throbbing on an intermittent basis. The pain increased significantly after the second dose and continues on an intermittent basis over a month after the first dose. At times the pain is extreme.
half of the upper arm was red; slightly elevated skin; arm that got the injection started itching; delayed skin rash at the injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE ERYTHEMA (half of the upper arm was red), VACCINATION SITE SWELLING (slightly elevated skin), VACCINATION SITE PRURITUS (arm that got the injection started itching) and VACCINATION SITE RASH (delayed skin rash at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to sween cream) and Penicillin allergy.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (half of the upper arm was red), VACCINATION SITE SWELLING (slightly elevated skin), VACCINATION SITE PRURITUS (arm that got the injection started itching) and VACCINATION SITE RASH (delayed skin rash at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (half of the upper arm was red), VACCINATION SITE SWELLING (slightly elevated skin), VACCINATION SITE PRURITUS (arm that got the injection started itching) and VACCINATION SITE RASH (delayed skin rash at the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-077736 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI On 25-May-2021: NNI; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the event, a casual relationship cannot be excluded.
This spontaneous report as received from a vaccine administrator via a company representative refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date. the patient was diagnosed with shingles. The outcome of shingles was unknown. The relatedness between the adverse event and ZOSTAVAX was not provided. Additional information is not expected as there are no reporter's contact details.
Really bad sweets, "like I just got out of the shower" ( for 4 days); Initially had pain in his left arm, it went away and came back a week later; Diarrhea every day since the shot; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Really bad sweets, "like I just got out of the shower" ( for 4 days)), PAIN IN EXTREMITY (Initially had pain in his left arm, it went away and came back a week later) and DIARRHOEA (Diarrhea every day since the shot) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FINASTERIDE (PROPECIA) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (Really bad sweets, "like I just got out of the shower" ( for 4 days)), PAIN IN EXTREMITY (Initially had pain in his left arm, it went away and came back a week later) and DIARRHOEA (Diarrhea every day since the shot). At the time of the report, HYPERHIDROSIS (Really bad sweets, "like I just got out of the shower" ( for 4 days)), PAIN IN EXTREMITY (Initially had pain in his left arm, it went away and came back a week later) and DIARRHOEA (Diarrhea every day since the shot) outcome was unknown.            The treatment information was not provided.
No adverse event; 16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 16-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 prophylaxis.     No Medical History information was reported.    In February 2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (16-month-old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine).    No concomitant medication were reported.  It was reported that a 16 month old patient received expired first monovalent primary dose of Moderna COVID-19 vaccine on unknown date after 14-FEB-2023. No treatment information was provided by the reporter.
pt recvd vax 1SEP95, 18SEP-19SEP exp difficulty, chewing on rt side of mouth, jaw was swollen
Approximately two and a half weeks after receiving rubella vaccine the patient began having pain in right ankle and both hands.  On 2/18/08 her ankle was swollen to double it's normal size, 2/22/08 still having arthritis symptoms in hands, her left is so swollen, she doesn't recognize it.  She is unable to wear her rings on her fingers.  On 2/29/08 she described her arthritic symptoms as resolving, the swelling had decreased and she is able to wear her rings.
Reported feeling "funny" and "uncoordianted" immediately following administration of vaccines. Reported feeling worse 12/5/03 with fever. Eyes began to swell 12/5/03. By 12/7/03 eyes were swollen bad pt couldn't open or close them. Reported feeling better today-no fever. "Still fees uncoordinated" and eyes are still a little puffy. Reports vomiting, coughing and sore throat on 12/7/03.
Patient hospitalized on medical floor. Nausea, intermittent abdominal pain, occasional diarrhea, fatigue and shortness of breath.  Minimal respiratory symptoms, full feeling in lungs. Vomitting, 3X and diarrhea 2X day of admission. Received dexamethasone. Admitted to hospital to manage covid pneumonia with GI symptoms.
I had a cough for two days that got worse,  nasal congestion & body aches.
I have developed a fine red rash over my neck, chest, and there are several patches of rash on my stomach now. This rash has also spread down the right arm a bit. In addition to rash, I also experienced more common side effects of fever, chills, body aches, fatigue and headache since 2/6 , milder now but still present.
BODY ACHES AND WHOLE RIGHT SIDE HURT; FEVER; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's past medical history included stent placed due to a blockage, and stroke, and concurrent conditions included heart problems.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, and expiry: 21-JUN-2021) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced fever. On 08-APR-2021, the subject experienced body aches and whole right side hurt. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 08-APR-2021, and had not recovered from body aches and whole right side hurt. This report was non-serious.
Patient fainted about 10 minutes after receiving first dose of Moderna.  Patient fell from chair with no warning.  He regained consciousness within a few minutes.  The paramedics came and checked patient out.  He left about 30 minutes later after reporting he felt better.
Passed out after feeling very nauseous. Loss of bladder control. Unconscious for about 30 seconds. Weak and shaking for several hours after.
Body pain in joints and muscle; injection site pain; Headache; Fatigue; Chills.
That same day I had joint, nerve and muscle pain, and inflammation. Lost mobility, walked like a 200 year-old woman,. Worst for 72 hours, but it lasted for weeks. Went to Urgent Care. Diagnosed as an inflammatory syndrome related to immune response, PCP doctor agreed.  Prescribed and took OTC meds. Still have occasional pains.
The first dose I just had pain in my arm. The second dose, I had pain in my arm and a severe headache. Some time had passed and towards the end of July, I had a headache, body sweats, body chills, coughing, sneezing and congestion so I went and got tested at a rapid test center and was confirmed to have COVID-19. I hadn't had contact with anyone since my vaccination, so when I felt the symptoms, I knew it had to be from the vaccine.
This case was reported by a nurse and described the occurrence of itchy rash in a female subject of unspecified age who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. On an unspecified date in 2005, on or before 04 November 2005, the subject received 1st dose of Fluarix (lot AFLUA154BA). At an unspecified time after vaccination with Fluarix, on or before 04 November 2005, the subject experienced a "generalized itchy rash." The subject was seen at a physician's office. The outcome of the event was not reported.
The pt's mother called to state that the child's arm was swollen from shot site to elbow. That call came in on 12/12/01. The RN called family on 12/14/01, to see how the child was doing and the mother stated there was much more swelling. Mother was advised to give child Tylenol and put a cold compress on shot site.
SOB, wheezing, rash, dizziness, nausea went to ER. Given to BENADRYL, Prednisone po. Given Albuterol.
Information has been received from a physician concerning a female who on 31-JUL-2007 was vaccinated with GARDASIL (lot number: 656371/0181U).  On 31-JUL-2007 the patient experienced syncope.  Subsequently, the patient recovered from syncope.  No further information is available.
This spontaneous report as received from a healthcare worker concerning a patient of unknown age and gender. Medical history and concurrent conditions were not reported. On 07-MAY-2014, the patient was vaccinated with one dose of RECOMBIVAX HB (dose, strength, lot number and expiration date were not reported) intramuscular route. Co-suspect and concomitant therapies were not reported. The healthcare worker reports that an improperly stored RECOMBIVAX HB was administered. The reporter stated that the RECOMBIVAX HB was exposed to a temperature of 34F for 30 minutes on 05-MAY-2014. No adverse effect reported. Additional information has been requested. These case is one (1) of ten (10) reports from the same reporter. (MARRS 1405USA011237, 1405USA013601, 1405USA013602, 1405USA013603, 1405USA013604, 1405USA013605, 1405USA013606, 1405USA013607, 1405USA013608 and 1405USA013609).
Skin redness, bumps and pustules on her legs. Child was brought to ED. Pt was discharged with diagnosis dermatitis of viral origin and to use calamine lotions for itching and Tylenol or Motrin for any pain or fever.
Temp of 102.8 a few hours after injection.  This temp was relieved after a couple of hours without any medication.; This is a spontaneous report from a contactable consumer or other non healthcare professional. A adult female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included unknown from an unknown date and unknown if ongoing.     The patient's concomitant medications were not reported. The patient experienced temperature of 102.8 a few hours after injection.  this temperature was relieved after a couple of hours without any medication on an unspecified date with outcome of recovered. The patient underwent lab tests and procedures which included body temperature at 102.8.  Follow-up (15Mar2021): This is a follow-up spontaneous report received from contactable consumer. This consumer reporting for female patient that, She became aware of the event on 8Mar2021.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Site: Pain at Injection Site-Mild, Additional Details: I selected wrong reasoning on previous report  as route but it was an event of she felt radiating pain day after shot
Body pain; Blood in ears; Shortness of breath; Congested; Flu-like symptoms; Sore and red at injection site; Sore and red at injection site; Headaches in temples and across head; Low grade fever; Really tired; Throwing up; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body pain), EAR HAEMORRHAGE (Blood in ears), DYSPNOEA (Shortness of breath), NASAL CONGESTION (Congested) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039V20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Body pain), EAR HAEMORRHAGE (Blood in ears), DYSPNOEA (Shortness of breath), NASAL CONGESTION (Congested), INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE PAIN (Sore and red at injection site), VACCINATION SITE ERYTHEMA (Sore and red at injection site), HEADACHE (Headaches in temples and across head), PYREXIA (Low grade fever), FATIGUE (Really tired), VOMITING (Throwing up) and NAUSEA (Nauseous). The patient was treated with ACETYLSALICYLIC ACID (ALKA-SELTZER) at an unspecified dose and frequency. At the time of the report, PAIN (Body pain), EAR HAEMORRHAGE (Blood in ears), DYSPNOEA (Shortness of breath), NASAL CONGESTION (Congested), INFLUENZA LIKE ILLNESS (Flu-like symptoms), VACCINATION SITE PAIN (Sore and red at injection site), VACCINATION SITE ERYTHEMA (Sore and red at injection site), HEADACHE (Headaches in temples and across head), PYREXIA (Low grade fever), FATIGUE (Really tired), VOMITING (Throwing up) and NAUSEA (Nauseous) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: low (Low) Low.         No concomitant medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.    Action taken with mRNA-1273 in response to the events was not applicable.
Information has been received from a medical receptionist concerning a 12 month old white male with no allergies and no relevant medical history who on 09JUL2003 was vaccinated with a subcutaneous first dose of varicella virus vaccine live in the right arm. Concomitant therapy on 09JUL2003 included a subcataneous first dose of measles virus vaccine live + mumps virus vaccine live + rubella virus vaccine live (second generation) in the left arm. Previously reported as no concomitant medication. On approximately 19JUL2003, " a few days later", the patient developed a "low grade fever", for one week. On 19JUL2003, he woke up with a rash on his stomach and blisters on one arm. The patient was treated with diphenhydramine hydrochloride (benadryl) for the itch and acetaminophen (tylenol) for the fever. Subsequently, the patient recovered. A product quality complaint was not involved. Unspecified medical attention was sought. No further information was available. No further information is expected.
received a 0.25ml dose of the vaccine four months after her second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a 0.25ml dose of the vaccine four months after her second dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 31-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a 0.25ml dose of the vaccine four months after her second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received a 0.25ml dose of the vaccine four months after her second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that patient was not immunocompromised back then, but at the time of reporting she was.  Treatment medication was not provided by the reporter.
8/29/2021  1110 Received COVID Booster 1800 Felt moderate soreness in left arm 2100 feeling exhausted and unwell took bedtime Morphine went to sleep 2200 began to feel dizzy and actually ran into bedroom door when going to use bathroom.   8/30/2021 0200  woke up with terrible chills and body aches 0500 more muscle aches, pains and chills. temp of 103.2 F Took Tylenol and Morphine Fever would not go down with Tylenol.  Temp range between 103.2 and 103.7 until 11pm also felt body aches, chills, fatigue and dizzy all day. 2200 Tylenol finally got the fever down to 102.2.   08/31/2021 Checked temp multiple times during night.  Ranged between 102.2-102.8 all night.  0500 woke up in tears with body aches and exhaustion, chills.  temp at 102.4 More  Tylenol at 6AM  Feeling back muscle pain feels like squeezing around chest.  Really uncomfortable  6:45 temp 100.2. Took more tylenol at 11:30   1430 98.6  Still having a lot of joint aches, pains and fatigue
On 5/18/99, the pt experienced a faint facial macular rash that extended to entire body (except to the palms), diarrhea, and a low grade fever.